Detection and Reporting of Adverse Reaction

Method of detection of ADR and How to Report them in Pharmacovigilance

1. Topic name – Detection and Reporting of Adverse Drug Reaction Name: Bhagat Rohit Babaso Sub – pharmacovigilance Class-final year Roll no - 03 Guided By Mrs Reshma V. Pawar Associate Professor, SPM’s College of Pharmacy, Akluj

2. 2 Patients susceptible to adverse drug reactions must be properly identified and monitored. Methods of detection of ADR:- Pre-marketing safety Evaluation Post marketing surveillance Causality assessment Communicating ADR Postal Survey Method Dechallenge/Rechallenge Detection of ADR

3. Pre-marketing safety Evaluation Animal studies -:Specific animal studies for carcinogenicity, teratogenicity and mutagenicity easily accessible Human studies:- Pre-marketing safety Evaluation Phase 0: microdosing study (max 100mg) Phase 1: in this low dose on low population are study Phase 2: in this efficacy and safety of drug study. Number of patients are more than phase 1 phase 3: in this phase safety Evaluation and tolerability are studied . In this patient are in large amounts Specific groups are studied 1) elderly patients . 2) compromised patients 3

4. Post marketing surveillance Spontaneous Report : reports of ADR by health care practitioner such as physicians ,nurses, pharmacist Clinical study: A) cohort studies – Patient exposed to Particular drug should be monitored and compared to unexposed group. B) Case control studies: a)Person affected due to adverse event being studied should be recognised and Each case should be compared to Several disease free control patients. Meta-analysis of clinical study Published case reports : various case reports studies and ADR detected. 4

5. Causality assessment Following knowledge of ADR to suspected medicine or other In case of ADR suspected Then assessment starts with Collection of relevant Data Related to patients demographic such as Time of action and duration of Action , Treatment of react , outcome and reports. Communicating of ADR: Following knowledge About rational and Safe use of medicines are provided Basis training of health professionals Conducting constant education Programs for health professionals. Counselling the patient. 5

6. It is main used for monitoring ADR of new drugs i.e.within1 to 2 years After Drug has been launched . Dechallenge/Rechallenge: Drug causing ADR Withdraw, if does not found any ADR then called positive Dechallenge If ADR found , then withdraw the drug ,again given to the drug to check ADR is called Rechallenge 6 Postal Survey Method

7. Reporting of ADR Reporting of ADR is One of the most important parameter Of medical treatment ADR involves the receipt, Data entering, assessment,adverse event Data and documentation. Spontaneous reporting of suspected ADR, a regional or country wide system for reporting is currently major source of information in pharmacovigilance . Who should Report ADR Healthcare professionals Nurses Pharmacist Marketing authorisation holders 7

8. 8 What to Report All serious reactions and interaction Poisoning due to traditional or herbal medicine All suspected ADR related to Drug- drug, drug – food Interaction. All ADR As a result of Prescription and Non-Prescription medicinal products All suspected ADR Irrespective to Product information delivered by Company . Where to Report : Peripheral pharmacovigilance centre (city wise ) Regional pharmacovigilance centre Central pharmacovigilance centre

9. Sections to validate Individual case safety Report 1) Patient identification 2)Reporter identification 3) Suspected ADRs 4) suspected medicine patient identification The Name, initials or number of the patient in a hospital, name of the medical institution, dispensary, clinic or pharmacy are to be indicated or recorded in the report. Age at a time of reaction , sex, weight, should be indicated. Reporter identification Name of the Reporter Qualification Contact details And address are indicated . 9

10. 10 Name of the suspected drug (s): Trade name should preferably be used, if trade name is not available, generic name may be used. Strength of the drug (s) should also be stated Dosage, frequency and route of administration: should be clearly mentioned. Therapy date: The dates of starting and end of the administration of each drug should be stated . Batch number and Expiry date: should be mentioned. Suspected ADR’s : Description of Reaction. Seriousness of Reaction. Date of start and stop of Reaction. Laboratory tests and relevant Data. Date of drug withdrawal / continuous of ADR. Suspected medicine

11. 11 1)Book of pharmacovigilance, Thakur publication Pvt.Ltd . First edition By Dr. Agnimitra Dinda , Monika saxena Page no- 26-32 Reference

12. 12 Thanks!