OPIOID MISUSE, ABUSE, AND DIVERSION

Along with attempts to improve identification and treatment of pain, there has been an equal rise in prescription opioid addiction and abuse in the United States. Opioid misuse, abuse, and diversion are major problems with serious consequences.

In the past, opioids were often not prescribed for a patient because of the fear of addiction. In the 1980s, the opioid epidemic in the United States arose through an assemblage of well-intentioned efforts to improve pain management by doctors and through aggressive marketing by pharmaceutical manufacturers. States began to pass intractable pain treatment acts, which removed threat of prosecution for physicians who treated their patients aggressively with a controlled substance. In 1995, the American Pain Society began a campaign that framed pain as a “fifth vital sign” that should be monitored and managed in the same way as heart rate and blood pressure (DeWeerdt, 2019).

Now practitioners have returned to the fear of addiction and become, once again, reluctant to prescribe opioids. Clearly, there is a dilemma between the need to address opioid abuse and overdose while continuing to ensure people with pain receive safe, effective treatment.

Scope of the Problem

The National Institute on Drug Abuse (2022a) reports that:

• Among people ages 12 and older in 2020, an estimated 2.3 million people in the United States had a prescription opioid use disorder in the past year.
• Nearly 92,000 persons in the United States died from drug-involved overdose in 2020 due to illicit drugs and prescription opioids. The national overdose deaths involving prescription opioids among all ages in 2020 was 16,416.
• Among young people in 2021, an estimated 4.4% of 12th graders reported misusing any prescription drug in the past 12 months.
• 50,000 individuals used heroin for the first time, and 14,480 deaths from heroin occurred in 2020.

Multiple variables contribute to the opioid crisis including:

• Geographic conditions
• Treatment accessibility
• Medication disposal services
• Workplace environment
• Prescribers’ perception of risk
• Overprescription of opioids or undertreatment of pain
• Types of prescription opioid formulation available
• Community norms
• Access to legal and illegal opioids
  (Jalali et al., 2020)

Drug diversion can be defined as any act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient and can occur anywhere along the continuum: manufacturer, wholesale distributor, retail pharmacy, hospitals and other healthcare organizations, prescribers, healthcare professionals who administer the medication, or the patient for whom the medication is prescribed (ASHP, 2022).

The effort to prevent misuse, abuse, and diversion involves government and regulatory agencies, drug researchers and manufacturers, as well as healthcare institutions and individual clinicians.

CDC Guidelines for Prescribing Opioids

In 2022, the CDC updated its guidelines for prescribing opioids for the treatment of pain. Whereas the 2016 guideline focused on recommendations for primary care physicians, the newer guideline expands the scope to additional clinicians whose scope of practice includes prescribing opioids (e.g., physicians, nurse practitioners and other advanced-practice registered nurses, physician assistants, and oral health practitioners). The 2022 guidelines address four main issues, including:

• Making a determination about whether or not to initiate opioids for pain
• Selecting the appropriate opioid and determining the dosage
• Deciding the duration of the initial opioid prescription and conducting follow-up
• Assessing the risk and addressing the potential harms of opioid use with the patient

The recommendations in the 2022 guidelines aim to improve communication between clinicians and patients about the risks and effectiveness of pain treatment; improve pain, function, and quality of life for persons with pain; and reduce the risks associated with opioid pain treatment (including opioid use disorder, overdose, and death) as well as with other pain treatment.

The practice guidelines include 12 recommendations for clinicians who are prescribing opioids for outpatients ages 18 years and older with pain that is acute (duration of <1 month), subacute (duration of 1–3 months), or chronic (duration of >3 months), excluding pain management related to sickle cell disease, cancer-related pain treatment, palliative care, and end-of-life care.

