Park Ridge, Ill.—While anesthesia drug shortages continue to disrupt patient access to healthcare by forcing the cancellation of surgical and other procedures, new survey data reveal that improved communication between drug manufacturers, pharmacists, anesthesia providers, and the U.S. Food and Drug Administration (FDA) would help mitigate the problem. Approximately 2,500 Certified Registered Nurse Anesthetists (CRNAs) responded to the survey conducted by the American Association of Nurse Anesthetists (AANA).
“Cancellations imperil our healthcare system by increasing costs, inconveniencing patients, and potentially placing both anesthesia professionals and their patients at risk for adverse health outcomes,” said Janice Izlar, CRNA, DNAP, president of the 45,000 member AANA. “However, the results of the AANA’s recent drug shortage survey suggest that cancellations can be reduced through better communication among those who manufacture, regulate, and administer anesthesia drugs.”
In response to an FDA call for comments on a new strategic plan to address drug shortages, the AANA recommended concrete ways to improve communication among the agency, manufacturers, anesthesia professionals, and pharmacists.
“The AANA applauds the FDA for its ongoing efforts to prevent drug shortages and implement policies that require manufacturers to provide advance notification of potential shortages,” said Izlar. “Additionally, based on the results of our survey, the FDA’s demonstrated commitment to open communication among all stakeholders is absolutely essential to minimizing the risk of shortages or mitigating the impact when they occur. The AANA looks forward to working closely with the agency to help ensure access to quality healthcare for our patients.”
The February 2013 survey showed that little progress has been made to alleviate anesthesia-related drug shortages. Ninety percent of CRNAs reported that their facilities are currently experiencing shortages, as compared with 95 percent in 2011. Nearly six percent of CRNAs responding to the survey indicated that the drug shortages have caused cases to be cancelled, virtually unchanged from a year and a half ago.
While the shortages continue, healthcare facilities are taking action to minimize schedule disruptions as much as possible by modifying anesthesia techniques, group purchasing drugs, using in-house pharmacies to compound syringes, and conserving drugs that are in short supply when other anesthesia options are available. However, according to survey respondents the most effective measure has been timely communication between pharmacy and anesthesia staff about drug shortages.
“Equally important to effective communication within facilities,” said Izlar, “is consistent, timely communication about shortages from the FDA and drug companies to the healthcare professionals in the facilities.”
CRNAs responding to the survey identified the following drug shortage information as most valuable to their practice: advance notice of a drug shortage (77 percent); anticipated duration of a shortage (76 percent); alternative drug choices and techniques (64 percent); medication inventory availability (53 percent); and source of the shortage (47 percent).
In a March 12 comment letter to the FDA, the AANA recommended that the agency’s proposed strategic plan to address drug shortages include communication components “to prevent and mitigate the effects of drug shortages.” Specifically, the AANA stressed the need for “enhanced communication regarding possible alternative medications, alternative suppliers, anticipated duration of shortages, and reasons for shortages,” and requested that the AANA be included in targeted alerts regarding drug shortages and added to the list of specialty organizations that provide guidance to the agency.
The AANA informed the FDA that although the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) requires drug manufacturers to provide advance notice of anticipated shortages, many CRNAs report that they receive little to no advanced notice in their facilities. Frequently they discover that a drug is not available immediately prior to a case. The AANA comment letter urges the FDA to develop guidance and regulations that direct the pharmaceutical industry to provide specific and complete information to the FDA and to purchasers about potential drug shortages to help mitigate the impact of shortages in the clinical area.
At the AANA’s annual assembly held in Washington, DC, April 21-23, several hundred concerned nurse anesthetists attended a panel discussion on anesthesia drug shortages featuring speakers from the FDA, American Hospital Association, and the AANA. In discussing the causes and effects of drug shortages, and how to mitigate their impact, the speakers closed the communication loop by stressing the importance of healthcare providers reporting shortages to the FDA as soon as they learn of them.