Drug Diversion and Controlled Substances Nursing CE Renewal Course for West Virginia Nurses

lts is a growing problem, especially when combined with alcohol. Having multiple health problems and taking multiple drugs can put the older adult population at risk of misusing drugs or becoming addicted. Also, a lack of knowledge about prescription drugs and their potential harm heightens the risk within this population (NIDA, 2020a; SAMHSA, 2021; Webster, 2017).  

In WV, the rationale for the heightened opioid epidemic is premised on a combination of socio-cultural and economic factors, the primarily rural area, limited access to healthcare services, a depressed economy, a lack of education, and the high rate of prescribing and dispensing of prescription opioids (Merino et al., 2019). 

Controlled Substances: The Basics 

According to NIDA (2020b), the three classes of medication that are most commonly misused include opioids, CNS depressants (i.e., tranquilizers, sedatives, and hypnotics), and stimulants. Opioids are prescribed for pain control and function by binding to mu-opioid receptors in the CNS to reduce or block the pain signal to the brain. They also affect receptors in the respiratory and gastrointestinal tract and are occasionally used to treat diarrhea and coughing. There are synthetic opioids, such as fentanyl, and naturally derived opioids from the opium poppy plant. Tramadol (Ultram) is a Schedule IV synthetic opioid commonly used to treat mild to moderate pain. Codeine is frequently prescribed to treat mild to moderate pain or coughing, either alone or in combination with acetaminophen as part of cough and cold formulas (NIDA, 2020b). According to the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research, other common Schedule II opioids prescribed for moderate or severe pain include:  

• hydrocodone (Vicodin, Lortab, Norco): commonly combined with acetaminophen, the most frequently prescribed opioid in the US 

• oxycodone (Percocet, Oxycontin): available as an immediate or extended-release formula, fast onset 

• morphine sulfate (IR, MSContin): available as an immediate or extended-release formula, PO/intravenous (IV) 

• oxymorphone (Opana, Opana ER): available as an immediate or extended-release, long half-life 

• hydromorphone (Dilaudid, Exalgo ER): made from morphine, but with a faster onset, PO/IV 

• fentanyl (Duragesic): transdermal patch lasting 72 hours, also available as IV (FDA Center for Drug Evaluation and Research, 2020) 

Adverse reactions to opioid use include respiratory depression, drowsiness, mental confusion, nausea/vomiting, dizziness, headaches, fatigue, pruritus, pinpoint pupils, urinary retention, and constipation. Since these drugs can induce euphoria, especially when taken at higher doses than prescribed or ingested via snorting or injection, they are at high risk for abuse and addiction. There is also an increased risk of developing drug tolerance and hyperalgesia (i.e., increased sensitivity to pain caused by damage to nociceptors or peripheral nerves with long-term use of opioids [FDA Center for Drug Evaluation and Research, 2020]).  

CNS depressants are a class of drugs that include tranquilizers, sedatives, and hypnotics and are often used to treat anxiety and sleep disorders. CNS depressants increase the activity of the neurotransmitter gamma-aminobutyric acid (GABA), producing a drowsy or calming effect. A few examples include benzodiazepines, such as lorazepam (Ativan), diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax), triazolam (Halcion), and estazolam (Prosom). These are categorized as Schedule IV medications and are typically prescribed to treat general anxiety, panic attacks, acute stress reactions, muscle spasms (diazepam [Valium]), seizure disorders (clonazepam [Klonopin]), and sleep disorders (triazolam [Halcion], estazolam [Prosom]). In general, this group requires great caution and is indicated for short-term use only due to the high risk of tolerance, dependence, and addiction. Concurrent use of benzodiazepines and opioid pain medications should be avoided due to the additive risks of these groups (NIDA, 2020b). 

Non-benzodiazepine sleep medications include zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata). These act on the same GABA type A receptors in the brain as traditional benzodiazepines but with a different chemical structure, which is thought to result in fewer side effects and a lower risk of dependence. However, these medications can cause headaches, amnesia, dizziness, and nightmares. Melatonin—a safer short-term option for insomnia—is an over-the-counter (OTC) supplement that boosts the body's natural sleep hormone levels. Ramelteon (Rozerem) is a prescription option that acts as a synthetic melatonin antagonist, binding to MT1 and MT2 receptors and helping induce sleep without any abuse or addiction potential (NIDA, 2020b).  

