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Adverse Drug Reactions 12/14/2012 1A D R: A D R INTRODUCTION An unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use. 12/14/2012 2Requires: Treatment Safety in dosing Discontinuation Caution in future Requires 12/14/2012 3Occurrence: Immediately or after prolonged use After termination Mild ADR is common (incidence 10- 25 %) With Polypharmacy Occurrence 12/14/2012 4Cont….: 12/14/2012 5 Cont…. Types of ADR: Type A Response is qualitatively normal Common Less serious Dose related Corrected by dose adjustment Includes side effects , toxic effect & withdrawal Types of ADR 12/14/2012 6 cont…..: Type B Because of patient peculiarities e.g. Allergy & Idiosyncrasy Dose related – uncommon Serious withdrawal of drug required Not always predictable & preventable cont….. 12/14/2012 7 Cont …..: Type C Associated with long term drug therapy E.g., Benzodiazepines dependence Analgesic Nephropathy Type D These reactions refers to teratogenic & carcinogenic effects These reactions are delayed in onset of action They are well known and can be anticipated Cont ….. 12/14/2012 8 Cont…..: Type E End of dose effects e.g. Abrupt cessation of corticosteroids produces acute adrenal insufficiency Type F Failure of therapy E.g. Anti tubercular therapy Cont….. 12/14/2012 9 Severity of ADR: MINOR No need of therapy MODERATE requires drug change, specific treatment, hospitalization SEVERE Potentially life threatening, permanent damage, prolonged hospitalization LETHAL Directly or indirectly lead to death Severity of ADR 12/14/2012 10 Prevention of ADR: Avoid inappropriate drugs in the context of clinical conditions Use right dose, route ,frequency based on patient variables Elicit medication history Elicit history of allergy Rule out drug interactions Adopt right technique of medication Carry out adequate monitoring Prevention of ADR 12/14/2012 11 Classification of ADR: SIDE EFFECTS Unavoidable ,predictable Occur at extension of same therapeutic effect E.g. Atropine - Dry mouth Promethazine – Sedation Estrogen (Antiovulatory) - Nausea Codeine (antitussive) –Constipation Sulfonylurea - Increase blood glucose level Classification of ADR 12/14/2012 12 Secondary effects: Indirect effect of therapy E.g.Lintetinol microflora killed by tetracycline super infection Corticosteroids' (immunity) –Oral candidiasis Secondary effects 12/14/2012 13Oral candidiasis: 12/14/2012 14 Oral candidiasis Toxic effects: Over dose or prolonged use of drugs Atropine – delirium Paracetamol – hepatic necrosis Barbiturates – coma Morphine – Respiratory failure Toxic effects 12/14/2012 15 EVALUATION: Airway Breathing Circulation Degree of consciousness History of exposure / ingestion Physical examinations EVALUATION 12/14/2012 16 Decontamination: Gastric lavage Induction of emesis Contraindication of emesis Activated Charcoal Decontamination 12/14/2012 17 Supportive care: Respiratory Cardiovascular CNS Supportive care 12/14/2012 18 Diagnostic study : Blood test ECG X- Ray Specific drug level Enhancing elimination Activated charcoal Force alkaline diuresis Haemodialysis /perfusion Diagnostic study 12/14/2012 19 Antidotes: Organophosphates -- Atropine ,Oximes Morphine -- Naloxones Benzodiazepines -- Flumazenyl Paracetamol --- N –acetyl cystine Antidotes 12/14/2012 20 4. Intolerance: Opposite to tolerance –sensitive to low doses Few doses of Carbamazipines causes ataxia, defective movement ,goiter Single dose of Triflupromazine –Muscular dystonia 4. Intolerance 12/14/2012 21 5. Idiosyncrasy: Genetically determined atypical ,bizarre effects Barbiturates- excitement & mental confusion Streptomycin –Deafness with single dose Deficiency of glucose 6 phosphate enzyme in individual, causes Haemorhoidal necrosis 5. Idiosyncrasy 12/14/2012 22 6. Drug Allergy: Immunologically mediated Independent of dose Occur in small proportion Prior sensitization required 1-2 weeks required after 1 st dose Drug acts as a Antigen Same drug may cause different allergy in different individuals 6. Drug Allergy 12/14/2012 23 Photosensitivity: Phototoxic – drugs accumulates in skin absorbs light to give photochemical reactions, photo biologic reactions Eg . Erythma edema blistering Photo allergic- drugs with cell mediated immune response, contact dermatitis on exposure to light Eg . Sulfonamides,Griseofulvin Photosensitivity 12/14/2012 24 Teratogenicity: Drugs used in pregnancy affects offspring's Eg . Thalidomide - phocomalia Phenytoine – cleft palate Oral hypoglycemic- neonatal hypoglycemia Tetracycline– Anomaly of teeth & bones Valproic acid – neural tube disorder War ferine - skeletal & CNS defects Teratogenicity 12/14/2012 25 Cleft palate: 12/14/2012 26 Cleft palate Phocomalia: 12/14/2012 27 Phocomalia Cont…: Carcinogenicity/ Mutagenicity Ant cancerous drugs Estrogen Drug induced diseases/ Latrogenic disease salicylates - peptic ulcer Phenothiazines – Parkinsonism INH -- hepatitis Cont… 12/14/2012 28 cont….: Drug withdrawal reactions Propanolol – hypertension Acute adrenal insufficiency following withdrawal of Corticosteroids www. authorstream .com cont…. 