Safe and Effective Prescription of Controlled Substances

4.0 Contact Hours

Syllabus

Learning Objectives

By the end of this module, the reader should be able to:

  • Describe the three different classes of controlled substances most commonly misused: indications, risks, benefits, common adverse effects, and alternatives for opioids, central nervous system (CNS) depressants and stimulants
  • Define medication tolerance, dependence and addiction
  • Discuss general guidelines for safe prescribing practices
  • Discuss pain management, including both acute and chronic pain and special considerations needed for controlled substance use in the elderly and pregnant populations
  • Review the special circumstances involved in palliative medicine and end-of-life care
  • Review the prevention, screening, and signs of potential substance abuse and addiction
  • Describe appropriate response to and current treatment options for substance abuse and addiction
  • Review the New York State and federal requirements for prescribing controlled substances

The Misuse of Controlled Substances

            According to the 2016 National Survey on Drug Use and Health conducted by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration, 3.3 million people age 12 and older were current misusers of prescription pain medications, and an estimated 11.5 million people misused pain medications in the past year.  The most commonly misused medications were hydrocodone products. 62.3% of those who misused pain medications in the last year replied that they misused due to physical pain and 53.3% obtained the last medications they used form a relative or friend while 36.8% got through a valid prescription. In 2016, an estimated 1.8 million people aged 12 and older had a prescription pain medication use disorder. The current misusers of tranquilizers, stimulants, and sedatives in 2016 was estimated at 2 million, 1.7 million, and 0.5 million respectively (SAMHSA, 2017). The Centers for Disease Control and Prevention (CDC) estimates that opioids, both prescription and heroin, killed more than 42,000 people in the United States in 2016, a new record high (CDC, 2017). Currently, according to the Drug Enforcement Agency (DEA), nurse practitioners, nurse midwives, and physician assistants are legally permitted to prescribe schedule II-V medications within the state of New York (DEA, 2018).



Controlled Substances: The Basics

The three classes of controlled substances most commonly misused or abused include opioids, CNS depressants and stimulants (NIDA, 2018).  Risk factors for controlled substance misuse include a personal or family history of alcohol or drug abuse, younger age, and a current psychiatric condition (SAMHSA, 2017). Opioids are usually prescribed for pain control and function as opioid agonists, 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 commonly prescribed to treat mild to moderate pain or cough, either alone or in combination with acetaminophen or within cough and cold formulas.  Other common schedule II opioids prescribed for moderate or severe pain include

  • Hydrocodone (Vicodin, Lortab, Norco): commonly combined with acetaminophen, most commonly prescribed opioid in the United State
  • Oxycodone (Percocet, Oxycontin): available as immediate or extended release formula, fast onset
  • Morphine sulfate (IR, MSContin): available as immediate or extended release formula, PO/IV
  • Oxymorphone (Opana, Opana ER): available as 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. Because they can induce euphoria, especially when taken in higher doses than prescribed or ingested via snorting or injection, these drugs are a high risk for abuse and addiction. Long term use of these drugs can also carry with it additional risk of drug tolerance and hyperalgesia, or an increased sensitivity to pain caused by damage to nociceptors or peripheral nerves (USFDA Center for Drug Evaluation and Research, 2018).

CNS depressants is a drug class that includes tranquilizers, sedatives, and hypnotics used to treat anxiety and sleep disorders by increasing the inhibitory activity of the neurotransmitter gamma-aminobutyric acid (GABA), inhibiting overall brain activity and producing a drowsy or calming effect. This class includes benzodiazepines, such as diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax), triazolam (Halcion), and estazolam (Prosom). They are schedule IV medications used to treat general anxiety as well as panic attacks, acute stress reactions, and occasionally muscle spasms (diazepam), seizure disorders (clonazepam) or sleep disorders (triazolam or estazolam). In general, this group of medications should be used with great caution for short-term use only due to a 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 medications (NIDA, 2017).  In order to offer similar but safer medications, the pharmacology industry developed non-benzodiazepine sleep medications including zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata).  They 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. They remain classified as schedule IV, with a low abuse potential, but these are newer drugs with fewer long-term studies completed at this point. They can commonly cause headaches, amnesia, dizziness, and nightmares. There exist even safer options for insomnia that should also be discussed and offered to patients who are at high risk or otherwise simply want to avoid taking controlled substances. Melatonin is an over the counter (OTC) option for sleep that simply boosts the levels of the body’s own sleep hormone melatonin. 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. For anxiety treatment, there are medications available to treat anxiety that are not controlled substances and therefore less risky, such as 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 potential overdose, but are still used in seizure disorders and during surgical procedures.  All CNS depressants can commonly cause drowsiness, confusion, and poor coordination.  CNS depressants 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 benzodiazepine overdose, there exists a benzodiazepine antagonist, flumazenil, that can be administered via an IV by emergency medical personnel (NIDA, 2018).

