About this course:
The purpose of this module is to provide a detailed overview of the safe and effective prescribing of controlled substances for registered nurses (RNs) and advanced practice registered nurses (APRNs) in West Virginia, in compliance with the state regulations and evidence-based guidelines for the prevention of prescription drug abuse and diversion, challenges in managing chronic pain, and best practices for prescribing controlled substances.
Course preview
The purpose of this module is to provide a detailed overview of the safe and effective prescribing of controlled substances for registered nurses (RNs) and advanced practice registered nurses (APRNs) in West Virginia, in compliance with the state regulations and evidence-based guidelines for the prevention of prescription drug abuse and diversion, challenges in managing chronic pain, and best practices for prescribing controlled substances.
Upon completion of this module, learners should be able to:
describe the epidemiology of controlled substance abuse and drug diversion within the US, define key terminology, and identify contributing and risk factors for potential misuse/abuse
identify the three different classes of controlled substances most commonly misused, including indications, risks, benefits, common adverse effects, and alternatives for opioids, central nervous system (CNS) depressants, and stimulants
explain safe prescribing based on best practices, clinical experience, and evidence-based guidelines
discuss acute and chronic pain management and special considerations for controlled substance use in specific populations (e.g., elderly, pregnant, and cancer patients) and end-of-life care
identify the prevention, screening, and signs of potential substance abuse and addiction and describe the appropriate response to and current treatment options for substance abuse and addiction
describe the West Virginia requirements for prescribing controlled substances and the Controlled Substance Automated Prescription Program (CSAPP)
The US opioid epidemic began in the 1990s when attitudes toward pain management and opioid safety shifted from conservative prescribing to widespread use (Lyden & Binswanger, 2019). Previously, these medications were primarily reserved for end-of-life care and severe cancer pain. However, patient advocacy groups and pain specialists, including the American Pain Society (APS), began to raise awareness of the inadequate treatment of non-cancer pain and the underutilization of pharmaceutical opioids, leading to a movement to treat pain as the "fifth vital sign." As a result, in 2001, the Joint Commission (TJC) set new pain management standards, which tied patient satisfaction and healthcare quality to pain control (Baker, 2017). In addition, pharmaceutical companies reassured the medical community that patients would not become addicted to therapeutic opioids (US Department of Health and Human Services [HHS], 2021). The increased awareness of pain management and the widespread marketing campaigns of pharmaceutical companies resulted in skyrocketing numbers of opioid prescriptions. In 2010, opioid prescribing peaked at 225 million prescriptions dispensed, equating to 81.2 prescriptions per 100 persons. In addition, between 1999 and 2009, opioid misuse began to increase, and mortality rates involving pharmaceutical opioids rose nearly four times (Guy et al., 2017).
Opioid prescribing rates stabilized in 2012 and slowly declined over the next 5 years (Lyden & Binswanger, 2019). However, as providers attempted to control the overprescribing of pharmaceutical opioids, many patients turned to illicit (e.g., heroin) and synthetic opioids (e.g., fentanyl). Drug overdose is a leading cause of accidental death in the US, with opioids being the most common drug type (Schiller et al., 2022). In 2017, President Trump declared the opioid crisis a nationwide public health emergency, joining forces with the US Department of Health and Human Services (HHS, 2017) to increase grant funding toward developing novel strategies to impede this growing and deadly problem. These efforts have brought a new level of urgency to the matter, but the problem persists and must be addressed uniformly across the healthcare system. Nursing is the nation's largest healthcare profession, caring for more patients than any other profession, so nurses serve vital roles in this process. Nurses and nurse prescribers must understand the signs, symptoms, and treatment of acute and chronic pain and the signs and symptoms of misuse and abuse (Schiller & Mechanic, 2019). For more information, see the NursingCE course The Nurse's Role in the Opioid Epidemic.
Scope of the Problem: The Misuse of Controlled Substances
According to the Centers for Disease Control and Prevention (CDC), prescription medications are the second most abused category of drugs in the US, following marijuana. Opioids are a primary driver of drug overdose deaths, with more than 932,000 people dying from a drug overdose between 1999 and 2020 and over 263,000 deaths involving prescription opioids. Although opioid prescribing rates in the US have been declining since 2012, the amount of opioids prescribed is still 3 times higher than in 1999. In 2020, at least 91,799 people died from a drug overdose, a 31% increase in the age-adjusted rate of overdose deaths from 2019 (21.6 per 100,000) t
...purchase below to continue the course
According to the 2020 National Survey on Drug Use and Health conducted by the US HHS Substance Abuse and Mental Health Services Administration (SAMHSA):
more than 9.5 million people misused prescription opioids,
2.7 million had an opioid use disorder (OUD),
902,000 used heroin, and
103,000 tried heroin for the first time.
