By Pat Anson, Editor
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.
“Yes, I think that’s absolutely possible. And very, very concerning,” says Judi Lund Person, VP of Regulatory and Compliance for the National Hospice and Palliative Care Organization.
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. 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.
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.
“We’ve had patients who’ve had a lot of trouble finding a pharmacy that carries certain opioids,” she said
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.
“What does that do for patients at the end of life who need these drugs? That, I think, is one of our biggest questions,” Person told PNN.
“Living and working in the Washington area, the pressure is on so much around the opioid addiction crisis, and looking for any and all opportunities to see if we can correct that. It doesn’t surprise me in any way that this is happening. Now, what we’ll do about it and how we switch over to other drugs that will be available is a completely different question. I don’t know what we’ll do.”
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. “I take hydrocodone for my rescue doses, 5 times a day, and I almost always use them unless I am totally sedentary. I think hydrocodone is being reduced by 36 percent.
“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there is 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.
“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 DEA said in a press release.
“This is a step in the right direction,” Sen. Dick Durbin (D-Illinois) said in an interview with WGN Radio. Durbin was among a group of senators that urged the DEA to lower the quota for opioids.
“Clearly there is more (opioids) than is necessary to alleviate pain. I’m the glad the DEA stepped up. It’s the first time.”
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.
“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the GAO report states.
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.
What has the DEA done in the last year to correct these problems?
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.
“We could not confirm whether DEA’s lack of timeliness in establishing quotas had caused or exacerbated shortages because of concerns about the reliability of DEA’s data, among other things. However, by not promptly responding to manufacturers’ quota applications, we concluded that DEA may have hindered manufacturers’ ability to manufacture drugs that contain schedule II controlled substances that may help prevent or resolve a shortage.”
The quotas for 2017 were released on October 5 -- the 10th straight year that DEA has missed the quota deadline.