Detection, reporting and monitoring of ad rs final ppt
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Adverse drug reactions (ADRs) are important to monitor through pharmacovigilance programs. Spontaneous reporting of ADRs by healthcare professionals and patients allows detection of rare or delayed reactions not seen in clinical trials. Common causes of ADRs include medication errors, non-compliance, and drug interactions. Serious ADRs can lead to death, hospitalization, disability or congenital abnormalities. It is important for doctors, nurses and patients to recognize and report any suspected ADRs to their national pharmacovigilance center to monitor drug safety. Proper causality assessment is needed to determine the likelihood of an ADR being caused by a suspected medication.
Detection, reporting and monitoring of ad rs final ppt
- 1. DETECTION, REPORTING AND MONITORING OF ADRs DR SABEENA K CHOUDHARY
- 2. Overview • ADRs ( types and importance) • ADR Reporting (Pharmacovigilance): what when and how to report these ADRs
- 6. History
- 7. • Everytime we give a drug we take a risk • Public and professional concern about these matters first arose in the late 19th century. • In 1922, there was an enquiry into the JAUNDICE associated with the use of SALVARSAN, an organic arsenical used in the treatment of Syphillis.
- 8. • In 1937 in USA, 107 people died from taking an Elixir Of Sulfalinamide that contained the Solvent Di-ethylene Glycol This led to establishment of FOOD AND DRUG ADMINISTRATION (FDA), which was given the task of enquiring into the safety of new drugs before allowing them to be marketed
- 10. • In 1961, it was reported in West Germany that there was an outbreak of PHOCOMELIA (hypoplastic and aplastic limb deformities) in the new born babies.
- 11. • The Thalidomide Incident led to development of a much more sophisticated approach to preclinical testing & clinical evaluation of drugs before marketing, & greatly increased awareness of adverse effect of drugs and methods of detecting them.
- 12. Importance of ADR’S in Therapeutics
- 13. Adverse event • Any untoward medical occurrence that may present during treatment with a pharmaceutical product • But doesn’t have a causal relation with this Rx
- 14. Adverse drug reaction • Response which is noxious and unintended , which occurs at doses normally used in humans for the Px, Dx or therapy of the disease or for modification of physiological function • All ADR are AE but not vice versa
- 15. Side effect • Any unintended effect (unwanted but unavoidable of a product occurring at normal dose which is related to the pharmacological properties of the drug ) Unwanted but often unavoidable pharmacodynamic effects of a drug at therapeutic doses” As Extension of therapeutic effect Atropine - dry mouth As distinctly different effect Promethazine – Sedation. Side effect exploited for therapeutic use Codeine – Diarrhoea
- 16. ADR vs side effect
- 19. Serious ADR • Death • Life threatening condition • Requires inpatient hospitalization/ prolongation • Persistent disability/incapacity • Congenital abnormality
- 20. Incidence Hospital in-patients:10-20% Deaths in hospital in-patients: 0.3-3% Hospital admissions: 0.3-5%
- 21. Why incidence is more ?
- 22. • Ever-increasing number of new drugs in the market • Number of drugs prescribed are high • Medication errors • Lack of awareness of a system for reporting ADR’S
- 23. Common causes Failing to take the correct dose at the correct times Overdosing Allergies to chemical components of the medicine Combining the medicine with alcohol Taking other drugs or preparations that interact with the medicine
- 24. Factors affecting Adverse Drug Reactions
- 25. Age Genetic influences Concurrent diseases (Renal, Liver, Cardiac) Previous allergies or adverse drug reactions Compliance with dosing regimen Total number of medications Misc. (diet, smoking, environmental exposure)
- 26. Idiosyncracy
- 27. Idiosyncracy • Genetically determined abnormal reaction to the agent • Interaction of the drug with the unique feature of the individual • Produces uncharacteristic reaction
- 28. Types of ADR’s
- 29. Rawlins and Thompson classification -1991 Type A Predictable -More Common(80%) -Augmented normal response -Dose dependent -Hypo/Hyper response Type B Unpredictable -Less common (6-10%) -Abnormal/bizarre response -Dose Independent -Genetic/Immunological
- 30. Type A Predictable -Low Mortality -d/t Pharmacological activity of drug -Rx : Dose Adjustment Eg., S/E, Toxic effect, Withdrawal effect Diarrhea due to antibiotics Type B Unpredictable -High Mortality -d/t Patient peculiarities -Rx : Withdrawal of drug Eg., Allergy, Idiosyncrasy Hypersensitivity to penicillin Types of ADR’s – Contd…
- 31. Type C (Chronic) - Reactions due to prolonged use of the Drug. e.g. HPA axis suppression by corticosteroids
- 32. Type D (Delayed) • Occuring years after the treatment • Can be due to accumulation E.g : Teratogenisis
- 33. Type E (End of use) • Occur on withdrawal especially when drug is stopped abruptly E.g. • Steroid withdrwal
- 34. Type F (Failure of drug) • Underdosing of medications • Drug interactions Eg: OCP failure
- 35. Type Mnemonic Example A Augmented Diarrohea due to antibiotics B Bizzare Hypersensitivity due to penicillin C Chronic Steroid decrease HPA axis D Delayed Teratogenicity, carcinogenesis E End of use Precipitation of MI by β blocker withdrawal F Failure OCP failure Types of ADR’s in Brief:
- 36. Mild No need of Rx, antidote or Hospitalization Moderate Requires drug change specific Rx, hospitalization Severe Potentially life threatening; permanent damage, and prolonged hospitalization. Lethal Directly or indirectly leads to death ADR GRADING
- 37. How to recognize an ADR
- 38. Who can get an ADR? Anyone who takes medicine Differential diagnosis should include the possibility of an ADR if the patient is taking any form of medication
- 39. If symptoms, Appears soon after a new drug is started Appears after an increase in dose Disappears when the drug is stopped Reappears when a drug is restarted When To Report :
- 41. • WHO international system(Uppsala monitoring centre, Sweden) • US FDA "Med watch" • UK "Yellow card system" • PvPI under CDSCO, India
- 42. • ACTIVE SURVEILLANCE • PASSIVE SURVEILLANCE
- 43. • SPONTANEOUS REPORTING SYSTEM : • Communication by HCP/ consumers/ pharma company to NCC/CDSCO/AMC
- 44. Why is ADR Monitoring Needed? • Unreliability of pre-clinical studies • Limitations of pre-marketing phases of clinical trial • Aggressive marketing strategies of pharmaceutical companies
- 45. Limitations of pre-marketing phases of clinical trial • Conducted in strictly controlled conditions, in highly selected and limited number of patients • Fails to detect rare and delayed ADRs • Do not provide data – - In children, elderly patients, pregnant/lactating women - In patient suffering from other disease - In patient receiving other drugs - On interpopulation difference
- 46. What to report • All types of suspected ADRs irrespective of whether they r known / uk, serious or non serious , frequent or rare, and regardless of an established causal relationship • Pharma meds and vaccines, drugs used in traditional meds , medical devices, contrast media • Any AE
- 47. • Doctors • Dentists • Nurses • Pharmacists Health care professionals • Patients • Consumers • Relatives Others Who can report ??
