More than 41 million Americans are struggling with a six-month-long shortage of Adderall, a medicine prescribed to control attention deficit hyperactivity disorder, depression, narcolepsy and other conditions. A large percentage of patients are children.
Reports of shortages at retail pharmacies first surfaced last summer and by October, the Food and Drug Administration issued a statement that the medicine was in short supply and projected that the issue would be resolved by November.
Even that short of a delay was considered hazardous for patients, experts said.
“The people that depend on the medication for daily functioning, for going to work, for being a good mother, for going to class, are struggling,” Fairlee C. Fabrett, director of training and staff development for the child and adolescent division at McLean Hospital in Massachusetts told the New York Times on Nov. 13. “This is not something to make light of.”
Fabrett said patients should work with their providers to get through the rough patch.
“This is not going to be forever," he said.
But a one-month delay has been repeatedly extended with no resolution in sight. On Thursday, the FDA issued a statement that the shortage would continue, with a hoped-for resolution in April.
The shortage has slowly caught the attention of Congress, with constituents registering concerns with lawmakers about the inability to get prescriptions filled and a lack of reliable information about why the problem has gone on so long.
Sen. Ron Wyden, D-Oregon, said the inability of the two federal agencies to present a coherent plan for remedying the shortage wasn't acceptable and called on the Food and Drug Administration to work more closely with the Drug Enforcement Agency to find a solution.
“Shortages of these medications are unconscionable, and I am working with the FDA and DEA to unsnarl this supply chain ASAP so Oregonians can have the access they deserve to the medications their doctors have prescribed for their health," Wyden said.
Oregon officials say there is little they can do since prescription drugs are approved and regulated on the federal level. Other than pass along concerns of the medical community, pharmacies and patients, there's nothing the state can do to get the supply-and-demand gap filled.
"There's not a lot of good levers," said Joe Schnabel, executive director of the the Oregon Board of Pharmacy.
Reports of shortages have grown with scores of stories from across the country highlighting people's struggles. A small sample of headlines:
"‘The worst it’s ever been’: mysterious US Adderall shortage puts ADHD patients at risk" — UK Guardian, Jan. 30
"Adderall’s Disappearing Act Has Left Millions Without Treatment" — Bloomberg News Service, Feb. 16
"National Adderall Shortage Enters Sixth Month, Alternative Medications Becoming Scarce" — NBC-4 Dallas, March 7.
"Drug makers and regulators deflect blame in ADHD medication shortage" — The Baltimore Banner, March 8.
Originally, federal officials pinned the shortage on a production slowdown at one company, Teva Pharmaceuticals.
But increasingly, the focus has been on the disconnect between two key federal agencies that control the demand and supply of the medicine.
Demand is handled by the Food and Drug Administration. Many medical professionals said the increase in prescriptions was legitimate as telehealth allowed people without ready access to a doctor to get prescriptions.
There's a debate over the increase. Critics say that a few telemedicine start-ups became pill mills, making big profits with little oversight.
Demand increased. But the agency handling supply — the Drug Enforcement Agency — said it saw no shortage.
Adderall, an amphetamine, is listed by the DEA as a Schedule II medicine. The category is for drugs that have significant medical purposes but "a high potential for abuse." DEA sets an annual aggregate production quota (APQ) to ensure enough of a drug is "available for national medical, scientific, and industrial use."
When asked by the Oregon Capital Bureau about the widespread reports of Adderall shortages, the Drug Enforcement Agency declined comment by a spokesperson. They responded with an email linked to a 22-page section published in early December in the Federal Register, the official journal of the U.S. government.
"DEA is aware of patient reports that pharmacies are unable to fill prescriptions for their prescribed Adderall or one of its generic versions," the DEA states in the register.
"DEA consults with FDA to set the APQ for amphetamine each calendar year. The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs."
Using data going back to 2020, DEA said in the register that manufacturers had not utilized the approved amounts of amphetamine in 2020, 2021 and 2022.
"Based on this trend, DEA has not implemented an increase to the APQ for amphetamine at this time," DEA said in the register. "Should the proposed established amphetamine APQ become inadequate to meet legitimate medical and scientific needs, sufficient reserve stocks, and export requirements, DEA has the authority and ability to adjust the APQ during the course of the year."
DEA "remains in communication with FDA regarding these shortage reports."
Asked for an update on the situation since December, DEA did not respond.
