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level: Level 4

Questions and Answers List

level questions: Level 4

QuestionAnswer
WHO casualty categories for ADR1 Established- supported by well-proven clinical studies 2 Probable- very likely but might not be proven clinically 3 Suspected- might occur and some data might be available 4 Possible- could occur and limited data are available 5 Unlikely- doubtful, no good evidence of an altered clinical effect is available
1 supported by well-proven clinical studies 2 very likely but might not be proven clinically1 Established 2 Probable
1 might occur and some data might be available 2 could occur and limited data are available 3 doubtful, no good evidence of an altered clinical effect is available1 Suspected 2 Possible 3 Unlikely
Science and activities relating to the detection, assessment understanding and prevention of adverse effects or any other drug related problemsPharmacovigilance
Pharmacovigilance ACTIVITIES INVOLVED IN IT1 POSTMARKETING SURVEILLANCE 2 DISSEMINATION OF ADR DATA 3 CHANGES IN LABELLING OF MEDICINES
Newly Licensed Monitored Intensively by Committee for Safety of Medicines (CSM) which reports to MHRA (Medicines and Healthcare Products Regulatory Agency) Usually reviewed after 2 YEARS If a drug is labelled with this, it means it is monitored EVEN MORE INTENSIVELYBlack Triangle Medicines
1 WHY REPORT ADRs? 2 ADR Report Form should include the following:1) 1 To prevent drug-induced human suffering 2 To avoid financial risks associated with unexpected risks 2) 1 Brand name of the suspected drug 2 The manufacturer (if generic) 3 The lot and batch number BTT