California APRN Course Bundle Part 1

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Schedule II Controlled Substances and the Risks of Addiction

Introduction   

Every clinician has cared for a patient in pain. Non-maleficence and beneficence, to do no harm and to do good, are the guiding ethical principles in patient care (16). Historically, easing pain and suffering was ethically straightforward- treating the pain was beneficial. Now, with the understanding of opioid misuse, clinicians may ease pain (beneficence), but cause opioid use disorder, abuse, and/or diversion and do more harm (maleficence).

Prescribing pain medications, especially schedule II controlled substances, comes with overwhelming responsibility and burden to the prescriber. The dual-edged sword of Schedule II controlled substances is to ease pain and to prevent misuse. To safely prescribe schedule II controlled substances, you must be aware of a myriad of facts, as well as clinically assess pain through the individual experience of each patient.

Case Scenario

Mary, a 34-year-old female patient you have cared for in the past for management of Type II diabetes, visits after moving furniture over the weekend. She is in apparent pain, holding her lower back and flinching with every movement. She is physically unkempt and appears exhausted. Mary states, “I’ve been trying to rest, I’ve iced the area and have been taking Ibuprofen every 6 hours and I can’t get any relief, I need something stronger.” What are your next steps?

In 2016, the US CDC issued guidelines for the prescription of opioids to treat chronic, non-cancer pain. These more restrictive guidelines were partly in response to the growing number of people using opioids and the AHRQ 2014 findings. The guidelines were adopted by many states, including limiting prescriptions for opioids for the treatment of chronic, non-cancer pain. This event caused inadequate pain control and suffering for many patients who truly needed opioids but couldn’t obtain them through prescription because many states used the CDC recommendations as law.

In May 2021, California alone saw the sudden closure of twenty-nine pain management centers leaving more than twenty thousand opioid-prescribed patients without help or anywhere to go (13).

Pain

Pain is a complex, not completely understood experience that is influenced by many components, including biological, psychological, and social factors (19).

Seeking relief from pain is one of the most common reasons patients reach out for medical care (19).

Pain Theory

Pain has existed since humans existed. The cause of pain has been explored for centuries. Even though our understanding of pain is still incomplete, there are many pain theories.

A brief, incomplete explanation of each theory is presented below (8,11):

• Intensity Theory: pain is an emotion.
• Cartesian Dualistic Theory: Pain is a consequence of committing immoral acts.
• Specificity Theory: Different sensations take different paths causing pain.
• Pattern Theory: Each sensation relays a particular pattern of signals to the brain, and then the brain reads the pattern to decipher the pain.
• Gate Control Theory:  Pain travels from the periphery to the spinal cord. When the pain gets to a specific magnitude, the “gate” opens. After the spinal gate is open, the pain signal can reach the brain where it is processed, and lastly, the patient feels pain.
• Neuromatrix Model: The central nervous system is responsible for painful sensations, not the periphery. Pain messages to the areas of the central nervous system work together to create messages to allow patients to feel pain, called the neurosignature.
• Biopsychosocial Model: The biopsychosocial model is a comprehensive pain model encompassing all spheres of our humanness. This theory hypothesizes that pain is not made up of any one cause, but the result of multifarious psychological, biological, and sociological interactions. The theory links psychological and sociological interactions to the biological and helps us understand associated opioid use disorder, abuse, and diversion.

Case Scenario

Mary starts crying and says, “I know I deserve this pain; I had an abortion when I was in high school, and I guess I’m paying for it now.”

Case Scenario

After trying to explain that the pain was caused by the injury, not the abortion, Mary asks more about what actually causes the pain she is experiencing.

Types of Pain by Origin

There are different types of pain, depending on the origin. Determining the origin of pain is essential in the assessment and determining if treatment should involve Schedule II controlled substances. The most common causes of pain (acute and/or chronic) include (8):

Neuropathic Pain

Neuropathic pain can be peripheral or central, and it comes from nerve compression or nerve changes from other pathologies.

Peripheral neuropathic pain- examples include post-herpetic neuralgia and diabetic neuropathy.

Central neuropathic pain – examples include post-cerebral vascular accident.

Nociceptive Pain

Nociceptive pain is from direct tissue injuries, usually from an external force.

Examples include sprains, bruises, burns, or dental procedures.

Musculoskeletal Pain

Musculoskeletal pain originates from bones, joints, ligaments, tendons, or muscles.

Examples include arthritis, fractures, or back pain.

Inflammatory Pain

Inflammatory pain is due to the inflammatory response and associated swelling.

Examples include swelling from tissue injury, infection, or autoimmune disorders.

Psychogenic Pain

Psychogenic pain is caused by psychological factors.

Examples include tension headaches or stomach pain caused by stress.

Mechanical Pain

Mechanical pain is caused by pressure exerted on the body structure or part.

Examples include low back pain, abnormal growth, or tumors. (8)

Case Scenario

As you assess Mary and her pain, she tells you about the furniture moving last weekend, and that she fell while carrying a couch down a flight of stairs with another person. “I thought I was going to pass out! I had to stop right there and just cry from the pain. I had my friend take me home and this is the first time I’ve come out of the house since Saturday. I can’t sleep and I’m not hungry. My roommate is mad because I haven’t done a thing.”

Pain Classifications

Determining the classification of pain- acute, chronic, or high-impact chronic will help the practitioner decide on appropriate treatment options.

Acute

Pain may be classified as acute pain. Acute pain comes on quickly and is limited (less than 1 month in duration) (18). Causes of acute pain can be a result of inflammation, injury, or a disease process. Acute pain interferes with daily functioning but usually subsides as the cause is treated. Acute pain may be described as throbbing, stabbing, or burning. Acute pain can cause physiologic symptoms including elevated heart rate and blood pressure.

Chronic

Pain can become classified as chronic when it lasts more than 3 months (8). Chronic pain is usually a result of injury, inflammation, treatment, or a pre-existing medical condition or disease (8).  Every aspect of a patient's life may be affected by chronic pain leading to poor physical and mental health. When experiencing chronic pain, reduced quality of life, sleep, libido, and appetite changes are common (4).

High-impact Chronic Pain

In 2019, about 20% of adults in the US had chronic pain, and close to 7% had “high-impact” chronic pain, meaning they had pain every day or most days during the past 3 months that impacted normal work and life activities (5,6).

Assessing Pain

When contemplating prescribing opioids for chronic pain, thorough patient assessment including risk assessment of opioid use. Assessments of the patient’s pain encompass the origin, type, and intensity of the pain, past and present treatments, any underlying problems, and how pain affects physical and mental functioning (13). Patient-reported outcome (PRO) tools may simplify and organize the documentation of these goals and can be used to track patient progress over time (13).

As nurses, we all have been taught how to assess pain using the OPQRST mnemonic:

• Onset
• Provocation/Palliation
• Quality
• Region/Radiation
• Severity
• Time

And the 7 components of pain assessment:

1. Onset/cause of pain
2. Location/distribution
3. Duration
4. Pattern
5. Character/quality
6. Aggravating factors
7. Alleviating factors/associated symptoms

These pain assessments only view the physical aspects of pain and are limited.

When assessing pain, these elements of pain experience need to be taken into consideration and include  (11):

Nociception

The signal sent to the brain from the periphery that injury or damage is present. What is the origin of the pain?

Pain

The subjective experience after brain-processed nociception. What is the patient’s subjective pain experience?

Suffering

The emotional response to nociception. What is the patient’s emotional response to the pain?

Pain behaviors

The actions patients have in response to the experience of pain. What behaviors or changes does the patient have in response to pain?

Looking at these elements of the pain experience allows the practitioner to get a more holistic, individualized view of pain from the patient’s perspective.

Using reliable, validated tools to assess pain is needed to accurately measure and track pain levels. Mental health screening may be used to gather baseline information about and screen for any mental health concerns the clinician may have. Several Patient-Reported Outcome (PRO) tools are available and suggested pain screening tools (13):

• Pain Intensity and interference (pain scale)
• Brief Pain Inventory - Short Form (BPI-SF)
• PROMIS Pain Interference
• Mental health screening (the type depends on the practitioner’s evaluation and as appropriate)(13)

2022 CDC Guidelines for the Prescription of Opioids to Treat Chronic Pain

In 2022, the CDC issued new guidelines for prescribing opioids to treat chronic pain (5,6). The new guidelines support clinical judgment and individualized patient-centered care. Even though the CDC stresses they are recommendations, many states are again using the guidelines to make changes in state laws about prescribing opioids and other Schedule II controlled substances. Every prescriber must read the guidelines and review state prescribing laws from 2022 forward. The guidelines serve as a resource for prescribers, and the recommendations should be adhered to with the caveat to always individualize care and do the best for the given situation.

There are five guiding principles when implementing the recommendations into clinical practice. These broad guiding principles should be foremost when dealing with patients’ pain.

Five Guiding Principles of the Guidelines

1. All pain, whether opioids are prescribed or not, needs to be assessed and treated on its own.

This reminds us that pain is pain and needs to be treated if opioids are prescribed or not.

2. Flexible, supportive, individualized care should be voluntary, and all recommendations are supportive of person-centered care.

This reminds us that we are dealing with a unique person, and our care should reflect that fact and we need patient input for person-centered care.

3. Pain should be managed using a multidisciplinary approach utilizing physical and behavioral health, and long-term services.

This reminds us we aren’t in it alone; a multidisciplinary approach allows the patient to receive the services they need from the appropriate provider.

4. Make sure the clinical practice guidelines aren’t used beyond their intended use. Incorporate them with clinical judgment and patient-specific needs.

This reminds us that the guidelines are recommendations, and we need to use clinical judgment and the needs of the patient to drive our care.

5. All layers of health systems need to be vigilant of health inequities and provide care and communication that is culturally and linguistically appropriate and accessible to all. Nonpharmacologic and pharmacologic pain management regimens should be affordable, diversified, and coordinated.

This reminds us that health inequities exist, and we need to provide care that is appropriate and accessible to all people to the best of our ability. (5,6)

Case Scenario

While explaining to Mary that you will give her printed care instructions before she leaves, Mary states, “Don’t bother, I can’t understand those instructions. They are way over my head, just tell me what I need to know.”

Four Key Issues Addressed By the Guidelines

The four key issues addressed by the new guidelines include specifics on opioid prescribing (5,6). These guidelines may also be applied to prescriptions of other Schedule II controlled substances.

The first issue, whether to start opioids for pain should be addressed with every patient who is experiencing pain. The other three issues are after opioids are prescribed.

1. Deciding whether to start opioids for pain.

Many factors need to be considered when deciding to prescribe opioids or not. Many times, pain can be controlled using nonpharmacological interventions and nonopioid medications.

2. Choosing an opioid and the appropriate opioid dose.

There is no perfect way to decide on an initial opioid dose. In general, starting with a low dose is safer.

3. Determining the length of time for the opioid prescription and conducting follow-up assessments.

Make sure to only prescribe the number of pills needed and schedule follow-up assessments.

4. Assessing the risk for and educating on the potential harms of opioids.

Each patient taking opioids needs to understand the harms of opioids and be assessed for harm before, during, and after opioid therapy (6).

Case Scenario

As you explore treatment options with Mary, she tells you, “I told you I need something strong, the good stuff. The rest won’t do a thing for my pain!”

Non-pharmacological Treatments for Pain

Nonpharmacological treatments for pain should be suggested as appropriate for patients in pain (6). These are usually cost-effective and have minimal downsides.

Examples of non-pharmacological treatments include (6):

• Exercise (aquatic, aerobic, and/or resistance)
• Application of heat/cold
• Elevation of affected body part
• Weight loss (for osteoarthritis or back pain)
• Massage
• Mindfulness-based stress reduction
• Yoga
• Acupuncture/acupressure
• Cognitive behavioral therapy
• Physical therapy
• Tai Chi
• Qigong

Case Scenario

While exploring non-pharmacological pain management options with Mary, she states, “My grandmother used to swear by hot baths with Epson salts for all pain! But why bother when you can take a pill, right?”

Non-schedule II Controlled Substances for Pain

As a prescriber of Schedule II controlled substances, remember that many non-opioid medications treat pain effectively (as or more effectively than opioids in many cases) including:

NSAIDS

Example: Ibuprofen

200 to 400 mg PO every 4 to 6 hours as needed. Max: 1,200 mg/day. Discontinue use if pain gets worse or lasts more than 10 days (15).

SNRI antidepressants

Example: Venlafaxine

37.5 mg PO once daily for 1 week, then 75 mg PO once daily for 1 week, and then 150 mg PO once daily. Doses up to 225 mg/day have been used. Guidelines state this medication is most likely effective and should be considered for the treatment of diabetic neuropathy (15).

Gabapentin

Example: Gabapentin

300 mg PO 3 times daily, at first. Titrate dosage is based on clinical response and tolerance. Max: 3,600 mg/day. Guidelines suggest gabapentin is most likely affective for diabetic neuropathy (15).

Case Scenario

You tell Maria that the ibuprofen she is taking is an excellent pain reliever and to continue taking it for the pain. She states, “I guess you haven’t been listening to me here, I still have pain so that means ibuprofen is useless to me.”

