AUG 4 -
(WASHINGTON) - The U.S. Drug Enforcement Administration
is proposing a reduction for controlled substances that may
be manufactured in the U.S. next year by 20 percent as
compared to 2017, per the proposed notice being published in
the Federal Register on August 7, 2017 and
available for public inspection today.
The
DEA has proposed to reduce more commonly prescribed schedule
II opioid painkillers, including oxycodone, hydrocodone,
oxymorphone, hydromorphone, morphine, codeine, meperidine
and fentanyl. Demand for these opioid medicines has
dropped, according to sales data obtained by DEA from IMS
Health, a company that provides insurance companies with
data on prescriptions written and prescription medications
sold in America.
"Physicians,
pharmacists, and patients must recognize the inherent risks
of these powerful medications, especially for long-term
use," said Acting Administrator Chuck Rosenberg. "More
states are mandating use of prescription drug monitoring
programs, which is good, and that has prompted a decrease in
opioid prescriptions."
The Proposed
Aggregate Production Quotas (APQ) for Schedule I and II
controlled substances that is being published in the Federal
Register reflects the total amount of controlled substances
needed to meet the country's legitimate medical, scientific,
research, industrial, and
export needs for the year and for the maintenance of reserve
stocks.
In 2016, the
Centers for Disease Control and Prevention issued guidelines
to practitioners recommending a reduction in prescribing
opioid medications for chronic pain. DEA and its federal
partners have increased efforts in the last several years to
educate practitioners, pharmacists, manufacturers, and the
public about the dangers associated with the misuse of
opioid medications and the importance of properly
prescribing.
When
Congress passed the Controlled Substances Act, the quota
system was intended to reduce or eliminate diversion from
"legitimate channels of trade" by controlling the quantities
of the basic ingredients needed for the manufacture of
controlled substances. The purpose of quotas is to provide
for an adequate and uninterrupted supply for legitimate
medical need of schedule I and schedule II controlled
substances, which have a high potential for abuse, while
limiting the amounts available to prevent
diversion.
DEA must
balance the production of what is needed for legitimate use
against the production of an excessive amount of these
potentially harmful substances. DEA establishes an APQ for
more than 250 schedule I and II controlled substances
annually.
In setting
the APQ, DEA considers data from many sources, including
estimates of the legitimate medical need from the Food and
Drug Administration; estimates of retail consumption based
on prescriptions dispensed; manufacturers' disposition
history and forecasts; 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 manufacturers
that apply for them. 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.