While the FDA has indicated there is no official shortage of the ADHD drug Adderall (amphetamine mixed salts) from Shire and its generics, pharmacies are reporting a lack of supply.

The American Society of Health-System Pharmacists (ASHP) is reporting shortages of several dosage sizes from several manufacturers. Amneal, Teva, Sandoz and Rhodes, which produce the generic version of Adderall, have reported supply issues to the University of Utah Drug Information Service, which supplies data to the ASHP’s drug shortages website. In addition, a recent National Community Pharmacists Association survey found 64% of independent pharmacies were having challenges obtaining Adderall.

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“It’s unclear how severe the issue is. Certainly, the products are being allocated, which means pharmacies can’t order the amount that they would like, which means some patients won’t be able to fill prescriptions at their usual pharmacy or potentially may be delayed,” ErinR. Fox, Pharm.D., BCPS, senior pharmacy director at the University of Utah Health, told Formulary Watch.

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The supply challenges are in part due to a labor shortage on Teva Pharmaceuticals’ packaging line, which has been resolved, per NBC News. Teva now has an active supply of branded and generic versions of Adderall and, while some pharmacies may experience a back order, it should be temporary, the company told NBC News.

Teva has all dosages of Adderall on back order, according to ASHP’s drug shortages site. The company estimates a release date in late September for its 5 mg capsules, early September for its 10 mg, 15 mg, and 20 mg capsules, and early- to mid-September for the 25 mg and 30 mg capsules.

There is no shortage of Sandoz’s generic Adderall currently, Leslie Pottvice president of communications for Sandoz US, told Formulary Watch. “If there were a drug shortage, we would have to report this to the FDA.”

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However, the DEA quota on manufacturing Adderall products is fixed annually, so there “isn’t much flexibility in the system to increase production,” according to Pott.

“Our customers commit to us via contracts what they intend to order from us each month, and we develop our manufacturing forecasts based on these predicted orders. We are then given access to the active pharmaceutical ingredient for this predicted level of ordering by the DEA. If a customer orders more from us than what they forecasted, we are unable to fulfill these orders and they are called ‘backorders’,” Pott added.

Sandoz has 15 mg Adderall capsules on back order and the company cannot estimate a release date, according to ASHP’s drug shortages website. Sandoz’s 20 mg capsules are on back order and the manufacturer estimates a release date in September.

Amneal has 5 mg capsules on back order and the company estimates a release date in late September. The company’s 15 mg and 25 mg capsules are on back order.

Source: https://t-tees.com
Category: WHO