Dear Madam, Dear Sir,
The Global Pharma Health Fund (GPHF), a charitable organisation voluntarily supported by Merck KGaA, is pleased to announce the release of its COVID-19 Special Manual Issue containing two test methods on dexamethasone tablet and injectable solutions for its Minilab testing platform, a self-contained mini-laboratory for rapid drug quality verification and easy detection of poor quality and fake medicines whose content is different, much higher or lower than stated on the label. The Minilab is particularly suitable for areas of the world where counterfeiting is widespread but where sophisticated instrumental analysis for their detection is not readily available.
COVID-19 increases the need for straightforward and affordable risk-based medicines quality monitoring in low-income countries. The Minilab's method inventory currently includes 100 active pharmaceutical ingredients in their respective finished products for the treatment of communicable and non-communicable diseases, e.g. antibiotics, antituberculostatics, antimalarials, antivirals, antidiabetics, anthiasthmatics, analgesics, and cardiovascular and gastrointestinal medicines.
The existing method inventory is now complemented by dexamethasone, which is used to relieve symptoms in severe COVID-19 cases. Known for decades, dexamethasone has recently been successfully repurposed for the treatment of COVID-19 intensive care patients. Since then, dexamethasone preparations are considered a scarce and precious commodity in many places.
Substandard and falsified medical products (SF medicines) pose a serious threat to health. They harm patients, undermine confidence in health professionals, medicines, health systems and programs. They also contribute to antimicrobial resistance and waste valuable resources. Since the start of the project, 900 Minilabs have been delivered to almost 100 countries. The Minilab of the GPHF contains all laboratory equipment, reagents and reference agents required for simple and inexpensive on-site testing with minimal training and maintenance.
To reduce the threat of falsified medicines, testing capacity for periodic inspections may need to be increased. The establishment of preventive test sites will help to expand the relevant pharmacy services and prevent the consumption of fake medicines for the benefit of individual patients and public health. Decades of investment in health care will not be translated into universal health coverage if the medicines patients take contain no, insufficient or the wrong active ingredients.
With the GPHF-Minilabs, more than 1000 counterfeit and substandard medicines have already been detected since the project began. Minilabs save lives. The new Minilab test methods for dexamethasone are available for free download here in English and French. They were developed in collaboration with USAID's Promoting the Quality of Medicines Plus (PQM+) program, implemented by the U.S. Pharmacopeial Convention (USP). Enjoy using them.
Richard Jähnke, PhD