About

Florida Domestic Violence

This fulfills the continuing education requirement of Domestic Violence for the state of Florida.

Florida domestic violence is defined as violent or aggressive behavior occurring within the home and usually involves the abuse of a spouse or partner.  In the United States alone, it is estimated that more than 10 million adults have been subjected to domestic violence during the course of a year. This statistic translates to an incident of domestic violence occurring every 3 seconds.  Due to the increasing prevalence of domestic violence in society, there is a high probability that all healthcare professionals will evaluate and treat a victim (and quite possibly a perpetrator as well) of domestic violence at some time during their healthcare career.  The importance of ongoing education and global awareness cannot be understated.  

Introduction

Domestic violence is defined as violent or aggressive behavior occurring within the home and usually involves the abuse of a spouse or partner. In the United States alone, it is estimated that more than 10 million adults have been subjected to domestic violence during the course of a year. This statistic translates to an incident of domestic violence occurring every three seconds. The National Coalition Against Domestic Violence reports some daunting statistics [1][6]:  

• 1 in 3 women and 1 in 4 men have experienced some form of physical violence by an intimate partner.  
• 1 in 4 women and 1 in 7 men have been victims of severe physical violence (such as beating, burning, strangling) by an intimate partner in their lifetime.  
• On average, more than 20,000 phone calls placed to domestic violence hotlines nationwide.  
• The presence of a gun in a domestic violence situation increases the risk of homicide by 500%; 19% of domestic violence involves a weapon; Most intimate partner homicides are committed with firearms. 
• 1 in 15 children are exposed to intimate partner violence each year, and 90% of these children are eyewitnesses to this violence.  
• From 2016 through 2018, the number of intimate partner violence victimizations in the United States increased 42%.  

Due to the increasing prevalence of domestic violence in society, there is a high probability that all healthcare professionals will evaluate and treat a victim (and quite possibly a perpetrator as well) of domestic violence at some time during their healthcare career. The importance of ongoing education and global awareness cannot be understated.  

In 2020, the COVID-19 pandemics’ stay at home/shelter in place orders resulted in spikes in calls to domestic violence hotlines. From layoffs and loss of income to decreased availability of shelters and backlogged courtrooms, fewer resources were made available to victims of domestic violence. These measures resulted in increases in both the incidence and severity of domestic violence. Sadly, the effects of this pandemic, especially on this issue, continue well into today [2].

Forms of Domestic Violence  

Domestic violence may encompass physical abuse, sexual abuse, emotional and verbal abuse, and spiritual and economic abuse. Defined as a pattern of behavior used to gain power or control over an intimate partner, a domestic violence abuser may use tactics that frighten, intimidate, hurt, blame, or injure a person. These behaviors often escalate over time in intensity and have resulted, at times, in life-threatening injuries or death of a victim [3].  

Intimate partner violence (IPV) is abuse or aggression that occurs in a romantic relationship. The term “intimate partner” refers to both current and former spouses and dating partners, including heterosexual and same-sex couples. The Centers for Disease Control and Prevention (CDC) further delineates IPV into four separate groups: physical violence, sexual violence, stalking, and psychological aggression [4].  

• Physical violence may include hitting, kicking, and punching someone.
• Sexual violence may include using force to get a partner to partake in a sexual act.
• Stalking may include unwanted and threatening phone calls or text messages.
• Psychological aggression may include insults, threats, name-calling, or belittling a partner.  

Teen Dating Violence (TDV) is defined as dating violence affecting millions of teenagers annually [5]. In addition to the threats from physical and sexual violence and other forms of aggression, TDV is often done electronically through repeated texting and placing sexual pictures of a person online without permission.  

The CDC statistics on teen dating violence report:  

• Nearly 1 in 11 female and about 1 in 15 male high school students report having experienced physical dating violence in the last year. 
• About 1 in 9 female and 1 in 36 male high school students report having experienced sexual dating violence in the last year. 
• 26% of women and 15% of men who were victims of contact sexual violence, physical violence, and/or stalking by an intimate partner in their lifetime first experienced these or other forms of violence by that partner before age 18.  

Domestic violence transects every community and affects all people, regardless of age, socio-economic status, race, religion, gender, or nationality [6]. Whether the violence results in physical or psychological injury, the effects can last a lifetime and affect multiple generations.  

Healthcare professionals are in a pivotal position to impact the lives of those affected by domestic violence positively. Oftentimes, they may be the first person to encounter a victim of domestic violence. Their ability to effectively evaluate the situation and provide time-sensitive, patient-centered care (including but not limited to treatment interventions, appropriate referrals, and follow-up care) can enhance immediate victim safety and reduce further injury, and improve the home front circumstances, moving forward.  

Healthcare professionals must be able to identify and assess all patients for suspected abuse, and be able to offer treatment, counseling, education, and referrals, as appropriate. These referrals may extend out to shelter options, advocacy groups, child protection services and legal assistance [7].  

Profiles of Victims and Abusers  

Anyone can become a victim of domestic violence. Victims of domestic violence come from all walks of life, all age groups, all socio-economic groups, all religions, and all nationalities [8]. Violence can occur in any relationship when one person feels they are entitled to control another person through whatever means of abuse possible. This abuse is cyclical and usually increases in frequency and intensity. Victims of such violence report feelings of isolation, helplessness, guilt, anxiety, and embarrassment. They may become suicidal, start abusing drugs and alcohol, and feel that they have no one to turn to for help.  

Although there isn’t a specific set of factors that result in “being a victim,” there are many thoughts as to what might affect a person’s active willingness to remain in a violent relationship. The following lists serve only as general guidance to inform the healthcare professional of possible underlying causes. Again, anyone can become a victim of domestic violence.  

Victims of Domestic Abuse

There is no single “characteristic” or risk factor that automatically causes a person to become a victim of domestic violence. Instead, it may be a series of events that cause a person to become more vulnerable and enter and remain within an abusive relationship [9].  

Domestic violence victims may have experienced violence during childhood, experienced total financial dependence on another person, or lacked basic social support (family and friends). These factors affect both the physical and psychological make-up of a person. Without intervention, these victims can develop personal esteem and confidence issues, further social isolation, economic dependency, and general feelings of insecurity. These effects may negatively affect the decision to stay in an abusive relationship.  

Researchers have found the following factors may place a person at a higher risk of becoming a victim of domestic violence, including (but not limited to) [10]:  

• Poor self-image/ low self-esteem 
• Financial dependence on the abuser 
• Feeling powerless to stop the violence or leave the relationship 
• Personal belief that jealousy is an expression of love 

Common characteristics of victims of domestic violence include, but are not limited to:  

• A history of abuse  
• A history of alcohol or substance abuse (for themselves or their partners) 
• Financial and family stressors- low income, limited family/friends contact, poverty status 
• A member of an ethnic minority/ immigrant group; Limited English vocabulary 
• Holds traditional beliefs that they should be submissive in a relationship 

Reasons a victim may choose to stay in the relationship:  

• A desire to end the abuse but not necessarily the relationship; they do love their abuser  
• Feelings of isolation and helplessness  
• Fear of judgment if they reveal the abuse by seeking help 
• Feelings that they may not be able to support themselves if they leave their abuser 
• Fears for the safety of children involved in the relationship  
• Fear of backlash from community or family and friends/lack of knowledge of services available  
• Strong religious/cultural belief system that reinforces staying in a relationship at all costs  

Abusers/Perpetrators of Domestic Violence

As with the DV victim, there is no one set of traits to identify a domestic violence abuser/perpetrator correctly. There are, however, some signs that may raise the red flag of suspicion when observed in a suspected domestic violence case.  

The National Coalition on Domestic Abuse has created a list of “red flag” indicators, including but not limited to the following [11]:  

• Extreme jealousy and possessiveness  
• Verbally abusive  
• Extremely controlling behavior  
• Blaming the victim for anything bad that happens  
• Control over all the finances in the relationship  
• Demeaning the victim publicly or privately  
• Humiliating or embarrassing the victim in front of other people  
• Control over what the victim wears  
• Abuse of other family members, including children (and even pets)  

The following is a general list of indicators that “may” help identify an abuser [12].  

• History of abuse within one’s family  
• History of personal physical or sexual abuse  
• A lack of appropriate coping skills  
• Low self-esteem  
• Codependent behavior  
• Untreated mental illness  
• Drug or alcohol abuse
• Socio-economic pressures related to the lower income status
• Prior criminal history

Screening for Domestic Violence 

Screening rates are as low as 1.5% to 13% among emergency and primary care physicians. The Academy of Medicine recommendation suggested that all women should be screened for sexual violence. Research found that healthcare providers working in emergency departments only screened 20–25% of their encounters. As a result, this decreased opportunities for intervention, increased safety, and prevention of future violence [13].  

Domestic violence (including Intimate partner violence) is an unfortunate cycle that may not be broken with a single emergency department visit; however, identifying and providing resources is necessary to make a difference, increase confidence and safety, and improve the overall health outcome for patients.  

Initial Interaction 

Compassionate, nonjudgmental screening by healthcare professionals affords the best opportunity for domestic violence victims to disclose their abuse. By recognizing signs of abuse and inquiring further, the nurse validates that the victim is worthy of care and confirms that the violence is a legitimate concern [14].  

The screening for domestic abuse should be done in a private environment. Language interpreters, not family and friends, should be utilized if needed. Universal screening should be used; therefore, preventing any victim from being “singled out” and ensuring all potential victims are screened appropriately. All healthcare professionals should remain nonjudgmental and compassionate during the screening process [15].  

During the interview process, assure the victim that all patients are screened for domestic violence. Also, inform the victim that DV affects many families, and that services are available to everyone who may be concerned about violence in their home.  

Screening Tools 

Examples of the following four screening tools can be found in the CDC’s Intimate Partner Violence and Sexual Violence Victimization Assessment Instruments for Use in Healthcare Settings. 

Hurt, Insult, Threaten and Scream (HITS)   

5-question screening tool assessing physical and verbal interactions with the partner; scores rank 1 (never) -5 (frequently); a score of 10 is considered positive.  

1. Physically hurt you?  
2. Insult or talk down to you?  
3. Threaten you with harm?  
4. Scream or curse at you?  
5. Force you to do sexual acts that you are not comfortable with?  

http://www.ctcadv.org/files/4615/6657/9227/HPO_HITS_Screening_Tool_8.19.pdf   

Woman Abuse Screening Tool (WAST)  

8-question screening tool assessing physical, emotional, and sexual intimate partner violence.  

http://womanabuse.webcanvas.ca/documents/wast.pdf  

Partner Violence Screen (PVS)  

3-question screening tool for interpersonal violence  

1. Have you been hit, kicked, punched, or otherwise hurt by someone within the past year? If so, by whom?  
2. Do you feel safe in your current relationship?  
3. Is there a partner from a previous relationship who is making you feel unsafe now?  

http://www.nnepqin.org/wp-content/uploads/2018/08/Screening-Tools-Partner-Violence-Screen-PVS.pdf   

Abuse Assessment Screen (AAS)  

A multiple section assessment tool for sexual and physical violence, including body maps for documentation of injuries. 

https://idph.iowa.gov/Portals/1/Files/FamilyHealth/abuse_assessment_tool.pdf    

Potential Signs of Domestic Violence 

The Crisis Prevention Institute (CPI) encourages to always be aware of physical signs and injuries that could be related to domestic violence, including but not limited to the following [16]:  

• Bruising in the chest and abdomen  
• Multiple injuries  
• Minor lacerations  
• Ruptured eardrums  
• Delay in seeking medical attention  
• Patterns of repeated injury  
• Injuries inconsistent with the presenting complaints  

Oftentimes, a domestic violence victim may seek medical attention for issues unrelated to a physical injury, such as:  

• A stress-related illness  
• Anxiety, panic attacks, stress, and/or depression  
• Chronic headaches, asthma, vague aches, and pains  
• Abdominal pain, chronic pelvic pain
• Vaginal discharge and other gynecological problems
• Joint pain, muscle pain
• Suicide attempts, psychiatric illness   

Other observations that may indicate a suspected domestic violence situation include:  

• Appear nervous, ashamed, or evasive 
• Seem uncomfortable or anxious when around their partner 
• Accompanied by their partner, who controls the conversation  
• Reluctant to follow advice 

As you continue to assess the patient, encourage them to talk and then listen carefully. Only upon listening will you have a better understanding of the patient’s current state and provide the necessary resources and referrals for them to find safety. Above all else, maintain open lines of communication in a safe, accepting environment and assure the victim that they do not deserve the abuse.  

Importance of Trauma-Informed Care  

While nurses play a critical role in recognizing suspected domestic abuse victims, they often do not feel confident in their role or the screening process itself. This may be due to a lack of communication skills, ongoing training on domestic violence or simple confusion over what victim assistance programs and resources are available [17].  

Facility-wide education on domestic violence should be ongoing. Policies and procedures should be on file, and collateral relationships should be in place with the local community and national resources. Finally, nurses should be trained in the delivery of trauma-informed care to ensure the highest quality of interaction with victims of domestic violence, much less all victims of trauma.  

Trauma-informed care has been defined as the patient-centered approach that encourages healthcare professionals to provide care that does not retraumatize the patient and the staff [18]. Trauma-informed care ensures that policies and practices in the healthcare setting are not only safe but non-threatening to the physical and mental well-being of those involved. Perceived threats can cause a “flight or fright” mentality that impacts both the ability to administer care and receive immediate care and follow-up recommendations.  

The experience of seeking medical care, whether in an emergency department setting or a clinic, can in and of itself bring another source of trauma. Trauma-informed care aims at reducing the impact of trauma on both the patient and provider by focusing on various checkpoints overseeing all interactions: safety, trustworthiness, empowerment, and respect.  

The following examples are practical tips that encourage trauma-focused care, ensuring the delivery of care in the least threatening manner to a suspected human trafficking victim (as well as each patient you may intersect with).  

• Always introduce yourself and your role within the patient’s care with every interaction.  
• Use open body language (direct eye contact, avoid standing “over” the patient as it may be perceived as threatening).  
• Explain procedures and timelines for results (“wait times”) to give patients a sense of control. Keep them informed of any changes/delays in their care.  
• Always ask before you touch a patient. This is a sign of respect and gives the patient a sense of control over their own bodies.  
• Protect patient privacy. Ask them who they would like present during their care; limit visitors if requested; close room doors (with their permission).  

During the interview and intervention process, it is also equally important that some things not be said to a suspected victim of domestic violence, such as negating, challenging, or doubting the victim. Examples include:  

• Why haven’t you called the police before now?  
• Some level of fighting occurs in all relationships.  
• Maybe you’re both going through a phase; it will probably stop on its own.  
• You wouldn’t stay in this situation if you really care about yourself/ your kids.  
• What did you do to make them get so angry?  
• Why didn’t you leave the first time you were hurt?  

By applying trauma-informed care to all your patients, you lower the risk of perceiving any (nursing and medical) interventions being perceived as a threat. This ensures a higher level of trust and respect, and safety for all patients (and staff) across the care spectrum.

Legal Issues: Florida Mandatory Reporting Laws  

The United States Department of Justice, defines domestic violence to include felony or misdemeanor crimes of violence committed by [19]:  

• a current of former spouse or intimate partner of the victim,   
• by a person with whom the victim shares a child in common,  
• by a person cohabitating with or has cohabitated with the victim as a spouse or intimate partner,  
• by a person similarly situated to a spouse of the victim under the domestic or family violence laws of the jurisdiction receiving grant monies,  
• by any other person against an adult or youth protected from that person’s acts under the jurisdiction’s domestic or family violence laws.  

The Florida Department of Children and Families defines domestic violence as patterns of actions or behaviors that adults or adolescents use against their partners or former partners to establish power and control. It can potentially include physical abuse, sexual abuse, emotional abuse, and economic abuse. It may also include threats, isolation, pet abuse, using children, and a variety of other behaviors used to maintain fear, intimidation, and power over one’s partner (19).” [28]. 

Under Florida law [21], Domestic Battery is classified as a first-degree misdemeanor, with penalties including up to one year in jail or twelve months’ probation and a $1,000 fine [21][29][30]. In addition, the accused may face additional penalties of a mandated Batterer Intervention Program [31].  

RAINN (Rape, Abuse, and Incest National Network) is the nation’s largest anti-sexual violence organization [22]. Under the “Laws of your state” section, they outline the mandatory reporting laws for Floridaall states. Florida’s mandated reporting law can be viewed there or on the Florida Courts website. 

Mandatory Reporting Requirements on Children 

Children are defined as any unmarried person under the age of 18 years who has not been emancipated by court order.  

Who is required to report (from a healthcare professional standpoint):  

• Physicians 
• Osteopathics physicians 
• Medical examiners 
• Chiropractors
• Nurses
• Some hospital personnel
• Nursing Home and assisted living facility staff
• Health or mental health professionals
• Social workers
• Paramedics
• Emergency medical technicians 

When is a report required:  

• When any person knows or has cause to suspect that a child is abused, abandoned, or neglected by a parent, legal custodian, caregiver, or another person responsible for the child’s welfare, or that a child is in need of supervision and care and has no one to provide care.  
• When any person knows or has cause to suspect that a child is abused by an adult other than a parent, legal custodian, or another person responsible for the child’s welfare.  
• When any person knows or has cause to suspect that the child is a victim of childhood sexual abuse or the victim of a known or suspected juvenile sexual offender.  

Reports can be made to the Department of Children and Families abuse hotline at 1-800-96-ABUSE (1-800-962-2873) or at Florida DCF Reporter Portal.

Elements of a Safety Plan (Escape Plan)  

Abusers may go to extremes to prevent a victim from leaving. This may result in the decision to escape an abusive relationship – one of the most dangerous times for the victim of domestic violence. The creation of a safety plan can assist in enhancing the safety of a victim during all phases of a relationship and during the planning phase of actually leaving the abuser.  

Knowledge of the various elements of a safety plan will enable the healthcare professional to initiate dialogue with a victim and guide them in the development of a personalized plan of safety moving forward. Discussion of safety plans/escape plans can be very difficult during the limited interactions of an emergency room or clinic visit; therefore, familiarity with the key elements of a plan will help navigate the victim to the most appropriate resources for their situation.  

The following overviews of a safety plan are from Safe Horizon and the National Domestic Violence Hotline [23][24]. The Safe Horizon is a victim assistance nonprofit for victims of violence and abuse in New York City since 1978. The following outline provides a detailed overview of the many aspects to consider when formulating a safety plan. Review the entire plan outlined on their website Safe Horizon. Consider creating a template handout for your facility to distribute to domestic violence victims.  

A safety plan is an outline that includes ways to remain safe while in a relationship, planning to leave, or after you leave [23]. A personalized safety plan assists in coping with emotions, telling friends and family about the abuse, and the steps to be taken in the event of necessary legal action. An effective safety plan should have specific details tailored to your unique situation.  

Considerations in creating your safety plan:  

• Do you have a trusted confidant – a friend, family member, or neighbor?  
• What are some areas in your neighborhood you could go to in an emergency?  
• Are there phone numbers you need to memorize in the event of an emergency?  
• Do you have children that need to be part of your safety plan? Where would your children go if they witnessed violence?  
• Do you need a safety plan for work or school?  
• Where can you safely store your safety plan? Computer? Phone?  

Before Leaving  

The decision to leave an abusive relationship requires courage and preplanning. Consider these measures before leaving to reduce the risk of violence [23]:  

• Record evidence of physical abuse  
• Plan with children and identify a safe place where they can go during moments of crisis. Reassure them that their job is to stay safe, not to protect you.
• Call ahead to see what the shelter’s policies are. They can provide information on how they can help and secure a space when it is time to leave.
• Try to set money aside or ask trusted friends or family members to hold money for you.  

When Leaving  

The following list of items serves as a guide for what to take [23]:   

Identification 

• Driver’s license or state I.D. card, social security card  
• Birth certificate and children’s birth certificates  
• Money and/or credit cards   
• Checking and/or savings account books  

Legal papers  

• A protective order, if applicable  
• Health and life insurance papers  
• Legal documents, including divorce and custody papers 
• Marriage license  

Emergency numbers 

• Local domestic violence program or shelter  
• Trusted friends and family members  
• The Hotline  

Other items to keep in mind: 

• Medications and refills (if possible)  
• Emergency items, like food, bottles of water, and a first aid kit  
• Multiple changes of clothes   
• Emergency money  
• Address book  
• Safe cell phone, if possible  

After Leaving  

The safety plan should always include ways to ensure your continued safety after leaving an abusive relationship. Here are some precautions to consider [23]:  

• Change locks and phone numbers if possible.  
• If possible, change work hours and the typical route.  
• Alert school authorities of the situation.  
• If a protection order is present, keep a certified copy present at all times, and inform friends, neighbors, and employers that you have a protection order in effect.  
• Consider renting a post office box or using a trusted friend’s address for mail (remember that addresses are used for restraining orders and police reports) 
• Use different stores and frequent different social spots.  
• Alert neighbors and work colleagues about how and when to seek help.  

If comfortable, tell people who can take care of your children or transport them to/from school and activities. 

Again, these suggestions provide an extensive overview of an escape plan. They are meant to assist a victim in the required methodical preplanning of a safety plan that reduces the threat of violence. Not all sections will apply to every victim, but healthcare professionals should be comfortable in discussing any aspects of a safety plan specific to the individual victim. 

The Effects of COVID-19 on Domestic Violence  

As discussed at the beginning of this course, the COVID-19 pandemic has negatively affected domestic violence incidence. Stay at home /shelter in place orders, job losses, mounting financial concerns, and lack of available shelters in many areas became the norm. Domestic violence victims were met with further hurdles to their safety and well-being, as they found themselves sheltering in place with their abuser, along with fewer resources available to them in their time of crisis.  

Domestic violence hotlines prepared for an increase in calls. However, many organizations found the opposite occurring. Calls to hotlines dropped, in some places greater than 50 percent. Victims were not able to safely connect with necessary services [25].  

Due to the restrictions of movement (curfews, travel bans, 14-day quarantine advisories), not only was it more difficult to escape, but injury from abuse may have gone unnoticed by family and friends as face-to-face interactions had been sidelined. In addition to job losses and financial insecurities, this isolation may have forced a victim to become even more dependent on their abuser [26].  

In March 2020, U.S. police departments reported an increase in domestic violence calls as high as 27% after stay-at-home orders were implemented. The number of Google searches for family violence-related help during the outbreak had been substantial. This increase in domestic violence had not only affected the United States. In the United Kingdom, calls to the Domestic Violence Helpline increased by 25% in the first week after implementing lockdown measures. Furthermore, in China, domestic violence had reportedly increased three times in Hubei Province during the lockdown [27]. The importance of ongoing domestic violence education and awareness cannot be overstated.  

In review, healthcare staff often treat victims of domestic violence. Trauma-informed care that is patient-focused affords both the staff and patient (victim) the best outcome in terms of successfully navigating the challenges of domestic violence and mandatory reporting laws.  

Facility-wide protocols should be in place regarding all aspects of patient care for suspected victims of domestic violence, including national hotline numbers, community resources, scene safety protocols, and house-wide education. Staff should be regularly educated on interviewing techniques, suspected DV victim indicators, and ongoing community collateral relationships. Improved recognition of these victims and knowledge on how to proceed with specific treatment protocols will lead to a higher level of positive outcomes for domestic violence victims and other forms of abuse.  

Time is of the essence when dealing with victims of DV. There may be a small window of opportunity to help these victims when they come to your facility. There may be numerous needs identified quickly (transportation, housing, interpretation services, crisis intervention, case management, safety planning, transitional shelter, and protective orders, to name a few). Staff must feel confident in their abilities to identify possible victims, guide them through the process of seeking help, and advocate for their safety and well-being. Knowledge of their facility protocols and community, state, and national resources will afford them the opportunity to deliver optimal care.

Case Study  

Mary, 26 years old, presents to the emergency department with complaints of abdominal pain, vague body aches, and a headache. During the triage screening, Mary has minimal eye contact with the nurse and appears inadequately dressed for the cold weather, arriving in only jeans, a t-shirt, gym shoes, and a light sweater. While the nurse helps Mary change into a hospital gown in a private examination room, she notices various bruises on Mary’s lower back, arms, and legs, all varying size and color. Mary states she slipped and fell recently at home. You observe that Mary is now avoiding all eye contact, staring down at the ground. She keeps looking at the door, and wall clock, mumbling, “He can’t know I’m here.”  

• What are your initial thoughts about Mary’s physical appearance?  
• What can you do to make Mary feel more relaxed, comfortable, and safe during her emergency room visit?  

Mary lives with her boyfriend, Bill. He works part-time; she is currently unemployed. She admits to the occasional use of alcohol and recreational use of marijuana “to help me relax. My anxiety is very bad lately.”  She mentions that her anxiety has increased because “Bill’s hours at work have been cut due to COVID-19 and we’re strapped for money. He is under a lot of pressure.”  

On further examination and laboratory testing, including a pelvic examination, it is confirmed that Mary is approximately six weeks pregnant and has a suspected sexually transmitted infection. Mary bursts into tears and says, “He is going to kill me. We can’t afford a baby. What am I going to do?!”  

• What are your concerns about this scenario? How will you address these concerns with your patient Mary?  
• Why might healthcare professionals, in general, feel uncomfortable speaking with Mary?  
• What are the top priorities of Mary’s care at this time?  
• What information would you document in the patient record during this visit?  

Mary begins to feel comfortable speaking to you about her situation. She reluctantly tells you that Bill pushed her down the back stairs yesterday after an argument but quickly apologized afterward. On another occasion, Bill “beat me up” when he ran out of beer before payday. She states he has been really angry lately over his hours being cut at work and is looking for another job. “A baby now,” Mary confides, “would be a terrible thing for Bill, but I want it. It’s my first, and I want it. Please help me.” Mary gives consent for you to contact your department social worker for additional guidance but does not want law enforcement notified.  

• What other key staff members need to be part of the care team for Mary?  
• What local and national resources can you refer Mary to at this time?  
• How would your plan of care change if Mary did not give consent for the social worker to be notified?  