Stimulants, such as methamphetamine, dextroamphetamine (Adderall and Dexedrine) and methylphenidate (Ritalin and Concerta) work by enhancing the effects of the neurotransmitters norepinephrine and dopamine in the brain. This causes increased alertness, attention, motivation, cognition and energy.  Unfortunately, it can also commonly cause vascular constriction leading to increased heart rate and blood pressure, increased respiratory rate and dilated airway, jitters, increased blood glucose, and difficulty sleeping.  This class of medications was historically used more commonly for conditions such as asthma and obesity, but due to the risks of misuse, abuse and potential addiction, they are now predominantly used to treat attention-deficit hyperactivity disorder (ADHD), narcolepsy, and rarely depression.  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.  They are often used for nonmedical purposes to enhance mental performance, and within the military to combat extreme fatigue. Repeated misuse of stimulants has been linked to feelings of hostility, paranoia, and psychosis, and overdose can lead to hyperthermia, arrhythmias, cardiovascular arrest, or seizures.  Due to the seriousness of all of the risks associated with these medications, they are classified as schedule II. A similar stimulant used to treat narcolepsy and extreme fatigue in Multiple Sclerosis, modafinil (Provigil), works to block the reuptake of dopamine. It has slightly safer profile, and is therefore categorized as schedule IV (NIDA, 2018).


Tolerance, Dependence and Addiction- what is the difference?

Tolerance, dependence and addiction are all terms that are used when discussing the safe prescribing of opioids, but these terms are similar and yet their differences are important enough to warrant a brief definition of each to help facilitate effective communication going forward.  Tolerance to a medication is defined as a lack of expected and historic response to a given medication dosage, necessitating an increase in dose to achieve the same prior pain relief response.  This occurs due to the brain’s physical adaptation to the presence of the drug after a period of time, and develops at varying times during treatment with opioids.  Physical dependence is defined as the body’s physical adaptation to the presence of the drug, whereby the drug is necessary for normal body functioning to occur, and withdrawal symptoms are seen when the drug is no longer present in the patient’s system. Psychological dependence occurs when the ingestion of a medication becomes associated with the alleviation of discomfort, such as pain, anxiety, depression, etc. The presence of that drug then becomes a calming and reassuring presence in the patient’s life, similar to a comfort or security object. Addiction is defined as a primary, chronic, neurologic, relapsing disease that is characterized by dependence along with a constant, focused need for something (for the purposes of this article, a medication) despite any cost and possible harmful consequences to the individual or others. Separate from these, there also exists another phenomenon, called pseudoaddiction, in which the patient becomes intensely fearful of being in pain.  This is common in postoperative patients, and usually manifests as clock-watching, asking to be awoken to receive pain medication, and hypervigilance with documenting and monitoring pain medications.  Pseudoaddiction usually resolves with effective pain management treatments and the resolution of painful stimuli in the postoperative patient, this is healing of the surgical site (Hudspeth, 2016).


Guidelines for Safe Prescribing Practices

Advanced practice nurses have been professionally trained to effectively and safely prescribe medications to both treat and manage medical conditions as a component of their overall treatment plan and care. However, the unique risks associated with controlled substances, their use, their misuse, and potential drug interactions are significant. Oftentimes, there exists limited formal pain management education in most advanced nursing programs.  The consistent and diligent review of best practices and the most recent evidence in the field of pharmacology are necessary components to a safe and effective medical practice (Hudspeth, 2016). We will briefly highlight general safe prescribing practices all prescribers should abide by.

