18011 - CAUSALITY ASSESSMENT OF REPORTED ADVERSE DRUG...

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C AUSALITY   A SSESSMENT   OF   R EPORTED   A DVERSE   D RUG   R EACTIONS Ana Filipa Macedo Faculty of Health Sciences  Portugal
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Safety is a relative concept   No drug which is pharmacologically  effective is entirely without hazard Efficacy Safety Quality
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2000 b.C. – HAMMURABI CODE:          “The Doctor who causes death                                 should loose his hands” 500 b.C. – HIP Ó CRATES:          “Primum non nocere” H ISTORICAL  P ERSPECTIVE 200 – GALENO:          Drugs have a main action                           and a secondary action  
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P ERSPECTIVA  H IST Ó RICA 1937 –  Sulfanilamide in Dietilenoglicol                /   Renal Impairment 1961 –   Thalidomide / Phocomelia - 10 000                                                                 Victims 1971 –  Dietilstilbestrol / Vaginal Carcinoma in  the daughters, 10 to 20 years after exposition  
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I NTERNATIONAL  P HARMACOVIGILANCE  S YSTEMS PREMARKETING INVESTIGATION   Long Latency ADR Chronic ADR  Rare ADR  Interactions Risk Groups Limitations POSTMARKETING INVESTIGATION   PHARMACOVIGILANCE
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   A DVERSE  D RUG  R EACTION “a response to a drug which is noxious  and unintended, and which occurs at  dose normally used in humans for the  prophylaxis, diagnosis or therapy of  disease, or for a modification of  physiological function   .”                                                                                                                                                                                                                           W.H.O 1972
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E PIDEMIOLOGY  OF   A DVERSE  D RUG  R EACTIONS    4 th  to 6 th  cause of death  in U.S.A. ,1994    5% of Hospital  Admissions   11% of Hospital  Patients   Doubles costs, length o stay and mortality risk   50% are potentially  preventable   Less than 1%  are  reported Medication Error (Preventable) Preventable ADRs ADRs not  Preventable Quality Problems Adverse Effects
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SAFETY  MONITORING Identification of a  Problem Problem  Characterization Benefit – Risk  Evaluation Risk  Management Communication Decision P HARMACOVIGILANCE
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