A crackdown by US drug wholesalers in response to the opioid crisis is preventing some pharmacists from dispensing a combination of stimulants and tranquilizers routinely prescribed by psychiatrists to help patients manage conditions such as anxiety and ADHD.
The top three U.S. pharmaceutical wholesalers – AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. — in July tightened scrutiny of suspicious drug orders as part of a $21 billion nationwide opioid settlement involving attorneys general from 46 states, the District of Columbia, and five territories.
Five independent pharmacists in five different US states told Reuters they had been notified by wholesalers in recent months that they would be cut off from distributing all controlled substances after filling prescriptions for psychiatric drugs such as the stimulant Adderall — used to treat attention deficit hyperactivity disorder (ADHD) – and anti-anxiety drug Xanax. The pharmacists spoke on condition of anonymity for fear of harming their business.
These psychiatric drugs are regulated by the federal government as controlled substances that have a high potential for abuse and addiction, but are not opioids.
The wholesalers imposed the bans because the pharmacies filled prescriptions written by doctors who regularly prescribed controlled substances or filled prescriptions that attributed both a stimulant and a sedative to the same patient, according to interviews with the pharmacists and letters from AmerisourceBergen to one of the pharmacies, seen by Reuters.
The U.S. Drug Enforcement Administration (DEA) identifies combination prescriptions of stimulants and sedatives as a red flag in its pharmacy guidelines on illicit drug use.
Three psychiatrists interviewed by Reuters described such combination prescriptions as medically valid and routinely provided for years to manage comorbidities or address stimulant side effects such as insomnia. Comorbidity refers to the simultaneous presence of two or more diseases or medical conditions in a patient.
An ADHD patient who takes Adderall during the day to focus may need the sedative temazepam to sleep at night, or clonazepam to treat anxiety, the psychiatrists said. ADHD and anxiety disorders are among the most common psychiatric disorders and have a comorbidity of 25% with each other.
Matthew Goldenberg, president-elect of the Southern California Psychiatric Society, a chapter of the American Psychiatric Association, said some members had complained that pharmacies were no longer comfortable filling combination prescriptions for controlled substances amid concerns that they might be blacklisted. could come.
“This is potentially harmful for many patients who have comorbid anxiety along with ADHD, or sleep problems along with ADHD,” he told Reuters. “I think it’s a trickle effect from the opiates.”
The impact on psychiatric drug prescribing by independent pharmacies of the increasing crackdown on opioids has not been previously reported. According to the National Community Pharmacists Association (NCPA), there are just over 19,400 independent pharmacies in the United States, representing just over one-third of all retail pharmacies.
The five pharmacists interviewed by Reuters said wholesalers’ ban on the supply of controlled substances threatened the viability of independent pharmacies, while chains like CVS Health Corp. and Walgreens Boots Alliance Inc. were knocked off the hook.
CVS, the largest US pharmacy chain, did not respond to requests for comment for this story. Walgreens, AmerisourceBergen’s largest shareholder, declined to comment. Reuters could not determine to what extent the chains were affected by the improved monitoring.
DISTRIBUTORS FACE “LEGAL, ETHICAL CHILD STRUGGLES”
The US opioid crisis has caused nearly 650,000 overdose deaths since 1999 and is getting worse, according to federal government data.
Over the past two years, the three drug wholesalers agreed to a series of settlements totaling billions of dollars after allegations that they fueled the opioid crisis by turning a blind eye to high-volume prescribers and “pill mills” that supplied addicts instead of patients. The companies have denied any allegations.
Under pressure from regulators, legislators and judicial authorities, the wholesalers developed algorithms to detect suspicious prescription patterns for opioids such as oxycodone and fentanyl, both used medically as pain relievers. They said publicly that they have improved that oversight this year.
Lauren Esposito, AmerisourceBergen’s vice president of external and executive communications, said the company maintains a “robust” program to monitor and stop suspicious orders of all controlled substances. It is committed to reducing the abuse of controlled substances without interfering with good faith clinical decisions made by physicians, she said.
“Pharmaceutical distributors must walk a tightrope legally and ethically between providing access to necessary medications and preventing the misuse of controlled substances,” Esposito said in a written statement. “We continue to advocate for greater clarity and regulatory guidance on this issue.”
Cardinal Health and McKesson did not respond to requests for comment.