Before you Prescribe

As with most medical conditions, treatment should begin with a comprehensive history and physical, including information and assessment specific to pain.  It should include a full list of current and past medical conditions, medications currently being prescribed and how they are being taken, and if possible, obtain a copy of the patient’s records from previous providers.  Review of systems should include questions related to controlled substances and their use, such as nausea, constipation, cognitive changes/impairment, and a full pain assessment including pain severity rating, location, quality, duration, treatment history, and aggravating/alleviating factors. You can choose the acronym or your choice for a full and consistent pain assessment every time (OLDCART, SOCRATES, OPQRST, etc). Pain severity is self-reported and should be consistent from visit to visit to allow for trend identification.  Commonly used tools for pain rating include the verbal rating scale (allow patient to choose from 3 to 6 adjectives to describe their pain ranging from no pain to severe pain), a numerical rating scale (allow patient to choose a number between 0 and 10), a picture scale (uses multiple facial expressions indicating increasing levels of discomfort) and a visual analog scale. The descriptor differential tool is the most reliable and consistent, but quite lengthy to administer. It utilizes 12 adjectives describing pain and the patient is asked to rate each adjective from 0 to 10.  Which tool you choose for each patient should be based on the individual circumstances. For example, children and those with language barriers of developmental delays may be best suited for the picture scale while a numerical rating may suffice in am emergent or urgent care setting where time and efficiency are a concern (Hudspeth, 2016). 

Additional components of the history should include a family history, a social history, a drug and alcohol use history, and a depression screening.  Family history should include substance use/abuse or psychiatric diagnoses specifically.  Social history should include socioeconomic status, employment status, marital status, education level, living situation, dependents, and legal issues, past or present.  Drug and alcohol use history should include questions detailing 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, etc (Hudspeth, 2016).  Most chronic pain patients have a comorbidity of depression, and are twice as likely to commit suicide as non-pain patients, so a 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 effective in the screening of chronic pain patients (Choi, 2014 and Wang, 2013).  Finally, an opioid abuse risk assessment tool, a urine drug test (UDT), and a review of your state’s prescription drug monitoring program (PDMP) should be completed before any controlled substance prescriptions are given. Some options for an opioid abuse risk assessment tool are as follows:

  • 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
  • Tobacco, Alcohol, Prescription medication, and other Substance Use Tool (TAPS)- self-administered tool that combines screening, and if positive, a brief assessment for adult patients (NIDA, 2018)
  • NIDA Drug Use Screening Tool: Quick (NM ASSIST) is a clinician-administered tool for adult patients, or the American Psychiatric Association’s adapted version NIDA-modified ASSIST is a self-administered version
  • CAGE Adapted to Include Drugs (CAGE-AID): a brief questionnaire based on the original CAGE tool utilized for alcohol
  • Screening to Brief Intervention (S2BI) and Brief Screener for Alcohol, Tobacco and other Drugs (BSTAD) are both self-administered tools designed specifically for adolescents
  • Diagnosis, Intractability, Risk, and Efficacy (DIRE) aims to determine suitability for long-term opioid use

This list is by no means exhaustive, and the most part of screening for risk is that the prescriber is familiar with the tool they are using, understands how and why it was developed, and trained properly in its execution and interpretation. Ultimately, a patient’s risk should be considered amongst all of the other data collected in order to make the best decision regarding appropriate treatment moving forward. Oftentimes, a high-risk score may result in a nurse prescriber referring the patient to a pain management clinic, with additional experience and expertise treating pain in more complex, higher-risk patients. Risk factors for drug misuse/abuse include younger age (18-25), women, older adults (age 58-75), a personal or family history of alcohol or drug abuse, and current psychological condition such as depression or bipolar disorder (Hudspeth, 2016 and NIDA, 2017/8).

The use of urine drug testing (UDT) can be a useful tool (especially for baseline and periodic testing if diversion or misuse is suspected) but is certainly imperfect. False positives can happen. Hydration, drug dose, metabolism, BMI, urine pH, duration of use, and individual drug pharmacokinetics can all affect the results. For example, hydrocodone has been detected in the results of patients using codeine, and hydromorphone has been detected in the results of patients using hydrocodone as these drugs are metabolites.  Manufacturer impurities have also shown hydrocodone amounts to be evident in oxycodone products. Poppy seeds or the herb Papaveris fructus may cause positive morphine results. 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. A positive result for an unexpected drug could mean the patient was taking the drug illicitly, it is a metabolite of a prescribed drug, or the positive result was false.  The cost of UDT should also be considered, discussed with the patient, and included in the provider agreement.  How the results of a UDT will be interpreted, confirmed, and used, including its effects on continuation of treatment, should be explained to the patient prior to testing. If female, also consider screening for pregnancy concurrently via a single urine sample/specimen (Hudspeth, 2016).