Controlled Substance Act

Title II of the Controlled Substance Act (CSA) established federal regulation of controlled substances in 1970 (9). It was largely created to make a legal foundation to combat drug abuse.

This act also gave power to the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) to determine classification schedules. Mandatory registration through the US Attorney General controls and restricts who may import/export, manufacture, distribute, or dispense controlled substances.

Currently, there are five schedules of Controlled Substances (20). A brief description of each follows with emphasis on schedule II controlled substances.

Prescribers need to be aware of the specific, current information regarding each medication they prescribe and how that information relates to the individual patient receiving care.

Schedule I-V Controlled Substances

Schedule I Controlled Substances

These drugs have a high potential for abuse. Marijuana is the only Schedule I product that may be obtained legally in certain states in the US.

Examples (20):

• Heroin
•  Lysergic acid diethylamide (LSD)
• Marijuana (cannabis)
• Peyote
• Methaqualone
• 3,4-methylenedioxymethamphetamine ("Ecstasy")

Case Study

Mary asks, “What about smoking pot for the pain? My neighbor told me I should and that it works great for his arthritis.”

)Schedule II Controlled Substances & Schedule IIN Controlled Substances

Drugs in this schedule have a high potential for abuse that may lead to serious psychological or physical dependence. Oxycodone, hydrocodone, and hydromorphone tablets are all derived from poppy plants and are morphine derivatives whereas fentanyl is synthetic and much more potent than other Schedule II controlled substances. (15) Most opioids go through first-pass metabolism in the liver before entering the systemic circulation and reaching target tissues. There are individual differences in how opioids are metabolized because there are differences in a patient's CYP-450 and UGT liver enzymes that are part of the metabolizing process (15).

Examples of drugs in this class:

Morphine-opioid agonist

Morphine Tablets: 15 mg PO every 8 to 12 hours, at first. Titrate dose every 1 to 2 days to achieve adequate analgesia. While discontinuing, decrease the dose by 25% to 50% every 2 to 4 days to prevent withdrawal symptoms. Extended-release tablets are only prescribed for opioid-tolerant patients (15).

Hydromorphone-opioid agonist

Dilaudid: 2 to 4 mg PO every 4 to 6 hours PRN initially (15).

Fentanyl-opioid agonist

Duragesic: Follow the FDA-approved conversion chart to convert 24-hour oral morphine equivalents dose to the corresponding transdermal fentanyl system dose. To start, apply at minimum a 25 mcg/hour transdermal patch for patients receiving at least 60 mg/day oral morphine equivalents. All other opioids should be stopped with transdermal fentanyl initiation (15).

Methadone-opioid agonist

Dolophine: 0.05 to 0.1 mg/kg PO every 6 hours, to start. Titrate dose by 0.05 mg/kg/dose until symptoms are managed. Taper dosage 10% to 20% of initial dose every 1 to 2 days, lengthening interval before discontinuation (15).

Meperidine-opioid agonist

Demerol tablets: 50 to 150 mg PO every 3 to 4 hours PRN (15).

Oxycodone-opioid agonist

OxyContin: 5 to 15 mg PO every 4 to 6 hours PRN (15).

Hydrocodone-opioid agonist

Norco: 2.5 to 5 mg hydrocodone/325 to 650 mg acetaminophen (1 to 2 tablets)  Q 4 to 6 PRN. Max: 30 mg hydrocodone/3,900 mg acetaminophen (12 tablets)/day (15).

Side Effects of Narcotics (Schedule II controlled substance)

Common side effects of narcotics (schedule II controlled substances) include:

• Nausea and vomiting (may also increase aspiration). Patients may need to be prescribed anti-emetics.
• Pruritus may cause skin irritation. Patients may need to take Benadryl to decrease itching.
• Dizziness- This is a safety concern, and the patient must know not to drive or be weary of falls.
• Dry Mouth- Hard candy or gum may alleviate this symptom.
• Sedation- This is a safety concern, and the patient must know not to drive or be weary of falls.
• Euphoria- Patients must understand not to drive, sign legal documents, or purchase items while “high.”
• Constipation-counsel to increase fluids and fiber in the diet, over-the-counter stool softeners may be recommended. (6, 20)

Schedule IIN stimulants examples:

• Amphetamine (Dexedrine, Adderall)
• Methamphetamine (Desoxyn)
• Methylphenidate (Ritalin)
• Amobarbital
• Glutethimide
• Pentobarbital (20)

Schedule III/IIIN Controlled Substances

These drugs have less potential for abuse than Schedule I or II drugs.

Examples:

• Medication with 90mg or less of codeine per dose
• Buprenorphine (Suboxone)

Examples of Schedule IIIN:

• Benzphetamine (Didrex)
• Phendimetrazine
• Ketamine
• Anabolic steroids (20)

Schedule IV Controlled Substances

These drugs have even less potential for abuse compared to Schedule III drugs.

Examples:

• Alprazolam (Xanax)
• Carisoprodol (Soma)
• Clonazepam (Klonopin)
• Clorazepate (Tranxene)
• Diazepam (Valium)
• Lorazepam (Ativan)
• Midazolam (Versed)
• Temazepam (Restoril)
• Triazolam (Halcion) (20)

Case Study

After reviewing Mary’s current medications, you see that she has been prescribed Triazolam by another provider.

How Opioids Work

Opioids work by sending chemical signals that bind and activate opioid receptors. There are four known opioid receptors, and they include DOP, KOP, NOP, and MOP. A brief list of effects elicited by each receptor follows (10):

• DOP-spinal and supraspinal analgesia and decreased gastric mobility.
• KOP- spinal analgesia, diuresis, and dysphoria (like MOP without the vital sign changes)
• NOP- hyperalgesia, allodynia, and analgesia
• MOP-sedation, respiratory depression, analgesia, bradycardia, nausea, and vomiting, and decreased gastric mobility.

Opioids used in practice wield actions at the MOP receptor (James & Williams, 2020). The MOP receptor effects are the classic opioid effects that most clinicians see when caring for a patient taking opioids.

Opioids are highly addictive simply because they make you feel good. The release of endorphins triggered by opioids causes a sense of pleasure and well-being.  As an opioid wears off, patients may find themselves craving the feel-good feeling again and take more opioids- not for pain, but to gain the good feeling back. There are psychological, genetic, and environmental factors that make patients at higher risk for abuse. They are also addictive because drug tolerance occurs and requires higher doses for the same effect.

The odds are a patient will still be on opioids a year after only five days on opioids (12).

Dosing

The first daily dose is a clinical decision made with the patient to provide individualized, appropriate care. When dosing opioids, use a Morphine Milligram Equivalent (MME) calculator. Use this tool to calculate the total daily opioid dose and document the MME. The total daily dose helps clinicians and patients figure out who may need additional monitoring, when tapering may be needed, and the risk of overdose (13). A patient's risks increase as the daily MME increases (13).

Assessing the Effectiveness of Opioids

Suggestions for assessing the response to opioids for pain include:

Assessing the 4 A’s

• Analgesia- are they getting pain relief, what are the pain scores?
• Adverse effects- what side effects are they experiencing from the drug?
• Activity- how has the drug affected their activities of daily living including work and sleep?
• Aberrancies- anything out of the ordinary (such as asking for a refill early, taking the drug other than prescribed)? (13)

Definitions Regarding Opioid Misuse

A bit about definitions. These terms about the consequences of opioid use are often used interchangeably and incorrectly (7). Note the differences in each and make sure the patients know them too.

Addiction

The continual need for a drug despite harmful repercussions.

Example: A patient buys opioids off the street illegally because they physiologically need the medication and will go to any lengths to receive it.

Pseudo-addiction

The persistent fear of pain, causing hypervigilance which may go away when the pain resolves.

Example: A patient will not go anywhere without their medications in hand because they are afraid of being without pain treatment and limit many activities due to the fear of having more pain.

Dependence

The body needs medication to function normally, and physiologic withdrawal symptoms occur without the medication.

Example: a patient becomes anxious and starts sweating an hour before a medication is due.

Tolerance

The body needs more of the medication to achieve the same response caused by the CNS adjusting to a medication over a period of time.

Example: a patient's pain rating was between 4 and 5 (out of 10) on an opioid and after a week of therapy the pain rating increases (between 6 and 8) on the same dose, and they come to their prescriber requesting more drugs to get the same effect.

Opioid Use Disorder (OUD)

Encompasses dependence and addiction specifically to opioid use. OUD is defined in the DSM-5 as a problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least two DSM-5 criteria occurring within a 12-month period. This disorder is on a continuum and can be measured as mild, moderate, or severe.

Example: A patient has been on oxycodone for 3 years for back pain and their MME is 80. They admit physical addiction and emotional dependence on opioids.

Drug Diversion

The unlawful use or distribution of a drug.

Example: A patient comes in with complaints of severe pain with the intention of getting opioids to sell for cash.

Drug Misuse

Taking the drug differently than prescribed.

Example: A patient was prescribed 20 Tylenol #3 tablets to take Q6 hours PRN and comes to the clinic asking for more drugs in 3 days because they took them more often than prescribed. (7)

Case Scenario

You decide to prescribe short-term opioid therapy for acute pain to Mary. What are your next steps?

Prescribing in California

When prescribing Schedule II controlled substances in California, you must be aware of applicable laws and guidelines.

The Medical Board of California published guidelines in 2023 for prescribing controlled substances for pain. The steps to prescribing Schedule II controlled substances in California and the associated laws are briefly as follows (13).

Steps for Prescribing

1. Establish a diagnosis and medical necessity.

The diagnosis should support opioid use, and the assessments support the medical necessity of the medication.

2. Explore non-controlled medication treatment.

Again, many pain situations are controlled using non-controlled medications.

3. If using Schedule II controlled substances: Use a patient-specific protocol for Schedule II medications.

Patient-specific protocols are required by California state law. A treatment plan should include a plan to discontinue or taper opioids as appropriate. The patient-specific protocol required nurse practitioners to furnish Schedule ll  controlled substances, as defined in Health and Safety Code 11055 and 11056 (27,28), in a protocol, contained in the standardized procedure or protocols that specifies which categories of patients may be furnished this class of drugs.

4. Make a treatment plan.

Treatment goals and objectives should be created when initiating an opioid trial. The goal of pain treatment should include documented improvement in pain, functioning, and a decrease in disturbances caused by pain. The plan should include an exit strategy of when and how the opioids will be discontinued.

5. Obtain consent.

By creating a formal agreement and obtaining consent for opioid use, prescribers include their patients and can document their participation and enter the discussion of the gravity of opioid use.

6. Enter a pain agreement.

The pain agreement can be tailored to the individual patient. Pain agreements can include safe medication administration and storage, what to do if medications are lost or if the pain increases. It can also include monitoring and compliance issues such as urine drug testing and pill counting. By entering a formal agreement, the patient realizes their accountability and responsibility in their pain management. Pain agreements can also be used to document teaching related to opioid use.

7. Counsel on overdose and OUD prevention.

The eleven criteria for OUD should be discussed with the patient prior to prescribing opioids. This item is key to safety education. Beyond that, signs, and symptoms of overdose, how to use naloxone, and when to call 911 or seek medical attention are lifesaving instructions that patients need to know.  According to California law, AB 2760, Wood, Chapter 324, Statutes of 2018, naloxone prescription must be offered to a patient when the dosage ≥ 90 MMEs (23).

8. Ongoing assessments (pain, risk for misuse, risk of OUD).

While on opioid therapy, documentation of ongoing assessments is necessary to support your treatment plan and may prompt changes to the plan as assessments change.

9. Compliance monitoring.

There are many aspects to compliance monitoring.

CURES/PAR

The law also requires compliance with California’s Prescription Drug Monitoring Program (PDMP) called CURES, AB 528, Low, Chapter 677, Statutes of 2019. To comply with CURES, all California-licensed prescribers are required to register for access to CURES once they are issued a Federal DEA Controlled Substance Registration certificate.

The California Controlled Substance Utilization Review and Evaluation System (CURES) is a database of Schedule II, III, and IV controlled-substance prescriptions dispensed in California. This system allows prescribers to review a patient's controlled-substance history. CURES is maintained by the Department of Justice.

CURES consult including A Patient Activity Report (PAR) generated from CURES (California’s prescription monitoring program) must be reviewed on each patient within 24 hours prior to  prescribing a controlled substance according to AB 528, Low, Chapter 677, Statutes of 2019.

CURES consultation is required at least every four months while receiving treatment.

Other compliance measures may include:

Drug testing

Urine drug testing can monitor if the patient is taking the opioids as described and detect if they are concurrently using substances that may make them at higher risk for OUD.

Pill counting

Having the patient bring their prescription to visits and verifying that the number of pills in the container correspond to the number that should be there based on the prescribing frequency is an active form of compliance monitoring and can be a part of a pain agreement or consent to treat.

Drug diversion

If a patient is found to be participating in drug diversion, depending on the nature of the diversion, appropriate reporting to the DEA or legal actions may be necessary.