For anxiety, pharmacologic options that are not controlled substances include buspirone (Buspar), which binds to serotonin and dopamine D2 receptors. Buspirone is generally better tolerated than benzodiazepines, with less drowsiness and lower abuse potential. Barbiturates, such as mephobarbital (Mebaral), phenobarbital (Luminal), and pentobarbital (Nembutal), are less commonly used medications for anxiety and sleep disorders due to their high risk of overdose. However, they are still used in seizure disorders and during surgical procedures. All CNS depressants can induce drowsiness, confusion, and poor coordination. These drugs should never be stopped abruptly but tapered slowly due to the risk of withdrawal symptoms, seizures, or other harmful effects. Barbiturate withdrawal can be especially dangerous and potentially life-threatening. In the case of a benzodiazepine overdose, flumazenil (Romazicon, a benzodiazepine antagonist) may be administered via an IV by emergency medical personnel (NIDA, 2020b). 

Stimulants like methamphetamine, dextroamphetamine (Adderall, Dexedrine), and methylphenidate (Ritalin, Concerta) are classified as Schedule II medications. They function by enhancing the effects of the brain neurotransmitters norepinephrine and dopamine, thereby increasing alertness, attention, motivation, cognition, and energy. Stimulants can also provoke vascular constriction, leading to increased heart rate, blood pressure, and respiratory rate; dilated airway; jitters; elevated blood glucose; and sleep disturbance. When misused, these drugs can cause euphoria related to increased brain dopamine activity. Abruptly stopping a stimulant can cause withdrawal, which is characterized by depression, fatigue, and sleep disturbance. Repeated misuse of stimulants has been associated with feelings of hostility, paranoia, and psychosis, and overdose can lead to hyperthermia, arrhythmias, cardiovascular arrest, or seizures (NIDA, 2020b). 

Guidelines for Safe Prescribing Practices 

One of the greatest challenges for prescribers is distinguishing between legitimate and illegitimate prescriptions of controlled substances (Webster, 2017). Given the unique risks associated with controlled substance use, misuse, and potential drug interactions, all providers must adhere to best practices for prescribing guidelines (Hudspeth, 2016a). The West Virginia Expert Pain Management Panel's Safe & Effective Management of Pain Guidelines (WV SEMP, 2016) extend the 2016 CDC Chronic Pain Opioid Guidelines. Together, these guidelines utilize the highest level of evidence-based practice regarding the safe prescribing, dispensing, monitoring, and risk reduction strategies for using controlled substances amid the rising opioid epidemic (CDC, 2016; Webster, 2017; WV SEMP, 2016). 

Risk Reduction and Screening  

Treatment must begin with a comprehensive history and physical, including a detailed assessment specific to pain. It should include a complete list of current and past medical conditions, current medications, and how they are taken. Next, a thorough and consistent pain assessment should be performed, including pain severity rating, location, quality, duration, treatment history, and aggravating/alleviating factors. Additional history components should include a detailed review of family history (substance use/abuse or psychiatric diagnoses), social history (socioeconomic status, employment status, education level, living situation, and dependents), drug and alcohol use, as well as a depression screening. Many patients with chronic pain also have a diagnosis of clinical depression and are twice as likely to attempt suicide as non-pain patients. Therefore, the consistent use of a depression screening tool is imperative to ensure adequate treatment of any comorbid psychiatric conditions that may be undertreated or untreated (Hudspeth, 2016a; NIDA, 2017). 

Prescription Drug Monitoring Program 

Most states (49 states, Washington DC, and Guam) have established statewide electronic databases or prescription drug monitoring programs (PDMP) to track and monitor opioid prescriptions. The PDMP collects designated data on controlled substances dispensed to or for each patient. This program intends to improve opioid prescribing, inform clinical practice, and protect high-risk patients. The key to the efficacy of PDMP systems is the mandate that all providers must check the system before initiating opioid therapy. The goal is to determine if the patient is receiving opioid dosages or dangerous combinations that place them at risk for overdose (CDC, 2021). 

