To strengthen PMS (post-market surveillance) in Indonesia, external researcher Amalia Hasnida is currently working on developing a market risk-based flagging tool to detect and prevent substandard, falsified, and degraded medicines in the market. The research is under supervision of the Health Care Governance research group, supervised by Maarten Kok and Elizabeth Pisani. This work is part of the Fellowship in Quality of Medical Products supported by the US Pharmacopeia.
Post-market surveillance
Protecting society from poor quality medicines in the market, or as commonly described in a regulatory term as post-market surveillance (PMS), has never been an easy task. Medicine regulator must prioritize which medicines to inspect, while at the same time considering the available resources and technology to perform their work. In Indonesia, with decentralized health care systems in 34 provinces and 416 districts, PMS could get even more complicated. Since 2014, Indonesia has implemented the world’s largest single-payer insurance scheme to achieve universal health coverage (UHC). Due to a structural deficit, cost containment has been applied including in medicine procurement, which puts the price as the main auction criteria. The imperatives to take down prices have incentivized the industry to produce substandard medicines and created a market opportunity for falsification as described on the Indonesian political economy case study here.
Building up an evidence base
We aim to complement the existing PMS tool by identifying “threat to quality” indicators based on market risk factors e.g. prices and validate the tool by performing laboratory testing on the flagged products. Our work is focusing on building up an evidence base to support healthcare decision-makers. Hence, we continuously engage and work in close consultation with public and private stakeholders, NGOs, and medical associations. We have formed a multi-disciplinary team by establishing a local research partnership with Pancasila University in Jakarta. Ultimately, we expect this enhanced PMS tool to safeguard the patients and sustain UHC by ensuring access to quality medicines.
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This article is written by external researcher Amalia Hasnida from the research group Health Care Governance.