Pharmacology: Adverse Drug Events

Study Notes

An injury resulting from the use of a drug, which can occur regardless of whether the drug is suspected to be the cause.

The main difference between these terms is that ADR is a harm usually suspected to be related to the drug, whereas ADE is harm associated with any dose of a drug, whether or not the dose is "normally used in man" or due to other confounders that arise during treatment.

Origins: Pharmacovigilance traces its roots back to the mid-20th century, when researchers began recognizing the need for systematic monitoring of adverse drug reactions (ADRs).
Thalidomide Tragedy: The thalidomide disaster of the 1950s and 1960s, where the drug caused severe birth defects, served as a wake-up call for the necessity of pharmacovigilance.
Regulatory Responses: In response to the thalidomide tragedy, regulatory agencies worldwide started implementing pharmacovigilance systems to monitor drug safety more effectively.

WHO Program: The World Health Organization (WHO) initiated its Programme for International Drug Monitoring in 1968, aiming to facilitate the exchange of information on ADRs among member countries and promote collaboration in pharmacovigilance activities.
Pharmacovigilance Guidelines: International bodies, such as the International Conference on Harmonisation (ICH) and the Council for International Organizations of Medical Sciences (CIOMS), developed guidelines and standards for pharmacovigilance practices.

Rawlins and Thompson classification: ADRs are classified into two broad categories, Types A and B.
DoTS Classification Example: Osteoporosis due to corticosteroids, classified as: Dose: collateral effect, Time: late, Susceptibility: age, sex.

MADRAC, DCA & NPRA: Malaysia set up its national pharmacovigilance system with the establishment of the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) in 1987, which acts as an advisory body to the Drug Control Authority (DCA) on local and international drug safety issues.

One of the pharmacovigilance requirements for pharmaceutical companies is the establishment of a pharmacovigilance system within their organizations, ensuring patient safety.