Standard Operating Procedure for Recording, Management and Reporting of Adverse Drug Reaction

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This standard operating procedure (SOP) describes the procedures to be used by the members of Pharmacovigilance Department of National Medicines and Healthcare Products Regulatory Authority (NMHRA), Medicine Safety Committee (MSC) and by health care professionals for the recording, management and reporting of suspected adverse drug reactions (ADRs) and other suspected adverse events (AEs) that are reported through the Afghanistan national spontaneous reporting system. Reporting suspected adverse events is an important element of health professionals’ responsibilities to help ensure patient safety.