SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S

SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology

1. 1 SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S A Seminar as a part of curricular requirement for I year M. Pharm I I semester Presented by Ms. B. Mary Vishali (Reg. No. 20L81S0104) Department of Pharmacology Under the guidance/Mentorship of Dr. Pradeep Kumar., PhD Assistant Professor Department of Pharmacology.

2. 2 Definitions Severity assessment Seriousness assessment Naranjo algorithm Preventability assessment References CONTENTS:

3. 3 Adverse Drug Reaction: According to WHO Adverse drug reaction is defined as ”A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.” Adverse Event: Adverse event is defined as ” Any medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.” Severity: It describes the extent to which the ADRs influence the everyday life of a patients.  Seriousness: It is of an ADR is related to its life threatening nature and is defined as any untoward reaction to the medicinal product that may result in death and requires patient hospitalization.  DEFINITIONS:

4. 4 1.Karch and Lasagna classify severity into minor, moderate, severe and lethal. Mild(Minor) Moderate Severe lethal 2.Hartwig et al categorized ADRs into seven levels as per their severity. Level 1 & 2 fall under mild category, level 3 & 4 under moderate and level 5, 6 & 7 fall under severe category. Severity Assessment:

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7. 7 Seriousness of reaction is categorized according to FDA criteria on the basis of their life threatening nature. Death Life-threatening Hospitalization (initial or prolonged) Disability or Permanent Damage Congenital Anomaly/Birth Defect Required Intervention to Prevent Permanent Impairment or Damage (Devices) Naranjo Algorithm: It is used to determine adverse drug reaction probability. Seriousness Assessment:

8. 8 Questions: Yes No Don’t know Score 1. Are there previous conclusive reports on this reaction? +1 2. Did the adverse event appear after the suspected drug was administered? +2 -1 3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? +1 4. Did the adverse reaction reappear when the drug was re-administered +2 -1 NARANJO ALGORITHM:

9. 9 5. Are there alternative causes(other than the drug)that could on their own have caused the reaction? -1 +2 6. Did the reaction reappear when a placebo was given? -1 +1 7. Was the drug detected in the blood(or other fluids)in concentrations known to be toxic? +1 8. Was the reaction more severe when the dose was increased or less severe when the dose was decreased? +1 9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 10. Was the adverse event confirmed by any objective evidence? +1

10. 10 According to WHO factsheet, it is estimated that at least 60% of ADRs are preventable. In some countries ADR-related costs, such as hospitalization, surgery and lost productivity, exceed the cost of the medications. Historically, studies have shown that between 20% and 80% of ADEs and ADRs are preventable with the majority of latter studies showing around 60- 70% preventability. Preventability of ADRs is assessed by using Schumock and Thornton scale. Preventability Assessment:

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12. 12 1. Parthasarathy G, Hansen k Nyfort, Nahata CM; A textbook of Clinical Pharmacy Practice; pp 89-97 2. Schumock GT and Thornton JP. Focusing on the Preventability of Adverse Drug Reactions. Hosp. Pharm. 1992;27:538. 3. Uppsala Monitoring Centre. Hospital based pharmacovigilance: a clinical pharmacist’s perspective. Uppsala reports. 2002;20:10–11.  REFERENCES :

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