1 month ago
AOL
As the nationwide Adderall shortage enters its fifth month, people who rely on medication to help manage attention-deficit/hyperactivity disorder are finding few, if any, available alternatives. There’s no sign of relief yet, and no easy solution to the problem, pharmacy experts say.
Widespread scarcity has hit Adderall alternatives, too.
As of January, the American Society of Health-System Pharmacists, which tracks drug availability, reported shortages affecting nearly 40 different doses or formulations of generic Concerta, a long-acting form of methylphenidate, the drug in Ritalin. Takeda Pharmaceuticals, which makes Vyvanse, also known as lisdexamfetamine, its generic, says there’s no shortage of that drug, but according to dozens of pharmacies reached by NBC News, Vyvanse has been on intermittent backorder for months.
Michael Ganio, senior director of pharmacy practice and quality at ASHP said an unexpected rise in demand was more to blame than manufacturing equipment or drug quality issues.
“All of our drug shortage infrastructure, and everything we have in place in this country to mitigate the impact of shortages is based on potential disruptions in supply,” Ganio said. “It’s been very unusual to have a shortage based on increase in demand.”
In recent years, ADHD medication prescriptions have risen more than the drug companies or government agencies predicted. According to the health data company Trilliant Health, Adderall prescriptions for adults rose 15.1% during 2020, double the 7.4% rise seen the year before.
In October, the Food and Drug Administration announced a national shortage of Adderall, citing “ongoing intermittent manufacturing delays.”
Dr. Sarah Cheyette began switching patients to alternative ADHD medications like Focalin, Vyvanse, Concerta and Ritalin when she learned pharmacies were out of Adderall late last year. The alternative drugs didn’t always work out, but for many patients, switching prescriptions made more sense than going without ADHD medication altogether.
“There’s a spillover from people who couldn’t get Adderall and have turned to other drugs,” said Cheyette, a pediatric neurologist who treats both children and adults who have ADHD at the Palo Alto Medical Foundation. “And it’s just getting worse.”
Some drug companies now say the supply problems could last well into the spring. Alvogen, which manufactures generic Adderall, expects its shortage to last until mid-April, according to the FDA’s database. Teva Pharmaceuticals, the country’s largest Adderall supplier, reports that issues with some of its Adderall dosages, particularly the more expensive brand-name versions of its fast-acting tablets, are now resolved but lists recovery dates for others as TBD (to be determined).
Most ADHD medications fall into a class of controlled substances called central nervous system stimulants. Because the medications have a well-documented history of abuse and addiction, the FDA and Drug Enforcement Administration limit how many pills a pharmacy can dispense at once and how frequently patients can refill their prescriptions. The DEA also sets limits on the active ingredients pharmaceutical companies use to make these drugs each year.
“The DEA is involved if any manufacturers try to scale up production,” Ganio said. The DEA calculates how much of a given drug ingredient is needed to meet demand, then allocates that precise amount. The problem, according to Ganio, is how DEA uses historical data — meaning prescription numbers from previous years — to set these amounts.
Demand forecasts based on historical data couldn’t predict the sharp rise in ADHD diagnoses during the pandemic, Ganio said. Now there’s a mismatch between DEA quotas and prescription numbers.
The quotas have been troublesome for companies like Novartis-owned Sandoz, which makes generic Adderall and Concerta.
“Since mid-2022, we found when a customer ordered more from us than what they forecasted, we were unable to fulfill those orders,” Leslie Pott, a Sandoz spokesperson, told NBC News in an email. “We petitioned the DEA for an increase in volume, with some requests accepted and some denied.” According to Pott, these customers range from hospitals and institutions to retail pharmacies, specialty pharmacies and wholesalers.
Ganio said the DEA is often willing to increase quotas if there’s legitimate patient demand. But it’s difficult to measure a demand increase while it’s happening. There’s no real-time coordinated system for tracking ADHD diagnoses on a national level like there is for Covid or the flu.
“Making more drugs is not as easy as just flipping a switch,” Ganio said. “The FDA and DEA are seeing more demand, but how much more?”
Doctors can’t cite exact numbers either, but many say they’ve noticed a clear increase in patients seeking ADHD treatment since pandemic lockdowns began.
“Like many crises, a lot of factors all came together to create a perfect storm,” said Cheyette, who herself saw many more patients for ADHD recently than in pre-pandemic years. “This is unbelievably unprecedented.”
As people began working from home or helping children with virtual school, they started to recognize ADHD symptoms, said Dr. Max Wiznitzer, a pediatric neurologist at University Hospitals Rainbow Babies and Children’s Hospital and Case Western Reserve University in Cleveland. This was especially true for adult women.
“All of a sudden, parents were seeing their children have difficulties staying focused, and we were identifying more kids who were symptomatic and needed intervention,” Wiznitzer said. “The parents of my patients have been asking about ADHD more often.” Since the pandemic began, Wiznitzer said he’s been prescribing ADHD medication to more adults.
Ashley Gandy, 39, who lives in Carrollton, Texas, takes Vyvanse for her ADHD, a prescription she got through a telehealth doctor. Her 6-year-old son takes Concerta, which his pediatrician prescribes. For several weeks in the fall, Gandy’s Vyvanse was on backorder, and now her usual pharmacy is out of her son’s Concerta.
“The CVS person told me they haven’t had any for a month and they didn’t expect to be getting it any time soon,” she said.
In late December, Rep. Abigail Spanberger, whose Virginia congressional district spans Fredericksburg and several other towns in the northeastern region of the state, wrote a letter petitioning the FDA and DEA to coordinate a federal response to the shortage. The advocacy branch of ASHP has also been pushing the government to improve how it addresses issues in drug supply and demand.
The scarcity of ADHD medication has addiction experts on high alert now, too.
According to Dr. Eric Kutscher, an addiction medicine specialist at NYU Grossman School of Medicine, the same reason these drugs are controlled substances in the first place — their potential for abuse — has him fearing the continued shortage. Without access to prescription stimulants, Kutscher said people with substance use disorders might “turn to a drug supply that’s more dangerous than ever.” Deaths from counterfeit Adderall laced with fentanyl have already been reported.
“We have a limited safe supply, and an available, very dangerous supply that could hurt a lot of people,” Kutscher said. “From a public health perspective, this is an emergency.”
A quick fix is unlikely, experts acknowledge.
From Ganio’s perspective, addressing the ADHD drug shortage is going to require much more transparency from drug companies and better, coordinated systems for forecasting drug demand.
Cheyette worries that a solution won’t come soon enough.
“These are not Beanie Babies that people can’t find,” she said. “These are medications people depend on to function.”
Continue reading...
