Title 26. REPORTING, EVALUATION, MONITORING, PREVENTING & MANAGEMENT OF ADR’S.pdf ✅

PHARMD GURU Page 2 EVALUATION OF ADRs: The cause(s) of each suspected ADR should be evaluated on the basis of the:  Patient’s medical and medication history.  The circumstances of the adverse event.  The results of dechallenge and rechallenge (if any).  Alternative aetiologies and a literature review. QUESTIONS USED IN THE EVALUATION OF ADR: 1. Was there a temporal relationship between the onset of drug therapy and the adverse reaction? 2. Was there is dechallenge; i.e., did the signs and symptoms of the adverse reaction subside when the drug was withdrawn? 3. Can signs and symptoms of the adverse reaction be explained by the patient’s disease state? 4. Were there any laboratory tests that provide evidence for the reaction being an ADR? 5. What was the patient’s previous general experience with the drug. 6. Did symptoms return when the agent was re-administered? DRUG MONITORING: 1. To assess the reaction: Emergency care/admission if ADR is Serious or life threatening; primary care; or seeks specialist advice. 2. To review the treatment: Either withdraw the suspected drug or reduce the dose. 3. To manage the symptoms of ADR and provide supportive therapy. 4. To record the ADR in the individual’s health record. Consider the submission of an ADR report (Yellow Card) if appropriate documentation for the future purpose. DETECTION AND MONITORING OF ADR: 1. Premarketing Studies: Preclinical studies done in animals (cannot extrapolate data with the human) Clinical

PHARMD GURU Page 4  Relationship to dose: Whether reaction minimized with reducing the dose; symptoms resolve when the medicine withdrawn and recur when reintroduced.  Other possible causes: Possibility of underlying illness or other disease; other medications (including OTC and Herbals); drug interactions (including diet). 3. Take complete drug history - Review any History of Allergy or previous ADR:  When the drug was started, dose, other drugs, OTC and herbal. Past ADRs Long duration of action or long term use effect can be expected for some drugs.  Review the adverse effect profile of the drugs, and check how common it is. 4. Further Examination and Investigations if required:  Specific investigations and laboratory tests required.  E.g.: Liver and Renal Function Tests.