PHARMACOVIGILANCE- ADR reporting in india

1. PRESENTED BY
K.SRAVYA
B.PHARMACY
RBVRR WOMENS COLLEGE OF PHARMACY

2.  Pharmacovigilance.
Pharmacovigilance program in India.
Role of consumer in reporting ADRs.
Factors that caused under reporting.
Importance of consumer reporting.
Consumer reporting in India.
References.

3. • Pharmacovigilance, also called as drug safety, is the pharmacological science
relating to the collection , detection, assessment, monitoring, and prevention
of adverse effects with pharmaceutical products.
What is ADR?
• The negative and undesirable effects of drug therapy are known as adverse
drug reaction.
• WHO- “A response to a drug that is noxious and unintended and that
occurs at doses normally used in human for the prophylaxis diagnosis or
therapy of disease or for physiological function”.

4. PHARMACOVIGILANCE (PV)
• It plays a consequential role in surveillance
of ADR, which is provoked by the drugs
used to cure diseases.
• WHO CAN REPORT PV?
 All health care professional's-
 (clinician's , dentist, pharmacist, nurses,
physicians, physiotherapist etc.)
All non health care professionals –
including consumer, patients etc. can
report ADR.

5. India initiated a concerted world health organisation(WHO) –Sponsored
.
It was renamed as in 2010 under aegis
of with ambitious goal and detailed
planning.
The program is now in its expansion phase with 150
functioning all over the country and has submitted around 75,000 ADR
reports to the global database of ADRs (vigibase)maintained by the
Sweden .
India ranked 7th among countries contributing safety data to vigibase with respect
to the number of Individual case study reports(ICSR) submitted in the year 2013.

6. The cornerstone of all pharmacovigilance programs is spontaneous reporting of
ADRs by doctors, nurses, pharmacist and allied healthcare professionals.
It is done by filling ADR forms which are designed specifically for healthcare
professionals. Spontaneous reports form a major source of data involved in drug
withdrawals throughout world.
Underreporting of ADRs is a long known limitation of spontaneous reporting
programs.
Several studies have revealed that doctors nurses and pharmacists in India are
aware of the need and mechanisms of spontaneous reporting but seldom put
them into practice.

7. Some factors that caused under reporting are:
 Spontaneous reporting requires time, care and diligence of healthcare professionals for which she/he is
not remunerated.
 Lack of easy access to functional PV systems.
 Fear of indictment and erosion of professional reputation.
 Lack of attitude
 Misconception about what to report.
 Such factors lately lead to the spontaneous reporting of ADRs by consumer/patients.
 Consumer initiated reporting of ADRs was practiced in USA from the start of its PV program in 1960s
following the thalidomide tragedy.
 Other countries have added the services later in their programs e.g., Netherlands( 2003),
Denmark(2003), Italy(2004), UK(2008),Norway(2013)
 The Netherlands and UK have shown that patient initiated ADR reporting is a reliable source of
information for supplementing drug safety monitoring.

8. Active players • Consumers are active players in drug safety and key stakeholders with
respect to PV
Earlier detection
• With consumer reporting , ADRs will be detected earlier and more
number of ADRs would be reported especially with respect to the over
the counter(OTC) medicines.
Consumer rights
• Consumer reporting will promote consumer rights.

9. • Consumers are being encouraged to report adverse reactions to medicines
through spontaneous reporting system.
• In order to strengthen the patient safety and direct participation of
consumer/patient in PV Program , NCC-PvPI has recently launched “medicines
side effect reporting form for consumers”{ blue form} at national level conference
on “participation of patient/consumer organisation in PvPI” at IPC on august
1,2014.
• Through till free helpline number : 1800-180-3024 (or)
email id: pvpi.compat@gmail.com (or)
to nearest AMC under PvPI by submitting blue form which can downloaded from
official website of IPC www.ipc.gov.in

10. Currently two forms available for reporting of ADRs-
“Suspected adverse drug reaction
reporting form” (red form)- for HCPs
“Medicine side effect reporting form”
(blue form)- for consumer/patient.

11. After release of consumer reporting form in English, NCC-PvPI released first version
of” Medicine side effect reporting form” in different regional languages Hindi,
Bengali, Tamil, Gujarat, Kannada, Oriya, Malayalam).
ADR reporting mobile application is also available in India i.e ADR PvPI

12. Consumer reporting cannot replace the exiting pharmacovigilance program but it
can complement and strengthen it.
Consumer reporting as a new concept will enhance the impact of reporting system
and can improve the knowledge about the ADRs of OTC medicines, the off-label use
of medications, traditional medicines, alternative medicines about whose risks
doctors may not familiar enough.
Patients positive attitude towards ADR reporting could be sustained by hosting
periodic public awareness campaigns addressing the importance of ADR.
Lack of awareness of ADR monitoring system is still prevalent among developing
and under developing countries.

13. REFERENCES
Prakash, J., Joshi, K., Malik, D., Mishra, O., Sachan, A., Kumar, B., Bhushan, S.,
Kalaiselvan, V. and Singh, G.N., 2019. “ADR PvPI” Android mobile app: Report
adverse drug reaction at any time anywhere in India. Indian journal of
pharmacology, 51(4), p.236.
Kalaivani, M., Kalaiselvan, V., Dabhi, K. and Singh, G.N., 2015. Direct consumer
reporting of ADRs to PvPI, a position paper of Indian pharmacopoeia
commission. Adv Pharmacoepidemiol Drug Saf, 4(184), pp.2167-1052.
Kalaiselvan, V., Kumar, P., Mishra, P. and Singh, G., 2015. System of adverse drug
reactions reporting: What, where, how, and whom to report?. Indian Journal of
Critical Care Medicine, 19(9), p.564.
Kalaiselvan, V., Prasad, T., Bisht, A., Singh, S. and Singh, G.N., 2014. Adverse drug
reactions reporting culture in Pharmacovigilance Programme of India. The Indian
journal of medical research, 140(4), p.563.