Mary wants to “go back home” tonight so as not to upset Bill when he returns later this evening. “It will be better this way.” She promises to leave him tomorrow and follow-up with the community referrals you gave her. Knowing that these plans may change, you advise Mary to create a safe escape plan “just in case.”  

• What items should be part of a safe escape plan?  
• How safe is it for Mary to return home?  
• What are your legal obligations to Mary regarding Florida’s mandatory reporting laws?  

As you are getting ready to leave at the end of your shift hours later, you see Mary arrive by ambulance. She is visibly injured with a broken nose and bloody lip. The emergency medical response team stated the neighbors called 911 when they heard Mary screaming in her apartment next door. No one else was in the apartment when they entered, and Mary would not tell them who injured her. You escort them to a private examination room. Mary sees you and yells, “He’s coming after me. Help me. He is going to kill me.”  

• What are your top priorities for Mary and the staff at this time?  
• What other hospital departments need to be notified?  

Mary’s boyfriend shows up, intoxicated, at the triage window, demanding to see Mary. He threatens to kick in the door to the main examination room if he cannot see Mary immediately. He is pacing back and forth in the triage area and refuses to sit down.  

• What additional security measures need to be in place upon the boyfriend’s arrival?  

Mary’s boyfriend is removed from the premises by local law enforcement. Mary is given the national hotline number and is contacting the local shelter at this time. Upon discharge, she is escorted by security personnel to the exit and leaves the facility with a shelter representative.

Florida-Specific Domestic Violence Resources 

Community Legal Services of Mid-Florida  

A full service civil legal aid law firm that promotes equal access to justice, providing professional legal aid on domestic violence to help low-income people protect their health, and their families.  

https://www.clsmf.org/violence-protection/ 

Coast to Coast Legal Aid of South Florida  

The Family Law Unit primarily focuses on representing victims of domestic violence in family law matters, such as obtaining an injunction (restraining order), dissolution of marriage cases (divorce), and custody litigation.  

https://www.coasttocoastlegalaid.org/   

Domestic Shelters.org  

Overview of 58 Florida based organizations offering domestic violence services in 47 different cities.  

https://www.domesticshelters.org/help/fl.florida 

Florida Department of Children and Families  

Florida Family Policy Council  

Resources to assist victims (and family members) to find help, safe shelter, legal aid, transitional services, and counseling.  

https://www.flfamily.org/get-help/domestic-violence   

Florida Department of Children and Families: 

Child Protective Services:  

https://www.myflfamilies.com/service-programs/abuse-hotline/  

Florida Abuse Hotline:  

The Florida Abuse Hotline accepts reports 24 hours a day and 7 days a week of known or suspected child abuse, neglect, or abandonment and reports of known or suspected abuse, neglect, or exploitation of a vulnerable adult.  

1-800-96-ABUSE (1-800-962-2873)  

TTY: 1-800-955-8771  

https://reportabuse.dcf.state.fl.us/  

MyFlFamilies.com  

These services include emergency shelter, counseling, safety planning, case management, child assessments, information, and much more.  

These shelters may be viewed on the MyFlFamilies.com website. Healthcare professionals should be familiar with shelters available in their surrounding area.  

Domestic Violence Hotline: 1-800-500-1119  

https://www.myflfamilies.com/   

Harbor House of Central Florida  

Offering housing placements service, legal aid, safety planning, support groups, and crisis intervention.  

(407) 886-2856  

https://www.harborhousefl.com/get-help/safety/  

The 15th Judicial Circuit of Florida Batterers Intervention Program (BIP)  

The Florida BIP is a 6-month intensive program to address root causes of domestic violence; it is at least 26 weeks of group counseling sessions. A list of statewide providers is available on this site.  

https://www.15thcircuit.com/program-page/bip   

The Salvation Army  

Offering emergency and transitional housing, as well as counseling and rehabilitation services.  

https://salvationarmyflorida.org/domestic-violence-program/ 

National Domestic Violence Resources 

Amend, Inc.  

AMEND is a nonprofit organization working to end domestic violence by providing counseling to men who have been abusive, advocacy and support to their partners and children, and education to the community. Based in Colorado. 

http://www.amendinc.org/ 

Emerge  

Emerge is a Massachusetts Certified Batterer Intervention Program & Training Site, offering abuser education groups and batterer intervention. Based in Massachusetts. 

617-547-9879   

https://www.emergedv.com/  

National Domestic Violence Hotline  

1-800-799-SAFE (7233)  

https://www.thehotline.org/  

Domestic Violence Prevention, Inc   

501C3 nonprofit offering education, counseling, and support services to domestic violence clients in multiple counties in Texas and Arkansas.  

903-793-HELP (4357)  

https://www.dvptxk.org/   

National Center on Domestic Violence, Trauma and Mental Health  

Offering direct website links to multiple national organizations working with domestic violence cases. 

http://www.nationalcenterdvtraumamh.org/resources/national-domestic-violence-organizations/ 

National Network to End Domestic Violence  

Offers a range of programs and initiatives to address the complex causes and far-reaching consequences of domestic violence.  

https://nnedv.org/   

New York Model for Batterer Programs National Organization for Men Against Sexism (NOMAS) Model for DV Offender Accountability 

Court-ordered program for batterer education, which includes a court-imposed consequence if the offender does not attend. Based in New York. Formerly known as the New York Model for Batterer Programs. 

845-842-9125 

https://www.nymbp.org/ https://nomas.org/ 

Women’s Law  

Providing state-specific legal information and resources for survivors of domestic violence.  

https://www.womenslaw.org/ 

Conclusion

Domestic violence is a national crisis that can lead to poor outcomes for victims. Nurses have the responsibility to ensure that victims are properly screened, provided appropriate education, and supported with resources for safety. Creating a safe space for victims to share concerns, helping them to create escape plans, and respecting their decision to stay or leave the relationship is all a part of providing the best care possible. 

Florida HIV/AIDS

This fulfills the continuing education requirement of Florida HIV/AIDS for the state of Florida.  

An estimated 1.2 million Americans are living with HIV. As many as 1 in 7 of them do not even know they are infected. The others utilize the healthcare system in a variety of ways, from testing and treatment regimens to hospitalizations for symptoms and opportunistic infections. Healthcare professionals in nearly every setting have the potential to encounter patients with HIV as the disease can affect patients of any age or stage of life (4). Proper understanding of HIV is important in order to provide high-quality and holistic care to these patients. For nurses practicing in the state of Florida, it is also important to understand the laws, statutes, and regulations regarding testing, treatment, reporting, and confidentiality related to Florida HIV and AIDS within the state.  

Introduction   

An estimated 1.2 million Americans are living with human immunodeficiency virus (HIV). As many as 1 in 8 do not even know they are infected (7). The others utilize the healthcare system in a variety of ways, from testing and treatment regimens to hospitalizations for symptoms and opportunistic infections.

Healthcare professionals in nearly every setting have the potential to encounter patients with HIV as the disease can affect patients of any age or stage of life. Proper understanding of HIV is important in order to provide high-quality and holistic care to these patients. For nurses practicing in the state of Florida, it is also important to understand the laws, statutes, and regulations regarding testing, treatment, reporting, and confidentiality related to HIV and AIDS within the state.  

Statistics 

Rates of infection are not equal across demographic groups, and certain factors may increase a person's risk. Patient information to consider when determining someone's risk includes:   

Age 

As of 2021, the age group with the highest incidence of new HIV diagnoses is 13-34 years, approximately 58% of new infections (7). Cases are down 18% in this age group from 2017.  

Race/Ethnicity 

African Americans had the highest number of new HIV cases in 2021, at approximately 40% (7). This is followed by Hispanic/Latinos at 29%, and whites at 26%.  

Gender 

Males are disproportionately affected by HIV, accounting for 81% of new cases in 2021 (7). Females accounted for 24% of new cases. This data refers to the sex of someone at birth. When looking at the transgender population, those who have transitioned male-to-female were 2% of new cases and female-to-male, less than 1% (7). 

Sexual Orientation 

Men who have sex with men (MSM) remain the population most at risk of HIV, accounting for around 70% of all new infections in 2021 (7). Cases are down 13.5% in this group from 2017.  

Location 

Different areas of the country are affected at different rates for a variety of factors, including population density, racial distribution, and access to healthcare. The southern states are unmistakably more affected than other regions, and accounted for 52% of new cases in 2021 (7). Western states account for 21%, Midwest 14%, and Northeast 14% (7). 

Transmission 

Perhaps the most elusive part of this virus for many years was how it spreads. We now know that HIV is spread only through certain bodily fluids. An accurate understanding of HIV transmission is important for healthcare professionals to provide proper education to their patients, reduce misconceptions and stigmas, and prevent transmission and protect themselves and other patients (8).  

Bodily Fluids 

Bodily fluids that can transmit the virus include (9):   

• Blood 
• Semen and pre-seminal fluid  
• Rectal fluid  
• Vaginal fluid  
• Breastmilk  
• Fluids that may contain blood such as amniotic fluid, pleural fluid, pericardial fluid, and cerebrospinal fluid   

If one of these fluids comes into contact with a mucous membrane such as the mouth, vagina, rectum, etc., or damaged tissue such as open wounds, or is directly injected into the bloodstream, then transmission of HIV is possible (8).  

Ways of Transmission 

Scenarios where transmission is possible include:   

• Vaginal or anal sex with someone who has HIV (condoms and appropriate treatment with antivirals reduce this risk)  
• Sharing needles or syringes with someone who has HIV  
• Mother-to-child transmission during pregnancy, delivery, or breastfeeding (appropriate treatment during pregnancy, c-section delivery, and alternative feeding methods reduce this risk)  
• Receiving a transfusion of infected blood or blood products (this is very rare now because of screening processes for blood donations)  
• Oral sex with someone who has HIV (though this is very rare)  
• A healthcare worker receiving a sharps injury with a dirty needle (risk of transmission is very low in this scenario)  

HIV cannot be transmitted via:   

• Saliva  
• Sputum  
• Feces  
• Urine  
• Vomit  
• Sweat  
• Mucous   
• Kissing  
• Sharing food or drink  
• Ticks or mosquitos 

Reducing Transmission & Infection Control 

Patient education about risk and protection against HIV, testing, and what to do if exposed should be standard practice for healthcare professionals in nearly all healthcare settings. Ideally, primary care should include risk screenings and routine patient education to help prevent infections from occurring (or preventing worsening of infections that have already occurred) (8).  

Prevention Strategies 

Strategies to help prevent the spread of HIV include (8): 

• Identifying those most at risk, particularly MSM, minorities, and those who use drugs by injection  
• Ensure patients are aware of and have access to protective measures such as condoms and clean needle exchange programs  
• Provide routine screening blood work for anyone with risk factors or desiring testing  
• Providing access to PrEP medications where indicated (discussed further below)  
• Staying up to date on current recommendations by the U.S. Centers for Disease Control and Prevention (CDC), and HIV developments  
• Maintaining a nonjudgmental demeanor when discussing HIV with patients, to welcome open discussion   

Pre-Exposure Prophylaxis 

For patients with a repeated or frequent high risk of HIV exposure, such as those with an HIV+ partner or those routinely using needles for drugs, pre-exposure prophylaxis (PrEP) may be a good choice to reduce the risk of contracting the virus. When used correctly, PrEP is 99% effective at preventing infection from high-risk sexual activity and 74% effective at preventing infection from injectable drug use (10).  

Depending on the type of exposure risk (anal sex, vaginal sex, needle sharing, etc.), PrEP needs to be taken anywhere from 7-21 days before it reaches its maximum effectiveness (10). Most insurances, including Medicaid programs, cover PrEP at least in part (10). There are also federal and state assistance programs available to make PrEP available to as many people who need it as possible. Some side effects are commonly reported, primarily gastrointestinal symptoms, headaches, and fatigue (10).   

Viral Load 

For those who have a confirmed diagnosis of HIV/AIDS, the focus should be promoting interventions that will prevent further transmission. One of the biggest determinants for transmission is the infected person's viral load. Individuals being treated for HIV can have their viral load measured to ensure viral replication is being controlled as intended. A viral load lower than 200 copies of HIV per milliliter of blood is considered undetectable, meaning the virus is not transmissible to others (4). Even for those not receiving treatment, there are methods to reduce transmission (11).  

Infection Control Methods 

Methods of infection control for healthcare professionals include (3):  

• Universal precautions when handling any bodily fluids  
• Eyewear when at risk for fluid splashing  
• Careful and proper handling of sharps  
• Facilities having a standard plan in place for potential exposures  

If an exposure or needlestick does occur, the patient would ideally submit to testing for HIV to determine if the staff member is at risk. If the HIV status of the patient is unknown or confirmed to be positive, post-exposure prophylaxis (PEP) may be advised to start within 72 hours of exposure (12).   

Florida HIV/AIDS Treatment

When HIV is appropriately treated, advancement from HIV to AIDS can be significantly reduced, and quality and longevity of life maximized. In 2018, the CDC estimated around 65% of all US citizens living with HIV were virally suppressed, and 85% of those receiving regular HIV-related care were considered virally suppressed at their last test (5). However, as mentioned earlier, an estimated 13% of all HIV cases do not know they are infected. Appropriate medical care and keeping viral loads undetectable is one of the single most effective methods of preventing transmission (4, 5).   

For those receiving treatment, a multifaceted and individualized approach can reduce a person's viral load, reduce the risk of transmission, reduce the likelihood of developing AIDS, and preserve the immune system. Regardless of how early someone receives treatment, there is no cure for HIV, and an infected person will be infected for life. All individuals diagnosed with HIV (even asymptomatic people, infants, and children) should receive antiretroviral therapy or ART as quickly as possible after a diagnosis of HIV is made. The classes and available medications for ART include the following (1). There are many other combination formula HIV medications, for example emtricitabine/tenofovir (brand name, Truvada), although not listed here.  

Nucleoside Reverse Transcriptase Inhibitors (NRTIs) 

Nucleoside reverse transcriptase inhibitors (NRTIs) inhibit the transcription of viral RNA to DNA blocking reverse transcriptase (an enzyme needed for HIV replication). 

• Abacavir 
• Emtricitabine  
• Lamivudine 
• Tenofovir disoproxil fumerate  
• Zidovudine  

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) inhibit the transcription of viral RNA to DNA by binding to and altering reverse transcriptase. As mentioned above, transcriptase is an enzyme HIV needs to make copies of itself. 

• Doravirine 
• Efavirenz 
• Etravirine  
• Nevirapine 
• Rilpivirine 

Protease Inhibitors 

Protease inhibitors block HIV protease (another enzyme needed for HIV replication). 

• Atazanavir 
• Darunavir  

• Fosamprenavir  
• Ritonavir  
• Saquinavir  
• Tipranavir  

Fusion Inhibitors 

Fusion inhibitors prevent the virus from entering the CD4-T lymphocyte cells (CD4 cells) of the immune system.  

• Enfuvirtide  

Integrase Strand Transfer Inhibitors (INSTIs)  

Integrase strand transfer inhibitors (INSTIs) block HIV integrase (an enzyme needed for HIV replication).  

• Cabotegrevir 
• Dolutegravir 
• Raltegravir 

Attachment Inhibitors 

Attachment inhibitors prevent HIV from entering CD4 cells by binding to the gp120 protein on the surface of the virus’ cell. 

• Fostemsavir 

Post Attachment Inhibitors 

Post attachment inhibitors prevent the virus from binding to and entering CD4 cells by block the CD4 receptors on the surface of some immune cells. HIV needs these receptors to enter the cells. 

• Ibalizumab-uiyk 

Capsid Inhibitors 

Capsid inhibitors interfere with the HIV capsid (a protein shell that protects the enzymes HIV needs for replication). 

• Lenacapavir 

Pharmacokinetic Enhancers 

Pharmacokinetic enhancers increase the effectiveness of HIV medications. 

• Cobicistat 

Florida HIV/AIDS Laws

The Omnibus AIDS Act is based on the premise that illness can be best controlled through public knowledge. If the public is aware of potential illness, and ways to avoid contracting and transmitting illness, that is the best method of prevention and further spread (2). The state of Florida became one of the first states with high rates of HIV infection within their population to enact legislation surrounding the AIDS epidemic. Transmission of HIV, as aforementioned, occurs through direct contact with virus-containing body fluids. Activities by which transmission involves such as sexual activity, needle stick, blood transfusion, or mother-to-baby, the government cannot regulate. Therefore, the governmental response to a disease epidemic must rely primarily upon the education of the public and its cooperation with their educational efforts and recommendations (2).  

Informed Consent 

The following are regulations surrounding informed consent and HIV testing in the state of Florida (2). 

Information Requirements 

Healthcare providers performing HIV tests must have advanced procedures in place regarding patient consent, testing samples, and informing patients of their results (2). “Since the 1998 amendments to the Act, health care providers must, as a matter of law, convey three pieces of information, all essentially involving the choice of a testing site, as part of the process of obtaining informed consent:  

1. Disclose that the provider is required by law to report the test subject’s name to the local county health department if the HIV test results are positive; 

1. Alert the patient that as an alternative, the patient may secure the HIV test at a site that tests anonymously, the locations of which the provider must make available; and 

1. Relate the extent of the confidentiality rights that adhere to the test results in the provider's patient records.” 

Minors 

“The general rule that parental consent is required prior to medical diagnosis or treatment of a minor does not apply when sexually transmitted diseases such as HIV infection are involved. Indeed, Florida specifically forbids telling parents the fact of the minor's consultation, examination or treatment for a sexually transmissible disease, such as HIV infection, either directly or indirectly (such as by billing a parent or their insurer for an HIV test without the child's permission).” 

“Infants and young children are treated as unable to make an informed decision and consent of their parents or legal guardian is required. For older children (such as teenagers), however, the provider must make an individual judgment whether the child, as phrased in Department of Health rules, ‘demonstrates sufficient knowledge and maturity to make an informed judgment,’ meaning, whether the child has the cognitive and emotional capacity to understand the risks and benefits of the test or treatment to which the child is being asked to consent.” 

Documentation 

“As with other medical procedures requiring informed consent, informed consent for HIV testing does not necessarily mean written consent. Except for donations of blood and other tissues and to obtain health or life insurance, Florida does not require providers to have the test subject sign a document authorizing the test. The health care provider need only enter a note in the medical record that the test was explained and consent was obtained.” 

Exceptions 

Exceptions to informed consent requirements by health care providers (2): 

Pregnancy 

“Following federal legislation and recommendations from CDC, Florida law in 1996 first imposed “mandatory offering” of HIV tests for all pregnancies upon presentation. In 2005, the statute was further amended to establish the present system of “opt out” testing, in which pregnant women are advised that the health care provider attending them will conduct an HIV test but that they have the right to refuse. The pregnant woman’s objection is required in writing, which must be placed in her medical record” (§384.31, F.S.)  

Emergencies 

“A provider may test without consent in "bona fide medical emergencies," but only if the provider documents in the medical record that the test results are medically necessary to provide appropriate emergency care or treatment to the test subject and the test subject is unable to consent” (§381.004(2)(h)3, F.S.).  

Therapeutic Privilege 

“The Act allows a "therapeutic privilege" that bypasses informed consent requirements when the provider's medical record documents that obtaining informed consent would be detrimental to the health of a patient suffering from an acute illness and that the test results are necessary for medical diagnostic purposes to provide appropriate care or treatment to the patient. This same privilege applies to all medical procedures for which informed consent is required. The statute emphasizes that this provision provides no basis for routinely testing patients for HIV without their informed consent” (§381.004(2)(h)4, F.S.).  

Sexually Transmissible Diseases 

“State laws permit HIV testing for sexually transmissible diseases on certain subjects, such as convicted prostitutes (§796.08, F.S.), inmates prior to release (§945.355, F.S.), and cadavers over which a medical examiner has asserted authority §381.004(2)(h)1.c., without the consent of the test subject. This exception includes exempting pregnancy “opt out” testing from informed consent requirements discussed above.”  

Criminal Acts 

“Victims of criminal offenses that involve transmission of body fluids may require the person charged with or convicted of the offenses to be tested for HIV infection by requesting a court to order the test” (§960.003(2), F.S.). “Similarly, when a defendant, prosecuted for certain offenses in which transmission might have occurred, has been ordered to or has voluntarily given a blood sample, the victim may request the sample be tested for evidence of HIV without the consent of the defendant” (§381.004(2)(h)6, F.S.).  

Organ and Tissue Donations 

“Various statutory provisions permit testing without informed consent in specifically identified specialty areas: certain blood and tissue donations; corneal removals and eye enucleation that Florida allows by law to be done without consent; autopsies to which consent to perform the autopsy was obtained” (§§381.004(2)(h)2, 5 and 9, F.S.).  

Research 

“Established epidemiologic research methods that ensure test subject anonymity is expected from informed consent” (§381.004(3)(h)8, FS) 

Abandoned Infants 

“When a licensed physician determines that it is medically indicated that a hospitalized infant have an HIV test, but the infant's parent(s) or legal guardian cannot be located after reasonable attempts, the test may be performed without consent. The reason why consent could not be obtained must be documented in the medical record and the test result must be provided to the parent(s) or guardian once they are located” (§381.004(2)(h)13, F.S.).  

Significant Exposure 

“The blood of the source of significant exposure to medical personnel or to others who render emergency medical assistance may be tested without informed consent” (§381.004(3)(h)10-12, FS).  

Repeat HIV Testing 

“Renewed consents are not required for repeat HIV testing either to monitor the clinical progress of a previously diagnosed HIV-positive patient or for conversion from a significant exposure” (§§381.004(2)(h)14 and 15, F.S.). 

Judicial Authority 

“A court may order an HIV test to be performed without the individual's consent” (§381.004(3)(h)7, FS). 

Florida HIV/AIDS Confidentiality

The following are regulations surrounding confidentiality of HIV testing in the state of Florida (2). 

Not every piece of medical information about a person who has been tested for HIV or assessed for AIDS is protected. “Only the fact that an HIV test was performed on an identifiable individual and any ‘HIV test result’ (negative as well as positive) are specially protected” (§381.004(2)(e), F.S.).  

The statute definitions (11): 

• HIV test: “test ordered after July 6, 1988, to determine the presence of the antibody or antigen to human immunodeficiency virus or the presence of human immunodeficiency virus infection” (§§381.004(1)(b), F.S.) 
• HIV test result: “laboratory report of a human immunodeficiency virus test result entered into a medical record on or after July 6, 1988, or any report or notation in a medical record of a laboratory report of a human immunodeficiency virus test” (§§381.004(1)(c), F.S.) 

“Only a laboratory report of an HIV test result entered in a medical record on or after July 6, 1988 (the effective date of the Omnibus AIDS Act), or any report or notation in a medical record of a laboratory report of an HIV test, falls within their scope.” 

“Explicitly excluded from the definition of an HIV test result are reports from patients of their HIV status to health care providers. Consequently, patient reports of their HIV test status from Department of Health anonymous testing sites, from home access HIV test kits or from any other sources do not constitute ‘HIV test results’ unless separately confirmed by the provider through a laboratory report or a medical record containing a laboratory report. Patient disclosures of an HIV test or infection to persons other than health care providers caring for the patient under the provisions of the Act also do not fall within the statute's special confidentiality protections.” 

Voluntary Partner Notification

The following are regulations surrounding voluntary partner notification of HIV exposure in the state of Florida (2). 

“The person ordering the HIV test (or that person’s designee), although under no liability exposure to the sexual or needle-sharing partners of their HIV-positive patients, is required to advise their patients with HIV-positive test results of the importance of notifying partners who may have been exposed” (§381.004(2)(c), F.S.). Practitioners are well advised also to tell the patient of the availability of voluntary partner notification services provided by the Department of Health. Under the authority provided in §384.26, F.S., county health department staff offers voluntary and confidential partner notification and referral services to persons infected with HIV. When notifying partners, county health department staff are required not to reveal the identity of the original client.” 

Florida HIV/AIDS Infection Reporting 

The following are regulations surrounding HIV infection reporting in the state of Florida (2). 

“In 1996, Florida became one of the first states with a high incidence of AIDS to authorize regulatory procedures requiring physicians and laboratories to report to local health authorities HIV-positive test results with patient identifiers” (§384.25, F.S.). “Practitioners and clinical laboratories that fail to report HIV-positive test results are subject to a $500 fine and disciplinary action by their licensing boards” (§384.25(4), F.S.).  

“This change was spurred in part by the Ryan White CARE Act. Enacted in 1990 and reauthorized in 2009 as the Ryan White HIV/AIDS Treatment Extension Act, this federal legislation now provides funding to urban areas, states and localities to improve the availability of care for low-income, uninsured and under-insured AIDS and HIV-infected patients and their families.”  

“Florida’s HIV infection-reporting requirements increases available Ryan White funding for persons with the illness and enables the Department of Health to link them to medical and support services earlier in the process of infection.” Under the rules by the Department of Health of Florida:  

1. “Practitioners must report to their local county health department within two weeks of the HIV-positive diagnosis of all persons, EXCEPT infants born to HIV-positive women, which must be reported the next business day” (Rule 64D-3.029, FAC and Rule 64D-3.030(5), FAC). 

1. “Clinical laboratories must report to the local health department HIV test results from blood specimens within three days of diagnosis” (Rule 64D-3.029, FAC).  

Florida Laws and Regulations

The following course content

Introduction

The state of Florida has several statutes that govern the practice of nurses. These statutes consist of Chapters 456 and 464 in Title XXXII Regulation of Professions and Occupations. The Florida Administrative Code is where Division 64B9 is located.  

Chapter 464, often called the Nurse Practice Act, is separated into two parts. Part I discusses the advanced practiced registered nurse, registered nurse, and licensed practical nurse. This statute ensures that every nurse practicing in Florida is held to and meets the same minimum standards for safe practice.

Because of this, nurses who do not meet the minimum requirements or display harm to society are not allowed to practice nursing in the state of Florida. The Board of Nursing is the governing body for the Nurse Practice Act and deals with matters such as providing licensure, creating rules, and managing disciplinary actions. Part II of chapter 464 focuses on the certified nursing assistant.  