1. Nonopioid therapies are at least as effective as opioids for many common types of pain. Maximize the use of nonpharmacologic and nonopioid pharmacologic therapies appropriate for the condition and the patient, and only consider opioid therapy for acute pain if benefits are expected to outweigh risks to the patient. Discuss benefits and risks with the patient prior to prescribing opioid therapy.
2. Nonopioid therapies are preferred for subacute and chronic pain. Maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient. Consider opioid therapy if expected benefits are anticipated to outweigh risks, and work with the patient to establish treatment goals for pain and function. Consider how opioid therapy will be discontinued if benefits do not outweigh risks.
3. When starting opioid therapy for acute, subacute, or chronic pain, prescribe immediate-release opioids instead of extended-release and long-acting (ER/LA) opioids.
4. When opioids are initiated for opioid-naive patients with acute, subacute, or chronic pain, prescribe the lowest effective dosage. If opioids are continued for subacute or chronic pain, prescribe the lowest effective dosage. Avoid increasing dosage above levels likely to yield diminishing returns in benefits relative to risks.
5. For those patients already receiving opioid therapy, carefully weigh benefits and risks and exercise care when changing opioid dosages. Work closely with patients to optimize nonopioid therapies while continuing opioid therapy. If benefits do not outweigh risk of continued opioid therapy, optimize other therapies and work closely with patients to gradually taper to lower dosages, or appropriately taper and discontinue opioids. Unless there are indications of a life-threatening issue such as warning signs of impending overdose (e.g., confusion, sedation, slurred speech), opioid therapy should not be discontinued abruptly, and clinicians should not rapidly reduce opioid dosages from higher dosages.
6. When opioids are needed for acute pain, prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.
7. Evaluate benefits and risks with patients within 1–4 weeks of starting opioid therapy for subacute or chronic pain or of dosage escalation. Regularly re-evaluate benefits and risks of continued opioid therapy with patients.
8. Before starting and periodically during continuation of opioid therapy, evaluate risks for opioid-related harms and discuss risks with patients. Work with patients to incorporate into the management plan strategies to mitigate risk, including offering naloxone.
9. When prescribing initial opioid therapy for acute, subacute, or chronic pain, and periodically during opioid therapy for chronic pain, review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program data to determine whether the patient is receiving opioid dosages or combinations that put the patient at high risk for overdose.
10. When prescribing opioids for subacute or chronic pain, consider the benefits and risks of toxicology testing to assess for prescribed medications as well as other prescribed and nonprescribed controlled substances.
11. Use particular caution when prescribing opioid pain medication and benzodiazepines concurrently and consider whether benefits outweigh risks of concurrent prescribing of opioids and other central nervous system depressants.
12. Offer or arrange treatment with evidence-based medications for patients with opioid use disorder. Detoxification on its own, without medications for opioid use disorder, is not recommended because of increased risks for resuming drug use, overdose, and overdose death.
    (Dowell et al., 2022)

Legislative Efforts

Most state legislation limits first-time opioid prescriptions to a certain number of days’ supply, and in a few cases, states also set dosage limits. Nearly half the states with limits specify that they apply to treating acute pain, and most states set exceptions for chronic pain treatment.

In addition to exceptions for chronic pain, most laws also exempt treatment for cancer and palliative care from prescription limits. Many also allow exceptions for the treatment of substance use disorder or medication-assisted treatment, or for the professional judgment of the clinician prescribing the opioid. Many laws stipulate that any exceptions must be documented in the patient’s medical record.

In addition, states are enacting laws related to prescription drug monitoring programs, access to naloxone, pain clinic regulation, provider education and training, as well as other topics (NCSL, 2022).

The Comprehensive Drug Abuse Prevention and Control Act has been in effect since 1971. This act created a schedule of controlled substances, ranking them according to their potential for abuse. Through revisions since 1971, the act now places drugs in categories based upon the substance’s potential for abuse and accepted medical use.