The most commonly misused medications were hydrocodone products; 64.6% of users reported misuse to manage physical pain, whereas 11.3% reported misuse to "feel good" or "get high." Regarding how the medication was acquired, more than 47.2% of respondents reported obtaining it through a relative or friend, whereas 42% had a valid prescription written by a licensed prescriber. The number of people who misused prescription pain relievers for the first time in 2020 was 1.2 million, representing an average of 3,288 per day (SAMHSA, 2021).
An estimated 252 people die daily from opioid overdose, and these numbers continue to rise. Data across the US indicate that West Virginia (WV) has the nation's highest age-adjusted mortality rate due to drug overdose. WV has 52.8 deaths per 100,000 individuals, followed by Delaware (48 per 100,000), the District of Columbia (43.2 per 100,000), Ohio (38.3 per 100,000), Maryland (38.2 per 100,000), and Pennsylvania (35.6 per 100,000). According to the National Institute on Drug Abuse (NIDA), the mortality rate of overdose in WV is more than 3 times higher than the national average (14.6 deaths per 100,000). Considered the epicenter of the opioid epidemic, WV has the country's highest rate of past-year OUD—12.9 per 1,000—and the highest rates of opioid prescribers. In 2018, licensed prescribers wrote 69.3 opioid prescriptions for every 100 persons, compared to the average US rate of 51.4 prescriptions per 100 (CDC, 2021a, 2022a; Merino et al., 2019; NIDA, 2020c).
Risk Factors for Potential Misuse/Abuse
The progressive rise in prescription drug misuse/abuse across the US is a byproduct of the complex interplay of many contributors. However, the CDC credits the increased prescribing of opioid analgesics as the most dominant contributing factor to the significant increase in drug availability and misuse/abuse potential. According to the HHS, additional societal and environmental factors include aggressive marketing by the pharmaceutical industry, the explosion of illegal web-based pharmacies that disseminate these medications without proper prescriptions and surveillance, and greater social acceptability for medicating a growing number of conditions (CDC, 2021b; HHS, 2019).
Personal risk factors for potential drug misuse/abuse include untreated psychiatric disorders, younger age, past or current substance abuse (including alcohol and tobacco use), family history of drug abuse, and family or societal environments that encourage these behaviors. While prescription drug abuse can happen at any age, it more commonly begins in teens or young adults. However, opioid mortality is higher in middle-aged people with comorbid substance abuse and psychiatric conditions. Prescription drug abuse in older adults 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, 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. Obtaining a copy of the patient's records from previous providers is advised whenever possible. A review of systems (ROS) should include questions related to controlled substance use and any side effects, such as nausea, constipation, cognitive changes, or other impairments. Next, a thorough and consistent pain assessment should be performed, including pain severity rating, location, quality, duration, treatment history, and aggravating/alleviating factors. Since pain severity is subjective, it is ideal to consistently use one tool to evaluate pain during each visit to allow for more accurate trend identification. The most commonly used tools for pain include the verbal rating scale (which allows patients to choose from 3-6 adjectives to describe their pain ranging from no pain to severe pain), a numerical rating scale (which allows patients to select a number between 0 and 10), a picture scale (uses multiple facial expressions indicating increasing levels of discomfort), and a visual analog scale (VAS; Hudspeth, 2016a; NIDA, 2017a).
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. The patient's history regarding drug and alcohol use should include past or present use of tobacco, alcohol, illicit drugs, and the misuse/abuse of any OTC or prescription medications in the past, including details such as timing, duration, drug of choice, treatment obtained, and pending legal decisions (Hudspeth, 2016a; NIDA, 2017a).
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. The Beck Depression Inventory (BDI), the 9-Item Patient Health Questionnaire Depression Module (PHQ-9), and the Profile of Mood States are helpful for depression screening among chronic pain patients. In addition, all patients being considered for chronic opioid therapy should first undergo screening for risk of substance misuse using an opioid abuse risk assessment tool (see Table 2 below). These tools can help guide patient stratification according to risk level and inform the appropriate degree of structure and monitoring required in the treatment plan. Also, patients who have been taking opioids for extended periods should be routinely screened using appropriate tools (Hudspeth, 2016a; NIDA, 2017a).
Regardless of the tool chosen, prescribers must be trained correctly in its execution and interpretation. As outlined earlier in this module, a high-risk screening score and/or the presence of additional risk factors should alert prescribers to consider patient referral to specialty care, such as a pain management clinic, a higher-skilled facility, or a medical group with more extensive experience and expertise in treating pain in complex, higher-risk patients (Hudspeth, 2016b; NIDA, 2017a, 2017b).
