PROVIDENCE — The nationwide shortage of Adderall, a medication used to treat ADHD and narcolepsy, is having an impact in New England, where some patients have been rationing the medication or going without their prescriptions for months. In Rhode Island, pharmacies are running out of stock of the brand-name medication and its generic formulations.
Here’s what you need to know.
What is Adderall?
Adderall is the brand name of a central nervous system stimulant used to treat Attention Deficit Hyperactivity Disorder and narcolepsy. The generic form, which is available in both tablets and capsules and can cost less than the brand name, is amphetamine/dextroamphetamine salts.
Adderall can be abused if it is not taken properly, and has been classified as a Schedule II Controlled Substance by the Drug Enforcement Agency. Other Schedule II narcotics include oxycodone, methadone, fentanyl.
How long has there been a shortage?
In October 2022, the FDA announced a shortage of immediate release formulation of amphetamine mixed salts, commonly sold as Adderall. The agency said it was in communication with all manufacturers of the medication and that some of the companies were experiencing ongoing “intermittent manufacturing delays.” At the time, the agency said there was not a sufficient supply to keep up with the market demand in the United States.
What’s causing the shortage?
Teva Pharmaceuticals Industries Ltd., one of the largest Adderall manufacturers, had production delays because of worker shortages in the summer of 2022.
Manufacturing delays have been “resolved,” FDA Jim McKinney spokesman told CNN in late February, but the shortage is now “demand-driven.” He said supply is expected to increase, but did not provide a timeline as to when the shortage could ease.
The FDA lists manufacturers that have reported Adderall shortages to the agency on its website. Reasons range from “demand increase” to “shortage of active ingredient.” In other cases, there is no reason listed.
Bloomberg reported Feb. 16 that companies at the end of last year had at least 34,980 kilograms — or 77,000 pounds — of amphetamine, the raw ingredient in Adderall. The outlet later reported that, according to the FDA, 38,000 kilograms of amphetamine would be sufficient to meet the demand for Adderall and its generics. The DEA set a quota at 42,400 kilograms, but it’s unclear how those quotas are doled out among manufacturers.
The DEA tracks and sets limits on production of amphetamine each year. A DEA spokeswoman told the Globe Wednesday that the agency consults with the FDA to set the Aggregate Production Quotas, or APQ.
The DEA has the authority and ability to adjust the APQ during the course of the year, she said. However, the majority of manufacturers contacted by the DEA or FDA “have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs.”
“Manufacturers have not fully utilized the APQ for amphetamine in support of domestic manufacturing, reserve stocks, and export requirements for the past three calendar years,” the spokesman said, referencing 2020, 2021, and 2022. “Based on this trend, DEA has not implemented an increase to the APQ for amphetamine at this time.”
She added: “Should the proposed 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.”
How has New England been impacted by the Adderall shortage?
On Tuesday, pharmacists who work for CVS said there were hardly any pills available within a 30-mile radius of Providence. One pharmacist, who asked not to be named, said doctors’ offices are instructing patients to “call around” to look for pills that might be available.
If a patient does find a pharmacy with the medication, the person must ask their doctor to direct their prescription to that particular pharmacy. That doesn’t reserve the medication for that patient, though, and the pharmacy may give the supply to someone else.
“So everyone is just calling nonstop,” the pharmacist told the Globe.
CVS spokesman Matta Blanchette told the Globe that the Woonsocket, R.I.-based company is aware of the “intermittent shortages of amphetamine in the supply chain.”
“Our pharmacists will work with patients who are prescribed this medication as needed,” he said.
Blanchette declined to say whether CVS was working with federal agencies to develop a timeline for when the issue might be resolved.
At Lifespan, Rhode Island’s largest health care system, Raymond Spinella, ambulatory pharmacist in charge, called the shortage “severe,” but workable.
“While Lifespan is running critically low on certain strengths of this medication, we consult with the patient’s physician if needed and dispense the medication in combined strengths to ensure the same dosage as prescribed,” Spinella told the Globe Wednesday. “With this strategy we have been able to continue to fulfill our patients’ needs in this challenging environment.”
Are independent pharmacies impacted?
Independent pharmacies were initially not as affected by the shortage as larger chains, but now the shortage is widespread.
“We were getting up to 35 calls a day from non-customers,” Nicholas Shanos, pharmacy manager of Suburban Pharmacy in Cranston, told the NBC-10 on Feb. 23. ”Customers that were just calling, googling pharmacies.”
Shanos added a voice message to the pharmacy’s phone system, which automatically lets callers know when they are out of Adderall.
Hasan Iqbal, a pharmacy manager at Park Ave Pharmacy in Cranston, told the TV station that they are on the phone with manufacturers “three to four times a day.” Iqbal said they started offering patients lower doses if the doses they are prescribed are not available.
Are there some states that are impacted more than others by the Adderall shortage?
Initial reports of the shortage first came out of southern states such as Alabama and Mississippi, where the issue has persisted.
Marilyn Augustyn, director of developmental and behavioral pediatrics at Boston Medical Center and professor of pediatrics at Boston University, said in December 2022 that parts of Boston have been spared compared to other parts of the country during the nationwide shortage. She said it may have to do with from where the medication is being shipped.
“I think it primarily has to do with the pipeline — shortages that have to do with shipping issues,” said Augustyn. “Earlier in the pandemic, we had a shortage of one of the methylphenidate family, and we had to switch kids to different preparations. Kids may do better on one, but the other one works by a similar mechanism.”
How many patients are affected by the shortage, and what happens next?
It’s unclear how many US patients have not been able to access their medications.
More than 41 million prescriptions for generic and brand-name Adderall were dispensed in 2021, according to IQVIA, an analytics provider for the life sciences industry. That’s an increase of more than 10 percent from the year prior.
Some industry experts say the uptick in prescriptions could be because there is more awareness about ADHD. Attention Deficit Hyperactivity Disorder used to be viewed as a condition that children could “outgrow.” By the 1990s, studies indicated that 50 percent to 66 percent of children with ADHD had symptoms persist into adulthood, according to the National Center for Biotechnology Information.
Some observers note that because of the rise of certain telehealth providers, stimulants may be overprescribed.
In mid-2022, Walmart and CVS said they would stop filling prescriptions for controlled substances — such as Adderall — from telehealth startups such as Cerebral Inc. and Done Health. Both companies became popular during the pandemic, and Cerebral was among the companies that the Department of Justice was investigating for “possible violations” of controlled substances laws.
Companies who manufacturer the drug say that federal agencies should rethink how the substance is regulated. Chairman and CEO of Aytu BioPharma Josh Disbrow wrote in a recent CNBC op-ed that the FDA should explore substitution flexibility for pharmacists to work with patients in times of shortages.
“Given the growing prevalence of ADHD among patients of all ages, it’s time for policymakers to rethink how these essential medicines — and the providers who prescribe and dispense them to patients — are regulated,” wrote Disbrow, whose company makes Adzenys XR-ODT, a competing drug to treat ADHD. “Only then can we ensure that shortages like this one don’t happen again.”