Pharmaceutical Technology - September 2021


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16 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m Drug Safety D rug shortages were a major concern before the COVID- 19 pandemic, which only served to further add pressure to an imperfect supply chain. The COVID-19 pandemic placed added pressure on bio/pharma's imperfect sup- ply chain, contributing to ongoing drug shortages and creating some new challenges. What has the industry learned from the pandemic and will practices and supply-related decisions change going forward? While FDA has prompted drug manufacturers to provide a warn- ing of pending shortages earlier in advance, the agency has noted new supply chain challenges related to transportation issues, manufactur- ing staff shortages due to COVID-19 outbreaks, and the increased de- mand for certain drugs for hospitalized patients with COVID-19 (1). In Europe, drug shortages generally are addressed by national au- thorities, and the European Medicines Association (EMA) becomes involved only in certain situations. EMA notes that challenges in the global supply chain remain due to decreased manufacturing capacity, logistical and transport challenges, and increased purchasing costs (2). As new challenges add to legacy supply chain problems, one fact remains: improvements are needed to lessen the risk of future drug shortages. Martin VanTrieste, president and CEO of Civica RX (a nonprofit generic drug company); Swati Patel, director of Clarkston Consulting (a global business consulting firm); and Paul McDonald, PhD, vice president of Proactive Worldwide (a market intelligence company) shared with Pharmaceutical Technology perspectives on supply chain disruptions, predictions for drug shortages, and suggested actions to alleviate threats to the drug supply. Changing the Course of Drug Shortages Meg Rivers The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes. RAWPIXEL.COM - STOCK.ADOBE.COM

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