malaria-medsOn June 12th, GAiA Co-director William Fisher presented at the Harvard Global Health Institute on the potential for miniature spectrometers to reduce the use and distribution of substandard   drugs in Sub-Saharan Africa, as part of GAiA’s summer lunch series, “Conversations in Global Health, Innovation & the Digital World.” In his talk, Fisher explained the issues that counterfeit and other substandard medicines cause, and illustrated how deploying drug-quality assessment technology like miniature spectrometers would increase the government’s ability to regulate drug distribution and empower individuals to confirm the authenticity of the drugs they purchase, ultimately increasing the use of therapeutically effective medicines. He then outlined a pilot project in Namibia being initiated to use this new technology in reducing distribution of falsified or degraded antimalarial medications.

The quality of medicines has an enormous impact on mortality and morbidity in the developing world. In 2013, the consumption of poor-quality antimalarials was associated with over 120,000 deaths in children under 5 years of age in 39 Sub-Saharan African countries (Renschler et al., 2015).  Medicines containing lower amounts of the active ingredient than indicated not only have reduced therapeutic effectiveness, but also increase selection for drug-resistant parasites and, thus, the risk of conditions that could spread resistance. Reduced therapeutic effectiveness of these counterfeit drugs also threatens patient confidence in medicine and health care providers. These problems highlight the need for an inexpensive, efficient method of testing purchased medicines. The ability to do so would allow public health workers, government officials, and citizens to ensure that patients are getting therapeutically effective drugs in their required doses, and would decrease counterfeit drug manufacturing in the long-term.

In conjunction with a mission-oriented American engineering lab, Fisher is exploring how miniature spectrometers can be used to combat substandard medicines through a Namibian pilot program. These devices function as a smartphone accessory, and produce an infrared spectrum indicating the chemical composition of a drug. This spectrum profile is then compared to a reference database of spectra for approved drug formulations.

 The graph findings of a miniature spectrometer detecting falsified anti-Malarial medication Coartem, in red, that deviates significantly from authentic Coartem, in blue.
The graph findings of a miniature spectrometer detecting falsified anti-Malarial medication Coartem, in red, that deviates significantly from authentic Coartem, in blue.
The testing can even be conducted through pharmaceutical packaging, increasing the ease with which medicines can be tested and reducing waste. Current government efforts to combat the counterfeit drug problem in Namibia involve collecting drug samples from different parts of the country which are then sent back to labs in the capital city for testing to determine authenticity. This costly and time-consuming process is also somewhat ineffective: by the time the government can test samples, the medicines in question may have already been distributed. The pilot program could provide a simpler, less costly solution by allowing officials to test medicines on site, getting results in the course of a day, rather than weeks. While the testing devices are currently planned to be distributed and used primarily by public health employees, Fisher noted that the user-friendly, inexpensive technology allows for the possibility of a decentralized system that empowers citizens to test the authenticity of their own medicines.

Simultaneously, miniature spectrometers hold the potential to regulate the intellectual property of pharmaceutical companies. Fisher detailed the possibility of a pharmaceutical company incorporating chemical markers into pills that would indicate their manufacturer. These markers would be detectable in the routine scanning of medicines and could be used to determine where drugs from a manufacturer are being distributed to, and whether they have been illegally redistributed. Use of this device would disincentivize middlemen from tampering with or illegally distributing medicine, enabling pharmaceutical companies to better pursue market access strategies such as differential pricing.  However, this level of detection and regulation may put intellectual property and public health interests at odds: how should public health officials respond in instances where a drug sample produces the spectrum indicating correct dosage composition and efficacy, but not the anti-counterfeiting chemical marker? Fisher highlighted this inherent tension as an issue that will need to be addressed down the road in order for the pilot program to expand.

Namibia is well-suited for this pilot program due to its low levels of corruption and existing public health initiatives. Fisher and his team hope to work with the governments of South Africa, Mozambique, Malawi, and Botswana to implement similar programs using miniature spectrometers. Going forward, the team will continue to address questions about the types of drugs to be used in reference databases, the ethics behind the device’s applications, and the program’s feasibility in different country contexts.

 

William Fisher Details a Pilot Program Using Technology to Combat Counterfeit Medicines