Life Science Compliance Update

March 21, 2016

CDC Releases Guidelines for Prescribing Opioids

The dramatic increase in overdose deaths due to opioids has been a major focus of political and medical leaders over the last few months, and the Center for Disease Control and Prevention recently released new guidelines for practitioners to think twice before prescribing opioid medications for their patients.

The guidelines, which are voluntary, ask primary care providers who are treating adults with chronic pain to consider alternatives to prescription painkillers such as oxycodone and hydrocodone, to limit treatment length, and to monitor their patients to see if the opioids are the best choice for them.

Even though the guidelines are nonbinding, they are important because they are a broad blueprint addressing opioid use. Some believe that doctors may begin to fear lawsuits if they do not follow them, and that insurance companies may begin to use them to determine reimbursement.

The guidelines, which are not meant to be applied to patients who suffer from terminal illness or to patients who have had surgery, call for doctors to first try ibuprofen and aspirin to treat pain and that opioid treatment for short-term pain last for three days and rarely longer than seven. In current practice, by contrast, patients are often given two to four weeks' worth of pills.

Dr. Thomas R. Frieden, the director of the CDC, stated, "it has become increasingly clear that opioids carry substantial risk but only uncertain benefits – especially compared with other treatments for chronic pain," on a phone call with reporters. He believes that "prescription opioids are just as addictive as heroin," and that prescribing opioids should be a "momentous decision."

The Guidelines

The Guidelines include twelve recommendations, with three noted by the CDC as "especially important" to assuring safety: non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care; when opioids are used, the lowest possible effective dosage should be prescribed to reduce risks of opioid use disorder and overdose; and providers should always exercise caution when prescribing opioids and monitor all patients closely.

The twelve recommendations are divided into three categories and are as follows:

  1. Opioids are not first-line therapy. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy, as appropriate.
  2. Establish goals for pain and function.
  3. Discuss risks and benefits, both before starting, and periodically during, opioid therapy.
  4. Use immediate-release opioids when starting.
  5. Use the lowest effective dose.
  6. Prescribe short durations for acute pain.
  7. Evaluate benefits and harms frequently. The first evaluation should be done within 1-4 weeks after starting opioid therapy, and at least every three months thereafter.
  8. Use strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use, are present.
  9. Review prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at a high risk for overdose. Clinicians should review the PDMP data when starting opioid therapy and at least every three months, sometimes more often.
  10. Use urine drug testing.
  11. Avoid concurrent opioid and benzodiazepine prescribing.
  12. Offer treatment for opioid use disorder.

The CDC has also created a checklist for providers to use when prescribing opioids for chronic pain, which can be found here.

Reaction

As with any large change, reactions run the gamut. Some groups, like the American Medical Association, "remain concerned" that the science justifying some of the recommendations was sparse and that the guidelines conflict with state laws.

However, several doctors groups have come out in favor, saying that the regulations provide backup for doctors and provide additional ways to educate their patients about the possible dangers with opioids.

Even members of Congress with a vested interest in the opioid epidemic have spoken out on the guidelines. House Energy and Commerce Committee Chairman Fred Upton and Health Subcommittee Chairman Joseph Pitts, who held half a dozen hearings on the topic over the past year alone, issued a joint statement on the topic,

"We look to build upon our efforts in the coming weeks as our members have introduced a number of meaningful solutions. There is no doubt that evidence-based guidelines should be developed so providers remain ever vigilant about the dangers of addiction when treating patients with pain. Today the CDC issued a number of recommendations for the treatment of chronic pain in primary care settings. While we are still reviewing the details, we look forward to working with CDC, FDA, NIH, and other stakeholders to strengthen the evidence-base and continuously improve best practices for pain management."

The CDC will continue to work with individual states, communities and prescribers to prevent opioid misuse and overdose by tracking and monitoring the epidemic and helping states with effective prevention and treatment programs. CDC will also continue to improve patient safety by giving healthcare providers data, tools, and guidance, to help them make informed treatment decisions.

Health and Human Services Secretary Sylvia Burwell has also made the opioid epidemic a priority. There is an evidence-based HHS-wide opioid initiative with a focus on three "priority areas": informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose), and expanding access to and the use of Medication-Assisted Treatment to treat opioid use disorder.           

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