CONTROLLED SUBSTANCES AND DISPENSING RESTRICTIONS

Schedule, Abuse Potential, and U.S. Approval	Dispensing Restrictions	Examples
(U.S. DEA, 2020)
Schedule I High risk for abuse, possible severe psychological and physical dependency No approved medical use; lack of accepted safety for use	May be used in the United States only in research situations	Heroin Gamma hydroxybutyric acid (GHB) Lysergic acid diethylamide (LSD) Marijuana Methaqualone
Schedule II High potential for abuse, possible severe physical or psychological dependency Approved for medical use in the United States, or currently accepted use with severe restrictions	Prescription orders must be written and signed; oral order (phone) permitted only in an emergency Prescription may not be refilled	Morphine Phencyclidine (PCP) Cocaine Methadone Hydrocodone Fentanyl Methamphetamine
Schedule III Less potential for abuse than I and II drugs, moderate to low physical or high psychological dependency Approved for use in the United States	Prescription order may be either written or oral Prescription may be refilled up to five times, at any time within six months from the date of the prescription Anabolic steroids	Codeine products with aspirin or acetaminophen Some barbiturates
Schedule IV Low potential for abuse. May lead to limited physical dependence or psychological dependence Currently accepted for use in the United States	Prescription order may be either written or oral (phoned to the pharmacy) Prescription may be refilled up to five times, at any time within six months from the date of the prescription	Anabolic steroids Codeine products with aspirin or acetaminophen Some barbiturates
Schedule V Low potential for abuse, limited physical or psychological dependence Currently accepted for use in the United States	Patient must be at least 18 years of age, offer some form of identification, and leave their name entered into a pharmacist’s log	Cough medicines with codeine

Abuse-Deterrent Opioids

In an attempt to respond to the abuse of opioid medications, abuse-deterrent products are being formulated and approved for use by the FDA. Abuse-deterrent drugs have been shown to meaningfully discourage use and deter abuse. However, these medications do not obstruct the use of opioids and do not prevent abuse. The science of abuse deterrence is quite new and rapidly evolving.

Abuse-deterrent formulations can be classified as a physical/chemical barrier that prevents drug release following manipulation of the drug or changes the physical form of the drug using chemicals that render it less amenable to abuse.

Agonist/antagonist combinations interfere with, reduce, or defeat the euphoria associated with abuse. The antagonist can be sequestered and released only when the product is manipulated. It is not clinically active when the drug is swallowed but becomes active when it is injected or snorted.

An aversion type of abuse-deterrent drug has a substance added that produces an unpleasant effect if the drug is manipulated or taken at a higher dosage than directed. It can include a substance that irritates the nasal mucosa if ground and snorted.

Delivery system methods can also offer resistance to abuse. Sustained-release depot injectable or subcutaneous implant formulations may be difficult to manipulate.

Other drugs may be classified as combinations in which two or more of the above methods could be combined to deter abuse.

Opioids with FDA-approved labeling describing abuse-deterrent properties include:

• Oxycontin
• Hysingla ER
• Xtampza ER
• RoyBond

Generic opioids with FDA-approved labeling describing abuse-deterrent properties include:

• Hydrocodone bitartrate

(U.S. FDA, 2021)

Management of Opioid Overdose

It is important to consider opiate overdose or toxicity in a lethargic patient with no other identifiable cause. Care of the patient at the scene depends on the vital signs. If the patient is comatose and in respiratory distress, airway control must be obtained prior to any other action. Endotracheal intubation is highly recommended for all patients unable to protect their airways.

If there is a suspicion of opiate overdose, naloxone is administered to reverse respiratory depression. Naloxone, an opioid antagonist, rapidly reverses an opioid overdose. One should be aware that naloxone can also cause agitation and aggression when it reverses the opiate.

If the patient is a known drug abuser, the lowest dose of naloxone to reverse respiratory distress should be administered. In the ambulance, the patient may become combative or violent, and use of restraints may be required. If the individual has no intravenous access, naloxone can be administered intramuscularly, intranasally, intraosseous, or via the endotracheal tube. Data show that the intranasal route is as effective as the intramuscular route in the prehospital setting (Schiller et al., 2022).

