PHARMACOVIGILANCE
Pharmacovigilance is the science and activities dealing with the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problems.
History of pharmacovigilance:
Scope of pharmacovigilance:
Improve patient care and safety through the use of medicines, as well as all medical and paramedical interventions.
Improve general health and safety regarding the use of medicines.
Contribution to assessing the benefit, harm, efficacy, and risk of medicines, to promote their safe, rational, and effective (including cost-effective) use.
Promote understanding, education, and clinical training in pharmacovigilance, as well as effective communication with the public.
Aims of Pharmacovigilance:
Essential to identify and measure ADRs in order to prevent further occurrence.
Identify early discovery and prevention of ADR occurrences.
To enhance drug safety tracking.
To provide improved patient care.
Objectives of pharmacovigilance:
Pharmacovigilance centres pursue four objectives:
To identify adverse drug reactions (ADRs)
To evaluate them
To study them
To notify prescribing physicians.
Need for pharmacovigilance:
WHO Programme for international drug monitoring:
WHO In order to oversee the technical and scientific aspects of the program, UMC was created as a WHO Collaborating Centre for International Drug Monitoring ten years after PIDM was first introduced by WHO.
In close coordination with WHO headquarters in Geneva, UMC conducts the following tasks as a WHO Collaborating Center:
Help the WHO in its efforts to advance science and its WHO PIDM initiatives pertaining to the identification, evaluation, comprehension, and mitigation of adverse effects and other drug-related issues.
Provide pharmacovigilance tools and services and offer quick access to data in VigiBase, WHO's worldwide database of reported potential adverse drug reactions, in accordance with WHO's guidelines.
Assist WHO by contributing to capacity-building activities relevant to the framework of the WHO PIDM.
Support WHO drug-risk mitigation strategies for low- and middle-income countries in the WHO PIDM.
World regulatory agencies:
Australia – TGA (Therapeutic Goods Administration)
Canada – HC (Health Canada)
China – CFDA (Chinese Food Drug Administration)
Europe – EMA (European Medicines Agency)
France – AFSAAPS - The French Agency for the Safety of Health Products
Germany – BfArM (Federal Institute for Drugs and Medical Devices )
India – DCGI (Drug Controller General of India)
Japan – PMDA (Pharmaceuticals Medical Devices Admin)
Korea – KFDA (Korea Food Drug Administration)
New Zealand – MEDSAFE
Saudi Arabia – SFDA (Saudi Food Drug Administration)
UK – MHRA (Medicine & Healthcare Regulatory Agency)
US – FDA (Food Drug Administration )
WHO – (World Health Organization)
Pharmacovigilance in India:
A massive amount of drugs are produced and consumed in India, which is the world's fourth biggest producer of pharmaceuticals.
The Central Drugs Standard Control Organization (CDSCO) has launched a well-structured and highly participative National Pharmacovigilance Programme (NPP) based on the WHO document titled "Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre."
Broad Objectives of the Programme:
To encourage the culture of AE notification and reporting
To create a viable and broad-based ADR monitoring programme in India
Specific Objectives of the Programme :
To establish an ADR database for the Indian population .
To raise public awareness of ADR monitoring .
To ensure the maximum safety of drug products in the Indian market.
To build infrastructure for ongoing regulatory review of PSURs .
Zonal Pharmacovigilance Centre (ZPCs)-2
King Edward Memorial Hospital Mumbai & AIIMS New Delhi
Regional Pharmacovigilance Centres (RPC)-5
Pondicherry (south), Kolkata, Mumbai, Nagpur & New Delhi
Peripheral Pharmacovigilance Centres (PPC)-28
PSG Institute of Medical Sciences and Research, Coimbatore
Manipal College of Pharmaceutical Sciences
Annamalai University, JSS Medical College and Hospital etc
What to report:
All AEs are thought to be the result of new drugs or drugs of contemporary interest.
Every possible medication interaction.
Any other drugs suspected of having a major impact on a patient's management, including reactions suspected of causing:
Death
Life-threatening (real risk of dying)
Hospitalisation (initial or prolonged)
Disability(Significant ,persistent or permanent)
Congenital anomaly/Birth defect
Required intervention to prevent permanent impairment or damage.
Who can report:
Patients, patients’ relatives or patient carers
Health care professionals(Physicians,dentists,pharmacist,radiographers,nurses)
Manufacturers
Authorities
Where to report:
Anyone in the nation can report to the nearest pharmacovigilance centre.
what happens to the information submitted
Peripheral Pharmacovigilance Centres
Regional Pharmacovigilance Centres (causality analysis)
Zonal Pharmacovigilance Centres (statical analysis)
Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden.
5 years roadmap of the pharmacovigilance programme of India(2010-2015)
Resources for pharmacovigilance centres :
The following books shall be provided to various centres as identified by the NPA:
Meyler’s Side Effects
AHFS Drug Information Handbook
Martindale / online
Davies Text Book of ADR
Physician’s Desk reference
British National Formulary
Drug bulletins
Different forms used to communicate ADRs
CDSCO – India
MedWatch - USFDA
CIOMS (Council for International Organizations of Medical Sciences) – Worldwide
Yellow card (MHRA) - UK
Active ingredients withdrew:
Thalidomide(1961) Congenital limb defects
Benoxaprofen(1982) Hepatotoxicity
Phenformin(1982) Lactic acidosis
Fenfluramine(1997) Heart valve abnormalities
Clobutinol(2007) Cardiac arrhythmias
Reference:
https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/about-the-who-
https://symbiosisonlinepublishing.com/pharmacovigilance/pharmacovigilance24.php
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576445/
Student Name: K. Sravanthi
Student ID: 052/032023
Qualification: Pharm. D
e-Mail ID: shravanthisreeram@gmail.com
Comments