10. Tapering and Discontinuing Opioid Therapy

Tapering or discontinuing opioids should be a part of the patient-specific plan and planned accordingly. (13)

Case Study

Mary appears overwhelmed and anxious as you go through the prescribing steps. She asks you, “Are you doing all this because you think I’m a drug addict?"

California Prescribing Laws

As mentioned, there are California laws specific to prescribing Schedule II controlled substances and NPs. It is paramount that NPs keep abreast of prescribing laws as they change rapidly. In addition to the laws already mentioned, a brief review of  California NPs’ legal requirements to prescribe schedule II -V medication follows.

AB II96, (Chapter) 748 1/2004 amended Business and Professions Code Section 2836.1 (21) gives nurse practitioners authority to prescribe Schedule II through V drugs. To prescribe in California, NPs need:

• BRN certification.
• An action furnishing number registered with the United States DEA (14).
• A DEA number.
• Complete continuing education requirements decided by the California  Board of Registered Nursing.
• Pads used to write prescriptions for controlled substances need to have a 12-character serial number and a corresponding barcode according to AB 149, Cooper, Chapter 4, Statutes of 2019.
• Electronic submission of a controlled substance prescription is required according to AB 2789, Statutes of 2018.

Case Scenario

Mary asks for a paper copy of her prescription because it’s easy for her to drop it off at the pharmacy in the store where she does her grocery shopping.

Patient Communication and Education

When prescribing opioids, patient education, and an open discussion on the potential harms of opioids is paramount for patient safety. Providers must effectively communicate with every patient, without bias and with cultural competence. By effectively listening and assessing each patient’s pain experience, the practitioner can more effectively and safely treat pain.

Essential topics for dialogue and discussion with patients before and during opioid treatment for acute and chronic pain include many aspects. Communication topics and suggestions from the 2022 CDC guidelines include (6):

1. Make a plan to discontinue when prescribing opioids.
2. Let a patient know whom and how to contact and protocols to follow for uncontrolled pain, so it can be quickly reassessed and managed.
3. Explain respiratory depression and opioid use disorder-how to avoid, how to recognize, and how to treat. Teach that taking opioids with benzodiazepines, sedatives, alcohol, or illicit drugs increases the chance of respiratory depression.
4. Advise patients of side effects and how to treat dry mouth, nausea, constipation, vomiting, drowsiness, and confusion.
5. Initiate an opioid tapering plan if opioids are prescribed more than a few days.
6. Teach that medication should only be taken as needed, not as often as prescribed. Encourage non-pharmacological treatments.
7. Remind the patient the medication is to make the pain tolerable, not to eliminate it, not to make you “feel good.”
8. Remind patients not to drive or operate machinery when taking opioids.
9. Talk to patients about safe medication handling, storage, and no sharing. Include how to dispose of medications safely and naloxone for an overdose.
10. Explain workplace toxicology testing and its potential to check the amount of opioids they are taking. Discuss using state prescription drug monitoring program (PDMP) data to evaluate the patients’ risk for an overdose.
11. Explain why opioid prescriptions should only contain the quantity needed for the anticipated period of severe pain.
12. Explain why within a month of prescribing opioids, the patient should be re-evaluated and prescription changes (escalating, de-escalating, or discontinuing opioids) made accordingly. If continued, re-evaluating will need to be performed at least monthly.
13. Let the patient know if they show signs of opioid use disorder or addiction, you will offer, or arrange evidence-based treatment. Educate the patient that stopping on their own can be deadly, and they need medical help.
14. Remind the patient there are no reliable ways to predict which patient will benefit from opioid prescriptions and which will be harmed (6).

Using these recommendations in your practice is essential for safely prescribing opioids. Review the complete CDC Guidelines for further information (6).

Risk Factors for Opioid Misuse

As a prescriber of opioids, you are responsible for understanding and recognizing opioid misuse, diversion, and OUD.

There are risk factors associated with the misuse of opioids. These risk factors increase the likelihood of opioid misuse or taking the medication differently than intended.

Risk factors of opioid misuse include (12):

• Being poor
• Unemployed
• History of substance abuse
• Environment that is high risk for misuse
• Adventurous or dangerous behaviors
• History of any mental disorder
• Stressful life
• History of drug or alcohol rehabilitation
• Female gender (12)

When patients have identifiable risk factors, prescribers should share this information with their patients, so they understand they are at risk for misusing opioids.

Tools for Assessment of Opioid Misuse Behavior

There are reliable and valid tools to assess opioid misuse behaviors, and the Medical Board of California endorses the use of these tools to assess opioid misuse behavior (13):

• TAPS
• SOAPP-R
• CRAFFT for adolescents (13)

Diversion

Drug diversion, or the illegal use or distribution of a drug, may lead to accidental overdose and a myriad of illegal activities (7). Prescribers need to be careful not to fall victim to drug diversion by protecting their prescribing information and watching out for patients who visit solely to receive narcotics.

Common Drug Diversion Activities include:

• Doctor shopping
• Prescription pad theft
• Selling drugs for money
• Giving drugs to someone other than to whom they are prescribed. (7)

Opioid Use Disorder

The term Opioid Use Disorder (OUD)  encompasses opioid dependence and addiction and can be mild to severe. Opioid use disorder (OUD) currently affects over three million people in the United States (1).

The diagnosis of OUD is made by meeting at least two DSM-5 criteria of the eleven within a year, according to the DSM-5 (1).  The key 11 criteria are as follows:

1. Increasing dose/tolerance
2. Wishing to cut down
3. Excessive time spent getting or using the medication
4. Strong want to use
5. Use interferes with normal daily obligations
6. Continued use despite life disruption
7. Use of opioids in hazardous situations like driving
8. Reduced interest in important activities
9. Continued use despite physical and/or psychological problems
10. Need for more of the medication for the same effect
11. Withdrawal symptoms occur when the dose is decreased

Estimates support that less than 20% of people in the United States with OUD are receiving effective available treatment (7).  Screening for OUD is part of prescribing. If OUD is found, start treatment, or arrange for the patient to receive treatment and further care from a substance use disorder treatment specialist certified by SAMHSA. Practitioners should not terminate care with a patient because of OUD, as this event could represent patient abandonment and is unsafe for the patient (6).

Case Scenario

Mary returns to the clinic for a follow-up five days after she was prescribed opioids. She tells you, “I’m really happy you went through all that stuff when you prescribed those painkillers to me. On that list of 11 things that I was supposed to watch for, I am already experiencing some. I don’t want to do anything on these drugs. There is no way I can be on these and live a normal life on them. I also found myself not wanting to take the pills or wishing I was off them because they messed up my life so badly. I want off.”

Tapering and Discontinuing Opioid Therapy

Discontinuing opioids can be achieved rapidly, as in the case of someone that was prescribed a 3-day course of opioids for an acute injury and healing has reduced the pain so opioids aren’t warranted, or slowly through tapering.  Tapering is the reduction of the daily opioid dose or daily MME. Tapering should be used as an exit strategy for opioids for patients who have been on long-term opioids or anyone who has withdrawal symptoms when trying to discontinue. Tapering about 10% per month or slower is usually better tolerated than rapid tapers, especially when patients have been taking opioids for a year or longer (6).

Reasons for tapering include:

• Implementing the planned opioid exit as part of the patient's treatment plan
• Pain resolution
• Pain not resolved, and a new treatment plan without opioids is introduced
• Patient is experiencing impairment of daily functioning
• Patient is showing signs of OUD, misuse, or diversion
• Patient experienced an overdose or event leading to hospitalization. (6)

Adjunct drugs can be co-prescribed to help withdrawal symptoms and make the taper more tolerable (6).

Examples of Adjunct Medications include (15):

• Clonidine - Alpha-2-Agnonist for sedative and antihypertension effects
• Hydroxyzine - Antihistamine for nausea, vomiting, anxiety, and itching
• Loperamide - Antidiarrheal, for diarrhea

Opioid Withdrawal symptom severity can be measured by the clinician using the Clinical Opioid Withdrawal Scale (COWS) or patients may self-report severity using the Subjective Opiate Withdrawal Scale (SOWS) (13). Treatments can be based on the severity of the symptoms (13).

If a patient has OUD, start treatment immediately. The use of Buprenorphine is appropriate and is within the NP’s prescribing privileges as a provider of Schedule II controlled substances (6, 13).

Buprenorphine is a schedule III-controlled substance, a partial opioid agonist with pain-relieving and addiction-relieving properties. It reduces pain, withdrawal symptoms, and craving (15).

Depending on the severity of withdrawal symptoms, the NP may also arrange for the patient to get treatment from a substance use disorder treatment specialist certified by SAMHSA (6).

Conclusion

Prescribing controlled substances is cumbersome, loaded with paperwork and forms, and full of legal caveats and ethical considerations. It is that way on purpose. When discouraged about the process, please remember all the people who have died or have had their lives destroyed by opioids before these laws and guidelines existed. The steps are taken to allow medication to do what it is supposed to do and address opioid misuse before it becomes a problem.

Schedule II Controlled Substances and Neonatal Abstinence Syndrome

Introduction   

The utilization of Schedule II controlled substances raises significant concerns regarding risks of addiction. In the context of women's health, Neonatal Abstinence Syndrome (NAS) resulting from maternal use of addictive substances, including Schedule II controlled substances, remains a critical focus in California (7).

This dual challenge necessitates a comprehensive understanding of the legal, medical, and ethical aspects surrounding the use of these substances. This course explores the specific risks associated with Schedule II controlled substances in California, focusing on addiction and its potential impact on women and neonates.

Understanding why Schedule II medications are used in women's health lays the foundation for in-depth exploration of their pharmacokinetics, dynamics, risks, legal considerations, and patient-specific protocols.

Overview of Schedule II Controlled Substances

Schedule II controlled substances are a class of medications with recognized medical benefits but also a high potential for dependence, misuse, and abuse (11). The term "Schedule II controlled Substances" refers to substances classified under the Controlled Substances Act due to their high potential for abuse and addiction.

Medications in this category include oxycodone, hydrocodone, hydromorphone, meperidine, methadone, morphine, dextroamphetamine, methamphetamine, methylphenidate, secobarbital, pentobarbital, and fentanyl, among others used for managing severe pain and complex health conditions.

Since the potential for addiction to Schedule II controlled substances is a significant concern, healthcare providers must align with federal and state regulations emphasizing safe use, patient education, proper dosage management, and vigilant assessment to prevent escalating addiction issues.

Oxycodone, hydrocodone, and hydromorphone tablets are all derived from poppy plants and are morphine derivatives, whereas fentanyl is synthetic and much more potent (13). Most opioids go through first-pass metabolism in the liver before entering the systemic circulation and reaching target tissues. There are individual differences in how opioids are metabolized because there are differences in patients' CYP-450 and UGT liver enzymes, which are part of the metabolizing process (13).

Examples of drugs in this class:

Morphine - opioid agonist

Example: Morphine Tablets 15 mg PO every 8 to 12 hours, at first. Titrate dose every 1 to 2 days to achieve adequate analgesia. While discontinuing, decrease the dose by 25% to 50% every 2 to 4 days to prevent withdrawal symptoms. Extended-release tablets are only prescribed for opioid-tolerant patients (13).

Hydromorphone - opioid agonist

Example: Dilaudid: Give 2 to 4 mg PO every 4 to 6 hours PRN initially (13).

Fentanyl - opioid agonist

Examples: Duragesic -follow the FDA-approved conversion chart to convert 24-hour oral morphine equivalents dose to the corresponding transdermal fentanyl system dose. To start, apply at minimum a 25 mcg/hour transdermal patch for patients receiving at least 60 mg/day oral morphine equivalents. All other opioids should be stopped with transdermal fentanyl initiation (13).

Methadone - opioid agonist

Example: Dolophine- 0.05 to 0.1 mg/kg PO every 6 hours to start. Titrate dose by 0.05 mg/kg/dose until symptoms are managed. Taper dosage 10% to 20% of initial dose every 1 to 2 days, lengthening interval before discontinuation (13).

Meperidine - opioid agonist

Example: Demerol tablets- 50 to 150 mg PO every 3 to 4 hours PRN (13).

Oxycodone - opioid agonist

Example: OxyContin- 5 to 15 mg PO every 4 to 6 hours PRN (13).

Hydrocodone-opioid agonist

Example: Norco- 2.5 to 5 mg hydrocodone/325 to 650 mg acetaminophen (1 to 2 tablets) Q 4 to 6 PRN. Max: 30 mg hydrocodone/3,900 mg acetaminophen (12 tablets)/day (13).

Side Effects of Schedule II Narcotics (14, 15)

Common side effects of schedule II narcotics include:

• Nausea and vomiting may also increase aspiration. Patients may need to be prescribed anti-emetics.
• Pruritus may cause skin irritation. Patients may need to take Benadryl to decrease itching.
• Dizziness-this is a safety concern, and the patient must know not to drive or be weary of falls.
• Dry Mouth-hard candy or gum may alleviate this symptom.
• Sedation- This is a safety concern; the patient must know not to drive or be weary of falls.
• Euphoria patients must understand not to drive, sign legal documents, or purchase items while "high."
• Over-the-counter stool softeners may be recommended for constipation-counsel to increase fluids and fiber in the diet.