- 48. Problems in ADR reporting Patient Related (i) Cannot recognize ADR (ii) Recognize but do not report (iii) Illiteracy Health professional Related (i) Cannot recognize ADR (ii) Recognize but do not report due to - Lack of time - Hesitancy - Ignorance - Fear of litigation - Guilt •
- 49. HOW TO REPORT??
- 53. Suspected adr
- 55. Causality Assessment • Routine procedure in Pharmacovigilance • Relationship of cause & effect • Most outcomes : multiple interacting causes • Aim : to define contribution due to drugs • Problems: ADRs rarely specific Diagnostic tests usually absent Re challenge rarely ethically justified
- 56. Causality Assessment Methods Algorithmic: Series of questions Answers are weighted Overall score determines causality category e.g. Naranjo’s scale Probalistic: Set of explicitly defined causality categories e.g. WHO UMC method
- 57. Questions Yes No Don’t Know 1) Are there previous conclusive reports on this reaction? +1 0 0 2) Did the ADR appear after the suspected drug was administered? +2 -1 0 3) Did the ADR improve when the drug was discontinued? +1 0 0 4) Did the ADR appear with re-challenge? +2 -1 0 5) Are there alternative causes for the ADR? -1 +2 0 6) Did the reaction appear when placebo was given? -1 +1 0 7) Was the drug detected in blood at toxic levels? +1 0 0 8) Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? +1 0 0 9) Did the patient have a similar reaction to the same or similar drug in any previous exposure? +1 0 0 10) Was the ADR confirmed by any objective evidence? +1 0 0
- 58. The Naranjo Probability Scale The score :- ≥ 9 = Definite 5-8 = Probable 1-4 = Possible 0 = Doubtful
- 60. Actions taken
- 66. Drugs restricted due to adverse reactions
- 67. Drug Year Adverse Reaction Outcome Sulfanilamide 1937 Liver damage due to diethylene glycol Solvent changed; FDA established Thalidomide 1961 Congenital Malformations Withdrawn Chloramphenicol 1966 Blood Dyscrasias Uses restricted Benoxaprofan 1982 Liver damage Withdrawn Aspirin 1986 Reye’s syndrome Uses restricted Flecainide 1989 Cardiac Arrhythmias Uses restricted Noscapine 1991 Gene toxicity Withdrawn Triazolam 1991 Psychiatric disorders Withdrawn
- 68. Drug Year Adverse reaction Outcome Temafloxacin 1992 Various serious adverse effects Withdrawn Co-trimoxazole 1995 Serious allergic reactions Uses restricted Terfenadine 1997 Interactions (e.g. with grapefruit juice) Withdrawn from OTC sale Sotalol 1997 Cardiac arrhythmias Uses restricted Astemizole 1998 Interactions Withdrawn Cisapride 2000 Cardiac arrhythmias Withdrawn Cerivastatin 2001 Rhabdomylosis Withdrawn
- 69. Drug Event Outcome Fenfluramine, Dexfenfluramine Heart valve disease, Pulmonary hypertension, Cardiac fibrosis Banned Sibutramine Heart attack , Stroke Banned Astemizole ,Terfinadine Arrhythmias Banned Rofecoxib ,Valdecoxib Myocardial infarction Banned Rosiglitazone MI, stroke,CHF,death Banned Cisapride QT interval prolongation- ventricular arrhythmias Banned Gatifloxacin Arrhythmias, Phototoxicity, Unpredictable hypoglycemia Banned Nimesulide (Paediatric) Fulminant hepatic failure Paediatric use -banned Phenylpropanolamine Hemorrhagic stroke Psychiatric disturbances Banned( Banned order under court stay)
- 70. Take home message… • Every drug which has an effect has an adverse effect every time a drug is given risk is involved • For rational use of drug not only its clinical indications are important but the knowledge of adverse effects as well • Early detection of adverse effects and its proper management can be life saving in many situations • ADR Reporting (Pharmacovigilance) plays a important role in the evolution and life history of a drug