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DEA proposes significant reduction in opioid production
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The U.S. Drug Enforcement Administration has proposed cutting production of controlled substances by 20% next year.
“Physicians, pharmacists and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” Chuck Rosenberg, acting administrator of the DEA, said in a press release. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”
The suggestion comes as state and federal agencies as well as the health care industry struggle to address the nation’s opioid epidemic that according to the CDC claims 91 lives every day. The DEA’s proposal covers codeine, fentanyl, hydrocodone, hydromorphone, meperidine, morphine, oxycodone and oxymorphone. According to the DEA, demand for these particular substances, collectively known as the schedule II opioid painkillers, has dropped.
In its release, DEA noted the stepped-up efforts to teach medical professionals about opioids and the risks involved in their misuse, such as the CDC guidelines for primary care physicians regarding these substances.
The proposal can be found on the Federal Register’s website and comments will be accepted until 11:59 p.m. EST on Sept. 6, 2017. The DEA will also contemplate information from various sources, such as manufacturers’ disposition history and forecasts, assessments of retail use, the FDA’s legitimate medical need for these substances, past allotment histories and the DEA’s internal tracking system as part of the decision-making process.
According to the release, once the new quotas are set, the DEA will distribute individual manufacturing and procurement quotas to those that request them. However, the agency also noted that these amounts may be revised to reflect market changes and other events, such as product recalls.
Further reading :
DEA. 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. Accessed Aug. 10, 2017.
Disclosure: Healio Family Medicine was unable to determine relevant financial disclosures prior to publication.
Perspective
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Lawrence Greenblatt, MD
Many primary care physicians are not aware of the fact that the United States Drug Enforcement Administration limits the quantity of controlled substances that can be legally manufactured in the United States. These limits are to allow for the legitimate prescribing, research, export and other uses of these medications and are not intended to reduce the supply available for patients receiving prescriptions. Next year, the DEA plans to reduce the maximum amount of schedule I and II controlled substances that can be manufactured, the proposed aggregate production quota, by 20%.
This is good news for PCPs who are concerned about the epidemic of opioid misuse, abuse and overdose deaths that are overwhelming our country. There is widespread agreement that opioids are overprescribed, including both prescriptions that probably were not necessary, where another less risky medication or modality could have been recommended, and also where the quantity prescribed was more than the patient required.
Research has found that most patients are inclined to hold onto unused opioids rather than dispose of them safely. This can, unfortunately, allow legitimately prescribed medications to become available to family, friends or other visitors to their homes who have intent to misuse or abuse these medications. When asked, many physicians believe that the majority of individuals who abuse prescription opioids are purchasing them from strangers, typically drug dealers. In the Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health from the Substance Abuse and Mental Health Services Administration (SAMHSA) and RTI International, 54% of the 12.5 million teens and adults who admitted to misusing prescription pain relievers reported obtaining their medication for free from a family member or friend. Only 5% purchased prescription pain relievers from a stranger or drug dealer. Thus, when PCPs avoid overprescribing, they are not only protecting their patients but also the patient's family and community.
The 2016 CDC guidelines emphasize avoiding opioid prescriptions wherever possible and using the lowest dose and shortest duration that is feasible to manage a patient's pain. A number of states, including Connecticut, Maine, Rhode Island, Virginia, Massachusetts, New York and North Carolina, have passed legislation limiting the duration of initial opioid prescriptions, typically to 7 days or less. Many experts would recommend these limits for PCPs even in states that do not require them.
There is a growing body of literature finding that physicians are prescribing greater quantities than patients actually require and that reducing quantities, even after surgical procedures, still results in significant leftover opioids and does not interfere with the patient's ability to manage their own pain.
PCPs, along with their specialty colleagues, are responding positively to information about opioid misuse and abuse and are reducing the quantities of opioid analgesics that they are prescribing.
References:
Hill MV, et al. Ann Surg. 2017;doi:10.1097/SLA.0000000000002198.
Lewis ET, et al. Clin J Pain. 2014;doi:10.1097/01.ajp.0000435447.96642.f4.
SAMHSA. Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health. NSDUH Data Review. 2016 September. Available at: https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR2-2015/NSDUH-FFR2-2015.htm.
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