Drug Shortages in Otolaryngology

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Since 2011, annual new drug shortages have fallen from a peak shortage of 267 drugs in 2011 to 185 in 2014; 68 have been reported so far in 2015. Among the common drug classes in short supply from 2010 through 2014, according to statistics gathered by the University of Utah Drug Information Service, are chemotherapy agents, central nervous system (CNS) agents, and antibiotics. Other drug shortages include those used to treat cardiovascular disease, autonomic diseases, gastrointestinal disorders, and eye, ear, nose, and throat conditions, as well as electrolytes and hormones.

The impact of these shortages on the healthcare system and patient care are substantial and include delays in the delivery of medical procedures and drug treatment protocols, higher relapse rates among patients with cancer and other chronic diseases, increased rates of medical errors, and reduced patient health outcomes. In addition, drug shortages may challenge healthcare providers by raising ethical issues about how to distribute drugs in short supply, as well as by requiring them to use alternative therapies that they may not have experience with. Furthermore, patients may choose to purchase needed drugs from other sources, including those found online or in foreign countries.

Further impact on the quality of patient care is seen in the adverse side effects reported after use of alternative therapies when drugs are in short supply. In a 2012 survey by the Institute for Safe Medication Practices (ISMP), pharmacists reported that the medications most commonly involved in adverse effects caused by drug shortages included chemotherapy (particularly doxorubicin), opioid analgesics (mostly fentanyl and morphine), electrolytes, antibiotics, phentolamine, and phytonadione (ISMP. 2012).

Given the negative impact that these shortages can and do have on patient care and outcomes, regulatory and legislative efforts continue to try to provide a systematic way of addressing the underlying reasons for shortages and to find ways to prevent drug shortages or mitigate their effects when they do occur.

The impact of these shortages on the practice of otolaryngology may be felt in a number of areas.

Impact on Otolaryngology

For otolaryngologists, the current antibiotics shortage may have the largest impact on practice. According to the University of Utah Drug Information Service, although the shortage in antibiotics dropped to 29 in 2012 and 17 in 2013 after a high of 35 shortages in 2011, in 2014 the number rose again, to 31.

According to a 2015 study that looked at antibacterial drug shortages from 2001 to 2013, a shortage of 148 antibacterial drugs occurred during this time frame, with a dramatic rise in shortages since 2007. From July to December 31, 2007, the study found a statistically significant increased monthly rate of drug shortages, and, as of December 2013, there were 26 antibacterial drugs still in short supply (Clin Infect Dis. 2015;60:1737-42. Of particular concern is the shortage of drugs used for treating highly drug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, and Psuedomonas aeruginosa. Furthermore, many drugs used as standard treatment are in short supply, such as aztreonam for patients allergic to penicillin and trimethoprim/sulfamethoxazole for patients with pneumocystis pneumonia.