Abstract
The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports.
Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value.
In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.
References
Nelson RC. We need a postmarketing drug development process [commentary]. Pharmacoepidemiol Drug Saf 2000; 9: 253–5
Benichou C. Adverse drug reactions: a practical guide to diagnosis and management. New York; JohnWiley & Sons, 1994
Begaud B, Evreux JC, Jouglard J, et al. Unexpected or toxic drug reaction assessment (imputation). Actualisation of the method used in France. Therapie 1985; 40: 111–8
Benichou C. Imputability of unexpected or toxic drug reactions. In: Benichou C. Adverse drug reactions: a practical guide to diagnosis and management. New York: Wiley & Sons, 1994: 271–5
Naranjo C, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45
Bright R, Nelson RC. Automated support for pharmacovigilance: a proposed system. Pharmacoepidemiol Drug Saf. In press
Acknowledgements
The authors have partnered to design and build ARGUSPV (registered, Relsys International, Inc.), a computer system that contains QScan (registered, QED Solutions Inc.), and supports good pharmacovigilance process (GPVP). Dr Nelson, the project leader, is a consultant to both companies.
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Nelson, R.C., Palsulich, B. & Gogolak, V. Good Pharmacovigilance Practices. Drug-Safety 25, 407–414 (2002). https://doi.org/10.2165/00002018-200225060-00004
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DOI: https://doi.org/10.2165/00002018-200225060-00004