WV SEMP guidelines also advise patients to undergo a urine drug test (UDT) at baseline and monitor compliance with prescribed medications if diversion or misuse is suspected. UDT can be a helpful tool but is imperfect as false positives can happen. Hydration, drug dosage, metabolism, body mass index (BMI), urine pH, duration of use, and individual drug pharmacokinetics can affect the results. Manufacturer impurities have shown hydrocodone (Vicodin, Lortab, Norco) amounts in oxycodone products. Poppy seeds or the herb Papaveris fructus may cause a false-positive morphine result. A negative result for a prescribed drug could indicate the patient was not taking the drug (at the correct dose or at all) or yield false results. A positive result for an unexpected medication could mean the patient took the drug illicitly, it is a metabolite of another prescribed drug, or the positive result was false. For female patients, consider screening for pregnancy concurrently via a single urine sample/specimen. The urine drug screening/testing results must be available before or at the point of treatment decisions (Hudspeth, 2016b; WV SEMP, 2016).
Finally, a complete physical exam must be performed and documented appropriately before any prescriptions are written, and exams should be done periodically throughout the treatment course. A physical examination is required in WV before prescribing all controlled substances, as a valid practitioner-patient relationship must be established. Under §60A-2-206 of House Bill 2768 (passed March 9, 2019), a practitioner must conduct and document the results of a physical examination every 90 days for any patient for whom they continue to treat with any Schedule II opioid drug. The physical examination should be relevant to the specific diagnosis and course of treatment. It should assess whether maintaining the course of treatment would be safe and effective for the patient. Furthermore, in WV, a pharmacist has the right to refuse to dispense a prescribed drug based on a reasonable belief that there is no practitioner-patient relationship (Hudspeth, 2016a; West Virginia Legislature, 2019).
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 PDMP is housed and operated by a state regulatory, administrative, or law enforcement agency. The housing agency disseminates information from the database to individuals who are authorized to receive the information for purposes identified by state law. States arrange individual systems to track and monitor prescriptions, but the details about use, access, drug inclusion, and the regulations and implications for prescribers vary greatly. Most states also have a method to access the patient's records in other or neighboring states (CDC, 2021c).
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. States differ in how frequently providers are mandated to monitor this system and which controlled substances are included. Reporting systems help reduce the diversion of illegitimate opiate prescriptions (CDC, 2021c).
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)
The statute cites an exemption for patients treated for cancer-induced pain and pain associated with a terminal illness. Since the CSAPP system complies with HIPAA Privacy and Security Rules, access is granted only to prescribers and dispensers who have been credentialed and agree to confidentiality requirements for access to and use of the information. For WV, this includes physicians, pharmacists, dentists, veterinarians, physician assistants, advanced practice nurses, other prescribers and dispensers, and opioid antagonist/non-control reporting users or provider delegates (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 (Hudspeth, 2016b; WV SEMP, 2016).
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. Prescribers should explain how the test results will be interpreted, confirmed, and used, including their effects on the continuation of treatment. The cost of UDT should also be considered, discussed with the patient, and included in the provider agreement. The risk of neonatal withdrawal syndrome during a potential pregnancy should also be included for female patients. The PPA can also establish informed consent, or there may be a separate document for informed consent. Regardless, informed consent must cover the nature of the specific drug prescribed, potential risks, benefits, and the desired outcomes and functional goals of treatment. The agreement should be updated if medications change during treatment. Most PPAs specify that the patient is expected to use a single prescriber for all their controlled substance needs, but some may limit the patient to one prescriber for pain medicine (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. Interviews with family members and caregivers can also be included in documentation records with a clear plan for resolution and/or future monitoring. All medical letters sent to patients should be included in the patient's medical record (EMR), and office staff should carefully document any phone calls made or received. Document every time PDMP reports are reviewed and any concerning findings. Any decision to terminate care needs to be documented thoroughly (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. Systemic corticosteroids do not have significant evidence to support their effectiveness or use and have substantial adverse effects, especially for diabetic patients (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. Opioid treatment should only be added when these treatments are deemed inadequate, and the potential benefits of opioids outweigh the risks (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. As with any new prescription medication, all current medications should be reconciled for potential interactions, and any medication allergies/sensitivities should be reviewed. 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 as compared to patients taking less than 20 MME/day. Fifty MME/day is about 50 mg of hydrocodone (Vicodin, Lortab, Norco) or 33 mg of oxycodone (Percocet) per day. Prescribers should become familiar with and maintain access to a calculator regularly to help determine a patient's current MME, change dosages, and transition between different medications using equivalent dosages. Several dose calculators are available free of charge online, including on the CDC and Centers for Medicare & Medicaid Services websites. Note that these calculators have their limitations and exceptions (CDC, 2021c; FSMB, 2017; Fudin et al., 2018).
To account for variability in the pharmacologic properties of each medication and patient individuality, extreme caution should be used to limit the risk of accidental overdose or underdose when changing opioids. Follow-up appointments should occur within 1-4 weeks of starting opioids or dose increases to assess benefits and any harms; once a patient is stable, follow-up visits can occur every 3 months. If risks or harms outweigh benefits at any point, opioids should be tapered to a lower dose or gradually discontinued, and other treatments should be optimized (CDC, 2016; Manchikanti et al., 2017).
