Adverse Drug Reaction
•Download as PPTX, PDF•
6 likes•527 views
This document discusses adverse drug reactions (ADRs). It begins by defining key terms like adverse drug event, adverse drug reaction, and side effects. It then classifies ADRs into different types (A through E) based on their mechanism and provides examples. The document also discusses classifying ADRs by severity and the WHO's classification system involving temporal relationship and de-challenge/re-challenge. It introduces the Naranjo Algorithm for assessing causality of ADRs and the Schumock and Thornton scale for assessing preventability. In closing, it offers to answer any questions about ADRs.
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Adverse Drug Reaction
Similar to Adverse Drug Reaction (20)
More from Pravin Prasad
More from Pravin Prasad (20)
Recently uploaded
Recently uploaded (20)
Adverse Drug Reaction
- 1. Adverse Drug Reactions Dr. Pravin Prasad MBBS, MD Clinical Pharmacology Assistant Professor Maharajgunj Medical Campus, TU 3 March 2020 (21 Falgun 2076), Wednesday 1
- 2. By the end of this discussion, BDS 1st year students will be able to Define and Understand different terminologies related to adverse drug reactions (ADRs) Classify types of ADRs Give examples of different types of ADRs Briefly outline causality assessment of ADRs 2
- 3. Adverse Drug Effects: Terminologies Adverse Drug Event: Any untoward medical occurrence that may present during treatment with the medicine, but which does not necessarily have a causal relationship with the treatment 3
- 4. Adverse Drug Effects: Terminologies Adverse 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. 4
- 5. Picturising the concepts 5 Adverse events Adverse drug events No causal relationship Adverse drug reactions Causal relationship present
- 6. Adverse Drug Effects: Terminologies Side Effects: Minor effects of type A events/effects 6
- 7. Adverse Effects: Classification Type Mechanism Examples A Augmented, dose related, Predictable • Postural hypotension with anti-hypertensives • Hypoglycaemia with hypoglycaemics • Hypokalemia with diuretics 7
- 8. Adverse Effects: Classification Type Mechanism Examples B Bizzare, idiosyncratic, not dose related, Non- predictable • Antibiotic induced rash • Phenytoin induced Steven-Johnson Syndrome/ Toxic Epidermal Necrolysis 8
- 9. Adverse Effects: Classification Type Mechanism Examples C Chronic/contin uous, time related • Analgesic Nephropathy • Dyskinesia with Levodopa D Delayed • Thalidomide induced phocomelia • Vaginal cancer due to diethylstilbestrol 9
- 10. Adverse Effects: Classification Type Mechanism Examples E End of treatment • Adrenocortical insufficiency due to abrupt corticosteroid withdrawal • Opioid withdrawal causing withdrawal syndrome • Insomnia due to abrupt benzodiazepam withdrawal Others: Type F, Type G 10
- 11. Adverse Effects: Classification According to severity, as: Mild 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 11
- 12. Adverse Effects: Classification According to severity, as: Severe Potentially life threatening, causes permanent damage or requires intensive medical treatment Lethal Directly or indirectly contributes to death of the patient 12
- 13. ADRs: WHO Classification Temporal relationship Previous Knowledge De-challenge Re-challenge Explained by disease or other drugs Definite (plausible) (plausible) (Cannot be explained) Probable (reasonable) (clinically reasonable) (Unlikely) Possible (reasonable) (lacking or unclear) / (Could be) Unlikely / (improbable) (plausible) Conditional/ Unclassified More data for proper assessment needed; additional data under examination Unassessable or unclassifiable Report suggestiong and adverse reaction; cannot be judged: information insufficient or contradictory; data cannot be supplemented or verified 13
- 14. ADRs: Other Classification Classification Comments Schumock and Thornton Preventability criteria Preventibility of ADRs Naranjo Algorithm Casuality Assessment 14
- 15. Naranjo Algorithm Yes No Do not Know or Not Done Are there previous conclusive reports on this reaction? +1 0 0 Did the adverse events appear after the suspected drug was given? +2 -1 0 Did the adverse reaction improve when the drug was discontinued or a specific was given? +1 0 0 Did the adverse reaction appear when the drug was re-administered? +2 -1 0 Are there alternative causes that could have caused the reaction? -1 +2 0 Did the reaction reappear when a placebo was given? -1 +1 0 Was the drug detected in any body fluid in toxic concentrations? +1 0 0 Was the reaction more severe when the dose was increased, or less severe when the was decreased? +1 0 0 Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 0 0 Was the adverse event confirmed by any objective evidence? +1 0 0 15
- 16. Naranjo Algorithm: Interpretation Calculated Score Intrepetation ≥ 9 Definite Adverse Drug Reaction (ADR) 5-8 Probable ADR 1-4 Possible ADR 0 Doubtful ADR 16
- 17. Preventability criteria according to Schumock and Thornton scale 17
Editor's Notes
- b
- Adverse Effects: any undesirable or unintended consequence of drug administration, could be medical or non-medical Adverse Drug Event: any untoward medical occurrence that may present during treatment with the medicine, but which does not necessarily have a causal relationship with the treatment Side Effects: minor effects of type A events/effects Adverse Drug Reaction: any noxious change which is suspected to be due to drug, occurs at doses normally used in man, requires treatment or decrease in dose, or indicates caution in future use of the same drug. Excludes trivial or expected side effects and poisoning or overdose
- Adverse Effects: any undesirable or unintended consequence of drug administration Adverse Drug Event: any untoward medical occurance that may present during treatment with the medicine, but which does not necessarily have a causal relationship with the treatment Side Effects: minor effects of type A events/effects Adverse Drug Reaction: any noxious change which is suspected to be due to drug, occurs at doses normally used in man, requires treatment or decrease in dose, or indicates caution in future use of the same drug. Excludes trivial or expected side effects and poisoning or overdose
- Adverse effects: Any un-desireable or unintended consequence of drug administration Type A: based on pharmacological properties of a drug, will occur in everyone if enough of the drug is given because they are due to excess of normal, predictable, dose-related, pharmacodynamic effects. Includes side effects, toxic effects, consequences of drug withdrawal (type E)??, mostly preventable and reversible. Eg
- Type B: will occur only in some people, patient dependent, includes allergy and idiosyncracy, less common, non dose-related, generally more serious, requires withdrawal of drug, can be predicted and prevented if genetic basis is known and individual phenotype is identified. Accounts for most drug fatalities
- Type E: ending of use reactions, discontinuation of chromnic therapy is too abrupt: corticosteroids withdrawal leading to rebound adrenocortical insufficiency, opiod causing withsrawal syndrome
- Maximum score : +13