Completeness and accuracy of adverse drug reaction documentation in electronic medical records at a tertiary care hospital in Australia.

Background: A large proportion of patients presenting to hospitals have experienced a previous adverse drug reaction (ADR). Electronic medical records (EMRs) present an opportunity to accurately document ADRs and alert clinicians against inadvertent rechallenge where there is a pre-existing reaction. However, EMR systems are imperfect and rely on the accuracy of the data entered. Objective: To ascertain the completeness of ADR documentation and the accuracy of the classification of ADRs as allergy versus intolerance in the EMR at a major metropolitan hospital in Australia. Method: Cross-sectional audit of the ADR field of the EMR for a sample of patients on four different wards over 3 weeks to ascertain the completeness of ADR documentation and the accuracy of classification of ADRs. Results: Of the 264 patients assessed, 102 (38.6%) had a total of 210 ADRs documented in the EMR. Of these, 105 (50%) were considered to have complete documentation; 63/210 (30.0%) were missing a reaction description and 88/210 (41.9%) were missing severity information. For those ADRs with a reaction description (n = 147), 97 (66.0%) were considered to be appropriately classified as allergy or intolerance. Conclusion: Incomplete and inaccurate ADR documentation was common. These findings highlight a need for optimising ADR documentation to improve appropriate medication use in hospital. Implications: Improved EMR design and education of healthcare workers on the importance of complete and accurate documentation of reactions are needed to improve completeness and accuracy of ADR classification.

The cost of pharmacovigilance: a time and motion study of an adverse drug reaction program.

OBJECTIVES: Adverse medication events are associated with a significant number of hospital admissions, and the appropriate recording of these events plays a vital role in medication safety. We set out to analyse the time and extrapolated cost in reporting adverse drug reactions (ADRs). METHODS: A time and motion study of the tasks involved in reviewing, assessing, reporting and communicating ADRs was done over a period of 2 months. KEY FINDINGS: We found a median of 69 min was needed in background work per ADR report. CONCLUSION: The commitment involved in the support of this program is considerable and will encourage further refinement to streamline the process.