Tackling the global impact of substandard and falsified and unregistered/unlicensed anti-tuberculosis medicines

Abstract

Substandard and falsified (SF) medicines are a global health challenge with the World Health Organization (WHO) estimating that 1 in 10 of medicines in low- and middle-income countries (LMICs) are SF. Antimicrobials (i.e. antimalarials, antibiotics) are the most commonly reported SF medicines. SF medicines contribute significantly to the global burden of infectious diseases and antimicrobial resistance (AMR). This article discusses the challenges associated with the global impact of SF and unregistered/unlicensed antimicrobials with a focus on anti-TB medicines. Tuberculosis (TB) is the 13th leading cause of death worldwide, and is currently the second leading cause of death from a single infectious agent, ranking after COVID-19 and above HIV/AIDS. Specifically in the case of TB, poor quality of anti-TB medicines is among the drivers of the emergence of drug-resistant TB pathogens. In this article, we highlight and discuss challenges including the emergence of SF associated AMR, patient mistrust and lack of relevant data. We also present study reports to inform meaningful change. Recommended solutions involve the adaptation of interventions from high-income countries (HICs) to LMICS, the need for improvement in the uptake of medication authentication tools in LMICs, increased stewardship, and the need for global and regional multidisciplinary legal and policy cooperation, resulting in improved legal sanctions.

Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

“…Poor-quality medicines pose a severe global public health threat but there is an insufficient evidence base to estimate the global prevalence of SF anti-TB medicines. The current global situation remains unclear, poorly documented, and the impact of SF medicines on engendering TB drug resistance uncertain 83. Only a handful of surveys have focused on specific drugs and in particular countries, and more information collected with standardised methodology is needed to compare between countries and regions.…”

Interactions between CNS and immune cells in tuberculous meningitis

“…Notably, in global TB deaths among HIV-negative or HIV-positive people, 54% or 51% were men, 32% or 38% were women, and 14% or 11% were children, respectively. In summary, approximately 90% of the TB patients are adults, with the number of men bigger than that of women in adult TB patients ( 3 ). In TB patients, M.tb mainly affects the lungs (pulmonary TB), and extrapulmonary sites including the central nervous system (CNS), lymph nodes, and pleura could also be affected ( 4 – 6 ).…”

Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi

“…Substandard and falsified (SF) medicines are a global public health concerns [ 1 ]. Substandard medical products are also referred to as ‘out of specification’ products [ 2 ].…”