If methadone (Methadose, Dolophine) is used, the prescriber must be able to provide evidence of appropriate education to manage this drug. The half-life of methadone is significantly longer than morphine (8-59 hours), with lipophilic storage, so great care should be taken with this drug to treat pain safely. Its low cost and ease of availability often make methadone (Methadose, Dolophine) an attractive option if used carefully by a skilled and experienced prescriber. In WV, nurse practitioners, physician assistants, and physicians can certify patients for medical marijuana. Patients must have documentation of a qualifying diagnosis, such as severe chronic pain or opioid use disorder. Prescribers must have a valid state license and DEA registration number, complete a 4-hour state-approved course in medical marijuana and then register with the state to certify patients. Patients are diagnosed and certified by a registered prescriber and then must register with the WV State Department of Health to obtain a registry ID card to purchase medical marijuana products. This pain control option may help limit the use of opioids, even for patients with acute or postoperative pain (Hudspeth, 2016b).
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. The side effect profiles can be especially devastating in this population. Some guidelines recommend topical NSAIDs for localized osteoarthritis (e.g., knee osteoarthritis) over oral NSAIDs for patients aged 75 years and older to minimize systemic effects (CDC, 2016; Ho et al., 2018).
When less harmful alternative pharmacological and nonpharmacological modalities are ineffective, the CDC's best practice opioid guidelines encourage prescribers to initiate therapy with controlled substances at the lowest possible dose and gradually increase only as needed (i.e., "start low and go slow"). For older adults receiving opioids, it is also advised to initiate a bowel program to prevent constipation. The 2015 American Geriatrics Society Beers Criteria (BC) of potentially inappropriate medication use in older adults advocates avoiding certain drugs in this population (CDC, 2016). Included in the most recent version are the following critical recommendations (American Geriatrics Society Beer Criteria Update Expert Panel, 2019):
Benzodiazepines should be avoided for insomnia, agitation, or delirium due to the associated fall risk and high rate of physical dependence.
Non-benzodiazepine, benzodiazepine receptor agonist hypnotics (eszopiclone [Lunesta], zaleplon [Sonata], zolpidem [Ambien]) should be avoided for insomnia.
Opioids should be avoided for those with a history of falls or fractures.
Antipsychotic drugs should be avoided as a first-line treatment for delirium unless the patient is a threat to self or others due to the increased risk of stroke and mortality in the elderly with dementia and olanzapine (Zyprexa) syncope.
Tricyclic antidepressants and skeletal muscle relaxants (cyclobenzaprine, [Flexeril] carisoprodol [Soma]) should be avoided or used with caution secondary to anticholinergic effects.
Indomethacin (Indocin, Tivorbex) and ketorolac (Toradol, PO/IV) should be avoided due to the risk of gastrointestinal (GI) bleeding and kidney damage; instead, use celecoxib (Celebrex), nabumetone (Relafen), naproxen (Aleve, Naprosyn, Vimovo), or ibuprofen (Advil, Motrin) in combination with a proton pump inhibitor for GI prophylaxis.
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. In 2014, the FDA removed the older system of ranking medications for pregnant women (Categories A, B, C, D, and X) and now requires specific information about pregnancy safety (including during labor and delivery), safety while breastfeeding, and safety for females and males of reproductive potential. Opioids are excreted in breast milk and increase the risk for CNS and respiratory depression in infants if taken by mothers while breastfeeding. These risks can be minimized by using the lowest effective dose to control pain. Regardless, every patient should be well informed of the potential risks before receiving any opioid or controlled substance prescriptions. 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; US FDA Center for Drug Evaluation and Research, 2020).
Special Considerations: Cancer Patients and End-of-Life Care
The treatment of cancer pain is highly complex, and each patient's disease prognosis, concurrent medications, and goals of care should be carefully considered for all decision-making. The treatment of pain within the specialty care of terminally ill patients does not typically conform to the aforementioned regulations. In the care of these patients, there is less concern for misuse, abuse, or addiction, allowing for a greater focus on effective pain relief. Concerns specific to these populations include overdose risk, respiratory depression, and potential loss of consciousness or hastening death. According to the National Consensus Project (NCP) for Quality Palliative Care clinical practice guidelines, medications should be increased gradually and only as tolerated, with the full consent of the patient or their proxy medical decision-maker/guardian or via an intact living will or advance directive. The patient and/or their caregivers should be fully informed of the potential risks of increased opioid doses. If the patient and their family prioritize pain relief over the length of life, the care team should accept and respect that decision. Generally, clinicians should never withhold needed pain medication from terminally ill patients for fear of hastening death if they have received informed consent from the patient to do so. Loss of consciousness should not be assumed to be caused directly by high doses of opioid painkillers for dying patients if those doses have been stable or slowly increasing, especially in chronic cancer pain (CDC, 2016; Hudspeth, 2016a; NCP for Quality Palliative Care, 2018).
