ADVERSE DRUG REACTION, types and reporting

Presentation includes a summarized overview of the adverse drug reaction.

1. TEERTHANKER MAHAVEER COLLEGE OF PHARMACY TMU, MORADABAD ADVERSE DRUG REACTION A PRESENTATION CLINICAL RESEARCH AND PHARMACOVIGILANCE COURSE CODE :- MPL204T FOR PARTIAL FULLFILMENT OF MASTER OF PHARMACY (PHARMACOLOGY) PRESENTED BY:- MOHIT PANDEY M.PHARM 2 SEM (PHARMACOLOGY) PRESENTED TO:- Dr. MAYUR PORWAL ASSOCIATE PROFESSOR PHARMACOLOGY

2. ADVERSE DRUG REACTION According to WHO “ A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function”. Noxious means :- injurious or harmful 2

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4. DETECTION OF ADR Pre-Marketing surveillance Post-Marketing surveillance Phase-1 Phase-2 Phase-3 Spontaneous ADR Reporting Epidemiological methods Case Control Cohort Studies 4

5. Post-Marketing surveillance Pharmacovigilance methodologies are used for detection of risk and for the collection of risk information. Two epidemiological methods are most commonly used which are: COHORT STUDIES :- Patient exposed to a particular drug and are followed up actively and systematically then the ADR frequencies are compared to an unexposed control population. CONTROL STUDIES :- Individual affected by the adverse event being studied are identified. Each case is matched with several disease ,both cases and controls are investigated their exposure to possible causative agents prior to occurrence of the event. The odd ratio calculated on the basis of exposure data. 5

6. 6 Any undesirable adverse event suspected to be associated with use of drug, biological product, herbal drugs,cosmetics,medical devices, should be reported. All ADRs as a result of prescription or non prescription. All suspected ADR regardless of whether or not the product was used in accordance with the product information provided by the company marketing the product. What to report? Patient information.( confidential manner ) Description of adverse reactions ( laboratory results, if available are to be included ) . Information related to the suspected drug(s). Information about how the adverse reaction had been managed. Information about the reporter. Minimum requirement to report an adr? REPORTING OF ADR

7. FIG.- ADR REPORTING PROCESS 7

8. 8 Source:- Pharmacovigilance Programme of India (ipc.gov.in)

9. SEVERITY AND SERIOUSNESS ASSESSMENT Seriousness Seriousness of an ADR is refers to its life threatening nature and is defined as “Any untoward reaction to the medicinal product that may result in death , requires inpatient hospitalization or results in prolongation of existing hospitalization , results in persistent or significant disability/incapacity , is a congenital anomaly/birth defect , or is a medically important event or reaction .” untoward :- unexpected Severity The term “Severe or severity” is often used to describe the intensity of a specific medical event ( graded as in mild,moderate,severe or lethal). 9

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11. Seriousness Assessment 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 11

12. TERMINOLOGIES IN ADR 12

13. References 13 Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D, Georgiev O. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy. SAGE open medicine. 2017 Jan 31;5:2050312117690404. Pharmacovigilance Programme of India (ipc.gov.in)

14. 14 Thank you