Clinician Efforts to Reduce Opioid Abuse

Clinicians have an important role to play in the detection and prevention of prescription drug misuse and abuse. It is critical that prescribers employ risk-reduction strategies when prescribing opioid medications. Before prescribing opioids, clinicians should become familiar with the CDC guidelines for prescribing opioids for chronic pain (see above) and utilize the prescription monitoring program to check for frequent or overlapping narcotic prescriptions. These programs are often state-run databases that collect pharmacy data on controlled substances that are dispensed.

There are a number of validated screening tools available for use to aid clinicians in early detection of problematic substance use. The Screener and Opioid Assessment for Patients with Pain (SOAPP-R) is one of several such tools used for screening, brief intervention, and referral to treatment.

An informed consent should be considered for patients who are beginning long-term therapy with opioid analgesics to help ensure they understand the side effects, risks, conditions, and purpose of their treatment. This document can clearly define treatment expectations and resolve any questions or concerns patients may have before treatment is initiated.

Clinicians frequently monitor patients in person to assess for and document benefits and harms of treatment, including concerning behaviors that may indicate misuse or a use disorder. Guidelines vary, but visits should generally occur at least every three months and more frequently in higher risk circumstances, such as during periods of dose adjustment.

Urine testing is commonly performed prior to and during chronic opioid therapy for patients with chronic pain. Scheduled or random urine drug testing (with informed consent) is often part of the opioid agreement.

Patients receiving long-term opioid therapy are monitored for the three components of addiction:

• Loss of control
• Craving and preoccupation with use
• Use despite negative consequence

Clinicians must be aware of indications of opioid use disorder, which include:

• Inconsistent healthcare use patterns
• Missed appointments
• Lack of engagement with nonmedication treatments
• Lack of follow-through with recommendations
• Illicit drug use
• Problematic medication (e.g., escalating doses, early refills)
• Family concerns about use
• Decreased function and loss of roles
• Extreme difficulty with even a slow opioid taper
• Signs/symptoms of drug use (e.g., intoxication, overdose, track marks)

Should the clinician determine substance use disorder may exist, the patient is provided with information about local inpatient detoxification services, methadone maintenance programs, or buprenorphine treatment.

It is important that clinicians recognize when to taper and/or transition a patient off of opioid-based medications and document why opioid treatment can no longer be prescribed (NIDA, 2020b; Mahajan, 2021; Becker & Starrels, 2021).

IDENTIFYING DRUG-SEEKING PATIENTS

Most patients who complain of pain are honestly seeking relief from discomfort. Others seek drugs in order to cope with addiction or to provide income. Differentiating between the two can be very difficult.

Drug seekers include people of every age, gender, and socioeconomic status. Often these people initially used prescription drugs for valid medical conditions, and drug-seeking behaviors may have developed as a result of disease progression, undertreatment of pain, tolerance to the medication, or unrecognized addiction. Only a small number of drug seekers do so to divert opioids for illicit sale.

There are some common characteristics that can provide clues regarding the nature of a patient’s intent. The patient who is drug seeking may:

• Come from a location that is far away, perhaps across state lines
• Have seen many doctors in a short period of time
• Present with specific complaints that are often subjective (back pain, headache)
• Bring old medical records they have been carrying around to many different doctors to get a pain prescription
• Use multiple pharmacies
• Claim an allergy to all pain medications except the one they are seeking as well as to diagnostic test contrast medium to avoid tests
• Suggest the medication, dose, and quantity being sought
• Be unwilling to consider any other treatments and does not want to listen to anything the clinician has to say
• Call or show up requesting a prescription at off hours, when the office is closing or right before the weekend/holiday when it is less likely their usual care provider(s) can be reached
• Lie or their story does not make sense (it is imperative to take a detailed history to look for inconsistencies in a made-up story)
• Exaggerate symptoms, with inconsistent behavior from waiting room to treatment room
• Become aggressive when different medications are suggested
• Give false information, such as a fake address or a disconnected phone number
• Be on multiple controlled substances, such as opioids and benzodiazepines
• Be excessively talkative, friendly, or helpful

However, drug-seeking patients with addictions are not the only ones who may engage in these behaviors. Over time, patients with true chronic pain can elicit some of these same behaviors (Girgis, 2021).

