Pharmacovigilance: An umbrella word for DRug safety.

A Pharmacovigilance: A worldwideA Pharmacovigilance: A worldwide
master key for drug monitoringmaster key for drug monitoring
Presented by:Presented by:
Maninder kaurManinder kaur
M.Pharm (Pharmacology)M.Pharm (Pharmacology)
Assistant professor at DVIPM, karnalAssistant professor at DVIPM, karnal

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 clinical
trials, Animal experiments & Phase 1 – 3 studies
prior 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 :3
ADRs 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
(Pharmacovigilance in India)

System of Safety Data Gathering
Patients
Healthcare
Professionals
Pharmaceutical
Companies
National Regulatory
Authority
Clinical Trials
International Safety
Databases
Pre-Approval
Post-Approval

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.

Four Drugs banned in all
countries but not in india

Special Cases for Pharmacovigilance
Some groups of medicinal products are not required to
document their safety – natural medicines, homeopathic
Preparations.
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 Pharmacovigilance
2. 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 & Conclusion
 To 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”

Pharmacovigilance: An umbrella word for DRug safety.

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