State Leaders Weigh in with the Feds on Opioid Issues

The Governor, Lt. Gov., Speaker, and Senate President

 Opioid prescriptions in the state have decreased by 35% since 2015 and the tragic death toll from opioid overdoses is trending down in Massachusetts. But despite the progress, the healthcare community and state political leaders are not letting up on the issue.
On April 2, Governor Charlie Baker, Lt. Gov. Karyn Polito, House Speaker Robert DeLeo, and Senate President Karen Spilka teamed up to draft a succinct letter to FDA Commissioner Scott Gottlieb, M.D., that contained two asks.
First, the elected leaders wrote, “[T]he FDA should revise the labeling for opioids to return to evidence-based language about the safety and efficacy of these drugs. Despite significant evidence that opioids are only effective for short-term treatment of acute pain, the FDA in 2001 changed the labeling to indicate that these addictive drugs could be prescribed for extended periods of time to treat chronic pain. Those suffering from chronic pain can and should continue to have access to pharmaceutical treatments that can help alleviate their suffering, but it is important that patients and their doctors are informed about the science when making those decisions. The FDA should not wait years for drug manufacturers to conduct studies on the effectiveness of opioids in treating chronic pain; the agency should rely on the significant body of existing research and immediately return to the labeling in place prior to 2001.”
Secondly, the Massachusetts leaders asked the FDA to use its new authority under the recently enacted SUPPORT Act to require “unit of dose packaging” for opioids. That is, dispensing prescriptions for opioids in per-dose packaging (for example, pushing a pill through a foil wrap) as opposed to giving a patient all of the pills in a single container.
“States are on the front lines of the opioid epidemic, but we cannot do this alone,” the Bay State leaders wrote.

The Attorney General

Massachusetts Attorney General Maura Healey joined 38 other AGs in signing a letter to the U.S. Department of Health and Human Services (HHS) criticizing the department for issuing draft opioid prescribing guidelines that vary from components of the 2016 guidelines that the Centers for Disease Control and Prevention (CDC) issued.
In general, the CDC guidelines call on prescribers to follow evidence-based recommendations for dispensing opioids, while HHS’s proposed guidelines leave dispensing decisions solely to the provider.
The AGs’ sharply worded letter say it is “incomprehensible that officials would consider moving away from” the CDC’s 2016 guidance.
The 39 AGs say they are concerned that the new rules downplay the risk of high-dose opioids, fail to acknowledge that “longer duration prescriptions increase patients’ risk for misuse,” and “provides no justification for moving away from the CDC recommendation that clinicians should avoid prescribing opioids and benzodiazepines concurrently whenever possible.”
“Since the CDC Guideline was issued, the evidence has continued to mount that opioids achieve limited pain relief for chronic non-cancer pain and are often no better than other options for treating acute pain,” the letter states. “… As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment that causes nearly 50,000 deaths annually.”
MHA, working with experts from its member hospitals and allies across other healthcare entities, has in recent years created evidence-based guidance for healthcare professionals to follow in an effort to curb substance use disorder. MHA has assisted hospitals in creating programs for Medication for Addiction Treatment within the Emergency Department, Opioid Management within a Hospital Setting, Emergency Department Opioid Management, and for Preventing Opioid Misuse in Hospitals. Information about these initiatives is located on PatientCareLink.