Chapter 456 is a statute directed at all healthcare providers and professions. This statute lists the provisions that Chapter 464 is built on.  

Division 64B9 is part of the Florida Administrative Code that provides specific rules that pertain to nurses and how the profession is regulated in terms of eligibility to take the examination of selected practice, set standards for nursing education curriculum and institutions, continuing education requirements, license renewal; rules for impairment of the nurse in the workplace and more.  

This course is designed to meet the requirements of Division 64B9-5 as it pertains to two continuing educational hours about Florida’s laws and regulations of nursing practice.  

Definitions (3, 4, 5) 

Advanced or specialized nursing practice — completion of post-basic specialized training, experience, and education that are appropriately performed by an advanced practice registered nurse. The advanced-level nurse can “perform acts of medical diagnosis and treatment, prescription, and operation” under the authorization of a protocol with the supervision of a physician. 

Advanced practice registered nurse (APRN) — any individual who is licensed in this state to practice professional nursing as defined above and holds a license in advanced nursing practice, including:  

• Certified Nurse Midwives (CNM or nurse midwife)
  • Able to perform superficial or minor surgical procedures as defined by a protocol and approved by the employing medical facility or with a backup physician in the case of a home birth. 
  • Start and perform approved anesthetic procedures. 
  • Order appropriate medications based on patient and condition. 
  • Manage care of the normal obstetrics patient and the newborn patient.  
• Certified Nurse Practitioners (CNP) 
  • Able to manage some medical issues guided by facility or supervising provider protocols.  
  • Manage and monitor patients who have stable, chronic illnesses. 
  • Start, monitor, and adjust therapies for select, uncomplicated illnesses.  
  • Order occupational and physical therapy based on patient needs. 
• Certified Registered Nurse Anesthetists (CRNA) 
  • Able to order pre-anesthetic medications as stated and approved by facility protocols and staff. 
  • Determine and consult with the supervising anesthesiologist about the proper anesthesia for patients based on labs, history, and physical and patient conditions. 
  • Assist with managing the patient in the post-anesthesia care unit. 
• Clinical Nurse Specialists (CNS) 
  • A nurse prepared in a CNS-focused program that meets the requirements of a typical APRN program. Additionally, they are trained in the area of expertise that pertains to the advanced practice of nurses. 
• Psychiatric Nurse 
  • Has a master’s or doctoral degree in psychiatric nursing and has a national advanced practice certification as a psychiatric mental health advanced practice nurse. 
  • has two years of post-master's clinical experience under the supervision of a physician. 
  • They can prescribe psychotropic controlled substances for the treatment of mental health disorders. 

Board — the Board of Nursing. 

Licensed Practical Nurse (LPN) — any person licensed in this state or holding an active multistate license under s. 464.0095 to practice practical nursing as defined below. 

Practice of practical nursing — the performance of select actions, including the management of specific treatments and medications, while taking care of the ill, injured, or infirm; prevention of illness, promotion of wellness, and health maintenance in others under the direction of a registered nurse, or a licensed provider: physician, osteopathic physician, podiatric physician, or dentist; and the teaching of general health principles and wellness to the public and students other than nursing students. A practical nurse is responsible and accountable for making decisions based on their educational preparation and experience in the profession. 

Practice of professional nursing — the performance of actions requiring substantial specialized knowledge, judgment, and nursing skill based on applied principles of physical, psychological, social, and biological sciences, which shall include, but are not limited to: 

• The nursing process consists of assessment, nursing diagnosis, planning, intervention, and evaluation of care; teaching and counseling of the ill, injured, or infirm in matters of health; prevention of illness, promotion of wellness, and maintenance of the health of others. 
• The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner as they are authorized to do so by the laws of this state to prescribe such medications and treatments. 
• The management and education of other individuals, such as nursing students, in the theory and performance of any of the acts described above. 

A professional nurse is responsible and accountable for making decisions based on the individual's educational preparation and experience. 

Registered nurse (RN) — means any person licensed in this state or holding an active multistate license under s. 464.0095 to practice professional nursing as defined above.  

A registered nurse first assistant (RNFA) — is a registered nurse who assists in surgery while in the hospital setting under a physician. They help maintain cost-effective and quality surgery for patients in Florida. They must be certified in perioperative nursing via a core curriculum approved by the Association of Operating Room Nurses, Inc. 

Board of Nursing: Members and Headquarters Location 

Florida’s Board of Nursing has 13 unique members that Florida's governor appoints. To maintain diversity and representation of the entire nursing profession, the following criteria must be met (5): 

• Seven members must be RNs with a minimum of four years of experience in practice.  
  • One must be an APRN 
  • One must be a nurse educator 
  • One must be a nurse executive 
• Three members must be LPNs with a minimum of four years of experience in practice.  
• The final three members have no connection to the nursing profession or affiliation or contract with a healthcare agency. 
• One member must be over the age of 60 
• All members must be residents of the state of Florida 

Membership terms last for four years; however, if the governor does not have a successor to appoint, the members can serve for another four years. The Board of Nursing's headquarters is in Tallahassee per Florida statute (5). 

The members of the Board have several roles and responsibilities while serving. Their primary job is to ensure that nurses practicing in Florida are doing so safely. To do this, the Board members can create and implement rules or provisions to add to the Nurse Practice Act.

They can approve educational programs for institutions wishing to teach nursing. They can take disciplinary action against a nurse for violating the Nurse Practice Act or other Florida laws. Disciplinary actions can consist of citations, fines, or disciplinary guidelines based on the nurse in question, previous offenses, and the severity of the violation. (5).  

Licensure by Examination and Endorsement 

Initial licensure requires an individual to examine their desired profession: NCLEX-RN, NCLEX-LPN, and either the American Nurses Credentialing Center (ANCC) or the American Association of Nurse Practitioners (AANP) version for those wishing to become an APRN. In order for the Board of Nursing to approve an individual to sit for their desired examination, a list of requirements must be met in total (5):  

• You must correctly complete an application for the desired examination and submit a fee set by the Board.  
• Submit to a background check conducted by the Department of Law Enforcement. 
• Must be in good physical and mental health and receive a high school diploma or equivalent. 
• Has completed the following requirements: 
  • Graduate from an approved program on or after July 1, 2009, OR 
  • Graduate from a prelicensure nursing education program that has been determined to be equivalent to an approved program by the Board before July 1, 2009 
• Must have the ability to communicate effectively in English as determined by the Department of Health through another examination as indicated. 

It is important to note that there is a section dedicated to the scenario of an individual failing the examination or needing to take it within six months of graduating.  

Candidates can take the test up to three times if they fail it. Suppose an individual needs to pass their examination of choice after three attempts. In that case, they must take a Board-approved remediation course before they can sit for the examination again. From there, they are given three more chances to take and pass the test before they must remediate again. Reexamination must occur within six months of the approved remediation course (5).  

If an individual fails to take their examination within six months of graduation, they must take an exam preparation course approved by the Board. It is to be advised that the individual must pay for the course without using federal or state financial aid (5).  

Courses completed in a professional nursing education program that are at least equivalent to a practical nursing education program may be used to satisfy the education requirements for licensure as a licensed practical nurse. This means a registered nursing program student could take the licensure for an LPN license once the courses they have taken meet the LPN licensure requirements (5). 

If a nurse holds licensure in another state or US territory and decides to obtain Florida licensure, theycan do so through endorsement. Florida requires those who apply to submit a nonrefundable fee, complete the application, and provide fingerprints for a criminal background check. The Florida Board of Nursing will not issue a license to an individual under investigation when applying (5).  

Military Spouses 

Applying for a license through endorsement is a route that can be used for nurses who are traveling with military spouses on official military orders. Nurses must have actively practiced nursing for two of the three years before applying for a license. Military spouses also have the option of obtaining a 12-month temporary Florida license if they meet the requirements (4):  

• Holds a valid nursing license in another state 
• Has a negative criminal background check 
• Has not failed their licensure exam 
• Has not had any disciplinary action taken against them in another state 

Licensure by Compact 

Over 40 states in the United States have created legislation to allow nurses to work under one multistate license (2). This means a nurse originally licensed in Florida could work in any other state that participates in the Nurse Licensure Compact without obtaining licensure for each state they wish to work in if they have a multistate license. This has proven especially useful over the years due to the growing nursing shortage and global pandemic.  

Many states like Florida are offering to provide multistate licenses to nurses during their initial examination. If a nurse does not obtain a multistate license initially, they can do so later. They must pay a fee and submit fingerprints for a background check. Nurses must also meet any other requirements set by the state of Florida (2).  

It is important to note that in Florida, the nurse who holds the compact license must claim residency in the state. If the nurse were to claim residency in another state, they would no longer have a multistate license issued by Florida. If the state they move to is part of the Nurse Licensure Compact, they might be eligible to obtain a compact license in their new home state (2, 5). 

(2) 

Delegation to the Unlicensed Assistive Personnel (UAP) or Unlicensed Personnel (UP) 

The Nurse Practice Act defines delegation as transferring a task or activity during a specific situation by a qualified nurse, through licensure and experience in the task, to a competent individual. Different facilities may have several ways of determining the competence of the individuals they employ, but ultimately, the decision rests with the RN or LPN.

The licensed provider must evaluate the task’s difficulty, the potential for predictable or unpredictable harm or rapid change in the patient’s condition, and the level of communication required with the patient. They must also consider the resources available and skills the UAP can do at their facility (4).  

When delegating, it is essential to assess the UAP’s skill set through validation or verification. The nurse should communicate clearly regarding the delegated task and explain the desired outcomes. They should also explain what undesired outcomes could occur, what should be done if an undesired outcome does happen when the task should be completed, and if supervision by the nurse is required.

The nurse should follow up to ensure the task was done correctly and within the set time frame. The nurse should be aware that the delegated task and any outcomes are the nurse’s responsibility, and they are ultimately held accountable for it. So, if it is an important task, it may be in the best interest of the nurse to delegate another task to the UAP and perform the critical task themselves (4).  

There are a few skills that cannot be delegated to the UAP: 

• A skill that is not within the delegating nurse’s scope of practice  
• Activities require using the nursing process or specific education, judgment, training, or skills. 
• Initial assessments and progress evaluations relate to the patient’s plan of care. 
• Skills that a UAP needs to display competence.  

IV Administration by LPNs 

As mentioned above, LPNs and RNs have a few variations in their scope of practice. LPNs can administer and perform some parts of IV medication therapy instead of the RN, who can do all. IV therapy administration is the infusion or injection of a medication via the intravenous system.

This method involves several aspects, including evaluating, observing, monitoring, discontinuing, titrating, managing, planning, documenting, and intervening during administration. RNs do not always have to be onsite when delegating IV administration to an LPN, but knowing policies and when an RN must be on site is essential (4).  

LPNs cannot do any of the following (4): 

• Initiate blood or blood products or plasma extenders. 
• Mix IV solutions. 
• Administer or initiate cancer treatments such as chemotherapy or investigational medications. 
• IV pushes, except for heparin or saline flushes. 

LPNs may care for patients receiving these therapies, such as actively receiving a blood transfusion, but they cannot do the above.  

LPNs can (4): 

• Calculate and adjust flow rates. 
• Observe and report any signs of adverse effects of IV medications. 
• Assess IV insertion sites and change dressings as needed and as educated. 
• Remove IV catheters or needles from peripheral veins. 
• Hang IV hydrating fluids. 

In order for an LPN to administer IV medications through a central line, they must do so under the direction of an RN and have four hours of IV therapy education on central lines. This four-hour requirement can be applied to the 30 total hours LPNs must do on IV therapy (4).  

LPN Supervision in Nursing Homes 

According to Florida law, LPNs can supervise other LPNs, certified nursing assistants (CNAs), or UAPs in the nursing home setting. To be considered for a supervisory position, the LPN must have completed 30 hours of board-approved, post-basic education courses under the supervision of an RN.

The LPN must also have at least six months of full-time clinical experience either in a hospital or nursing home setting. If the LPN takes a course outside of the Board’s approval courses, the provider of said course must test the LPN and provide attestation of the LPN’s competency (4). 

The supervisory LPN’s role is to provide other LPNs, CNAs, and UPAs with guidance and inspection of their completed task per their appropriate scope of practice. The LPN can only delegate tasks within their scope of practice and be assured that the one they are delegating to demonstrates competency (4). 

Certified Nursing Assistant (CNA) 

The certified nursing assistant is similar to the UAP. Still, to be certified, they must have completed a background check conducted by the Board of Nursing, prove they can read and write, and pass the nursing assistant examination. Once the criteria listed have been met, CNAs can provide general care and assist with activities of daily living under the direction of an RN or LPN. They can also participate in postmortem care and perform CPR (4).  

Maintaining Medical Records 

For RNs and APRNs in private practice, the Florida Nurse Practice Act has two rules regarding maintaining medical records. The first applies to the death of the nurse. Whoever legally represents the RN or APRN must post a notification in the county newspaper stating where the medical records are being stored and who to contact if an individual wants to obtain the records. The documents must be stored for a minimum of two years after the death of the nurse (4).  

At the 24-month mark, several notices must be posted in the county newspaper, one notification for four consecutive weeks, that the medical records will be destroyed four weeks after the last day of the fourth week that the notice was published (4).  

The second rule pertains to an RN or APRN who has terminated or relocated their practice. The rule states that the RN or APRN maintains and holds onto the medical records for at least two years. They must let those who were patients know about the date of termination or relocation and where the medical records can be retrieved.

The notice must be made public, such as in a newspaper, with a minimum appearance of four times over four weeks. A sign must be placed at the location of the business about the termination or relocation until the termination or relocation happens. This sign must tell patients about the opportunity to obtain their medical records (4). 

Continuing Education (CE) Requirements 

Florida law requires that for renewal of a nursing license, the nurse seeking renewal must complete a set amount of CE hours. Over the two years, 24 hours must be completed, one for each month. Two of those hours must be about the Florida Nurse Practice Act and the other laws that pertain to the nursing profession.

Two hours are required to investigate medication errors and how to prevent them. A one-hour HIV/AIDS is necessary for initial renewal but does not have to be repeated. There must be a two-hour course on domestic violence done every third renewal. As of August 2017, a two-hour course on recognizing impairment in the workplace is required with each renewal (4).  

In Florida, completed CE courses are automatically reported to a tracking system created by the Department of Health’s Division of Medical Quality and Assurance (MQA) or manually by the individual. Those who attend CE courses will obtain a certificate of attendance. The attendee is advised to maintain a copy of those certificates for at least four years.

For Florida, the provider of the course, the individual or company that is offering the training, has 90 days (about 3 months) to report to the tracking system, so if the nurse’s date of renewal is less than 90 days, it is suggested that the course be manually reported by the nurse (4). 

If a nurse has two licenses, such as RN and LPN or APRN and RN, they may be able to comply with both license requirements through one set of CE requirements. For example, an RN with an LPN license can meet all the CE requirements of the LPN license by completing the RN requirements (4). 

Nurses who serve as expert witnesses and provide expert opinions in writing can obtain 2.5 hours for each case. The case must cite at least two current articles of reference being reviewed regarding the Nurse Practice Act (4). 

There are a few exemptions to completing the CE renewal requirements. It is advised that the nurse contact the Board of Nursing with specific questions or concerns regarding renewal and CE requirements (4): 

• If the nurse is on active duty for the US military within six months of the renewal date. 
  • This does not apply to short periods of active duty, such as summer or weekend drills. 
  • This does not apply to those on duty in the US Public Health Service. 
• If the nurse’s spouse is a member of the US military and the nurse was absent from the state of Florida because of military duty. 
  • The nurse must provide adequate proof of the spouse’s absence and military status. 

Disciplinary Action 

As mentioned above, the Florida Board of Nursing, as outlined in the Nurse Practice Act, can discipline nurses as they see fit regarding all violations of Florida rules and laws. The Board created a variety of ways a nurse can be punished, ranging from probable-cause panels to citations to disciplinary hearings to loss of nursing license. The severity of the violation reflects on which method the Board of Nursing may take (5). 

There are three probable-cause panels in Florida: North Florida, Central Florida, and South Florida. The purpose of these panels is to determine if there was “probable cause” or reasonable ground for the reported case. They decide if a case needs action taken. The panel members review each case and compare it to others of a similar nature, how the Board has treated those cases in the past and what the Board’s guidelines entail. The panel can recommend and consider rules regarding procedures, penalties, and disciplinary actions (5)  

Citations can be given in lieu of other forms of discipline. The citation is issued within six months of a complaint being filed and contains the request for the recipient to fix the violation within a specified time frame. These violations are usually classified as “minor” in nature, such as false advertising, falsely using a nursing title, or failure to report the change of address or updates of information required by the Board.

Other reasons a citation can be issued include failing to report a misdemeanor within 30 days of a ruling or failing to utilize the law-required prescription drug monitoring system. Each of these citations can come with a fine, usually ranging from $100 to $250 in amount; however, if a nurse is found guilty of sharing passwords, codes, keys, or other forms of entry to a secure medication administration device or information technology system a fine of $1,500 can be given. In addition, the nurse would have to take a two-hour CE course on legal nursing aspects within 60 days of the citation being issued (5).  

The Board of Nursing has the power to take any of the below appropriate actions against nurses who have violated parts of the Nurse Practice Act. It is important to note that any of the actions can be combined, depending on the severity of the violation and the action taken by the nurse after the violation was committed (5): 

• Probation, suspension, or revocation of a license 
  • It can be emergently done depending on the situation.  
• Require CE course(s) to be done 
• Letter of concern 
• Reprimand 
• Administer a fine 
• A personal appearance is required before the Board of Nursing to monitor compliance. 
• Restrict or limit a nurse’s scope of practice. 
  • Example: prohibiting a nurse from administering any narcotics after they are participating in drug diversion 
• Referral to the Intervention Project for Nurses (IPN) 

The Board of Nursing has also created an extensive, but not all-encompassing list of reasons why a nurse can be disciplined (5): 

• Sexual misconduct 
• Unprofessional conduct 
• Participating in crime related to healthcare fraud 
• Making or filing a false report to appease state or federal law 
• Willfully hindering another individual in filing a report that is required by state or federal law 
• Testing positive on any drug screen when the individual has no medical/other reason for using the drug 
• Inability to practice nursing with satisfactory skill and provide safe patient care due to the use of narcotics, drugs, alcohol, chemicals, or other substances that may impair an individual 
• Inability to practice nursing with satisfactory skill and provide safe patient care due to an illness, physical or mental condition 
• Failing to meet minimal standards of acceptable nursing practice 
• Accepting and performing professional responsibilities the nurse knows or has reason to know they are not skilled to perform 
• Delegating or contracting for the performance of professional duties by a person who the nurse knows or has reason to know is not qualified by training, experience, and authorization required to perform 
• Failing to identify the type of license the nurse is practicing under through written (can include a nametag) or oral notice to a patient 
• Performing or attempting to perform healthcare services on the wrong site or the wrong procedure on the wrong patient includes unauthorized procedures  
• Performing or attempting to perform healthcare services that are medically unnecessary or otherwise not related to the patient’s diagnosis or medical condition(s) 
• Being convicted or found guilty of or pleading nolo contendere (no contest) to a crime in any jurisdiction that directly relates to the practice of nursing or the ability to practice nursing 
• Being convicted of or found guilty of, or pleading nolo contendere to misdemeanors related to failure to protect an adult from abuse, neglect, and exploitation; fraudulent practices; theft and robbery; or having committed an act of domestic violence or child abuse 
• Defaulting on a student loan that has been issued or guaranteed by the state or federal government 

As with everything in life, the Board of Nursing has created guidelines for imposing discipline. They have a set minimum and maximum amount when it comes to fines. They have time frames for probation or supervision, conditions regarding probation, or the reinstatement of a license. What route they decide to take depends upon the specific case being presented to them. Sometimes, the circumstances presented to the Board are enough to elicit decisions outside the general guidelines. Some of these circumstances are (5): 

• Length of time a nurse has practiced 
• Presents a danger to the public 
• Any visible effort at rehabilitation 
• Treatment and disciplinary hearing costs 
• Actual physical or other forms of damage caused by the nurse 
• Financial hardships 

The Board has a timeframe in which a complaint must be filed. Most of the time, it is within a six-year window from the time the incident occurred. However, in certain circumstances—criminal actions, sexual misconduct, impairment of the nurse, or usage/diversion of controlled medications—the Board may allow the complaint’s time frame to extend beyond the six-year timeframe.

Suppose action such as fraud, intentional misrepresentation, or concealment is utilized to hide the violation during the six years. In that case, the timeframe to file a complaint can be extended to 12 years from when the incident occurred (5).  

If the Board of Nursing suspends a nurse’s license or agrees to have the license suspended to avoid further action against them, the nurse can possibly file a petition to have their license reinstated. Any final orders or terms issued during the initial suspension must be met as a whole, and the nurse must be able to demonstrate the ability to perform nursing practice safely.

Sometimes, a time frame is set for when a nurse can file a petition; sometimes, there is not. If this is the case, a nurse can appeal as soon as they can after meeting the terms and conditions given to them by the Board (5).  

The Board will determine what a nurse must do to demonstrate safe practice. This is based on the violation. For example, a nurse who is working while under the influence of medications or alcohol may be ordered to attend a treatment program with proof of sobriety, references, and completion of any court-mandated sanctions. Nurses must often present to the Board of Nursing in person and speak on their ability to practice nursing (5) safely.  

The three-strike policy is utilized when it comes to reinstating a license. Suppose a nurse has been found guilty on three separate occasions of a complaint about drug/narcotic usage or the diversion of medications from patients to the nurse for personal use or to sell. In that case, the Board will not reinstate the license (5).  

Relicensing a nurse who has had their license revoked is similar to what happens when a license is suspended. However, the nurse must reapply for the permit and meet all conditions set by the Board. Nurses may have to sit for another examination or take board-approved continuing education if the nurse has been out of practice for an extended period of time. They may require a nurse to participate in Florida’s Intervention Project for Nurses (IPN) program or at least be evaluated for it (5).  

Nurses are held accountable for reporting the actions of other nurses and any misconduct to the Board of Nursing. They must report sexual misconduct or healthcare fraud. If they know or have reason to believe that another nurse is not practicing safely or is practicing under the influence of alcohol or medications, they are required to report it (5).

Florida’s Intervention Project for Nurses (IPN) 

Created in 1983 under the authority of the Nurse Practice Act, IPN was designed to protect the public by monitoring nurses whose skills have been compromised due to improper use of medications or alcohol or the impairment of mental or physical health. IPN is not a treatment center.

Instead, they provide nurses with access to Board-approved practitioners who specialize in addiction, mental health, and other medical conditions to assist the nurses in restoring themselves to a level of safe practice. They also conduct monitoring after a nurse has been discharged from treatment, interventional training, consultations, and advocacy for those who participate (1).  

As mentioned above, nurses have an obligation to report themselves or nurses who are, or they have reason to believe, unsafely practicing nursing while under the influence of alcohol or medications. The report is confidential if a nurse self-reports or is reported to the IPN only and they complete treatment and five years of monitoring. If the Board of Nursing becomes involved, either through a failure to report or complete treatment, disciplinary action may be taken (1).  

In the beginning, nurses are not able to practice during the initial evaluation period or when the treatment is being determined. After a treatment plan is made, it is up to the discretion of the IPN and the providers involved in the treatment to say if the nurse is able to continue working as a nurse. Restrictions on a nurse’s practice are often implemented during the beginning phase of treatment(1).  

To be determined “fit to practice,” the nurse must meet all requirements set by their providers and the IPN. They must sign an advocacy contract, submit to random drug tests, verbalize their understanding of practice restrictions, and participate in a weekly support group for nurses (1).

Conclusion

Despite the extensive outline of the Nurse Practice Act and other state rules in this course, it only briefly narrates all Florida laws pertaining to nurses. In addition to this course, nurses must stay on top of new legislation being proposed and implemented regarding their profession and continually review the content in the state laws. Nurses who travel to other states to practice their profession should be educated on each state’s rules regarding nursing practice, as they can differ from state to state. A conscious effort must be made to follow the laws set in place to practice nursing safely and legally in the state of Florida.

Florida Medical Errors

This fulfills the continuing education requirement for Medication Errors Prevention for the state of Florida.  

For as long as there have been medical professionals, there have been medical errors.  Medical errors can be small and seemingly insignificant to a catastrophic sentinel event.    

The Joint Commission (TJC) is a healthcare accrediting agency that sets the standard for patient safety.  Each year, TJC publishes a list of national patient safety goals.  These goals are focused on the prevention of medical errors.  In 2019, the World Health Organization (WHO) found that medical errors harmed up to 40% of patients within the global healthcare system.  These medical errors not only cause harm to millions of people worldwide, but they also cost billions of dollars on an annual basis (8). 

There are many different types of medical errors.  They include, but are not limited to: medication errors, healthcare-acquired infections, surgical errors, lab errors, falls, documentation issues, and omitted care.  Healthcare workers must be aware of the possible harm that can be caused by medical errors and the ways in which they can be prevented.   

Introduction   

For as long as there have been medical professionals, there have been medical errors.  Medical errors can be small and seemingly insignificant to a catastrophic sentinel event.    

The Joint Commission (TJC) is a healthcare accrediting agency that sets the standard for patient safety.  Each year, TJC publishes a list of national patient safety goals.  These goals are focused on the prevention of medical errors.  In 2019, the World Health Organization (WHO) found that medical errors harmed up to 40% of patients within the global healthcare system.  These medical errors not only cause harm to millions of people worldwide, but they also cost billions of dollars on an annual basis (8).

There are many different types of medical errors.  They include, but are not limited to: medication errors, healthcare-acquired infections, surgical errors, lab errors, falls, documentation issues, and omitted care.  Healthcare workers must know the possible harm caused by medical errors and how they can be prevented.   

