OBJECTIVES:

Substandard and falsified medicines (SFM) are acknowledged as a public health concern of global importance. Post-market surveillance (PMS) aims to prevent and detect SFM, however there is remarkably scarce evidence about the cost and value for money of PMS activities: how much does PMS cost? How effective is PMS in detecting SFM? How much should governments invest in it? We present initial findings from an ongoing project in Indonesia (STARMeds) that improve our knowledge on the costs and efficacy of PMS.

METHODS:

Between February and May 2022 the STARMeds project has collected more than 1,000 medicine samples for five molecules (amlodipine, amoxicillin, cefixime, dexamethasone and allopurinol) in seven Indonesian districts. The samples underwent laboratory analyses for concentration of active pharmaceutical ingredient, dissolution, uniformity, and antimicrobial activity; complete lab results are expected in January 2023. We further collated data on STARMeds resources related to all stages of PMS including design, fieldwork, and laboratory analysis. These comprise of staff costs, determined via a administrative records and a time-and-motion study, capital costs and consumables, costs of laboratory analysis, and other resources.We are using activity-based costing principles to estimate the financial and economic cost of PMS from two perspectives: the research team and the national medicines regulator.

RESULTS:

We will calculate indicators that capture the unit costs per time, product and collection method. We will evaluate the impact of uncertainty in both activity and costing data on our findings, specifically related to the number of samples collected, and uncertainty in key cost data, including laboratory costs.

CONCLUSIONS:

We expect our findings to bring urgently needed and novel information on the cost and value-for-money of PMS. These may prove valuable for planning and budgeting to regulators and researchers in Indonesia and elsewhere, particularly in low- and middle-income settings, as well as international organisations working on health regulation.