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The US Drug Enforcement Administration (DEA) has reduced the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the US by 25% or more.
The US Drug Enforcement Administration (DEA) has reduced the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the United States by 25% or more.
According to DEA’s new Final Order, hydrocodone drug production must be reduced by 66% in 2017. Plus, the Aggregate Production Quota (APQ) has been reduced for oxycodone, hydrocodone, fentanyl, hydromorphone, morphine, and related medications. “Much of this reduction is attributed to the elimination of a 25 percent buffer that was added to the APQ annually in 2013 through 2016 to guard against shortages,” DEA said in a statement.
“Demand for these opioid medicines, represented by prescriptions written by DEA-registered practitioners, has decreased according to sales data obtained by DEA from IMS Health,” DEA said.
DEA also made the decision to help curb opioid abuse. The 2015 National Survey on Drug Use and Health (NSDUH) released in September found that 6.5 million Americans over the age of 12 years used controlled prescription medicines non-medically during the past month, second only to marijuana and more than past-month users of cocaine, heroin, and hallucinogens combined.
The Centers for Disease Control and Prevention (CDC) also issued new voluntary guidelines in March for prescribing opioid medications for chronic pain, excluding cancer, palliative, and end-of-life care.
And, in February, FDA also announced several measures aimed at curbing opioid abuse. The new plan calls for increasing abuse-deterrent formulations of opioid medications and upping access to naloxone and alternative pain treatments.
Meanwhile, DEA said the purpose of quotas are to provide for the adequate and uninterrupted supply for legitimate medical need of the types of schedule I and II controlled substances that have a potential for abuse, while limiting the amounts available to prevent diversion, CDC said.
In setting the APQ, DEA considers data from many sources, including estimates of the legitimate medical need; estimates of retail consumption based on prescriptions dispensed; manufacturers’ data on actual production, sales, inventory, exports, product development needs, and manufacturing losses; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.
“Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those companies that apply for it. DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls,” the agency said.
Read more: CDC issues opioid prescribing guidelines