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Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Mechanism of Antibiotic Resistance in MRSA01:25

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Antibiotic resistance in bacteria arises when microorganisms evolve the ability to withstand drugs designed to kill them or inhibit their growth, rendering once-effective treatments useless. This phenomenon, driven by genetic change and selection under antibiotic exposure, poses a profound threat to modern medicine. Mechanisms include drug-inactivating enzymes (e.g., β-lactamases), efflux pumps that eject antibiotics, mutations altering antibiotic targets, decreased drug uptake, and...
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An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
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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.

Infectious Diseases and Therapy
|September 20, 2014
PubMed
Summary

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.

Keywords:
Adverse eventsAntimicrobialsDrug reportingDrug shortagesInfectious diseasesPatient outcomesSurvey

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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.