DEA cuts opioid production quotas by 25%

DEA Opioid Cuts Could Affect Terminally Ill Patients — Pain News Network – By Pat Anson, Editor – October 07, 2016

The DEA announced earlier this week that it is reducing production quotas for almost every Schedule II opioid pain medication next year by 25 percent or more.

Steep cuts in the production of opioid pain medication planned by the U.S. Drug Enforcement Administration could worsen drug shortages and affect pain patients receiving end-of-life hospice care.

The quota cuts include opioids such as hydrocodone, oxycodone, fentanyl, hydromorphone and morphine – many of which are used to give pain relief to patients in palliative and hospice care.  

The DEA said the cuts are needed to prevent the diversion and abuse of opioids, and because opioid prescribing has been in decline for several years.

If the DEA, meaning “our government”, knows that opioid prescriptions are decreasing even as overdoses continue to climb, it should be obvious that the two do NOT correlate.

Still, the war against prescription opioids continues, though it will become increasingly difficult to maintain the pretense that this is combating heroin overdoses.

But Person says some patients in palliative care – who are generally disabled and chronically ill, but still living at home  – are already having trouble getting their opioid prescriptions filled.

Person is worried that the DEA’s production cuts will also make it difficult for hospices to obtain opioids for terminally ill patients. Her organization, which represents about 4,000 hospice facilities in the United States, is still examining the possible impact of the opioid cuts.

Person says there are 1.4 million Medicare patients in hospice care and several million more receiving palliative care.

Many chronic pain patients who are not in palliative or hospice care say opioids are already hard to get, because many doctors are reluctant to prescribe them and some pharmacies claim they’re out of stock.

“I am really, really scared about my future and others. So many others are already suffering needlessly. How many more are going to be thrown under the bus?” asks Rich Martin, a Nevada pharmacist who was forced into early retirement by chronic back pain

“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there are indeed inadequate opioids for treatment of legitimate pain patients.  Then pharmacies may actually be telling the truth when they say they are out of opioids.”

The DEA says its opioid quotas are sufficient to provide “adequate and uninterrupted supply for legitimate medical need,” and could be adjusted if problems develop.

GAO Questions DEA’s Competency

Many Americans may not be aware of the significant role DEA plays in regulating the nation’s drug supplies. Drug manufacturers apply to the DEA every year to produce opioids and other controlled substances, and the agency determines how many – the quota – each drug maker can produce.

But in a recent series of highly critical reports, a congressional watchdog agency questioned the DEA’s competency in regulating pharmaceutical drugs.

In March 2015, the DEA was criticized in a lengthy report by the Government Accountability Office (GAO) for its inability to deal with drug shortages, a problem so serious it was called “a risk to public health.”

The GAO said that between 2001 and 2013, there were 87 “critical” shortages of controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants.

A second GAO report in July 2015 faulted the DEA for heavy-handed tactics during pharmacy investigations. Many pharmacists said they were worried about being fined or having their licenses revoked, and blamed the DEA for poor communication and unclear rules.

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report said.

Of the 11 recommendations made by the GAO to improve the quota system and prevent drug shortages, the DEA has fully implemented only two of them.

One of the problems the DEA failed to address is the timeliness of its release of production quotas

Under guidelines set in 2006, the DEA is supposed to set quotas for controlled substances on or before May 1 of each year, to give drug manufacturers enough time to adjust their production schedules for the following year.

“DEA officials attributed this lack of compliance to inadequate staffing and noted that the agency’s workload with respect to quotas had increased substantially,” the GAO said in a report this summer.

The quotas for 2017 were released on October 5 — the 10th straight year that DEA has missed the quota deadline.  

Read full article and comments at DEA Opioid Cuts Could Affect Terminally Ill Patients.

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