West Virginia Monitoring Program 

In 2013, WV launched the RxDataTrack Controlled Substance Automated Prescription Program (CSAPP). The CSAPP is an online database that complies with the Health Insurance Portability and Accountability Act (HIPAA), allowing for the tracking and reviewing of controlled substance prescription history to assist with diversion at the prescriber, pharmacy, and patient levels (West Virginia Board of Pharmacy [WVBOP], 2019). According to WV SEMP Guidelines (2016), all licensees who dispense Schedule II, III, and IV controlled substances to residents of WV must provide the dispensing information to the WVBOP every 24 hours. In addition, according to WV Code §60A-9-5 of House Bill 2768, all practitioners who prescribe or dispense Schedule II, III, or IV controlled substances must: 

• register with the WV Controlled Substances Monitoring Program and maintain access 

• access the CSAPP upon initially prescribing or dispensing any pain-relieving controlled substance for a patient, and at least annually after that 

  • physicians working in pain management clinics must check the CSAPP at the initiation of controlled substance therapy and at least every 90 days after that (WVBOP, 2019) 

Informed Consent and Treatment Agreements 

A treatment agreement or a patient and provider agreement (PPA) should be obtained before the initial opioid prescription. The PPA underscores the critical importance of the proper use of prescribed pain medications, outlining the standards of care and the expectations of treatment. It promotes collaboration and mutual commitment from both parties, sets realistic expectations with measurable functional goals for therapy, and states why the agreement may be terminated. At a minimum, it should address the potential side effects, possible overdose, respiratory depression, development of physical dependence or tolerance, drug interactions, inadvertent ingestion by children or others, and drug misuse or abuse by the patient, their household contacts, or friends. Furthermore, prescribing policies should be clearly defined, including the number and frequency of refills, policy on early refills, and procedures for lost, damaged, or stolen medications. If UDTs or pill counts are performed periodically, the PPA should address this topic and indicate how medication refills and changes should be requested and obtained by the patient and handled by the office staff and providers. The PPA can also establish informed consent, or there may be a separate document for informed consent (Hudspeth, 2016b; WV SEMP, 2016). 

Documentation 

Documentation is critical when prescribing controlled substances for safety and legal reasons. Documentation in the medical record should be clear and concise and include all details outlining dose adjustments or medication changes with associated justifications and equivalency calculations, the effectiveness of treatments based on consistent pain assessments repeated at each visit, and any adverse effects and related treatments. Documentation should also specify whether the patient is adhering to the treatment plans as outlined in the PPA and include results of any UDTs or pill counts. Any concerning or aberrant behavior should be carefully documented with as much detail as possible (Hudspeth, 2016b; Pain Assessment and Management Initiative [PAMI], 2019). 

Management of Acute and Chronic Pain 

Alleviation of pain and suffering has always been a fundamental tenet of medical care. Pain occurs in 2 main categories: acute (under 3 months) and chronic (over 3 months); treatment and management options differ significantly between these groups. Acute pain is often self-limiting; if nonpharmacological treatment can be used effectively, it is recommended instead of medication use. Nonpharmacological treatments such as heat, ice, massage, acupuncture, and spinal manipulation have low- to moderate-quality evidence but negligible risk. If pharmacological treatment is required, treatment should start with non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen [Advil, Motrin], naproxen [Aleve, Naprosyn, Vimovo]), acetaminophen (Tylenol) and/or skeletal muscle relaxants such as carisoprodol (Soma) and cyclobenzaprine (Flexeril). Gastrointestinal and cardiovascular risks are associated with NSAID use; however, celecoxib (Celebrex) and nabumetone (Relafen) are gastroprotective in the short term. Studies have also shown that adding misoprostol (Cytotec), a proton pump inhibitor, or an H2 blocker is gastroprotective for short-term use. Naproxen (Aleve, Naprosyn, Vimovo) and meloxicam (Mobic) appear to be the safer options in terms of cardiovascular risk (Ho et al., 2018; Qaseem et al., 2017). 

Other treatments often used successfully for pain management include cognitive behavioral therapy (CBT), exercise therapy, and physical therapy. These treatments should be tried first or incorporated with any pharmacological treatment that is deemed appropriate. Additional nonopioid medications, such as gabapentin (Neurontin) and pregabalin (Lyrica), or antidepressants such as venlafaxine (Effexor), duloxetine (Cymbalta), or tricyclic antidepressants, should also be considered (CDC, 2016; PAMI, 2019).  

