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

C (2019b) credits the increased prescribing of opioid analgesics as the most dominant contributing factor for the significant increase in drug availability, and in turn, misuse/abuse potential. According to the HHS (2019), 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, as well as greater social acceptability for medicating a growing number of conditions (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, as well as family or societal environments that encourage these behaviors (Webster, 2017). While prescription drug abuse can happen at any age, data reveals it more commonly begins in teens or young adults. However, in contrast, opioid mortality prevalence is higher in those who are middle-aged with comorbid substance abuse and psychiatric conditions (SAMSHA, 2018). 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 heighten the risk within this population (NIDA, 2018b). 

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

Controlled Substances: The Basics

According to NIDA, (2018a), three classes of medication that are most commonly misused include opioids, central nervous system (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 central nervous system 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 cough.  There are synthetics, such as fentanyl, or naturally-derived opioids from the opium poppy plant.  Tramadol 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 cough, either alone or in combination with acetaminophen, or within cough and cold formulas.  According to the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (2018), 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 U.S.
• Oxycodone (Percocet, Oxycontin): available as immediate or extended-release formula, fast onset.
• Morphine sulfate (IR, MSContin): available as an immediate or extended-release formula, PO/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 lasts 72 hours, also available as IV.

Adverse reactions of opioid use include respiratory depression, drowsiness, mental confusion, nausea/vomiting, dizziness, headache, fatigue, pruritus, pinpoint pupils, urinary retention, and constipation. Since these drugs can induce euphoria, especially when taken in higher doses than prescribed or ingested via snorting or injection, they are a high risk for abuse and addiction. Long-term, there exists a risk of developing drug tolerance and hyperalgesia, which is increased sensitivity to pain caused by damage to nociceptors or peripheral nerves (U.S. FDA Center for Drug Evaluation and Research, 2018). 

CNS depressants refer to a class of drugs that include tranquilizers, sedatives, and hypnotics, and are often used to treat anxiety and sleep disorders. CNS depressants inhibit 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] or estazolam [Prosom]). In general, this group requires great caution and is indicated for short-term use only due to the very 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 two groups of drugs (NIDA, 2018a).  

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, thought to result in fewer side effects and less risk of dependence. These medications can cause headaches, amnesia, dizziness, and nightmares. Melatonin is a safer option for insomnia, as it is an over-the-counter supplement that boosts the levels of the body's natural sleep hormone. Ramelteon (Rozerem) is a prescription option that acts as a synthetic melatonin antagonist, binding to MT1 and MT2 receptors, helping to induce sleep without any abuse or addiction potential (NIDA, 2018a). 

For anxiety, pharmacologic options that are not controlled substances and therefore less risky include buspirone (Buspar), which binds to serotonin and dopamine D2 receptors. Buspirone is generally better tolerated than benzodiazepines, with less drowsiness and less 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. 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 off 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, a benzodiazepine antagonist, flumazenil (Romazicon) may be administered via an IV by emergency medical personnel (NIDA, 2018a).

Stimulants, such as methamphetamine, dextroamphetamine (Adderall and Dexedrine) and methylphenidate (Ritalin and Concerta) are classified as schedule II medications. They function by enhancing the effects of the neurotransmitters norepinephrine and dopamine in the brain. This leads to increased alertness, attention, motivation, cognition, and energy.  Stimulants can further induce vascular constriction leading to increased heart rate, increased blood pressure, increased respiratory rate, dilated airway, jitters, increased blood glucose, and sleep disturbance. When misused, these drugs can cause euphoria related to the increased dopamine activity in the brain.  Abruptly stopping a stimulant can cause a withdrawal 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, 2018a).

Guidelines for Safe Prescribing Practices 

One of the most difficult challenges for prescribers is to distinguish between the legitimate prescription of controlled substances versus illegitimate purposes (Webster, 2017). Given the unique risks associated with controlled substance use, misuse, and potential drug interactions, all providers must adhere to best practice prescribing guidelines (Hudspeth, 2016a). The West Virginia Expert Pain Management Panel Safe & Effective Management of Pain Guidelines (WV SEMP, 2016) serve as an extension of 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 regarding the use of controlled substances amid the rising opioid epidemic (CDC, 2016; WV SEMP, 2016).

Risk Reduction and Screening 

Treatment must begin with a comprehensive history and physical, including detailed assessment specific to pain.  It should include a full list of current and past medical conditions, current medications, and how they are taken. It is advised to obtain a copy of the patient’s records from previous providers whenever possible.  A review of systems should include questions related to controlled substance use and any side effects, such as nausea, constipation, cognitive changes, or other impairments. 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 (allow patient to choose from three to six adjectives to describe their pain ranging from no pain to severe pain), a numerical rating scale (allow patient 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 (Hudspeth, 2016a).

