July 24, 2024

Patients diagnosed with conditions like anxiety and sleep disorders have become caught in the crosshairs of America’s opioid crisis, as secret policies mandated by a national opioid settlement have turned filling legitimate prescriptions into a major headache.

In July, limits went into effect that flag and sometimes block pharmacies’ orders of controlled substances such as Adderall and Xanax when they exceed a certain threshold. The requirement stems from a 2021 settlement with the US’s three largest drug distributors — AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. But pharmacists said it curtails their ability to fill prescriptions for many different types of controlled substances — not just opioids.

Independent pharmacists said the rules force them come up with creative workarounds. Sometimes, they must send patients on frustrating journeys to find pharmacies that haven’t yet exceeded their caps in order to buy prescribed medicines.

“I understand the intention of this policy is to have control of controlled substances so they don’t get abused, but it’s not working,” said Richard Glotzer, an independent pharmacist in Millwood, New York. “There’s no reason I should be cut off from ordering these products to dispense to my legitimate patients that need it.”

It’s unclear how the thresholds are impacting major chain pharmacies. CVS Health Corp. didn’t provide comment. A spokesperson for Walgreens Boots Alliance Inc. said its pharmacists “work to resolve any specific issues when possible, in coordination with our distributors.” 

Secret Limits

The Drug Enforcement Administration regulates the manufacturing, distribution and sale of controlled substances, which can be dangerous when used improperly. Drugmakers and wholesalers were always supposed to keep an eye out for suspicious purchases and have long had systems to catch, report and halt these orders. The prescription opioid crisis, enabled by irresponsible drug company marketing and prescribing, led to a slew of lawsuits and tighter regulations on many parts of the health system, including monitoring of suspicious orders. One major settlement required the three largest distributors to set thresholds on orders of controlled substances starting last July.

The “suspicious order” terminology is a bit of a misnomer, pharmacists said. The orders themselves aren’t suspicious, it’s just that the pharmacy has exceeded its limit for a specific drug over a certain time period. Any order that puts the pharmacy over its limit can be stopped. As a result, patients with legitimate prescriptions get caught up in the dragnet.

Adding to the confusion, the limits themselves are secret. Drug wholesalers are barred by the settlement agreement from telling pharmacists what the thresholds are, how they’re determined or when the pharmacy is getting close to hitting them

The exact limit for each pharmacy is kept secret in order to prevent pharmacists from gaming the system, according to Krista Tongring, leader of the DEA compliance practice at Guidepost Solutions and a former agency attorney.

The purpose, she said, is to keep pharmacies from manipulating “their ordering patterns so as to get around the thresholds.”

Caught In a Dragnet

The settlement agreement, which is public, lays out general guidelines. A Cardinal Health document reviewed by Bloomberg News says that limits are calculated on a daily, monthly, and quarterly basis. But without more detailed information, it’s impossible for pharmacists to predict when they are going to have to turn patients away. 

“You don’t know what you’re going to get” when you place an order, Glotzer said. “It’s no way to do business, let’s put it that way.”

Glotzer said that he’s had trouble getting all attention-deficit/hyperactivity disorder medications including Concerta and Ritalin. Supply chain issues had already created scarcity of the drugs. Adding on to those troubles, Glotzer can’t order them even when they are in stock from one of his wholesalers, Cardinal. In February, they only sent him 100 pills because he hit his threshold, compared to about 3,700 the month before, he said. They hadn’t shipped any more by March 23, he said. He was able to get some from McKesson, but not nearly enough for all of his patients, he said.

Benjamin Jolley, an independent pharmacist in Salt Lake City, said that Cardinal stopped shipping him any controlled substances in November after the pharmacy hit its limit for fentanyl lozenges, prompting a review. So he had to turn away hundreds of patients who had prescriptions for medicines to treat ADHD, chronic pain, cancer pain and other diseases.

An ‘Ethical Tightrope’

Cardinal’s move indicated they had decided “we’re going to make this someone else’s problem,” Jolley said. “We’re going to make your patients go to other pharmacies that buy from McKesson or AmerisourceBergen and therefore it will be their problem now, and not our problem of looking bad to the DEA or the various states we signed the agreement with.”

Cardinal said in a statement that the thresholds “have caused some supply challenges” and that the company works “with each customer individually to resolve any issues with their orders.” A spokesperson for AmerisourceBergen said that distributors like the company “have been asked to walk a legal and ethical tightrope” between making medicines available and limiting diversion, and that they need more guidance from regulators. McKesson didn’t respond to requests for comment.

Pharmacies can request increases to their thresholds, but those take time to adjudicate, leaving patients scrambling to find their daily medicines elsewhere in the meantime.

Wholesalers have always been required to identify suspicious orders from pharmacies as part of the government’s regulation of controlled substances. Federal laws and rules, enforced by the DEA, mandate that wholesalers report suspicious orders to the agency. But lawsuits alleged that the wholesalers flooded the market with pills, contributing to an addiction epidemic that has killed more than half a million people since 1999. 

As a result of the settlement, distributors “updated and improved” their systems for monitoring orders, said Pete Weinberger, plaintiffs’ liaison counsel in the national opioid lawsuit. AmerisourceBergen has said publicly that the policy changes would result in more cancelled orders. Cardinal has said similarly in literature distributed to pharmacists. 

Some pharmacists are finding creative solutions. Matt Weisser, an independent pharmacist near Seattle, said he sometimes buys a smaller quantity of double-strength pain pills for his patients to cut in half. He also worked with a patient’s doctor to time a prescription so it was due to be filled after the monthly limit resets.

“We’ve had to figure out clever strategies in order for us to order the product,” Weisser said.