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 AE/ADRs by manufacturers and line (hotline, fax, email) for national EMR database in all health workers. Tap inter- the public in drug stores and medical institutions. Invest in national organizations to help other health facilities to facili- surveillance technology for more create venues for sharing of good tate participatory reporting of efficient monitoring of Adverse practices, and provide technical suspected drug effects. Effects/Adverse Drug Reactions. opportunities to capacitate personnel.
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- Limited resoures. Insufficient human, technical, and derreported. Most reports come from private industries; financial resources are alloted for ADR regulatory bodies. very few reports come from the public sector. Lack of data. Drug policies are still based on Western Misinformation and Low level of knowledge. Medical evidence. Absence of a nationally representative database professionals are routinely misinformed about drug on drug effects fails to address actual ADR concerns in the safety by drug companies. 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/