Factors That Impact the Occurrence of Medical Errors 

There are multiple factors that can increase the probability of a medical error occurring.  Healthcare worker behaviors and attitudes, staffing, and communication are among those that have the most significant impact on medical errors. 

In healthcare, a risky behavior is an action that may lead to a compromise in patient safety.  Why would any healthcare worker engage in at-risk behaviors?   Healthcare workers, especially nurses, are generally compassionate and are ultimately looking out for the patients' welfare in their care.  Risky behaviors produce a quick, positive reward without any perceived risk of patient harm.  These risky behaviors can range from a simple short-cut like not checking two patient identifiers to a blatant disregard for hospital/facility policy.  In all instances, the risk for patient harm is real and will eventually occur (13). 

Understaffing in the hospital setting continues to be a factor contributing to medical errors.  Poor nurse-to-patient ratios can lead to a variety of medical errors.  Ordered patient care may go undone, leading to further medical errors adverse patient outcomes (7).  Understaffing leads to fatigue and burnout.  A nurse in this state of mind is prone to committing medical errors. 

Miscommunication between healthcare professionals and patients and miscommunication between healthcare professionals also contribute to the occurrence of medical errors.  As part of their national patient safety goals, TJC has had a communication component almost every year.  They have recognized that effective communication is paramount in the prevention of medical errors.  A lack of effective communication can be a leading cause of every type of medical error. 

In an effort to decrease communication errors, TJC has taken measures to ensure that effective communication is promoted in a variety of different situations.  TJC has instituted a list of unacceptable medical abbreviations.  This list will decrease medication errors by removing confusion when medications are ordered (11).  They also developed a handoff communication protocol for facilities to implement.  The handoff communication occurs anytime that care is passed from one caregiver to another.  In Florida medical errors prevention, this communication protocol is used to ensure that all pertinent patient information is passed on to the next healthcare worker rendering care to the patient.  By using effective handoff communication, all information should be passed on, and mistakes should be avoided (10).  

Recognizing Error-Prone Situations 

 Studies have shown that the majority of medical errors occur in the inpatient setting.  The most common areas for medical errors are the operating room (OR), the emergency room (ER), the intensive care unit (ICU), and the medical/surgical floors (1).   

What is it about the inpatient setting that makes it such an error-prone area?  More specifically, why do medical errors occur in the ICU, OR, and ER?  These are all high-stress areas where effective communication between all parties is vital.  Breakdown in communication in these areas will lead to catastrophic medical errors.  When the stress level rises, the probability of medical errors occurring also rises.  These are also fast-paced areas where the condition can change in the blink of an eye.  When we work in such a busy area, we can forget important details.  Effective communication is a big part of Florida medical errors prevention.  Miscommunication in these environments is a recipe for medical errors.  

As the most common type of medical errors is medication errors, we do need to talk about medication administration.  Nurses are taught the five rights of medication administration in nursing school:  

1. Right drug. 
2. Right patient. 
3. Right dose. 
4. Right route. 
5. Right time. 
   

When working in a busy inpatient setting, nurses may fail to perform the five rights in order to save time (5).  Neglecting any one of the five rights of medication administration can cause a medical error.

Processes to Improve Patient Outcomes 

In the technological age in which we live, it is more important than ever before that healthcare facilities consistently demonstrate good patient outcomes.  The Centers for Medicare & Medicaid Services (CMS) places great importance on the patient experience and their perception of their healthcare experience quality.  Every patient who experiences a hospital stay may be asked to complete a Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.  The survey results are published quarterly on the CMS Hospital Compare website.  There, patients can compare the hospital's results and choose a hospital where they would like to have their care rendered (4).  A medical error could very well cause a patient to give a facility a poor rating on the HCAHPS survey. That is why we must take Florida medical errors prevention seriously.

When medical errors have occurred, they will often result in a risk management response to investigate why the error has happened and how it can be prevented in the future – a root cause analysis (RCA).  An RCA will often lead to department-driven performance improvement projects (PIP) to eradicate the problem and improve patient outcomes.  A proactive facility trying to minimize medical errors will have multiple department and facility-wide PIP. 

As previously stated, each year TJC publishes a list of patient safety goals.  These goals will often guide a facility on specific patient outcomes that have required attention for improvement on a national level.  They focus on the prevention of medical errors, and as such, they can steer PIP.  Accreditation hinges on the ability of a facility to improve and consistently deliver positive patient outcomes.  Below is the current list of TJC's patient Safety Goals: 

1. Identify patients correctly.

Use at least two ways to identify patients. For example, use the patient's name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment.

2. Improve staff communication.

Get important test results to the right staff person on time.

3. Use medicines safely.

Before a procedure, label medicines that are not labeled. For example, medicines in syringes, cups, and basins. Do this in the area where medicines and supplies are set up. 

Take extra care with patients who take medicines to thin their blood. 

Record and pass along correct information about a patient's medicines.

Find out what medicines the patient is taking. Compare those medicines to new medicines given to the patient.

Give the patient written information about the medicines they need to take. Tell the patient it is important to bring their up-to-date list of medicines every time they visit a doctor.

4. Use alarms safely.

Make improvements to ensure that alarms on medical equipment are heard and responded to on time.

5. Prevent infection.

Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

6. Identify patient safety risks.

Reduce the risk for suicide.

7. Prevent mistakes in surgery. 

Make sure that the correct surgery is done on the correct patient and at the correct place on the patient's body. 

Mark the correct place on the patient's body where the surgery is to be done. 

Pause before the surgery to make sure that a mistake is not being made.

(12)

Responsibilities for Reporting as a Part of Florida Medical Errors Prevention

Each individual facility across the nation may have different policies and procedures for the reporting of medical errors within their facilities.  There is, however, a growing trend throughout the healthcare industry of creating a culture of safety.  The culture of safety promotes the reporting of medical errors and "near misses" in an open, transparent and non-punitive manner.  Facilities are taking a stand to ensure patient and staff safety over other competing goals within their system (14).  Near miss reporting allows for issues to be addressed and corrected before an actual error occurs.  Taking a non-punitive approach to self-reporting of medical errors promotes accurate reporting and allows for a true picture of what is happening in the facility. 

The State of Florida has mandated that all licensed healthcare facilities implement an internal risk management program.  In Florida medical errors prevention, it is the responsibility of the risk management team to: 

1. Investigate and analyze the frequency and cause of general and specific types of patient adverse incidents. 
2. Develop measures to minimize the risk of adverse incidents. 
3. Analyze patient grievances that relate to care and quality of services. 
4. The development and implementation of an incident reporting system. 

State law further requires that the Agency for Healthcare Administration (AHCA) post quarterly reports on adverse incidents (9). 

Safety Needs of Special Populations 

There are certain groups of people that are especially vulnerable to experience a medical error.   

Elderly 

The elderly are especially susceptible to medical errors.  Generally, as we get older, we tend to start taking more medications.  Complex medication regimens offer a greater opportunity for medication errors.  Many medications require close monitoring of vital signs and/or blood levels.  Drug-related issues are a major driving force for both ER visits and nursing home admissions among the elderly (3).  Declining cognition, poor vision, and increased forgetfulness associated with aging can also play a part in medication errors.  Education with frequent reinforcement and the use of support people are crucial to help prevent medication errors.   

The elderly are also at a higher risk for falls.  Falls within a medical facility can lead to further medical complications, increased length of stay, and serious injury.  Patients at risk for falls need to be identified and place on a fall prevention protocol. 

 Children 

 Children are on the other side of the spectrum and are also another group that are at higher risk for medical errors.  Younger children may be unable to accurately voice exactly their problem is, or what symptoms they are experiencing.  They must rely on both parents and other caregivers for the coordination of their care.  Though a parent may know their child well, they may not be able to properly convey their child's issues to the healthcare professional.  It is also important to realize that children are not little adults.  Care plans must be catered to their specific phase of life. 

Limited Health Literacy/Education

Another population that is vulnerable to medical errors are patients with limited health care literacy or education.  These patients may have difficulty obtaining, retaining, and implementing health information to make proper decisions for their healthcare needs.  Populations within this group may include the elderly, low-income populations, immigrants, and minorities.  There is also a strong correlation between limited health literacy and the uninsured, undereducated, and unemployed populations.  It is important that information be presented to this group at a level that they can understand.  The use of interpreters can also be helpful if the patient does not have a good grasp of the English language (6). 

Public Education 

Now, more than ever before, the general public has greater access to information of all sorts.  This includes access to health information, specifically, patient outcomes.  The public is able to make informed decisions on where they would like to be cared for by comparing healthcare facilities.   

The public is seeking information not only on which facility is the safest with the best outcomes but also on ways that they can actively prevent medical errors from happening to them.  There are many resources that patients can find online to help them recognize scenarios that may place them at risk for the occurrence of medical errors.  The Agency for Healthcare Research and Quality (AHRQ) has published a list of 20 tips patients can use to help prevent medical errors: 

Medicines 

1.    Make sure that all of your doctors know about every medicine you are taking.
This includes prescription and over-the-counter medicines and dietary supplements, such as vitamins and herbs. 

2.    Bring all of your medicines and supplements to your doctor visits.
"Brown bagging" your medicines can help you and your doctor talk about them and find out if there are any problems. It can also help your doctor keep your records up to date and help you get better quality care. 

3.    Make sure your doctor knows about any allergies and adverse reactions you have had to medicines.
This can help you to avoid getting a medicine that could harm you. 

4.    When your doctor writes a prescription for you, make sure you can read it.
If you cannot read your doctor's handwriting, your pharmacist might not be able to either. 

5.    Ask for information about your medicines in terms you can understand—both when your medicines are prescribed and when you get them: 

• What is the medicine for? 
• How am I supposed to take it, and for how long? 
• What side effects are likely? What do I do if they occur? 
• Is this medicine safe to take with other medicines or dietary supplements I am taking? 
• What food, drink, or activities should I avoid while taking this medicine? 

6.    When you pick up your medicine from the pharmacy, ask: Is this the medicine that my doctor prescribed? 

7.    If you have any questions about the directions on your medicine labels, ask.
Medicine labels can be hard to understand. For example, ask if "four times daily" means taking a dose every 6 hours around the clock or just during regular waking hours. 

8.    Ask your pharmacist for the best device to measure your liquid medicine.
For example, many people use household teaspoons, which often do not hold a true teaspoon of liquid. Special devices, like marked syringes, help people measure the right dose. 

9.    Ask for written information about the side effects your medicine could cause.
If you know what might happen, you will be better prepared if it does or if something unexpected happens. 

Hospital Stays 

10. If you are in a hospital, consider asking all health care workers who will touch you whether they have washed their hands.
Handwashing can prevent the spread of infections in hospitals. 

11. When you are being discharged from the hospital, ask your doctor to explain the treatment plan you will follow at home.
This includes learning about your new medicines, making sure you know when to schedule follow-up appointments, and finding out when you can get back to your regular activities.
It is important to know whether or not you should keep taking the medicines you were taking before your hospital stay. Getting clear instructions may help prevent an unexpected return trip to the hospital. 

Surgery 

12. If you are having surgery, make sure that you, your doctor, and your surgeon all agree on exactly what will be done.
Having surgery at the wrong site (for example, operating on the left knee instead of the right) is rare. But even once is too often. The good news is that wrong-site surgery is 100 percent preventable. Surgeons are expected to sign their initials directly on the site to be operated on before the surgery. 

13. If you have a choice, choose a hospital where many patients have had the procedure or surgery you need.
Research shows that patients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition. 

Other Steps in Florida Medical Errors Prevention

14. Speak up if you have questions or concerns.
You have a right to question anyone who is involved with your care. 

15. Make sure that someone, such as your primary care doctor, coordinates your care.
This is especially important if you have any health problems or are in the hospital. 

16. Make sure that all your doctors have your important health information.
Do not assume that everyone has all the information they need. 

17. Ask a family member or friend to go to appointments with you.
Even if you do not need help now, you might need it later. 

18. Know that "more" is not always better.
It is a good idea to find out why a test or treatment is needed and how it can help you. You could be better off without it. 

19. If you have a test, do not assume that no news is good news.
Ask how and when you will get the results. 

20. Learn about your condition and treatments by asking your doctor and nurse and by using other reliable sources.
For example, treatment options based on the latest scientific evidence are available from the Effective Health Care Web site. Ask your doctor if your treatment is based on the latest evidence (2). 

Case Studies 

Mr. Smith is a 68-year-old male with diabetes type 2, hypertension, and chronic renal failure stage 4.  He takes both long-acting and short-acting insulin for his diabetes and a beta-blocker for his high blood pressure.  He is also taking a diuretic to help regulate his fluids.  Mr. Smith was recently admitted to the hospital for a hypoglycemic event.  Once in the hospital, Mr. Smith expressed to his nurse that he has been having difficulty reading his medication labels.  He also confided that he feels dizzy when he stands up and has fallen back onto his bed on more than 1 occasion.   

After two days, Mr. Smith was ready to be discharged.  The diabetic educator brought him some pamphlets and educated him on proper blood glucose monitoring and insulin administration.  His blood pressure medicines were also changed, and Mr. Smith was given a new prescription to be filled once he left the hospital.  He was alone when discharge instructions were given, and his current medications were not removed from his medicine bag.   

Two days later, Mr. Smith was readmitted to the hospital with hypoglycemia and hypotension (BP 87/52).

Exercise

1. What are some factors that lead to the occurrence of medical errors with Mr. Smith? 

2. What are the medical errors that occurred? 

3. What could the nurse/educator have done differently to prevent further medical errors, using steps addressed in this Florida medical errors prevention course? 

Bernice is a staff nurse working in a busy ICU.  Due to the COVID-19 pandemic, the unit has been short-staffed, with each nurse taking care of 3-4 patients.  This is Bernice's fifth day in a row, working fourteen plus hours.  There have been multiple "code blue" situations in the ICU over the course of Bernice's workweek, some involving her patients.  She was only able to have a full lunch hour on her second day, and she has not been able to sleep much during the night.   

One of her patients was having severe abdominal pain, 9/10 on the pain scale.  Bernice went in to administer the ordered narcotic and injected the wrong patient. 

Exercise 

1. What factors lead to Bernice's medical error? 

2. What could have been done to prevent the error? 

3. Is this a situation that could happen in a unit where you work?

Conclusion  

Medical errors are an ongoing problem in the healthcare setting.  They affect patients in all phases of life and come with a large price tag of both money and medical resources.  It is everyone's responsibility to help prevent the occurrence of medical errors.  Though we may not be able to totally eradicate them, we can all play a big part in Florida medical errors prevention by learning from previous mistakes and taking measures to ensure that they do not happen again. 

Florida Recognizing Impairment in the Workplace

This fulfills the continuing education requirement of 2 contact hours on Recognizing Impairment in the Workplace for the state of Florida.    

Up to 20% of nurses in the United States are chemically dependent. Substance use disorders, addictions, drug diversions, and other related impairment processes present a threat to the health and safety of those around them. Increasing in concern are overdoses and deaths that are on the rise due to substance abuse and addiction. Early identification of the signs and symptoms of a substance abuse disorder in the workplace contributes to reducing the risk and harm to patients and other healthcare team members. Co-workers play a crucial role in recognizing and reporting suspicious behaviors to their supervisors or appropriate personnel. 

Introduction – Florida Recognizing Impairment in the Workplace

Impairment within the workplace of a healthcare environment is, unfortunately, more common than one may realize. Impairment results when a healthcare professional cannot provide competent and safe patient care because they may be impaired by alcohol, prescription, or non-prescription drugs, or other mind-altering substances (2).  Impairments can also result from a psychological or neurological condition that may affect a person’s judgment. Because of impairment, the healthcare professional is unable to perform duties essential to their profession safely. 

Acknowledging the Problem 

Ideally, from a professional standpoint, healthcare personnel should acknowledge their condition and seek help voluntarily without requiring intervention; however, this is often not the case. Co-workers play an important role in helping the impaired person get treatment. Often, the abuser has denial with the condition, the social stigma, or fear of potential job loss. Colleagues are often reluctant to report their co-workers because they feel it is not their responsibility. They feel like the individual they are reporting may be punished excessively. They may believe that someone else has already addressed the issue or fear the loss of their colleague’s job or license. Despite these potential reasons, colleagues may have certain legal responsibilities in identifying and reporting. States may have specific reporting laws that could hold colleagues responsible for harm to patients if they fail to report.

Definitions 

Substance Use Disorder :  a disease of the brain characterized by the recurrent use of substances such as alcohol and drugs that cause clinical and functional impairment such as health problems, disability, and failure to meet responsibilities at work or school.  

The disease involves reward, withdrawal, memory, and motivation and can be classified as mild, moderate or severe depending on the level of impairment (1).  

Addiction:  the most severe, chronic stage of substance use disorder. There is a substantial loss of self-control, indicated by compulsive substance use despite the desire to stop using (1). 

Drug Diversion:  is the transfer of any substance from the purpose for which it was intended for any illicit use, such as personal use or sale (1). 

Impairment: is the inability or impending inability to engage safely in professional and daily life activities as a result of physical, mental, or behavior disorders such as substance use, abuse, or addiction (1). 

Impairment Behaviors in the Workplace  

Some behaviors are associated with emotional problems but are specific to alcohol or other drug abuse. Some signs common to alcohol and other drugs may also be signs of psychological or psychiatric conditions (2). Each situation is individualistic to the person. Health care professionals must be educated appropriately regarding the signs and symptoms of chemical dependence. The workplace is often the last place that addiction may manifest; disruptions in family, personal health, and social life can happen while the workplace remains unaffected.

Behaviors Associated with Substance Abuse

• Severe mood swings/personality changes 
• Frequent or unexplained tardiness, work absence, illness, or physical complaint 
• Elaborate excuses 
• Under-performance 
• Difficulty with authority 
• Poorly explained errors, accident, or injury 
• Confusion, memory loss, difficulty concentrating 
• Visibly intoxicated 
• Refuses drug testing 

Signs Associated with Substance Abuse

• Unreliability in keeping appointments and meetings 
• Trouble with relationships (professional familial, marital) 
• Physical indications such as track marks or bloodshot eyes 
• Signs indicative of drug diversion 
• Deterioration in personal appearance 
• Significant weight loss or gain 
• Discovered comatose or dead  

Signs and Behaviors Associated to Drug Diversion Specific to Anesthesia Personnel (1)   

• Consistently uses more drugs for cases than colleagues. 
• Frequent volunteering to administer narcotics, relieve colleagues for casework
  
• Heavy wastage of drugs 
• Frequent trips to the restroom or breaks 
• Drugs and syringes in pockets 
• Anesthesia record does not match up with drug dispensed and administered to patient 
• Patient has unusually significant or uncontrolled pain after anesthesia.
  
• The patient has a higher pain score as compared to other anesthesia providers. 
• Times of cases do not correlate when provider dispenses drug from automated dispenser 
• Inappropriate drug choices and doses for patients are made by the provider 
• Missing medications or prescription pads  

Substances such as opioids (e.g., morphine and fentanyl), inhalational anesthetics and volatile agents (e.g., sevoflurane, nitrous oxide), and intravenous anesthetic agents (e.g., propofol) are readily available to many healthcare providers (1). Despite medication dispensing and audit controls in place, drugs can be diverted for misuse. This may happen through the procurement of medicines directly from the pharmacy, automated dispensing units, retrieval from sharps containers of medication remaining in syringes, directly from patient medications, or indirectly through dilution of a medication that appears that nothing is missing from the container (1).

Regardless of the substance being abused, impairment in the workplace can negatively impact patient and provider safety. Facilities should have policies and education addressing symptom awareness, prevention, and reporting to help minimize the risk of diversion and adverse outcomes. Studies have shown that substance use disorder is a disease of the brain (1). As a responsible healthcare provider, by arming yourself with knowledge and the signs and behaviors of impairment in the workplace, it will prevent further harm. 

Healthcare providers are usually successful at disguising their issues or potential signs are ignored because they are respected or an intelligent member of the healthcare team. Significant changes in behavior in the workplace may various many causes. If signs of substance abuse and drug diversion are left unrecognized or reported, the user may be placed in danger and patient safety compromised. Impaired health professionals sometimes develop coping mechanisms that allow them to cover up their diminished capacity to provide safe and efficient patient care. Eventually, mistakes are made, including medication and procedural errors that become apparent to their co-workers (3).

Consequences of Drug Diversion and Substance Use in the Workplace  

Healthcare providers are responsible for their patients’ safety, including their duty to deliver safe and competent care without impairment. Impairment in the workplace can create a disorganized environment (1). The consequences to associate with substance use and drug diversion in the workplace may cause the following consequences for the patient themselves, their colleagues, and the facility in which they are employed. 

Patient

• Pain, anxiety, and side effects from improper dosing 
• Allergic reaction to wrongly substituted drug 
• Victim of medical errors
  Loss of trust in the healthcare system
  Communicable infection from a contaminated needle (1) 

Impaired Professional

• Adverse health effects related to abuse 
• Chronic health problems (heart disease, liver impairment) 
• Familial and financial difficulties 
• Loss of social status 
• Felony prosecution, incarceration, and civil malpractice 
• Actions against a professional license 
• Accidents resulting from physical harm (1) 

 Colleagues

• Injury or infection from blood-borne pathogens from improperly stored equipment 
• At risk for shared-patient care responsibilities with an impaired professional resulting in adverse patient outcomes 
• The stress of increased workload from an impaired healthcare team member 
• Disciplinary action for false witness of leftover medication, improper disposal, or failure to report (1) 

 Facility   

• Costly investigation 
• Civil liability for patient harm 
• Damaged reputation due to public knowledge of mandatory reporting or drug diversion instances, especially those that led to patient harm 
• Poor work quality 
• Loss of revenue from diverted drugs or reimbursement from adverse events due to impaired provider (1) 

The use of addictive substances over time may result in the deterioration of the healthcare professional’s overall health. For example, the use of stimulants may result in cardiovascular problems such as angina, hypertension, and Myocardial Infarction. Alcohol can lead to liver disease, such as cirrhosis. Depression, suicide, and anxiety are mental health disorders that are often coexisting problems with substance abuse. The healthcare workers’ impairment can also lead to traumatic injuries such as falls, fractures, and head injuries (1).

Florida Rules and Regulations  

Many states have rules and regulations regarding the use of alcohol and controlled substances that include disciplinary action. Drug diversion is a significant offense that is taken very seriously. Almost every state requires the reporting of a health practitioner who is suspected of impairment in the workplace. The penalties associated with this vary state by state. Florida requires that all nurses take a Florida Recognizing Impairment in the Workplace CE course every other renewal to improve the recognition and outcomes of workplace impairment.

The state of Florida has an efficient reporting system. Nurses report to the Florida Department of Health or Intervention Project for Nurses (IPN). The IPN’s mission is to enhance public safety by assisting nurses and other nursing related personnel whose practice may have been impaired by substance abuse (4). Their call of the acknowledgment of impairment remains confidential. The Intervention Project for Nurses in Florida allows for an opportunity for intervention and the monitoring of nurses that are using alcohol or controlled substances (4). 

The IPN after receiving a referral of impairment will:  

• Initiate a consultation 
• Provide an intervention 
• The nurse will be required to stop practicing within 1-3 days-the entire process may take up to 12 months
• Assist the person in obtaining the appropriate treatment needed
• Evaluate the progress of the person and the adherence to their treatment plan
• Continuously monitor the person for 2-5 years

Reporting and Intervention  

Once a nurse or other employee has determined that there is an issue with a coworker regarding impairment in the workplace, an intervention must occur to prevent further harm from happening to patients, themselves, or other co-workers. According to the Intervention Project For Nurses, the co-worker determines that there is sufficient evidence and documentation to support their concerns of the impairment of a health professional, an intervention should be planned (4). The planning and participation related to such intervention is usually the responsibility of the employee’s nursing manager. 

• Intervention process steps: (4)  
• Prepare a plan 
• Review documentation 
• Request help from others 
• Ask the person to listen to what is said before allowing them to respond 
• Stick to their job performance 
• Have evaluator options ready 
• Expect denial 
• Report as necessary to the Board
  

Return to Practice  

A recovering nurse’s return to practice requires planning and oversight by a nursing manager. Once a nurse has been determined that they are safe to return to practice, several things must fall into place. These things include developing a return to practice guidelines for that specific employee, such as returning to work agreement. Experts must also advocate for the employees to return to work, provide support, review expectations, monitor requirements, and answer questions (4).

Considerations Of Relapse 

Substance use is a chronic illness that comes unfortunately with periods of remission and exacerbation. The rate of relapse among nurses is lower than the general population (4). This is due to several factors, such as support programs and stringent state monitoring programs. Despite the fact, some nurses relapse. Knowledge of the management of relapse in the workplace is a crucial part of impairment in the workplace and plays a significant role in the safety of patients and other employees (4).

Conclusion – Florida Recognizing Impairment in the Workplace

Substance abuse is a chronic and progressive disease. Being able to recognize impairment in the workplace is imperative for the safety of patients, the impaired person, and other co-workers. Impairment can come in many forms. Being knowledgeable of the signs and symptoms as well as reporting responsibilities and policies will not only improve safety but also improve the overall practice environment. Nurses can be very good at picking up subtle clues as to another individual’s impairment. Be aware, be knowledgeable, and be supportive. 

Florida Human Trafficking

This course meets the Florida Human Trafficking requirement for nurses in the state of Florida.

Human trafficking is a significant humanitarian issue in the United States and the world that has continued to grow in the past several years despite government and public efforts to combat it. With increasing news coverage of high-profile human and sex trafficking cases, the problem was recently brought into the American public’s eye. However, the results published by the Polaris Project make it evident that human trafficking is not just a problem of the elite or occurring in poorer areas. It is within our own neighborhoods, workplaces, and throughout the State of Florida. 

For healthcare workers in Florida, human trafficking can be prevented through gaining the knowledge to recognize the warning signs and specific characteristics of a potential trafficking victim; the most effective ways to intervene, which will enable the victims to gain access to help; and where to garner additional support in addressing the issue. 

