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Adverse drug reaction.pptx
- 1. ADVERSE DRUG REACTIONS Dr. Rakesh Ghimire, MBBS, MD Clinical Pharmacology Assistant Professor Department of Clinical Pharmacology Institute of Medicine (IOM)
- 2. Definitions WHO: “a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis and therapy of the diseases or for the modification of physiological function” Reference: www.who.int
- 3. Definitions UMC: “an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention and specific treatment, or alteration of the dosage regimen or withdrawal of the product” Reference: Ralph Edwards and Jeffery Aronson. Adverse drug reactions: definitions, diagnosis, and management. The Lancet 2000; Volume 356, No. 9237, p1255–1259.
- 4. History “All drugs are poisons; the dosage makes it either a poison or a remedy.” Paracelsus, a 16th century alchemist “Cured yesterday of my disease, I died last night of my physician.” Matthew Prior, 18th century I do not want two diseases - one nature made, one doctor made. Napoleon Bonaparte 1820 AD
- 5. History Frederic the Great dictated that the life of a seller of a magic elixir or love potion would be forfeit if a purchaser died. (18th century) 100 people died in France using a contaminated boil treatment in 1954. Thalidomide tragedy 1960, large number of children were born with limb deformities. Following this incident major changes occurred in monitoring of ongoing safety of medicines.
- 6. Terminologies Unexpected ADR Refers to a reaction, the nature and severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug.
- 7. Terminologies Serious ADR Any medical occurrence that at any dose normally used in humans: results in death requires inpatient hospitalization or prolongation of existing hospitalization results in persistent or significant disability or incapacity is life threatening
- 8. Terminologies Medication error An error in ordering, transcribing, dispensing, or administering a medication, regardless of whether an injury occurred or whether the potential for injury was present.
- 9. Terminologies Adverse drug event/experience (ADE) Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have causal relationship with this treatment. ADE = ADR + medication errors
- 10. Terminologies Suspected ADR Any adverse drug event for which there is reasonable possibility that the drug caused the ADE.
- 11. Terminologies Side effects Any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug. Often unavoidable PD effects Predictable, usually not serious
- 12. Terminologies Secondary effects Indirect consequences of a primary action of a drug. Toxic effects Result of the excessive pharmacological action of the drug due to over dosage or prolonged use.
- 13. Terminologies Intolerance Appearance of characteristic toxic effects of a drug in an individual at therapeutic doses. Idiosyncrasy An inherent qualitative abnormal reaction to a drug usually due to genetic abnormality.
- 14. Terminologies Drug allergy (hypersensitivity) Immunologically mediated reaction producing stereotype symptoms unrelated to the pharmacodynamic profile of the drug Cross sensitivity
- 15. Terminologies Photosensitivity Cutaneous reaction resulting from drug induced sensitization of skin to UV radiation Phototoxic Drug/metabolites accumulates in skin, undergoes a photochemical reaction local tissue damage (sunburn) Photoallergic Drug/metabolites triggers a cell mediated immune response upon exposure to light
- 16. Types On the basis of severity Minor: no therapy, antidote or prolongation of hospitalization is required. Moderate: requires change in drug therapy, specific treatment or prolongs hospital stay by at least one day. Severe: requires intensive medical treatment. Lethal: directly or indirectly contributes to death of the patient.
- 17. Types Onset of event Acute: within 60 minutes Anaphylactic shock, bronchoconstriction Sub-acute: 1 to 48 hours Rash, serum sickness Latent: > 2 days Eczematous eruptions, tardive dyskinesia
- 18. A: Dose related Mnemonic Augmented Features Common Related to a pharmacological action of the drug Predictable High morbidity Low mortality Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 19. A: Dose related Examples Toxic effects: Digoxin toxicity Side effects: Anticholinergic effects of TCA Management Reduce dose or withhold Consider effects of concomitant therapy Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 20. B: Non-dose related Mnemonic Bizarre Features Uncommon Not related to a pharmacological action of the drug Unpredictable Low morbidity High mortality Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 21. B: Non-dose related Examples Immunological reactions: penicillin hypersensitivity Idiosyncratic reactions: acute porphyria, malignant hyperthermia Pseudo-allergy: ampicillin rash Management Withhold and avoid in future Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 22. C: Dose related and time related Mnemonic Chronic Features Uncommon Related to the cumulative dose Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 23. C: Dose related and time related Examples HPA axis suppression by corticosteroids Management Reduce dose or withhold, withdrawal may have to be prolonged Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 24. D: Time related Mnemonic Delayed Features Uncommon Usually dose related Occurs or becomes apparent some time after the use of the drug Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 25. D: Time related Examples Teratogenesis: vaginal adenocarcinoma after diethylstilbestrol Carcinogenesis Tardive dyskinesia Management Often intractable Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 26. E: Withdrawal Mnemonic End of use Features Uncommon Occurs soon after withdrawal of the drug Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 27. E: Withdrawal Examples Opiate withdrawal syndrome Myocardial ischemia after β-blockers withdrawal Management Reintroduce and withdraw slowly Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 28. F: Unexpected failure of therapy Mnemonic Failure Features Common Dose related Often caused by drug interactions Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 29. F: Unexpected failure of therapy Examples Inadequate dosage of an oral contraceptive particularly when used with enzyme inducers Management Increase dosage Consider effects of concomitant therapy Types: Ralph Edwards and Jeffery Aronson. The Lancet 2000
- 30. Pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. (WHO 2002 )
- 31. 1968 - WHO Collaborating Centre for International Drug Monitoring, Geneva 1978 - Moved to Uppsala after agreement between Sweden and WHO Many countries have official bodies that monitor drug safety and reactions. In the United States, the Food And Drug administration (FDA) is responsible for monitoring post-marketing studies . Pharmacovigilance History Reference www.who-umc.org
- 32. In October 2006, the Department of Drug Administration (DDA) was nominated as the focal point for pharmacovigilance in Nepal. Regional pharmacovigilance centers are TUTH, MCOMS, KIST, NMC. Pharmacovigilance in Nepal
- 33. Government of Nepal Ministry of Health and Population Department of Drug Administration Adverse Drug Reactions Reporting Form Hospital record No. or chart No. or patient ID No. ________ Patient's Name: ________________________ Sex: F/ M Age _______ Description of the adverse reaction/s: Onset date of reaction: ______ _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Information on Suspected Medicine Medicines (Brand & Generic Name, Manufacturer, Batch No., Dosage Form) Daily dosage Date started Date stopped Reason for use Additional relevant information (eg. medical history, test result, known allergies, drug interactions) _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ Reported by: Name:_________________________ Hospital / Department:____________________ Date: _________________________ Signature: _____________________________ Please return this form to your local Drug Information Unit or Hospital Pharmacy. Thank you for taking the time to fill in this report!
- 34. Methods of pharmacovigilance Spontaneous Reporting Intensive monitoring (hospital) Prescription Event Monitoring Case Control Surveillance Comprehensive population databases Data-mining Patient series Observational studies Reference www.who-umc.org
- 35. ADR Flow Health care workers Pvig Center Regional Centre Zonal Centre National centre UMC WHO database Reference www.pharmainfo.com
- 36. THANK YOU 36