Schedule IIN stimulants examples (15):

• Amphetamine (Dexedrine, Adderall)
• Methamphetamine (Desoxyn)
• Methylphenidate (Ritalin)
• Amobarbital
• Glutethimide
• Pentobarbital

Schedule III/IIIN Controlled Substances (15)

These drugs have less potential for abuse than Schedule I or II drugs.

Examples:

• Medication with 90mg or less of codeine per dose
• Buprenorphine (Suboxone)

Examples of Schedule IIIN:

• Benzphetamine (Didrex)
• Phendimetrazine
• Ketamine
• Anabolic steroids

Significance of Using Schedule II Controlled Substances in Pharmacotherapeutic Management of Women's Health

Women's health conditions often demand a tailored approach due to physiological differences, hormonal fluctuations, and reproductive considerations. Pharmacotherapeutic management plays a crucial role in addressing the specific needs of women, and the significance of using Schedule II controlled substances cannot be understated.

These medications provide essential relief from pain and discomfort associated with various conditions often encountered in women's health, like endometriosis, postoperative pain, postpartum pain, fibromyalgia, or chronic pelvic pain, enabling women to lead healthier, more fulfilling lives. By closely monitoring patients, healthcare providers can harness the benefits of these medications while minimizing the risks (4).

Using Schedule II Controlled Substances Outside Acute Care Hospitals

While acute care hospitals are well-equipped to manage pain, many women's health conditions extend beyond these settings. As a result of that, utilizing Schedule II controlled substances outside acute care settings is a carefully considered approach in the pharmacotherapeutic management of women's health conditions. Let us see some reasons below:

Continuity of Care

Transitioning from inpatient to outpatient care requires maintaining a consistent level of pain management. For conditions requiring Schedule II controlled substances, continuation of therapy post-discharge ensures that pain relief remains adequate and uninterrupted.

Acute Postoperative Pain

Following surgical interventions, women may experience acute postoperative pain. Schedule II controlled substances can offer potent pain relief during immediate recovery, enabling patients to engage in necessary activities without excessive discomfort (2).

Reduction of Hospital Stay

In some instances, effective pain management with Schedule II controlled substances may lead to shorter hospital stays. Once stabilized, patients can be safely discharged with a prescription for continued pain relief, reducing healthcare costs and bed occupancy (2).

Pharmacokinetics and Pharmacodynamics of Schedule II Controlled Substances

Pharmacokinetics and pharmacodynamics are essential pillars in pharmacology, offering insights into how medications interact with the human body. These principles play a pivotal role in Schedule II controlled substances, characterized by their potential for significant therapeutic benefits and inherent risks.

Understanding how these medications are absorbed, distributed, metabolized, and eliminated and how they exert their effects is paramount in ensuring safe and effective treatment for various health conditions. By understanding the details of pharmacokinetics and pharmacodynamics, healthcare providers can optimize treatment plans, mitigate risks, and improve patient outcomes (2).

Pharmacokinetics

Pharmacokinetics involves understanding how the body processes a medication from its administration to its elimination, and it involves four main stages: absorption, distribution, metabolism, and elimination.

Understanding the principles of pharmacokinetics is pivotal when considering Schedule II medications since the stages collectively determine a medication's effectiveness, duration of action, and potential interactions with the body. By grasping these concepts, healthcare providers can optimize treatment plans, ensuring safe and efficient outcomes for women's health conditions. Let us delve into absorption, distribution, metabolism, and elimination below.

Absorption

Absorption refers to the process by which a medication enters the bloodstream from its administration site, determining its onset of action and intensity of action. For example, after taking an oral dose of oxycodone, the medication is absorbed into the bloodstream through the stomach and small intestines.

For oral medications, the absorption rate of the specific medication and the presence of food in the stomach can influence the time it takes to be absorbed. On the other hand, Schedule II medications administered intravenously are rapidly absorbed, leading to swift pain relief as the medication directly enters the bloodstream.

Distribution

Distribution involves the transportation of the medication throughout the body, influenced by factors like blood flow, tissue permeability, and protein binding. In the case of patients with impaired blood flow, there might be a delay in the distribution of the medication, affecting the onset and duration of its effects.

Metabolism

Metabolism is the process by which the body transforms medications into metabolites, primarily occurring in the liver through enzymatic reactions. Patients with liver dysfunction might experience impaired metabolism, accumulating the medication and its metabolites, potentially resulting in adverse effects.

Elimination

Elimination involves the removal of the medication and its metabolites from the body, primarily through the kidneys via urine. Patients with impaired kidney function might face challenges in eliminating the medication, leading to its prolonged presence in the body and potential toxicity.

Pharmacodynamics

Pharmacodynamics explores how medications interact with the body to produce their effects. Understanding the mechanisms of action of Schedule II medications is essential for making informed treatment decisions. Let us explore these mechanisms below.

Receptor Interactions

Medications in this category work by binding to specific receptors on cells, triggering a cascade of events that lead to therapeutic effects (10).

These medications bind to opioid receptors in the brain and spinal cord, altering pain perception and relieving pain. A patient prescribed this opioid for pain management might experience varying degrees of pain relief based on individual differences in receptor sensitivity and medication affinity.

Enzyme Inhibition or Activation

Medications in this category influence enzymatic activity in the body by inhibiting or activating enzymes, impacting biochemical pathways (10).

These medications work either by inhibiting the reuptake of neurotransmitters to create therapeutic effects or by activating certain enzymes in the body to produce analgesic effects. Enzyme inhibition can lead to medication-medication interactions. Therefore, a patient on a Schedule II medication that inhibits a liver enzyme might experience altered metabolism of another medication, impacting its efficacy.

Cellular Signaling Pathways

Medications in this category modulate signaling pathways within cells, altering cellular responses and physiological processes (10).

These medications exert their effects by interacting with opioid receptors in the nervous system, leading to the modulation of signaling pathways involved in pain perception.

Ion Channel Modulation

Medications in this category impact ion channels, influencing the flow of ions across cell membranes and altering electrical activity (10).

These medications stabilize neuronal membranes and prevent seizures. Patients on medications that affect ion channels might need close monitoring, as changes in electrical activity can lead to adverse effects such as cardiac arrhythmias.

Transporter Interactions

Medications in this category influence membrane transporters, affecting the uptake or out-flowing of substances across cell membranes (10).

These medications enhance the reuptake of neurotransmitters, improving mood and emotional well-being. Transporter interactions can impact medication levels, so patients on medications that affect transporters might require dose adjustments when co-administering other medications that share the same transporter.

Application of Pharmacokinetic and Pharmacodynamic Principles to Women's Health Conditions

Applying pharmacokinetic and pharmacodynamic principles to women's health conditions involves considering the unique characteristics of women. Let us explore further below.

Pregnancy

Pregnancy alters blood volume, cardiac output, and metabolism, affecting medication absorption, distribution, and elimination.

For example, when a pregnant woman with chronic pain is prescribed a Schedule II medication, the dosage might need adjustments because her medication absorption might be enhanced due to increased blood flow. For this reason, a pregnant woman prescribed a Schedule II medication should have her treatment plan reassessed regularly to account for changing pharmacokinetics and potential fetal exposure.

Menstrual Cycle

Hormonal changes during the menstrual cycle can impact medication receptor sensitivity and responsiveness.

Therefore, a woman with endometriosis taking a Schedule II medication might experience changes in medication efficacy during her menstrual phase due to fluctuating hormone levels. As a result, the timing of medication administration for women with hormone-sensitive conditions can be optimized based on the menstrual cycle to align with peak receptor responsiveness.

Age

Aging reduces renal and hepatic function, affecting medication clearance and metabolism.

For example, due to decreased renal function, an older woman taking a Schedule II medication for pain management might experience delays in the medication's elimination might be delayed, necessitating lower doses. Regularly monitoring older women on Schedule II medications is crucial to prevent accumulation and potential adverse effects due to impaired medication elimination.

Hormonal Changes

Hormonal changes during menopause can influence medication receptor expression and sensitivity.

For example, hormonal shifts during menopause might alter the impact of medications on neurotransmitter receptors, affecting their efficacy. Therefore, medication selection and dosing adjustments for women experiencing menopausal hormonal changes should be guided by a thorough understanding of receptor interactions.

Metabolic Variability

Genetic variability can lead to differences in medication metabolism among women.

For example, in the case of two women with the same condition taking the same Schedule II medication, genetic variations might cause one woman to metabolize the medication more quickly, requiring higher doses for therapeutic effects. Genetic testing to identify metabolic variations can guide personalized dosing strategies for women on Schedule II medications.

Addiction and Neonatal Abstinence Syndrome

The risks of addiction associated with their use and the occurrence of Neonatal Abstinence Syndrome (NAS) in infants born to mothers who have used these substances. Understanding these risks is crucial for healthcare providers to provide informed care to women and their newborns.

Understanding Addiction

Addiction is a complex physiological and psychological phenomenon where an individual becomes dependent on a substance for various reasons, including pain relief or euphoria. Due to altered brain pathways associated with reward, addiction poses a significant risk, especially in patients with a history of substance abuse, genetic predisposition, or co-occurring mental health disorders (13).

Maternal addiction to Schedule II medications during pregnancy can lead to neonates having withdrawal symptoms. For example, a pregnant woman using Schedule II medications might unknowingly expose her baby to the substance, resulting in neonatal abstinence syndrome (NAS). As a result, women using these medications during pregnancy require specialized prenatal care to mitigate the risk of NAS and support neonatal well-being.

Identifying addiction signs and symptoms in pregnant patients is pivotal for timely intervention and ensuring maternal and fetal well-being. Healthcare providers need to be equipped to recognize the cues. Examples of such cues include behavioral changes like unexplained mood swings, irritability, anxiety, depression, frequent medical visits, discrepancies between self-reported medical history and prescription records, poor prenatal care adherence, unusual requests for specific medications, overusing or finishing prescriptions too quickly, social isolation, or poor self-care and nutrition.

By acknowledging addiction mechanisms, recognizing risk factors, and addressing psychological and physiological aspects, healthcare providers can implement preventive strategies, individualized treatment plans, and comprehensive care to ensure the well-being of women needing Schedule II medications.

Understanding Neonatal Abstinence Syndrome (NAS)

Neonatal Abstinence Syndrome (NAS) occurs when infants are exposed to medications, including opioids, in utero and experience withdrawal symptoms after birth.

Women who take Schedule II controlled substances during pregnancy can transfer these substances to their fetuses, resulting in a complex set of withdrawal symptoms experienced by the infants after birth, for example, irritability, tremors, feeding difficulties, vomiting, diarrhea, excessive crying, and even seizures. According to (9), it is essential to monitor and manage NAS to ensure the well-being of newborns and prevent long-term complications like developmental and cognitive challenges.

Tips

Healthcare providers must assess pregnant women for substance use, including prescribed medications, to anticipate the potential risk of NAS in neonates.

Long-term follow-up is essential to monitor the developmental progress of neonates with NAS and provide appropriate support as needed.

Preventive Strategies for Addiction and Neonatal Abstinence Syndrome

Preventive strategies for addiction and Neonatal Abstinence Syndrome are integral to promoting the well-being of pregnant patients and their newborns. By embracing preventive measures, healthcare practitioners contribute to reducing addiction risks and improving maternal and neonatal outcomes (7). Let us explore some preventive strategies below.

Patient Education

Empowered patients are better positioned to make informed choices, actively participate in their care, and contribute to addiction prevention and improved neonatal outcomes (12).

For example, suppose a nurse-midwife educates a pregnant patient about the potential effects of opioids on the developing fetus. In that case, the informed patient can be empowered to actively participate in treatment decisions while considering potential consequences and alternatives.

Healthcare providers can provide education on the following topics: The risks and benefits of Schedule II medications, how to recognize the signs of addiction, the importance of adhering to prescribed dosages, the potential risks of neonatal exposure to opioids and NAS, the importance of communicating openly with healthcare providers about substance use concerns, the importance of promptly reporting adverse effects of medication to allow for timely intervention and addiction prevention.

Screening and Assessment

Screening and assessment are pivotal in preventing addiction and Neonatal Abstinence Syndrome (NAS) associated with using Schedule II controlled substances. By identifying at-risk individuals, healthcare practitioners can tailor interventions, develop preventive measures, make informed treatment decisions, monitor progress, and provide timely support.

Effective screening and assessment benefits are significant and contribute to improved patient outcomes. For example, when a nurse-midwife incorporates substance use screening as part of routine prenatal assessments, there are higher chances of improved patient outcomes due to timely identification of risks and timely support.

Early Intervention Programs

Early intervention programs are crucial in preventing addiction and Neonatal Abstinence Syndrome (NAS) related to the use of Schedule II controlled substances. These programs provide proactive strategies to identify at-risk individuals, offer support, and implement preventive measures that improve patient and newborn outcomes (12).

Holistic Approach to Addressing Addiction and Neonatal Abstinence Syndrome (NAS)

A holistic approach to addressing addiction and neonatal outcomes involves recognizing the interconnectedness of physical, emotional, and social factors in maternal and fetal well-being. Healthcare practitioners, particularly nurse midwives, play a crucial role in adopting a comprehensive approach encompassing medical care, emotional support, and community resources. Let us explore the details below.