The SUPPORT Act of 2018, designed to address the opioid epidemic, required the DEA to implement a program with distributors to record suspicious orders of controlled substances and share that information with state governments. It also authorized the DEA and the US Food and Drug Administration (FDA) to guide pharmacies on suspicious orders.
The DEA, in response to Reuters’ questions, said it does not “participate in the practice of medicine” and does not determine what would constitute an “antagonistic combination” of drugs.
An FDA spokesperson said it generally does not regulate the practice of medicine and cited National Institute on Drug Abuse (NIDA) guidelines that stimulants should not be used with other medications unless recommended by a physician.
DEPRESSION
Daniel, a 37-year-old California private equity executive, said he had to ration Adderall twice in the past two months because his pharmacy had asked him to delay filling a combination prescription or partially fill it elsewhere out of concern that the pharmacy can be blacklisted by wholesalers.
Daniel, who declined to give his last name due to medical privacy concerns, said his pharmacist asked that he only dispense his Klonopin, prescribed for anxiety, and fill his Adderall prescription elsewhere so the pharmacy wouldn’t get in trouble. He refused to identify the pharmacy.
“I am the president of a company. I have to make confident decisions, and fear is not something that makes that possible,” he told Reuters.
Psychiatrists said the problem has been exacerbated for some patients by a nationwide shortage of Adderall in recent months due to production delays at Teva Pharmaceutical Industries Ltd. TEVA.TA, the Israel-based company that produces it. Teva said that, in addition to the production problems, there was a “significant increase” in national prescriptions for the drug.
“If you take a dose of Adderall and you stop taking it, you can feel terrible,” said Eric Levander, a Los Angeles psychiatrist, who said at least five of his patients couldn’t fill their prescriptions at multiple pharmacies because of the crackdown. .
Aside from the medical drawbacks, patients risk being flagged as suspicious in the state’s Prescription Drug Monitoring Program (PDMP) databases — which are accessible to law enforcement — because they try to fill prescriptions in several places, he said . ‘Pharmacy shopping’, when it comes to attempting to fraudulently obtain a narcotics drug, is generally a criminal offense and can result in heavy fines or imprisonment.
“I had a patient who was off stimulant medication for a few days, and he was depressed for a week after that and screwed up his exams,” Levander said.
NO REVIEWS
AmerisourceBergen had informed customers in March that changes to its Controlled Substance Monitoring Program (CSMP) would go into effect July 1 as a result of the nationwide settlement, according to a presentation made public by the company.
AmerisourceBergen predicted that an increased number of orders would be flagged as suspicious. Previously, the company reviewed suspicious orders and then either approved or canceled the shipments, but it said such orders would be automatically canceled under the new system and reported to regulators without review. AmerisourceBergen said all three wholesalers had to meet the exact same requirements.
Anne Burns, vice president of the American Pharmacist Association (APhA), said wholesalers initially focused their scrutiny on opioid orders, but increased their research on stimulants following a surge in the illicit market for them.
Reports from pharmacies across the country suggested that focus was also shifting to other controlled substances, she added.
“We’ve really pushed the DEA and wholesalers … to be more transparent about how these decisions are made, about what the pharmacy can or can’t order,” Burns said.
The pharmacists interviewed by Reuters said they had not received clear rules about which combinations of drugs are problematic, nor about the ratio of controlled substances as a percentage of the total number of prescriptions considered suspicious.
Pharmacy owners in California, New York, Florida, Iowa and Kansas interviewed by Reuters described an almost identical pattern for the three wholesalers.
First, individual orders would be rejected without explanation, followed by a letter from the wholesaler suspending controlled substance orders for a year, citing red flags such as suspicious drug combinations or filling prescriptions from doctors who prescribe too many controlled substances. prescribe.
Subsequently, pharmacies were given a chance to appeal that decision, only to be told within a month that their response was not satisfactory and that the ban on ordering controlled substances would remain in place.
“It’s a real challenge for smaller pharmacies to defend themselves against this kind of behavior,” said Al Harris, attorney for Ken’s Sunflower Pharmacy in Kansas.
The pharmacy sued AmerisourceBergen for breach of contract after it banned Sunflower from ordering controlled substances in June because it filled prescriptions written by a doctor who over-prescribed controlled substances and too many prescriptions containing “antagonistic combinations.”
“My client is not running oxycodone under the streets,” Harris said. “He’s a small pharmacy and they can crack down on him without being financially disadvantaged.”
AmerisourceBergen said its diversion control program applied to all orders from all companies — regardless of chain or independent affiliation.
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