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Seminar adverse drug reaction
- 1. ADVERSE DRUG REACTION Dr Sneha Dange JR1 Dept. of Pharmacology GMC Nagpur
- 2. OVERVIEW Important Definitions History Types of ADR Organ specific ADR ADR reporting (pharmacovigilance) Summary 7/16/2021 2 Adverse drug reaction
- 3. Adevrse Drug Reaction (ADR) “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 or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.” 7/16/2021 3 Adverse drug reaction
- 4. Adverse Drug Events “Any untoward medical occurrence that may present during treatment with a medicine but does not have causal relationship with the treatment.“ 7/16/2021 4 Adverse drug reaction
- 5. Serious Adverse Event 7/16/2021 Adverse drug reaction 5 Any untoward medical occurrence, that at any dose; Results in death Requires hospitalization or prolongation of existing hospitalization Results in persistent significant disability or incapacity Requires intervention to prevent permanent injury
- 6. History o From the earliest times, pharmaceutical formulations have been recognized as being potentially dangerous. o Public and professional concern about these matters first arose in the late 19th century. o In 1922, there was an enquiry into JAUNDICE associated with the use of SALVARSAN, an organic arsenical used in the treatment of Syphillis. 7/16/2021 6 Adverse drug reaction
- 7. In 1937 in USA, 107 people died from taking an Elixir Of Sulfanilamide 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 7/16/2021 7 Adverse drug reaction
- 8. 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. 7/16/2021 8 Adverse drug reaction
- 9. 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. 7/16/2021 9 Adverse drug reaction
- 10. Types of ADR 7/16/2021 10 Adverse drug reaction
- 11. Rawlins and Thompson’s classification 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 withdrawl F Failure OCP failure 11
- 12. Type A (Augmented) More common,dose dependent Augmented normal response Predictable ,Low mortality d/t pharmacological action of drug Rx- dose adjustment Eg. side effects, toxic effects, secondary effects 7/16/2021 12 Adverse drug reaction
- 13. Type B (Bizzare) Less common, Dose independent Abnormal/bizzare response, unpredictable Genetic/immunological High mortality, d/t pecularities of patient Rx-withdrawal of drug e.g. Allergy,idiosyncrasy 7/16/2021 13 Adverse drug reaction
- 14. Type C (Chronic) Reactions due to prolonged use of drugs Dose and time dependent eg. Cushing syndrom due to corticosteroids. Colonic dysfunction after prolonged use laxatives. 7/16/2021 14 Adverse drug reaction
- 15. Type D (Delayed) Occuring after years of treatment Time dependent e.g: Secondary cancers in patients treated for Hodgkin’s disease. Teratogenic effects. 7/16/2021 15 Adverse drug reaction
- 16. Type E (End of treatment) Occur when drug is suddenly discontinued e.g: Withdrawal seizures - phenytoin. Rebound hypertention - propranolol. 7/16/2021 16 Adverse drug reaction
- 17. Type F (failure of drug) Occurs when administration of drug does not produce therapeutic effect e.g: Genetic variability Drug interactions 7/16/2021 17 Adverse drug reaction
- 18. Grades of ADR 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 7/16/2021 18 Adverse drug reaction
- 19. Categories of ADR 7/16/2021 Adverse drug reaction 19
- 20. 1.Side Effects “Unwanted and unavoidable effects of a drug at therapeutic doses” Eg. Extension of therapeutic effect Atropine - dry mouth As distinctly different effect Promethazine – Sedation. Side effect exploited for therapeutic use Codeine – Diarrhoea 7/16/2021 20 Adverse drug reaction Categories of ADR (Contd..)
- 21. Categories of ADR (Contd..) 2.Secondary effects “Indirect consequence of Primary action of the drug.” Eg. Tetracycline - Superinfection Corticosteroids - Activation of latent Tuberculosis 7/16/2021 21 Adverse drug reaction
- 22. 3.Toxic Effects “Excessive pharmacological action of a drug due to over dosage or prolonged use” E.g. - Functional alteration : Atropine - delirium - Drug induced tissue damage : PCM – Hepatic necrosis - Extension of therapeutic effect : Barbiturates- Coma - Another action : Morphine – Respiratory failure 7/16/2021 22 Adverse drug reaction Categories of ADR (Contd..)
- 23. 4.Intolerance “Appearance of characteristic toxic effects of a drug at therapeutic doses” Eg. Triflupromazine (single dose) – Muscular dystonia Chloroquine (single dose) - Vomiting 7/16/2021 23 Adverse drug reaction Categories of ADR (Contd..)
- 24. 5.Idiosyncrasy Unusual response to a drug due to genetic abnormality. Drug interacts with some unique feature of individual, not found in majority subjects, & produces the uncharacteristic reaction. Eg. Chloramphenicol - aplastic anaemia,, Succinylcholine - Malignant hyperthermia 7/16/2021 24 Adverse drug reaction Categories of ADR (Contd..)
- 25. 6.Drug allergy Acquired, altered reaction of the body to drug. Immunologically mediated reaction. occur even with much smaller doses Also called Drug hypersensitivity Not genetic, not occur in all Occurs on re-exposure 7/16/2021 25 Adverse drug reaction Categories of ADR (Contd..)
