Severity, seriousness, predictability and preventability assessment
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This document discusses the assessment of severity and seriousness of adverse drug reactions (ADRs). It defines severity as the intensity of a medical event, categorizing ADRs as mild, moderate or severe based on management steps. It also describes several classification scales for ADR severity, including one by Karch and Lasagna and the Modified Hartwig's and Siegel Scale. The document defines seriousness classification according to regulatory criteria. It then discusses preventability and predictability of ADRs, describing scales by Schumock and Thornton for preventability and the distinction between Type A and Type B reactions in terms of predictability.
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Severity, seriousness, predictability and preventability assessment
- 1. SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR Dr. Ramesh Bhandari Asst. Professor Department of Pharmacy Practice, KLE College of Pharmacy, Belagavi
- 2. SEVERITY •The term severity is often used to describe the intensity of a medical event. •Severity assessment categorizes the ADRs as mild, moderate or severe based on the steps taken for the management of the ADRs.
- 3. SEVERITY • KARCH AND LASAGNA classified severity into minor, moderate, severe and lethal as defined below: Minor: No antidote, treatment or prolongation of hospitalization required. Moderate: A change in drug therapy (e.g.: modified dosage, addition of a drug), but not necessarily discontinuation of the drug is required; hospitalization may be prolonged, or specific treatment may be required. Severe: Potentially life threatening, causing permanent damage or requiring intensive medical care. Requires drug discontinuation. Lethal: Directly or indirectly contributes to the death of the patient.
- 4. MODIFIED HARTWIG’S AND SIEGELASSESSMENT SCALE • Hartwig et. al robustly categorized ADR severity into seven levels according to clinical consequence, including resultant harm and intensity of medical intervention required. oLevel 1 and 2 fall under mild category oLevel 3 and 4 fall under moderate category oLevel 5, 6 and 7 fall under category severe category.
- 5. Modified Hartwig and Siegel • Mild: Level 1: The ADR requires no change in treatment with the suspected drug Level 2: The ADR requires that the suspected drug be withheld, discontinued or otherwise changed. NO antidote or other treatment is required, and there is no increase in length of stay.
- 6. Modified Hartwig and Siegel • Moderate: Level 3: The ADR requires that the suspected drug be withheld, discontinued or otherwise changed, and / or an antidote or other treatment is required. There is no increase in length of stay Level 4 (a): Any level 3 ADR that increases length of stay by at least one day Level 4 (b): The ADR is the reason for admission.
- 7. Modified Hartwig and Siegel • Severe: Level 5: Any level 4 ADR that requires intensive medical care. Level 6: The ADR causes permanent harm to the patient Level 7: The ADR either directly or indirectly leads to the death of the patient.
- 8. SERIOUSNESS CLASSIFICATION • A serious adverse event or reaction is any untoward medical occurrence that at any dose: Results in death Is life threatening Requires inpatient hospitalization or prolong hospitalization Results in persistent or significant disability Is a congenital anomaly/birth defect
- 10. PREVENTABILITY OFADRs • Schumock and Thornton criteria: • It has three sections namely definitely preventable, probably preventable and not-preventable. • Section A comprises of five questions while section B has four questions. • All the answers are categorized as “yes” or “no”. • ADRs are “definitely preventable” if answer was “yes” to one or more questions in section A. • If answers are all negative (“no”), then proceed to section B • ADRs are “probably preventable” if answer was “yes” to one or more questions in section B. • If answers were all negative then proceed to section C. • In section C, the ADRs are not-preventable.
- 12. PREDICTABILITY Of ADRs • Type A (Predictable): Extension of pharmacological effect Often predictable and dose dependent Example: Dry mouth induced by anti-cholinergics. • Type B (Non-predictable): Idiosyncratic or immunologic reactions Rare and unpredictable Example: Penicillin induced anaphylactic shock.
- 13. REFERENCES 1. Karch FE, Lasagna L. Adverse drug reactions. JAMA. 1975; 234(12):1236 2. S. K. Gupta. Textbook of Pharmacovigilance. 2nd Edition. Jaypee Brothers Medical Publishers. 2019.
- 14. THANK YOU