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. A strong professional relationship with the network of local pharmacists can also aid prescribers in monitoring for altered, falsified, or otherwise suspicious-looking prescriptions. For patients, misuse and abuse can best be prevented by taking all medications exactly as prescribed and discussing any changes with the prescriber before making them (Hudspeth, 2016a; NIDA, 2020b).
Manufacturers of medications are studying and trialing various methods to make medications less vulnerable to abuse or misuse; these methods are called abuse-deterrent formulations (ADFs). ADFs include physical or chemical barriers to prevent dissolving, grinding, or crushing; agonist/antagonist combinations; aversive substances added that are released if the product is manipulated or taken in a way other than directed; delivery systems that are implanted or injected to release long-acting medication slowly; or new molecular entities/prodrugs that render a drug inactive unless it is taken orally. Additional regulations may prevent misuse or abuse. For example, in 2014, hydrocodone (Vicodin, Lortab, Norco) was recategorized as a Schedule II drug by the DEA. Research is ongoing regarding targeting alternative pathways, such as the endocannabinoid system. Further research is needed on the effective treatment of chronic pain and risk factors for SUD (Hudspeth, 2016b; 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 (US FDA Center for Drug Evaluation and Research, 2020).
In WV, statewide take-back events have been promoted and scheduled regularly to accept expired, unused, and unwanted medication (Product Stewardship Institute, 2019). WV also created the Dispose Responsibly of Prescriptions (DRoP) program, which provides permanent drug drop boxes to law enforcement agencies across the state to reduce the public's access to unused prescription medication (Office of Inspector General [OIG], 2019).
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).
The COMM tool (see Table 2) is a 17-item questionnaire for patients currently being prescribed opioids or other controlled substances. It formally and objectively assesses for signs and symptoms of abuse, psychiatric disorders, deceitfulness, noncompliance, and high-risk behavior patterns. In all cases, surveillance of controlled substance users should also include regular monitoring of the state's PDMP, UDT, and pill counts. These monitoring methods should be clearly defined in the PPA and explained to the patient. Finally, an open, face-to-face conversation between the prescriber or another member of the healthcare team and the patient regarding their pain, treatment plan, and current medication usage—along with an invitation for questions or concerns using open-ended questions and non-judgmental language—is crucial for patient screening. Data support the prescribing or offering of naloxone (Narcan) as a potential overdose-reversal agent. This is appropriate for high-risk patients exhibiting disturbing signs of drug misuse. Additionally, careful consideration should be made regarding a referral to a pain management center or an addiction specialist for high-risk patients. If not, documentation about why this was not done needs to be thorough. If treatment will be transferred to another prescriber, or if medication will be tapered and stopped safely, this information needs to be communicated directly to the patient with a full explanation and detailed documentation in the patient's chart (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. According to the FSMB (2017), continuation, modification, or termination of opioid therapy for pain is contingent on "the clinician's evaluation of (1) evidence of the patient's progress toward treatment objectives and (2) the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion" (p. 11).
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. The PPA plays a critical role in this process, so termination must be addressed comprehensively in the initial contractual agreement and updated accordingly. Termination always carries the risk of exposing the patient to severe pain (Perfolizzo et al., 2019).
For acute pain, the WV SEMP guidelines encourage providers to help patients develop and identify functional SMART (specific, measurable, attainable, realistic, and timely) goals. Developing end-of-therapy goals for pain based on the expected time frame of the healing process (i.e., postoperative pain) reduces the potential for misuse/abuse and long-term issues. For chronic pain management, functional goals are often more difficult since the resolution of the syndrome, or the elimination of pain, is not expected to occur. However, reasons for the potential termination of therapy should be part of the treatment plan. Termination should be discussed at three stages of treatment: during the initial consultation (and when devising the PPA), during treatment, and before ending the intervention (WV SEMP, 2016).
Strategies for termination of COT include the following (Perfolizzo et al., 2019):
Establish open, honest communication and dialogue with the patient from the point of the initial consultation.
Comprehensively address termination in the informed consent and PPA process and readdress or refer to them as necessary during therapy.
Set SMART goals at the beginning of treatment.
Balance clinical judgment and individualization; incidents or events that cause concern regarding a pain agreement need to be interpreted in context.
Opioid taper: Tapering should be performed after a discussion with the patient. There are multiple ways to taper a patient; generally, the longer a patient has been on opioids, the longer a successful taper will take.
Avoid terminating the relationship when a patient is in crisis without a referral to a specialized facility and a warm handoff to the receiving provider. If a patient is terminated while in crisis, it could reasonably be considered abandonment and escalate negative behaviors.
As part of the termination preparation process, each patient should be given information about other resources (e.g., community resources, support groups, nonpharmacological pain modalities) with appropriate documentation.
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. Some programs may also include incentives for compliance, while family or group therapy expands the focus to include interpersonal relationships and life skills. Medications used in opioid abuse disorder treatment can alleviate withdrawal symptoms and limit cravings, thus helping limit the risk of relapse (SAMHSA, 2022b). Medication options for opioid use disorders are as follows (SAMHSA, 2022b):
Buprenorphine (Buprenex, Sublocade) is a partial opioid agonist (binds to receptors but only partially activates) used to reduce cravings. Prescribers must be certified to prescribe; implantable or once-monthly injections available.
