ADR’s DETECTION,REPORTING & METHODS IN CASUALITY ASSESSMENT.pptx

PHARMACOVIGILANCE-ADR’s DETECTION,REPORTING & METHODS IN CASUALITY ASSESSMENT.pptx

1. ADR’s DETECTION,REPORTING & METHODS IN CASUALITY ASSESSMENT . By Hema Sri M( M.Pharm,RPh -DHA) Asst.Professor , Pharmacy Practice Dept. AM REDDY COLLEGE OF PHARMACY .

2. METHODS OF DETECTION OF ADR’s Premarketing safety evaluation Post marketing surveillance Causality assessment Communicating ADR’s Postal survey method Dechallenge / Rechallenge

3. Premarketing safety evaluation Animal studies: Carcinogenecity Mutagenecity Teratogenecity Human studies: Phase 0-Microdosing studies (100mg Max) Phase 1 –Low dose on low population Phase 2-Efficacy & safety (more than phase 1)  Phase 3-Evaluation & Tolerability(Large number)

4. Post marketing surveillance Spontaneous report  ADR by health care Clinical studies Cohort studies –patient exposed to particular dose & compared to unexposed. Case control studies- Person affected ADR’s( recognised & compared) Published case reports-- studies

5. Causality assessment ADR’s to suspected medicines In case of ADR suspected  assessment starts collection of relevant data: Time of action Duration of action Treatment of reaction Outcome & report

6. Communicating ADR’s Knowledge about medicines Training to healthcare professionals Conducting constant education programme Counseling the patients

7. Postal survey method Standardized surveys  Questionnaries are sent by post 1-2 years after drug has been launched Collect information about ADR’s

8. Dechallenge/ Rechallenge This refers to the stopping of the drug, usually after an adverse event(AE) Dechallenge may be complete o r partial. i.e drug is fully stopped or decreased in dose And AE may fully disappears or only partially decreased Result of the dechallenge can be confusing Rechallenge refers to the restarting of the same drug after having stopped it usually for an AE

9. REPORTING ADR’s Most important in medical treatment Receipt, Data entering, Assessment, Documentation Spontaneous reporting of suspected ADR’s possible at regional & country level web system PV Reporting authorities: Healthcare professionals, N urses, pharmacist, marketing authority holders Reporting data: All serious reactions & interactions such as poisoning, drug-drug, drug-food interactions Sections to validate individual case safety report such as patient identification, reporter identification, suspected ADR’s, suspected medicines

10. METHODS IN CASUALITY ASSESSMENT Definition: It is the assessment of relationship between a drug treatment & the occurrence of an adverse event. It is an essential part of ADR report and important task conducted by ‘National Pharmacovigilance Programme ’. Methods: 1.Expert judgements or global introspection 2.Algorithms 3.Probabilistic methods (Bayesian approaches)

11. 1.Expert Judgements or Global I ntrospection These are inividual assessments based on previous knowledge & experience in the field using no standardized tool to arrive at conclusions regarding causality. Swedish method of Wilholam  1.The temporal sequence--how time sequence of event related to the drug administration 2.Previous information on the drug 3.Dose relationship 4.Response pattern to drug 5.Rechallenge 6.Alternative etiological conditions 7.Concomitant drugs

12. WHO –UMC Causality assessment criteria: 1.Time relationship between drug use & AE 2.Absence of other competing causes 3.Response of drug withdrawal & dose reduction(Dechallenge) 4.Response of drug re administration( Rechallenge )

13. Certain: Right timing, no other cause, withdrawal response possible, rechallenge “definitive” . Probable : Right timing, other cause unlikely, withdrawal response possible, , rechallenge not required. Possible: Right timing other causes possible. Unlikely: Poor timing other causes more likely.

14. 2.Algorithms These are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship Problem specific flow charts  step by step instructions how to arrive at an answer Questionnaire probability of causation(when ADR is suspected) No single algorithm accepted as the gold standard because of the shortcomings & disagreements that exist between them.

15. 3.PROBABILISTIC METHODS