Prevalence and Definitions

The Polaris Project estimates that collectively there are over 25 million victims of human trafficking worldwide. These are individuals that have been forced into sexual or labor servitude. Of those, several hundred thousand are estimated to be in the United States (1). It is very difficult to estimate accurately as so often this is a crime that is unseen and hidden from the public eye. Since 2007, there were  20,415 contacts made concerning human trafficking reported within Florida to the National Human Trafficking Hotline via telephone calls, texts, or online submissions. Of those, there were 6,168 cases of human trafficking with 15,063 victims being identified.These numbers exemplify the number of potential victims that are not reaching out for help. 

Often, when human trafficking is discussed, a common misconception is that it is simply the transporting of humans. Human trafficking covers a much broader scope than this. It is this a modern age form of slavery and involves the exploitation of individuals for monetary or sexual gain. As stated by the Department of Homeland Security, “Human trafficking involves the use of force, fraud, or coercion to obtain some type of labor or commercial sex act” (3). 

As defined by U.S. law, there are three categories of human trafficking (all from 1): 

• Children under the age of 18 induced into commercial sex 
• Adults (age 18 or over) induced into commercial sex through force, fraud, or coercion 
• Children and adults induced to perform labor or services through force, fraud, or coercion 

The majority of trafficking in the United States involves sex crimes, followed by labor.  An increase of rates with 16% for sexual exploitation and 25% for labor was noted in North America during Covid-19 restrictions (4). These crimes may be occurring simultaneously to the same victim. Types of trafficking can include forced prostitution, pornography, strip dancing, criminal enterprise and bonded labor in domestic servitude or migrant work. Outside of street prostitution, sex trafficking is most likely to be occurring in venues such as strip clubs, massage parlors, or other fictitious business fronts for prostitution. A major difference with sex trafficking of minors is that, unlike adults, force, coercion, or fraud does not need to be present for prosecution (6). As there are a number of different avenues for and types of human trafficking, recognition can be challenging. 

Risk Factors

The profile of the human trafficking victim is not easy to define. Victims of human trafficking come from varied backgrounds that may or may not be what is expected or stereotypical. Victims may come from any race, socioeconomic status, color, religion, age, gender, sexual orientation or gender identity, and on. The main commonality is that there is a layer of deception whereby the human trafficker is targeting a vulnerability in the victim. As stated by the Department of Justice, trafficking victims are deceived with “... false promises of love, a good job, or a stable life and are lured into situations where they are made to work in deplorable conditions with little or no pay” (5). There are some trends noted that do make certain populations more at risk, but keep in mind that this does not encompass all potential victims and vigilance should be taken to avoid assumptions. 

The risk factors for human trafficking are just as varied and dependent upon the type of trafficking and method by which the abuser is able to hold the victim indentured or captive. This figurative prison may be physically, emotionally, or monetarily induced. The Center for Disease Control and Prevention (CDC) lists the following characteristics and factors: 

• Many victims are women and girls, though men and boys are also impacted. 
• Victims include all races, ethnicities, sexual orientations, gender identifies, citizens, non-citizens, and income levels. 
• Victims are trapped and controlled through assault, threat, false promises, perceived sense of protection, isolation, shaming, and debt.           

Several higher risk populations have been identified through the data gathered from the Polaris Project. It was found that children who were or had been within the foster care system or runaway homeless youth were more likely to encounter sexual victimization. Other factors include substance abuse, recent relocation or migration, unstable housing situations, and underlying mental health disorders (7). 

As a population that is often overlooked, shamed, or lacks resources, members of the lesbian, gay, bisexual, transgender, queer, or questions (LGBTQ) community are more vulnerable to being subject to human trafficking. Up to 40% of homeless youth are part of the LGBTQ community and may not seek assistance for fear of being shunned (8). 

Illegal and sponsored immigration remains at a higher risk of trafficking and exploitation. The NHRTC reports a significant number of calls that reference foreign nationals (2). Individuals wishing to become American citizens are lured with the promise of freedom in exchange for large fees that are made impossible to be worked off. While there are laws in place to prevent, this type of servant bondage is forced upon the victims who are in a new country and often lack resources or are unable to seek assistance due to cultural, language, and accessibility barriers. Further, cases have been reported where the employer or trafficker withhold visas or identification barriers in order promote compliance and essentially are holding the victim hostage (9). 

Recruitment Techniques

A major tactic of the perpetrators of these crimes is to prey on vulnerable individuals with a lack of resources. Thus, a primary ploy used is a layer of deception whereby the human trafficker is targeting the needs or wants of the victim. 

Traffickers are often individuals that the victim has come to trust. This may be a girlfriend or boyfriend, spouse, or other family member. Victims are also commonly sold to outside parties. 

In cases of sexual trafficking, typically young women and men are groomed and given preferential treatment, gifts, and drugs until they become reliant upon the “John”. In other cases, individuals are tempted with the promise of a better life, or in the case of immigration, the sponsorship for a visa (9). 

Florida Human Trafficking & Mandatory Reporting

Mandatory reporting of human trafficking by health care professionals is incorporated into the law in a growing number of locations in the United States. Health care professionals are already mandated reporters through previous existing laws that require reporting of child abuse, domestic violence, as well as knife and gunshot wounds (10). 

The following states the criminal and civil liability of failing to follow the law as a mandatory reporter in some states: 

In a civil action, the mandated reporter may be held liable for all damages that any person suffers due to the mandated reporters’ failure to file a report. In a criminal action, the mandated reporter may be found guilty of a misdemeanor punishable by imprisonment for up to 93 days and a fine of $500. 

Reporting of suspected adult human trafficking is not as clear in regard to mandatory reporting. However, vulnerable adults suspected of being abused, exploited, or victimized fall under the same guidelines and are reported to CI in the same manner as above.  

Federal Laws

Today, there are 39 states that have committed to the crusade of establishing a statute banning human trafficking.  

A specific U.S. Federal law addressing trafficking crimes was first enacted with the Trafficking Victims Protection Act of 2000. The bill has since been revised several times; however, the fundamental of it is to provide guidance and authorization for their “three-pronged approach that includes prevention, protection, and prosecution” and covers both sex and labor trafficking (11). 

Preventing Sex Trafficking and Strengthening Families Act of 2014 and The Justice for Victims of Trafficking Act of 2015 are both aimed at providing victims increased protection for exploitation and increased resources specifically aimed at prevention and support for child and youth sex trafficking crimes (11). 

The Customs and Facilitations and Trade Enforcement Reauthorization Act of 2009 is aimed towards prohibiting the importation of goods made by the benefit of human trafficking (11). 

Recognizing Signs of Human Trafficking

According to the Department of Health and Human Services, close to 90% of human trafficking victims visit a health care facility at least once while in servitude and are not identified as such by health care providers (14). This is due to a lack of education, lack of consistent use of identification and screening tools, and time constraints within the current health care system. As a mandatory reporter and healthcare team member, it is imperative to use best practice in recognizing the signs and symptoms as well as the tools that are available. 

Signs and Symptoms

Human trafficking victims may present to a healthcare setting with primary or underlying signs that may be related to physical or mental abuse. These signs and symptoms may be related to the reason that they are seeking treatment or may be identified by the healthcare provider during a thorough assessment. The following physical and psychological sequelae may be noted during an assessment as potential evidence of victimization (all derived from 9, 15): 

Physical

• Unexplained or implausible injuries
• Bruising
• Wounds and Cuts
• Missing or broken teeth
• Closed head injuries
• Blunt force trauma

Neurological

• Headaches
• Migraines
• Memory loss or difficulty concentrating
• Vertigo
• Insomnia
• Brain trauma

Gastrointestinal

• Diarrhea
• Constipation

Dietary

• Malnutrition
• Anorexia
• Severe weight loss

Cardiovascular and Respiratory

• Tachyarrhythmias
• Hypertension
• Respiratory Distress

Reproductive System

• Sexually transmitted disease
• Vaginal and/or anal fissures
• Previous Abortions

Psychological

• Depression
• Suicidal Ideation
• Anxiety
• Self-harm including cutting or branding
• Drug and alcohol abuse
• PTSD symptoms
• Regression
• Anger
• Dissociative and depersonalization tendencies

Red Flags and Indicators

There are several characteristics that should be kept in mind as red flags during the interview and assessment that may indicate potential trafficking. These include, but are not limited to (all derived from 9, 15, 14): 

• Tattoos that indicate ownership, a number, or tracking system or are out of character/obscene
• Inappropriate clothing for climate
• Workplace violence or abuse
• Unsanitary living conditions
• Multiple families or people sharing a living space that is too small
• Shares living space with employer
• Is not in control of financial assets
• Refusal to speak alone with health professionals
• Accompanied by individual that refuses to allow patient to speak for themselves or be alone
• Sex work under age 18
• Answers are scripted
• Answers are implausible or contraindicate
• Appears younger or older than stated age

Interview Tools and Techniques

Check with your facilities protocol for specific guidance on assessment and examination protocols for suspected abuse victims. There are also many scripted interviewing tools available online that assist with asking targeted questions. First and foremost, it is important to establish the patient’s safety and to gain trust. 

Gaining trust can be difficult and conducting assessments and interviews should be completed in a non-threatening environment with an unbiased and non-judgmental tone. Creating a space that is quiet and will not be interrupted is important. This will ensure that the potential victim feels safe communicating and is not concerned that she or he will be overheard. Present your demeanor in a non-threatening manner, at eye level, and focus on being attentive with observant listening. Maintain respectful eye contact to convey interest and reflective listening. If taking notes during the interview is required, explain to the patient what will be documented and what it will be utilized for (15). 

The National Human Trafficking Resource Center (NHTRC) offers a plethora of resources and scripted questions. The following are general questions on assessing if the individual is being forced into a situation and can be applied to any of the specific types of human trafficking (all from 15): 

“Did someone control, supervise or monitor your work/your actions?”
“Was your communication ever restricted or monitored?”
“Were you able to access medical care?”
“Were you ever allowed to leave the place that you were living/working? Under what conditions?”
“Was your movement outside of your residence/workplace ever monitored or controlled?”
“What did you think would have happened if you left the situation?"
"Was there ever a time when you wanted to leave, but felt that you couldn’t?"
"What do you think would have happened if you left without telling anyone?”
“Did you feel that it was your only option to stay in the situation?”
“Did anyone ever force you to do something physically or sexually that you didn’t feel comfortable doing?”
“Were you ever physically abused (shoved, slapped, hit, kicked, scratched, punched, burned, etc.) by anyone?”
“Were you ever sexually abused (sexual assault/unwanted touching, rape, sexual exploitation, etc.) by anyone?”
“Did anyone ever introduce you to drugs or medications as a method of control?”

While screening tools provide a base for asking difficult questions, the NHTRC advises “Before screening, users should also be prepared to draw upon the expertise of local legal and medical staff and to refer identified trafficking victims to appropriate housing, health, and social services in their area . . . the tool is a complement to, not a substitute for, specialized training in human trafficking, good professional practice and victim-centered service” (15). 

The NHTRC also provides a 24-hour national hotline that is able to guide health professionals through completing assessments and determining the next best steps to intervene or offer the victim assistance. 

Interventions and Collaboration

When presented with a suspected human trafficking victim, it is likely that the individual will not be alone. Maintaining safety and support for the patient may require separation from the suspected trafficker. While this may not be possible, an attempt should be made to bring the patient to a room or examination area unaccompanied. 

Be conscious of any cultural preferences that may affect the patient. If there are language barriers preventing meaningful communication, enlist the assistance of a professional interpreter. This is especially vital in cases where the accompanying visitor or family is attempting to interpret for the patient and may be filtering the victim’s responses. 

For patients that seek healthcare related to sexual abuse, a SANE assessment and rape kit should be obtained per facility protocol. With permission, patients should be tested for sexually transmitted infections including HIV, gonorrhea, UTIs, syphilis, and pubic lice, as well as a pregnancy test for females. Forced and coerced abortions are frequent among minor females in the sex industry (16). 

Thorough documentation of the patient’s reported reason for visit, physical and neurological assessment including any trauma, bruising, wounds, affect, and pertinent statements should be noted in the patient’s electronic medical record. 

Educate yourself on local resources and be able to provide assistance with finding access to healthcare, mental health, and rehabilitative resources that are available in the community. Victims may not want to take pamphlets with them that may be found, so providing locations or addresses of shelters or clinics with operating times may be a safer option. 

Collaborate with the healthcare team, law enforcement, and social work for suspected child or vulnerable adult trafficking. 

Mandatory reporting of suspected cases of child abuse or trafficking is not encumbered by HIPAA disclosure when reporting to authorities; however, when reporting suspected adult trafficking, disclosure and permission must be granted unless there is an imminent threat to the safety of the patient, or the patient has been identified as a vulnerable population. Thoroughly assess if the individual meets criteria as a vulnerable adult and proceed accordingly. If the adult does not meet criteria, permission must be gained to report. 

If a competent adult does disclose that they are a trafficking victim, determine if the patient is in immediate, life-threatening danger. If so, follow facility protocol and encourage and support the patient in reporting to a law enforcement agency. If there is no immediate danger, supportive care and assistance should be provided. The patient should be informed of the options available for social services, reporting, and resources. The creation of a safety plan is highly recommended (13). 

Prevention

Prevention of human trafficking requires public education, awareness, and knowing how to properly respond when faced with suspicions. The Blue Campaign is a strategy from the Department of Homeland Security to bring national awareness to the issue and provide specialized training to law enforcement and federal employees. Blue Campaign pamphlets and other materials are available at their website, www.dhs.gov/blue-campaign, for distribution. 

The Center for Disease Control takes the stance that sex trafficking is preventable via community awareness and acknowledging exploitation when it does occur. They state “Strategies based on the best available evidence exist to prevent related forms of violence, and they may also reduce sex trafficking. States and communities can implement and evaluate efforts that: 

• Encourage health behaviors in relationships
• Foster safe homes and neighborhoods
• Identify and address vulnerabilities during health care visits
• Reduce demand for commercial sex
• End business profits from trafficking-related transactions” (6).

One of the largest barriers to prevention in the healthcare system is the inability to recognize signs and symptoms. As cited above, a significant number of human trafficking victims have filtered in and out of healthcare systems without being recognized. This misses the opportunity to connect, provide resources, and offer further assistance. The NHTRC provides many resources for training within healthcare facilities and standardized forms and interviewing questions that may be tailored to individual situations and facility needs. 

Patient Education

UNICEF provides excellent resources for human trafficking prevention. Below is an excerpt from UNICEF, with “key messages” for children, which can help prevent trafficking. 

1. Educate yourself on the issue, and learn the signs of a trafficked victim.
2. Don’t accept friend requests from people you don’t know on social media. Traffickers commonly use sites like Twitter, Facebook, and Instagram to lure their victims.
3. Be aware of how traffickers recruit people, and pay attention to your surroundings.
4. Don’t reveal too much about yourself (i.e. your full name, address, school, or living situation) to people you don’t know, whether on your social media sites or in person, no matter how friendly the person may be.
5. Never agree to meet someone you don’t know without first consulting a trusted adult (i.e. parent, teacher, guidance counselor).
6. If you feel uncomfortable or are hesitant about a situation, confide in an adult who you can help you make the best choices.
7. Making a decision to leave a situation or relationship where you feel unsafe or are being harmed or threatened can be hard and scary. If possible, talk to someone you trust, like a friend, family member, counselor, or youth worker.
8. If you are in immediate danger or are being physically harmed, call 911 for help.
9. If running away from home, try to find a safe place to go or call the runaway switchboard at 1-800-Runaway.
10. If you suspect you or a friend are at risk trafficking, call the National Human Trafficking Hotline at 888-3737-888 or text “BeFree” (233733)

About

➀ Read and Learn

The following course content

Introduction   

For centuries, humans have been using, developing, and synthesizing opioid compounds for pain relief. Opioids are essential for treating patients who are experiencing severe and sometimes even moderate pain. Chronic pain can negatively affect our lives. In 2011, the cost of chronic pain ranged from $560 to $635 billion in direct medical expenses, lost productivity, and disability. An estimated one in five U.S. adults had chronic pain (11).

Introduction of opioid drug class, indications for use, most prescribed opioids, and their effects.

Opioids usually bind to mu-opioid receptor sites, where they have agonist effects, providing pain relief, sedation, and sometimes feelings of euphoria. Opiates refer only to natural opioids derived from the poppy plant. The term "opioids" includes all-natural, semi-synthetic, and synthetic opioids.

Opioids are classified into several categories based on their origin and chemical structure:

1. Natural Opioids (Opiates): These come from the opium poppy plant. Examples include morphine and codeine.
2. Semi-Synthetic Opioids: These are natural opioids that are chemically modified. Examples include drugs like oxycodone, hydrocodone, oxymorphone, and hydromorphone.
3. Synthetic Opioids: These opioids are entirely synthesized in a laboratory and do not have a natural source. Examples include fentanyl, tramadol, and methadone (4).

Providers must always caution patients about the benefits and risks. The main advantage of opioid medication is that it will reduce pain and improve physical function. A provider may use a 3-item Pain, Enjoyment of Life, and General Activity (PEG) Assessment Scale:

1. What number best describes your pain on average in the past week?
2. What number best describes how, during the past week, pain has interfered with your enjoyment of life?
3. What number best describes how, during the past week, pain has interfered with your general activity?

The desired goal is a 30% improvement overall with opioid treatment. (Centers for Disease and Control)

Providers must also go over potential side effects and warnings. Side effects include sedation, dizziness, confusion, nausea, vomiting, constipation, itching, pupillary constriction, and respiratory depression. Providers should discuss the importance of taking medication as prescribed. Taking opioids in larger than prescribed dosage, or in addition to alcohol, other illicit substances, or prescription drugs, can lead to severe respiratory depression and death. Individuals should not drive when taking opioids due to the sedating effects and decreased reaction times.

There are now thousands of different Food and Drug Administration (FDA) approved opioids available for providers to prescribe. They can be administered via other routes and come in various potencies. The strength of morphine is the "gold standard" used when comparing opioids. A morphine milligram equivalent (MME) is the degree of µ-receptor agonist activity. The following is a sample of some of the most prescribed opioids and their MME:

To utilize this information, multiply the dose for each opioid by the conversion factor to determine the quantity in MMEs. For example, tablets containing hydrocodone 5 mg and acetaminophen 325 mg taken four times a day would include a total of 20 mg of hydrocodone daily, equivalent to 20 MME (11).

A history of opioids leading to the current epidemic

While the current opioid epidemic has caused devastating effects in recent years, destruction from opioids has been going on for centuries. In the early 1800s, physicians and scientists became aware of the addictive qualities of opium. This finding encouraged research to develop safer ways to deliver opioids for pain relief and cough suppression, which led to the development of morphine. By the mid-1800s, with commercial production and the invention of the hypodermic needle, morphine became easier to administer.  

During the Civil War (1861 to 1865), injured soldiers were sometimes treated with morphine, and some developed lifelong addictions after the war. Without other options for pain relief, physicians kept giving patients morphine as treatment. Early indicators that morphine should be used cautiously were largely ignored. Between 1870 and 1880, the use of morphine tripled. Even with the problems associated with opioids, they continued to serve a vital part in the pain treatment of patients, and their use and development continued (6).  

Opioid prescribing increased fourfold during 1999–2010. Along with the increase in opioid prescriptions during this time, how they were prescribed also changed; opioids were increasingly prescribed at higher dosages and for longer durations. The number of people who reported using OxyContin for non-medical purposes increased from 400,000 in 1999 to 1.9 million in 2002 and to 2.8 million in 2003. This was accompanied by an approximately fourfold increase in overdose deaths involving prescription opioids (8).  

In 2020, approximately 1.4 million people were diagnosed with opioid use disorder (OUD), of those associated with opioid painkillers, as opposed to 438,000 who have heroin-related OUD (1, 4). Over 100,000 people died of a drug overdose, with 85% involved in an opioid (1, 4).  

Widespread efforts were made to combat this growing issue. The prescribing rate peaked and leveled off from 2010-2012 and has been declining since 2012. In 2021, an estimated 2.5 million adults had been diagnosed with OUD. However, the amount of MME of opioids prescribed per person is still around three times higher than in 1999 (5). 

 Controlled Substances

On July 1, 1973, the Drug Enforcement Administration (DEA) was established in the United States. The Diversion Control Division oversees pharmaceuticals. Within this Division are five levels of controlled substances, which classify illicit and medicinal drugs (7).  

Schedule I Controlled Substances

No medical use, lack of accepted safety for use under medical supervision, and high abuse potential.

Examples of Schedule I substances are heroin, lysergic acid diethylamide (LSD), and marijuana (cannabis).

Schedule II/IIN Controlled Substances (2/2N)

High potential for abuse, which can lead to severe dependence.

Examples include hydromorphone, methadone, meperidine, oxycodone, and fentanyl. Other narcotics in this class include morphine, opium, codeine, and hydrocodone.

Some examples of Schedule IIN stimulants include amphetamine, methamphetamine, and methylphenidate.

Other substances include amobarbital, glutethimide, and pentobarbital.

Schedule III/IIIN Controlled Substances (3/3N)

Less potential for abuse than substances in Schedules I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence.

Include drugs containing not more than 90 milligrams of codeine per dosage unit like Acetaminophen with Codeine and buprenorphine.

Schedule IN non-narcotics includes benzphetamine, phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone.

Schedule IV Controlled Substances

Have a low potential for abuse relative to substances in Schedule III.

Examples include alprazolam, carisoprodol, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, and triazolam, Tramadol.

Schedule V Controlled Substances

Low potential for abuse relative to Schedule IV and primarily consist of medications that have small quantities of narcotics.

Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams and ezogabine (10).

Explore behaviors that indicate opioid seeking, misuse, or addiction in patients.

Opioid use disorder (OUD) causes significant impairment or distress. Diagnosis is based on the following criteria: unsuccessful efforts to reduce or control use or use that leads to social problems and a failure to fulfill obligations at work, school, or home. The term Opioid Use Disorder is the preferred term; "opioid abuse or dependence" or "opioid addiction" have negative connotations and should be avoided. (3).

OUD occurs after a person has developed tolerance and dependence, resulting in a physical challenge to stop opioid use and increasing the risk of withdrawal. Tolerance happens over time when a person experiences a reduced response to medication, requiring a larger amount to experience the same effect. Opioid dependence occurs when the body adjusts to regular opioid use. Unpleasant physical symptoms of withdrawal occur when medication is stopped. Symptoms of withdrawal include anxiety, insomnia, abdominal pain, vomiting, diarrhea, etc. (5).

Patients who have OUD may or may not have practiced drug misuse. Drug misuse, the preferred term for "substance abuse," is the use of illegal drugs and the use of prescribed drugs other than as directed by a doctor, such as using more amounts, more often, or longer than recommended or using someone else's prescription (3).

Some indications that a patient may be starting to have unintended consequences with their opioid prescription may include the following symptoms: craving, wanting to take opioids in higher quantities or more frequently, difficulty controlling use, or work, social, or family issues. If providers suspect OUD, they should discuss their concerns with their patients nonjudgmentally and allow the patient to disclose related concerns or issues. Providers should assess the presence of OUD using the DSM-5 criteria.

Providers can use validated screening tools such as:

• Urine and oral fluid toxicology testing
• Drug Abuse Screening Test (DAST)
• Tobacco, Alcohol, and/or other Substance use Tools (TAPS)
• A three-question version of the Alcohol Use Disorders Identification Test (AUDIT-C)

The following patients are at higher risk for OUD or overdose:

• History of depression or other mental health conditions
• History of a substance use disorder
• History of overdose
• Taking 50 or greater MME/day or taking other central nervous system depressants with opioids

The 12 components of the CDC’s recent guidelines for opioid prescribing.

In 2022, the CDC updated the 2016 guidelines to help prescribers navigate prescribing opioids amid an epidemic. These guidelines are directed toward prescribing medications to adults to be taken in the outpatient setting, for example, primary care clinics, surgery centers, urgent cares, and dental offices. These do not apply to providers caring for individuals with sickle-cell disease, cancer, those receiving inpatient care, or end-of-life or palliative care. They are also intended to serve as a guideline, and each treatment plan should be specific to the unique patient and circumstances.

Some of the Goals of the guidelines are to:

• Improve communication between providers and patients about treatment options and discuss the benefits and risks before initiating opioid therapy.
• Improve the effectiveness and safety of treatment to improve quality of life.
• Reduce risks associated with opioid treatment, including opioid use disorder (OUD), overdose, and death.

Recommendation #1: Determining when it is appropriate to initiate opioids for pain.

An essential part of the prescribing process is determining the anticipated pain severity and duration based on the patient’s diagnosis. Pain severity can be classified into three categories when measured using the standard 1-10 numeric scale. Pain scores 1-4 are considered mild, 5-6 are moderate, and 7-10 severe. Opioids are typically used for moderate to severe pain.

The patient’s diagnosis will allow the provider to determine if pain initially falls into one of the following three categories of anticipated duration: acute, subacute, and chronic. Acute pain is expected to last for one month or less. Acute pain often is caused by injury, trauma, or medical treatments such as surgery. Unresolved acute pain may develop into subacute pain if not resolved in 1 month. If pain exceeds three months, it is classified as chronic. Pain persisting longer than three months is chronic. It can result from underlying medical conditions, injury, medical treatment, inflammation, or unknown cause.

The CDC guidelines state that non-pharmacologic and non-invasive methods are the preferred first-line method of analgesia, such as heat/cold therapy, physical therapy, massage, rest, or exercises, etc. Despite evidence supporting their use, these therapies are only sometimes covered by insurance, and access and cost can be barriers, particularly for uninsured persons who have limited resources, no reliable transportation, or live in rural areas where treatments are not available.

When this is insufficient, non-opioid medications, such as Gabapentin, acetaminophen, or nonsteroidal anti-inflammatory drugs (NSAID), should be considered next. Selective antidepressants and anticonvulsant medications may also be effective. Some examples of when these drugs may be appropriate include neuropathic pain, lower back pain, musculoskeletal injuries (including minor pain related to fractures, sprains, strains, tendonitis, and bursitis), dental pain, postoperative pain, and kidney stone pain.