DEA has maintained silence, even as Congress has become tentatively involved.
U.S. Rep. Abigail Spanberger, D-Va., was the first to question the reasons for the shortage. A former CIA officer familiar with federal agency internal operations, Spanberger asked Drug Enforcement Agency Acting Administrator Anne Milgram to explain the shortage and the agency's plans for getting medicine to those with legitimate, often decades-long, prescriptions.
"The shortage has had serious effects on many ADHD patients’ ability to function in their daily lives," Spanberger wrote in February. "Providers have begun switching patients to alternative medications for ADHD, though alternatives do not work as well as the originally prescribed medication for some patients. Especially concerning are reports that desperate patients have died after turning to counterfeit pills laced with fentanyl."
Wyden said the Adderall prescription shortage in Oregon was adding to an already difficult experience for many in Oregon, where Bi-Mart has withdrawn from the pharmacy business, leaving many rural areas of the state far from the remaining pharmacies in operation. That's increased the demand at those still in business, making the shortage of Adderall worse.
Bi-Mart closed its 56 remaining pharmacies in Oregon, Washington and Idaho at the end of 2021, citing pressure from prescription benefit middlemen squeezing payments for medicines and other inadequate insurance reimbursements. The employee-owned chain, based in Eugene, had closed 20 pharmacies in the Pacific Northwest in 2017. The company agreed to transfer its patient records to Walgreens. But not all areas with Bi-Marts have Walgreens nearby.
“A huge part of quality of life for Oregonians, particularly in rural parts of our state, depends on their community’s independent pharmacy having the ability to offer access to generics for Adderall and other crucial medications,” said Wyden, who is chair of the Senate Finance Committee.
Caught in the middle are patients who tell of taking prescriptions to pharmacies, only to be told there is no Adderall available and future supplies are unknown. Concerns over DEA sanctions have led most pharmacies to decline to tell customers when they might get a shipment or what other pharmacies might have what the patient is prescribed.
Even large chain pharmacies cannot transfer prescriptions between stores even a few blocks away. If a patient can locate a pharmacy with the prescription, the doctor has to cancel the original prescription and send a new one to the new outlet. By then, the medicine might be gone.
The DEA also does not allow for changes between immediate and extended release versions. Any dosage changes — total or specific to the pill — also require a new prescription. So a patient who goes to a pharmacy with a prescription for 60mg taken as two 30mg immediate release pills twice a day cannot receive 60mg as three pills taken three times daily.
Medical providers and others have come up with a list of commonly repeated suggestions of how to cope: Try different pharmacies. Small mom-and-pop pharmacies may have supplies that have been exhausted by the major chains. Ask your doctor about changing medications - maybe Vyvanse or Ritalin.
But as the delay has gone on, Vyvanse and Ritalin and other medicines such as Concerta have also come into short supply. The brand-name alternatives are often not covered under insurance plans, meaning patients have to pay up to hundreds of dollars for the medicine or go without.
Patients will ration their supply, taking less than prescribed so that when the next 30-day prescription bumps up against the shortage, they have some medicine to try to bridge the gap.
But the lack of supply amid an excess of demand over a long period of time can lead to desperation. Giving or selling someone Adderall is a felony. Despite being illegal, sharing prescriptions among friends and family is common, according to press reports in several states. Some Adderall sold on the street or in Mexico is counterfeit, sometimes laced with deadly opioids like Fentanyl.
"People have a lot of bad choices," said Schnabel, the Oregon Board of Pharmacy executive director. "That can be very dangerous."
Schnabel, said the Oregon Board of Pharmacy knows that the shortages undercut the lack of equal access to medicines. Those who have the time to call repeatedly during the week, to go to pharmacies to check on supplies, can build relationships with the pharmaceutical gatekeepers, have providers who will swiftly turn around prescription changes, or have the money to pay for new prescriptions or brand-name alternatives to generics are going to come out ahead.
"People who are privileged and more connected find a way," Schnabel said. "We want to ensure that pharmacies are distributing the limited amounts equitably."
Only President Joe Biden and Congress can get the federal agencies to deal with the shortage, or even respond to queries from lawmakers, Schnabel said.
"Pressure coming from congresspersons and senators — that is what needs to be supplied," Schnabel said.
Gosh. I thought that in capitalism, wellbeing and health were up to the individual. Bootstrap that Adderall! Make it yourself in the backyard, in your bunker!
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