Additional components of the history taking 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 over the counter or prescription medications in the past, including details such as timing, duration, drug of choice, treatment obtained, pending legal decisions, and so forth (Hudspeth, 2016a).  

Many patients with chronic pain also have a diagnosis of clinical depression and are twice as likely to commit 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 under- or untreated (Buhrman, 2015).  The Beck Depression Inventory (BDI), the 9-Item Patient Health Questionnaire Depression Module (PHQ-9) and the Profile of Mood States have been shown useful in the screening of chronic pain patients (Choi, 2014).

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. Patients who have been taking opioids for extended periods should also be routinely screened using appropriate tools (Hudspeth, 2016a).

Table 2: The WV SEMP Guideline Recommendations:

For Patients Being Considered for Opioid Therapy	For Patients Already Receiving Opioid Therapy
Opioid Risk Tool (ORT) 5-question self-administered tool that assesses personal/family history screens only for future risk of drug misuse and is designed for adult patients	Current Opioid Misuse Measure (COMM) Brief patient self-assessment to monitor chronic pain patients on opioid therapy
Drug Abuse Screening Test  (DAST-10) 10-item brief screening tool that can be completed in less than 8 minutes and assesses drug use in the past 12 months	Pain Medication Questionnaire (PMQ) 26-item self-report assessment to screen for opioid-medication misuse
Diagnosis, Intractability, Risk, & Efficacy Score  (DIRE) A tool designed to predict patients who will have "effective analgesia and be compliant" with opioid treatment; aims to determine suitability for long-term opioid use	Prescription Drug Use Questionnaire (PDUQ) 42-item screening tool developed to help recognize the addictive disease in chronic pain patients who use opioids; evaluates the pain condition, opioid use patterns, social and family factors, family history of pain and substance abuse syndromes, patient history of substance abuse, and psychiatric history

(CDC, 2016; WV SEMP, 2016)

Regardless of the tool chosen, prescribers must be trained correctly in its execution and interpretation. A high-risk screening score, and/or the presence of additional risk factors as outlined earlier in this module, should alert the prescriber to consider patient referral to specialty care. Refer the patient to a pain management clinic, or a higher-skilled facility or medical group with more extensive experience and expertise treating pain in complex, higher-risk patients (Hudspeth, 2016b; NIDA, 2017).

WV SEMP guidelines (2016) also advise that patients undergo a urine drug test (UDT) at baseline and to monitor for compliance of prescribed medications if diversion or misuse is suspected. UDT can be a useful tool but is imperfect as false positives can happen (WV SEMP, 2016). Hydration, drug dose, metabolism, BMI, urine pH, duration of use, and individual drug pharmacokinetics can all affect the results. Manufacturer impurities have shown hydrocodone (Vicodin, Lortab, Norco) amounts to be evident 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 all, not taking the correct dose, or the results are false entirely. A positive result for an unexpected medication could mean the patient was taking 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 timing of the urine drug screening/testing needs to be in line with the results being available before or at the point of treatment decisions (Hudspeth, 2016b).

Finally, a complete physical exam must be performed and documented appropriately before any prescriptions are written, and periodically throughout the treatment course (Hudspeth, 2016a).  The state of West Virginia specifies that a physical examination is required prior to the prescribing of all controlled substances, as a valid practitioner-patient relationship must be established prior. Under §60A-2-206 of House Bill 2768 (passed March 9, 2019), a practitioner is required to conduct and document the results of a physical examination every 90 days for any patient for whom he or she continues to treat with any Schedule II opioid drug. The physical examination should be relevant to the specific diagnosis and course of treatment and should assess whether maintaining the course of treatment would be safe and effective for the patient. Further, in West Virginia, a pharmacist has the right to refuse to dispense a prescribed drug if they have reason to believe that there is no practitioner-patient relationship (West Virginia Legislature, 2019).

Prescription Drug Monitoring Program

The vast majority of 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. The intent is to improve opioid prescribing, inform clinical practice, and protect patients at high risk.  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 under state law 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, which drugs are included, and the regulations and implications for prescribers vary greatly. Most states have a method by which you can access the patient's records in other or neighboring states as well as your own (CDC, 2017). 