- 26. Type of reaction Time before clinical sign Characteristics Example Anaphylactic (Immediate IgE- mediated anaphylaxis) < 30 min IgE binds to must cell or basophil,causes degranulation of must cell & basophil& release of reactive subs. histamine Penicillin anaphylaxis Cytotoxic (Antibody- Dependent Cellular Cytotoxicity 5 – 12 hr Antigen cause formation of IgG or IgM antibodies to bind that . Drug forms an antigenic complex with the surface of the cell and combination with antibody activate complement system causing cell destruction. Thrombocytopenia: Quinidine SLE:Hydralazine or Procainamide. Immune complex mediated 8-10days antigen antibody form complexes that causes inflammation Steven-Johnson Syn Serum Sickness Cell mediated allergy(delayed type) 2-3 days Antigen specific receptors develop on T- lymphocytes. Subsequent administration leads to local or tissue allergy. Contact dermatitis
- 27. 7.Photosensitivity Photochemical / biological Reaction UV - B Hyperpigmentation & desquamation Eg., Acute – Demeclocycline Chronic – Nalidixic acid, sulfonamides, phenothiazines, thiazides Cell mediated immune response UV - A Papular & eczematous, flare & wheal Eg., Sulphonamides, sulphonylureas, griseofulvin, chloroquine, Carbamazepine Phototoxic Photoallergic 7/16/2021 27 Adverse drug reaction Categories of ADR (Contd..)
- 28. 8.Drug dependence and addiction Drugs capable of altering mood and feelings are liable for repetitive use to derive euphoria, withdrawal from reality, social adjustment, etc. Psychological dependence: Individual believes that optimal state of well being is achieved only through the actions of the drug. E.g. Opioids, Cocaine. 7/16/2021 28 Adverse drug reaction Categories of ADR (Contd..)
- 29. Physical dependence: Altered physiological state produced by repeated administration of a drug which necessitates the continued presence of the drug to maintain physiological equilibrium. E.g. Opioids, Barbiturates, Alcohol, Benzodiazepines 7/16/2021 29 Adverse drug reaction Categories of ADR (Contd..)
- 30. 9.Mutagenicity and carcinogenicity Capacity of a drug to cause genetic defects and cancer respectively. Chemical carcinogenesis generally takes several (10- 40) years to develop. Unpredictable E.g., Estrogen- Endometrial carcinoma. OCP- Ca cervix, breast Ca 7/16/2021 30 Adverse drug reaction Categories of ADR (Contd..)
- 31. 10.Teratogenicity Capacity of drug causing foetal abnormalities when given to pregnant woman US FDA graded documentation of risk for causing birth defects into five categories ABCDX Eg: Phenytoin – cleft palate Valproate – Spina bifida 7/16/2021 31 Adverse drug reaction Categories of ADR (Contd..)
- 32. 7/16/2021 32 Adverse drug reaction
- 33. 11.Tachyphylaxis When responseiveness diminishes after repeated and frequent administration of a drug, the response is said to be subject to tachyphylaxis. Eg. Tyramine can cause depletion of all NE stores if we use it repeatedly at short interval, resulting in tachyphylaxis. 7/16/2021 33 Adverse drug reaction Categories of ADR (Contd..)
- 34. Organ specific toxicity 7/16/2021 34 Adverse drug reaction
- 35. Haematopoietic toxicity Sr. No. Drugs ADR’S 1 Quinine, Rifampicin, Sulfonamide, Thiazide Thrombocytopenia. 2 Carbamazepine, Sulfonamide, carbimazole, clozapine Fatal neutropenia , drug allergy (type II reaction), Granulocytopenia 3 Chloramphenicol Aplastic anemia 4 Anti cancer, cytotoxic drugs Direct bone marrow depression 5 Primaquine, quinine, chloroquine, dapsone, sulfonamide Hemolytic anemia
- 36. Hepatotoxic Drug ADR Chloroform, Halothane, enflurane Hepatotoxicity – jaundice Chlorpromazine, erythromycin,androgen Cholestatic jaundice INH, Rifampicin, Methyldopa Hepatocellular necrosis – jaundice Methotrexate, Alcohol Cirrhosis of liver Paracetamol overdose Hepatocellular necrosis Minocycline Chronic Active Hepatitis 36
- 37. Renal toxicity Sulfonamide- Glomerulonephritis. Aminoglycoside -Acute tubular necrosis. NSAID–Acute interstitial nephritis. ACE inhibitors– nephrotic syndrome 7/16/2021 37 Adverse drug reaction
- 38. How to prevent ADR 7/16/2021 Adverse drug reaction 38 Rational use of drugs Proper drug history and drug allergy history To check possiblity of drug interaction Assessment of risk benefit ratio Advice pt, not to take drugs without advice
- 39. Reporting of ADR 7/16/2021 39 Adverse drug reaction
- 40. ADR reporting Pharmacovigilace “The science and activities relating to detection, assessment, understanding & prevention of adverse effects or any other drug related problem.“ 7/16/2021 40 Adverse drug reaction
- 41. Aims and Objectives 7/16/2021 Adverse drug reaction 41 Contribute to assessment of benefit,harm,effectiveness & risk of medicines,encouraging their safe,rational &more effective use To improve public health & safety in relation to use of medicine Promote understanding,education & clinical training in pharmacovigilance & its effective communication to public
- 42. Summary ADR are ‘’adverse effects’’ which has causal relationship with drugs Types of ADR – type A, type B, type C,type D,type E type F Severity – Mild, Moderate, Severe, Lethal Others – side effects, secondary effects, toxic effects, allergy, idiosyncracy, intolerence, photosensitivity, drug dependence, mutagenicity,carcinogenicity,teratogenicity, tachyphylaxis ADR reporting(Pharmacovigilance) plays an important role in drug evolution & safty of public health 7/16/2021 42 Adverse drug reaction
- 43. References Goodman and Gilman's -13th The Pharmacological basis of Therapeutics Principles of pharmacology-HL Sharma & KK Sharma ADR: Definition,diagnosis & management The LANCET,Vol 356,2000. 7/16/2021 43 Adverse drug reaction