Comprehensive Assessment

Comprehensive assessment is a valuable tool in addressing addiction and Neonatal Abstinence Syndrome (NAS) linked to the use of Schedule II controlled substances (12). This holistic approach ensures that healthcare practitioners thoroughly evaluate the patient's medical history, substance use, and overall well-being. Comprehensive assessment leads to a holistic understanding of the patient's unique situation, resulting in personalized treatment plans.

The benefits of comprehensive assessment are significant, as they contribute to tailored interventions and improved outcomes. For example, when the nurse-midwife conducts a comprehensive assessment to understand a pregnant patient's addiction challenges and support needs, there is a high likelihood of promoting well-being.

Non-pharmacological Interventions

Non-pharmacological interventions offer valuable alternatives in addressing addiction and Neonatal Abstinence Syndrome (NAS) related to Schedule II controlled substances (12). These interventions focus on using alternatives other than prescription medications to manage pain, reduce reliance on opioids, and promote overall well-being.

Types of Non-Pharmacological Interventions for Women include physical therapy such as massage and acupuncture; emotional support, cognitive-behavioral therapies, mindfulness, meditation, and guided imagery; nutritional counseling focused on maintaining a balanced diet that supports overall health; exercise/movement; counseling and social support groups.

Non-pharmacological interventions for babies include swaddling, gentle rocking, and minimizing sensory stimulation to help soothe affected neonates.

Pharmacological Interventions

Pharmacological interventions offer valuable tools in addressing addiction and Neonatal Abstinence Syndrome (NAS) related to Schedule II controlled substances.

Types of Pharmacological Interventions include Opioid Substitution Therapy involving opioid agonists or partial agonists, such as methadone or buprenorphine, to mitigate withdrawal symptoms, support addiction treatment, and minimize neonatal exposure. Pain management medications such as non-opioid analgesics or local anesthetics can help control pain without opioids. These medications reduce the need for opioids, lowering the risk of addiction and NAS.

Pediatric doses of medications like morphine or methadone are used to gradually wean the neonate off the addictive substance, ease withdrawal, and ensure safe neonatal outcomes.

Multidisciplinary Collaboration

Multidisciplinary collaboration interventions are essential in addressing addiction and Neonatal Abstinence Syndrome (NAS) associated with using Schedule II controlled substances.

These interventions involve a coordinated effort among various healthcare professionals, including obstetrics, addiction medicine, neonatology, and mental health, to ensure comprehensive care for both the mother and the neonate. The benefits of multidisciplinary collaboration interventions include expertise from diverse specialties, tailored treatment plans, and a holistic approach to care.

Long-Term Recovery Planning

Long-term recovery planning is pivotal in addressing addiction and Neonatal Abstinence Syndrome (NAS) linked to Schedule II controlled substances.

Developing comprehensive recovery plans extending beyond pregnancy offers numerous benefits for individuals and their neonates (12). These benefits include sustained sobriety beyond pregnancy, reduced risks of relapse, reduced likelihood of NAS in subsequent pregnancies, and improved maternal health.

Legal Framework for Dispensing Controlled Substances

Understanding the legal framework is crucial for healthcare providers to ensure compliance with state and federal regulations while providing safe and effective care. This module explores federal and state regulations, the distinctions between dispensing and administering, the nurse-midwife's role in adhering to legal requirements, and the implications for patient care.

Federal and State Regulations on Controlled Substances

Controlled substances, including Schedule II medications, are regulated by federal and state laws, resulting in the need for healthcare providers to be familiar with both sets of regulations. The Controlled Substances Act at the federal level categorizes medications based on their potential for abuse, and the Medication Enforcement Administration (DEA) is the government agency responsible for enforcing regulations.

State laws often complement federal regulations with additional requirements and guidelines. As a result, California's legal framework surrounding the use of Schedule II controlled substances underscores the need for careful adherence to state and federal laws and regulations (8).

Useful links

Code of Federal Regulations regarding controlled substances

California State regulations regarding controlled substances

Joint Statement from the California Department of Justice, California State Board of Pharmacy, and the Medical Board of California Regarding Secure Prescription Forms

Dispensing vs. Administering: Understanding the Difference

Dispensing involves the act of providing a patient with a prescribed medication. Administering, on the other hand, refers to physically giving the medication to the patient. Nurse-midwives have the authority to administer medications in various settings, but dispensing controlled substances requires a separate authorization or license, depending on state regulations (5). Understanding these differences is vital for healthcare practitioners to ensure compliance, patient safety, and effective medication management.

Key Differences

Role: Dispensing involves preparing and providing medications to patients for self-administration while administering entails healthcare professionals directly delivering the medication to the patient.

Location: Dispensing can occur at pharmacies or healthcare facilities, whereas administration occurs within healthcare or home settings.

Authorization: Dispensing requires a valid prescription, whereas administering necessitates an authorized practitioner's order.

Documentation: Dispensing involves proper labeling and instructions for patient use while administering mandates and accurate record-keeping of the medication's administration.

Control Measures: Dispensing adheres to controlled substance prescription requirements while administering requires adherence to patient-specific protocols and regulations.

Nurse-Midwife's Role in Ensuring Legal Compliance with Legal Requirements

Nurse-midwives are vital in ensuring legal compliance when dealing with controlled substances. This involves accurate record-keeping, understanding the scope of practice, and collaborating with other healthcare providers when necessary.

In addition to that, adhering to strict state laws and federal regulations is essential to safeguard patient safety, maintain professional integrity, and promote effective medication management. Staying updated on regulation changes and participating in continuing education are essential for maintaining compliance (3). Let us explore the nurse-midwife's responsibilities in legal compliance.

Understanding Legal Requirements

Nurse-midwives must comprehensively understand California's state laws and federal regulations governing Schedule II controlled substances because familiarity with their prescription requirements, documentation standards, and patient-specific protocols is crucial (8).

Prescription and Ordering

Nurse-midwives must ensure that prescriptions for Schedule II controlled substances are valid, accurate, and comply with legal specifications since properly authorized practitioner orders are essential for administering Schedule II medications (8).

Patient Assessment and Monitoring

Nurse-midwives are responsible for conducting thorough patient assessments to determine the appropriateness of Schedule II medications since ongoing monitoring of patients' responses to medications and their potential side effects is essential (1).

Patient Education and Informed Consent

Nurse-midwives must provide patients with comprehensive information about Schedule II medications' risks, benefits, and alternatives. Informed consent discussions should encompass potential addiction risks and neonatal outcomes, ensuring patients make well-informed decisions (1).

Documentation and Record-Keeping

Accurate and detailed documentation of medication administration, patient assessments, and communications is imperative because proper documentation ensures transparency, accountability, and compliance with legal requirements (6).

Collaborative Approach

Nurse-midwives must collaborate with healthcare teams, pharmacists, and other professionals to ensure coordinated patient care. Effective communication facilitates adherence to legal requirements and patient-specific protocols (1).

Continuous Education and Professional Development

Nurse-midwives must engage in ongoing education to stay updated with evolving regulations, guidelines, and best practices since professional development enhances the nurse-midwife's ability to navigate legal complexities and provide optimal care (1).

Patient-Specific Protocols

Schedule II medications require a delicate balance between achieving therapeutic benefits and minimizing potential risks, including addiction and Neonatal Abstinence Syndrome (NAS). Patient-specific protocols play a pivotal role in ensuring safe and effective medication management. By adhering to these protocols, healthcare practitioners can ensure optimal patient care while navigating legal and ethical considerations.

Importance of Patient-Specific Protocols in Schedule II Controlled Substance Use

Patient-specific protocols are tailored guidelines designed to provide a clear and comprehensive approach to medication administration, considering the individual patient's needs, medical history, and unique circumstances like pregnancy status, concurrent medications, and potential contraindications. The importance of patient-specific protocols in administering Schedule II controlled substances includes the following:

They ensure that the administration of these medications is tailored to the patient's specific health status, ensuring that potential interactions, contraindications, and appropriate dosages are considered. This helps to minimize adverse events, side effects, unintended reactions, or complications associated with Schedule II medications.

They ensure that dosages are optimized based on age, weight, and metabolic rate. Customized dosages maximize therapeutic benefits while avoiding potential overdose risks.

They consider patient preferences, lifestyles, and cultural factors, promoting medication adherence. Improved adherence contributes to treatment effectiveness and better patient outcomes.

They address addiction risks associated with Schedule II substances by tailoring treatment plans and medication management to minimize misuse.

They ensure that healthcare providers comply with legal and ethical standards and promote bona fide patient-practitioner relationships when using Schedule II medications.

Components of Patient-Specific Protocols

Components of patient-specific protocols serve a specific purpose, grounded in patient safety, legal compliance, and effective medication management. Let us discuss the components below.

Scope and Purpose

This component clearly defines the scope and purpose of the protocol, specifying the medications covered and the conditions under which they will be administered, setting the context for healthcare practitioners.

Authorization and Qualifications

This component specifies the authorized healthcare providers who can execute the protocol, outlining the qualifications, training, and licensing required for practitioners to be eligible for administering Schedule II medications.

Patient Assessment

This component describes the required patient assessment criteria to determine Schedule II medication use appropriateness, highlighting factors such as medical history, current medications, and potential contraindications. This ensures patients receiving Schedule II medications are appropriate candidates based on medical history and current conditions.

Dosage and Administration

This component provides precise dosage guidelines for each medication covered in the protocol, specifying the route of administration, frequency, and maximum dosage limits to prevent adverse events.

Monitoring and Documentation

This component outlines the monitoring parameters that practitioners need to observe during and after medication administration, emphasizing the importance of documenting patient responses and any adverse effects.

Communication and Collaboration

This component highlights the importance of communication among healthcare team members when administering Schedule II medications and encourages collaboration to ensure comprehensive patient care.

Emergency Response

This component guides managing emergencies or adverse reactions related to Schedule II medications, giving detailed steps to be taken and resources to be utilized in case of unforeseen incidents.

Legal and Regulatory Compliance

This component addresses legal requirements, state regulations, and federal laws that must be followed when administering Schedule II medications while ensuring practitioners are well-informed about their responsibilities and liabilities.

Review and Update Process

This component specifies a process for regularly reviewing and updating the protocol to align with changing needs, medical practices, regulations, and guidelines.

Aligning Protocols with Business and Profession Code, Section 2746.51

Per the California Business and Professions Code, Section 2746.51, protocols for Schedule II controlled substance medications encompass several essential components. These components are meticulously designed to ensure patient safety, legal compliance, and effective medication management by nurse-midwives. Here is a list of the components:

Patient Assessment and Evaluation

This component involves evaluating the patient's medical history, current health status, existing medications, allergies, and potential contraindications (5). A comprehensive patient assessment is fundamental before furnishing a Schedule II controlled substance.

Medication Information

This involves giving detailed information about the specific Schedule II controlled substance, including the medication's name, dosage forms available, dosing guidelines, route of administration, and any relevant precautions (5).

Indications and Contraindications

This involves clearly outlining the conditions or situations for which the controlled substance is being prescribed (indications), as well as circumstances where its use is prohibited due to potential risks (contraindications) (5).

Dosage and Administration

This involves providing precise dosing instructions, including dosage strength, frequency, treatment duration, the appropriate administration method, and necessary preparation steps (5).

Monitoring and Assessment

This component specifies the parameters for monitoring the patient's response to the medication. It also involves outlining the desired therapeutic outcomes, potential side effects, and the plan for assessing the patient's progress (5).

Documentation and Record-Keeping

This involves emphasizing the importance of maintaining accurate and comprehensive documentation, including recording the patient's informed consent, the furnished medication details, the rationale for the prescription, and any follow-up assessments (5).

Emergency Situations and Adverse Reactions

This involves giving detailed steps to be taken in case of emergencies or adverse reactions related to the controlled substance, including the appropriate interventions and the procedure for seeking further medical assistance (5).

Collaboration and Referral

This component highlights the importance of interdisciplinary collaboration and communication, specifying when it is necessary to consult or refer the patient to other healthcare professionals based on the patient's response or changes in condition (5).

Conclusion

As we reach the end of this course, we celebrate your dedication to advancing your knowledge and expertise in women's health. In this course, we delved into essential principles, regulations, and considerations surrounding using Schedule II controlled substances in out-of-hospital patient care, including the pharmacokinetic and pharmacodynamic principles and the risks of addiction and neonatal abstinence syndrome associated with using Schedule II controlled substances.

With the insights and knowledge gained throughout this course, healthcare providers would be well-prepared to make meaningful contributions to women's health, advocate for patient safety, ensure ethical practices, and deliver patient-centered care.

Safe Prescribing of Opioid Drugs

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).

Dosing and Monitoring

Clients prescribed buprenorphine must stop using opioids for at least 12 to 24 hours before the first dose; this varies depending on which opioid they are stopping. For short-acting opioids like heroin and oxycodone, buprenorphine may be started 6-12 hours after the last dose. With longer-acting opioids such as morphine or extended-release preparations of oxycodone, buprenorphine should be delayed for about 24 hours. For the longest action opioids, fentanyl patch, 48 -72 hours must be between the last dose and buprenorphine initiation (3).