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 for 7-10 days before starting.
Studies regarding the best methodology for MAT continue, including exploring the administration of long-acting buprenorphine (Buprenex, Sublocade) to overdose patients in EDs and the application of MAT programs among incarcerated populations. In 2016, the opportunity to undergo the required training for a prescribing waiver for buprenorphine (Buprenex, Sublocade) was extended to NPs and PAs nationally. The waiver requires 24 hours of training, and additional details for interested providers can be found on the SAMHSA website. Prescribers and the public can also search for authorized prescribers by the state through the SAMHSA website. Currently, 420 authorized buprenorphine (Buprenex, Sublocade) prescribers are in WV (SAMHSA, 2022a).
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. Treatment with the same behavioral therapies, including CBT, is effective for patients recovering from CNS depressant or stimulant addiction. Unfortunately, while research continues, there are currently no FDA-approved medications for treating CNS depressant or stimulant addiction (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. While naloxone (Narcan) is an effective opioid antagonist, it has no reversal effect on tramadol (Ultram), alcohol, CNS depressants, or stimulants. If this medication is ineffective after two doses, other explanations for the patient's symptoms should be explored and considered, including benzodiazepine overdose, and other treatments, such as flumazenil (Romazicon, a benzodiazepine antagonist), should be attempted (CDC, 2019; FDA, 2020).
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. Prescribers should consider this safety option for patients currently taking a high dose of opioids (over 90 MME/day), chronic opioids (over 3 months), concurrent opioids and benzodiazepines, current ongoing treatment for a drug use disorder, a history of opioid misuse or overdose, or immediate family members with a history of opioid misuse or overdose. A naloxone (Narcan) prescription should also be considered during periods of transition from one opioid to another in case of accidental overdose. Patients in secluded rural settings; with chronic respiratory disease, current alcohol use, renal disease, hepatic disease, cardiac disease, or HIV/AIDS; or on depression/antidepressant medication should also be considered good candidates for naloxone (Narcan) rescue prescriptions. Naloxone (Narcan) prescriptions should also be granted to caregivers who request them. Patients, as well as their family members and caregivers, must be educated on the signs/symptoms of an opioid overdose, such as snoring or choking sounds, shallow respirations, unresponsiveness, bradycardia, hypotension, and pale, clammy skin that may appear blue or gray. While naloxone does cross the placenta, no adverse effects have been noted in animal studies, and the benefits of overdose reversal are thought to outweigh the risks. Researchers have not determined whether naloxone is excreted in breast milk (CDC, 2019; FDA, 2020). In 2015, the WV legislature passed Senate Bill 335, making naloxone (Narcan) available to first responders and relatives, friends, caregivers, or others in a position to assist someone at risk of experiencing an opiate-related overdose (OIG, 2019).
Specific Rules and Regulations for West Virginia
To mitigate the opioid epidemic, WV passed the Governor's Substance Abuse Prevention Bill (SB 437) in 2012, mandating that all healthcare providers who prescribe, dispense, or administer controlled substances must participate in continuing education related to prescription drug abuse and drug diversion. According to Rule WV 19 CSR 11, nurses licensed in the state must obtain three contact hours initially, followed by one contact hour yearly, to fulfill this legislative requirement (West Virginia RN Board, n.d.). West Virginia Code Chapter 60A governs the prescribing, dispensing, and consumption of controlled substances. This law establishes the standards for controlled substance prescribing, including reporting system requirements for prescribers and pharmacists in WV. The Rules and Regulations on Controlled Substances in West Virginia (Chapter 60A) specify the following (OIG, 2019):
Practitioners shall maintain a written record of all controlled substance prescriptions and a medical record for all patients receiving controlled substances. This record must include patient identification data, their chief concern, present illness, and physical examination as indicated (which must be completed prior to any prescriptions being issued but may have been performed by a consulting physician or hospital when records are available for review by the prescriber), diagnosis, data which support the diagnosis or treatment, and the treatment regimen (i.e., amount, strength, and directions for the use of any controlled substances).
All practitioners who prescribe or dispense Schedule II, III, or IV controlled substances must register with the controlled substance monitoring program, and practitioners must document the information obtained from the CSMP search in the patient's medical record.
All prescribers must check the CSMP database when issuing an initial prescription. If a prescriber continues to treat a patient with a controlled substance, the prescriber must continue to monitor the CSMP database at least annually. Physicians and other licensed pain management clinic practitioners must check the CSMP database when issuing an initial prescription and at least every 90 days.
Before prescribing any medications in WV, all practitioners must perform a physical examination and establish a valid practitioner-patient relationship.
All prescribers must follow the tamper-resistant (TR) forms law to prevent the use of fraudulent prescriptions to obtain controlled substances.
