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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 19
October 1, 2022

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Updates on Monkeypox 

The U.S. Food and Drug Administration (FDA) is working to increase access to monkeypox testing in an effort to combat the current national outbreak. Early detection of the disease can prevent its spread to others and temper growth of the outbreak, but availability of tests has been limited. On September 7, 2022, the FDA announced their plan to review newly developed tests with high priority and released guidance regarding enforcement policies and their recommendations for emergency use authorization (EUA) requests for monkeypox tests. This guidance was in response to a declaration by the Secretary of the Department of Health and Human Services, indicating the urgent need for these tests. With this new guidance, test developers will be given specific recommendations on how to verify tests for accuracy and reliability. The FDA suggests commercial manufacturers inform them within 30 days if they plan to design a monkeypox test. As of now, the FDA has issued only one EUA for a diagnostic test. The test, developed by Quest Diagnostics, uses lesion swab specimens to detect monkeypox as well as other similar viruses.

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Drug Safety

FDA Alerts Insulin Pump Users for Potential Cybersecurity Risk

On September 20, 2022, the FDA alerted patients who use the Medtronic MiniMed 600 Series Insulin Pump System of a potential cybersecurity risk with the system. One feature of the MiniMed 600 series pump system is that it can be paired with wireless components. If an unauthorized person is nearby when pairing occurs, they may potentially gain access to the insulin pump due to a communication protocol issue. An insulin pump is a small medical device used for blood sugar control in patients with diabetes. They are used to deliver doses of insulin at scheduled times, both consistently throughout the day (basal insulin dosing) as well as when a diabetic patient is eating and needs additional insulin to process the sugar associated with their snack or meal (bolus insulin dosing). If a breach in the communication protocol occurs, the pump may deliver too much or too little insulin. Medtronic informed its users about the cybersecurity risk and the preventative actions they can take. To date, no incident related to the cybersecurity risk has been reported. The FDA and Medtronic are taking action to identify and prevent adverse events related to this cybersecurity risk. Users may call Medtronic at 1-800-646-4633 if they have additional questions. Incidences related to this cybersecurity risk should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Nationwide Adderall Shortage  

There has been a nationwide shortage of Adderall, a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) and daytime sleepiness, and its generic alternatives. Adderall is a combination of two stimulants, dextroamphetamine and amphetamine, and is categorized as a controlled substance because of its potential for dependence. Teva Pharmaceuticals is the biggest supplier of Adderall in the United States. Due to Teva’s recent labor shortage and an unexpectedly high demand for Adderall prescriptions, many small pharmacies have been having trouble obtaining an adequate supply of it to fill all the prescriptions they receive. Patients unable to get their prescription may need to switch to another medication temporarily to manage their symptoms. Many pharmaceutical manufacturers have started providing or increasing supply for brand or generic Adderall but federal limitations on how much of the schedule II medications an individual company can manufacture have led to the demand still not able to be met. Now that Teva’s labor shortage has been resolved, their production of Adderall is expected to return to normal and there is hope that the shortages could be resolved soon.

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Sotyktu™ (deucravacitinib)

Oral tablets approved for the treatment of moderate-to-severe plaque psoriasis in adult patients who are eligible for systemic treatments or phototherapy. [09/09/2022 – BRISTOL-MYERS SQUIBB]

New Drug Approval: Terlivaz® (terlipressin)

Injectable solution approved for kidney function improvement in adult patients with hepatorenal syndrome. [09/14/2022 – Priority Review; Orphan Drug – MALLINCKRODT] 

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New Generics

New Generics Entering the Marketplace

Timoptic® in Ocudose® (timolol maleate solution)
Indication: Open-Angle Glaucoma
Dosage Form/Strength: 60 x 0.3 ML unit doses of eye drop solution
Average Wholesale Price (AWP): Generic = $551 | Brand = $598