Rx Opioid Shortages Persist With No Federal Action
/By Pat Anson, PNN Editor
There is no end in sight to shortages of opioid pain medication in the US, with the federal government taking no apparent action to increase opioid production and several drug makers unable to estimate when full supplies will be restored.
In a recent update, the American Society of Health-System Pharmacists (ASHP) said five generic drug makers were running low or have exhausted their supply of oxycodone/acetaminophen tablets, which are better known as the brand names Percocet and Endocet. The medication is usually prescribed for moderate to severe pain.
ASHP asked drug makers about their current supplies and received these responses:
Camber has no doses of oxycodone/acetaminophen available. The tablets are on back order and “the company cannot estimate a release date.” Camber said it was still awaiting DEA approval for additional supplies.
Amneal and KVK-Tech said they had limited supplies of 5 and 7.5 mg oxycodone/acetaminophen tablets, and that 10 mg tablets were on back order with no estimated resupply date.
Major anticipates getting 7.5 mg tablets in late September and 10 mg tablets in late October.
Rhodes said it had 7.5 and 5 mg tablets on “intermittent back order” and would only be releasing supplies as they become available.
Percocet and Endocet tablets in various doses are still available from Endo and Par Pharmaceuticals, according to the ASHP.
Shortages of oxycodone/acetaminophen tablets, as well as immediate release oxycodone and hydrocodone/acetaminophen tablets, were first reported by ASHP several months ago. But they have yet to appear on the FDA’s drug shortage list or even be publicly acknowledged by the agency.
In a recent joint letter, FDA Commissioner Robert Califf, MD, and DEA administrator Anne Milgram said they were working “as quickly as possible” to resolve persistent drug shortages. But the letter only addressed shortages of prescription stimulants used to treat ADHD, and makes no mention of opioids.
When asked by PNN, one federal health official did acknowledge shortages of opioid medication, but was vague about possible solutions.
“This is an important issue that CDC and other federal partners are aware of and working to find solutions to,” said Stephanie Rubel, who heads the CDC’s Overdose Preparedness and Response Team (ORRP). Rubel’s office works with other federal and state agencies to reduce the serious risks posed to patients who suddenly lose access to prescription opioids.
“As part of ORRP’s work, we strongly encourage state health officials to proactively partner with pharmacists and pharmacies to ensure that impacted patients are able to continue receiving appropriate pain management care after a disruption,” said Rubel in a statement to PNN. “Because ORRP cannot provide medical care or make referrals to healthcare providers, advanced preparation and partnerships with pharmacists is essential to ensure continuity of care.”
But many pharmacists have their hands tied due to opioid litigation. Last year, three large drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on the pharmacies they do business with. Most pharmacies are capped on the amount of opioids they can dispense in any given month, regardless of patient needs. An unusually large order for opioids could get a pharmacy red-flagged by its wholesale supplier and the order cancelled.
Another reason for the shortages are persistent problems in the drug supply chain and the heavy US reliance on foreign suppliers for many drugs, especially low-cost generic ones. A third factor is aggressive cuts in the opioid supply by the DEA, which sets annual production quotas for controlled substances that drug manufacturers must follow.
Whatever the cause, it’s leaving many patients with uncontrolled pain and little faith in their government.
“I've been on hydrocodone for 10 years. With the shortage that is going on in Las Vegas, I've been out for 4 weeks,” one patient told PNN. “Unfortunately, the pain has made it too difficult to take care of myself. I cannot clean, cook or sleep without my pain levels increasing. I've been living on frozen foods and Alka Seltzer.”
“I live with 200 other seniors in a low-income complex. I’ve seen three older veteran residents commit suicide because they couldn’t get pain medication. I know several other seniors who live with horrible pain and are not able to get medication,” another patient told us.
“The US Government is just screwing us over by limiting what the pharmacies can get and what their suppliers can make. This is driving people to buy pain meds off the street and that's like playing Russian roulette,” said another patient who has trouble getting Norco prescriptions filled by his pharmacy. “Our government is supposed to help us, not hurt us.”
Drug makers are required to report shortages and supply interruptions to the FDA, but prescribers, pharmacies and consumers can also report them by email to drugshortages@fda.hhs.gov.
To report a drug shortage to the ASHP, click here.
