“This impacts physicians’ practice overflow, but more notably it affects their patients who now have anxiety knowing that they’re not going to get their doctor’s first choice of drug for them,” he said. Overall, these shortages impact the quality and safety of patient care.
Explore This IssueOctober 2015
As one solution for this problem, the FDA currently requires that pharmaceutical manufacturers inform them about when production interruptions or changes could lead to a reduced supply of drugs or when a single-source drug is discontinued, said Dr. Denneny (see “FDA App for Identifying Drug Shortages,” below).
He emphasized that the manufacturer still decides whether a change is significant enough to require FDA notification or not, however. “The FDA cannot require a company to make a drug, make more of a drug, or change a drug’s distribution, so more advanced warning and better strategies to communicate about potential shortages would be beneficial in terms of preparation,” he said.
Anand K. Devaiah, MD, associate professor in the department of otolaryngology-head and neck surgery at Boston University School of Medicine and chair of the AAO-HNS Medical Devices and Drugs Committee, also emphasized the importance of having a system in place to alert doctors when critical shortage levels of a drug are nearing. He warned, however, about not cutting corners on safety. “We should not circumvent the protections for manufacturing and compounding,” he said, noting the hard lessons that have been learned when this occurs. “Any solutions need to include appropriate safety precautions, whether we are in a state of shortage or not.”
He said working with the FDA can be helpful in creating solutions to the underlying problems that lead to drug shortages.
Dr. Denneny pointed out a couple of FDA practices currently used as short-term solutions. One is their ability to give support to manufacturing when the shortage is due to a production issue. Another may be to import needed drugs from abroad; however, the FDA allows this only in rare cases, due to the variation in safety standards and protections among different countries.
As for dealing with a drug shortage in the short term, physicians usually end up looking for an alternative, said Dr. Denneny. “If there isn’t an available or appropriate alternative, they may end up not treating the presented condition,” he said.
Mary Beth Nierengarten is a freelance medical writer based in Minnesota.