Now I understand how the DEA is able to state with a “straight face” that they don’t control/ration controlled meds and interfere with pt’s access in getting them. I have read a couple of comments about the Walgreen, CVS, Walmart lawsuit by 50 state AG’s , native American groups and others that those three chain pharmacy chains agreed to “reduce opioid Rx dispensed”. So here was have 50 state Attorney Generals, hiring law firms on a contingency basis – so that the states are not putting any tax payer monies at risk. If the win, the states get a windfall of money from the lawsuit as does the law firms involved. Whatever is contained in the final settlement, like reduce opioid Rx dispensing… the DEA can claim that they didn’t cause that. Just like the DEA & VA had no input in the CDC 2016 opioid dosing guidelines?
This could be the “final straw”, in proving that the major drug wholesalers and major chain drug stores are complicit in discriminating against a segment of the population (disabled) and are being intentionally denying medically necessary medication, which is most likely a civil rights violation under the Americans with Disability Act. Unless these settlements are “sealed” and not available for public view, it would appear that discriminating against disabled pts. Could the community need to sue whatever corporate executive(s) that signed the agreement. I suspect that each of those large corporations have something in their policies and procedure manuals that if an employee breaks/violates the law, the corporation is not responsible for their actions.
Xanax and Adderall Access Is Being Blocked by Secret Drug Limits
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 “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.
Read More: FDA Lacks the Tools to Prevent Surprise Drug Shortages, Senators Say
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.
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The term “mom and pop” business had always bothered me. I thought it sounded a bit condescending and dismissive when I would hear representatives from big businesses talk about it, almost like they were giving small business owners a little pat on the head. But Wednesday was “Mom and Pop Business Owner’s Day,” and my attitude about the phrase evolved during a week in D.C. when independent pharmacies were in the spotlight.