The use of electronic databases to track controlled substance prescriptions, or PDMPs has become widespread (now available in 49 states, Washington DC, and Guam). Their purpose is to improve opioid prescribing, inform clinical practice, and protect patients at risk. 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 varies greatly. Most states (California and Florida do not) also have a method by which you can access the patient’s records in other or neighboring states as well as your own. Currently, Missouri is the only state without a statewide PDMP. However, St Louis County has developed its own PDMP, and other counties in the state are permitted to utilize their system, so currently 79% of the population of Missouri is covered by the St Louis County PDMP. The key to all PDMP systems is mandated, real time reporting by pharmacies, and a mandate that all providers check the system PRIOR TO prescribing controlled substances to a patient. Differences exist between the states regarding how frequently this system should be monitored by providers, and which schedules of controlled substances are included. Also, some federal agencies are beginning to participate, including the Veterans Administration (VA) and the Indian Health Services (IHS) (CDC, 2017 and NAMSDL, 2018).

Finally, a complete physical exam should be performed and documented appropriately prior to any prescriptions being granted, and periodically throughout treatment course (Hudspeth, 2016). In fact, the state of New York specifies this requirement in its prescriptive rules and regulations (section 80.63).  In the presence of a new medical condition or problem requiring a controlled substance prescription, prescribers in New York may prescribe a 5-day supply of controlled substance medication to a patient without performing a physical exam only in the case of an emergency if the prescriber has a prior relationship with that patient (NYSDoH, N.D.).

Safe and Effective Treatment

After making the critical decision to prescribe a patient a controlled substance based on all the information gathered above, what can nurse prescribers do to manage that treatment plan safely and effectively? Recommendations start with two important documents- informed consent and a patient provider agreement (PPA). The informed consent puts down on paper what should be communicated directly to the patient during the initial visit, prior to prescribing. It should include the specific drug being prescribed, risks, benefits, and desired outcome/goals of treatment and should be updated when medications are changed.  Those goals should be collaborative. At a minimum, risks should include 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. If female, the risk of neonatal withdrawal syndrome if the patient were to become pregnant should also be included (Hudspeth, 2016).  The PPA is a separate document, signed by both the provider and the patient, that covers the responsibilities/expected behaviors of both parties, the goals and potential risks of controlled substance use, and the consequences for noncompliance.  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. This provides the prescriber with a clear exit strategy should treatment need to be discontinued.  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, but allow the patient to obtain prescriptions from other providers for other controlled substances such as benzodiazepines, testosterone, stimulants for ADHD/ADD, etc (Hudspeth, 2016).  While PPAs are recommended, there is limited evidence clarifying they actively deter misuse/abuse (Albrecht, 2015). Quality sample PPAs can be obtained through the NIH/NIDA website (NIDA, 2017).

The first initial opioid prescription should be considered a trial, with follow-up appointment scheduled at a predetermined time to review effectiveness and success based on established treatment goals.  As with any new prescription medication, all current medications should be reviewed 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. Mild pain likely does not warrant an opioid, but non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen should be trialed first. Moderate pain can often be managed with weaker opioids such as codeine or tramadol, a synthetic analog of codeine with a low affinity for opioid receptors.  Treatment for severe pain, in a patient that can swallow, should be started with a stronger oral opioid such as hydrocodone, oxycodone, morphine, or hydromorphone.  Fentanyl and methadone 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 with opioid-naive patients until the dose is stabilized. Dose adjustments may need to be made as early as every 2-3 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.  It is recommended that prescribers become familiar with certain medications that they prefer and commonly prescribe in order to familiarize themselves with the details of those particular drugs extensively and avoid prescribing different or unfamiliar medications when possible (CDC, 2017; Hudspeth, 2016; PAMI, 2016; and Qaseem, 2017).

Documentation is key when prescribing controlled substances, both for safety and legal reasons. Patient visit notes should be clear, concise, and include all details of any dose adjustments or medication changes with associated justifications and equivalency calculations, effectiveness of treatments based on consistent pain assessments repeated at each visit, and any adverse effects and associated treatments required. Documentation should also specify if the patient is adhering to 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.  Any letters sent to patients should be included in the patient’s electronic 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, 2016).


Pain Management

                  To alleviate pain and suffering is one of the basic tenets of medical care since its inception. Pain can be broken down into two basic categories, acute (<3 months) and chronic (>3 months). Their care differs greatly.

