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PHARMD GURU Page 1 ADVERSE DRUG REACTION MANAGEMENT ROLE OF PHARMACIST IN THE MANAGEMENT OF ADRs: 1. Monitoring the patients who are at greater risk of developing ADRs. 2. Monitoring the patients who are prescribed with drugs highly susceptible to cause ADRs 3. Assessing and documenting the patient’s previous allergic status 4. Assessing the patient’s drug therapy for its appropriateness 5. Assessing possible drug interactions in case of multiple therapies 6. Assessing health care professionals in detection and assessment of ADRs 7. Encouraging/ stimulating healthcare professionals in reporting on ADR 8. Documentation of suspected reported reactions for future reference 9. Follow up of patients to assess the outcome of the reaction and management 10. Obtaining feedback about the reported reaction 11. Educating healthcare professionals about the importance of an ADR 12. Educating patients. Causes for ADR: 1. Predisposing factors. 2. Poly-pharmacy. 3. Multiple and intercurrent diseases (renal (or) hepatic problems). 4. Age ( Geriatrics, Paediatrics). 5. Drug characteristics (Highly toxic, narrow therapeutic index). 6. Gender (women are more susceptible). 7. Race and genetics (Genetic defects). DEFINITIONS, DEVELOPMENT AND SCOPE OF CLINICAL PHARMACY
PHARMD GURU Page 2 Mechanism of Adverse Drug Reactions: I) Type A adverse drug reactions: 1) Pharmaceutical causes:  Drug quantity present in a particular product.  Changes in the drug release properties.  Salt forms of the drug used. 2) Pharmacokinetic causes:  Alterations in absorption, distribution, metabolism and elimination. 3) Pharmacodynamic causes:  Increased sensitivity of target tissue or organs may predispose a person to adverse drug reactions.  Drug receptors.  Homeostatic mechanism.  Disease conditions unmask adverse drug reactions. II) Type B Adverse drug reactions: Caused due to:  Decomposition of the active ingredient.  Excipients (Additives, Preservatives, Coloring and Solubilizing agents).  Synthetic byproducts of active ingredients. PREVENTION OF ADVERSE DRUG REACTION:  Cannot be totally avoided.  It can only be minimized.
PHARMD GURU Page 3 Steps taken include:  Avoid inappropriate drugs in the context of clinical condition.  Use appropriate dose, route, frequency based around the patient variables (age, gender, other drugs, other disease conditions etc.).  Elicit medication history, considered untoward incidents, rule out drug interactions.  Elicit history of allergies.  Carry out appropriate monitoring. MANAGEMENT OF ADVERSE DRUG REACTIONS: The ADRs are can be managed by following methods: 1. Assess the nature and severity of the reaction:  Whether an urgent action is required or can be managed by primary care. E.g.: whether an anaphylactic shock or something minor. 2. Review on the presenting symptoms:  Timing: Time of start of the reaction after giving the drug; Time taken to abate after the stopping of drug or reducing the dose.  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.
PHARMD GURU Page 4 Assess the reaction: Emergency care/admission, if adverse drug reaction is a serious or life threatening, primary care, or seek specialist advice. Review the treatment: Either withdraw the suspected drug or reduce the dose.  Manage the symptoms of adverse drug reaction and provide supportive therapy.  Record the adverse drug reaction in the individual's health record.  Consider the submission of adverse drug reaction report (yellow card), if appropriate.  Documentation for the further purpose.

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