According to the Opioid Reduction Act of 2018 (West Virginia Code § 16-54-1), prescribers must do the following:
Discuss the risks associated with opioid use and discuss alternatives to opioid therapy (i.e., physical therapy, massage).
Limit the number of opioids prescribed as follows:
Do not issue more than a 4-day opioid supply within an ED or an urgent-care setting; prescribers in urgent-care settings may issue an additional 7-day prescription with a documented medical rationale for exceeding the 4-day supply limit
Adults receiving an initial opioid prescription in an ED are limited to a 4-day supply of opioid medication.
Minors in the ED are limited to a 3-day supply, and the ED physician must explain the risks of addiction to the patient's parents.
Private practices are limited to prescribing a maximum 7-day supply at the lowest effective dose that, in the physician's best medical judgment, represents the best course of treatment.
Dentists and optometrists are limited to prescribing a 3-day supply of opioid pain medicine.
As of 2015, licensed healthcare providers may prescribe an opioid antagonist to first responders, individuals at risk of overdose, and relatives and friends of individuals at risk of overdose. Providers dispensing opioid antagonists must provide educational materials on overdose prevention, treatment programs, and the administration of opioid antagonists.
According to the West Virginia Board of Pharmacy (WVBOP), which governs the prescribing of controlled substances and outlines the prescriptive authority of APRNs, the following standards are required (WVBOP, 2022; West Virginia Legislature, 2022):
APRNs will be granted prescriptive authority once they meet eligibility requirements, which include:
successful completion of an advanced pharmacotherapy graduate-level course with at least 45 contact hours of pharmacology
documentation of the use of pharmacotherapy in clinical practice during their educational program
evidence of 15 graduate-level pharmacology contact hours within 2 years before the application for prescriptive authority
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.
Each prescription and subsequent refills given by the APRN shall be documented in the patient's chart.
All prescriptions shall include the following information: name, title, address, and phone number of the prescriber; name and date of birth of the patient; date of the prescription; full name of the drug, the dosage, the route of administration, and directions for its use; the number of refills; DEA number of the prescriber (when required by federal law); and the prescriptive authority identification number issued by the board.
An APRN shall, at the time of the initial prescription, record the plan for continued evaluation of the effectiveness of the controlled substances prescribed.
An APRN shall prescribe refills of controlled substances according to current laws and standards.
References
American Geriatrics Society Beers Criteria Update Expert Panel. (2019). American Geriatrics Society 2019 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society, 67(4), 674-694. https://doi.org/10.1111/jgs.15767
Baker, D. W. (2017). History of the joint commission's pain standards. JAMA, 317(11), 1117-1118. http://doi.org/10.1001/jama.2017.0935
Centers for Disease Control and Prevention. (2016). CDC guideline for prescribing opioids for chronic pain – United States, 2016. https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
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). America's drug overdose epidemic: Data to action. https://www.cdc.gov/injury/features/prescription-drug-overdose/index.html
Centers for Disease Control and Prevention. (2021c). Prescription drug monitoring programs (PDMPs). https://www.cdc.gov/drugoverdose/pdmp/states.html
Centers for Disease Control and Prevention. (2022a). Drug overdose deaths. https://www.cdc.gov/drugoverdose/data/statedeaths.html
Centers for Disease Control and Prevention. (2022b). Prescription opioids. https://www.cdc.gov/drugoverdose/deaths/prescription/overview.html
Drug Enforcement Administration. (n.d.). Diversion control division. US Department of Justice. Retrieved June 6, 2022, from https://www.deadiversion.usdoj.gov/prog_dscrpt/index.html
Federation of State Medical Boards. (2017). Guidelines for the chronic use of opioid analgesics. https://www.fsmb.org/siteassets/advocacy/policies/opioid_guidelines_as_adopted_april-2017_final.pdf
Fudin, J., Raouf, M., Wegrzyn, E. L., & Schatman, M. E. (2018). Safety concerns with the Centers for Disease Control opioid calculator. Journal of Pain Research, 11, 1–4. http://doi.org/10.2147/JPR.S155444
Guy, G. P., Zhang, K., Bohm, M. K., Losby, J., Lewis, B., Young, R., Murphy, L. B., & Dowell, D. (2017). Vital signs: Changes in opioid prescribing In the United States, 2006-2015. Morbidity and Mortality Weekly Report, 66(26), 697-704. http://doi.org/10.15585/mmwr.mm6626a4
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
Hudspeth, R. S. (2016a). Safe opioid prescribing for adults by Nurse Practitioners: Part 1. Patient history and assessment standards and techniques. The Journal for Nurse Practitioners, 12(3), 141-148. https://doi.org/10.1016/j.nurpra.2015.10.012
