#1. Senate approves $8 Billion “Opioid Crisis Response Act” of 2018 containing over 70 proposals
On Monday, the widely-anticipated Senate approval of the Opioid Crisis Response Act of 2018 became a reality. The total spending allocated is to be about $8 Billion with $4.7 Billion already approved in March and another $3.7 Billion anticipated to be approved next month.
The legislation is a sort of A-Z coverage, across research and development, treatment, recovery, and law enforcement to stop the illegal flow of synthetic opioids into the country.
A summary of what the legislation covers was shared earlier and can be found here.
The next step is to reconcile the Senate version with the one that the House passed in June to then send a final copy to the President for signature.
#2. FDA takes new steps to regulate safety of immediate-release opioid pain medications
The FDA keeps up its flurry of activity to combat the opioid epidemic by announcing this week new steps in their effort as related to approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).
The expanded REMS for the first time now applies to immediate-release (IR) opioid analgesics used commonly in the outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid pain medications as well, which have been subject to a REMS since 2012.
Among several measures, for the first time training is required to be made available to health care providers who are involved in the management of patients with pain (and not only to prescribers). This includes nurses and pharmacists.
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint).
The number of products affected by this week’s action has increased considerably. Previously the ER/LA Opioid Analgesic REMS included 62 products, the modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these new REMS requirements.
#3. HHS issues guidance to use telemedicine in the prescribing of buprenorphine for opioid use disorders
This week while doling out $1 Billion in funding to states related to fighting the opioid epidemic, HHS stepped up calls to leverage all resources particularly telemedicine. Click here to access the HHS guidance document, Telemedicine and Prescribing Buprenorphine for the Treatment of Opioid Use Disorder.
The HHS website states the following:
HHS is working with the Drug Enforcement Administration (DEA) to understand how telemedicine can best be leveraged to expand buprenorphine-based Medication Assisted Treatment (MAT). HHS has developed a clinical case scenario to provide clinicians with an example of clinical practice engagement consistent with the DEA Statement and applicable HHS administered authorities.
- DEA Diversion Control Division E-mail Statement: Use of Telemedicine While Providing MAT
- HHS Clinical Case Scenario
#4. Don’t Punish Pain movement holds nationwide rallies on 9/18 across 34 states
A grassroots effort that has gained momentum is the Don’t Punish Pain organization. The organization is advocating on behalf of all the patients suffering from chronic pain who have found their pain medications unexpectedly taken away from them as an unfortunate consequence of the opioid epidemic.
September 18, 2018 saw 78 rallies held nationwide in 34 states and the District of Columbia. Click here to find out more and how to get involved in this effort going forward.
Many patients who are dealing with chronic pain have found their opioid prescriptions restricted, cut off, or not being covered after a certain limit by payers. The FDA recently announced that they would be revisiting the 2016 CDC prescribing guidelines to be more condition specific. It is hoped that these efforts will result in case-by-case judgment for pain medication prescribing for patients so that no one will be left to suffer on a daily basis and find their ability to function severely restricted. And, while the new guidelines are being developed, it is hoped that the FDA and CDC will advise doctors to appropriately support patients with chronic pain. It is also hoped that all the stories and feedback from participants in the Don’t Punish Pain rallies this week will be used to guide the discussions and policies.