Secret Limits Placed on Pharmacies Force Needy Patients to Scramble

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.

Limits are now in 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, Cardinal Health 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.”

Drug makers 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.  One major settlement required the three largest distributors to set thresholds on orders of controlled substances.  Even if an order isn't suspicious, it may result in a particular pharmacy exceeding 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.”

Without detailed information on the daily, monthly and quarterly limits set by the DEA, 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. He was able to get some from McKesson, but not nearly enough for all of his patients, he said.