The Opioid Crisis: A Call to Action

Rx/Pharmacy on March 25, 2016
Posted by Abidemi Oyebode, R.Ph., MBA - Clinical Pharmacist

The National Survey on Drug Use and Health (NSDUH) showed that in 2012 about 2.1 million Americans were addicted to opioid pain medications, roughly 467,000 addicted to heroin and about 2.5 million Americans with opioid use disorder but receiving legitimate prescriptions.  According to the CDC, opioids were involved in 16, 235 deaths in 2013 and 28,647 deaths in 2014 and overdoses from opioids have quadrupled from since 2000.  This is a crisis.

In the late 1990s, the notion was that there is no ceiling on maximum doses for opioids even for non-cancer pain.  This lead to guidelines and regulations for opioid prescribing that was quite liberal.  Washington state, for example, had verbiage in its state administrative code to the effect that disciplinary action would not be taken against prescribers as a result of the quantity or frequency of opioids prescribed. The opioid crisis that has ensued has shown that more stringent guidelines and oversight is needed to tackle this problem.

The CDC unveiled its long-awaited guideline for opioid prescribing in chronic pain sufferers, excluding patients who are actively receiving cancer treatment, or palliative care.  The recommendations address the lack of consistency in opioid prescribing practices among primary care providers in an effort to curb over-prescribing of opioids.  The twelve recommendations, described below, fall within three main areas – Determining when to initiate or continue opioids for chronic pain, Opioid selection dosage, duration, follow-up, and discontinuation, and Assessing risk and addressing harms of opioid use.

Determining when to initiate or continue opioids for chronic pain

  1. Start with Non-pharmacologic and non-opioid pharmacologic therapy
    • Non-opioid medications such as NSAIDS* (Ibuprofen, naproxen) or acetaminophen should be considered before opioids
    • If opioids used, then should be in conjunction with non-opioid medications and non-pharmacologic therapy such as massage, relaxation, acupuncture
  2. Establish treatment goals prior to initiating therapy
    • Set realistic goals for pain and function
    • Continue opioids only if benefits do not outweigh risks and clinically meaningful improvement is observed
  3. Discuss realistic benefits and risks of opioid therapy with patients prior to and during therapy

Opioid selection, dosage, duration, follow-up, and discontinuation

  1. Start opioid therapy with immediate-release formulations instead of extended-release or long-acting formulations
  2. Start low; go slow
    • Start at the lowest effective dosage
    • Reassess benefits vs. risk when increasing to doses greater than or equal to 50 morphine milligram equivalents (MME)/day
    • Doses greater than or equal to 90 MME/day should be avoided
  3. Opioids for acute pain should be for immediate release formulations and for a quantity no greater than needed for expected duration of pain.
    • Acute pain duration should be for three days or less and typically, no more than seven days
  4. Assess patient within 1 to 4 weeks of starting opioid therapy
    • Evaluate benefits vs. risk at least every 3 months
    • If benefits do not outweigh harm, taper and discontinue opioid

Assessing risk and addressing harms of opioid use

  1. Prior to and periodically during therapy, evaluate risk factors for opioid related harm
    • Establish strategies to mitigate risk including offering naloxone when factors that increase risk for opioid-related overdose are present
  2. Use state prescription drug monitoring program (PDMP) to review history of controlled substance prescriptions
    • Recommended at the initiation of therapy and periodically throughout therapy
  3. Use urine drug testing to assess for prescribed medications and illicit drugs
    • Initiated at the start of therapy and at least annually thereafter
  4. Avoid prescribing opioids with benzodiazepines
  5. Offer or arrange for treatment for opioid use disorder
    • Evidenced based treatment typically medication-assisted with buprenorphine or methadone, as well as behavioral therapy

The guidelines introduce a much needed roadmap for opioid prescribing in the treatment of chronic pain by primary care physicians (PCP).  PCPs, typically the initial entry point for chronic pain patients, could benefit from increased education in the treatment of chronic pain that includes evidence based non-pharmacologic options.  According to the CDC, primary care providers account for approximately half of all opioid prescribing in the United States, so the guideline is geared mainly towards them.  While not mandatory, some believe that these recommendations will become the standard for chronic pain management, in non-oncologic, non-palliative care patients, given the clout of the CDC.

Many agencies were given an opportunity to weigh in on these recommendations prior to the release of the final document.  Though in favor of some of the regulations, one concern echoed by agencies, like the American Academy of Family Physicians (AAFP) and the American Medical Association (AMA), was the poor, or in some cases lack of, evidence supporting some of the recommendations notably the three day and 90 morphine milligram equivalent/day limits.  The American Society of Health-System Pharmacists (ASHP) would like to see a more robust prescription drug monitoring policy that includes a national network that allows providers and pharmacists to track opioid use.

For states that have introduced regulation to combat prescription opioid abuse, the CDC recommendations should not usurp state law.  But, there is concern that these recommendations will be used by insurance companies or lawmakers to define opioid prescribing limits.

The CDC is not the only agency weighing in with a response to the opioid crisis.  As part of the effort to increase awareness about the potential dangers of opioids, the FDA is requiring a black box warning, on immediate release formulations, of the risks abuse, addiction, overuse, misuse, and death.  The FDA is also requiring that a warning about the risks of neonatal opioid withdrawal syndrome (NOWS) in chronic opioid use during pregnancy be included.  Warnings about the effects of opioids on the endocrine system (causing conditions such as adrenal insufficiency) and effects on sex hormone levels (androgen deficiency) will also be included.  Though, some of these warnings were part of the 2013 FDA labeling standards for long acting and extended release opioid formulations, they are now required for immediate release formulations as well.  The FDA is also requiring the indication be updated to reflect that immediate release opioid formulations should only be used for pain severe enough for opioids, and refractory to alternative treatment options such as non-opioid analgesics, and opioid combination products.  Lastly, the FDA is requiring that all opioid formulations to include information about safety concerns due to interaction with other drugs that can lead to serotonin syndrome, a condition that affects the central nervous system.

It is without a doubt that we are a nation with an opioid crisis that will require many agencies coming together to resolve.  A key issue is the lack of understanding about safe prescribing of opioids.  Certainly, agencies like the FDA and CDC help provide guidance but more needs to be done to get this crisis under control including better prescribing guidelines, which the CDC is attempting to tackle, a more robust PDMP that mandates physician registry/use, and increased prescriber education, especially around overdose and the use of medication-assisted dependency treatment.  Regardless of which side of the argument one is on, the CDC guidelines present a starting point to help curb opioid over-prescribing by primary care physicians.  More information on these guidelines and additional physician resources can be found on the CDC website