Journal Article Annotations
2017, 4th Quarter
Annotation by Sean Heffernan, MD
Type of study: Not a study, but rather final order of action
The finding: Every fall, the DEA proposes production quotas of scheduled substances. Enforcement of such quotas is an important means to control diversion of scheduled substances. The quotas aim to provide the sufficient amount of available substances, while avoiding excess that could be susceptible to diversion. Sales figures from IMS Health indicate a decline in demand, according to the DEA, so for the second consecutive year the quota will significantly decrease.
On November 8, 2017, Robert W. Patterson, Acting Administrator of the DEA, issued the final order that initial 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act will decrease by approximately 20%.
While annual quotas have been standard, this announcement is especially significant as it is part of a multifaceted approach to lower the rate of opioid diversion and abuse.
The reduced quota was initially proposed in August (Fed Regist. 2017 Aug 7;82(150):36830-4. Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018. Drug Enforcement Administration, Department of Justice.), and was subject to public comments, many of which expressed concern that this would limit access to opioids for people with medical indications for their use.
Strength and weaknesses: N/A
Relevance: There has been widespread concern that the lower quota has increased the potential for hospital shortages of opioids. Some patients with pain have already encountered access issues.
In August, then-Acting Administrator Chuck Rosenberg emphasized the role of prescribers to limit the circulation of opioids: “Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use… More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions” (https://www.dea.gov/divisions/hq/2017/hq080417.shtml). A prescription drug monitoring program (PDMP) is an electronic database that tracks controlled substance prescriptions. PMDPs aim to inform physicians of other medicines a patient has been prescribed and can contribute to assessment of medication-taking behavior.
Taking these ideas together, one might infer that the next steps will include increased focus on use of available non-opioid/non-scheduled medications for chronic pain relief, further development of new non-opioid medication options, and greater integration of non-medication interventions for chronic pain.
Of note, this is not the first time the DEA quota system has been used to limit the production and supply of a controlled substance. The DEA began to decrease the available production of methaqualone (Quaalude) in 1973, and ultimately discontinued its availability in 1985.