By Ronald S. Litman
In January 2020, the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA (AADPAC) met jointly with the Drug Safety and Risk Management Advisory Committee (DSaRM) to consider approval of three opioid-related new drug applications (NDAs).
This year I began a two-year appointment as Chair of the FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC). Our committee is asked to convene several times a year to discuss and advise the FDA on new drug applications (NDAs) related to the practice of anesthesiology and pain management.
Most AADPAC meetings are held to discuss novel opioid formulations, such as abuse deterrent opioid formulations (ADFs). On some occasions, the meetings do not concern NDAs, but are held to provide our opinions to the FDA about opioid-related topics such as naloxone availability, or the effectiveness of the TIRF (transmucosal immediate release fentanyl) REMS (risk evaluation and mitigation strategy) program.
This June we will discuss the utility and safety high dose opioids in the outpatient setting. Advisory committees are convened at the discretion of the FDA, but in 2016, as part of the Opioids Action Plan, FDA expanded the use of the AADPAC to include all NDAs that are either non-ADF opioids, or ADF opioids that “raise novel issues”. Read More
Recent studies have highlighted the inherent susceptibility for medication errors by anesthesia providers in the perioperative environment. In a prospective survey at Massachusetts General Hospital, investigators identified a concerning potential error rate of 1 in 20 medication administrations, many of which resulted in patient harm.
To those of us who toil daily in the trenches of the operating room, this come as no surprise, for we are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels and administers the medications, independently and without secondary verification or use of technologic support. In one sense this may seem to be an advantage, for if there are fewer intermediaries, such as pharmacists or registered nurses, there are fewer humans to make a mistake. On the other hand, more intermediaries or additional verification might identify previously unrecognized errors. Read More
Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.
Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.
In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More
The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.
Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?