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:

  1. https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/about-the-who-

  2. https://symbiosisonlinepublishing.com/pharmacovigilance/pharmacovigilance24.php

  3. 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


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