This initiation schedule means clients will be in the early stages of discomfort and withdrawal. Administration of buprenorphine when clients still have opioids in their bloodstream will lead to competition for receptor sites, rapidly replacing the opioid with buprenorphine and causing acute and more severe withdrawal symptoms.

Depending on the severity of a client's addiction, they may complete the first step of abstaining and withdrawal in an inpatient setting. Once the initial withdrawal symptoms have passed and the initial dose of buprenorphine has been given, the client may be discharged home to continue buprenorphine initiation on an outpatient basis (3).

Initial doses are typically 2-4mg, with up to 4mg given to clients used to higher potency or larger doses of opioids. The dose is gradually increased to meet the client's individual needs, with a maximum dosage of 24mg per day. The average client requires 8-12 mg per day and can reach this dose within the first 2-4 days. It is recommended that doses be supervised by a pharmacist at the dispensing pharmacy for the first two months of treatment to ensure compliance and clients are less likely to relapse (3).

The length of treatment with buprenorphine depends on each client's case and, for some, may be indefinite. Clients who do wish to wean off buprenorphine can begin the process once they are stable and experiencing few or no cravings, and a minimum of 8 weeks from treatment initiation. Doses are moved to alternating days and eventually discontinued altogether (3).

Side Effects and Contraindications:

As with any medication, there are potential side effects, including:

Common Side Effects

• Nausea
• Vomiting
• Drowsiness
• Dizziness
• Headache
• Memory loss
• Sweating
• Dry mouth
• Miosis
• Postural hypotension
• Sexual dysfunction
• Urinary retention

Serious side effects

• CNS depression
• QT prolongation
• Reduced seizure threshold
• Potential for abuse or overdose (3)

Buprenorphine is contraindicated for clients with a past hypersensitive reaction to it. It should be used cautiously for clients with respiratory suppression, older adults, or for those with liver pathologies. Regular monitoring of liver enzymes via lab work is essential (3).

It is a Category C medication for pregnancy, and the risks versus benefits should be carefully weighed. Buprenorphine does cross the placenta and increases the risk of withdrawal symptoms and neonatal abstinence syndrome (NAS) after delivery. However, for pregnant clients with the highest risk of relapse and abuse of opioids, evidence does support that continuation of buprenorphine during pregnancy may improve maternal and fetal outcomes (3).

Buprenorphine may be abused by crushing tablets, snorting the powder, or dissolving it into an injectable solution. Safety measures against this include supervised administration by a pharmacist and the addition of naloxone, which blocks the buprenorphine effects. While the effect ceiling of buprenorphine makes overdose difficult, combining the drug with benzodiazepines, alcohol, or other drugs can compound the CNS depressant effects and increase the risk of overdose (3).

Clinicians need to have a comprehensive health history of clients before initiating buprenorphine so that all risks and potential interactions can be addressed appropriately.

Role of the Pharmacist

Pharmacists play a significant role in the success of MAT involving buprenorphine. Outpatient doses are monitored by the dispensing pharmacist daily, with at-home quantities being allowed on a limited basis (such as weekends or travel) and only for the most motivated and compliant clients. Vital signs are collected before each dosage, with careful monitoring for hypotension or bradypnea. The dose may be skipped for clients who experience excessive side effects, and the client can return the next day for their dose.

Clients presenting with signs of overdose (usually to the ED) may receive naloxone, which will reverse overdose symptoms within 1 hour. Overdose symptoms include dizziness, pinpoint pupils, hypotension, bradypnea, hallucinations, seizure, or unconscious state.

If a client misses a dose, does not show up for it, or is experiencing significant side effects from buprenorphine, the prescribing clinician should be notified so that the treatment plan can be revisited and revised if needed (3).

Considerations for the Prescriber

When considering which medication to prescribe for MAT, prescribers should understand that buprenorphine offers advantages over methadone.

• Lower risk of abuse
• Safer, including at higher doses.
• Therapeutic dose achieved quickly.
• Easier to taper.
• Can be obtained from any provider rather than a methadone clinic.
• Less stigma

The cost of a 30-day supply is around $300. Buprenorphine/naloxone combinations are a little more expensive at $400/month. While prior authorization is usually required, most commercial insurance and state Medicaid programs will cover the medication.

Buprenorphine is a Schedule III Controlled Substance; however, recent federal regulations have been aimed at approving access to MAT, and any provider with an active DEA license may prescribe buprenorphine as allowed by state regulations. Specialized clinics are not required (as they are with methadone), and it is dispensed at regular pharmacies.

Prescribers are encouraged to participate in additional training about MAT with buprenorphine, but it is not required. Detailed documentation must be completed, including the reason for prescribing, start and end dates of treatment, the pharmacy used, the credentials of who will supervise administration, and frequency of follow-up and compliance monitoring. The sublingual and buccal routes are the only forms of medication used for MAT; patches, IM, and IV preparations are not routinely used for MAT.

The success of buprenorphine treatment depends on the client's education. Addiction potential, risk of combination with other CNS depressants, and side effects vs. signs of overdose should all be discussed with clients and their support system (3).

Methadone

Mechanism of Action and Metabolism

Methadone is a synthetic opioid and a full agonist of the Mu-receptor site, stimulating the same effects as opioids.

• Euphoria
• Analgesia
• Sedation

It can be used as a potent analgesic for pain not responding to traditional medications, such as in clients with cancer or terminal illness, as well as for MAT and neonatal abstinence syndrome (NAS).

For this course, it will be discussed as a MAT agent, used in treatment for clients addicted to opioids such as:

• Heroin
• Fentanyl
• Oxycodone
• Hydrocodone
• Morphine
• Hydromorphone (2)

Methadone is a full agonist at the Mu-receptor, meaning it is a more potent and more easily addictive medication than partial agonists like buprenorphine. Methadone has a long half-life (8-60 hours), occupying the Mu-receptors and blocking short-acting opioids from making a client high. The longer half-life also leads to less severe cravings and withdrawal symptoms. Methadone is also an antagonist to the N-methyl-d-aspartate (NMDA) receptor, which adds to its pain relief action (2).

It has high oral bioavailability, is active in the bloodstream within 30 minutes of ingestion and remains elevated for around 24 hours. It is broken down via CYP3A4 and CYP2B6 enzymes and metabolized through the liver, making it a good option for clients with renal problems.

Medications such as ciprofloxacin, benzodiazepines, fluconazole, cimetidine, and fluoxetine may slow methadone metabolism, increasing the available drug and the side effects of overdose risk. Other medications may speed metabolism and decrease the effects of methadone, including phenobarbital, phenytoin, rifampin, ritonavir, and carbamazepine (2).

Available Forms

Methadone is available in many forms, including oral, IM, subcutaneous, IV, and intrathecal, though only the oral is typically used for MAT.

• Methadone - tablets
• DISKETS - dispersible/dissolvable tablet
• Methadone HCL Intensol - 10mg/ml suspension
• Methadone - dispersible tablet (2)

Dosing and Monitoring

Oral dosing is initiated at 30-40 mg/day with a slow titration of 10-20 mg/week until the optimal dosage is reached. The optimal dosage varies by client and depends on the drug they are replacing, tolerance to opioids, and side effects experienced. A dosage between 80- 150 mg/day is the typical goal. (2)

If parenteral methadone is given, it is usually 50%-80% of the oral dosage.

Blood sugar, EKG, and methadone blood levels should be checked regularly, every week for higher-risk patients, and every 3-6 months for those in good health and compliance. The target methadone blood level is around 400 ug/ml (2).

Side Effects and Contraindications

Potential side effects are directly related to stimulation of the opioid receptors and include:

• Diaphoresis
• Flushing
• Pruritus
• Nausea
• Dry mouth
• Constipation
• Sedation
• Lethargy
• Respiratory Depression
• QT prolongation
• Hypoglycemia (2)

Methadone should be considered with a comprehensive view of a client's health history and other medications. Clients with CNS-related disease processes (trauma, increased ICP, dementia, or delirium) must be monitored closely or have other medication considered.

Methadone should not be used simultaneously as other opioids, benzodiazepines, alcohol, or antipsychotics due to increased CNS effects. Methadone is a Pregnancy Category C medication, and risks versus benefits should be weighed carefully. Infants exposed to methadone in utero are at increased risk of NAS after delivery (2).

Overdose can occur, and clients and support systems should be educated on signs of overdose.

• Lethargy
• Somnolence
• Stupor
• Coma
• Miosis
• Bradycardia
• Hypotension
• Respiratory sedation
• Cardiac arrest

Naloxone is used to reverse overdose (2).

Considerations for Prescribers and Clinics

Methadone is a Schedule II Controlled Substance, meaning it has a high abuse potential and must be carefully monitored. The Prescription Drug Monitoring Program (PDMP) is an electronic database used nationwide to register the distribution of controlled substances so that clients do not seek care at multiple clinics or pharmacies to obtain more of a controlled substance.

When prescribing methadone, providers should check the PDMP for both methadone and other prescription opioids so that they are fully aware of other medications clients may be receiving from other places. Regular urine drug screening should be performed to make sure clients are not using other substances not obtained by prescription and that they are testing positive for methadone, meaning they are genuinely taking it if administration is not observed (2).

At the beginning of treatment, methadone is given in the office under a nurse's supervision, and then clients are monitored for adverse effects. Some take-home doses (up to 7 in the first two weeks) may be arranged for weekends or during travel, but this possibility is limited during the first few weeks of treatment. As treatment progresses and compliance is demonstrated, clients may self-administer more doses at home (up to 28 doses per month) and go longer between visits to the clinic. The total length of treatment varies but is often 1-2 years and can even be indefinite (7).

There are methadone clinics that work entirely in the scope of addiction management, but primary care providers may prescribe methadone as well. Prescribers must have an active DEA license and comply with state-based controlled substance regulations (2).

Naltrexone

Mechanism of Action and Metabolism

Naltrexone has been in use since the 1960s and is an opioid antagonist. It competes primarily with the mu-receptor but also serves as an antagonist at the kappa and delta receptors. As an antagonist, it competes with agonists such as opioids and alcohol and blocks the effects of agonists at those sites.

• Prevents euphoria.
• Prevents intoxication.
• Reduces tolerance (6)

Naltrexone also acts on the hypothalamic-pituitary-adrenal axis, modifying it to reduce cravings and suppress alcohol consumption.

It is FDA-approved for use in clinical practice for the treatment of:

• Alcohol use disorder
• Opioid use disorder (prescription and non)

Naltrexone is absorbed orally and undergoes extensive metabolism via the first-pass effect. However, this does not affect its potency as naltrexone's active metabolite, 6β-naltrexone, acts as a potent opioid antagonist. The medication's half-life is around 4 hours but can last up to 24 hours. If administered parenterally, it bypasses the first pass and is even longer acting, with a half-life of 5-10 days. Naltrexone is excreted by the kidneys (6).

Available Forms

Naltrexone is available in an oral tablet and IM injection. Available preparations include:

• Generic naltrexone tablets
• Revia (oral tablet)
• Depade (oral tablet)
• Vivitrol (solution for IM injection, extended-release) (6)

Dosing and Monitoring

Since naltrexone will compete for and block all opioid receptor sites, the risk for withdrawal symptoms is high, and clients must stop the use of alcohol or opioids for 7-10 days before beginning treatment to lessen the risk of withdrawal symptoms. A naltrexone challenge is recommended at the start of therapy.

This consists of administering small amounts of naltrexone subcutaneously or via IV and monitoring the client and their vital signs for signs of withdrawal, such as:

• Nausea
• Vomiting
• Diaphoresis
• BP changes
• Tachycardia
• Rhinorrhea
• Agitation
• Tremors
• Abdominal pain
• Pupillary dilation (6)

If a client fails the naltrexone challenge and has not been long enough since their last use of alcohol or opioids, the naltrexone initiation should be delayed, and the test should be repeated in 24 hours. If clients tolerate the naltrexone test and the negative result, they may begin naltrexone treatment (6).

For oral tablets, dosing usually starts at 25 mg for the first dose. Clients are observed for withdrawal symptoms and side effects; an additional 25 mg is given 1 hour later. After that, clients take 50 mg per day. Clients may continue with 50mg daily or take 100 mg every other day or 150 mg every 3rd day (6).

Alternatively, naltrexone may be given via IM injection for more extended action, improving compliance and reducing relapse. Particularly for alcohol or heroin dependence, data indicates that the IM route has much higher success rates than the oral route. If a client receives the IM injection, 380 mg is given to the gluteal muscle every four weeks (6).

Side Effects and Contraindications

Most common side effects of naltrexone include:

• GI irritation
• Diarrhea
• Abdominal cramps
• Nausea
• Vomiting
• Hypertension
• Headache
• Anxiety
• Low energy
• Joint or muscle pain
• Nervousness
• Sleep disruption

Less commonly, clients report:

• Loss of appetite
• Constipation
• Dizziness
• Irritability
• Depression
• Rash
• Chills (6)

Caution should be used for clients with liver function issues and renal impairment. It is Category C for use during pregnancy, and the risks versus benefits of use in pregnancy must be carefully considered. It also crosses into breast milk and must be considered carefully.

