Substandard and Falsified (SF) medicinal products are counterfeit medicines and medicines that fail to pass quality standards and/or the specifications required to approve the medicine for the market. SF medicines have emerged as a serious threat to global public health over the last few decades, and according to the World Health Organization (WHO), they will remain a threat over the next decade. SF medicines affect countries across the economic spectrum, but they are especially prevalent in low- and middle-income countries (LMICs); the WHO estimates that about 10.5% of medicines in LMICs are likely SF medicines.
Pharmacovigilance systems differ worldwide due to varying healthcare infrastructures and regulations, and although many countries have methods for reporting suspicious medicines, these are often underutilised by healthcare providers because of fears of repercussions, difficulty identifying SF medicines, and unclear processes.
Studies across multiple countries reveal significant gaps in healthcare professionals’ (HCPs) knowledge and practices regarding SF medicines. In Saudi Arabia, for example, about half of pharmacists had never used the national vigilance system and lacked awareness of detection technologies. Similarly, 55.6% of HCPs in Eritrea did not know how to report SF medicines, and 34.9% were unsure what to report. In Sweden, 72% of community pharmacists expressed a need for more knowledge on SF medicines. Comparable concerns have also been observed among nurses and physicians, who, despite being aware of SF medicines, often lacked clarity on reporting procedures.
Barriers to reporting include difficulties in identifying SF products, complex reporting systems, and fear of reputational harm, as seen in Tanzania and Indonesia. In Iraq, while 61% of pharmacists acted on alerts from the national pharmacovigilance agency, a quarter were unwilling to report SF medicines. A survey by Johns Hopkins in the U.S. and South Africa found that 74% of providers cited inability to detect counterfeits as a reporting barrier, and 80% did not view SF medicines as a serious concern.
Strengthening pharmacovigilance systems globally to identify SF medicines is integral to enhancing detection and improving the ability to quantify the scope and public health impact of SF medicines. Establishing international partnerships among regulatory agencies, pharmaceutical companies, and organisations such as the WHO will help facilitate cross-border sharing of data on SF incidents and pharmacovigilance findings.
Technologies like blockchain, which create an immutable, transparent record of every step in the medicinal product supply chain to enable secure traceability and easy verification of drug authenticity, may play an instrumental role in enhancing surveillance and pharmacovigilance efforts to combat SF medicines. Utilising big data analytics to aggregate and analyse large volumes of data from various sources, including sales, distribution networks, and consumer reports, may help detect anomalies indicating SF activity. Artificial intelligence (AI) and machine learning algorithms could also be harnessed to develop predictive models that may help to identify high-risk areas for SF medicines based on historical data and emerging trends.
Implementing AI tools to monitor online platforms, e-commerce sites, and social media for signs of SF medicine sales and using Natural Language Processing to monitor online discussions and consumer feedback may enable prompt identification of potential SF medicine issues.
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The implementation of ISO IDMP standards and the global Pharmaceutical Product Identifier (PhPID) is expected to strengthen efforts to combat substandard and falsified medicines by enabling consistent, cross-border identification of medicinal products. This harmonisation has the potential to improve traceability, support faster safety alerts, and enhance data sharing between regulators and healthcare systems. By linking equivalent products globally, IDMP and PhPID should help detect and respond to SF medicine incidents more effectively, reinforcing pharmacovigilance and public health protection.
In addition to technology, educating about SF medicines is essential. Organisations like WHO, “Fight the Fakes,” the Partnership for Safe Medicines, regulators, and the pharmaceutical industry deliver programmes to inform healthcare providers and the public about counterfeit medicine risks and reporting methods. Continuing education via webinars and online courses keeps providers updated on detection techniques and regulations. Incorporating SF medicine content into university curricula or specialised workshops further raises awareness among students in the pharmaceutical and healthcare fields.
Educating the public could take the form of community outreach programs such as seminars and workshops, as well as resources for patients and consumers on the dangers of SF medicines, risks of unauthorised ecommerce websites, and how to verify their authenticity. Developing engaging content for use in various media platforms, such as television, radio, and online channels, to broadcast messages about the risks and identification of SF medicines can reach a broader and more diverse audience.
Ultimately, addressing the global threat of substandard and falsified medicines requires a multifaceted, collaborative approach. Strengthening pharmacovigilance systems, harnessing innovative technologies, and investing in comprehensive education for both healthcare professionals and the public are essential pillars of a robust response. Only through coordinated international efforts, transparent data sharing, and a commitment to ongoing learning can the detection and prevention of SF medicines become truly effective. By empowering stakeholders at every level, from regulators and providers to patients and communities, we can collectively improve the safeguards for public health and uphold the integrity of the global medicine supply chain.
This article was written with contributions from Professor Saifuddin Ahmed, Johns Hopkins Bloomberg School of Public Health.