The key to the efficacy of PDMP systems is the mandate that all providers 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. Differences exist between the states regarding how frequently providers should monitor this system, and which controlled substances are included. Reporting systems help reduce the diversion of illegitimate opiate prescriptions (CDC, 2017).

West Virginia Monitoring Program

In 2013, West Virginia launched the RxDataTrack Controlled Substance Automated Prescription Program (CSAPP). The CSAPP is an online, Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant database that allows for the tracking and review of controlled substance prescription history, as a means 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 West Virginia must provide the dispensing information to the West Virginia Board of Pharmacy (BOP) each 24-hour period basis.”  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 West Virginia Controlled Substances Monitoring Program and maintain access;
• Access the CSAPP at defined intervals: upon initially prescribing or dispensing any pain-relieving controlled substance for a patient, and at least annually thereafter;
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  • Physicians working in pain management clinics are required to check the CSAPP at the initiation of controlled substance therapy and a minimum of every 90 days thereafter (WVBOP, 2019).

The statute cites an exemption for patients being treated for cancer-induced pain and pain associated with a terminal illness. As the CSAPP system is compliant with HIPAA Privacy and Security Rules, access is granted only to those prescribers and dispensers which have been credentialed and agree to confidentiality requirements for access to and use of the information. For West Virginia, this includes physicians, pharmacists, dentists, veterinarians, physician assistants, advanced practice nurses, other prescribers and dispensers, as well as 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 expectation of treatment. The tool promotes collaboration and mutual commitment from both parties, sets realistic expectations with measurable functional goals for therapy, and also states reasons in which the agreement may be terminated (WV SEMP, 2016). 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/household contacts/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 to be performed periodically, this should be included in the PPA, as well as how medication refills and changes should be requested and obtained by the patient and handled by the office staff and providers. The prescriber should explain how the results of the test will be interpreted, confirmed, and used, including its effects on the continuation of treatment.  The cost of UDT should also be considered, discussed with the patient, and included in the provider agreement.   If female, the risk of neonatal withdrawal syndrome if the patient were to become pregnant should also be included (Hudspeth, 2016b).  The PPA can also serve to establish informed consent, or there may be a separate document for informed consent. Regardless, informed consent must include the nature of the specific drug prescribed, potential risks, benefits, as well as the desired outcomes and functional goals of treatment. The agreement should be updated when medications are changed during treatment. Most PPAs specify that the patient is expected to use a single prescriber for all of their controlled substance needs, but some may simply limit the patient to one prescriber for pain medicine (Hudspeth, 2016b).  

Documentation

Documentation is critical when prescribing controlled substances, both for safety and legal reasons. Documentation in the medical record should be clear, 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, as well as any adverse effects and related treatments.  Documentation should also specify if 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 for those same reasons with a clear plan for resolution and/or future monitoring (Pain Assessment and Management Initiative [PAMI], 2019).  Any letters sent to patients should be included in the patient’s medical record (EMR), and any phone calls made or received should be carefully documented by office staff.  Document every time PDMP reports are reviewed and any concerning findings. A decision to terminate care needs to be documented thoroughly (Hudspeth, 2016b).

Management of Acute and Chronic Pain 

To alleviate pain and suffering is one of the basic tenets of medical care since its inception. Pain can be broken down into two main categories, acute (<3 months) and chronic (>3 months); however, the treatment and management differ significantly. Acute pain is often self-limiting, and if non-pharmacological treatment can be used effectively, it is recommended over medication use.  Non-pharmacological treatments such as heat, ice, massage, acupuncture, or 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, acetaminophen (Tylenol), and/or skeletal muscle relaxants such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Vimovo), carisoprodol (Soma), and cyclobenzaprine (Flexeril) (Qaseem, Wilt, Mclean, & Forciea, 2017).  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 H2 blocker is gastroprotective for short-term use. Naproxen (Aleve, Naprosyn, Vimovo) and meloxicam (Mobic) appear to be the least risky options in terms of cardiovascular risk (Ho et al., 2018). Systemic corticosteroids do not have significant evidence to support their effectiveness or use and certainly have substantial adverse effects, especially in the diabetic patient (Qaseem et al., 2017).  

Other treatments often used successfully for pain include cognitive behavioral therapy, exercise therapy, and physical therapy (CDC, 2016). These treatments should be tried first or incorporated with any pharmacological treatment that is deemed appropriate. Additional nonopioid medications, such as gabapentin (Neurontim) 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 (PAMI, 2019). 

