Case Reports as Evidence in Pharmacovigilance

Parkinsonism Associated with Gabapentinoid Drugs: A Pharmacoepidemiologic Study

“…Reporting incurs the legal responsibility of the reporter. Case reports in pharmacovigilance databases should be considered not only mere lines of pharmacoepidemiologic data because, individually, each line really represents a true clinical event with a precise medical meaning . Moreover, reports recorded in pharmacovigilance databases have been found to be particularly useful for generating or test hypotheses, as in this study.…”

“…Moreover, reports recorded in pharmacovigilance databases have been found to be particularly useful for generating or test hypotheses, as in this study. As emphasized by Aronson, these spontaneously reported events can be regarded as pure gold or extremely high‐grade ore and constitute a valuable component of reference sets used to measure data‐mining performance. Data‐mining methods of analyzing large databases containing information about individual cases have been shown to be powerful for detecting signals of previously undetected harms .…”

Assessing the toxicological significance of new psychoactive substances in fatalities

“…In this paper, we present a system that allows the toxicological significance of new psychoactive substances to be assessed for the purposes of risk assessmentan essential component in helping characterize the potential health and social risks of a substance .1,2,9,25 This, in turn, can help inform public health policy and practice in respect to risk reductionincluding informing risk communication activities, harm reduction, as well as decision making such as consideration of the need for control measures. Causality assessment/ classification systems all have limitations [26][27][28][29][30][31][32][33] but there is a need for systematic, reproducible and transparent approaches. 56,57 Whilst there is equally a need for validation and additional research of this particular approach, the TSS addresses many of the challenges in the assessment of new substances and provides a basis for further discussion and future studies.…”

“…This is somewhat similar to the field of pharmacovigilance, where a number of causality assessment/classification systems have been developed for assessing the likelihood of the involvement of a medicine in an adverse event. [26][27][28][29][30][31][32][33] The aims of this paper are three-fold: (1) highlight the need for such systems; (2) demonstrate one such system, known as the toxicological significance score (TSS), which has been developed to support the risk assessment of new psychoactive substances by allowing the role of specific new psychoactive substances in deaths to be better assessed and classified; and (3) call for further research into such systems in order to help support evidence-based assessments and strengthen the risk assessment of new psychoactive substances.…”

Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics

“…Given the valuable role they play in monitoring drug safety, it is unfortunate that case reports, together with spontaneous reports, are generally ranked the lowest on evidentiary hierarchy, which typically categorises randomised controlled trials (RCTs), systematic reviews and meta-analyses of trials as constituting the strongest forms of evidence. Published case reports do have their own limitations, which they share with spontaneous reports, regarding computation of incidence but in the context of ADRs or uncommon events, RCTs may not be the best sources of information for several well-known reasons, such as limited sample size, duration of therapy and restricted and highly selective eligibility criteria [ 7 ].…”