Shortages are leaving patients in the lurch.
Pharmacists are grappling with shortages of amoxicillin and Adderall due to increased demand for the antibiotic and manufacturing issues with Adderall.
The FDA listed amoxicillin oral powder for suspension on its Drug Shortages web site in late October, while the American Society of Health-Systems Pharmacists’ (ASHP) Drug Shortages site began listing numerous formulations of amoxicillin in shortage on October 20, 2022.
“This shortage is a challenging one as some of the commonly prescribed strengths and forms of the medication are not available. Patients and providers may find that they have to call around to multiple pharmacies to find available supply,” said Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP.
Rather than resulting from manufacturing challenges, the shortage appears to be caused by a rise in demand, Ganio noted, “likely tied to the increase of respiratory syncytial virus cases and other respiratory illnesses reported nationwide.”
Nearly 66% of pharmacies are having challenges obtaining amoxicillin, according to a new National Community Pharmacists Association (NCPA) survey of 8000 pharmacy owners and managers,1 whereas 89% are realizing a shortage of Adderall. Overall, 98% of pharmacies are experiencing some type of drug shortage.
Sandoz is one of a handful of manufacturers that are reporting short supply of amoxicillin.
“We are currently confronted with a considerable increase in antibiotics demand, which is leading to a tight supply situation: at the moment we are able to meet historical demand for our antibiotics, but we are facing challenges to meet this sudden spike in demand now that the flu season is in full swing,” said Leslie Pott, vice president of communications for Sandoz US.
Sandoz also realized some market dynamics from (short-term) competitor stock outs, “leading to un-forecasted high sales in our products resulting in supply challenges,” Pott added.
“The combination of rapid succession of the pandemic impact and consequent demand swings, manufacturing capacity constraints, scarcity of raw materials, and the current energy crisis means we currently face a uniquely difficult situation,” Pott said.
Pharmacists are likely communicating with prescribers to determine the best available amoxicillin product for patients during the intermittent shortage, Ganio said.
The good news is that there are alternative therapies if amoxicillin is not available, Ganio said. “Depending on the diagnosis, pharmacists may recommend alternatives like a cephalosporin or amoxicillin/clavulanate if therapeutically appropriate,” he noted.
According to ASHP, most of the amoxicillin products in shortage are expected to return to normal levels by the end of this year, but the shortage could extend into early next year.
The Adderall shortage, which pharmacies have been reporting since this summer, is also causing significant issues. The FDA officially posted a drug shortage notice for the medication, which treats both attention-deficit/hyperactivity disorder and narcolepsy, on October 12, 2022.
“FDA is in frequent communication with all manufacturers of amphetamine mixed salts, and one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays,” the FDA said in the notice. “Other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet US market demand through those producers.”
“Until supply is restored, there are alternative therapies including the extended-release version of amphetamine mixed salts available to health care professionals and their patients for amphetamine mixed salt approved indications,” the FDA said. "Patients should work with their health care professionals to determine their best treatment option.”
Adderall is a “very impactful shortage affecting both patients and clinicians,” Ganio noted. Finding an alternative therapy Adderall is not as easy as switching between other classes of medication, like a blood-pressure or cholesterol medication, he explained.
"Medications for this indication often require dosing adjustment over time to find the right dose, so for patients who are stable on an amphetamine salt combination product, this shortage is very disruptive.”
In addition, amphetamine mixed salts are schedule-II controlled substances, so prescriptions cannot be transferred from pharmacy to pharmacy. “If a patient does find a pharmacy with the medication in stock, their prescriber will have to send a new prescription to that pharmacy. So, in addition to the disruption to the patients, this can also take time away from pharmacists and clinicians helping to manage the shortage,” Ganio said.
Ganio attributes the shortage both to an increase in demand for the amphetamine salt combination products and a disruption in manufacturing.
Although Teva was previously experiencing a labor shortage, the manufacturer said it is now resolved, Ganio noted.
Both NCPA and ASHP executives are concerned about the multitude of drug shortages that continuously cause headaches for pharmacies, health care providers, and patients.
“We’re heavily reliant on foreign countries, some of which can be adversarial, for many of our pharmaceuticals. And the supply chain issues that resulted from the pandemic have not been fully resolved,” said NCPA CEO B. Douglas Hoey, in a news release.2
“Community pharmacies are the last link in the supply chain, and the only one that deals with patients directly. If there’s a disruption anywhere between the manufacturer and the patient, it affects the entire health care system and community pharmacists are the ones helping patients figure out their options,” Hoey added.