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Adverse drug reaction reporting system: developing a well-monitored program
Abstract:
The spontaneous reporting of adverse drug reactions (ADRs) at the St. John's Hospital and Memorial Medical Center was well below that reported in the literature. After review of procedures for reporting of ADRs at these institutions, the authors developed a system that was approved by their joint P & T Committee. The ADR reporting program developed uses concurrent monitoring of most hospital inpatients and a retrospective review of all emergency room patients. In the year after program implementation, 162 ADR reports were documented. From this program, a group of serious ADRs to one agent was identified and reported, both to the Food and Drug Administration and to the manufacturer. A well-developed ADR monitoring program may lead to heightened physician and nurse awareness and early problem identification, possibly decreasing morbidity for hospitalized patients.
Insights
Implementing a new adverse drug reaction (ADR) reporting system at two hospitals significantly increased documented ADRs. This proactive monitoring enhances healthcare professional awareness and aids in early identification of drug-related problems.
Area of Science:
- Pharmacovigilance
- Hospital Pharmacy
- Patient Safety
Background:
- Spontaneous reporting of adverse drug reactions (ADRs) was suboptimal at St. John's Hospital and Memorial Medical Center compared to literature benchmarks.
- Existing ADR reporting procedures were reviewed to identify areas for improvement.
Purpose of the Study:
- To develop and implement an improved system for reporting adverse drug reactions within hospital settings.
- To enhance the detection and documentation of ADRs.
Main Methods:
- A new ADR reporting program was developed and approved by a joint Pharmacy & Therapeutics (P&T) Committee.
- The program incorporated concurrent monitoring of most hospital inpatients.
- Retrospective review of all emergency room patient cases was also implemented.
Main Results:
- Following program implementation, 162 ADR reports were documented within one year.
- A cluster of serious ADRs associated with a specific drug agent was identified.
- These serious ADRs were reported to the Food and Drug Administration and the drug manufacturer.
Conclusions:
- A comprehensive ADR monitoring program can elevate physician and nurse awareness of potential drug-related issues.
- Proactive monitoring systems may facilitate earlier identification of ADRs.
- Improved ADR detection has the potential to reduce morbidity among hospitalized patients.