Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance.

Elizabeth Pisani,Mawaddati Rahmi,Amalia Hasnida,Steven Harsono,Maarten Olivier Kok,Yusi Anggriani

doi:10.2196/29309

Abstract

The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying “cases” for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.

Highlights

Background on Substandard and Falsified MedicinesIn late 2017, World Health Organization’s (WHO’s) press department issued a press release with the bold headline: “1 in 10 medical products in developing countries is substandard or falsified” [1]
With governments scrambling to secure supplies of diagnostic tests, medicines, and vaccines to cope with the COVID-19 pandemic, WHO and others have issued new warnings stating that the world may face an increased threat of poor-quality medicines [2,3,4,5]
The meta-analysis that gave rise to WHO's press release, which said that 10% of medical products in developing countries are substandard or falsified, is careful to note the many limitations of that estimate

Summary

Introduction

With governments scrambling to secure supplies of diagnostic tests, medicines, and vaccines to cope with the COVID-19 pandemic, WHO and others have issued new warnings stating that the world may face an increased threat of poor-quality medicines [2,3,4,5] These include substandard medicines, which are made by registered pharmaceutical companies in regulated factories but do not meet the quality standards set out in their market authorization paperwork, either because they were poorly made or because they have degraded since manufacture. The meta-analysis that gave rise to WHO's press release, which said that 10% of medical products in developing countries are substandard or falsified, is careful to note the many limitations of that estimate This meta-analysis was based on studies of uneven sizes and methods, conducted largely in low-income countries with limited domestic pharmaceutical industries, and heavily skewed toward antimalarials and a few other medicines that most interest global health agencies. Ozawa and colleagues [18] found that studies reported a prevalence of substandard or falsified medicines between 0.8% and 89% in Africa and a prevalence of between 0.7% and 50% in Asia

Objectives

Findings

Methods