                  Acute pain is oftentimes self-limiting, and if non-pharmacological treatment can be used effectively, it is recommended over medications.  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 NSAIDs and/or skeletal muscle relaxants such as ibuprofen, naproxen, carisoprodol, and cyclobenzaprine (Qaseem, 2017).  Gastrointestinal and cardiovascular risks are associated with NSAIDs, so these need to be considered as well. Regarding the gastrointestinal risks of NSAIDs, celecoxib and nabumetone have been shown to be gastroprotective in the short term, and studies have shown that adding misoprostol, a proton pump inhibitor or H2 blocker is gastroprotective. Naproxen and meloxicam seem to be least risky options in terms of cardiovascular risk (Dean, 2011). Systemic corticosteroids do not have great evidence to support their effectiveness or use, and certainly have substantial adverse effects, especially in the diabetic patient (Qaseem, 2017).  If opioids are to be used for acute pain, as recommended by the state of New York and the CDC, all prescription quantities should be limited to no more than seven days in duration, and most can and should be limited to three days (NYSDoH, 2017).

                  Chronic pain (excluding cancer patients, palliative care, and end-of-life care) treatment, like acute pain, should always start with and include non-pharmacologic and nonopioid treatment options as above.  Other treatments often used successfully for chronic pain include cognitive behavioral therapy, 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 neuropathics gabapentin and pregabalin or antidepressants such as venlafaxine, duloxetine, 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 (NIDA, 2017; Qaseem, 2017; and PAMI 2016). Goals should be agreed upon prior to treatment initiation (see PPA section above for further details on this) as well as a plan for discontinuation of treatment if benefits do not outweigh risks and there is no clinically meaningful improvement in pain and function.  Risks, benefits, and responsibilities of both patient and provider should be clearly communicated within the informed consent and PPA so that they can be reviewed periodically whenever necessary (Hudspeth, 2016). 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 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 or 33 mg of oxycodone per day.  Prescribers should become familiar with access to a calculator to regularly, quickly, and accurately determine a patient’s current MME and use this formula during any medication dosage changes, and for transitions between different medications to establish equivalent dosages (CDC, 2017).  Several exist online, including CDC, Centers for Medicare & Medicaid Services (CMS.gov) and NYC.gov (CDC, 2017 and CoNYDoH, N.D.).  CDC has come under some scrutiny recently for its published opioid guidelines, being called too strongly anti-opioid.  Certainly, these calculators can have their limitations and complicated exceptions (Fudin, 2018). Extreme caution should be used when prescribing methadone, which is extremely complicated to dose, and tapentadol, which is a centrally acting analgesic with an added mechanism of norepinephrine reuptake inhibition in addition to its mu-receptor agonism (USFDA Center for Drug Evaluation and Research, 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 incidental overdose or under dose. Follow-up within 1 to 4 weeks of starting opioids or dose increases is recommended to assess benefits and any harms, and once stable, every 3 months (CDC, 2017).  If at any point, risks or harm outweigh benefits, opioids should be tapered to a lower dose or gradually discontinued and other treatments optimized.  The PDMP database in your state should be reviewed initially and at least every 3 months for all patients receiving opioid prescriptions (Hudspeth, 2016).  The CDC recommends baseline UDT and repeat testing at least annually for chronic opioid pain patients (CDC, 2017).

If an advanced practice nurse prescriber makes the decision to prescribe methadone, the CNP should 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 in order to treat pain safely.  However, the low cost and ease or availability often make methadone an attractive option if used carefully by a skilled and experienced prescriber (Hudspeth, 2016).

In the state of New York, nurse practitioners and physician assistants (along with doctors) are also able to certify patients for medical marijuana. Patients must meet certification qualifications with 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 4-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 New York State Department of Health to obtain a registry ID card in order 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 (NYSDoH, 2018).