If opioids are prescribed for acute pain, CDC prescribing guidelines (2016) advise prescribers to limit the initial prescribing of opioids to between three and seven days. They also advise avoiding co-prescribing opioids and benzodiazepines due to the high risk of overdose when used together (CDC, 2016). The PDMP database should be reviewed initially for all patients receiving opioid prescriptions (Hudspeth, 2016a).  The initial opioid prescription should be considered a trial, with a follow-up appointment scheduled at a predetermined time to review effectiveness and success based on established treatment goals (CDC, 2016).  As with any new prescription medication, all current medications should be reconciled for potential interactions and any medication allergies/sensitivities reviewed. Due to increased risk for overdose and adverse effects, avoid combining opioids with benzodiazepines whenever possible (Qaseem et al., 2017). 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 stronger 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 two to four hours should be started initially with opioid-naive patients until the dose is stabilized. Dose adjustments may be necessary as often as every two to three days. Extended-release (ER) or long-acting (LA) formulas with a half-life of 8-12 hours in the same family are commonly added later if long-term use is required (PAMI, 2019).

According to the American Society of Interventional Pain Physicians (Manchikanti et al., 2017), chronic pain (excluding cancer patients and end-of-life care) treatment should always start with and include non-pharmacologic and nonopioid treatment options as above.  When initiating opioid therapy for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, it is highly recommended that the lowest dose possible is given; beginning with a short-acting opioid and/or rotating to a long-acting/extended-release, if indicated (FSMB, 2017). The lowest effective dose of immediate-release opioids should be used initially, avoiding ER or LA versions until a stable dosage has been established.  Primary care providers should reassess risks and benefits of treatment when prescribing more than 50 morphine milligram equivalents (MME) per day and should avoid (and carefully justify) prescribing more than 90 MME/day.  According to the CDC, the risk of overdose is increased by at least twice in patients taking 50 MME/day or more, as compared to patients taking < 20 MME/day. 50 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 (CDC, 2017).  Several dose calculators are available free of charge online, including the CDC website and the Centers for Medicare & Medicaid Services website. However, these calculators have their limitations and complicated exceptions (Fudin, Raouf, Wegrzyn, & Schatman, 2018).

Variations and exceptions need to be made to account for variability in the pharmacologic properties of each medication and patient individuality when changing from one opioid to another, and extreme caution should be used to limit the risk for accidental overdose or under dose. Follow-up appointments should occur within one to four weeks of starting opioids or dose increases to assess benefits and any harms, and once stable, every three months (CDC, 2016). If at any point, risks or harm outweigh benefits, opioids should be tapered to a lower dose or gradually discontinued and other treatments optimized (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.  However, the low cost and ease of availability often make methadone (Methadose, Dolophine) an attractive option if used carefully by a skilled and experienced prescriber (Hudspeth, 2016b). In West Virginia, nurse practitioners and physician assistants (along with doctors) can certify patients for medical marijuana. Patients must have documentation of a listed qualifying diagnosis, such as severe chronic pain, opioid use disorder, or as a replacement for opioids.  Prescribers must have a valid state license, DEA registration number, complete a four-hour state-approved course in medical marijuana, and then register with the state to participate and begin certifying patients. Patients are diagnosed and certified by a registered prescriber and then must register with the West Virginia 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 in patients with acute or post-operative pain (Haddy, 2017). 

Special Considerations: The Older Adult and Pregnant Patients

Special considerations should be applied when prescribing for populations at potentially higher risk for harm, including older adults (>65), those with renal or hepatic insufficiency, or those who are pregnant. While pain is more commonly reported in the elderly related to the natural aging processes and wear and tear on the human body, advancing age is often accompanied by physiological changes that affect the absorption, metabolism, and excretion of medications. In addition, older adults may be at increased risk for falls and fractures related to opioids, and clinicians are advised to consider a falls-risk when selecting and dosing potentially sedating medications such as tricyclics, anticonvulsants, or opioids (CDC, 2016). Clinicians should weigh risks and benefits of use, dose, and duration of agents such as acetaminophen (Tylenol) and NSAIDs when treating older adults, as the side effect profiles can be equally devastating in this population. Some guidelines recommend topical NSAIDs for localized osteoarthritis (e.g., knee osteoarthritis) over oral NSAIDs in patients aged ≥ 75 years to minimize systemic effect (Ho et al., 2018). 

When less harmful alternative pharmacological and non-pharmacological modalities are ineffective, the CDC (2016) best practice opioid prescribing guidelines encourage prescribers to initiate therapy with controlled substances at the lowest possible dose and gradually increased only as needed (start low and go slow). It is also advised when prescribing opioids to older adults to initiate a bowel program to prevent constipation (CDC, 2016). 

