A Pharmacovigilance: A A Pharmacovigilance: A worldwide master key for drug worldwide master key for drug

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A Pharmacovigilance: A A Pharmacovigilance: A worldwide master key for drug worldwide master key for drug

monitoringmonitoring

Presented by:Presented by:

Maninder kaurManinder kaur

M.Pharm (Pharmacology)M.Pharm (Pharmacology)

Assistant professor at DVIPM, Assistant professor at DVIPM, karnalkarnal

Pharmacovigilance:• Pharmacovigilance (PV) also called as

drug safety. Pharmakon (in Greek) :Drug Vigilare (in Latin) : to keep

watch

• It is the umbrella word for ADR’s monitoring.

Definition• Accon to WHO “It is pharmacological

science relating to the detection , assessment, understanding and prevention of adverse effects”

AIM• To improve patient care and safety. • To contribute to the assessment of benefit,

harm ,effectiveness and risk of medicines.• To promote education and clinical training. • To promote rational and safe use of

medicines.

Need of Pharmacovigilance

• Humanitarian Concern.• Safe use of medicines.• ADR’s are expensive.• Promoting rational use of

medicines.• Ensuring public confidence.

Reason :1

Humanitarian concern:Insufficient evidence of safety from clinicaltrials, Animal experiments & Phase 1 – 3

studiesprior to marketing authorization.

Reason:2

Medicines are supposed to save lives: Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. 

Reason :3ADRs are expensive !! ADR’s as cause of admission to hospital; analysis of 18820 patients.•6.5% admission due to ADR’s•ADR related cost to the country exceeds the cost of medications themselves.

Reason: 4

Promoting rational use of medicines and adherence Reason :

Reason:5 & 6

5) Ensuring public confidence Reason

6) Ethics :To know of something that is harmful to another person who does not know, and not telling, is unethical

Function:

• Receive and manage ADR data.• Develop tools. • Analyse. • Signal detection :Identification of

previously unknown drug reactions.• Communicate.

Pharmacovigilance system

• Records medication related errors• Analyses those errors • Implements interventions• Promotes patient safety• Prevent 'preventable errors‘

Preventable Errors

• Handwriting of prescriptions• Drug interactions.• Similar-sounding and look-alike names and

packages of medication.• Level of stress on workplace.• Unclear records in information system• Disruptions in information availability and flow

How to prevent errors• Introduction of advanced medical

information systems– Electronic Health Record (EHR) – Automatic checks for dose, interactions,

allergies, resistance.– Personalized prescription (on base of

pharmacogenetic data).• Analyze all errors, research what enabled

them. • Try to design uncomplicated processes.

Historical background

Historical background

INDIA in this Duration:

Historical background(Pharmacovigilance in India)

System of Safety Data Gathering

Patients

HealthcareProfessionals

PharmaceuticalCompanies

National RegulatoryAuthority

Clinical Trials

International SafetyDatabases

Pre-Approval

Post-Approval

National scenario

International scenario:

WHO HQ + 6regional

offices

WHO Collaborating

centre, Uppsala

National centers

Collaboration with WHO-UMC

•  Collaboration with World Health Organization-Uppsala Monitoring Centre (UMC) WHO and UMC work with and provide technical support to more than 94 countries worldwide. The long term objective of the Pvpi is to establish a  ‘ Centre of Excellence ’  for Pharmacovigilance in India.  To achieve this objective, the Pvpi National Coordinating Centre will collaborate with the WHO Collaborating Centre - Uppsala Monitoring Centre (UMC) based in Sweden. 

Partners in Pharmacovigilance:

• The pharmaceutical industry

• Regulatory authorities

• WHO collaborating centre for international drug monitoring

• CIOMS(Council for International Organization of Medical Sciences )

Role of clinical pharmacist in Pharmacovigilance:

• Provide medical history.• Create database.• Monitoring patient.• Improving patient compliance • Documentation of case for future reference.• Follow up of patients to assess outcomes.• Encouraging health professional and patients.• Patient and health care professional education.

Drugs Banned

Four Drugs banned in all countries but not in india

Special Cases for PharmacovigilanceSome groups of medicinal products are not required

todocument their safety – natural medicines,

homeopathicPreparations.1. Natural (herbal) medicines :• Exact composition is often not known, efficacy nor

safety is usually not documented• 37 ADR reports in Australia related to Echinacea

use in allergy.

Special Cases for Pharmacovigilance2. Homeopathic preparations:• Zycam Cold Remedy case – unusual dilution

resulted in permanent loss of smell in several subjects and 340 filed.

• Content of alcohol in some preparations for children is higher than allowed in allopathic medicines.

Summary & ConclusionTo minimize the harm, medicines should

be good:

In all, Pharmacovigilance will promote: • Systematic and rational use of medicines.• Boost confidence for safety.

Institute offering Pharmacovigilance courses

• Clinwellkriger training & research institute , Bangalore.

• Bioinformatics institute in India, Noida.• Empower school of health,Kalkaji, Delhi.• Indian institute of pharmaceutical

marketing (IIPM), Lucknow . • New York university, New York, USA. • Yale university, Chicago, USA.

Scope of Pharmacovigilance in india

References • WHO Policy Perspectives on Medicines- Pharmacovigilance :

Ensuring the safe use of Medicines, Geneva .(2004). • Safety of medicines-A guide to detecting and reporting

adverse drug reactions, WHO Geneva (2002).• National Pharmacovigilance Protocol , Ministry of Health &

Family Welfare, Government of India, March 2003. • Central Drugs Standard Control Organization

http://cdsco.nic.in/html/Drugsbanned.html • Adverse reactions, post marketing surveillance and

pharmacoepidemiology by Judith K. Jones & Juhana E. Idanpaan-Heikkila in Pharma . Medicine by Denis M. Burley.

• Guidelines for Good Pharmacoepidemiology Practices (GPP), International Society for Pharmacoepidemiology , August 2004.

“People who are vigilant do not die; people who are negligent are as if dead”