ADDRESSING DRUG-SEEKING BEHAVIORS

There are a number of strategies healthcare providers can utilize in the management of individuals with drug-seeking behaviors. The following are suggestions made by medical risk management advisors:

• Perform a complete review of the patient’s pertinent history, and conduct a thorough medical evaluation, addressing and documenting all objective signs and symptoms of pain.
• Exercise concern when dealing with patients who are not interested in having a physical examination, are unwilling to authorize release of prior medical records, or have no interest in a diagnosis or a referral.
• Be cautious if a new patient has an unusual knowledge of controlled substances or requests a specific controlled substance and is unwilling to try any other medication.
• Utilize the state prescription monitoring program (PDMP) to identify patients at risk for drug diversion and/or “doctor shopping.”
• Implement a systematic procedure for refilling prescriptions and educating appropriate staff regarding the policy.
• Inform patients verbally and in writing about the medication refill procedure.
• Establish a treatment agreement with the patient that outlines the provider’s expectations, which should address:
• Number and frequency of prescription refill
• Early refills
• Replacement of lost or stolen medications
• Specific reasons for discontinuing or changing the drug therapy
• Consider referral to or consultation with a pain management specialist for patients not responding to the treatment plan.
• Exercise the right to terminate a patient who fails to follow the treatment plan or adhere to the treatment agreement.
  (Jakucs, 2021; Johnson, 2017)

Confronting patients believed to be seeking drugs can be difficult. Confrontation may turn out to be therapeutic, but it can also be dangerous. It is best to avoid confronting a drug-seeking patient alone. The clinician should consider involving psychiatric support, social service assistance, facility security, and in some instances, local law enforcement.

Drug Diversion and Addiction among Healthcare Professionals

Because healthcare professionals are trusted with others’ health and well-being, they are not often suspected of drug addiction themselves; however, they are just as likely as anyone else to become addicted and are at a higher risk for addictive behaviors involving opioids because of their increased access to them.

ADDRESSING DRUG DIVERSION IN HEALTHCARE WORKERS

It is a legal and ethical responsibility for healthcare professionals to uphold the law and to help protect society from drug abuse, and it is a professional responsibility to prescribe and dispense controlled substances appropriately, guarding against abuse while ensuring that patients have medication available when it is needed. Each healthcare professional also has a personal responsibility to protect their practice from becoming an easy target for drug diversion and must be aware of the potential situations where it can occur and the safeguards that can be utilized to prevent such diversion.

Healthcare professionals often avoid dealing with drug impairment in their colleagues. It is natural to be reluctant about approaching such colleagues for fear of their anger since it may result in retribution. Another concern is fear for the colleague’s loss of professional practice. As a result, employers or coworkers can become enablers of those colleagues whose professional competence is being impaired by drug abuse, and thereby are being protected from the consequences of their behavior. Some enabling behaviors include:

• Ignoring poor performance
• Lightening or changing the colleague’s patient assignment
• Accepting excuses
• Allowing oneself to be manipulated
• Being fearful of confronting a colleague if patient safety is in jeopardy

When the signs and symptoms of drug abuse are evident in a colleague, it is time to become concerned and involved, taking the following steps:

• Check the agency’s written drug and alcohol policy and follow recommendations.
• Document suspicions regarding the colleague, including any complaints, concerns, behavior patterns, or witnesses to behaviors.
• Bring concerns to management.

If it is known that drugs are being sold or stolen, it is important not to intervene alone and to contact security or notify the police. If a DEA registrant becomes aware of a theft or significant loss involving controlled substances, it must also immediately be reported to the nearest DEA office, the healthcare worker’s state licensing board, as well as the local police department (U.S. DEA, 2019).