Special Considerations: The Older or Pregnant Patient

Special consideration should be when prescribing for older (>65) or pregnant patients. Pain is more common in the elderly, and aging causes physiological changes that affect the absorption, metabolism, and excretion of medications. For these reasons, medications should be started at the lowest possible dose and gradually increased only as needed (start low and go slow). It may also be helpful, in opioids, to initiate a bowel program to prevent constipation. The 2015 American Geriatric Society Beers Criteria (BC) of potentially inappropriate medication use in older adults publishes medications that should be avoided (Terrery & Nicoteri , 2016). Included in the most recent version are the following recommendations:

  • Benzodiazepines should be avoided for insomnia, agitation, or delirium due to fall risk and high rate of physical dependence, especially longer acting versions
  • Non-benzodiazepine, benzodiazepine receptor agonist hypnotics (eszopiclone, zaleplon, zolpidem) should be avoided for insomnia regardless of duration due to fall/fracture risk and high rate of physical dependence, especially in patients with dementia/cognitive impairment
  • 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 patient is a threat to self or others due to increased risk of stroke and mortality in the elderly with dementia and olanzapine syncope
  • Tricyclic antidepressants and skeletal muscle relaxants (cyclobenzaprine, carisoprodol) should be avoided/used with caution secondary to anticholinergic effects
  • Indomethacin and ketorolac (PO/IV) should be avoided due to risk of gastrointestinal (GI) bleeding and kidney damage, replaced instead with celecoxib, nabumetone, naproxen or ibuprofen in combination with proton pump inhibitor for GI prophylaxis (Terrery & Nicoteri, 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. Opioid use in pregnancy is not well studied, but there has been no evidence for an increased risk of minor or major fetal malformations.  The most substantial risks are that of potentially fatal neonatal withdrawal syndrome, lower birth weight, and premature birth, but animal studies have shown no evidence of teratogenicity. Opioids are excreted in breastmilk and increase the risk for CNS and respiratory depression if taken while breastfeeding.  These risks can be minimized by using the lowest effective dose to achieve pain control, but the patient should be very well informed of all of these risks prior to issuing any opioid or controlled substance prescriptions.  Acetaminophen can be used in pregnancy and while breastfeeding relatively safely. Nonsteroidal anti-inflammatory drugs should be avoided in pregnant patients, especially during the first trimester and after 30 weeks gestation, due to risk of bleeding and risk of 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 risk of congenital abnormalities, especially if used in the first trimester. Other risks of benzodiazepine use during pregnancy includes postnatal withdrawal symptoms, neonatal flaccidity, respiratory and feeding difficulties, and hypothermia.  Zolpidem (Ambien) was category C in the old system due to lack of evidence. Cases have been reported of severe neonatal respiratory depression, withdrawal, and flaccidity, but no teratogenicity has been observed, although animal studies showed issues with skeletal ossification at high doses. Zolpidem is excreted in breastmilk and caution should be advised. Stimulants, such as methylphenidate, were a category C and are not well studied in pregnant women but were shown to cause congenital abnormalities at very high doses in animal studies.  It is unknown if methylphenidate is excreted in breastmilk, but amphetamines are (Hudspeth, 2016 and USFDA Center for Drug Evaluation and Research, 2018).

Cancer, Palliative, and End-of-Life Care

The treatment of cancer pain is extremely complex, and is usually best managed by oncologists, not advanced practice nurse prescribers. The patient’s disease prognosis, concurrent medications, and individual goals of care should be considered (Hudspeth, 2016). The treatment of pain within the specialty care of terminally ill patients does not typically conform to the standard aforementioned 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.  Concerns within these populations continue to be overdose, respiratory depression, and potential loss of consciousness or hastening of end-of-life. 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, but if pain relief is prioritized by the patient and family over 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.  Loss of consciousness in this population is more commonly related to metabolic encephalopathy, infection, or brain metastases (Berger, 2013).  There is no legal protection for assisted suicide or euthanasia in the state of New York, but the state Task Force on Life and the Law developed a report, originally published in 1994, which sheds light on the legal protections in the state of New York for the treatment of pain in the terminally ill patient as follows:

“Professional medical standards should recognize the provision of effective pain relief and palliative care, including treatment for depression or referral for treatment, as a basic obligation all physicians owe to their patients. Physicians should seek their patients' participation in decisions about withdrawing or withholding life-sustaining treatment early enough in the course of illness to give patients a meaningful opportunity to have their wishes and values respected. Health care professionals have a duty to offer effective pain relief and symptom palliation to patients when necessary, in accord with sound medical judgment and the most advanced approaches available. New York State statutes and regulations should be modified to increase the availability of medically necessary analgesic medications, including opioids. This should be done in a balanced manner that acknowledges the importance of avoiding drug diversion. Physicians, nurses, and patients must be aware that psychological and physical dependence on pain medication are distinct phenomena. Contrary to a widely shared misunderstanding, psychological dependence on pain medication rarely occurs in terminally ill patients.  While physical dependence is more common, proper adjustment of medication can minimize negative effects. The provision of appropriate pain relief rarely poses a serious risk of respiratory depression.  Moreover, the provision of pain medication is ethically and professionally acceptable even when such treatment may hasten the patient's death, if the medication is intended to alleviate pain and severe discomfort, not to cause death, and is provided in accord with accepted medical practice” (New York State Task Force on Life and the Law, 2011)