The 2015 American Geriatric Society Beers Criteria (BC) of potentially inappropriate medication use in older adults publishes medications that should be avoided (Terrery, 2016). Included in the most recent version are the following critical recommendations:

• Benzodiazepines should be avoided for insomnia, agitation, or delirium due to 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 in 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 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/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, replaced instead with celecoxib (Celebrex), nabumetone (Relafen), naproxen (Aleve, Naprosyn, Vimovo) or ibuprofen (Advil, Motrin) in combination with proton pump inhibitor for GI prophylaxis (Terrery, 2016).

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 of opioid use in pregnancy with congenital disabilities, including neural tube defects, congenital heart defects, preterm delivery, poor fetal growth, stillbirth, and potential for neonatal opioid withdrawal syndrome (CDC, 2016).  In 2014, the FDA removed the older system of ranking medications for pregnant women (Category A, B, C, D, and X), and now requires detailed 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 breastmilk and increase the risk for CNS and respiratory depression in the infant if taken by the mother while breastfeeding.  These risks can be minimized by using the lowest effective dose to achieve pain control. Still, the patient should be well informed of all of the potential risks before issuing any opioid or controlled substance prescriptions. Acetaminophen can be used in pregnancy and while breastfeeding relatively safely. NSAIDs should be avoided in pregnant patients, especially during the first trimester and after 30 weeks’ gestation, due to the risk of bleeding and premature ductal closure. NSAIDs appear safe to use during breastfeeding, however. Benzodiazepines were a category D and should be avoided in pregnant and breastfeeding patients, as they are known to cross the placenta and are excreted in breastmilk.  They have been shown to increase the risk of congenital abnormalities, primarily if used in the first trimester (US FDA Center for Drug Evaluation and Research, 2018).

Special Considerations: Cancer Patients and End-of-Life Care

The treatment of cancer pain is extremely complex, and the patient’s disease prognosis, concurrent medications, and individual goals of care should be carefully considered for all decision-making (Hudspeth, 2016b). The treatment of pain within the specialty care of terminally ill patients does not typically conform to the aforementioned standard regulations. Within the care of these patients, there is less concern for misuse, abuse, or addiction, and more focus can be placed on effective pain relief (CDC, 2016). Concerns within these populations continue to be an overdose, respiratory depression, and potential loss of consciousness or hastening of end-of-life. According to the National Consensus Project’s (NCP, 2018) Clinical Practice Guidelines for Quality Palliative Care, 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 caregivers should be fully informed of these potential risks of increased opioid doses. Still, if the patient and family prioritize pain relief over the length of life, that decision should be accepted and respected by the care team. It is generally accepted that 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 always be assumed to be directly caused by high doses of opioid painkillers in the dying patient if those doses have been stable or slowly increasing over time, especially in chronic cancer pain (NCP, 2018). 

Prevention of Drug Abuse/Misuse

Prevention of misuse and abuse of controlled substance medications starts with the prescriber, ensuring formal continuing education regarding indications, risks, and benefits of these medications and safe prescribing practices that guide medical decision-making with the best available evidence-based practices to limit risk to the patients and society as a whole. An honest dialogue with the patient regarding risks, benefits, treatment goals, treatment alternatives, and expectations of both parties before prescribing can help prevent misuse of potentially dangerous medications.  This includes the use of the aforementioned informed consent and PPAs, with updates and changes to these documents as treatment is adjusted over time. A good professional relationship with the network of local pharmacists who are familiar with the local prescribers can also be helpful in monitoring for altered, falsified, or otherwise suspicious looking prescriptions. For patients, misuse and abuse can best be prevented by taking their medications exactly as prescribed and discussing any changes with the prescriber before making them (Hudspeth, 2016a; NIDA, 2018a).

Manufacturers of medication are studying and trialing various methods to make medications less vulnerable to abuse or misuse, called abuse-deterrent formulations (ADF).  This includes 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 slowly release long-acting medication over time; or new molecular entities/prodrugs that render a drug inactive unless it is taken orally.  From an administrative or regulatory perspective, misuse may be prevented with additional regulation. This was the case in 2014 when hydrocodone (Vicodin, Lortab, Norco) was moved to a schedule II category drug by the DEA. Other research is ongoing regarding medications that target alternative pathways, such as the endocannabinoid system, and further research is needed on the effective treatment of chronic pain and risk factors for substance abuse disorders (Hudspeth, 2016b; NIDA, 2018a).

