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Understanding and Resolving Drug Shortages in the Pharmaceutical Industry

机译:Understanding and Resolving Drug Shortages in the Pharmaceutical Industry

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摘要

People undergoing treatment for attention deficit/hyperactivity disorder (ADHD), certain cancers, various infectious diseases, and pain management may find themselves on a medication waiting list due to a worldwide drug shortage. Various drugs such as Adderall, often prescribed for those with ADHD, as well as cisplatin and carboplatin, used in chemotherapy for several different cancers, are all in short supply. Because there are no alternatives for many of the drugs on the shortage list, patients need to either skip treatments or take lower dosages of the medications. In some cases, there are alternative treatments, but most are either not as effective or can lead to adverse outcomes. The U.S. Food and Drug Administration (FDA) has a mandate to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs and biological products by enforcing current regulations through product surveillance programs and by performing regular compliance inspections. This poses challenges for the regulatory watchdog because the agency also bares the responsibility of ensuring that there are enough medications and therapies to go around. Despite the efforts of the FDA and other global regulatory agencies to ensure the ample supply of safe and effective medications, there are still alarming numbers of public health concerns stemming from drug shortages.

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