There is limited data about the overdose of naltrexone, and there may be very few symptoms if an overdose occurs. Clients should be monitored for signs of liver dysfunction, seizures, depression, and suicidal ideations. No antidote for naltrexone is currently available.

Naltrexone is contraindicated for clients who failed a naltrexone challenge, test positive for opioids or alcohol on drug screening, have a history of seizures, or have experienced a past hypersensitivity reaction to naltrexone.

Clients may switch from buprenorphine or methadone to naltrexone at some point in treatment. Both medications are agonists at the opioid receptor sites, so changing to naltrexone (an antagonist) may increase the risk of withdrawal symptoms for the first two weeks of treatment (6).

Considerations for Prescribers

Because naltrexone does not cause any euphoria or "high," the abuse potential is non-existent. It is not a controlled substance and can be prescribed by any clinician with prescriptive authority. However, its use is typically only by those who work in mental health or addiction medicine. Clients can take the medication at home or go to the clinic for IM injections.

Many considerations for naltrexone use center around monitoring for side effects and treatment compliance. Baseline and periodic drug screening and liver function tests are prudent. Clients' support persons should be educated on compliance and signs of relapse. The IM formulation should be considered for those with poor compliance or most at risk for relapse (6).

Nursing Considerations

Nurses will encounter clients with addiction and even those receiving MAT in a variety of settings, including:

• Outpatient clinics for routine care of any health issues
• ED admission for acute problems not related to addiction.
• Inpatient hospitalization related to other health problems.
• Outpatient setting for participation in MAT or addiction management.
• ED admission for acute problems related to substance abuse or toxicity of MAT medication.
• Inpatient mental health admission for mental health and addiction issues

Regardless of the setting and if the client is being seen for an addiction issue or something else, it is crucial for nurses to be familiar with MAT medications and how they work to provide safe and competent care. Nurses may need to:

• Administer medication.
• Monitor lab results.
• Observe for side effects, toxicity, or withdrawal symptoms.
• Coordinate care within a multidisciplinary team
• Communicate with therapeutic and nonjudgmental techniques.

Case Study

Justin is a 32-year-old male who presents to the ED with nausea, lethargy, and confusion worsening over the last 24 hours. Upon exam, the nurse notes diaphoresis, slurred speech, and pinpoint pupils. His vitals are RR 10, HR 54, BP 82/58, SPO2 97%, Temp 99.0.

He reports taking Wellbutrin 150mg daily for depression and smoking cessation, methadone 100mg daily for history of oxycodone abuse, and was started on ciprofloxacin 250mg BID for a UTI 2 days ago at urgent care.

His labs are significant for a WBC of 15,000 but otherwise regular. He tests positive for methadone, which is expected, but not for other substances. He reports being compliant with MAT and avoiding opioid use for nine months.

It is determined that Justin is experiencing methadone toxicity due to the slowed metabolism of the drug from the combination of methadone and ciprofloxacin. He is given naloxone in the ED, and within an hour, his symptoms have improved significantly, and his vital signs are typical. His antibiotic is switched to cefdinir, and he is discharged home in stable condition with instructions to follow up with his PCP within 1-2 days.

Conclusion

Substance use disorders are a long-standing and dangerous pathology experienced by millions of people each year. At the same time, the stigma of seeking help for such disorders has been eroding in recent years; there has also been a renewed push by the federal government to address the issue in evidence-based and meaningful ways, with access to effective treatment being at the top of the priority list.

Addiction treatment programs utilizing MAT will likely become much more popular in the coming years, and nurses will be on the front lines of this therapy. For nurses to provide competent and comprehensive care to this client population, up-to-date and accurate knowledge is necessary.

Following a DNR: An Ethical Dilemma in Nursing

Introduction   

End-of-life issues are often full of emotion and difficult to deal with for all involved. Do-not-resuscitate (DNR) orders can present many moral and ethical dilemmas in nursing. It takes the entire healthcare team, including the patient and their family, to ensure that all final wishes for the patient are followed. In order to understand this ethical dilemma in nursing, we must first define what ethical dilemmas are and what a DNR order is. 

What is an Ethical Dilemma in Nursing? 

Ethics are a system of moral principles or rules of conduct recognized by a particular group; however, the American Nurses Association (ANA) has developed its own code of ethics (1). The ANA Code of Ethics with Interpretive Statements includes nine provisions that direct a nurse’s moral and ethical practice, it reads:  

Provision 1

The nurse practices with compassion and respect for the inherent dignity, worth, and unique attributes of every person.  

Provision 2

The nurse's primary commitment is to the patient, whether an individual, family, group, community, or population.  

Provision 3

The nurse promotes, advocates for, and protects the rights, health, and safety of the patient.  

Provision 4

The nurse has authority, accountability, and responsibility for nursing practice; makes decisions; and takes action consistent with the obligation to provide optimal patient care.  

Provision 5

The nurse owes the same duties to self as to others, including the responsibility to promote health and safety, preserve wholeness of character and integrity, maintain competence, and continue personal and professional growth.  

Provision 6

The nurse, through individual and collective effort, establishes, maintains, and improves the ethical environment of the work setting and conditions of employment that are conducive to safe, quality health care.  

Provision 7

The nurse, in all roles and settings, advances the profession through research and scholarly inquiry, professional standards development, and the generation of both nursing and health policy.  

Provision 8

The nurse collaborates with other health professionals and the public to protect human rights, promote health diplomacy, and reduce health disparities.  

Provision 9

The profession of nursing, collectively through its professional organizations, must articulate nursing values, maintain the integrity of the profession, and integrate principles of social justice into nursing and health policy (2). 

An ethical dilemma in nursing arises when decisions are made that go against the ANA Code of Ethics with Interpretive Statements.  

It is important to note that the nurse's main duty is to be an advocate for their patient, meaning that all actions should be in the patient’s best interest. Adhering to this principle will ensure a clear moral path where any ethical dilemma in nursing can be avoided.   

DNR 

A DNR is an order written by a physician that is usually given to those who are critically or terminally ill. The order states that in the event of cardiopulmonary arrest, should the patient's heart stop or should they stop breathing, cardiopulmonary resuscitation (CPR) will not be administered. The decision for a DNR order is always discussed with the patient if they are conscious and have the capacity to make informed decisions. Should the patient be incapacitated, their power of attorney (POA), health care agent, or family member may be allowed to make the decision for a DNR. If a patient is known to be gravely ill, they may already have an existing DNR order, or an advanced directive/living will. Once this document is produced for the institution, the order will go into effect. If a DNR order has been put in place by the patient and physician, the family should not have the power to lift the order once the patient deteriorates and can no longer make decisions (3). 

There was a time in the history of healthcare when there were different tiers of a DNR order. For example, there used to be a medication only/chemical code where medication could continue to be administered, but no compressions or artificial respirations could be performed by the healthcare team; in the end, this proved to be a wasted effort as the medication would be circulated and provide no effect. Many institutions have gotten away from the tires of DNR; what I mean by this is, either there is a DNR order in place for a patient, or there is not. 

Ethical Dilemma in Nursing: DNR 

If a DNR order is put in place by the physician in conjunction with the patient, how could there possibly be any ethical dilemmas in nursing? There should be no problems associated with a DNR order; however, ethical dilemmas arise when the team (patient, physician, healthcare workers, and family) are not all on the same page regarding the DNR. One of the main problems is that different healthcare workers have different interpretations of what a DNR means. It must be understood that a DNR means “do not resuscitate,” and does not mean “do not treat.” To better explore the ethical dilemmas in nursing associated with a DNR order, we will look at scenarios that I have come across over my 25 years of nursing: 

Scenario 1 

A patient is sent from a telemetry unit to radiology for a CT scan. The patient has severe cardiomyopathy and requests a DNR upon admission. The order is noted on the patient’s chart. When they are sent to radiology for the scan, the floor nurse neglects to place the code status on the patient hand-off form. During the scan, the patient becomes unresponsive, and a code blue is called; CPR is initiated, and the patient is intubated.   

During the resuscitation, it is discovered that the patient has a DNR order. The physician running the code continues with CPR, rationalizing that they could ‘not just stop’ the life-saving measures that they had already begun. The patient is revived and transferred to the ICU. Later, during the admission, the family withdraws life support, and the patient expires.  

In this first scenario, we can see that a communication error led to the DNR order not being followed. Once discovered, the physician in charge refused to comply with the order.  Ultimately, the patient passed after a few days on life support.   

This ethical dilemma came to play once the code team realized that the patient had a DNR. The code could have been stopped at this point, and the lead physician could have spoken with the patient's family to explain what had occurred. Many facilities do have policies in place where if a patient goes for a procedure/surgery, the DNR order may be on hold during the time that they are in the procedure; this does not generally include diagnostic scans.   

Scenario 2

A G-tube is ordered for a terminally ill cancer patient. The patient is unable to eat and needs a G-tube for nutrition and medication administration. When the gastroenterologist comes in to do the consult, they discover that the patient has a DNR order. They refuse to place the G-tube due to the DNR order and claim that the G-tube is a ‘life-saving’ measure. The patient is sent back up to their room without having the G-tube placed. After two days, a second consult is placed, and a different doctor approves and places the G-tube. 

The ethical dilemma in this scenario is that the provider refuses to provide treatment based on a poor understanding of what a DNR really means. Again, DNR does not mean “do not treat.”  There are many procedures that can and should be performed regardless of a patient's code status. Though a G-tube can prolong someone's life, it also serves as a means to keep them comfortable through both nutrition and the administration of needed medications, including analgesics. A G-tube insertion can ultimately assist the patient to die with dignity by allowing them to receive alimentation and medicines. It is not solely the provider's responsibility to decide what measures are heroic and which are not. The entire multidisciplinary healthcare team should be involved in the care of the patient, especially when questions could arise as to if a certain procedure is ethical.   

This scenario led to a peer review of the provider's actions.   

Scenario 3

A patient, along with their healthcare team and family, has decided to enact a DNR order. They have been gravely ill for a long time and want "nature to take its course." After the DNR order was placed, one of their family members arrive from out of town; they do not agree with the DNR order and want it to be revoked. The patient refuses, and the DNR is left in place. The next day, the patient becomes unresponsive while the family member is in the room. They insist that the nurse begin CPR and threatens legal action if the code blue is not started immediately. The nurse becomes intimidated by them, as they do not fully understand the DNR order, and commences the code blue. 

The patient is revived and is transferred to the ICU. They voice their anger to the healthcare team about their wishes not being followed; CPR was not to have been administered. Three days later, they become unresponsive and expired; however, this time CPR was not administered, and the DNR was followed. 

Once again, the ethical issue occurred due to misunderstandings and a lack of knowledge from both the patient’s family and the healthcare team. The family member sought to go against the patient's explicit wishes to cancel the DNR. When they would not, as soon as the patient became unresponsive, they demanded that the staff perform CPR. The nurse should have refused, as the family member was not the legal decision-maker, and the patient's expressed wishes were known prior to them falling unresponsive; instead, the nurse breached the DNR and performed life-saving measures. 

Conclusion 

A DNR order is put in place when a patient does not want life-saving measures to be performed. The healthcare team and family are involved in the decision-making process, but the decision ultimately belongs to the patient. A patient with a DNR order still needs to be treated for their medical problems and, like any other patient, needs to be treated with dignity and respect. It is important that the healthcare team understands what the DNR encompasses and who can make decisions for the patient should they deteriorate. The nurse must always do what is best for the patient and follow the ANA Code of Ethics with Interpretive Statements. 

Managing Conflict in a Nurse Leader Role

Introduction

Every organization will experience some degree of conflict at one time or another; healthcare is no exception. Uniquely, conflict can create serious issues regarding care delivery, patient safety, and patient outcomes. Other end results include cost impacts related to staff turnover in an already understaffed industry, regulatory fines, and even law suits due to errors; more serious results include psychological impacts on staff members. Characteristics, leadership styles, and the ability to handle conflict are vital to those fulfilling a nurse leader role. This educational course will help you to identify conflict, the components of conflict, reasons for conflict in healthcare as well as management strategies. Conflict management is not just the responsibility of one in a nurse leader role, but that of all team members, especially the registered nurse. "Conflict management helps foster stronger relationships horizontally between employees and vertically between employees and management by increasing awareness and understanding of different points of view and educating staff about how to avoid conflict in the first place" (1). 

Conflict 

Conflict is defined as an internal discord resulting from differences in ideas, values, or feelings between two or more parties. Evoking feelings of hostility, anxiety, and stress can be extremely disruptive to a unit or department's functioning. Another definition includes a disagreement through which the parties involved perceive a threat to their needs, interests, or concerns. Workplace conflicts in the healthcare environment tend to be far more complicated because they often involve ongoing, complex relationships that are based on emotion (1). 

