Health Policy Brief

Volume 3: Issue 1 (2nd Quarter 2017)

Department of Health Manila, Philippines

UNIVERSAL HEALTH CARE SERIES

Protecting consumers through improved

Pharmacovigilance

RECOMMENDATIONS

Initiate web-based electronic Link incentives to reporting of Dedicate a specific reporting

reporting portals linked to
national EMR database in all
medical institutions. Invest in
surveillance technology for more
efficient monitoring of Adverse
Effects/Adverse Drug Reactions.
AE/ADRs by manufacturers and
health workers. Tap inter-
national organizations to help
create venues for sharing of good
practices, and provide technical
opportunities to capacitate
personnel.
line (hotline, fax, email) for
the public in drug stores and
other health facilities to facili-
tate participatory reporting of
suspected drug effects.

OVERVIEW
The growing population and economic development in the Asia Pacific region point to a pharmaceutical market
of 350 billion dollars in 2016. China alone is predicted to be the world’s second-largest single pharmaceutical
market by 2020 (Scheeren et al., 2013). With the increased market demand and activities, strong Pharmacovigi-
lance (PV) must ensure compliance of drug companies to laws and regulations on drug safety.

KEY MESSAGES

Decentralized monitoring of AE/ADRs Expedited and organized reporting

collected from multiple sentinel sites of serious expected and unexpected
across the country may guarantee adverse drug effects help the regulators
descriptive and inclusive data results immediately contain public harm.
from the population.

Post-marketing surveillance of drug

Underreporting of AE/ADRs lead to lack
reactions help track the performance
of representative data and country-
of their product after release in the
specific policies on drugs regulation.
market.
 Pharmacovigilance Experience in the Asia Pacific

India China South Korea

Serious unexpected ADRs Decentralized monitoring of ADRs Decentralized system of
reported in 15 days Four-level surveillance network: ADR reporting
Pharmacovigilance Programme 1 national PV center All reports consolidated
in India (PvPI) operationalized 34 Provincial centers in one central center
in July 2010 400+ municipal, county centers Channels used for reporting:
call centers, fax, email

Japan 2 Phases:
Post-Marketing a. Early Post-Marketing Phase
Surveillance required Vigilance (first 6 months)
of all pharmaceutical b. Clinical Experience
companies Investigation Studies

2007
Philippines DOH issuance of guidelines
Drug surveillance for reporting Adverse Events
integrated in national Following Immunization (AEFI)
immunization 2010
programs Implementation of guidelines
for investigation of AEFI
2011
Creation of the National
Pharmacovigilance Program
2017
Development of guidelines
for ADR reporting in other public
health programs

Singapore Australia
Post-Marketing Assessment Voluntary reporting of ADRs; cases
of health products directly reported by health profes-
Modes for assessing ADRs: sionals and patients
- reports from manufacturers/ Initiatives to support the reporting:
health professionals - web-based electronic platform
- literature review - dedicated reporting lines
- exchange of regulatory
information

Challenges in Drug Surveillance

Underreporting. Actual cases of AE/ADRs are still un-
derreported. Most reports come from private industries;
very few reports come from the public sector.
Misinformation and Low level of knowledge. Medical
professionals are routinely misinformed about drug
safety by drug companies.
Limited resoures. Insufficient human, technical, and
financial resources are alloted for ADR regulatory bodies.
Lack of data. Drug policies are still based on Western
evidence. Absence of a nationally representative database
on drug effects fails to address actual ADR concerns in the
country.

Produced by the Department of Health, Health Policy Development and Planning Bureau
Editorial Board: Usec. Lilibeth David, Dir. Kenneth Ronquillo/ Editorial Staff: Dr. Beverly Lorraine Ho, Barbara Michelle de Guzman,
Ma. Catherine Arzobal/ Design and Illustration: Jake Matthew Kho, Luis Emmanuel De Vera, Armund Arguelles. This note was devel-
oped by Armund Arguelles from the DOH based on the Asia Pacific Pharmacovigilance Standards Overview 2016 report by Pharma IQ
of IQPC. Health Policy Briefs provide policy options for discussion and for possible adoption by the health sector. The views expressed
in this publication do not necessarily reflect the views of the Department of Health.

REFERENCES:
Biswas, P. (2013). Pharmacovigilance in Asia. Journal of Pharmacology & Pharmacotherapeutics. Retrieved from https://www.ncbi.nlm.nih.gov
Nwokike, J., Ludeman, E. & Thumm, M. (2013). Comparative analysis of pharmacovigilance systems in five Asian countries.
Scheeren, J., Woolley, K.L., & Dang, Thuy. (2013). Opportunities and challenges of global drug development in Asia: are you ready?. Regulatory Focus: N.p.
World Health Organization. (N.d.). Pharmacovigilance. Retrieved from http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/