Opioid Best Practice Checklist

Although evidence is insufficient and called into question, opioids can be effective for carefully selected and managed patients as part of pain management. Functional improvement is the primary endpoint; pain reduction is one means to achieve that goal. This is a guide to risk managing potentially life-threatening opioid outcomes: non-medical use, addiction, respiratory depression, cardiac events, overdose, and overdose death. Not addressed here are other adverse events. The strength of recommendations is variable but based on the best evidence available, though the literature generally addresses the risk management elements independently and not in combination. For example, it is unknown if single pharmacy requirements help when Prescription Drug Monitoring Programs (PDMPs) are used or if dose-related overdose risk remains elevated when risk management elements are employed. Opioid risk management – also useful for benzodiazepines, stimulants, cannabinoids – is a stepwise process as follows:

Risk Evaluation

Initial visit and ongoing

Since patient report alone is inadequate, use multiple means (clinical interview and tools) to identify risks, resilience:

  1. Obtain patient history corroborated by family, friends, medical records:
    1. Caucasian Male Younger age: < 65 years old but especially < 30 years old
    2. Personal history of opioid use problems: Abuse/Addiction Aberrancies
      Use of multiple prescribers or pharmacies identified through the PDMP
    3. Personal history of other addiction-prone substance problems identified through SBIRT
      Tobacco, Alcohol, Cannabis, Cocaine, Illicit drugs
      Secondarily screen for problematic substance use: Tobacco, Alcohol, Cannabis, Drugs
    4. Personal history psychiatric/mood: Depression, Anxiety, PTSD, BPD, Psychosis
    5. Personal history: sexual trauma, Respiratory Sleep Apnea, memory problems, Hepatitis, legal problems
    6. Concurrent sedating/respiratory depressant medications, notably benzodiazepines
    7. Family history of substance use problems
  2. Consider risk screening tools: SOAPP (best validation) ORT Other
  3. Examine the patient for active substance abuse and mood indicators
  4. Test urine/oral fluid: Point of care → Definitive testing: GC/MS or LC/MS-MS
  5. Consider calculated daily morphine equivalent dose of opioids, wary that low dose prescribing poses risk

Risk Stratification

Initial visit and ongoing
Based on risk evaluation, assign a level of risk for controlled substance use – Low, Intermediate, High – which determines if the patient might 1) not be an opioid candidate; or 2) be a candidate for opioids less addiction-prone (e.g., buprenorphine, methadone, tramadol, tapentadol); or 3) be a candidate for standard opioids. If opioids are prescribed, the level of risk then determines the frequency of monitoring (below).

Risk Mitigation

Initial visit and ongoing
Strategies to help prevent and limit negative consequences to prescribed opioids going forward:

  1. Establish realistic goals of opioid therapy: typically 30% pain and functional improvement that are personalized
  2. Employ opioid-sparing strategies: non-opioids, interventions
  3. Provide patient education and informed consent: how to use opioids, risks, benefits, alternatives
  4. Educate the patient about medication security: Secure storage, safe disposal
  5. Consider abuse-deterrent formulations which may benefit individual patients, but perhaps not community wide
  6. Prescribe the lowest dose necessary to achieve goals
  7. Prescribe naloxone (IM / IV, auto-injector, nasal spray) and provide overdose rescue education
  8. Test for hypoxia in at-risk patients: nocturnal oximetry, sleep studies
  9. Consider specific opioid risks, notably methadone (↑overdose death rate) and oxycodone (greater likability)
  10. If high dose, consider opioid-induced hyperalgesia and pharmacogenetics → consider opioid taper or switching
  11. For methadone ensure QTc acceptably low on the EKG
  12. Controlled Substance Agreement as a communication tool to catalog:
    1. Single controlled substance prescriber, possibly also psychiatrist (benzodiazepine)/surgeon (peri-operative)
    2. 1-2 pharmacies to be used exclusively by the patient
    3. Exceptions and process for emergent opioid needs
    4. Refill expectations and process
    5. Monitoring expectations and process
    6. Prohibited patient behavior specifically addressing alcohol, cannabis, illicit drugs
    7. Potential responses to aberrancies

Risk Monitoring

Follow-up visits regularly: monthly but can be up to 3 months in stable, non-aberrant situations

  1.  Inquire about and observe for opioid efficacy: function and analgesia
  2. Inquire about and observe for behavioral aberrancies. (Tools: Addiction Behaviors Checklist, COMM)
  3. Inquire about and observe for psychiatric/mood problems . (Tools: PHQ-2, PHQ-9)
  4. Review online PDMP regularly
  5. Random, regular urine or oral fluid drug testing with definitive GC/MS or LC/MS-MS testing
    Low risk: 1-2 per year, Moderate risk: every 3-4 months, High risk: every 1-3 months or more
  6. Consider controlled substance product counts (pills, films, patches, etc.)
  7. Consider evaluation for opioid-induced change in respiratory safety with nocturnal oximetry, sleep studies
  8. For methadone ensure QTc remains acceptably low after dose changes, new medications, annually

Risk Aberrancy Management

As aberrancies are identified
Pseudoaddiction can occur, but allowing egregious or frequent aberrancies simply enables poor outcomes.
Balanced responses should be proportionate to aberrancy severity, frequency, and type, including:

  1. When possible, retain the patient in her/his medical home, maintaining treatment alliance while changing plans:
    1. Leveraged adherence coaching with increased monitoring + an ultimatum
    2. Referral to an addiction, psychiatric, or pain specialist
    3. Taper→discontinue opioids and/or other controlled substances
      Treat opioid withdrawal, using the Clinical Opioid Withdrawal Scale to determine withdrawal severity
  2. When necessary, terminate the patient from the practice in a proper, respectful, and therapeutic manner to encourage subsequent treatment adherence and aberrancy resolution with the patient’s new provider

Laws, Regulations, Policies

  1. National and state-by-state pain statutes & regulations (Accessed 4/1/16)
  2. DEA FDA CDC Opioid Guide 2016 Office of National Drug Control Policy (Accessed 4/1/16)
  3. Legal Side of Pain (Accessed 9/5/15)

Team-Based Approach

  1. Medical home model, building out a multidisciplinary, coordinated team of providers for the patient
  2. Document thoroughly and provide records to team members with particular attention to a mechanism to accumulate and track aberrancies as well as responses to aberrancies
  3. Continuously communicate and coordinate care planning with other providers and pharmacists involved in the patient’s care with all essential information efficiently and in compliance with HIPAA, the Federal confidentiality statute (42 C.F.R. Part 2) and state regulations.

2016 North Colorado Health Alliance