Safe Storage and Disposal

Patients should be counseled on the importance of the safe storage of medications to avoid intentional or accidental use by anyone other than the patient for which 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 blacking out all prescription detail information).  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, 2018).

In West Virginia, statewide take-back events have been promoted and scheduled regularly at sites throughout the state to accept expired, unused, and unwanted medication (Product Stewardship Institute, 2019). Further, West Virginia created the Dispose Responsibly of Prescriptions (DRoP) program, which provides permanent drug drop boxes to law enforcement agencies across the state to reduce the access to unused prescription medication by the general public. As of February 2018, there are 85 DRoP program locations in West Virginia (Office of Inspector General [OIG], 2018).

Signs and Symptoms of Drug Abuse/Misuse

Recognizing and responding to risk factors of drug misuse/abuse is an important nursing responsibility that can help reduce prescription drug abuse and diversion.  Red flags that a patient may be misusing or diverting their controlled substances include rapid increases in the amount of medications needed, frequent/unscheduled refill requests, repeated dramatic stories about prescriptions or medication being lost or stolen, multiple visits with multiple providers or pharmacies, resistance to nonopioid and nonpharmacological treatments, frequent after-hours calls to the on-call prescriber, or multiple trips to the emergency department resulting in prescriptions.  Prescribers should be aware of the common pitfall of assuming a well-liked or well-known patient is at lower risk for abuse/misuse.  Patients that 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 that are currently being prescribed opioids or other controlled substances to formally and objectively assess for signs and symptoms of abuse, psychiatric disorders, deceitfulness, noncompliance, and high-risk behavior patterns. As previously stated, surveillance of controlled substance users should also include regular monitoring of the state’s PDMP, as well as UDT and/or pill counts. These monitoring methods should be clearly defined in the PPA and explained to the patient up-front. 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 to patient screening. There is data supporting the prescribing or offering of naloxone (Narcan) as a potential overdose reversal agent. This is appropriate in high-risk patients exhibiting disturbing signs or symptoms of drug misuse that the prescriber deems aberrant. Additionally, careful consideration should be made regarding a referral to pain management or an addiction specialist for high-risk patients. If not, documentation as to why this was not done needs to be thorough and extensive. 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 regarding why with corresponding 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” (FSMB, 2017, p.11).

The most common reasons for termination of COT include the achievement of the functional goals of therapy, and/or when therapy must end for other reasons (treatment policy nonadherence, follow-up nonadherence, or concern for misuse/abuse or diversion). Appropriate termination helps to avoid the betrayal of trust and abuse of power, prevents harm, and conveys caring. The PPA plays a critical role in this process, and therefore 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 and sending the wrong message to the patient (McDonald, 2015).

For acute pain, the WV SEMP (2016) guidelines encourage providers to help patients develop and identify functional S.M.A.R.T. goals (Specific, Measurable, Attainable, Realistic, and Timely). By developing end of therapy goals for pain based on the expected time frame of the healing process (i.e., postoperative pain), it reduces the potential for misuse/abuse and long-term issues (WV SEMP, 2016). 

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 surrounding the potential termination of therapy should be part of the treatment plan from the very beginning. It is recommended that termination is discussed at three stages of treatment: during the initial consultation (and when devising the PPA), during treatment, and when ending the intervention (WV SEMP, 2016).

Strategies for termination of COT include the following:

• 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 back to as necessary during the duration of therapy.
• Set S.M.A.R.T 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 within the context of the whole patient.
• Opioid taper: Tapering should be performed after discussion with the patient. There is no “one way” to taper a patient, yet generally, the longer the patient has been on opioids, the longer it will take for a successful taper.
• Avoid terminating the relationship when a patient is in crisis without referral to a specialized facility and a warm handoff to the receiving provider. If a patient is terminated while in crisis, it might reasonably be considered abandonment and escalate abhorrent behaviors.  
•  As part of the termination preparation process, the patient should be given information about other available resources (community resources, support groups, nonpharmacological pain modalities), and document that resources have been provided (McDonald, 2015).