12/14/2012 29 Yellow Card System: Scheme was 1 st introduced in UK in 1964 after the thalidomide tragedy , By Dr. Bill Inman This receives reports of suspected adverse drug reactions from health care professionals & patient for medicines and vaccines This scheme was run by MHRA & CHM Yellow card system helping to make medicines safer Yellow Card System 12/14/2012 30 cont…: The Medicine and Health care Product Regulatory Agency (MHRA) ,and Commission on Human Medicine (CHM) run the UK ‘s spontaneous ADR reporting scheme called Yellow Card Scheme cont… 12/14/2012 31 MHRA with support of 5 yellow c card center: Yellow card centre Northern & Yorkshire Yellow card centre North West Yellow card centre Scotland Yellow card centre Wales Yellow card centre West Midlands MHRA with support of 5 yellow c card center 12/14/2012 32 cont….: These centers help to raising awareness of the yellow card scheme 7 provide education and training in their region ( including advice on what to report and help in completing the forms) They also provide information on drugs safety matters at regional level cont…. 12/14/2012 33 cont…. : Yellow card data is presented on websites in the form of a DRUG ANALYSIS PRINT which gives complete list of all suspected adverse drug reactions cont…. 12/14/2012 34 ANAPHYLAXIS: Serious allergic reactions i.e. rapid in onset & may cause death It typically results in a no. of symptoms including an itchy, rashes , throat swelling & low B. P. On a pathologic level, anaphylaxis is due to Release of mediators or non immunologic mechanism Primary treatment is injection of Epinephrine with other complementary measures ANAPHYLAXIS 12/14/2012 35 Anaphylaxis: 12/14/2012 36 Anaphylaxis Sign and symptoms: Skin – Generalized hives Itchiness, Flushing Angiodema Swelling of tongue and throat Respiratory – Shortness of breath Wheeze Strider ( upper respiratory obstructions) Sign and symptoms 12/14/2012 37Sign And symptoms: 12/14/2012 38 Sign And symptoms cont…..: Cardiac – Coronary artery spasm with MI Disarrhythmia & cardiac arrest Those having coronary diseases have at higher risk of cardiac anaphylaxis Others – GI symptoms may include crampy abdominal pain diarrhea vomiting cont….. 12/14/2012 39 CAUSES: Can occur in response to almost any foreign substances Common trigger includes venom from insect bites & stings , food and medication Less common causes Physical factor - Exercise Biological agent , Latex hormonal changes, food additives (mono sodium glutamate) topical medications CAUSES 12/14/2012 40Anaphylaxis reactions: 12/14/2012 41 Anaphylaxis reactions Pathophysiology: It is due to release of inflammatory mediators & cytokinines from mast cells & basophiles , typically due to immunological response Ig E + Antigens activates FcRi receptor on mast cells & basophiles Lead to release of Histamines causes Contraction of bronchial smooth muscle, Pathophysiology 12/14/2012 42Cont..: Triggers vasodilatation Increase leakage of fluid from vessels Cont.. 12/14/2012 43 Management: Epinephrine (Adrenaline) - Is primary treatment for anaphylaxis with no absolute contra indications It is given I. m. into mid anterolateral thigh as soon as diagnosed The injection is repeated every 10- 20 min. if there is insufficiency response A second dose is administered 16- 30 % of episode Management 12/14/2012 44 cont…: People on beta b can blockers may be resistant to the effect In that case I.v . glucagon can be administered Antihistamines (both H1 & H2) Corticosteroids Nebulized Salbutamol Use the Airway ,Breathing , Circulation, Disability, Exposure (ABCDE) approach to treat at primary level cont… 12/14/2012 45 References: Essential s of Pharmacotherapeutics, By F. S. K. Barar page no. 36 38 References 12/14/2012 46: 12/14/2012 47 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.