Anti-infective drug shortages affect clinical care, outcomes

Welcome to the latest public health emergency: Shortages of anti-infective agents. These shortages can adversely affect clinical care and patient outcomes, according to a new study.

“Anti-infectives often represent irreplaceable life-saving treatment,” wrote the authors of a study on anti-infective shortages to be published in the March 1, 2012, issue of Clinical Infectious Diseases. “Very few antimicrobial options exist in many cases due to increasing drug resistance. Multiple bacterial pathogens have now earned the status of multidrug resistant, extremely drug resistant, or pandrug resistant.”

Agents in short supply are typically parenterals, including acyclovir, ciprofloxacin, piperacillin-tazobactam, streptomycin, and sulfamethoxazole-trimethoprim. But the list of unobtainable or difficult-to-obtain agents includes ointments (erythromycin ophthalmic and mupirocin) and oral solids (isoniazid). Conditions subject to inappropriate treatment due to shortages include sepsis, endocarditis, meningitis, neurosyphilis, tuberculosis, and multiple forms of pneumonia.

Typical reasons for shortage include raw material shortages, manufacturing issues, increased demand, product contamination and other good manufacturing procedure violations, and manufacturer decisions to halt production. Manufacturers are not required to disclose the causes underlying a product shortage.

An active "gray market" has developed to provide product that cannot be obtained through normal distribution channels, the authors noted. There is little regulation of the gray market and product may have been improperly handled, counterfeited, or recalled. Gray market pricing is up to 5 times normal despite the lack of product quality assurance.

More effective anti-infective stewardship can help lessen the impact of drug shortages, the authors suggested. The authors also supported Congressional action to increase FDA regulatory authority to deal with drug shortages.