Treatment of Drug Abuse/Misuse and Addiction

Substance abuse disorders are brain disorders that can be effectively treated. Effective treatment must be multi-factorial and individual, often involving detoxification, counseling, and medications.  For opioid use disorders and addiction, this combination is referred to as medication-assisted treatment (MAT). The goal of treatment is to correct the imbalance in brain circuits that mediate reward, decision making, impulse control, learning, and other functions to restore the patient to a normal affective state.  The counseling most often used is behavioral treatment such as cognitive-behavioral therapy or contingency management, which help change previous thinking patterns and behavior and teach coping strategies and avoidance of triggers to limit the future 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 help by alleviating symptoms of withdrawal and limiting cravings, thus helping to limit the risk of relapse. Medication options for opioid use disorders are listed, with individual details, below:

• Buprenorphine (Buprenex, Sublocade)- partial opioid agonist (binds to receptors but only partially activates) used to reduce cravings. Prescribers must be certified to prescribe, implantable or once-monthly injection available.
• Methadone (Methadose, Dolophine)- synthetic opioid agonist that has been used for over 40 years to help limit symptoms of withdrawal/cravings, available only through specially-licensed opioid treatment programs (OTPs).
• Naltrexone (Vivitrol)- opioid antagonist (prevents opioids binding to/activating receptors) used for addiction treatment, available as a long-acting injection, can be prescribed by any licensed prescriber, the patient must detoxify/abstain for seven to ten days before starting, lower abuse/diversion potential (SAMHSA, 2015).

Studies regarding the best methodology for MAT continue, including exploring the administration of long-acting buprenorphine (Buprenex, Sublocade) in emergency departments to overdose patients and the application of MAT programs in 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 on a national level. The waiver requires 24 hours of training, and additional details for interested providers can be found on the website for the Substance Abuse and Mental Health Services Administration (www.samhsa.gov). Prescribers and the public can also search for authorized prescribers by state through the SAMHSA website. As of the writing of this article, there are currently 415 authorized buprenorphine (Buprenex, Sublocade) prescribers in the state of West Virginia.  (SAMHSA, 2019).

For those with CNS depressant use disorder, great care needs to 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 aforementioned behavioral therapies is effective in patients recovering from CNS depressant or stimulant addiction.  Unfortunately, while research continues, there are currently no FDA-approved medications for the treatment of CNS depressant or stimulant addiction (NIDA, 2018b).

Naloxone (Narcan)

Naloxone (Narcan) is an opioid antagonist that blocks opioids from binding to and activating opioid receptors in the CNS and is used as a reversal/rescue drug in the case of an opioid overdose. It can reverse the respiratory depression seen in patients who have ingested large amounts of prescription opioids or heroin within two to five minutes and can be repeated if no response is seen at that time. It can be administered by first responders and emergency medical providers as well as bystanders. It typically stays in the patient's system for 30-90 minutes, depending on the patient's body mass, metabolism, etc., and may require more than one dose depending on the half-life of the opioid ingested. It is given as a nasal spray or intramuscular injection.  While it is an effective opioid antagonist, it has no reversal effect on tramadol, alcohol, CNS depressants, or stimulants.  If 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 (Calás, 2016).  

Administration of naloxone (Narcan) may cause symptoms of opioid withdrawal, including sweating/chills, nausea, vomiting, agitation/anxiety, fever, and runny nose, hypertension, shivering/shaking, and muscle aches. Prescribers should consider this safety option in patients currently taking a high dose of opioids (>90 MME/day), chronic opioids (greater than three months), concurrent opioids and benzodiazepines, current ongoing treatment for drug use disorder, past 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 or with chronic respiratory disease, current alcohol use, renal disease, hepatic disease, cardiac disease, HIV/AIDS, or depression/antidepressant medication use should also be considered good candidates for naloxone (Narcan) rescue prescriptions. Naloxone (Narcan) prescriptions should also be granted to caregivers who request them. It is essential that patients, as well as family members and caregivers, are 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 be blue or gray. While naloxone does cross the placenta, no adverse effects were seen in animal studies, and the benefits of overdose reversal are thought to outweigh the risks. It is still unknown if it is excreted in breastmilk (Calás, 2016). 

In 2015, the West Virginia legislature passed Senate Bill 335 making naloxone (Narcan) available to first responders and to relatives, friends, caregivers or a person in a position to assist someone at risk of experiencing an opiate-related overdose (OIG, 2018).

