Much ado about Medicine Quality

17 June 2016

Poor quality medicines are impacting an increasing number of pharmacological drug classes, including anti-infectives, and are found in countries worldwide.

The WWARN Medicine Quality Group is committed to help fight the global pandemic of poor quality medicines that threatens the lives of millions of people. Poor quality medicines can be classified as falsified, substandard or degraded. Falsified medicines are those that purport to be authorised medicines but are in fact deliberately and fraudulently mislabelled with respect to identity and/or source. They may contain the correct active ingredients (but usually the incorrect amount), wrong active ingredients or no active ingredients at all. Substandard medicines are products, developed by authorised manufacturers, which do not meet their own quality standards and specifications. Degraded medicines leave the factory at the right standard, but deteriorate because of inappropriate storage, such as lack of refrigeration, especially in hot climates.

Poor quality medicines are impacting an increasing number of pharmacological drug classes, including anti-infectives, and are found in countries worldwide. They affect the lives of individual patients and impact wider healthcare systems from supply chains to illegal distribution activities.

Poor quality artemisinin-based combination therapies (ACTs) – the currently recommended antimalarials to treat Plasmodium falciparum malaria in 81 countries – are at the centre of the pandemic. Large quantities of poor quality ACTs, especially with sub-therapeutic concentrations of antimalarials, are reducing the treatment efficacy of these life-saving medicines and are likely to be contributing to the rise of antimalarial medicine resistance.

To respond to these challenges, WWARN’s Medicine Quality Group is facilitating expertise-sharing and information-gathering on a global scale to increase our understanding of the prevalence and distribution of poor quality medicines. Our team is reviewing publically available data from a wide range of sources (including scientific and lay literature and from medicine regulatory agencies’ websites). The findings demonstrate the challenges of interpreting the data gathered from such diverse sources. They also highlight the location of major geographical gaps in published information on antimalarial quality estimated to equate to 53% or 51 of the 96 malaria endemic countries worldwide that have no information available on medicine quality.

The Antimalarial Quality (AQ) Surveyor is the first freely available global repository of all published antimalarial quality reports from the last 60 years. This online mapping tool is updated monthly with new reports and can provide users with customised summaries of published reports of antimalarial medicine quality across multiple countries and over a specified time frame. The AQ Surveyor provides a platform to encourage further discussion on poor quality medicine epidemiology, detection and prevention between researchers, policy-makers, funders and pharmaceutical companies. It supports the efforts of national and international organisations working to provide patients with quality-assured and effective antimalarial medicines.

The group is also collaborating with academics, medicines regulatory agencies and international organisations to develop and assess the performance of affordable, rapid and user-friendly diagnostic tools. The field testing is setting a benchmark on the effectiveness of devices, such as those based on near-infrared techniques, and provides feedback to manufacturers so that they can evolve and improve the tools over time. This field-based approached is also strengthening the capacity of researchers and health workers to use diagnostics, especially in low- and middle-income countries. 

In addition to the absence of reliable antimalarial quality data, there is a poor understanding across the health sector on the terms and definitions used to define medicine quality. Disease-ridden communities remain largely unaware of the risks involved in taking poor quality medicines and medicines regulatory authorities’ have limited financial and human resources to tackle the issues. With an absence in global criminal laws to prosecute and protect, it is no surprise that the issue is getting worse.

The Medicine Quality Group is comprised of a network of international partners who advocate for better communication and global coordinated action between national and international organisations, customs officials, police, pharmaceutical companies and researchers to help close the gaps in available data-driven evidence, increase our understanding of the factors contributing towards medicine resistance, and ensure that we save more lives.

From July 4-9th 2016, the London School of Hygiene & Tropical Medicine will host a Medicine Quality Course that brings together staff and studentsfrom public health, regulatory, pharmaceutical, biomedical, chemistry and legal disciplinesto learn and discuss together. The course will provide evidence that can inform policy and build research capacity for the future – from chemical analysis innovation to legal analysis to mapping, epidemiology and public perceptions.

Building on the expertise gathered in the field of poor quality ACTs, the Medicine Quality Group plans to create additional visualisation tools – similar to the AQ Surveyor – to present data on the quality of other important medicines such as antibiotics, antituberculosis medicines, antiretrovirals, maternal and sexual health medicines and antidiabetics. These analyses and resources will be made available through the Infectious Diseases Data Observatory website over the coming months.

For information on our work, or to share your ideas for collaboration, please contact our Medicine Quality Coordinator Céline Caillet via email: celine [dot] caillet [at] wwarn [dot] org.