Tight Rx Opioid Supply Causing Shortages of Oxycodone and Hydrocodone
/By Pat Anson, PNN Editor
At least three U.S. drug companies have reported shortages of oxycodone, the latest sign that efforts to limit the supply of opioid pain medication have gone too far and are harming patients.
On March 17, the American Society of Health-System Pharmacists (ASHP) added immediate release oxycodone to its nationwide list of drug shortages, with shortages of 5, 15, 20 and 30 mg tablets being reported by Amneal, Camber and Rhodes Pharmaceuticals. Other drug companies still have oxycodone tablets of various doses available, according to ASHP.
Amneal and Rhodes did not provide a reason for their shortages, while Camber told ASHP it was “awaiting DEA quota approval for active ingredient,” which presumably is oxycodone. All three companies, which specialize in making generic drugs, said the tablets were on back order.
“We have been following up on some reports of these shortages and have recently added immediate-release oxycodone tablets to our shortage database,” said Michael Ganio, PharmD, Senior Director of Pharmacy Practice and Quality at ASHP.
In addition to the oxycodone shortage, Ganio told PNN there were anecdotal reports of hydrocodone medications being in short supply.
“We have not heard back from all manufacturers of hydrocodone/acetaminophen products, but some have reported availability while others have reported some package sizes are not currently available,” Ganio said in an email. “We don’t have state-by-state data, so unfortunately I cannot offer any insight on specific (pharmacy) chains or states. However, it’s common with shortages that manufacturers with product available will limit sales to existing purchasers. That can mean products may not be available depending on previous purchase history from those pharmacies.”
(Update: On May 26, the ASHP added hydrocodone/acetaminophen tablets made by several generic drugmakers to its list of shortages.)
The ASHP’s list of shortages usually mirrors the drug shortage list maintained by the Food and Drug Administration, but the federal agency does not currently list either oxycodone or hydrocodone tablets as being in short supply.
‘It’s Gotten Worse’
Pain patients have complained for years about pharmacists being unable to fill their opioid prescriptions, usually claiming they were “out of stock” or awaiting a delayed shipment. But the problem seems to have become more widespread in recent months.
“I've gone through shortage just this month for oxycodone yet again. I've also had shortage for morphine in the past,” said Michelle Farrell, who lives in Arizona. “My normal pharmacy said it was due to restrictions in place by the manufacturer this month. They were limiting the distributor and on down the (supply) chain.”
After several days delay, Farrell was able to get her oxycodone prescription filled at another pharmacy.
A woman in Orange County, California said her CVS pharmacy was out of oxycodone for months.
“I have gone 4 months (fills) of an alternative medication because 10 mg oxycodone 10-325 has been completely out of stock at my home CVS store, as well as stores within a 20 mile radius. Yesterday was the first time my pharmacy could fill my prescription. Thank god. It is destabilizing having to be forced off your stable medical regimen,” she said in an email.
A woman in Melbourne, Florida recently told PNN she had to visit several pharmacies to get a prescription filled for hydrocodone. She needs pain medication for spondylarthritis and fibromyalgia.
"I called CVS about picking up my medicine and I was told there is no hydrocodone available anywhere, it's with the manufacturer and had been out a month. Their pharmacist said he has no idea when they will be available again," said Kristina, who asked that we not use her last name.
“I called a different CVS and she said the same thing, it's a national shortage, had been for about 3 weeks…. I was told there were 3 pills of 5mg hydrocodone within a 20-mile radius of (area code) 32926.”
CVS did not respond to a request for comment. Neither did the Florida Department of Health or the Florida Board of Pharmacy.
Kristina was eventually able to get her prescription filled, but only after her doctor got around the problem by increasing her dosage to 7.5 mg tablets of hydrocodone, which were available. Ironically, the manufacturer of those tablets was Amneal, one of the companies now reporting shortages of oxycodone.
What can a patient do when faced with a shortage? The ASHP recommends sharing as much information as possible with pharmacists about their medical history.
“The pharmacist can typically talk to the prescriber to find an alternative based on what products are available. However, if the medication is a Schedule II controlled substance, transferring prescriptions between pharmacies is not allowed. If another pharmacy has a product available, the prescriber will have to send a new prescription for the medication,” said Ganio.
“All of this sets up a challenging dynamic of doing double work, especially when pharmacies are experiencing some staffing shortages. We know that drug shortages can be frustrating for patients, and they can also impact care, which is why ASHP is working to push for transparency and resiliency in the system to avoid these situations in the future.”
Likely Reasons for Shortages
There are several possible reasons for the shortages. One is ongoing problems in the drug supply chain caused by the COVID-19 pandemic. The U.S. still relies heavily on foreign sources for many drugs and their active ingredients, a situation a U.S. Senate report this week called an “unacceptable national security risk.”
Another reason is aggressive cuts in the opioid supply by the Drug Enforcement Administration. Since their peak in 2013, DEA production quotas for drug manufacturers have fallen by 65% for oxycodone and 73% for hydrocodone. The DEA says it’s tightening the supply to prevent diversion, even though its own estimates show that less than 1% of prescription opioids are used by someone they are not intended for.
Third, the DEA and the Department of Justice have been aggressive in going after doctors who prescribe opioids in high doses, which made many physicians leery of going to prison or paying steep fines, which one doctor likened to extortion. Rather than risk their livelihoods and freedom, some doctors stopped prescribing opioids.
The fourth likely reason for the shortages is opioid litigation. As The New York Times explained in a recent article, three large drug distributors reached a $21 billion settlement with 46 states last summer, requiring them to impose strict limits on the pharmacies they do business with. Pharmacies are capped in the amount of opioids and other controlled substances they can dispense in any given month, regardless of patient needs. A unusually large order for opioids could result in a pharmacy getting red-flagged and the order cancelled.
‘Pendulum Swung Too Far’
The end result of all these efforts is that opioid prescribing in the U.S. has fallen by nearly 50 percent, even as drug deaths continued to climb to record levels, fueled primarily by street drugs made with illicit fentanyl.
“It seems like the pendulum has swung too far in the other direction, where people deserving and people needing controlled substances are unable to access them,” said Colin Banas, MD, Chief Medical Officer for DrFirst, a healthcare technology consultant.
A recent survey of 400 patients by DrFirst found that one in four (27%) had run out of medication while waiting for their prescription to be renewed. Many had to contact their pharmacy or doctor more than once to get their prescription renewed.
Banas is concerned that DEA plans to reimpose “guardrails” on prescribing that were suspended during the pandemic will undermine telehealth and make it even harder to get controlled substances. The DEA’s proposed rules, which many consider confusing, will require patients to have an in-person meeting with a provider before being prescribed a Schedule II controlled substance like oxycodone.
“If I need to see a pain specialist and I’m in a very rural area, and the closest doctor is 90 miles away… there’s some very legitimate concern where we might be cutting those patients off by requiring the in-person visit,” Banas told PNN.
One of the twisted ironies of the oxycodone shortage is that 30 mg tablets that are so difficult to get from a U.S. pharmacy are widely available on the black market — but they are counterfeit. Known on the street as M-30s or Mexican Oxy, the blue pills look just like the real thing, but are made with a potentially lethal dose of illicit fentanyl. Some Mexican pharmacies are selling them to unsuspecting U.S. tourists who can’t get them at home.