Specific Rules and Regulations for the State of West Virginia

To mitigate the opioid epidemic, West Virginia passed the Governor's Substance Abuse Prevention Bill (SB 437) in 2012, mandating that all healthcare providers who prescribe, dispense, or administer controlled substances participate in continuing education related to prescription drug abuse and drug diversion. According to the West Virginia Legislative Code of Rule WV 19 CSR 11, nurses licensed in the state are required to obtain three contact hours initially, followed by one contact hour every year thereafter to fulfill this legislative requirement (West Virginia RN Board, 2019).  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 West Virginia. The Rules and Regulations on Controlled Substances in West Virginia (Chapter 60A) specify the following:

• Practitioners shall maintain a written record of all controlled substance prescriptions, as well as a medical record for all patients receiving controlled substances. This record must include patient identification data, chief complaint, present illness, 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 and those records are available for review by the prescriber), diagnosis, data which support diagnosis or treatment, and the treatment regimen to include 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 CSMP and practitioners must document the information obtained from CSMP search in the patient’s medical record.   
• All prescribers are required to check the CSMP database when issuing an initial prescription. If the prescriber continues to treat the patient with a controlled substance, the prescriber must continue to monitor the CSMP database at least annually. Physicians and other practitioners in a licensed pain management clinic must check the CSMP database when issuing an initial prescription and at least every 90 days. 
• All practitioners must perform a physical examination and establish a valid practitioner-patient relationship before prescribing any medications in West Virginia.
• 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:
  • Discuss the risks associated with opioid use and discuss alternatives to opioid therapy (i.e., physical therapy, massage, etc.);
  • Limit the number of opioids prescribed as follows:
  • 
    
    • Prescribers may not issue more than a four-day opioid supply within an emergency room (ER) or an urgent-care setting. Prescribers in urgent-care settings may issue an additional seven-day prescription if the medical record documents a medical rationale for exceeding the four-day supply limit;
    • Adults receiving an initial opioid prescription in an emergency room (ER) are limited to four-day supply of opioid medication;
    • Minors in the ER are limited to a three-day supply, and the ER physician must explain the risks of addiction to the parents of the minor;
    • Private practices are limited to prescribing a maximum seven-day supply which must be the lowest effective dose which in the physician’s best medical judgment is the best course of treatment;
    • Dentists and optometrists are limited to prescribing a three-day supply of opioid pain medicine.
• As of 2015, licensed health care providers may prescribe an opioid antagonist to first responders, individuals at risk of having an overdose, and relatives and friends of individuals at risk of having an overdose. Providers dispensing opioid antagonists must provide educational materials on overdose prevention and treatment programs as well as materials on administering opioid antagonists to recipients (OIG, 2018).

According to the West Virginia Board of Pharmacy (WVBOP, 2015) which governs the prescribing of controlled substances and outlines prescriptive authority of advanced practice registered nurses (APRNs), the following standards are required:

• Under West Virginia Code, § 30-7-15, APRNs are not authorized to hold Schedule II Controlled Substance prescriptive authority.
• Drugs excluded from prescriptive authority of APRNs include:
  • Schedules I and II of the Uniform Controlled Substances Act;
  • Antineoplastics;
  • Radio-pharmaceuticals; 
  • General anesthetics;
  • MAO Inhibitors, except when in a collaborative agreement with a psychiatrist. 
• West Virginia APRNs are authorized to prescribe Schedule III-V controlled substances. Drugs listed under Schedule III and benzodiazepines are limited to a 72-hour supply without a refill.
• The APRN may prescribe medications from Schedules IV through V in the quantity necessary for up to a 90-day supply, with only one refill, and the prescription shall expire in six months, with the following exceptions:
  • Prescriptions for phenothiazines shall be limited to up to a 30-day supply and nonrefillable;
  • Prescriptions for non-controlled substances of antipsychotics and sedatives prescribed by the advanced practice registered nurse shall not exceed the quantity necessary for a 90-day supply shall provide for no more than one prescription refill and shall expire in six months. 
• According to a collaborative agreement as outlined in the law governing prescriptive authority, the APRN may prescribe an annual supply of any drug, except for controlled substances, which is prescribed for the treatment of a chronic condition, other than chronic pain management.  
• The maximum dosage of any drug, including antidepressants, prescribed by the APRN shall be consistent with their area of practice. 
• Each prescription and subsequent refills given by the APRN shall be documented in the patient's chart.  
• The APRN shall not prescribe other prescription drugs or refills for a period exceeding six months; this limitation shall not include contraceptives or those treating a chronic condition.
• An authorized APRN may write or sign prescriptions or transmit prescriptions verbally or by other means of communication.
• 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; number of refills; DEA number of the prescriber (when required by federal laws); and the prescriptive authority identification number issued by the board. 
• An APRN shall at the time of the initial prescription record in the patient 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.
• Drugs considered to be proven human teratogens shall not be prescribed during a known pregnancy by the APRN. This prohibition includes all Category D and X drugs from the FDA categories of teratogen risks. Category C drugs should only be given if the patient’s benefit justifies the potential risks to the fetus, and only after consultation with the collaborating physician (WVBOP, 2015).

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