Utilizing risk management
REMS is not a four-letter word
by Steven Wright, MD
In 2007 the FDA Amendments Act authorized the FDA to develop legally enforceable Risk Evaluation and Mitigation Strategies (REMS) for pharmaceutical companies to ensure safe medication use. Physicians, in turn, face certain downstream obligations when it comes to medication safety and responsible prescribing, especially when it comes to opioids.
When the treatment of pain generators is unresponsive for more than three to six months, the chronic pain diagnosis is used to reflect the inability to heal; this occurs daily and indefinitely for 25 million Americans. The opium poppy has been known to provide analgesia for thousands of years and has received over-amped accolades by many like Sir William Osler calling it “God’s own medicine.” Evidence of long-term efficacy, while generally considered insufficient, can be seen in clinical practice. However, the past injunctive to regard pain as a vital sign – misconstrued to demand opioids – paired with a disregard of addiction became a substrate for the current crisis.
What, then, are clinicians to do if opioids are to be considered at all?
Risk management is a stepwise process that can reduce the likelihood of negative outcomes, and includes:
1. Risk Screening
2. Risk Stratification
3. Risk Mitigation
4. Risk Monitoring
5. Aberrancy Management
Initial risk screening begins with identifying major risk factors: a personal and family history of substance use disorder, and a personal history of psychiatric problems / sexual trauma. Current use of addiction-prone substances is determined with drug testing, the online prescription drug monitoring program database (PDMP), and patient report (SBIRT: Screening Brief Intervention and Referral to Treatment) corroborated by family, friends and medical records. For those reporting substance use, secondary screeners can help determine problematic use of alcohol (Alcohol Use Disorders Identification Test, or AUDIT), cannabis (CUDIT), and other drugs (DUDIT). Risk for future opioid-related aberrancies can be addressed with imperfect screeners, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP), which has the best validation.
Medical judgement takes all this into account to determine risk stratification, which assigns a level of controlled substance risk: low, intermediate or high. This estimate will, in turn, help determine the frequency and type of monitoring. If the risk is high, controlled substance use should proceed cautiously – if at all.
If the decision is made to proceed with opioid therapy, risk mitigation is performed to minimize future risks by following these steps:
1. Goal setting for function and analgesia
2. Regular opioid sparing trials
3. Informed consent: risks, benefits, alternatives, use
4. Lowest opioid dose necessary, tracked by Morphine Equivalent Dose calculation
5. Abuse deterrent formulation considerations (debated)
6. Medication security (storage, disposal) instructions
7. Naloxone prescription with overdose rescue instructions
8. Controlled Substance Agreement outlining expected/prohibited behavior, monitoring permissions, and potential responses to aberrancies
If the decision is made to prescribe opioids, then this should be done on a trial basis only and ongoing safe use should be addressed through risk monitoring, which includes:
1. Behavioral aberrancy surveillance through patient report and observation – the Clinical Opioid Misuse Measure is useful
2. Online PDMP review
3. Definitive drug testing
4. Pill counts
5. Screening with overnight oximetry for nocturnal hypoxia
6. QTc interval on the EKG if methadone is prescribed
If opioid-related aberrancies are identified, then aberrancy management responses include:
1. Adherence coaching
2. Specialty referral: pain management, addiction, psychiatry
3. Opioid discontinuation
4. Discharge from the practice as a last resort
Einstein once said, “Keep things as simple as possible…but not simpler.” This risk management model is trimmed to limit complexity without losing the best practice elements. Keep it simple by seeing patients monthly (rarely more often) to address the “5 A’s”: analgesia, adverse events, activities of daily living (function), affect (mod) and aberrancies. Keep it simple by understanding and running interference on your own tendency to over- or under-trust, to over- or under-prescribe.
Our obligation, though, is not so simple; overdose deaths rose 15 percent in each of the last two years for which we have data (2014, 2015). Disheartening, as there has been so much effort to reverse this trend. On the other hand, since in up to 80 to 95 percent of overdose fatalities there were indicators of addiction prior to death, thoughtful risk management – REMS – if widely employed, might play an important part in identifying those with Opioid Use Disorder, moving them off standard opioids, and assisting them into a recovery process, ultimately saving lives.
Not too bad for a four-letter word. REMS: Don’t let patients head to the pharmacy without it.
Posted in: Colorado Medicine | Initiatives | Prescription Drug Abuse