1. BY,
Dr. SAMYUKTHA KANDULA,
1 ST YEAR POSTGRADUATE,
DEPARTMENT OF
PHARMACOLOGY,
ANDHRA MEDICAL COLLEGE.
PHARMACOVIGILANCE
utilisation of data collected, application of PV, WHO programme for
international drug monitoring & future prospects
4. Signal generation & strengthening
AIM: Early detection of signals to
possible adverse reactions
Signal - strengthened by further
analysis and helps regulatory
authorities.
5. Drug Regulation
• All available domestic and international safety information of an approved medical
product is continuously monitored by the drug regulatory authority & MAH.
• Data is used in the adaptation of the approved product information like the inclusion of
new adverse effects and warnings,
6. Education
• Used to update the knowledge of healthcare professionals during continuous medical
education programmes on pharmacovigilance.
8. • Pharmacovigilance in national drug policy
• Pharmacovigilance in the regulation of medicines
• Pharmacovigilance in clinical practice
• Pharmacovigilance in disease control public health programs
9. PHARMACOVIGILANCE IN
NATIONAL DRUG POLICY
• The provision of good quality, safe, and effective medicines and their appropriate use.
• Establishing a national medicine regulatory agency and a designated centre for the
study of adverse reactions.
• Multidisciplinary collaboration between various departments of the Ministry of Health
and with other stakeholders
• Education on the rational use of medicines and pharmacotherapy monitoring.
10. PHARMACOVIGILANCE IN
THE REGULATION OF MEDICINES
• Clinical trials.
• The safety of complementary and traditional medicines, vaccines, and biological
medicines.
• The development of lines of communication between all parties, which have an
interest in medicine safety, ensures that they are able to function efficiently and
ethically, particularly in times of crisis.
• MUTUAL SUPPORT OF PHARMACOVIGILANCE PROGRAMS AND DRUG
REGULATORY AUTHORITIES.
11. PHARMACOVIGILANCE IN
CLINICAL PRACTICE
• Safety monitoring of medicines in common use should be an integral part of clinical practice.
• Education and training
• medicine safety
• exchange of information between national pharmacovigilance centres
• the coordination of such exchange
• linking of clinical experience of medicine safety with research and health policy,
• serve to enhance effective patient care.
• A regular flow and exchange of information on medicine-induced diseases.
12. PHARMACOVIGILANCE IN
DISEASE CONTROL PUBLIC HEALTH PROGRAMS
• Pharmacovigilance should be a priority for every country with a public health disease
control program.
• In countries where there is no regulatory or safety monitoring system in place, or in
remote areas with little or no healthcare surveillance or infrastructure, has been
identified as a matter of concern.
• In some settings, several disease control initiatives involving the administration of
medicines to large communities are being implemented within the same population
with little knowledge of, or regard to, how these various medicines could interact with
each other.
14. • Started in 1968, WHO program for international drug monitoring was a means of
pooling existing Data on ADRs.
• More than 100 countries are currently participating
• WHO along with its collaborating centre in Uppsala, Sweden are responsible to
maintain the global ADR database, Vigibase.
• VIGIBASE - largest database of its kind in the world with 30 million reports of
suspected ADRs since 1968.
15. ANALYSIS OF THE REPORTS IN
DATABASE
• Identify early warning signals of serious adverse reactions to medicines
• Evaluate the hazard
• Undertake research into the mechanisms of action to aid the development of safer
and more effective medicines.
16. Advisory committee
• Provision of expert advice on all matters relating to the safery of medicines.
• Facilitate consistent policies and action among member countries.
• Advise authorities who may be concerned to take action in respected countries.
17. Success ?
• Dependant on contributions of national pharmacovigilance centers.
• Essential pool of experience and competence.
19. • E-CLINICAL OR E-HEALTH SOLUTIONS provide several core benefits: time savings, high
quality, cost reductions, and increased efficiencies with safer and more efficacious
medicines.
• STANDARD-BASED PHARMACOVIGILANCE SYSTEM with connection to electronic medical
records, and clinical data management systems enables early drug safety detections,
data mining, results interpretation, assisting in safety decision-making, and clinical
collaborations among clinical partners or different functional groups.
• A PUBLICLY ACCESSIBLE GLOBAL SAFETY DATABASE that is updated on a frequent basis.
20. References
1. Utilisation of data collected- postgraduate pharmacology -Sougatha Sarkar ch.20
pharmacovigilance pg no.87-88.
2. Application of pharmacovigilance - Ritu Parna Maiti postgraduate topics in pharmacology
3rd edition ch. ADR monitoring and pharmacovigilance pg no.221.
3. WHO program for international drug monitoring & Future prospects- Ritu Parna Maiti
postgraduate topics in pharmacology 3rd edition ch. ADR monitoring and pharmacovigilance
pg no.221-222.
