By Pat Anson, PNN Editor
President Trump this week signed into law the Support for Patients and Communities Act, a comprehensive and mostly bipartisan legislation that combined over 70 bills passed by Congress aimed at fighting the opioid epidemic.
"Together we are going to end the scourge of drug addiction,” Trump said at a bill-signing ceremony at the White House. “Or at least make an extremely big dent in this terrible, terrible problem.”
While most of the Support Act is aimed at slowing the flow of illicit drugs and subsidizing the $35 billion dollar addiction treatment industry, there are some key elements that will affect millions of Americans who take opioids for chronic or acute pain.
Most are designed to limit access to opioid medication and further reduce the supply, which has nearly been cut in half since 2016.
The new law authorizes the Food and Drug Administration to require that some opioids be dispensed in so-called “blister packs” to limit the number of pills that can be prescribed and dispensed at one time. That type of packaging would primarily be for patients with short-term, acute pain who need only a few days’ supply. But it could also lead to a standardization of doses and make refills more difficult for patients who are slow to recover from surgery or trauma.
“The doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate,” said FDA commissioner Scott Gottlieb, MD, in a statement.
“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”
The Support Act also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal options. The goal again is to get unused medications out of medicine cabinets where they could be stolen or diverted.
The new law also supports an effort recently launched by Gottlieb to develop opioid guidelines for acute pain. The guidelines won’t replace or change the CDC’s controversial guideline for chronic pain, but they will be developed with more transparency. Gottlieb has instructed the National Academies of Sciences, Engineering, and Medicine to hold a series of public meetings and to seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.
The Support Act also gives more authority to the FDA to require longer post-market studies on the safety and efficacy of drugs. Current evidence on the long-term use of all pain medication – not just opioids – is extremely limited. That has led to exaggerated claims from opioid critics that there is “no evidence” that opioids are safe or effective long term. Those same critics often call for greater use of non-opioid medications, such as gabapentin and pregabalin, when there is little long term evidence to support their use either.
The Support Act also calls on other federal agencies to enact measures to prevent the diversion and abuse of opioids and other controlled substances:
All prescriptions for controlled substances covered under Medicare Part D or Medicare Advantage must be transmitted electronically starting Jan. 1, 2021.
The Department of Health and Human Services (HHS) will develop guidelines for pharmacists to decline to fill prescriptions they think may be fraudulent or questionable.
Medicaid programs will be required to have “safety edits” in place for opioid refills and to monitor the concurrent use of opioids with potentially risky drugs such as benzodiazepines.
A web portal will be created to allow communication between HHS, CMS and Medicare Advantage insurers to share information about providers under investigation for inappropriate prescribing of opioids.
HHS will develop guidelines to allow the inclusion of opioid addiction history in patient electronic health records.
One pain management expert cautioned that some provisions of the Support Act put too much of an emphasis on opioid medication.
“Excessive focus on reducing opioid supply in the legislation can lead to more harm than good. We cannot continue to ignore the needs of people in pain at the expense of preventing illicit drug use,” Lynn Webster, MD, past president of the American Academy of Pain Medicine told Pain Medicine News.
“We have seen draconian steps by the VA (Department of Veterans Affairs) and other payors to force opioid reduction in patients who have been stable and functional for years. This is cruel and simply not right. My hope is that the act is implemented with compassion for people with addiction and pain, but that they allow science and not prejudices and politics to inform policy.”