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.
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.
The New Mexico Department of Health Indicator-Based Information System (2022) reports that:
- Eight of the 10 leading causes of death in New Mexico are at least partially related to the abuse of alcohol, tobacco, or other drugs.
- New Mexico has the highest drug-induced death rate in the nation.
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.
- 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.
- 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.
- When starting opioid therapy for acute, subacute, or chronic pain, prescribe immediate-release opioids instead of extended-release and long-acting (ER/LA) opioids.
- 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.
- 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.
- When opioids are needed for acute pain, prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
New Mexico Board of Nursing Rules for Management of Chronic Pain with Controlled Substances
The following rules are to be used to determine whether an advanced practice nurse’s prescriptive practices are consistent with the appropriate treatment of pain.
RULES
Pain management for patients should include a contractual agreement and the use of drug screens prior to treatment with opiates and during the course of treatment to identify actual drugs being consumed and to compare with patients’ self-reports. If concerns about misuse are identified, the patient will be referred for appropriate consultation and scheduled for reevaluation at appropriate time intervals.
The prescribing, ordering, administering, or dispensing of controlled substances to meet the individual needs of the patient for management of chronic pain is appropriate if prescribed, ordered, administered, or dispensed in compliance with the following:
- Obtain a complete history and physical examination that includes:
- Psychological status
- Pain status
- Previous history of significant pain
- Past history of alternative treatments tried
- Potential for substance abuse
- Coexisting diseases or medical conditions
- Medical indications or contraindications against use of a controlled substance
- Be familiar with and use screening tools and the spectrum of available modalities in the evaluation and management of pain; and consider an integrative approach to pain management specialists including but not limited to:
- Acupuncturist
- Chiropractor
- DOM (Doctor of Oriental Medicine)
- Exercise physiologist
- Massage therapist
- Pharmacist
- Physical therapist
- Psychiatrist
- Psychologist
- Other APN
- Develop a written treatment plan tailored to meet individual patient needs.
- Consider the patient’s age, gender, culture, and ethnicity.
- Clearly relate the objectives to be used for evaluation of treatment:
- The degree of pain relief to be expected
- Improved physical and psychological function
- Other accepted methods
- Include a statement of need for further testing, consults, referrals, or use of other treatment modalities.
- If pain relief plateaus on controlled substance analgesic(s), the treatment plan should include an evaluation of continuing or tapering the controlled substance therapy.
- Provide education and discussion about risks and benefits of using controlled substances to patient, surrogate, or guardian; document this education in the patient’s record.
- Keep complete and accurate records of care provided and drugs prescribed.
- When controlled substances are prescribed, the name of the drug, quantity, and prescribed dosage should be recorded. Prescriptions for opioids shall include indications for use.
- For chronic non-cancer pain patients being treated with controlled substances, use a written agreement for treatment outlining patient’s responsibilities, including the use of one practitioner and one pharmacy for all chronic pain management prescriptions whenever possible
- Management of patients needing chronic pain control requires monitoring by the attending or consulting practitioner.
- The practitioner shall periodically review:
- The course of treatment for chronic non-cancer pain
- The patient’s state of health
- Any new information about the etiology of the chronic non-cancer pain at least every 3 months
- In addition, advanced practice nurses (APN) should consult, when indicated by the patient’s condition, with healthcare professionals who are experienced in chronic pain control. Such professionals need not specialize in pain control. For assessment of benefit and need, consultation should:
- Occur early in the course of long-term treatment
- At reasonable intervals during continued long-term treatment
- Drug screening is expected and should be done when other factors suggest an elevated risk of misuse or diversion.
- If, in the practitioner’s opinion, a patient is seeking pain medication for reasons not medically justified, the practitioner is not required to prescribe controlled substances for the patient.
(NMAC, 2022)
NEW MEXICO PRESCRIPTION MONITORING PROGRAM (PMP)
Any advanced practice nurse (APN) who holds a federal Drug Enforcement Administration registration and a New Mexico controlled substance registration shall register with the Board of Pharmacy to become a regular participant in PMP inquiry and reporting.
Prior to prescribing or dispensing a controlled substance for the first time to a patient for a period greater than four days, or if there is a gap in prescribing for 30 days or more, a PMP report must be reviewed for the preceding 12 months. When available, similar reports from adjacent states should be reviewed.
A PMP report shall be reviewed and documented at least once every three months during continuous use of a controlled substance for each patient.
An APN does not need to obtain and review a PMP report prior to prescribing, ordering, or dispensing a controlled substance to a patient for a period of four days or less, to a patient in a nursing facility, or to a patient in hospice care.
Following review of the PMP report for a patient, the APN shall identify and be aware of a patient who is currently:
- Receiving opioids from multiple prescribers
- Receiving opioids for more than 12 consecutive weeks
- Receiving more than one controlled substance analgesic
- Receiving opioids totaling more than 90 morphine milligram equivalents per day
- Exhibiting a potential for abuse or misuse
Upon recognition of any of these conditions, the APN, using professional judgement based on prevailing standards of practice, shall take action as appropriate to prevent, mitigate, or resolve any potential problems or risks that may result in opioid misuse, abuse, or overdose (NMAC, 2022).
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).
Indications of Opioid Use Disorder
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.
PAIN MANAGEMENT AGREEMENT
A pain management agreement documents the understanding between a prescriber and a patient regarding prescribed medications being taken for pain management. Its purpose is to prevent misunderstandings about certain medications and to help the prescriber and patient comply with laws regarding controlled substances. A typical pain management agreement:
- Requires the patient to use one pharmacy only for all prescription refills
- Identifies expected benefits of medications and the risk associated with their misuse
- Lists the possible side effects that can occur
- Requires notification when the same or similar medication is prescribed by other healthcare providers
- Lists the conditions for issuing refills or replacement prescriptions
- Requires regular evaluations of pain
- Requires random screenings for misuse of medication
- Describes the conditions under which therapy can be changed or discontinued
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).
NEW MEXICO RULES FOR TREATING PATIENTS WITH SUDs
The New Mexico Board of Nursing rules require advanced practice nurses licensed to practice in an opioid treatment program to:
- Review a Prescription Monitoring Program (PMP) report upon a patient’s initial enrollment into the opioid treatment program
- Review a PMP report every 3 months thereafter while prescribing, ordering, administering, or dispensing opioid treatment medications for the purpose of treating opioid use disorder
- Document the receipt and review of a report in the patient’s medical record
(NMAC, 2022)