2017: The Year of Reduced Opioid Manufacturing
In the wake of increased opioid overdose and dependence, the United States Drug Enforcement Administration (DEA) recently announced the amount of opioid medication to be produced in 2017 will be reduced.
Next year, production for nearly every schedule II opiate and opioid medication will be reduced by at least 25%. For example, the amount of hydrocodone produced in 2017 will be 66% of 2015’s level.
The Final Order from the DEA established the 2017 Aggregate Production Quota (APQ). This reduces the amount of morphine, fentanyl, oxycodone, hydrocodone, hydromorphone, and other opiate-based medications. It contains the total amount of each controlled substance to meet current needs for scientific, medical, research, industrial, export, and maintenance of current reserve stock.
IMS Health sales data indicates there is less of a demand for these medications. The need is based on the number of prescriptions written by DEA-registered practitioners. Though the manufacturing reduction is in part a result of the increased concern about abuse and opioid-related deaths, it is also related to the fact that the CDC released guidelines earlier in 2016 suggesting these prescriptions be reduced as part of chronic pain treatment. But the majority of the reduction for 2017 comes as a result of eliminating the 25% buffer included in the 2013-2016 APQs to protect against medication shortages.
The APQ system is meant to provide enough of a supply of medication so that all legitimate medical needs for schedule I and II medications are met, but to limit the amount available for diversion. These quotas are established every year for more than 250 controlled substances, and can change from one year to the next, based on a number of factors.
Once the APQ is set, the DEA decides what the individual manufacturing and procurement quotas to companies that apply for it. Under the rules, the DEA can make revisions to any company’s quota at any time over the course of the year based on increased sales, additional manufacturers coming to market, new product development, product recalls, or increased exports.
Anyone who is currently receiving a prescription from a DEA-registered practitioner will continue to have their medication as prescribed. If changes are made throughout the course of the year, there should be no worry about the supply of medication. There’s a buffer in the APQ to allow for new prescriptions so those who have a temporary need for the medicine will still able to get it. The APQ changes are not intended to cause the public and pharmacists to worry about the availability of medication.