Articles related to DRUG SHORTAGES

Join us as we explore the dynamic world of compounding pharmacies tackling the challenging semaglutide shortages head-on. Compounding pharmacies have stepped up to address the shortage of two semaglutide products, Ozempic and Wegovy. Consequently, they’re facing increased scrutiny from federal and state regulators, as well as Novo Nordisk, the manufacturer of these products. Novo Nordisk is actively monitoring and taking action against entities unlawfully selling compounded semaglutide. The company has sent cease-and-desist letters to some 503A pharmacy compounders. This move is seen as the first step towards potential legal actions. The Alliance for Pharmacy Compounding has defended the rights of 503A pharmacies to compound active pharmaceutical ingredients (APIs) in brand-name medications for specific patients, as long as the brands are on the FDA’s “currently in shortage” list. However, the distinction between legitimate 503A pharmacy compounders and shady operators has been blurred. These operators have rushed to fill the semaglutide gap without proper oversight of their compounding safety processes, source of APIs, or marketing techniques. This negligence could potentially cause serious patient harm. Kristina Bryowsky, PharmD, MBA, Vice President of Pharmacy Services for SSM Health Care, Missouri Region, believes that 503A compounding pharmacies should be allowed to make a product for […]

Oncologists and cancer drug shortages are creating a crisis, with patient care at risk and legal liabilities looming. In the face of critical cancer drug shortages, oncologists grapple with suboptimal patient care and possible legal liabilities. The issue worsens due to insufficient guidelines for alternative treatment options. A contributing factor is the weak financial incentive for drug manufacturers to produce unprofitable generic drugs, compared to branded ones. Consequently, there’s greater dependence on foreign factories, leading to supply chain hitches and quality control issues. Barbara McAneny, MD, CEO of New Mexico Cancer Center, foresees drug shortages persisting, particularly affecting low-cost treatments. The American Society of Health-System Pharmacists (ASHP) reports shortages of vital oncology drugs like methotrexate, cisplatin, carboplatin, and fluorouracil, crucial for treating various common cancers. Furthermore, the lack of guidelines on alternative treatments exacerbates oncologists’ concerns about patient outcomes and legal liabilities. This absence of direction leaves physicians making crucial decisions single-handedly. In response, the American Society of Clinical Oncology (ASCO) has formed an advisory group to develop clinical guidance during these drug shortages. Immediate recommendations include reprioritizing nonessential use of scarce antineoplastic drugs, increasing interval cycles, reducing doses when clinically acceptable, and selecting evidence-based alternatives. Dr. Jeff Patton, CEO […]

The United States is currently experiencing a shortage of Adderall, a medication used to treat attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) and narcolepsy. The FDA, in frequent communication with manufacturers, has not provided a clear timeline for when the shortage will be resolved. The shortage is attributed to various factors. The demand for Adderall has increased significantly, with a 10% rise in prescriptions filled in 2021 compared to the previous year. The US Drug Enforcement Agency’s efforts to combat prescription drug misuse have also played a role in limiting production. Furthermore, the pandemic led to the emergence of telemedicine startups, making it easier for individuals to obtain Adderall prescriptions, sometimes inaccurately. While waiting for the supply to be restored, healthcare professionals can consider alternative therapies such as dexmethylphenidate, methylphenidate, and dextroamphetamine.

Akorn previously manufactured a long list of generic drugs, including orals, injectables, and topicals for a wide range of indications, from antivirals and antibiotics to ophthalmic agents, asthma medications, and analgesics. Some of these agents have other manufacturers, but Akorn was either the sole supplier or had a very large market share for others.

The shortage is driven by increased prescribing due to bacterial infection coexisting with RSV infection, and in cases where it is not possible to tell if the patient is experiencing a bacterial or viral URI. Substitute antibiotics to consider include cephalosporins and amoxicillin-clavulanate.

Teva Pharmaceuticals is the primary supplier of both branded and generic versions of the stimulant, which is approved to treat ADHD and narcolepsy. Teva has cited increased demand, workforce shortages, and manufacturing disruptions due to packaging constraints as reasons for the supply problems.