California Schedule II Controlled Substances and Risk of Addiction

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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.

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