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Pharmacovigilance is the science of monitoring the safety of medicines. Its goals are to improve patient safety, assess the benefits and risks of medicines, and promote their rational use. Methods of pharmacovigilance include individual case safety reports, clinical reviews of reports, cohort event monitoring, analysis of electronic patient records, and periodic safety update reports. The Pharmacovigilance Programme of India officially started in 2004 to monitor drug safety as the pharmaceutical industry in India grows rapidly. It is controlled by several government agencies and aims to ensure all medicines used in India are appropriately evaluated for safety.

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4K views3 pages

PV PDF

Pharmacovigilance is the science of monitoring the safety of medicines. Its goals are to improve patient safety, assess the benefits and risks of medicines, and promote their rational use. Methods of pharmacovigilance include individual case safety reports, clinical reviews of reports, cohort event monitoring, analysis of electronic patient records, and periodic safety update reports. The Pharmacovigilance Programme of India officially started in 2004 to monitor drug safety as the pharmaceutical industry in India grows rapidly. It is controlled by several government agencies and aims to ensure all medicines used in India are appropriately evaluated for safety.

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Pharmacology Ms. Meenu Bhati (Asst.

Prof at CBS)

Pharmacovigilance
Pharmacovigilance (PV) also called as drug safety.
Pharmakon-------in greek----drug
Vigilare -----------in latin------to keep watch
Pharmacovigilance is the science &activities relating to the detection, assessment,
understanding and prevention of adverse effects.
Aims:
• To improve patient care and safety
• To improve public health and safety
• To contribute to the assessment of benefit, harm ,effectiveness and risk of
medicines
• To promote rational and safe use of medicines
Methods 0f pharmacovigilance:
1. Individual case safety reports: Like yellow card system of the
Pharmacovigilance section of the U.K. Their strength in signaling causal
associations depend on the skill and experience of the reporter and the
documentation and characteristics of the event.
2. Clinical review of case reports:The quality of reports is variable , large national
and international organizations collect hundreds of thousands of reports each year ,
every one of which can’t possibly be reviewed by the available experts.
3. Cohort event monitoring: systems for intensified follow up of selected medicinal
products.
4. Longitudinal electronic patient records: They cover large populations, provide
detailed information on both exposed and unexposed patients.Information is
extracted directly from the computer systems in which physicians store patient’s
data.
5. Spontaneous reporting: The reporting might be directly to the company, or it
could be to the regulatory authority. When becoming aware of a serious adverse drug
reaction, health care providers, pharmacies, pharmaceutical companies shall report
to the health authority.
Reporting methods: shall submit reports by post, fax or internet.
Pharmacology Ms. Meenu Bhati (Asst. Prof at CBS)

A verbal report is acceptable in urgent situations, but written submission should be


completed before the deadline.
6. Periodic safety update reports: Pre marketing clinical trials may not be
sufficient to reflect the product safety profile. Therefore medically advanced
countries impose the “post marketing drug safety monitoring period”on new drugs.
According to the “regulation of medical products under safety monitoring” if
pharmaceutical companies fail to submit PSUR as required, then the health authority
may reassess the safety of the concerned product.

• Pharmacovigilance programme of India (PVPI) Introduction –


Officially started on 23 November 2004 at new Delhi. Pharmaceutical industry
in India is valued at 90,000crore and is growing at the rate of 12-14% per
annum.Total export of pharma products is to the extent of 40,000crore.India is
now being recognized as the “global pharmacy of generic drugs”
India is also emerging rapidly as a hub of global clinical trials & destination for
drug discovery and development.
PVPI is under control of
1. CDSCO (Central Drugs Standard Control Organization)
2. Directorate general of health services
3. Indian pharmacopeia commission (Ghaziabad)
The programme is conducting by NCC(National Coordinating Centre)
STEERING COMMITTEE
• Chairman-drugs controller general (India), New Delhi
MEMBERS
1. scientific director, Indian pharmacopoeia commission , Ghaziabad
2. Head of dept. of pharmacology, AIIMS
3. Nominee of director general, ICMR
4. Assisstant director general as representative of directorate general health
services
Pharmacology Ms. Meenu Bhati (Asst. Prof at CBS)

5. Undersecretary as representative of the ministry of health & family welfare


6. Nominee of vice chancellor of medical/pharmacy University
7. Nominee of the medical council of India
8. Nominee of the pharmacy council of India

***END***

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