Stages

Conflict has different stages, and for those fulfilling a nurse leader role, it is useful to become aware of these so you can develop stage-appropriate interventions. The stages of conflict include: 

• Latent: At this point, the participants are not even aware of the conflict. Differences exist; perhaps, something has happened. 
• Perceived: The participants have become aware of the conflict. 
• Felt: The stress and anxiety of the conflict are being felt. 
• Manifest: The conflict is open and observable. 
• Aftermath: The result of the conflict, which can be either negative or positive (2).  

The earlier the conflict is identified, the less time it may remain open. Preserving the safe and efficient functionality of the unit or department is one reason why early management is important.

Types

Healthcare and nursing present a unique environment, which can lead to different types of conflict. We all bring our values, ideas, thoughts, and education to this work environment.  The types of conflict most identified within the healthcare environment includes a nurse-to-nurse, nurse-to-outside departments, physician-to-nurse, and generational differences. Let’s break these down.  

Nurse-to-Nurse Conflict (Horizontal)

Nurses often work closely with other teams where there are different values, opinions, and ages; the environment can be emotionally charged. Oftentimes, conflict resolution skills are not taught in school. The conflict can be staff nurse-to-staff nurse or staff nurse-to-nurse leader. 

 Nurse-to-Outside Department (Interdisciplinary)

The nurse is often the leader of the interdisciplinary team. Again, this is an area where there is little if any conflict training. Each department tends to be loyal and supportive of their department when there is conflict. This type of conflict often is between the physician and nurse.   

Generational Differences

Unprecedented, the nursing workforce currently spans five different generations, each with different characteristics and work ethics. The different generations are described as follows: 

• Silent Generation: Born between 1922 – 1946. They are known as traditionalists.  Characteristics include respect for authority, hardworking, and sacrifice for work. This generation values loyalty and may delay retirement (3). 
• Baby Boomers: Born between 1947 – 1964. Characteristics include a belief that workers need to pay their dues. Oftentimes, the generation includes workaholics with traditional learning styles; rewards are expected for hard work (3). 
• Generation X: Born between 1965 – 1977. Characteristics include independence, self-reliance, and skepticism of authority. This generation tends to work better with flexibility (3). 
• Millennials (or Generation Y): Born between 1978 – 1991. Characteristics include team-oriented, technological, entrepreneurial, and the need for quick feedback. This generation wants to be coached and mentored (3).  
• Generation Z born after 1991. Although there is a lot we do not know yet about this generation, some of their characteristics include tech-savviness, being a self-starter, and pragmatic (3).  

Most of you are familiar with the phrase, "nurses eat their young." This is not a new concept, and despite the valiant efforts of organizations, this type of conflict has persisted. Usually, horizontal, nurse-to-nurse bullying with the older generations makes the new generations feel unwelcome, incapable, and unwilling to help when asked (4). However, it is important to note that the opposite is also a workplace issue. Younger, newer nurses are perceived as faster, able to utilize technology at lightning speed, and can cope better with variable shifts than older nurses. This gives the newer nurse a perceived power gradient over the older nurse and can be used as a form of bullying (4). 

Leadership 

Qualities 

Leadership requires many qualities; this should begin with relational intelligence.  Relational intelligence revolves around the idea of how you positively navigate through relationships with others. For one fulfilling a nurse leader role, this skill is absolutely necessary for your team’s success (5). Although nurse leaders are looked to when there is conflict, it is not solely their responsibility to resolve it, but that of all team members (5).  

Other qualities needed include integrity, critical thinking, communication, dedication, self-awareness, and professionalism. There is not an adequate or inadequate strategy to deal with conflict. However, early detection of conflict and adoption of the most effective conflict resolution behavior is essential in organizations as soon as possible (6). How these qualities are learned is an important issue. Many nurse leaders have little training to prepare them for the responsibility of conflict resolution. However, unresolved or unmanaged conflict may end with work disruption, poor work performance, tardiness, absenteeism, low staff morale, low staff productivity, increased psychological distress, and burnout (6). It can affect the productivity of the organization. 

Another important quality to develop at all levels of nursing especially for those in a nurse leader role is communication skills; including both how the message is sent, and how the message is received. Listening skills is a vital aspect of nursing and oftentimes, we are moving at a fast pace and already thinking about an answer before the person finishes speaking; with that being said, misunderstandings are easy to cause but not always so easy to fix.  

For nurse leaders, it is important to recognize and engage in managing conflict. Many times, there are barriers, including time constraints, fear of retaliation, and fear of exclusion. Of course, no one wants conflict, and sometimes this results in an attempt to soothe and prematurely place a solution. Those in the nurse leader role must learn how to positively engage in conflict resolution and stay engaged to promote collaboration and effective care. Being successful includes dialogue, coaching, the identification of the potential conflict, education, and training. 

Styles 

Leadership styles are the set of management thoughts and behaviors related to your personality, communication preferences, strengths, weaknesses, and values (7). Styles can develop over time or be influenced by the organization. The most common styles leadership styles are (7):  

• Democratic: The democratic style is team-oriented and involves openness in conversations and management. Although the leader has the final say, the opinions of others are valued; this style tends to be successful. 
• Autocratic: The autocratic style is the opposite of the democratic style; where the leader has their way and does not consider or consult team members. This style does not tend to be successful.   
• Transformational: The transformational style has defined goals, a clear direction, and looks at the big picture. Those in the leadership role share their vision with staff and thinks outside the traditional path; this style tends to be successful. 
• Coaching: The coaching style is similar to the transformational style and involves mentoring to bring the team closer. Having the nurse leader walk the direct care nurse through a variety of conversations to resolve a dispute or disagreement provides the opportunity for alternative solutions to be considered; this also tends to be a successful style.  
• Lassiez-Faire: The lassiez-faire style is casual and laid back; meaning there is little leadership. In fact, authority is turned over to the staff. Generally, this style does not want to deal with conflict and is not successful.  
• Situational: The situational style is used when instant change is needed for safety or regulatory reasons. Often the style is used to respond to an event and is not always accepted by staff. 

While developing a style, it is important to allow for the expression of multiple viewpoints and how to build better relationships (8). The absentee leader does little to communicate, mentor, and plan. The incompetent leader has little involvement in planning and faces serious moral issues. If the environment is not maintained and cohesive, job satisfaction and performance can be impacted negatively.   

Regulatory Issues and Conflict 

In 2008, The Joint Commission released a sentinel event alert addressing disruptive behaviors and provided recommendations as to how organizations should address their relational issues and conflicts. The defined behaviors recognized more of the physician-to-nurse issues, but placed all disruptive behavior on its radar. Identified behaviors included: verbal outbursts, physical threats, uncooperative attitudes, and cooperation refusal (i.e. not taking pages or answering calls). Other behaviors include condescending language and refusing to complete tasks (9). Disruptive behaviors often go unreported, and therefore unaddressed for several reasons. Whether that is fear of retaliation and the stigma associated with "blowing the whistle" on a colleague, or a general reluctance to confront an intimidator, it all contributes to underreporting of intimidating and/or disruptive behavior (9). Part of the sentinel event has given guidance on what defines behaviors and required resolutions. Organizations are required within this mandate to develop a specific ‘Code of Conduct’ that outlines acceptable and disruptive behaviors as well as the processes managing these behaviors. Additionally, organizations are to develop policies and procedures that clearly state zero tolerance and provide training and education; this includes physicians.    

Regarding nurse-to-nurse (horizontal) disruptive behavior, the American Nurses Association (ANA) Code of Ethics for Nurses includes interpretive statements outlining that nurses are required to "create an ethical environment and culture of civility and kindness, treating colleagues, coworkers, employees, students, and others with dignity and respect," (10). Similarly, nurses must be afforded the same level of respect and dignity as others; thus, the nursing profession should no longer tolerate violence of any kind from any source. As someone who is fulfilling a nurse leader role, it is essential that you refer to the ANA Code of Ethics for Nurses when managing conflict within the workplace.  

Nurse Leader Role: Conflict Strategy 

As one involved in a nurse leader role, in order to effectively eliminate or manage conflict, it cannot be ignored. Engagement must be an ongoing process. To be successful, one must learn to not only engage in conflict, but remain engaged to promote collaboration and effective care coordination (11). The earlier conflict is identified, the better, as dysfunctional patterns can take place and can potentially define the culture of the department.   

Common Strategies (11):

• Safe Space: It is important that staff feel they are meeting in a safe space, and that there is privacy and support. 
• Coaching: Coaching can be in either group or individual settings. Coaching sessions are confidential (unless otherwise agreed upon), must follow a consistent format, and include a written summary of the session. 
• Facilitation: There is usually a defined agenda. You will need someone neutral who can see past the fireworks or walls of silence and assist the group with arriving at the core problems or issues. 
• Dialogue: The importance is to have a discussion that addresses the issue and clears the air; avoid saying “always” and “never.” Nursing leaders and direct care nurses need to engage in dialogues that address conflict and conflict management behavior as a first step in creating a healthy work environment (1).  
• Collaborative: Collaborative works with the group problem solving together.  
• Storytelling: Storytelling works with traditional stories that are told to help move from personal experiences to broader, helping to negotiate group conflict.  
• Mediation: Can be formal or informal. 
• Education and training: Nurses need to be educated on conflict and conflict management strategies that address and effectively resolve conflict. Learning conflict management strategies empowers nurses to resolve conflict early and influence the work environment in which they deliver patient care. "The training should not be limited to the handling of interpersonal conflicts; it should include all types of conflict commonly encountered in the healthcare setting. Additionally, individuals who have a propensity for managing conflict well should be identified and developed” (1). Education and training should also include communication skills.  

"Leaders can change the climate in the workplace and promote better collaboration among workers by interrupting a group's dysfunctional behavior patterns," (12). Adding the skills of self-awareness and emotional skills helps to bring a team together. Relational ethics emphasizes the importance of mutually respectful relationships. People work to improve their awareness of how their choices and actions help shape their conversations and social interactions. The relational approach addresses conflict as it unfolds – just as a relationship evolves and unfolds over time. It incorporates the essential qualities that form the core of human relationships. It is hard to imagine an approach to conflict that excludes consideration of integrity, respect, identity, compassion, humility, shame, trust, fear, hope, pride, acceptance. Love, joy, and other human dynamics are at the heart of most conflicts (12). 

Emotional and social intelligence are defined as "skills that enable an individual to understand the impact of emotions on behavior and thinking, to regulate emotions and behavior, to understand the importance of emotions in others, and to understand social interactions and engage in adaptive ways with others in social situations," (12).  

An Example of Failed Conflict Management from a Nurse Leader Role 

This story is based on a true example experienced by the author; names and locations have been changed. 

Looking back to the 1980s, the nursing profession was struggling with shortages and how to produce more nurses quickly. During this time, the entry-level for nursing was either a three-year hospital diploma program or a BSN. Many times, nurses were made managers without experience. In a small California Neonatal Intensive Care Unit (NICU) in the mid-1980s, this unit called ‘neonatal’ was staffed by only nurses. The original manager was a diploma graduate who had newborn experience for many years, but not in the NICU specialty; however, she was beloved. Over the next two years, there were four different managers who did not work out. To be honest, the staff did not want it to work out but were weary and wanted some leadership.  The next nurse manager, Mary, was a BSN graduate with little NICU experience and no management experience; she immediately made several changes that completely divided the staff. During this time, one staff nurse, Jane, was undergoing some extreme personal issues.  She and Jane absolutely did not get along. Jane had been a nurse in this unit for over ten years and was an excellent clinician, but she had become a nightmare to work with. She was mean to her colleagues and had become a bully. Additionally, she would never help others, except for the few in her circle.  

Human Resources offered no help.  

The morale was dismal, and staff began to leave. During this time, to the horror of the staff, Jane committed suicide. The note she left cited personal issues, but also included the horrible work relationship she had with Mary as part of her reason. Staff felt responsible and guilty; they completely divided, making work a nightmare. Few resources were given to help with the situation, and many staff members left within the year; perhaps, an experienced manager may have been able to diffuse the situation differently.  

This is an extreme example but one that illustrates what can happen without leadership at both the unit and senior management level. In situations of conflict, the most powerful weapon we have is control over our own behavior.  If there is a single contributory factor that reduces and eliminates negative conflict, it is trust. Our ability to trust each other greatly impacts our working lives, family interactions, and achievement of personal and organizational goals. To create trust, it is necessary to avoid aggressive behaviors and at the same time develop supportive behaviors where people are respected for what they are or what they believe in and are treated equally without bias or prejudice. If a conflict develops at any level, it should be resolved with mutual benefit in mind (12).   

Conclusion 

Those with a nurse leader role have large responsibilities. They need to understand the definitions of conflict and how to manage it as soon as possible. They need to acknowledge the responsibilities of conflict resolution. Part of this responsibility is understanding the type of conflict, leadership qualities and styles, regulatory issues, and the ramifications of poor management. These ramifications can result in serious medical errors, patient safety concerns, poor patient outcomes, and psychological manifestations for staff.  

Not every nurse is a leader, but part of their role should understand conflict and conflict management. "Nursing professionals must use constructive conflict management approaches rather than destructive conflict management approaches when dealing with conflict situations. It is necessary to avoid aggressive behaviors and at the same time develop supportive behaviors where people are respected for what they are or what they believe in and are treated equally without bias or prejudice," (14). 

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