title: Good pharmacovigilance practices: technology enabled.
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.
authors.affiliation: RCN Associates, Inc., Annapolis, Maryland 21403, USA. rcnelson@rcnrx.com
authors.forename: Robert C
authors.initials: RC
authors.lastname: Nelson
authors.forename: Bruce
authors.initials: B
authors.lastname: Palsulich
authors.forename: Victor
authors.initials: V
authors.lastname: Gogolak
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D016208:Databases, Factual / Q000592:standards; D004341:Drug Evaluation / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D016903:Drug Monitoring / Q000379:methods / Q000592:standards; D006801:Humans; D017891:Pharmacoepidemiology / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000592:standards; D013223:Statistics as Topic / Q000592:standards; D013678:Technology, Pharmaceutical / Q000592:standards* / Q000706:statistics & numerical data