Providers, however, must also consider the risks and benefits of long-term NSAID use because it may also negatively affect a patient’s gastrointestinal and cardiovascular system. Depending on the diagnosis, a patient may also require an invasive or surgical intervention to treat the underlying cause to alleviate pain.

If the patient has pain that does not sufficiently improve with these initial therapy regimens, at that point, opioids will be the next option to be considered.

It does not mean that patients should be required to sequentially “fail” nonpharmacologic and non-opioid pharmacologic therapy or use any specific treatment before proceeding to opioid therapy. Example: A patient for whom NSAIDs are contraindicated has recently sustained a rotator cuff injury and is experiencing moderate pain to the point at which it is disturbing their sleep, and it will be several weeks before they can have surgery.

Recommendation #2: Discuss with the patient realistic treatment goals for pain and overall function.

Ideally, goals include improving quality of life and function, including social, emotional, and physical dimensions. The provider should help guide these patients to realistic expectations based on their diagnosis. This may mean that the patient may anticipate reduced pain levels but not complete elimination of pain. The provider should discuss the expected or typical timeframe where they may need medications.

If medications are anticipated for acute or subacute pain, a discussion about the expected timeframe for pain should be highlighted in the debate. The patient may then better understand if their recovery is progressing. For chronic conditions, the conversation will focus on or may emphasize the overall risks of beginning long-term medication therapy. They may also advise patients, particularly those with irreversible impairment injuries, that they may experience reduced pain but will not regain function. A withdrawal plan will be discussed if opioid therapy is unsuccessful or the risk vs. benefit ratio is no longer balanced.

The second section of recommendations covers the selection of opioids and dosages.

Recommendation #3: Prescribe immediate-release (I.R.) opioids instead of extended-release and long-acting (ER/LA) opioids when starting opioid therapy.

Immediate-release opioids have faster-acting medication with a shorter duration of pain-relieving action. ER/LA opioids should only be used in patients who have received specific dosages of immediate-release opioids daily for at least one week. Providers should reserve ER/LA opioids for severe, continuous pain, for example, individuals with cancer. ER/LA opioids should not be for PRN use. The reason for this recommendation is to reduce the risk of overdose. A patient who does not feel adequate relief or relief fast enough from the ER/LA dose may be more inclined to take additional amounts sooner than recommended, leading to a potential overdose.

Recommendation #4: Prescribe the lowest effective dose.

Dosing strategies include prescribing low doses and increasing doses in small increments. Prescribe the lowest dose for opioid patients. Carefully consider risk vs. benefits when increasing amounts for individuals with subacute and chronic pain who have developed tolerance. Providers should continue to optimize non-opioid therapies while continuing opioid therapy. It may include recommendations for taking non-opioid medications in addition to opioids and non-pharmacologic methods.

Providers should use caution and increase the dosage by the smallest practical amount, especially before increasing the total opioid dosage to 50 or greater morphine milligram equivalent (MME) daily. Increases beyond 50 MME/day are less likely to provide additional pain relief benefits. The greater the dosage increases, the tendency for risk also increases. Some states require providers to implement clinical protocols at specific dosage levels.

Recommendation #5: Tapering opioids includes weighing the benefits and risks when changing the opioid dosage.

Providers should consider tapering to a reduced dosage or tapering and discontinuing therapy and discuss these approaches before initiating changes when:

• The patient requests dosage reduction or discontinuation,
• Pain improves and might indicate the resolution of an underlying cause,
• Therapy has not reduced pain or improved function,
• Treated with opioids for a long time (e.g., years), and the benefit-risk balance is not clear.
• Receiving higher opioid dosages without evidence of improvement.
• Side effects that diminish the quality of life or cause impairment.
• Opioid misuse
• The patient experiences an overdose or severe event.
• Receiving medications or having a condition that may increase the risk of an adverse event.

Opioid therapy should not be discontinued abruptly unless there is a threat of a severe event, and providers should not rapidly reduce opioid dosages from higher dosages.

Patient agreement and interest in tapering will be key components of successful tapers. Integrating behavioral and non-opioid treatment and interventions for comorbid mental health conditions before/during a taper can help manage pain, strengthen the therapeutic relationship between the provider and patient, and improve the likelihood of positive tapering outcomes. When dosages are reduced or discontinued, a taper slow enough to reduce symptoms and withdrawal should be used. Patients should receive education on possible withdrawal symptoms and when to contact the provider.

For those taking opioids for a shorter duration, a 10% decrease of the original dose per week or slower until close to 30% of the initial amount is reached, followed by a weekly reduction of roughly 10% of the remaining dose) is less likely to trigger withdrawal. Tapers of 10% per month or less are better tolerated than rapidly tapering off when patients have been taking opioids for a longer duration (e.g., for a year or longer). Significant opioid withdrawal symptoms can indicate the need to slow the taper rate further. Short-term medications might also help manage withdrawal symptoms. Providers should follow up frequently (at least monthly) with patients engaging in opioid tapering.

Close monitoring is required for patients who cannot taper and who continue on high doses or otherwise high-risk opioid regimens and should collaborate with patients to mitigate overdose risk. Some patients with unanticipated challenges to tapering may need to be evaluated for OUD.

The third section focuses on the duration of opioid therapy and routine patient follow-up.

Recommendation #6: Prescribing no greater quantity than needed for the expected duration of severe pain requiring opioids.

A few days or less is often enough when opioids are used for common causes of nonsurgical acute pain. Many states have passed legislation that limits initial opioid prescriptions for acute pain to less than seven days. Many insurers and pharmacies have enacted similar policies. Providers should avoid prescribing additional opioids to patients if pain continues longer than expected.

Providers should prescribe and advise opioid use only as needed rather than on a scheduled basis (e.g., one tablet every 4 hours). Limiting the duration of therapy can decrease the need to taper. However, tapering may need to be considered if patients take these medications around the clock for more than a few days.

Longer durations of therapy may be needed when the injury is expected to result in prolonged severe pain (e.g., greater than seven days for severe traumatic injuries). Patients should be evaluated at least every two weeks if they are receiving opioids for acute pain. Suppose opioids are continued for a month or longer. In that case, providers should address potentially reversible causes of chronic pain so that the length of therapy does not continue to extend.

Recommendation #7: Evaluate the benefits and harms of opioid therapy regularly.

The benefits and risks for Evaluating benefits and risks within 1-4 weeks of starting long-term opioid therapy for subacute and chronic pain should be evaluated within 1-4 weeks of initiating therapy and after dosage increases.

The evaluation should include patient perspectives on progress and challenges in moving toward treatment goals, including sustained improvement in pain and function. The Three-item Pain, Enjoyment of Life, and General Activity (PEG) assessment scale could be utilized to help determine patient progress.

Providers should also ask patients about common adverse effects, such as constipation and drowsiness, and assess for outcomes that might be early warning signs for more serious problems such as overdose or OUD.

Patient re-evaluation should occur after therapy begins (about two weeks) when ER/LA opioids are prescribed if the total daily opioid dosage is greater than or equal to 50 MME/day or if there is a concurrent benzodiazepine prescription. These individuals are at a higher risk for overdose. Follow-up for individuals starting or increasing the dosage of methadone is recommended every 2-3 days for the first week. Providers should reassess all patients receiving long-term opioid therapy at least every three months.

The last section of recommendations covers patients at risk for OUD and overdose.

Recommendation #8: Use strategies to mitigate risk by evaluating risk for opioid-related harms, discussing risk with patients, and incorporating risk reduction strategies into the treatment plan.

The patient’s habits (including alcohol and illicit drug use) and behavioral and mental health must be considered. Patients with a history of substance use disorders, depression, and/or mental health disorders have a higher risk of overdose and OUD. Even though the dangers of opioid therapy are higher with these patients, they may still require opioid treatment for pain management.

Psychological distress can interfere with the improvement of pain and/or function in patients experiencing chronic pain; using tools like the Generalized Anxiety Disorder (GAD)-7 and the Patient Health Questionnaire (PHQ-9 or PHQ-4) to assess for anxiety, post-traumatic stress disorder (PTSD), and depression might help providers improve overall pain treatment outcomes. They should also ensure that treatment for depression and other mental health conditions is effective, consulting with behavioral health specialists when needed.

Additionally, providers should:

• Educate on the risks of overdose when opioids are combined with other drugs or alcohol.
• Use caution when prescribing opioids for people with sleep-disordered breathing due to their increased risk for respiratory depression. The provider may ascertain if a patient is compliant with prescribed CPAP.
• Use caution and increased monitoring for patients with renal or hepatic insufficiency.
• Use caution and increased monitoring for patients aged 65 years or older.
• Offering naloxone when prescribing opioids, particularly to patients at increased risk for overdose.

If patients experience a nonfatal opioid overdose, providers should evaluate for OUD. Providers should reduce opioid dosage, discontinue opioids when indicated, continue monitoring, and support for patients prescribed or not prescribed opioids.

Recommendation #9: Reviewing prescription drug monitoring program (PDMP) data.

Providers should review PDMP data specifically for prescription opioids, benzodiazepines, and other controlled medications patients have received from additional prescribers to determine all the opioids the patient could potentially receive. Patients with multiple prescriptions and from various providers are at an increased risk for overdose or OUD. PDMP data should be reviewed before initial drugs for subacute or chronic pain and at least every three months during long-term opioid therapy.

Recommendation # 10: Considering the benefits and risks of [urine] toxicology testing.

Toxicology testing should be used to inform and improve patient care. Providers, practices, and health systems should minimize bias in testing and not test based on assumptions about different patients.

Recommendation # 11: Use caution when prescribing opioid pain medication and other medications concurrently.

Benzodiazepines and opioids can cause CNS depression and potentiate opioid-induced decreases in respiratory drive. Because other CNS depressants can potentiate respiratory depression associated with opioids, benefits vs. risks should be considered.

Recommendation # 12: Offering or arranging treatment for OUD if needed.

Includes referring a patient to a specific treatment center where behavior therapy and medications may be prescribed.

Prescription Drug Monitoring Programs (PDMP) and Electronic Prescribing.

Prescription Drug Monitoring Programs (PDMP) is a database that keeps track of controlled substance prescriptions. It helps to improve opioid prescribing, inform clinical practice, and protect at-risk patients. A pharmacist must enter controlled substances into the state PDMP when dispensing them. When the pharmacist enters this data, it may occur at various intervals, from one month, daily, or even "real-time." However, a PDMP is only helpful if providers check the system before prescribing (10).  

Some states have implemented legislation that requires providers to check a state PDMP before prescribing certain controlled substances and in certain circumstances. Most current mandates require that all prescribers query PDMPs when prescribing any opioid. Some states require prescribers to query PDMPs every time a controlled substance is prescribed, while others require a query only for the initial prescription. Subsequent checks of PDMPs also vary from every time a drug is issued to specific intervals (e.g., every 90 days, twice a year, annually) should prescribing continue.  

Some mandates have categorical requirements; e.g., a query must be made if the prescription is over a three-day or seven-day supply or if a certain prescribed level of MME is exceeded. Other states' mandates are based on subjective criteria, e.g., a prescriber's judgment of possible inappropriate use or the prescriber's discretion regarding whether to query the PDMP. Finally, some states mandate that only prescribers in opioid treatment programs, workers' compensation programs, or pain clinics must query PDMPs (10, 11).  

In addition to PDMPs, there has been an increase in requirements for providers to utilize Electronic Prescribing for Controlled Substances (ECPS). Electronic prescribing programs for both providers and pharmacies must meet DEA requirements. The DEA's March 31, 2010, conditions were updated on July 27, 2023 (12).  

On January 1, 2023, the Centers for Medicare and Medicaid Services (CMS) implemented additional requirements for controlled substances for recipients of Medicare Part D. There are over 51 million U.S. people enrolled in Medicare Part D (Center for Medicare Advocacy, 2023). In addition to state laws, these rules require that prescribers e-prescribe at least 70 percent of controlled substances for patients that have Medicare Part D. A waiver may be approved if the prescriber cannot conduct electronic prescribing due to circumstances beyond the provider's control (12).  

Starting June 27, 2023, the 'Consolidated Appropriations Act of 2023' requires new or renewing Drug Enforcement Administration (DEA) registrants, to have at least one of the following: 

• A total of eight hours of training from specific organizations on opioid or other substance use disorders 
• Board certification in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, American Board of Addiction Medicine, or the American Osteopathic Association 
• Graduation within five years and status in good standing from medical, advanced practice nursing, or physician assistant school in the U.S. that included an opioid or other substance use disorder curriculum of at least eight hours (11, 12).  

Providers must follow either state law or DEA/CMS regulations, whichever is more stringent. The following map indicates various rules in each state, which will continue to change when new legislation is enacted (11, 12).  

Important teaching points about opioid storage and disposal.

Safe Storage 

Patients should understand that prescription opioids need to be stored securely (i.e., keeping them in a locked area). This is especially true if children, teens, and other visitors in the house may be aware of their presence. Teens and young adults are the biggest misusers of prescription pain medication. In 2018, over 695,000 youths ages 12–17 and 1.9 million young adults ages 18–25 reported misusing prescription pain medication in the past year. Young people may misuse prescription opioids for many reasons, including curiosity, peer pressure, and wanting to fit in. Another reason teens and young adults may decide to take prescription opioids is because they can be easier to get than other drugs. Studies show that 53% percent of people over 12 who obtained prescription pain medication for non-medical use received them from a friend or relative (13).  

Safe Disposal 

Patients should be advised on how to get rid of unused or expired medications. The best option is to immediately take them to a drug take-back site, location, or program. These sites or programs can be found online, or the pharmacist may have information. If it is not feasible for the patient to get rid of the drug using a take-back program, the patient should be advised to check if it is on the FDA flush list. If it is, the medication should be flushed down the toilet. Again, the list of drugs is available on the FDA website. If it is not on that list, it should be discarded in the trash at home.  

Patients should follow these disposal instructions: Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds. Next, place the mixture in a container such as a sealed plastic bag; then throw away the container in your trash at home. Last, the patient should remove or permanently cover all personal information on the prescription label of empty medicine bottles or packaging, then trash or recycle the open container (14).  

OUD treatment, including medications.

Treatment for OUD is multi-faceted and typically includes both mental health components and FDA-approved OUD treatment medications. Mental health components may consist of counseling or a structured treatment program. Cognitive behavioral therapy (CBT) may also be beneficial. A potential barrier to OUD treatment, on the provider's and patient's behalf, is the perception that patients must engage in counseling to start or continue receiving OUD treatment medication. While the mental health components are essential, there may be barriers for patients to begin mental health treatment programs, which include expense, travel, and available openings within the programs. Medication therapy may be a helpful start for these patients (9). 

FDA-approved medications indicated for the treatment of OUD include methadone, buprenorphine, and naltrexone. Suboxone is a combination drug composed of buprenorphine and naltrexone.  

Medication has several advantages as part of the OUD treatment plan.  

• Help the individual to remain safe and comfortable during detox. 
• Reduce or eliminate cravings for opioids 
• Minimize relapse since the individual is not experiencing uncomfortable withdrawal symptoms 
• Allow the individual to focus on therapy without being distracted by withdrawal symptoms and cravings 
• Increase safety in cases of overdose 

Methadone 

Methadone is a full agonist opioid and is a Schedule II controlled medication. Methadone can be prescribed purely for the treatment of pain, as well as for OUD. Methadone treatment for OUD can only be provided through a Substance Abuse and Mental Health Services (SAMHSA)-certified opioid treatment program. Patients taking methadone to treat OUD must receive the medication under the supervision of a clinician. After consistent compliance, patients may take methadone at home between program visits. The length of methadone treatment should be a minimum of 12 months. Methadone doses are often adjusted and readjusted. Methadone is slowly excreted, and there is overdose potential if not taken as prescribed (9).  

Buprenorphine 

Buprenorphine is a partial agonist opioid. Buprenorphine can be prescribed by any provider with a current, standard DEA registration as a Schedule III Controlled Substance. Like opioids, it produces effects such as euphoria or respiratory depression. With buprenorphine, however, these effects are weaker than those of full opioids such as heroin and methadone. It also has unique pharmacological properties that help lower the potential for misuse and diminish the effects of physical dependency opioids, such as withdrawal symptoms and cravings (9). Subutex was a brand-name version of buprenorphine, discontinued in 2011 after new formulations that were less likely to be misused were developed.  

Naltrexone 

Naltrexone is an opioid antagonist, not addictive, and does not cause withdrawal symptoms. It blocks the euphoric and sedative effects of opioids by binding and blocking opioid receptors and reduces and suppresses opioid cravings. There is no potential for misuse and diversion. Naltrexone can be prescribed in any setting and can be taken as a pill or once monthly extended-release intramuscular injection (9).  

It was estimated 2021 that of the 2.5 million people with OUD, only 36% received any treatment, and only 22% received medications. A part of the July 27, 2023, Consolidated Appropriations Act amended the Controlled Substances Act to eliminate the requirement that providers obtain a specific waiver (a DATA waiver) to prescribe buprenorphine (including Suboxone) to treat opioid use disorder, known as the X-waiver. Additionally, there are no longer any caps on the number of patients a practitioner can treat. This, however, does not change the requirements for methadone treatment (15).  

Case Study #1

Patient Name: John Henderson,

Gender: Male

Age: 60

Height: 6' 1"

Weight: 190 lbs.

He is employed as a grocery store manager. Reports not using tobacco; drinks alcohol occasionally and has no illicit drug use. He has hypertension and high cholesterol and takes Losartan 50mg daily and Atorvastatin 20 mg daily.

This patient presents to a primary care office with pain and stiffness in the shoulder joint, which has progressively worsened for six months following rotator cuff surgery. He states his pain is unchanged, and he has a limited range of motion. It has been interfering with his ability to do his job. He said he went to physical therapy for a few weeks after his surgery but admitted he did not often complete the home exercise program regimen. An MRI was obtained and showed he had adhesive capsulitis. What are treatment options to consider for "frozen shoulder"?

Given the patient's diagnosis, non-opioid therapy options include nonsteroidal anti-inflammatory drugs, intraarticular glucocorticoid injections, steroid injections into the shoulder joint, range of motion exercises, physical therapy, and consulting with an orthopedic specialist who may recommend a joint manipulation under anesthesia. Each of these should be considered before opioid therapy.

Nursing Considerations 

Nurses remain the most trusted profession for a reason, and advanced practice registered nurses (APRNs) are often pillars of patient care in several health care settings. Patients turn to nurses for guidance, education, and support. While there are no specific guidelines for the nurse’s role in opioid education and management, here are some suggestions to provide quality care for patients currently taking opioid medications. 

Obtain a Detailed Health History 

Often times, pain and mental health can be dismissed and overlooked in health care settings. If a patient is complaining of symptoms that could be related to pain, inquire more about that complaint. Ask about how long the symptoms have lasted, what treatments have been tried, if these symptoms interfere with their quality of life, and if anything alleviates any of these symptoms. If you feel like a patient's complaint is not being taken seriously by other health care professionals, advocate for that patient to the best of your abilities. A detailed pain assessment and history can provide context for opioid pain management and a patient's plan of care. When taking a health history, ask about any prior surgeries, major life stressors in the past year, or any prior opioid usage.  

Review the Medication History 

Often times, in busy clinical settings, reviewing health records can be overwhelming. Many people take pain medications, including opioids, for various reasons. Ask patients how they are feeling on the medication, if their symptoms are improving, if there are any changes to medication history, and if they use any other substances other than prescribed medications, such as alcohol, tobacco, or other drugs. Remember, prescription medications are not the only medications people take. Confirm medication route, dosage, frequency, and all the details to make sure you and the patient are on the same page and to avoid medication errors and complications. Medication history should be reviewed at every encounter. 

Avoid Making Judgements 

Society often stigmatizes open discussions of prescription medication and pain. Patients may avoid asking for pain medication for fear of being perceived as a "drug seeker." Other times, patients may have OUD and continuously ask for an increased number of opioid medications. Be willing to be honest with yourself about your comfort level discussing topics and providing education on opioid medications, drug interactions, and pain management. Be willing to address any questions/concerns the patients may have without making judgements. 

Communicate the Plan of Care 

Communicate the plan of care to other staff involved for continuity of care. For several patients, especially for patients with chronic pain or who use opioids long-term, care often involves a team of mental health professionals, physical therapists, nurses, specialists, pharmacies, and more. Ensure that patients' records are up to date for ease in record sharing and continuity of care and to reduce the incidence of opioid medication errors. 

Engage in Self Learning 

Stay up to date on continuing education related to opioid medications, pain management, and prescribing regulations. Evidence-based information and scope of practice is always evolving and changing. You can then present your new learning and findings to other health care professionals and educate your patients with the latest information. You can learn more about the latest research on pain management medications, non-pharmacological pain management options, and opioids by following updates from evidence-based organizations, such as the CDC or your local health department.  

Perform Pain Assessments  

As we know, it is not possible to look at someone with the naked eye and determine if they are in pain. Sometimes, it may be obvious when a patient is in pain (e.g., visible lacerations) and need pain management options, such as opioids. Other times, pain management is addressed as a result of taking a complete health history, listening to patient's concerns, completing a pain assessment, and offering testing to determine the cause of pain. 

Assess for Opioid Use Disorder 

While it is not possible to look at someone and determine if they have OUD, APRNs should pay attention to certain behaviors, for example, when a patient continually asks for more opioid medications or mentions that they are experiencing many symptoms common to those of OUD. OUD may be diagnosed as a result of completing a health history, listening to patient's concerns, and offering testing to determine the cause of pain. Remember, anyone can have OUD, and no two OUD patients appear the same.  

Provide Patient Teaching 

Patients should know that anyone has the possibility of experiencing side effects of opioid medications, just like with any medication. Patients should be aware that if they notice any changes in their breathing, changes in their heart rate, or feel like something is a concern, they should seek medical care. Because of social stigma associated with opioids and pain management, people may be hesitant to seek medical care because of fear, shame, and embarrassment. However, as more research and social movements discuss opioid use, there is more space and awareness for opioid education and opioid overdose prevention.  

Nurses should also teach patients to advocate for their own health in order to avoid possible opioid complications and poor pain management.  

Here are important tips for patient education in the inpatient or outpatient setting.  

• Tell the health care provider of any existing medical conditions or concerns (need to identify risk factors) 
• Tell the health care provider of any existing lifestyle concerns, such as alcohol use, other drug use, sleeping habits, diet, menstrual cycle changes (need to identify lifestyle factors that can influence opioid use and pain management) 
• Tell the health care provider of any prior experiences with opioid medication (if applicable) and any medication reactions or side effects (need to identify risk factors, address pain management appropriately, identify any allergies, and avoid possible opioid overdose symptoms) 
• Tell the health care provider if you have any changes in your breathing, bodily functions, or heart rate (potential opioid overdose symptoms) 
• Tell the nurse or health care provider if you experience any pain that increasingly becomes more severe or interferes with your quality of life 
• Keep track of your pain, overall health, medication use, and health concerns via an app, diary, or journal (self-monitoring for any changes) 
• Tell the health care provider right away if you are having thoughts of hurting yourself or others (possible increased risk of suicidality and public safety concerns) 
• Take all prescribed medications as indicated and ask questions about medications and possible other treatment options, such as non-pharmacological options or surgeries 
• Tell the health care provider if you notice any changes while taking medications or other treatments to manage your pain (potential worsening or improving health situation) 

Research

There is extensive publicly available literature on opioids medications. These can be found via the National Institutes of Health website and other evidence-based journals. As research is dependent upon the available of study participants, there are several ways people who take opioids can become part of research. If a patient is interested in participating in clinical trial research, APRNs can encourage them to seek more information on clinical trials from local universities and health care organizations. 

Case Study #2

• Patient: Pilar 
• Age: 40 
• Height: 5' 1" 
• Weight: 135 lbs. 

Pilar presents to the urgent care clinic today complaining of a severe migraine, which started yesterday. Her history includes a hip injury following a car accident three years ago in which she developed chronic post-traumatic arthritis in the hip. After a total hip arthroplasty, she was diagnosed with heterotopic ossification (bone grows in tissue where it shouldn’t). For the past year, she has been taking 20 mg of oxycodone twice daily to manage chronic hip pain after unsuccessful non-opioid therapies. She has three children with no known pregnancy or postpartum complications. She previously worked part-time as an administrative assistant but has been off work since the car accident. She has post-traumatic stress disorder (PTSD) related to the accident. She has been prescribed Xanax 0.5mg up to three times daily for anxiety. She does not smoke, drink alcohol, or take illicit substances. 

• What are some specific questions you'd want to ask about the hip arthritis? 
• What are some health history questions you'd want to highlight? 
• What lab work or testing would you suggest to perform?  

For her migraine, Pilar stated she needed to take more of her oxycodone to deal with the pain and because she could not sleep last night. She is concerned because she is running out of pills. She said her primary care doctor's office was closed, so she came to the urgent care.  

• What are some non-pharmacological interventions you can do for Pilar's pain? 
• What are some questions you'd want to ask about her migraine? 
• What are side effects of opioids would you discuss with her? 

Here are some things to consider for Case Study #2.  

• Discuss concerns with the patient. This includes taking the opioid more often than prescribed, potential problems with respiratory depression, and overdose.  
• Recommend trying eletriptan or dihydroergotamine nasal spray first rather than additional opioids. 
• Review the PDMP to see the prescription history for this patient. Attempt to contact the primary care provider to develop a plan of care. 
• Consider conducting toxicology testing 
• Consider offering naloxone  
• Use the DSM-5 criteria to assess the presence (and severity) of OUD or arrange an assessment with a substance use disorder specialist. Offer treatment for OUD if it is confirmed. 

Case Study #3 

Sabrina is a 16-year-old Black high school student working as a waitress at a local restaurant. She arrives to the local pediatric emergency room after her shift with her mom because she thinks she is experiencing a sickle cell crisis. Sabrina reports that she has these crises every few months, and this is probably the third time she's been in this much pain. She reports being at this same ER last year for something similar. Her mother is completing paperwork and would like Sabrina to get some pain medication as well.  

