Workshop –Cum-Training program on Pharmacovigilance
Indian Pharmacopoeia Commission is organising a Workshop cum Training Programme on Pharmacovigilance for NABH Accredited Hospitals on Monday, July 11, 2022 between 9 am to 1 pm at Shekhar Hospital, Uttarpradesh
Total seats: 50, Registration will be accepted based on first come first serve basis.
Registration fee is Rs.1180 inclusive of GST. Last date for registration is July 6 2022.
Virtual Training on Pharmacovigilance for NABH Accredited Hospitals was conducted by IPC – Indian Pharmacopoeia Commission , recently to create an awareness on Pharmacovigilance and Reporting of adverse drug reactions (ADRs).This write up prepared is based on the training given by IPC Team and various experts like Dr. Jai Prakash Officer-in-Charge, PvPI, Mr Prashant Paschal, Assistant Director NABHQCI New Delhi, Dr. Vandana Roy AMC Coordinator MAMC-New Delhi, Dr. Rahul Shukla AMC Coordinator Yashoda Super Speciality Hospital, Kaushambi, Ghaziabad and my own search from various sources.
Pharmaceutical medicines are designed to cure, prevent or treat diseases; however, no medicine is without side effects and there are also risks particularly adverse drug reactions (ADRs) which can cause serious harm to patients.
It is been reported that adverse drug reactions (ADRs) are poorly reported in developing country including India. It is estimated that only 2-4% of adverse drug reactions (ADRs) are reported and only 10% of serious adverse drug reactions are reported world wide.
Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human and helps in to reduce the harm to future patients.
What is ADR:
The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”
In addition to Drugs the vaccines, Medical Devices, Biosimilars, Diagnostic Agents are considered for ADR.
Classification of ADR:
Adverse drug reactions are classified into six types (with mnemonics):
Type A :dose-related (Augmented), Type B : non-dose-related (Bizarre), Type C : dose-related and time-related (Chronic), Type D : time-related (Delayed), Type E :withdrawal (End of use), Type F : failure of therapy (Failure).
A simple and common method of classifying ADRs is to divide them into two types – Type A and Type B. This is also known as the Rawlins–Thompson classification.
Patients taking medication from specific classes like –
Anti diabetics and Hypoglycemic Agents
Reporting of ADR:
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to National Coordination Centre (NCC) or Adverse Drug Reaction Monitoring Centres (AMC).There are around 34 AMC centers in India. The pharmaceutical companies can also send individual case safety reports for their product to NCC.
Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs can be also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to 5:30 pm.The mobile Android application for ADR reporting has also been made available to the public.
There are many methods to analyze the ADR the most acceptable method is The WHO-UMC causality criteria.
The WHO-UMC causality criteria [WHO].
Conditions (all conditions need to be complied with for each causality criterion)
Event/laboratory test abnormality with plausible time relationship to intake of a drug Cannot be explained by disease or other drugs Response to withdrawal plausible Event definitive pharmacologically or phenomenologically Rechallenge satisfactory, if necessary
Event or laboratory test abnormality, with reasonable time relationship to drug intake Unlikely to be attributed to disease or other drugs Response to withdrawal clinically reasonable Rechallenge not required
Event or laboratory test abnormality, with reasonable time relationship to drug intake Could also be explained by disease or other drugs Information on drug withdrawal may be lacking or unclear
Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable Disease or other drugs provide plausible explanations
Event or laboratory test abnormality More data for proper assessment needed, or Additional data under examination
Report suggesting an adverse reaction Cannot be judged because information is insufficient or contradictory Data cannot be supplemented or verified
How to make the Hospital Adverse Drug Reaction Monitoring Centres (AMC):
The Hospital can send letter of intent to INDIAN PHARMACOPOEIA COMMISSION. National Coordination Centre – Pharmacovigilance Programme of India (NCC-PvPI),MINISTRY OF HEALTH & FAMILY WELFARE, GOVERNMENT OF INDIA SECTOR-23, RAJ NAGAR, GHAZIABAD- 201 002. Tel No: 0120- 2783392, 2783400, 2783401, Fax: 0120-2783311 e-mail: firstname.lastname@example.org, email@example.com, Web: www.ipc.gov.in