Cardiac Output, Venous Return, and Their Regulation
Pharmacovigilance: An umbrella word for DRug safety.
1. 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
2. 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.
3. Definition
• Accon to WHO “It is pharmacological
science relating to the detection ,
assessment, understanding and
prevention of adverse effects”
4. 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.
5. Need of Pharmacovigilance
• Humanitarian Concern.
• Safe use of medicines.
• ADR’s are expensive.
• Promoting rational use of medicines.
• Ensuring public confidence.
7. Reason:2
Medicines are supposed to save lives:
Dying from a disease is sometimes unavoidable;
dying from a medicine is unacceptable.
8. 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.
10. 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
11. Function:
• Receive and manage ADR data.
• Develop tools.
• Analyse.
• Signal detection :Identification of
previously unknown drug reactions.
• Communicate.
12. Pharmacovigilance system
• Records medication related errors
• Analyses those errors
• Implements interventions
• Promotes patient safety
• Prevent 'preventable errors‘
13. 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
14. 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.
19. System of Safety Data Gathering
Patients
Healthcare
Professionals
Pharmaceutical
Companies
National Regulatory
Authority
Clinical Trials
International Safety
Databases
Pre-Approval
Post-Approval
23. 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.
24. Partners in Pharmacovigilance:
• The pharmaceutical industry
• Regulatory authorities
• WHO collaborating centre for international
drug monitoring
• CIOMS(Council for International
Organization of Medical Sciences )
25. 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.
28. 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.
29. 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.
30. 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.
31. 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.
33. 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.
34. “People who are vigilant do not
die; people who are negligent
are as if dead”