Antibiotic Shortages: A Serious Safety Concern
Shortages of antibiotics in the U.S. has dominated the headlines in recent years. In fact, according to experts, antibiotics are being removed from the market six times faster than new ones are being produced. Between 2001 and 2013, there were shortages of 148 antibiotics. This is of great concern to the FDA and the healthcare community as many of these antibiotics were the sole drugs to treat certain antibiotic-resistant infections or for certain infectious conditions in children. Many life-threatening infections can be picked up from being in the hospital (nosocomial infection), outpatient surgery or doctor’s office.
In a 2015 study done at George Washington University, nearly half the shortages were for antibiotics needed to treat severe infections, including Clostridium difficile, carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa, among others. MRSA is an antibiotic-resistant bacteria that infects some 78,000 people a year and can be deadly, according to the CDC.
Even common therapies, like aztreonam used to treat serious infections in patients allergic to penicillin, and trimethoprim/sulfamethoxazole, used to treat pneumocystis pneumonia, were in short supply with no alternate manufacturers. Manufacturing site problems, shortage of raw material, low commercial incentive, and lack of approved manufacturers all can lead to drug shortages. Researchers contend that shortages will continue and that the U.S. government and FDA need to be involved to ensure adequate supplies of life-saving antibiotics.
However, FDA officials are working closely with industry, health care providers and patients. to take action against drug shortages. Although manufacturers are not required to notify the FDA of drug shortages, when they do, the FDA can work with other firms to determine if the drug can be made. The FDA has the ability to expedite inspections and approvals to help lessen the impact of a drug shortage, including antibiotics.
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