If opioids are prescribed for acute pain, CDC prescribing guidelines advise limiting the initial prescribing of opioids to between 3 and 7 days. They also advise against co-prescribing opioids and benzodiazepines due to the high risk of overdose when used together. The PDMP database should be reviewed initially for all patients receiving opioid prescriptions. The initial opioid prescription should be considered a trial, with a follow-up appointment scheduled to review effectiveness and success based on established treatment goals. Moderate pain can often be managed with weaker opioids such as codeine (Tylenol #3) or tramadol (Ultram), which is a synthetic analog of codeine with a low affinity for opioid receptors. Treatment for severe pain should start with a more potent oral opioid such as hydrocodone (Vicodin, Lortab, Norco), oxycodone (Percocet), morphine (MS Contin), or hydromorphone (Dilaudid). Fentanyl (Duragesic) and methadone (Methadose, Dolophine) should be avoided as first-line options due to their dosing challenges. Immediate-release (IR) medications with a half-life of 2-4 hours should be started initially for opioid-naive patients until the dose is stabilized. Dose adjustments may be necessary as often as every 2-3 days. Extended-release (ER) or long-acting (LA) formulas with a half-life of 8-12 hours from the same family are commonly added later if long-term use is required (CDC, 2016; Hudspeth, 2016a; PAMI, 2019; Qaseem et al., 2017). 

According to the American Society of Interventional Pain Physicians, chronic pain treatment (excluding cancer patients and end-of-life care) should always start with and include non-pharmacologic and nonopioid treatment options as described above (Manchikanti et al., 2017). When initiating opioid therapy for severe pain that requires daily, around-the-clock, long-term opioid treatment, the lowest dose possible should be given, beginning with a short-acting opioid and/or rotating to a LA/ER, if indicated. The lowest effective dose of immediate-release opioids should be used initially, avoiding ER or LA versions until a stable dose has been established. Primary care providers should reassess the risks and benefits of treatment when prescribing more than 50 morphine milligram equivalents (MME) per day and carefully justify prescribing more than 90 MME/day. According to the CDC, the risk of overdose is at least doubled in patients taking 50 MME/day or more than those taking less than 20 MME/day (CDC, 2021b; FSMB, 2017; Fudin et al., 2018). 

Special Considerations: Older Adults and Pregnant Patients 

Special considerations should be applied when prescribing for populations at potentially higher risk for harm, including older adults (over 65), those with renal or hepatic insufficiency, or those who are pregnant. While pain is more commonly reported by the elderly due to natural aging, advancing age is often accompanied by physiological changes that affect medication absorption, metabolism, and excretion. In addition, older adults may have an increased risk of falls and fractures related to opioids, and clinicians are advised to consider a patient's fall risk when selecting and dosing potentially sedating medications such as tricyclics, anticonvulsants, or opioids. Clinicians should weigh the risks and benefits of the use, dose, and duration of agents such as acetaminophen (Tylenol) and NSAIDs when treating older adults (CDC, 2016; Ho et al., 2018).  

While opioid use in pregnancy is not well studied, use can be associated with risks to both the mother and the fetus. Some studies have shown an association between opioid use in pregnancy with congenital disabilities, including neural tube defects, congenital heart defects, preterm delivery, poor fetal growth, stillbirth, and the potential for neonatal opioid withdrawal syndrome. Opioids are excreted in breast milk and increase the risk for CNS and respiratory depression in infants if taken by mothers while breastfeeding. Acetaminophen (Tylenol) can be used safely in pregnancy and while breastfeeding. Due to the risk of bleeding and premature ductal closure, pregnant patients should avoid NSAIDs, especially during the first trimester and after 30 weeks of gestation. NSAIDs appear safe to use during breastfeeding, however. Benzodiazepines were Category D and should be avoided in pregnant and breastfeeding patients, as they cross the placenta and are excreted in breast milk. In pregnancy, they increase the risk of congenital abnormalities, primarily if used in the first trimester (CDC, 2016; FDA Center for Drug Evaluation and Research, 2020). 