Prevention, Screening, and Signs/Symptoms of Drug Abuse/Misuse

Prevention of misuse and abuse of controlled substance medications should start with the provider, specifically formal continuing education regarding indications, risks and benefits of these medications and safe prescribing practices that guide your medical decision making with the best evidence possible 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 prior to prescribing can help prevent misuse of the potentially dangerous medications.  This includes the use of 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 (and only their medications) exactly as prescribed, discussing any changes with the prescriber prior to enacting a change in strength or dosing frequency, and safely storing medications to avoid intentional or accidental use by anyone other than the patient for which they were prescribed. Per the FDA, any expired or unnecessary medications should be deposited at a registered take-back event or location or disposed of in the household trash (pills should be mixed with dirt, coffee grounds, or cat litter and disposed of with the household trash sealed in a ziploc 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.  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 or 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 renders 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 was moved to a schedule II category drug by the DEA. Additional 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 that lead some patients to substance abuse disorders (Hudspeth, 2016 and NIDA, 2018).

Screening for drug abuse/misuse should not only include the formal screening tools mentioned above prior to starting any controlled substances but could also include the Current Opioid Misuse Measure (COMM), which is a 17-item questionnaire for current opioid users which assesses for signs and symptoms of abuse, psychiatric disorders, evidence of willful dishonesty, provider visitation patterns, and medication noncompliance. As previously stated, periodic review of your state’s PDMP (and possibly neighboring states depending on your proximity to the state line), pill counts, and UDTs should also be an important aspect of screening for misuse.  Also, the provider spending a few minutes talking with the patient about their pain and treatment plan, current medication usage, along with an invitation for any questions and concerns, using open-ended questions and non-judgmental language cannot be understated (Hudspeth, 2016).

There exist some red flags that a patient may be misusing or diverting their controlled substances. These 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, or frequent after-hours calls to the on-call prescriber or 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 with an otherwise correctable condition with medications should be monitored closely. There is data supporting the prescribing or offering of naloxone, as potential overdose reversal agent, in high-risk patients exhibiting disturbing signs or symptoms of drug misuse that the prescriber deems aberrant. In these patients, careful consideration should be made regarding referral to a pain management or addiction specialist, and if not, documentation as to why this was not done needs to be thorough and extensive (Hudspeth, 2016).


Naloxone (Narcan)

This opioid antagonist functions by blocking opioids from binding to and activating opioid receptors in the CNS and can be used as a reversal/rescue drug in the case of opioid overdose. It can reverse the respiratory depression seen in patients who have ingested large amounts of prescription opioids or heroin within 2-5 minutes and can be repeated if no response is seen in 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 (a benzodiazepine antagonist) should be attempted.  Administration of naloxone may cause symptoms of opioid withdrawal, including sweating/chills, nausea, vomiting, agitation/anxiety, fever, 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 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 rescue prescriptions. Naloxone prescriptions should also be granted to caregivers who request them. It is important 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, pale, clammy skin that may be blue or grey in color. 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 and CoNYDoH, N.D.).

 

Treatment of Drug Abuse/Misuse and Addiction

Substance abuse disorders are brain disorders that can be effectively treated, although 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 are behavioral treatments 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. They may include family or group therapy and expand to also focus on interpersonal relationships and life skills. Medications used in opioid abuse disorder treatment help by alleviating symptoms of withdrawal and limiting cravings, thus helping limit the risk of relapse. Medication options for opioid use disorders are listed, with individual details, below:

  • Buprenorphine- partial opioid agonist (binds to receptors but only partially activates) used to reduce cravings- prescriber must be certified to prescribe, implantable or once-monthly injection available
  • Methadone- 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- opioid antagonist (prevents opioids binding to/activating receptors) used for addiction treatment, available as long-acting injection, can be prescribed by any licensed prescriber, patient must detoxify/abstain for 7-10 days prior to starting, lower abuse/diversion potential

