Adverse drug reaction and its types

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1. Presentation On Adverse Drug Reaction And its types Shree Medical and Technical college, Bharatpur-12, Chitwan Presented by: Sanjay Kumar Yadav B. Pharm., 8 th sem. 6/16/2018 1

2. Table of content Introduction Classification of ADRs Risk factors of ADRs Detection of ADRs Monitoring of ADRs 6/16/2018 2

3. Introduction According to WHO defination , “Any noxious, unintended, undesirable or unexpected response to a drug that occurs at doses normally used in human for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” 6/16/2018 3

4. Classification of ADRs On the basis of Onset On the basis of Severity On the basis of Types 6/16/2018 4

5. Classification of ADRs A. On the basis of Onset Acute >within 60 minutes Sub-acute >1 to 24 hours Latent >2 days 6/16/2018 5

6. Classification of ADRs B. On the basis of Severity Mild  bothersome but requires no change in therapy Moderate  requires change in therapy, additional treatment, hospitalization Severe  disabling or life threatening 6/16/2018 6

7. Classification of ADRs C. On the basis of Types Edward and Aronson classification: Type A (Augmented) Type B (Bizarre) Type C (Chronic) Type D (Delayed) Type E (End of treatment) Type F (Failure ) Type G ( Genotoxicity ) Type H (Hypersensitivity) Type U (Un-classified) 6/16/2018 7

8. Conti… 1. Type A (Augmented) Often predictable and dose dependent Can be alleviated by a dose reduction Eg . Anticogulants  bleeding Beta blocker  bradycardia 2. Type B (Bizarre) Rare , unpredictable and dose independent Host dependent factors important in predisposition Eg . Penicillin  anaphylaxis Anticonvulsant  hypersensitivity 6/16/2018 8

9. Conti… 3. Type C (Chemical / Chronic) Associated with long term use Involves dose accumulation Eg . Paracetamol  hepatotoxicity Anti- malarials ocular toxicity 4. Type D (Delayed) Delayed effects and dose independent Can be due to accumulatiuon Eg . Chemotherapy  secondary tumours Analgesics  nephropathy 6/16/2018 9

10. Conti… 5. Type E (Exit / End of treatment) Occurs on withdrawal especially when drug is stopped abruptly. Eg . Phenytoin withdrawal  seizures 6. Type F (Failure) Unexpected failure of therapy. Common and dose related Often caused by drug interaction 6/16/2018 10

11. Risk factors of ADRs Age Gender Compliance Multiple medications Nutritional status Maternity status End organ dysfunction Altered physiology Prior history of ADRs Inappropriate medication prescribing, use 6/16/2018 11

12. Detection of ADRs Pre- marketing studies / Pre-marketing clinical trials 2. Post-marketing surveillance / Post-marketing studies Eg . a.) Cohort studies ,b.) Control studies 3. Under reporting 4. Communicating ADRs 6/16/2018 12

13. Monitoring of ADRs Identify ADRs Assessing causality (relationship between drug and suspected reaction) Documentation of ADRs Reporting serious ADRs to pharmacovigiliance centre 6/16/2018 13

14. References Text book of clinical pharmacy practice – G Parthasarathy . Page no: 105-118 https://www.slideshare.net/DrKhushbooBhojwani/adverse-drug-reaction-monitoring-84219366 www.cc.nih.gov http://slideplayer.com/slide/3915451/ 6/16/2018 14

15. Thank you… 6/16/2018 15