INDICATORS OF DRUG ADDICTION IN THE WORKPLACE

The following signs and symptoms may indicate a drug-related problem in a healthcare professional:

• Recurring absences or tardiness
• Frequent disappearances from the work site, such as long trips to the bathroom or stockroom where drugs are kept
• Excessive amounts of time spent near a drug supply
• Volunteering for overtime and being at work when not scheduled to be there
• Unreliability in keeping appointments and meeting deadlines
• Work performance that alternates between high and low productivity
• Mistakes made due to inattention, poor judgment, and bad decisions
• Confusion, memory loss, and difficulty concentrating or recalling details and instructions
• Ordinary tasks requiring greater effort and consuming more time
• Deterioration in interpersonal relations with colleagues, staff, and patients
• Rarely admitting errors or accepting blame for errors or oversights
• Sloppy recordkeeping, suspect ledger entries, and drug shortages
• Inappropriate prescriptions for large narcotic doses
• Insistence on personally administering injectable narcotics to patients
• Progressive deterioration in personal appearance and hygiene
• Uncharacteristic deterioration of handwriting and charting
• Wearing long sleeves when inappropriate
• Personality changes, mood swings, anxiety, depression, lack of impulse control
• Suicidal thoughts or gestures
• Patient and staff complaints about healthcare provider’s changing attitude/behavior
• Increasing personal and professional isolation
  (U.S. DEA, 2019)

Addressing Pain in Individuals with Substance Use Disorders (SUDs)

Opioid use for pain management for patients with a history of SUDs may be considered if their use is carefully managed. This involves selecting the appropriate opioid, dosage titration, treatment agreements, and testing and monitoring.

When choosing the appropriate opioid, providers should select a medication that is safe and start with a low dose to ease pain, then titrate as needed to maintain pain relief without decreasing function or risking addiction or relapse.

When an effective dose has been determined, total opioid dose is increased slowly and only if needed, as tolerance develops. When monitoring for dosage, providers must be aware of both tolerance and hyperalgesia concerns. Tolerance can occur regardless of opioid type, dosage, route of administration and dosage schedule. Clinicians should be aware that hyperalgesia, or oversensitivity to pain, can occur in some patients using opioids for chronic pain.

When patients develop tolerance to the analgesic effects of a particular opioid, providers can consider either escalating the dosage or switching from one opioid to another, at a low dose that will effectively relieve pain without increasing the risk of relapse.

Before initiating opioid treatment, providers should determine whether the patient has access to a naloxone kit and prescribe one if they do not. (See also “Management of Opioid Overdose” earlier in this course.)

When pain has been resolved, the provider should gradually discontinue opioid therapy. Other reasons for discontinuing opioid treatment include:

• Opioids are no longer effective
• Adverse effects are unmanageable
• The patient does not adhere to the treatment agreement
• The patient is misusing or diverting the medication

If the reason is due to nonadherence to the treatment agreement or misuse of opioids, the patient should be referred for addiction treatment (SAMHSA, 2021).

ASSESSING RISK FOR DEVELOPING SUBSTANCE USE DISORDERS

Before introducing any opioids into a patient’s treatment regimen, an assessment is done to determine the patient’s risk for developing a substance abuse disorder (SUD).

Screening tools available to clinicians include:

• Opioid Risk Tool (ORT)
• Drug Abuse Screen Test (DAST-10 and DAST-20 for adolescents)
• Screener and Opioid Assessment for Patient with Pain-Revised (SOAPP-R)
• Brief Screener for Alcohol, Tobacco, and other Drugs (BSTAD)

These tools, however, commonly result in inaccurate findings and misinterpretations. For instance, since screening tools often rely on a patient’s self-report, a patient may falsify responses on questionnaires to avoid detection as a high-risk patient.

Other recommendations include drug testing, primarily urine screening. Drug testing offers a critical adjunct to clinical assessment of SUD risk. However, due to the ease with which samples can be adulterated, providers must carefully review their collection protocols and sample validation procedures to ensure optimal accuracy, which may require observed collection (NIDA, 2022b; Rosenquist, 2022).