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
Lyden, J., & Binswanger, I. A. (2019). The United States opioid epidemic. Seminars In Perinatology, 43(3), 123-131. https://doi.org/10.1053/j.semperi.2019.01.001
Manchikanti, L., Kaye, A. M., Knezevic, N. N., McAnally, H., Slavin, K., Trescot, A. M., Blank, S., Pampati, V., Abdi, S., Grider, J. S., Kaye, A. D., Manchikanti, K. N., Cordner, H., Gharibo, C. G., Harned, M. E., Albers, S. L., Atluri, S., Aydin, S. M., Bakshi, S., . . . Hirsch, J. A. (2017). Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician, 20(2S), 3-92. https://pubmed.ncbi.nlm.nih.gov/28226332
Merino, R., Bowden, N., Katamneni, S., & Coustasse, A. (2019). The opioid epidemic in West Virginia. The Health Care Manager, 38(2), 187-195. https://doi.org/10.1097/HCM.0000000000000256
National Consensus Project for Quality Palliative Care. (2018). Clinical practice guidelines for quality palliative care (4TH ed.). https://www.nationalcoalitionhpc.org/wp-content/uploads/2018/10/NCHPC-NCPGuidelines_4thED_web_FINAL.pdf
National Institute on Drug Abuse. (2017a). Improving opioid prescribing. National Institutes of Health. https://nida.nih.gov/publications/improving-opioid-prescribing
National Institute on Drug Abuse. (2017b). Other opioid prescribing resources. National Institutes of Health. https://www.drugabuse.gov/nidamed-medical-health-professionals/tool-resources-your-practice/other-opioid-prescribing-resources
National Institute on Drug Abuse. (2020a). Drugs, brains, and behavior: The science of addiction. National Institutes of Health. https://www.drugabuse.gov/publications/drugs-brains-behavior-science-addiction/drug-misuse-addiction#footnote
National Institute on Drug Abuse. (2020b). Misuse of prescription drugs. National Institutes of Health. https://www.drugabuse.gov/publications/misuse-prescription-drugs/overview
National Institute on Drug Abuse. (2020c). West Virginia: Opioid-involved death and related harms. National Institutes of Health. https://nida.nih.gov/download/21991/west-virginia-opioid-involved-deaths-related-harms.pdf
Office of Inspector General. (2019). Factsheet: West Virginia's oversight of opioid prescribing and monitoring of opioid use. https://oig.hhs.gov/oas/reports/region3/31803302_Factsheet.pdf
Pain Assessment and Management Initiative. (2019). Pain management & dosing guide. https://com-jax-emergency-pami.sites.medinfo.ufl.edu/wordpress/files/2019/06/PAMI-Dosing-Guide-July-2019.pdf
Perfolizzo, J. V., Varrassi, G., Paladini, A., & LeQuang, J. (2019). Stopping or decreasing opioid therapy in patients on chronic opioid therapy. Pain and Therapy, 8(2), 163-176. https://doi.org/10.1007/s40122-019-00135-6
Product Stewardship Institute. (2019). What to do with leftover medicines – West Virginia. https://www.productstewardship.us/page/1045
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
Schiller, E. Y., Goyal, A., & Mechanic, O. J. (2022). Opioid overdose. StatPearls [Internet]. https://www.ncbi.nlm.nih.gov/books/NBK470415/
Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States: Results from the 2020 national survey on drug use and health. https://www.samhsa.gov/data/report/2020-nsduh-annual-national-report
Substance Abuse and Mental Health Services Administration. (2022a). Buprenorphine practitioner locator. https://www.samhsa.gov/medication-assisted-treatment/find-treatment/treatment-practitioner-locator
Substance Abuse and Mental Health Services Administration. (2022b). Medication-assisted treatment (MAT). https://www.samhsa.gove/medication-assisted-treatment
US Department of Health and Human Services. (2017). HHS acting secretary declares public health emergency to address national opioid crisis. https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html
US Department of Health and Human Services. (2019). Pain management best practices inter-agency task force report: Updates, gaps, inconsistencies, and recommendations. https://www.hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf
US Department of Health and Human Services. (2021). What is the US opioid epidemic? https://www.hhs.gov/opioids/about-the-epidemic/index.html
US Food and Drug Administration. (2020). New recommendations for naloxone. https://www.fda.gov/drugs/drug-safety-and-availability/new-recommendations-naloxone
US Food and Drug Administration Center for Drug Evaluation and Research. (2020). Drug safety and availability: Medication guides. https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
Webster, L. R. (2017). Risk factors for opioid-use disorder and overdose. Anesthesia Analgesia, 125(5), 1741-1748. https://doi.org/10.1213/ANE.0000000000002496
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. (2019). Committee substitute for house bill 2768 [passed March 9, 2019; in effect ninety days from passage]. http://www.wvlegislature.gov/Bill_Text_HTML/2019_SESSIONS/RS/bills/HB2768%20SUB%20ENR.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
West Virginia RN Board. (n.d.). Education. Retrieved June 7, 2022, from https://wvrnboard.wv.gov/education/Pages/default.aspx#rnedrequirements