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

Abstract

This article, which encourages physicians to publish case reports of adverse drug reactions (ADRs), is a review of how well-documented published case reports have contributed to promoting public safety and health and thus served to advance basic pharmacology. The origin of a number of regulatory guidelines can ultimately be traced to safety concerns triggered by such reports. It illustrates how case reports of ADRs, when coupled with simultaneous monitoring of drug pharmacokinetics, have also led to further investigations resulting in major advances in pharmacology, especially pharmacogenetics, mechanisms of drug–drug interactions and modulation of drug metabolism during inflammatory co-morbidities. Published case reports differ significantly from spontaneous case reports since they enjoy quality-compliant peer review and an immediate wider visibility among the readership, triggering others to report similar cases, and ultimately leading to prescribing restrictions on or withdrawals of the drug from the market depending on the risk. Therefore, the reporter should not be discouraged by (a) the unusual or bizarre nature of the reaction; (b) the interval, however long, from commencing drug administration to the onset of the suspected reaction; (c) however well-known the drug or the period for which it has been on the market; and (d) any pressure not to publish. Case reports should be published in reputable journals that are searchable through databases such as PubMed.

Withdrawal of prenylamine: perspectives on pharmacological, clinical and regulatory outcomes following the first QT-related casualty

“…This has also been observed with a number of other drugs. 31 These reports corroborated the susceptibility of female sex to the adverse effects of drugs and not only did this spurn much research into sex-related differences in basic pharmacology but also resulted, ultimately, in regulatory requirements for subgroup analysis of clinical trials data by demographic characteristics. 31,134 More importantly, prenylamine drew attention to the proarrhythmic risks of drugs, the scale of which unfolded after its withdrawal, and this resulted in regulatory requirements to characterize drugs for their cardiac safety.…”

“…31 These reports corroborated the susceptibility of female sex to the adverse effects of drugs and not only did this spurn much research into sex-related differences in basic pharmacology but also resulted, ultimately, in regulatory requirements for subgroup analysis of clinical trials data by demographic characteristics. 31,134 More importantly, prenylamine drew attention to the proarrhythmic risks of drugs, the scale of which unfolded after its withdrawal, and this resulted in regulatory requirements to characterize drugs for their cardiac safety. Perhaps the most significant benefit accrued following investigations into the mechanism of action of prenylamine, which opened up a new pharmacotherapeutic class of drugs and paved the way for synthesis and marketing of modern, more effective and safer calcium antagonists extensively used today in a wide range of cardiovascular diseases.…”

“…Initial publication of a case report of an adverse drug reaction (ADR) has not infrequently heralded an avalanche of other reports of the ADR, exposing the presence of a major drug-related risk to the public, and typically culminating in either the restrictions on the use of a medicinal product or its withdrawal from the market. 31 Often, these reports have also served to advance pharmacology and therapeutics. 31 Although a number of other drugs have illustrated this important role of published case reports, prenylamine illustrates this further and quite vividly in the context of drug-induced torsadogenesis.…”

“…31 Often, these reports have also served to advance pharmacology and therapeutics. 31 Although a number of other drugs have illustrated this important role of published case reports, prenylamine illustrates this further and quite vividly in the context of drug-induced torsadogenesis.…”

Pharmacovigilance: Present Scenario and Future Goals

“…Be that as it may, the aptitude of a pharmacist about a medication, particularly if recently advertised, assume a progressively huge job in ADRs answering to the experts which helps in either withdrawing the item from the market or cause naming changes. 45 Following Thalidomide-Induced Phocomelia catastrophe, Bowles asked ADR revealing as a factor in underwriting of pharmacists in 1964. 46 Pharmacists working in network drug store have an additional advantage of distinguishing and revealing ADRs while managing on the counter medicines and natural items.…”