There continues to be a discrepancy in the estimated number of people in the US with opioid use disorder and the capacity of available OTPs and trained prescribers of buprenorphine, so this highly effective treatment remains difficult to access for patients that desperately need help for their addiction. Studies regarding the best methodology for MAT continue, including exploring the administration of long-acting buprenorphine 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 was extended to NPs and PAs on a national level. The training consists of a 24-hour program, 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 over 3,000 authorized buprenorphine prescribers in the state of New York.  The SAMHSA website also provides a search engine for OTPs by state, or providers can reference the Office of Alcoholism and Substance Abuse Services website (www.oasas.ny.gov) and utilize their provider and program search tool. OTPs are also able to dispense buprenorphine as a component of MAT (CoNYDoH, N.D. and SAMHSA, 2015).

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. Stimulants 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 has been shown to be 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, 2018).


Specific Rules and Regulations for the State of New York

All prescribers licensed under Title Eight of the Education Law in New York to treat humans and who have a DEA registration number to prescribe controlled substances, as well as medical residents who prescribe controlled substances under a facility DEA registration number, must complete at least three (3) hours of coursework or training in pain management, palliative care, and addiction every three years. The Rules and Regulations on Controlled Substances in NYS (Part 80) specifies that:

  • Practitioners shall maintain a written record of prescriptions of all controlled substances, as well as a medical record for all patient receiving controlled substances that includes 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 use of any controlled substances
  • Preprinted prescriptions are prohibited. As of 2016, all prescriptions, including controlled substances, must be submitted electronically (or written on an official NYS prescription, ONYSRx, with ink or printed in the event of a power outage or technical failure, or by practitioners who meet one of the exceptions listed in Article 2A - Section 281 or Title 10 Part 80 Section 80.6 and include handwritten signature of prescriber) containing the date as well as the patient’s name, sex, address and age; the prescribers name, telephone number, address, and DEA registration number; the drug’s name, strength, quantity in both numerical and written word form and the directions for use, including dose, frequency, and maximum daily dose.
  • There are no refills allowed on Schedule II medications or benzodiazepines, and no more than 5 refills allowed on Schedule III-V.
  • Emergency prescriptions may be called into pharmacies by prescribers for schedule II or III medications or benzodiazepines for no more than a five-day supply, as long as the official written or electronic prescription is delivered to the pharmacist within 72 hours. For schedule IV (except benzodiazepines) medications this limit is a 30-day supply, or quantity #100, whichever is less.
  • A new prescriber may prescribe a controlled substance to a patient as part of a continuing treatment plan in the temporary absence of the initial prescriber as long as the new prescriber has access to that patient’s record, including a physical exam completed prior to the initial controlled substance being prescribed, or with the approval from the original prescriber via direct consultation.
  • In the presence of a new medical condition or problem requiring a controlled substance prescription, prescribers in New York may prescribe a five-day supply of controlled substance medication to a patient without performing a physical exam only in the case of an emergency if the prescriber has a prior relationship with that patient.
  • A practitioner (or any prescriber) will be held legally liable for providing any prescriptions of controlled substances to an addict or habitual user not in the course of professional treatment but for the purpose of providing the user with medication sufficient to keep them comfortable by maintaining their customary use, unless that patient has incurable known disease, such as cancer or advanced tuberculosis, or addicts who are aged and infirm and withdrawal would be dangerous to life
  • No prescriptions exceeding a 30-day supply of schedule II drugs is permitted, and additional prescriptions may not be issued for at least 23 days.
  • Effective July 22, 2016, there exists a 7-day supply limit for any opioid prescriptions at an initial consultation or treatment for acute pain. Upon any subsequent consultations for the same pain, the practitioner may issue, in accordance with existing rules and regulations, any appropriate renewal, refill or new prescription for an opioid.
  • Chorionic gonadotropin may be prescribed for up to 3 months, and anabolic steroids for up to 6 months, in the treatment of panic disorders, attention deficit disorder (ADD), chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, relief of pain in conditions known to be chronic or incurable, narcolepsy, hormone deficiency states in males, gynecological conditions or metastatic breast cancer, anemia, or angioedema
  • Within the state of New York, naloxone can be accessed without a doctor’s prescription, and sometimes with no out-of-pocket cost to the patient, via an authorized opioid overdose program or at a participating pharmacy via the voluntary standing order program (currently includes CVS, Duane Reade, Rite Aid and Walgreens) (NYSDoH, N.D.). 



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