1. Callister, Lynn Clark PhD, RN, FAAN

Article Content

A concerning and growing issue globally is the dramatic increase in the production and distribution of substandard and falsified (SF) medical products (Pisani, 2017). The World Health Organization (WHO) report on global surveillance and monitoring for SF medical products highlights major challenges, particularly in middle- and low-income countries, where disease burden is high and health resources are limited (Pisani). Types of SF defined by WHO include 1) substandard medical products which are regulated drugs that fail to meet quality standards or specifications, unregistered or unlicensed medical products that are untested, and unapproved drugs and 2) falsified medication products that deliberately misrepresent their identity, composition, or source (Pisani). Cases of SF medical products are monitored by the WHO Global Surveillance and Monitoring System; however, they are significantly underreported (Mackey, 2018).


Nayyar et al. (2019) reported that in low-income countries, more than 155,000 young children die yearly as a result of distribution of SF drugs used to treat malaria, pneumonia, and other infectious diseases. Pfizer Global Security, a pharmaceutical firm attempting to counteract counterfeit drugs under the Pfizer label, identified 95 SF medications in 113 countries in 2018. Africa is particularly being targeted for surveillance because this region is a target for criminal activity with countries having porous borders. As the market has grown tremendously in recent years for medications, vaccines, and diagnostic kits, so has production and distribution of SF grown exponentially. Increase in SF medical products occurs when there is constrained access to affordable, safe, and effective medical products; low standards of governance and poor ethical standards; and limited technical capacity for manufacturing, quality control, and appropriate distribution (Pisani, 20l7).


Recommended interventions to prevent, detect, and respond to the SF global pandemic have been generated by WHO. Prevention actions include increased education and heightened awareness; development of a comprehensive legal framework; communication between healthcare professionals, the pharmaceutical industry, and others; and ongoing engagement with multistake holders (Pisani, 2017). Detection efforts include border control, effective reporting systems, risk-based inspection and surveillance, and access to field screening of drugs documenting the prevalence of SF. Response initiatives include alerts and recalls, strengthening regulation of medical products, strengthening regulatory and criminal laws, and generating evidence-based policies and procedures (Pisani).


The WHO, pharmaceutical companies, and other global institutions are partnering to reduce production and distribution of SF. A promising surveillance effort being implemented in Africa and Asia is the low-cost Global Pharma Health Fund Minilab in 10 faith-based drug supply organizations in 7 countries of Africa and Asia. Samples are tested locally with low-cost simple technology and confirmed by a quality control lab in Kenya. Antimalarials and antibiotics were the largest percent of SF documented (Petersen, Held, & Heide, 2017). This initiative implements WHO recommendations to insure women and children will receive safe and effective medications to promote their health.


Substandard or falsified medical products are not limited to middle- and low-income regions. They are found throughout the world. Maternal and child nurses should educate women and their families about identifying a potential SF medical product, including those purchased via the Internet. These include checking for spelling or grammatical errors, checking manufacturer expiration dates, checking for discoloration and smells, and discussing concerns with a pharmacist or healthcare provider (WHO, 2019). Gaining and sharing knowledge about this global issue is an essential nursing intervention.




Mackey T. K. (2018). Prevalence of substandard and falsified essential medicines: Still an incomplete picture. JAMA Network Open, 1(4), e181685. doi:10.1001/jamanetworkopen.2018.1685 [Context Link]


Nayyar G. M. L., Breman J. G., Mackey T. K., Clark J. P., Hajjou M., Littrell M., Herrington J. E. (2019). Falsified and substandard drugs: Stopping the pandemic. The American Journal of Tropical Medicine and Hygiene, 100(5), 1058-1065. doi:10.4269/ajtmh.18-0981 [Context Link]


Petersen A., Held N., Heide L. (2017). Surveillance for falsified and substandard medicines in Africa and Asia by local organizations using the low-cost GPHF Minilab. PLoS One, 12(9), e0184165. doi:10.1371/journal.pone.0184165 [Context Link]


Pisani E. (2017). WHO global surveillance and monitoring system for substandard and falsified medical products. Geneva, Switzerland: World Health Organization. [Context Link]


World Health Organization. (2019). Substandard and falsified medical products (Fact Sheet). Geneva, Switzerland: Author. Retrieved from[Context Link]