Prevention of Drug Abuse/Misuse 

Prevention of the misuse and abuse of controlled substance medications starts with prescribers, especially ensuring formal continuing education regarding the indications, risks, and benefits of these medications and safe prescribing practices that guide medical decision-making to limit risk to patients and communities. An honest dialogue with each patient regarding the risks, benefits, treatment goals, treatment alternatives, and expectations of both parties before prescribing can help prevent the misuse of potentially dangerous medications. This includes utilizing informed consent and PPAs, with updates and changes to these documents as treatment is adjusted over time (Hudspeth, 2016a; NIDA, 2020b). 

Safe Storage and Disposal 

Patients should be counseled about the importance of the safe storage of medications to avoid intentional or accidental use by anyone other than the patient for whom they were prescribed. Proper medical disposal helps eliminate excess quantities of controlled substances and reduce the likelihood that these drugs will be diverted. According to the FDA, any expired or unnecessary medications should be deposited at a registered take-back event/location or disposed of in the household trash (pills should be mixed with dirt, coffee grounds, or cat litter and sealed in a bag, and all empty pill bottles should be thrown away separately after covering all prescription details). If no drug take-back program is readily available, used or unwanted fentanyl patches and other medication can be flushed down the toilet if necessary (FDA Center for Drug Evaluation and Research, 2020). 

Signs and Symptoms of Drug Abuse/Misuse 

Recognizing and responding to drug misuse/abuse risk factors are important nursing responsibilities that can help reduce prescription drug abuse and diversion. Signs that a patient may be misusing or diverting their controlled substances include rapid increases in the doses of medications needed, frequent or unscheduled refill requests, repeated excuses about prescriptions or medication being lost or stolen, multiple visits to multiple providers or pharmacies, resistance to nonopioid and nonpharmacological treatment options, frequent after-hours calls to the on-call prescriber, or multiple trips to the emergency department (ED) resulting in prescriptions. Prescribers should avoid the common pitfall of assuming a well-liked or well-known patient is at a lower risk for abuse/misuse. Patients who repeatedly delay needed or planned surgeries and opt instead to treat an otherwise correctable condition with medications should be monitored closely (Hudspeth, 2016b). 

Termination Strategies for Chronic Opioid Therapy (COT) 

As with the treatment of any medical condition, the goal of terminating COT is to restore health and resume pre-illness activities of daily living. Termination is an intentional process that occurs when a patient has achieved most of the functional goals of treatment and/or when therapy must end for other reasons. The most common reasons for COT termination include the achievement of the functional goals of therapy and/or when therapy must end for other reasons (e.g., treatment policy nonadherence, follow-up nonadherence, or concern for misuse/abuse or diversion). Appropriate termination helps avoid feelings of betrayed trust, prevents harm, and conveys intentionality (Perfolizzo et al., 2019). 

Treatment of Drug Abuse/Misuse and Addiction 

Substance abuse disorders are multifaceted but can be effectively treated. Treatment must be multifactorial and individual, often involving detoxification, counseling, and medications. For OUDs and addiction, this combination is referred to as medication-assisted treatment (MAT). The goal of treatment is to correct the imbalance in brain pathways that mediate reward, decision-making, impulse control, learning, and other functions to restore the patient to a normal affective state. Behavioral treatment such as CBT or contingency management often helps change previous thinking patterns and behavior and teaches coping strategies and avoidance of triggers to limit the risk of relapse. Medications used in opioid abuse disorder treatment can alleviate withdrawal symptoms and limit cravings, thus helping limit the risk of relapse. Medication options for opioid use disorders are as follows (SAMHSA, 2022): 

• Buprenorphine (Buprenex, Sublocade) is a partial opioid agonist (binds to receptors but only partially activates) used to reduce cravings.  

• Methadone (Methadose, Dolophine) is a synthetic opioid agonist that has been used for over 40 years to help limit symptoms of withdrawal/cravings. It is available only through specially-licensed opioid treatment programs (OTPs). 

• Naltrexone (Vivitrol) is an opioid antagonist (prevents opioids from binding to and activating receptors) that is used for addiction treatment. It is available as a long-acting injection and can be prescribed by any licensed prescriber. Patients must detoxify/abstain from opioids for 7-10 days before starting.  

