The online version of this article (doi:10.1007/s40121-014-0040-z) contains supplementary material, which is available to authorized users.
The number of drug shortages in the United States has increased in recent years. While some literature exists on factors that contribute to antimicrobial shortages, the need remains to accurately gage the level of patient harm incurred as a result of realized antimicrobial shortages. Furthermore, current methods of reporting adverse drug events are known to under-report instances of patient harm. We sought to develop an ongoing and accurate method of reporting patient harm due to antimicrobial shortages, which was convenient, anonymous, and allowed clinicians to estimate the causality due to a shortage.
We distributed a public SurveyMonkey® (SurveyMonkey, Palo Alto, CA, USA) link to gather information regarding institution (for de-duplicating purposes), patient age, sex, antimicrobial product on shortage, type of infection requiring treatment or prophylaxis, adverse event, and patient outcome.
To date complete data were reported on four patients being treated for infections that included Stenotrophomonas maltophilia bacteremia, Pneumocystis jirovecii pneumonia, neonatal sepsis of unknown etiology, and cytomegalovirus colitis. Antimicrobials that were unavailable to patients included sulfamethoxazole–trimethoprim, gentamicin, and foscarnet. Two adverse events (a delay in treatment and an inability to treat with other antimicrobials due to resistance) were attributed with probable causality due to a shortage, while the remaining adverse events (death and an inability to tolerate high oral doses) were attributed to have unlikely and possible causalities due to a shortage, respectively.
These methods encourage reports of antimicrobial shortage harms.
United States Food and Drug Administration. Drug shortages frequently asked questions. http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050796.Htm. Accessed Sep 8, 2014.
McLaughlin M, Kotis D, Thomson K, et al. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. 2013;19:783–8. PubMed
SurveyMonkey ®. http://www.surveymonkey.com. Accessed 31 Oct 2013.
National Cancer Institute. NCI guidelines for investigators: adverse event reporting requirements for DCTD (CTEP and CIP) and DCP, INDS and IDES. http://ctep.Cancer.Gov/protocoldevelopment/electronic_applications/docs/aeguidelines.Pdf. Accessed 11 Dec 2013.
United States Food and Drug Administration. FDA adverse event reporting system (AERS). http://www.Fda.Gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/default.Htm. Accessed 11 Dec 2013.
- Developing a Method for Reporting Patient Harm Due to Antimicrobial Shortages
Milena M. McLaughlin
Marc H. Scheetz
- Springer Healthcare
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