When authorities confiscate counterfeit pharmaceuticals, what happens next? Ecaterina Marshall explores safe disposal, mitigating environmental harm, and Benin’s answer to a 118-ton problem.
More than 100,000 deaths per year in Africa are linked to counterfeit medicines, either because the medicines were substandard or simply contained no active ingredients at all. Using counterfeit medicines with an insufficient dosage of active ingredients can lead to drug resistance, particularly in the case of diseases such as malaria and tuberculosis. The problem with pharmaceutical counterfeits in Africa became so rampant that it had to be addressed by the international community. In September 2016, 16 African customs administrations participated in the World Customs Organization’s Action against Counterfeit and Illicit Medicines, seizing over a ten-day period illicit and potentially dangerous medicines worth approximately more than $60 million.
However, catching the fraudsters is only half of the problem — the next step is disposing of the counterfeit medicine. Pharmaceutical waste management presents one of the hidden costs beyond product price. For example, an average hospital in the U.S. produces nearly 7,000 tons of waste every day. Across the health-care industry in the U.S., disposal costs amount to $10 billion each year. Proper management of pharmaceutical waste — that is collection, storage, handling, transport, and disposal of waste which contains expired, counterfeit, contaminated or damaged medicines or medical products — is a crucial part of a health-care supply chain. If pharmaceutical waste is not managed correctly, it can become extremely harmful to the environment and create a public health hazard.
Pharmaceutical waste cannot be disposed of in a traditional landfill, and special precautions must be taken when handling and disposing of pharmaceutical waste to avoid water and soil contamination. To make potentially hazardous waste safe before disposal, it must typically be biologically, chemically, or physically treated.
An Enormous Challenge
Benin, home to nearly 11 million people, has long suffered from the challenge of counterfeit pharmaceutical waste management. With only 2.5 percent of GDP allocated to public health in 2013, proper handling, collection, and disposal of counterfeit pharmaceutical waste could not possibly compete with the myriad other public health priorities such as malaria, maternal and child health, and HIV/AIDS.
Under a multi-agency operation supported by the National Police of Benin, the Ministry of Health and the Ministry of Interior & Public Security, an estimated 88 tons of unusable counterfeit pharmaceutical products were seized by Beninese authorities in September 2016. The seized commodities were packed and transported to two secure warehouses in Cotonou for interim storage. Additionally, 30 tons of counterfeit medicines were seized by Beninese customs officers during border control operations. The counterfeit medicines were transferred to the Ministry of Health compound in Cotonou and placed in a secured facility. The Ministry of Health of Benin estimated the total quantity of seized pharmaceutical commodities to be 118 tons. The sheer amount of seized counterfeit commodities presented an additional challenge to the government of Benin. According to the 2016 Guidelines for the Management of Pharmaceutical Waste in Benin, the commodities were to be unpacked, segregated, crushed, neutralized using cement, and deposited in a suitable local landfill site in Benin. Failure to destroy these commodities in a compliant and cost-effective way could cause water or soil contamination, bringing an additional unnecessary burden to the Beninese health authorities. This was the first situation of such scale that prompted Benin to seek technical assistance from USAID.
USAID Lends a Hand to Benin
USAID’s Global Health Supply Chain Technical Assistance (GHSC-TA) Francophone Task Order stepped in with a comprehensive plan to address the 118 tons of counterfeit pharmaceuticals. The project conducted a rapid assessment study which evaluated the storage conditions of the seized commodities and the capacity of the available local service providers to dispose of pharmaceutical waste. Although storage conditions were satisfactory for a short-term solution, they were clearly insufficient for extended periods of time. Many of the counterfeit products contained hazardous ingredients. Any natural or manmade accident, such as residential fire leading to the release of hazardous fumes into the atmosphere, could have detrimental consequences for the environment and people. The project developed an action plan to manage and dispose of accumulated counterfeit pharmaceutical products and swiftly moved to its implementation.
To avoid a potential disaster and prevent undesirable consequences from improper storage of hazardous pharmaceutical waste, GHSC-TA trained a local service provider on the inertization of hazardous pharmaceutical waste. This approach involves mixing pharmaceutical waste with cement and other substances, such as lime, before disposal to minimize the risk of toxic substances contained in the waste migrating into surface water or groundwater. In this approach, the local service provider would remove the packaging and grind the pharmaceuticals. The mix of cement, pharmaceutical waste, water, and lime forms a homogenous mass, which produces cubes or pellets to be transported to a suitable government authorized landfill. The local service provider will destroy the 118 tons of seized counterfeit pharmaceuticals in December 2017 and January 2018.
This is the first counterfeit pharmaceutical waste management operation conducted in Benin with the support of USAID. It demonstrates a shift in how Benin and other developing countries deal with pharmaceutical waste, moving from expensive exporting to more technologically advanced countries to building capacity in-country. Counterfeit medicines are an ongoing problem, and this won’t be the last time Benin has to deal with this issue. With the help of GHSC-TA, Benin now has a local service provider trained and equipped to conduct safe, environmentally compliant pharmaceutical waste management. In addition, the project assisted the Ministry of Health of Benin to revise guidelines for waste management organization for future endeavors. In 2017, Benin’s Congress adopted the MEDICRIME Convention, a binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health. This is one steady step towards a sustainable health supply chain system in West Africa.