For patients with CNS depressant use disorder, great care must be taken to avoid sudden cessation of these medications. Drug detoxification for these medications should be done under medical supervision, as withdrawal symptoms can be severe and potentially life-threatening. Stimulant withdrawal can be uncomfortable, although less dangerous than CNS depressant withdrawal, and stimulant medications should be tapered to ease withdrawal symptoms (NIDA, 2020a). 

Naloxone (Narcan) 

Naloxone (Narcan) is an opioid antagonist that blocks opioids from binding to and activating opioid receptors in the CNS. It is used as a reversal/rescue drug in the case of an opioid overdose. It can reverse the respiratory depression experienced by patients who have ingested large amounts of prescription opioids or heroin within 2-5 minutes. Naloxone (Narcan) can be repeated if no response is seen. It can be administered by first responders, emergency medical providers, and bystanders. Narcan typically stays in a patient's system for 30-90 minutes, depending on the patient's body mass and metabolism, and may require more than one dose based on the half-life of the opioid ingested. It is given as a nasal spray or intramuscular injection. Administration of naloxone (Narcan) may cause symptoms of opioid withdrawal, including sweating/chills, nausea, vomiting, agitation/anxiety, fevers, runny nose, hypertension, shivering/shaking, and muscle aches (CDC, 2019; FDA, 2020). 

Specific Rules and Regulations for West Virginia 

According to the WVBOP (2020), which governs the prescribing of controlled substances and outlines the prescriptive authority of APRNs, the following standards are required (WVBOP, 2020; West Virginia Legislature, 2022): 

• When required, the APRN shall submit written verification of an agreement to a collaborative relationship with a licensed physician holding a WV license. 

• Under West Virginia Code, § 30-7-15 and the West Virginia House Bill 214, passed in April 2022, APRNs are not authorized to hold Schedule I Controlled Substance prescriptive authority. An APRN may prescribe up to a 3-day supply of a Schedule II narcotic. There are no other limitations on prescriptive authority for APRNs in WV. 

 

References 

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Centers for Disease Control and Prevention. (2019). Life-saving naloxone from pharmacies. https://www.cdc.gov/vitalsigns/naloxone/index.html 

Centers for Disease Control and Prevention. (2021a). 2019 drug overdose death rates. https://www.cdc.gov/drugoverdose/deaths/2019.html 

Centers for Disease Control and Prevention. (2021b). Prescription drug monitoring programs (PDMPs). https://www.cdc.gov/drugoverdose/pdmp/states.html 

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Ho, K. Y., Gwee, K. A., Cheng, Y. K., Hon Yoon, K., Tak Hee, H., & Omar, A. R. (2018). Nonsteroidal anti-inflammatory drugs in chronic pain: Implications of new data for clinical practice. Journal of Pain Research, 11, 1937-1948. https://doi.org/10.2147/JPR.S168188 

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Hudspeth, R. S. (2016b). Safe opioid prescribing for adults by Nurse Practitioners: Part 2. Implementing and managing treatment. The Journal for Nurse Practitioners, 12(4), 213-220. https://doi.org/10.1016/j.nurpra.2015.11.032 

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Qaseem, A., Wilt, T. J., Mclean, R. M., & Forciea, M. A. (2017). Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 166(7), 514-530. https://doi.org/10.7326/m16-2367 

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West Virginia Board of Pharmacy. (2019). Welcome to CSAPP. https://www.csappwv.com/Account/Login.aspx?ReturnUrl=%2fDefault.aspx 

West Virginia Board of Pharmacy. (2020). Pharmacy laws and legislative rules of West Virginia governing the practice of pharmacy controlled substances act. https://www.dhp.virginia.gov/pharmacy/pharmacy_laws_regs.htm 

West Virginia Expert Pain Management Panel. (2016). Safe & effective management of pain guidelines. http://sempguidelines.org/wp-content/uploads/2016/09/WV-Pain-Management-Guidelines-No-Appendix.pdf  

West Virginia Legislature. (2022). 2022 second extraordinary session enrolled House Bill 214. http://www.wvlegislature.gov/Bill_Status/bills_text.cfm?billdoc=HB214%20ENR.htm&yr=2022&sesstype=2X&i=214