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

PHARMD GURU Page 1 REPORTING OF ADRs: Most ADRs are not reported and this can lead to delays in identifying important reactions. The reasons for failure to report ADRs have been called the ‘seven deadly sins’. Pharmacists should attempt to address these and encourage their medical and nursing colleagues to report ADRs, in addition to sending in their own reports. The regulatory authorities in many countries have systems for reporting ADRs and it is important to find out how ADRs are reported and whether pharmacists can submit reports. In the UK, doctors, dentists, pharmacists, nurses, and patients can report ADRs to the Medicines and Healthcare products. Regulatory Agency (MHRA) through the yellow card scheme. New drugs are labelled with a black inverted triangle in the British National Formulary (BNF), and the MHRA requests that all ADRs to these drugs are reported. For established drugs, unusual or significant reactions should be reported. Yellow card data can be accessed online. FAILURE TO REPORT ADRS: (THE ‘SEVEN DEADLY SINS’): 1) Complacency — a mistaken belief that only safe drugs are allowed onto the market and that these will not cause serious ADRs. 2) Fear of involvement in litigation, or of a loss of patient confidence. 3) Guilt that a patient has been harmed by a prescribed treatment. 4) Ambition — to collect and publish a personal series of cases. 5) Ignorance of what should be reported or how to make a report. 6) Diffidence — a reluctance to report an effect for which there is only a suspicion that it is drug-related. 7) Lethargy — this may include a lack of time or interest, inability to find a report card, etc. EVALUATION OF ADRs: The cause(s) of each suspected ADR should be evaluated on the basis of the:  Patient’s medical and medication history. REPORTING, EVALUATION, MONITORING, PREVENTING & MANAGEMENT OF ADR’S

PHARMD GURU Page 3 2. POST MARKETING SURVEILLANCE: The Information from the healthcare system is spontaneous forwarded to adverse reaction reporting. PREVENTION OF ADRS: ADRs are cannot be totally avoided. It can only be minimized. STEPS TAKEN INCLUDE: 1. Avoid inappropriate drugs in the context of clinical condition. 2. Use appropriate dose, route, frequency based on the patient variables (age, sex, other drugs, other disease conditions, etc.,) 3. Elicit medication history. 4. Considered untoward incidents. 5. Rule out drug interactions. 6. Elicit history of allergies. 7. Carryout appropriate monitoring. ADVERSE DRUG REACTION MANAGEMENT: 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 a 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.
PHARMD GURU Page 4  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.