• What are some specific questions you'd want to ask about her health? 
• What are some health history questions you'd want to highlight? 
• What lab work or testing would you suggest to perform?  
• What pain assessments would you perform on Sabrina? 

Sabrina agrees to provide bloodwork, complete imaging, and be admitted. She said that no health care provider talked to her about how painful sickle cell crises can be, and she doesn't routinely take pain medication because she "doesn't want to be addicted." Sabrina and her mom heard about pain management options for these extremely painful episodes from social media and the internet and would like Sabrina to get her pain controlled. Sabrina said that she had some opioids last time she was in the ER, but she doesn't remember the name. Her mom doesn't remember the name either, but she remembers it was in an IV medication.  

• How would you discuss Sabrina's pain management concerns? 
• Given Sabrina's age, medical history, and prior history of opioid use, what medication options would be appropriate for a sickle cell crisis in an adolescent?  

Sabrina has been in the pediatric ER for over a day receiving IV hydromorphone. She reports some relief, but Sabrina and her mom are concerned. Sabrina wants to live her life like a normal teenager without being in the hospital every few months for pain. Her mom asks if there is a way to have pain medication at home. Both Sabrina and her mom would like to know if there is anything that can be done to help with the pain outside of medications as well. Sabrina doesn't want to use pain medications daily but wants to have them at home just in case she can't get to the hospital.  

• Knowing Sabrina's concerns, what are some possible non-pharmacological pain management options? 
• Knowing Sabrina's health history, what would be some patient education talking points about at-home opioid medications and possible side effects?   
• What are some possible consequences of leaving pain improperly managed?  

Conclusion

Even providers who do not prescribe opioids should be familiar with the effects of opioids and OUD due to its high prevalence in the United States. Understanding the types of pain, how pain occurs, and how it impacts a person's quality of life is especially important. There is still an associated stigma among patients who use Opioids to treat chronic pain conditions. It is essential to recognize that there are times when opioid use is appropriate, as long as the provider practices the recommended guidelines and sound clinical judgment.

Tirzepatide for Type 2 Diabetes and Weight Management

Introduction   

The emergence of the drug tirzepatide is becoming more popular and widespread and is being utilized among those with diabetes and also those who desire to lose weight. It is one of the newest diabetic drugs given by injection that also triggers dramatic weight loss in those who use the injections.

The U.S. Food and Drug Administration (FDA) approved tirzepatide in 2022 for individuals with diabetes, particularly Type 2 Diabetes. The FDA officials have not approved tirzepatide yet for weight loss, but they are currently tracking the medication and may have a recommendation for its approval by the end of this year. Clinical trials have shown that individuals with an elevated body mass index (BMI) and who did not have diabetes lost a considerable amount of weight when they received tirzepatide (1).

Advanced Practice Registered Nurses (APRNs) need to understand how to safely prescribe tirzepatide and the reasoning as to why it causes weight loss for specific individuals.

Drug Classification

Tirzepatide is part of a class of medications called glucose-dependent insulin tropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonists. It comprises a 39 amino acid linear synthetic peptide conjugate to selective receptor agonists in preclinical and clinical trials.

Tirzepatide is used for treating Type II diabetes in adults as an adjunct to diet and exercise. It is also used for weight loss in some individuals and has gained increased attention as a new therapeutic agent for glycemic and weight control.

Social media has had a significant influence and increased the desire to use tirzepatide, and while individual results vary, the weight loss in adults ranged from 12 – 25 pounds.

Online pharmacies, diet clinics, and medical spas are implementing thousands of ads on social media to capitalize on a surge of interest in the drug.

Indications of Usage

The use of tirzepatide is being used for both Type II diabetes and weight control in certain patients. It has been a game changer for people living with Type II diabetes. The drug’s primary use is as an adjunct to diet and exercise to improve glycemic control in adults with diabetes.

The drug has also proven beneficial for weight loss in patients experiencing obesity, and those who are taking the highest dosage have shared a body weight reduction of 15.7% (2). Tirzepatide is an injectable prescription medication used together with diet and exercise, and it is not yet known if it can be used safely with patients who have had pancreatitis.

It is important to remember that it is not to be used for patients with Type I diabetes, but it is safe for Type II diabetic patients. Also, the safety of tirzepatide has yet to be discovered for children and those under 18; therefore, the medication should not be used for this age group.

In studies conducted with or without diabetic medicines, 75% – 90% of patients taking tirzepatide reached an overall A1C of less than 7% with an average starting A1C of 7.9 – 8.6% across the following dosages – 5mg, 10mg, and 15mg. The study results were measured at weeks 40 and 52 (3).

Use of Tirzepatide with Diabetic Patients

Tirzepatide can be used for patients with Type II diabetes in combination with a diabetic-friendly diet and exercise. The drug works by lowering the patient’s overall blood sugar and also improves the A1C results of patients over some time. The injection has been approved by the FDA to treat Type II diabetes and is administered once weekly (4).

It is considered the first in a new class of medications – a dual glucose-dependent insulin tropic polypeptide (GIP) and glucagon-like-peptide-1 (GLP-1) receptor antagonist. The mechanism of how it works mimics two gut hormones (GIP and GLP-1). These hormones are essential in how patients digest food and regulate blood glucose after meals. The hormones also play a role in making individuals feel fuller and curb specific food cravings.

The provider can prescribe tirzepatide before attempting other diabetic medications if a patient has a BMI of 30 or greater or 27 or greater with weight-related conditions and if the drug is combined with a personalized weight loss plan that addresses physical activity, nutrition, and lifestyle changes.

However, due to the cost and some insurance companies not covering the injection unless the patient has both diabetes and obesity, the provider must carefully consider prescribing this medication.

Case Study

The patient states this ‘miracle drug’ is worth paying for out of pocket!

Jeff Capron, a 53-year-old Boonville, New York, web developer, started taking tirzepatide in December 2022. His friend had reported good results with the medication, so Jeff looked into the research studies behind it and then spoke with his primary physician.

The physician said, “Yeah, let’s give it a shot,” even though he did not have much experience with it. The physician did not have an opinion one way or the other than looking at the data set and seeing no reason why they could not try it.

Jeff’s hemoglobin A1C went from 10.1% to 6% in 3 months, which was very promising. “I never had that kind of experience with any medication for diabetes.” There is a range in how much A1C reduction people experience with tirzepatide, but many people taking it can get their A1C under 7% — an ideal goal for people with Type 2 diabetes.

Jeff experienced constipation and a little trouble sleeping early, but both issues disappeared quickly. He says, “I wake up in the morning, and my fasting blood sugars are normal.”

The medication took effect, he says, within 12 hours. He compared the feeling to having a gastric bypass.

“You cannot overeat food. As soon as you overeat, you almost feel ill.” While it generally takes a few months to notice effects like A1C reduction and significant weight loss, side effects such as lower appetite may be felt immediately.

Weight loss was not his primary goal, but he lost about 35 pounds on the medication in the first five months. He also lost his sweet tooth. “I can maybe count three sweet things I have eaten since December.”

Jeff found that his appetite slowly recovered days after taking tirzepatide. “You take the shot every Sunday, and by Saturday, you start to get a lot of appetite,” he says. “It does not seem to affect your weight. If I eat a little bit more on Saturday night, on Sunday, the scale will not move one way or the other.”

Jeff is allergic to hornets, so he already carries an auto-injector. He was not worried about using another drug delivered through a needle. “It’s just a push button,” he says. It also helped that his wife is a nurse. “So, I had her with me the first time to ensure I was doing it right. I didn’t even feel it.”

When Jeff was first prescribed tirzepatide, his insurance covered it. The company has since removed that benefit. He has filed an appeal but pays about $1,000 monthly out of pocket for his weekly injections. He plans to keep paying as long as necessary.

He considers the financial burden well worth it. “I have never had a medication that worked as well before for chronic conditions,” Jeff says. “I’ve been blown away by it. For me, it’s a miracle drug. It got rid of my diabetes” (4).

Use of Tirzepatide for Weight Loss Management

As mentioned, this medication is indicated for patients with a BMI of >30 or a BMI of >27 with qualifying comorbidities. Obesity can become a chronic lifetime disease, and for conditions such as these, the patient needs to implement therapy for the lifetime of the disease.

In a study conducted for tirzepatide, there was a dramatic increase in effectiveness compared to traditional nonsurgical interventions such as diet, exercise, and lifestyle changes. However, it has been noted that taking tirzepatide on an ongoing basis is recommended and necessary to maintain any weight loss achieved from the medication.

If a patient stops taking the drug, likely, it will no longer work (5).

Public health officials have expressed concerns about using the drug long-term. Still, data is currently lacking regarding long-term effectiveness, treatment duration, and maintaining weight reduction once the therapy is discontinued.

A recent trial consisted of 783 participants with a BMI greater than 30, and these participants agreed to take either a 10mg or 15mg dose of tirzepatide over 36 weeks. The injection is given once weekly, so this would equal a total of 36 injections.

By the end of 36 weeks, participants lost more than 21% of their body weight. After 36 weeks, participants continued on tirzepatide or received placebo treatment for the following year. The patients needed to be made aware of which treatment they were receiving.

Those still taking tirzepatide injections weekly after 88 weeks lost an additional 7% of their body weight, and those taking the placebo regained 15% at the end of 88 weeks (5).

Common Side Effects and Contraindications

Side Effects

Patients vary immensely with different experiences and side effects related to tirzepatide; however, the following are the most common side effects experienced by those taking the medication:

• Nausea
• Decreased appetite
• Vomiting
• Diarrhea
• Indigestion
• Constipation
• Stomach Pain

Tirzepatide usually does not cause fatigue, leaving one feeling weak, tired, and low energy. However, fatigue can be a common side effect of Type II diabetes.

It is important to note that most individuals who experience nausea, vomiting, and diarrhea episodes do so while the dosage increases, and typically, the symptoms decrease over time. G.I. effects were more prominent in those taking tirzepatide than those taking the placebo. The individuals not in the placebo group were more likely to stop treatment due to the unpleasant side effects (3).

Contraindications

Tirzepatide may cause thyroid tumors, including thyroid cancer, and it is essential to watch for possible symptoms, such as swelling or a lump in the neck, hoarseness, shortness of breath, or trouble swallowing.

Tirzepatide should also not be prescribed to any patient with Type 1 Diabetes.

One of the main ways that tirzepatide works is by stimulating the release of insulin from the pancreas, and due to this fact, there have not been many studies and clinical trials that include those with Type I diabetes.

However, this is not to say that prescribers have never ordered tirzepatide for those with Type I diabetes. Still, it is essential to note that if prescribed, it would be in addition to traditional insulin therapy.

• Personal or family history of a type of thyroid cancer known as medullary thyroid carcinoma (MTC).
• Any history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Patients who are allergic to the actual medication or any of its ingredients.
• Younger than 18 years of age

Safe Prescribing Practices, Guidelines, and Considerations for Providers

Safe Prescribing Practices

As with all prescribed medications, safe standards of care must be implemented and followed to ensure patient safety is maintained. The same applies to providers considering prescribing tirzepatide, and specific criteria must be met beforehand. The following information discusses guidelines involving exclusion and inclusion criteria for providers to prescribe tirzepatide (6) accurately.

Guidelines

Exclusion Criteria – If present, the following indicates that the patient should not receive tirzepatide:

• Diagnosis of Type I diabetes
• Personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2
• Severe gastrointestinal dysmotility
• History of pancreatitis
• Pregnancy
• Proliferative Diabetic Retinopathy (PDR), severe Nonproliferative Diabetic Retinopathy (NDR), clinically significant myalgic encephalomyelitis (M.E.), or diabetic macular edema (DME) unless the risks/benefits have been discussed with the patient and are documented in the patient's health record along with monitoring plans and follow-up with an eye specialist who is informed at the time of initiation.

Inclusion Criteria – All of the following must be met for tirzepatide to be prescribed:

• Diagnosis of Type II diabetes
• A BMI of 25 or greater
• Inadequate glycemic control on at least 1mg of semaglutide injection plus two or more glucose-lowering drugs
• Change needed to achieve goal A1C is less than 1%.
• Goal A1C should be based on those recommended in the Diabetic Guidelines.
• Adherence to current diabetic medications as evidenced by a review of the prescription refill history during the six months.

Additional Inclusion Criteria – All of the following must be met for tirzepatide to be prescribed:

• Patients with atherosclerotic cardiovascular disease or chronic kidney disease
• Patients of childbearing potential who are using oral contraceptives

Inclusion Criteria for Weight Loss

• BMI of >30 or >27 with patient weight conditions.

Considerations for Providers

There are specific considerations that prescribers must be aware of when contemplating if a patient should receive the medication tirzepatide. The following is imperative and must be considered each time the medication is prescribed to a patient:

• Clinical Indications – indicated for treating adults with insufficiently controlled diabetes mellitus as an add-on therapy to diet and exercise; as monotherapy when metformin is considered inappropriate due to contraindications or intolerance; and other medicinal products for treating Type II diabetes.
• Monitoring of medication – routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value but is recommended for early detection of Medullary Thyroid Cancer (MTC).
• Cost – the average price for tirzepatide ranges from $1,071-$1,351 without any coupons or insurance. Savings Card – manufacturer provided; patients can pay as little as $25 monthly for up to 12 injections. Savings Card – manufacturer provided; patients can pay as little as $25 monthly for up to 12 injections.
• Benefits and Risks – One must evaluate the effectiveness of diabetes and the weight loss experienced. Some of the risks must be evaluated, such as increased cost of medication, unpleasant gastrointestinal side effects, poor insurance coverage, and drug shortages. The FDA has warned that the medicine can cause thyroid C-cell tumors in rats, and it is not sure whether tirzepatide causes similar tumors.

How long does it take for tirzepatide to begin working?

Tirzepatide will start to lower one's blood sugar levels immediately, but it can take 8 to 12 weeks to reach one's target A1C goal.

Compared to other diabetic treatments, studies have shown that it can take eight weeks to reach an A1C target of less than or equal to 7% and 12 weeks to get an A1C of less than or equal to 6.5%. Significant weight loss can occur as early as 28 weeks.

Safe Administration

It is essential to follow the correct steps for safe administration of tirzepatide as listed below:

• The recommended starting dosage is 2.5mg, injected subcutaneously once weekly. The 2.5mg dosage is for treatment initiation and not for glycemic control.
• After four weeks, increase the dosage to 5mg, injected subcutaneously once weekly.
• If additional glycemic control is needed, increase the dosage in 2.5mg increments after at least four weeks on the current dose.
• The maximum dosage is 15mg, injected subcutaneously once weekly.
• If a dose is missed, instruct patients to administer it as soon as possible, within four days (96 hours) after the missed dose. If more than four days have passed, skip the missed dose, and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once-weekly dosing schedule.
• The day of weekly Administration can be changed, if necessary, as long as the time between the two doses is at least three days (72 hours).
• Before initiation, train patients and caregivers on proper injection techniques.
• Instruct patients using the single-dose vial to use a syringe appropriate for dose administration (e.g., a 1ml syringe capable of measuring a 0.5 mL dose).
• Administer the medication once weekly, any time of day.
• Inject the medication subcutaneously in the abdomen, thigh, or upper arm.
• Rotate injection sites with each dose.
• Inspect the medication visually before use. It should appear clear and colorless to slightly yellow. Do not use the medicine if particulate matter or discoloration is seen.
• When using the medication with insulin, administer it as separate injections and never mix. It is acceptable to inject tirzepatide and insulin in the same body region, but the injections should not be adjacent.

Does the tirzepatide injection hurt when administered?

Pain from the injection site has not been reported as a common side effect, but it may occur.

Due to the injection being given subcutaneously, slight pain or discomfort can occur.

Alternatives to Tirzepatide for Weight Loss Management

In some instances, patients need to be aware of alternatives to tirzepatide in case they cannot take the actual injection for whatever reason. In cases such as these, there are alternative supplements that can be purchased over the counter, and they include the following (7):

• PhenQ – top OTC choice – comprehensive weight loss solution that targets specific body regions, facilitates prompt fat loss, and expedites the weight loss journey.
• PhenGold – the most potent OTC weight loss alternative – one of the top weight loss supplements that boost metabolism, making one less hungry, less tired, and an overall improved feeling.
• Capsiplex BURN – the best choice for men – helps to burn fat faster and keep blood sugar levels in check. It helps to keep one's muscles, curbs hunger, gives one more energy, and torches stubborn fats.
• Trimtone – the best choice for women – helps women to lose weight, eat less, increase metabolism, burn extra calories, and boost energy.
• Prime Shred – best fat burner for men – boosts metabolism, keeps muscles intact, increases energy, and helps maintain focus.

The advanced practicing nurse or prescriber needs to inform patients about alternative options such as these in an effort for individuals to understand that other choices are available and can be used. Many individuals need to be more knowledgeable about alternatives besides tirzepatide due to the extra hype from social media sources that promote advertisements related to tirzepatide only but do not mention the other options.

Why does social media influence and encourage patients to take tirzepatide?

Social media trends can be helpful but can also become harmful by setting unrealistic expectations and promoting a diet culture mentality. They can create an unhealthy obsession with "clean" eating, especially in the younger populations.

Due to this, many individuals take the medication despite any occurrence or history of Type II diabetes, and the drug can ultimately become misused.

It has been noted that there is an influx of patients requesting this medication for weight loss instead of the intended purpose, which is to help control Type II diabetes.

Tirzepatide represents one of the most recent non-medical treatments aimed at managing the symptoms of Type II diabetes. While it is not indicated for weight management, diabetic patients who receive it frequently report a significant reduction in body weight.

 Empirical evidence suggests the efficacy of tirzepatide in weight management, and certain physicians currently endorse the Administration of the medication as a therapeutic and effective means to overcome obesity.

What are some severe side effects of tirzepatide that can impact patient safety?

The Administration of tirzepatide can benefit many individuals, but some severe side effects must be mentioned.

These include thyroid tumors, thyroid cancer, pancreatitis, hypoglycemia, serious allergic reactions, kidney issues, severe stomach problems, vision changes, and gallbladder issues. All these side effects must be taken seriously and reported, as they can lead to life-threatening

Conclusion

Medications like tirzepatide are game changers for those patients with type 2 diabetes that have failed other medications. Unfortunately, several companies seek to profit from its weight-loss benefits through aggressive marketing campaigns that limit the available supply and increase the costs for those who need it. As healthcare providers, we need to use sound clinical judgment and follow the exclusion/inclusion criteria and other guidelines before prescribing this medication, so we do not unintentionally cause harm while looking to appease our patients who request this.

Semaglutide and Type 2 Diabetes

Introduction   

In 2017, the FDA approved the semaglutide injectable (Ozempic) for treating type 2 diabetes. The drug has experienced widespread acceptance due to its positive effects on weight loss and lowering of chronic health risks. The drug has risen in popularity over the past few years, as many well-known actors/actresses/songwriters, and more came forward, publicly sharing their weight loss journey.

This rise in popularity has also resulted in significant shortages of this medication, negatively impacting the lives of the diabetic community, local pharmacies, and healthcare providers. The goal of this continuing education course is to educate and empower the healthcare provider in all aspects of this drug regimen: clinical indications, patient education, cost options, and benefit/risk analysis.

Diabetes Overview

Diabetes is a chronic medical condition. Despite advances in diet, medications, and monitoring devices, diabetes diagnoses continue to grow at staggering rates. The Institute for Health Metrics and Evaluation (IHME) reports that over 529 million people worldwide are currently living with diabetes, and that number is expected to grow to 1.3 billion in only 30 years. While the risk factors for diabetes are vast in number (poor diet, inadequate activity, obesity, sedentary lifestyles, daily stressors, and more), the sad reality is that this chronic medical condition will most likely linger on for generations to come despite our efforts to contain this health epidemic (1).

According to the latest research on diabetes, there are over 37 million people in the United States alone with diabetes as of 2022. Statistically, approximately 28 million of them have a confirmed diagnosis, while another estimated 8 million are experiencing symptoms, without an official diagnosis. Diabetes currently ranks as the 7^th leading cause of death in the United States (2).

Types of Diabetes

In basic terms, diabetes is an impairment in one’s ability to either adequately produce or utilize insulin, which results in elevated levels of circulating glucose. Chronically elevated glucose levels affect blood vessels at every level, causing chronic inflammation and raising the risk of heart disease, stroke, blindness, and atraumatic amputations.

There are three main types of diabetes:

Type 1 diabetes is thought to be an autoimmune disease. Approximately 5-10 percent of people with diabetes are diagnosed with type 1 diabetes. The diagnosis usually occurs in early childhood, and results in a lifetime use of insulin to regulate blood glucose levels.

Type 2 diabetes is thought to be related to dietary and lifestyle choices. It accounts for nearly 90-95 percent of diabetes diagnoses. Usually occurring later in life (adult-elderly population), it is believed to be related to factors such as diet, activity, weight gain, and related factors. Type 2 diabetes is usually controlled by diet and exercise, in addition to oral medications, although injectable insulin may be included in the treatment plan.

Gestational diabetes refers to elevated glucose levels occurring during pregnancy for patients who are not diabetic at the onset of pregnancy. This version of diabetes usually resolves itself post-partum, although a woman may develop type 2 diabetes later in life, unrelated to pregnancy.

Type 2 diabetes in children: no longer a “later in life diagnosis”

Children are now being diagnosed with type 2 diabetes at an alarming rate. Despite widespread education and an increased awareness of diabetes, our up-and-coming generation is unhealthier than ever. Many families lack access to healthy food for their families, due to both general socioeconomic challenges and an increased rate of food insecurity. (19)

The CDC recommends care providers have resources for diabetic patients and their families, such as food and nutrition programs, budget-friendly diabetes meal plans, how to save money on diabetes care, and coping strategies for diabetes. (19)

Diabetes Signs and Symptoms, Diagnostic Testing

There are various ways to test for diabetes. The fasting blood sugar (FBS)/ fasting glucose level is a simple way to test for diabetes.

The normal fasting glucose level is below 100mg/dl. The fasting glucose result of 100-125mg/dl indicates prediabetes and results above 126mg/dl indicate diabetes.

The hemoglobin A1C blood test is another test used to confirm the diagnosis of diabetes. The patient does not need to be fasting for this test; thus, it is easier to order this test regardless of the time of day. This blood test reflects the average glucose level over the period of 2-3 months.

The normal A1C level is below 5.7%. Test results between 5.7%- 6.4% indicate prediabetes. Test results above 6.5% indicate diabetes.

A random glucose reading above 200mg/dl, done at any time of day, indicates diabetes.

The diagnosis of diabetes is by blood tests, and for improved accuracy, should be based on two separate readings, done (at least) a day apart. In the case of fasting and random blood tests, dietary intake (large amounts of carbohydrates in a single meal) may adversely affect test results. This is not the case when using A1C testing for a confirmation diagnosis, as the results are the average of a 2–3-month span.

Target blood levels for a person with diabetes (3).

Target blood glucose levels for people with diabetes are as follows:

• Fasting glucose 80-130mg/dl.
• Postprandial blood glucose level- less than 180mg/dl
• A1C level 7-8%.

These target ranges are general guidelines. Patient-specific ranges will be dependent on a variety of factors, including preexisting comorbidities, overall health status, age, and activity levels.

The hallmark signs/symptoms of diabetes

1. Polyuria- increased urination
2. Polydipsia- increased thirst
3. Polyphagia-increased hunger/appetite

The truth is, as healthcare providers, you will have patients who have no hallmark signs and symptoms of diabetes; the diagnosis will be found during annual preventive examinations often unrelated to any chronic disease. For this reason, many insurance companies now cover numerous preventive screenings, including diabetes screenings, as part of their wellness and prevention initiatives. These tests are often approved based on a patient's age, or preexisting conditions, rather than outright signs and symptoms.

Lifestyle Interventions and the Diabetes Prevention Program

The initial diagnosis of diabetes can be managed in a variety of ways, depending on the severity of the illness at the time of diagnosis. Lifestyle interventions (behavior modification education) are of utmost importance in the care and management of people with diabetes. Research over the past few decades has consistently shown that such interventions have immense positive effects on the successful long-term management of diabetes.

The official Diabetes Prevention Program was created in 2010 (4) and confirmed the effects of lifestyle interventions in the management of diabetes:  Lifestyle interventions decreased the incidence of type 2 diabetes by 58% compared with 31% in the metformin-treated group. Thus, these findings now serve as the blueprint, if you will, for all-inclusive, patient-specific disease management guidelines. These lifestyle interventions will be discussed in detail later in the program.

Additional Resources on Diabetes Prevention

• Detailed History of the Diabetes Prevention Program
• Detailed on the National DPP Lifestyle Change Program

Semaglutide

Semaglutide is an injectable drug used in the treatment of type 2 diabetes. It was approved by the FDA in May of 2017.

It is a once-a-week injectable and belongs to the drug class known as glucagon-like peptide-1 receptor agonists (GLP-1RAs) (5). It has been referred to as a “miracle weight loss drug” among those who are living with obesity, despite frequent side effects, unusually high out-of-pocket costs, drug shortages, and weight regain when attempting to stop using the medication.

GLP-1 receptor agonist: Hormone Review

GLP-1 RAs are a class of medications used to treat Type 2 diabetes, and in some cases, obesity treatment. They are also known as GLP-1 receptor agonists, incretin mimetics, and GLP-1 analogs.

Ghrelin and Leptin (6)

Ghrelin and Leptin are two hormones that greatly influence appetite and the sensation of fullness. Often referred to as the “hunger hormone.” Ghrelin is responsible for many functions, including playing a key role in metabolism through glucose and insulin regulation.

Ghrelin, produced in your stomach, signals your brain when you are hungry, and results in increased food intake.

Leptin, conversely, is produced in your fat cells, and signals to the brain when you have eaten enough (by a decrease in appetite).

