Developing a Method for Reporting Patient Harm Due to Antimicrobial Shortages
Milena M McLaughlin1,2, Erik Skoglund1, Zachary Pentoney1
1Midwestern University, Chicago College of Pharmacy, Downers Grove, IL, USA.
Introduction:
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.
Methods:
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.
Results:
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.
Conclusion:
These methods encourage reports of antimicrobial shortage harms.
Insights
Clinicians can now anonymously report patient harm from antimicrobial drug shortages. This new method helps accurately gauge the impact of unavailable medications on patient outcomes, addressing a critical gap in current adverse event reporting systems.
Area of Science:
- Medical Sciences
- Pharmacology
- Public Health
Background:
- The United States faces increasing drug shortages, particularly impacting antimicrobial availability.
- Existing literature inadequately quantifies patient harm from antimicrobial shortages.
- Current adverse drug event reporting systems are known to under-report patient harm.
Purpose of the Study:
- To develop an accurate, convenient, and anonymous method for reporting patient harm resulting from antimicrobial shortages.
- To enable clinicians to estimate the causality between antimicrobial shortages and patient harm.
Main Methods:
- A public online survey (SurveyMonkey) was distributed to gather data.
- Information collected included patient demographics, infection type, antimicrobial on shortage, adverse events, and patient outcomes.
- Data on institution were collected for de-duplication purposes.
Main Results:
- Data were reported for four patients with infections including Stenotrophomonas maltophilia bacteremia and Pneumocystis jirovecii pneumonia.
- Unavailable antimicrobials included sulfamethoxazole-trimethoprim, gentamicin, and foscarnet.
- Adverse events included delayed treatment (probable causality), inability to treat due to resistance (probable causality), death (unlikely causality), and intolerance to alternatives (possible causality).
Conclusions:
- The developed methods facilitate the reporting of harms associated with antimicrobial shortages.
- This approach aims to improve the understanding and documentation of patient harm due to medication unavailability.
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