Glucagon-like peptide-1 receptors

Known as GLP1 receptors, Glucagon-like peptide-1 receptor proteins are located in the beta cells of the pancreas as well as in the neurons in the brain. GLP-1 receptors are involved in the regulation of blood glucose levels and affect the secretion of insulin. These cells encourage the release of insulin from the pancreas, increase the volume of beta cells, and reduce the release of glucagon. In doing so, they increase the feeling of fullness during and between meals, suppressing the appetite and slowing gastric emptying.

What is meant by receptor agonist and antagonist?

The term agonist refers to any substance that mimics the actions of a hormone in producing a specific response: a receptor antagonist blocks a response from occurring.

Opioids are examples of receptor agonists in that they produce responses such as analgesia.

Naloxone/Narcan is an example of a receptor antagonist, in that it binds to a receptor site and decreases/blocks a response from occurring.

Semaglutide mechanism of action (7)

GLP-1 agonists work in several ways to positively affect glucose levels. Their mechanism of action includes the following:

• Increasing (stimulating) insulin secretion by the pancreatic beta cells.
• Decreasing the production of glucagon, a hormone that raises blood glucose levels
• Decreasing (slowing) gastric emptying
• Decreasing appetite (and thereby reducing food intake) by creating a sensation of stomach fullness

Through these mechanisms of action, semaglutide results in a lowering of serum glucose/A1C levels, which lowers the risk of cardiovascular events. Studies have also shown that semaglutide resulted in weight loss (approximately 8-14 pounds on average {dose dependent results}.

Side Effects of Semaglutide

Common side effects of semaglutide (8)

Common side effects may include any of the following:

• Nausea and vomiting
• Headache
• Diarrhea and stomach pain
• Upset stomach, indigestion, constipation, flatulence

These side effects usually subside within a few weeks, as the patient becomes acclimated to the medication.

Serious side effects of semaglutide

• Hypoglycemia- enhanced/worsened when used in combination with other diabetes medication. Symptoms may include drowsiness, confusion, weakness, irritability, and headache.
• Symptoms may include abdominal pain and distension, nausea and vomiting, fever, and back pain.
• Diabetic retinopathy. Symptoms may include blurred vision, vision loss, and diminished night vision.
• Kidney damage/injury/failure. Symptoms may include fatigue, nausea, diminished urine output, confusion, and edema of extremities.
• Gallbladder disease. Symptoms may include gallstones, abdominal pain, nausea and vomiting, and poor appetite.

Black Box Warning (9)

Semaglutide has a Black Box Warning for thyroid cancer. This is the most serious warning from the Food and Drug Administration (FDA) and is intended to alert consumers to the potential risks of a medication.  This black box warning was issued when research found that the drug increased the risk of thyroid tumors in animals.

It is not known if semaglutide actually causes tumors in humans.

Contraindications

• Semaglutide is contraindicated in people with a personal or family history of MTC (medullary thyroid cancer) or in patients with multiple endocrine neoplasia syndrome type 2.
• Known hypersensitivity to semaglutide or any of the product components

Cautions

As noted under “serious side effects”, there have been reports of new illnesses or worsening of existing health conditions occurring “post-marketing”. Thus, healthcare providers are strongly encouraged to continue ongoing surveillance of any patients on semaglutide therapy. In addition, there is insufficient data available regarding the use of semaglutide by pregnant women. Women are therefore highly encouraged to stop any treatment with semaglutide for at least 2 months prior to a planned pregnancy.

Dosing

Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It is looked upon favorably to reduce the risk of cardiovascular events in adults with T2DM and a preexisting history of cardiovascular disease. This drug is FDA-approved for use in people with diabetes, with a BMI of 27% or higher (a BMI of 25-29.9% is considered overweight).

Semaglutide (Ozempic) is available as an injectable prescription medication. Doses include 0.5mg, 1mg, or 2 mg, once weekly.

The injection should be administered subcutaneously to the abdomen, thigh, or upper arm. Injection sites should be rotated, and given as a single injection.

Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly.

• If additional glycemic control is needed, increase the dose to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose.
• If additional glycemic control is needed, increase the dose to 2 mg once weekly after at least 4 weeks on the 1 mg dose

Administer once weekly at any time of day, with or without meals.  The maximum dose recommendation is 2mg/weekly once weekly.

Note: The initial 0.25-mg dose is intended for treatment initiation and is not effective for glycemic control

Missing Dose Guidelines

• If the missed dose is ≤5 days: Administer dose as soon as possible
• If missed dose >5 days: Skip the missed dose and administer the next dose on the regularly scheduled day; patients can then resume their regular once-weekly dosing schedule

Administration Day Guidelines (10).

The administration day each week can be changed, if necessary, as long as the time between 2 doses is at least 2 days (>48 hours)

Dose Availability (packaging)

• 2mg/1.5mL (1.34mg/mL); delivers doses of 0.25mg or 0.5mg per injection or four to eight doses per injection pen
• 4mg/3mL (1.34mg/mL); delivers 1mg per injection or 4 doses per injection pen
• 8mg/3mL (2.68 mg/mL); delivers 2mg per injection or 4 doses per injection pen

Treatment Goals- Effects on A1C and Weight (11)

A majority of adults who were placed on injectable semaglutide for diabetes management achieved a target A1C under 7% and were able to maintain it.

• Dose specific effects on A1C were as follows:
• 0.5mg dose injection yielded a 1.4% decrease
• 1.0mg dose injection yielded a 1.6% decrease
• 2.0 mg dose injection, in combination with diabetes pills, yielded a 2.1% decrease in A1C.

Adults taking semifluid injectables for diabetes management also noted weight loss.

• 8-pound weight loss reported with 0.5mg dose injection
• 10 pounds weight loss reported with 1.0mg dose injection
• Up to 14 pounds of weight loss reported with a 2.0mg dose injection

Prescribing insights: Long-Term therapy for a chronic condition?

Semaglutide is viewed favorably as a treatment option for Type 2 diabetes. It appears to lower A1C levels and body weight in the majority of patients, lowering their risk of future cardiovascular events.

The question of long-term medication use, for a chronic health condition, is being heavily discussed in the media. While a percentage of people can decrease or eliminate the need for chronic medications through significant lifestyle changes, there have been reports of weight gain in those who stopped taking this injectable medication.

Without intense lifestyle behavior modification education, there is a heightened risk of weight regain in the absence of such medications. Leaders in the treatment of obesity and related illnesses have commented that this drug is intended for long-term use.

Examples of this include the following:

“GLP-1 medications [like Ozempic] are designed to be taken long-term... They are chronic medications for the treatment of chronic conditions (both diabetes and obesity) (12)". - Christopher McGowan, M.D., a gastroenterologist specializing in obesity medicine and endobariatrics

“As with many chronic conditions, most people who use the drugs for diabetes or weight loss will need to keep taking them to keep benefiting from them. Depending on your individual situation, and without sustained lifestyle changes, it is likely you would need to be on these medications indefinitely to maintain weight loss (13)." - Dr. Cecilia Low Wang, a UCHealth expert in endocrinology, diabetes and metabolism.

Cost Concerns

At this time, injectable semaglutide, FDA-approved for the treatment of Type 2 diabetes, has a self-pay price tag of $935.77 per month (4 injections). With FDA approval, many people with diabetes, insured under commercial plans, receive the drug for the cost of their copay. Those patients without coverage may use pharmacy discount cards that reduce the price, on average, to $814.55/month.

The following links are available to familiarize yourself with patient assistance programs related to semaglutide injectables.

Semaglutide Cost Savings Programs

The following links are provided to explore various semaglutide cost savings programs.

• Novo Care's Ozempic Saving Offer
• How much does Ozempic (0.25 Or 0.5 Mg/Dose) cost?
• GoodRx

Emerging Concerns: Semaglutide and gastroparesis

In August 2023, a first-of-its-kind lawsuit was filed in Louisiana, against the makers of semaglutide. The lawsuit states the makers of this injectable drug did not adequately warn patients about the risk of severe gastrointestinal issues/possible gastroparesis.

The plaintiff in this case had used both Ozempic and Mounjaro and experienced repeated episodes of severe gastrointestinal events, warranting trips to the emergency room and additional medications to alleviate her symptoms (14). While this lawsuit is in the developing stages, it bears mentioning in terms of concerns over long-term usage of the drug and possible complications.

While the drug labeling for semaglutide (Ozempic) does not specifically mention gastroparesis, the semaglutide/Mounjaro drug label does state that the drug has not been studied in patients with severe gastrointestinal disease and is therefore not recommended in these patients.

Up to 50% of people with diabetes have some degree of delayed gastric emptying, but most have no digestive symptoms or have only mild symptoms. For some people with diabetes, problems managing blood glucose levels may be a sign of delayed gastric emptying (15).

Healthcare providers should evaluate all patients with diabetes for possible symptoms of underlying gastroparesis, such as the feeling of fullness shortly after beginning a meal, or the inability to finish a regular meal. Other symptoms of gastroparesis may include abdominal pain, nausea, bloating, vomiting, and anorexia.

Diabetes and gastroparesis

Uncontrolled or poorly controlled diabetes can affect nerve endings systemwide. Diabetes is a very common cause of gastroparesis. Although the condition is rare it occurs more often in people with chronic conditions such as diabetes, autoimmune diseases, and nervous system disorders. Nerve endings are injured or damaged, cease to function properly, and result in delayed gastric emptying. The delay in gastric emptying can cause various symptoms, such as nausea, vomiting, bloating and distension, abdominal pain, and poor appetite.

In addition to underlying medical conditions, some medications may cause symptoms of gastroparesis (delays in gastric emptying and overall gastric motility. These medications include narcotics, antidepressants, and anticholinergics.

Left untreated, diabetic gastroparesis may lead to malnutrition, electrolyte imbalances, and poor glucose management and control.

Diabetes Lifestyle changes: Patient education (16)

1. Weight Management
2. Healthy Eating
3. Physical Activity
4. Smoking Cessation
5. Stress Management

The importance of patient education regarding lifestyle changes is a priority. As with any chronic medication condition, the patient and their family/support system must be given every opportunity to educate and empower themselves on self-management of their disease process. Patients must be given the benefit of the doubt that they can indeed embrace their health and well-being and work with their healthcare provider in maximizing their health outcomes.

For diabetes mellitus, numerous lifestyle behaviors should be addressed and actively worked on, so that the patient receives the maximum health benefits. The following lifestyle behaviors are in no particular order; they all warrant discussion at every office visit.

Diet

A person with diabetes should be educated on the effects of food and nutrition on their glucose level. Referrals to a dietitian/nutritionist or Certified Diabetes Care Education Specialist (CDCES) should be considered a top priority. Well-balanced nutritional intake, appropriate carbohydrate awareness, calorie monitoring if weight loss is appropriate to your specific patient) and medication/food interactions are all essential aspects of dietary lifestyle education. Many commercial insurance plans, as well as hospital community outreach programs, offer diabetes self-management classes.

Activity (17)

The CDC recommends a target goal of 150 minutes weekly, Patients should be educated on the positive effects of daily activity on overall health and well-being, stress management, and metabolism. Patients should find activities they are genuinely interested in, involve family and friends, and slowly build greater endurance through increased intervals of longer duration.

Sleep hygiene (18)

Patients should be educated on the positive effects of a good night’s sleep. The aim should be approximately 7-8 hours of restful sleep. Electronics should be powered down and (optimally) removed from the bedroom. A dark, well-vented, cool room temperature is encouraged, and large meals and late-evening caffeine should be avoided.

Medication adherence/ literacy

Medication education is critical to the health and well-being of a patient. Routine education of the patient, and family members or support systems when available, should be supportive and patient-specific. Patients should be assessed on language barriers, literacy issues, and related comprehension concerns. Medication education should include effects, side effects, treatment goals, and sick day management. Emergency care issues should also be discussed. Any monitoring equipment (continuous glucose monitors, accuchecks, lancets) should be reviewed with patients and confirmed with return verbalization and demonstration.

As discussed in this course, patients with chronic diseases must learn self-management techniques to optimize their health and well-being. They must become confident in their understanding of their disease process and take ownership of their health. In doing so, they minimize the risk of long-term complications, improve their self-worth, and actively invest (both time and money) in their future.

Ozempic Case Study

• 52-year-old female
• Height 67 inches
• Weight 225 pounds
• B/P 138/84, Heart rate 76 NSR
• BMI 35.2%
• Nonsmoker, occasional social drinker
• Multiple attempts at dieting without success.
• Diagnosed T2DM approx. 6 months ago current A1C 7.5%; initial medication Metformin 500mg BID tablets; tolerated well. No GI upsets.

Today’s appointment is for evaluation and additional medication consideration (the patient requested this appointment)

The patient was diagnosed with T2DM approximately 6 months ago. Initial A1C 8.0%. Current A1C 7.7%

Despite an improved diet and adherence to the medication regimen, the patient voiced frustration at the lack of weight loss. Requesting additional medication. Has a neighbor friend who began injectable Ozempic and is having “really great results with it. I want to start on it as well”.

• What are your thoughts on prescribing semaglutide injectable for this patient?
• What objective health data points should be taken into consideration regarding prescribing semaglutide for this patient?

The patient has expressed frustration that despite taking her medications and adjusting her diet, she has not lost any weight in the past 6 months. She has “heard from her neighbor friend that the weight just melts off immediately” and she is ready to start this medication.

• What concerns do you know about this patient's understanding of weight loss as it relates to semaglutide?
• What prescribing information, specific to semaglutide and weight loss, could you share with your patient regarding realistic weight loss targets?
• In addition to teaching your patient proper injection technique for the use of semaglutide, what other lifestyle education behaviors should you discuss at this point?
• What information should you share with your patient regarding the long-term use of semaglutide and the potential risks of stopping this medication (as it relates to weight regain)?

Your patient decides to go ahead with the semaglutide regimen.

• What are some patient education guidelines regarding common side effects of this medication?
• How often is the dose increased? What is the maximum dose this patient can receive weekly?

Your patient wants to know how long she will be taking this medication.

• What talking points will you cover regarding the long-term use of this medication?
• How do you best prepare this patient for long-term success with this medication?
• What lifestyle behavior modification education would you discuss with your patient, to give her the best chance at successfully managing her diabetes?

Medication Assisted Treatment

Introduction   

Medication Assisted Treatment (MAT) is a treatment modality for substance use disorders. It combines counseling and behavioral therapies for addiction with medications used carefully to reduce the physical symptoms of cravings and withdrawal and assist clients in the recovery process. With half of people 12 and older reporting use of an illicit substance at least once and 21 million Americans experiencing addiction, this is an important and relevant topic (4).

Historically, an intense stigma is attached to both addiction and some of the medications used to treat addiction. A thorough understanding of substance use disorders, available MAT therapies, and care of affecting clients are essential topics for nurses to be familiar with, particularly those working in psychiatry, pain management, or addiction medicine.

Overview of Addiction and Substance Abuse:

Drug and alcohol abuse and addiction are chronic, complicated issues involving persistent changes to the brain. There is a stigma or misunderstanding that people with substance abuse disorders can stop any time they want to or lack the willpower or moral fortitude to stop using. This is entirely untrue, and even people who are "recovering" and have not had any drugs or alcohol in years can easily relapse into addiction once those brain changes have occurred (5).

When a person uses drugs or alcohol, the brain's reward center is flooded with dopamine. This provides a "buzz" or pleasurable sensation that may create the desire to use more of the same substance. Over time, and with regular use of the substance, the brain becomes accustomed to the flooding of dopamine and reduces the reward response, a process known as tolerance.

It will now take the same person a more significant amount of the substance to achieve the same "buzz" or "high" they used to feel. This process can also dull the pleasure response to activities not involving substance use, such as food, socialization, or sexual activity. Over time, the chemical changes in the brain can progress to include decreased functioning of learning, decision-making, judgment, response to stress, memory, and behavior (5).

To understand substance abuse disorders, it is first essential to understand some basic definitions. These terms are sometimes used interchangeably, but they mean different things and represent different stages of disease.

Definitions

Substance Use: Substance use is any consumption of drugs or alcohol, regardless of frequency or amount. An occasional glass of wine or taking an edible at a party is an example of substance use. Substance use does not cause problems or dependency in many people (5).

Substance Abuse: Substance abuse is the continued use of drugs or alcohol, even when they do cause problems. Conflict or problems at home, school, work, or legal issues related to the use of drugs or alcohol are signs of abuse. For example, being sent home from school for smoking in the bathroom or failing a drug test at work (5).

Substance Dependence or Addiction: Dependence and addiction can be used interchangeably or is sometimes called substance use disorder. Addiction occurs when a person cannot stop drinking or using drugs despite creating problems in their life. People who are addicted may experience cravings until they use a specific substance, or they may experience uncomfortable physical symptoms, known as withdrawal if they do stop (5).

The American Psychiatric Association (APA) utilizes the following criteria to diagnose clients who suffer from addiction. The more criteria a client answers yes to, the greater their problem with substance use.

Six or more positive criteria are indicative of addiction.

1. Using substance in more significant amounts or for more extended periods than intended
2. Trying to stop using but being unable to
3. Increased amounts of time getting, using, or recovering from use of the substance
4. Experiencing cravings or urges to use.
5. Continuing to use the substance despite problems with relationships or social situations.
6. Missing work, social, or recreational obligations or activities because of substance use
7. Participating in risky behavior because of substance use
8. Continuing to use the substance despite psychological or physical health problems.
9. Needing to use more substance over time to achieve the desired effect.
10. Experiencing withdrawal symptoms when stopping the substance (1).

Substance Abuse Statistics

Many factors go into gathering data on substance abuse disorders, from underreporting, the nuance between use, abuse, and addiction, and the large variety of substances available, with the legality of some substances varying by state or age.

The statistics below from 2020 are not meant to be an exhaustive list of substance use disorders in this country but rather an overview of some of the more prevalent addiction-related issues.

• 50% of people 12 years and older have used an illicit substance at least once.
• 5% of Americans 12 years and older have used drugs within the last month.
• This is a 3.8% increase from the previous year.
• About 50% of Americans 12 and over drink alcohol
• 4% of those people have an alcohol use disorder.
• About 20% of Americans use tobacco products or vape
• 18% of Americans over 18 used marijuana in the last 12 months
• 30% of those have some level of misuse or addiction.
• Marijuana is commonly involved in polysubstance use, paired with alcohol or other drugs.
• 7% of Americans over 12 misused opioids in the last 12 months
• 96% of those used prescription pain relievers
• Opioid prescriptions peaked in 2012, with 81.3 prescriptions per 100 people.
• The rate has declined recently due to increased attention to this crisis.
• In 2018, the rate was down to 51 prescriptions for every 100 people
• Fentanyl is now rising as a new and deadly concern.
• 5 million prescriptions were written for fentanyl in 2015.
• Fentanyl is involved in 53% of overdose deaths.
• 7% of all Americans misuse a prescription drug.
• 1% of those misuse stimulants
• 2% of those misuse sedatives
• 5% misuse painkillers
• Over 70,000 drug overdose deaths occur annually in the United States (4)

Risk Factors

A combination of factors is involved in the risk of addiction, and no one factor can determine if someone will develop addiction or after how many uses this will occur.

The addiction process does occur more easily or progresses more rapidly for people with certain risk factors, including:

Genetics

There is a strong genetic correlation with addiction, indicating that biology plays a significant role in the disorder. Family history of addiction, gender, ethnicity, and comorbid mental health conditions can all influence the risk of addiction. (5)

• Children of addicts are eight times more likely to develop an addiction at some point.
• In 2020, among those using illicit or misusing prescription drugs, 22% were male and 17% female.
• Only 20% of users in drug treatment programs are women.
• 9% of people with substance abuse disorders also have at least one mental health disorder (4)

Environment/Non-Genetic Demographics

The attitudes about drugs and alcohol from those in a person's network and life experiences play a role in the risk of addiction. Substance use among friends, family, or coworkers increases the risk that a person will also use substances. Exposure to substance use from a young age relaxed parental attitudes about substance use, and peer pressure from friends can increase the risk. Certain stressful life circumstances such as veteran status, history of sexual or physical assault, or being part of the LGBTQ community can also increase risk. (5)

• 20% of people in urban areas used illegal drugs in 2020 compared to 5% in rural locations.
• 51% of Americans with an illegal pain relief medication obtained it from a friend or relative.
• 7% of LGBTQ Americans abuse illicit drugs.
• 2% of LGBTQ Americans abuse alcohol.
• 7% of Veterans abuse illicit drugs.
• 80% of Veterans abuse alcohol (4)

Developmental Stage

Substance use at any age can lead to addiction, but children and teens are at particular risk due to their underdeveloped brains. The parts of the brain responsible for decision-making, risk assessment, and self-control do not fully develop until the early 20's, putting teenagers at increased risk of dangerous behaviors. In addition, the effects of drugs and alcohol on the developing brain may mean that those parts of the brain never fully develop at all for teens with substance abuse disorders. (5)

• 70% of users who try an illegal substance before age 13 will develop a substance use disorder within the next seven years.
• This is for only 27% of people who first try an illegal substance after age 17.
• 47% of youths report trying an illegal substance by the time they graduate high school (4)

Overview of Medication Assisted Treatment (MAT)

Treatment of substance abuse disorders is a complex and often tumultuous process. The nature of the brain changes that occur during addiction means that a person is never entirely "cured" but will always be considered "recovering" as the risk for relapse is always present. Effective treatment must be multifaceted and often involves removing triggers (such as people, places, and stressors) that may prompt a person to use again behavioral therapy, and medications to curb withdrawal symptoms and reduce cravings.

Medication Assisted Treatment (MAT) is a treatment that involves FDA-approved medications, in combination with behavioral therapy, in the recovery process for substance abuse disorders. Several medications are available for MAT, and evidence continues to emerge that the treatment is highly effective if used correctly.

However, it is a vastly underused and understudied treatment modality. MAT has been available in some form for over 50 years but is just starting to gain traction among the medical community (and policymakers) in recent years, with the federal government calling for more research and increased accessibility for the treatment (8).

The height of the opioid crisis in the last several years has highlighted the magnitude of drug addiction and deaths in the United States, bringing renewed attention to MAT as a treatment option. So, how does MAT work? Prescription medication is given to both stimulate the receptors seeking the abused substance and block the drug's euphoric effects.

Over time, this normalizes brain chemistry and helps the person break the habit of using without the discomfort of cravings and withdrawal symptoms. Gradually, the prescription medication dosage is reduced, all the while in conjunction with behavioral therapy and lifestyle changes, and eventually, the client should be able to stop the medication altogether, often within 1-3 months (8).

MAT does require close supervision by a trained medical professional and an appropriate facility for treatment. It can be done on an inpatient, partial inpatient, or outpatient basis. There may be side effects to the medication, and there is a risk of misusing or developing addiction to the new drug, though the successful outcomes often outweigh this risk. Clients must also participate in behavioral therapy for a comprehensive and effective treatment plan. As with any treatment regimen, careful consideration of the client's history and circumstances is essential (8).

Pharmacokinetics

Currently, there are three medications with FDA approval for MAT: buprenorphine, methadone, and naltrexone. Each will be discussed in depth below.

Buprenorphine

Mechanism of Action and Metabolism

Buprenorphine is an opioid partial agonist, acting on the same receptors as other opioids but with weaker effects. It can be used for the treatment of misuse of opioids, including:

• Heroin
• Fentanyl
• Oxycodone
• Hydrocodone
• Morphine
• Methadone (3)

Opiate receptors are G-protein coupled receptors (GPCRs) with four major types: Mu, Delta, Kappa, and opioid receptor like-1 (ORL1). Stimulation of these receptors results in varying levels of the following effects:

• Euphoria
• Relaxation
• Pain relief
• Sleepiness
• Sweating
• Constipation
• Impaired concentration
• Reduced sex drive (3)

Buprenorphine has a high affinity to the Mu-opioid receptor and is a partial agonist at this site, causing reduced opioid effects with a plateau or ceiling at higher doses. This limits dangerous effects and makes overdose unlikely. It also has slow dissociation from the site, allowing milder and more easily tolerated withdrawal effects compared to full agonists like morphine and fentanyl. Buprenorphine is also a weak kappa receptor antagonist and delta receptor agonist, reducing the craving sensation and improving tolerance to stress (3).

Buprenorphine has poor bioavailability when given orally due to the first-pass effect, where most of the drug is broken down in the liver and intestines. Because of this, sublingual or buccal are the preferred routes of administration and the most common forms in which the drug is manufactured. Transdermal patches and IV and IM forms exist, though not for use in MAT (3).

CYP34A enzymes break down buprenorphine, so other drugs, such as ketoconazole, may inhibit metabolism and increase available levels of buprenorphine. CYP34A inducers such as carbamazepine, topiramate, phenytoin, and barbiturates may speed metabolism and lower available levels. Once broken down, the med takes the form of norbuprenorphine and is excreted in the feces (3).

Available Forms

Buprenorphine is available by itself and with naloxone (in a 4 to 1 ratio). However, in oral form, naloxone is not readily absorbed, and buprenorphine is the only genuinely active ingredient. This combination is beneficial should clients try to inject their buprenorphine to get high; naloxone is a fast-acting opioid antagonist that is active when used intravenously and would block the opioid effect of buprenorphine, rendering it useless for recreational use and ensuring it has no street value.

The currently available preparations of buprenorphine for MAT include:

• Generic Buprenorphine/naloxone sublingual tablets
• Subutex - Buprenorphine sublingual tablets
• Suboxone - Buprenorphine/naloxone sublingual films
• Zubsolv - Buprenorphine/naloxone sublingual tablets
• Bunavail - Buprenorphine/naloxone buccal film (3)

Sublingual products dissolve within 2-10 minutes. Bloodstream absorption begins quickly, bypassing the first pass effect. Buprenorphine has a slow onset of action, peaking about 3-4 hours later. Metabolism is also slow, with the half-life lasting anywhere from 25 to 70 hours (an average of about 38 hours). This long half-life means the drug can be spaced out to every other day administration once weaning begins (3).

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