While substandard and falsified medical products are found worldwide, they are more prevalent in countries with under-resourced national medicine regulatory authorities. Substandard and falsified medical products may lack efficacy, contain contaminants (e.g., bacteria, toxins, other impurities), and their use may promote drug resistance. As described in the Oxford Statement (DOI:https://doi.org/10.1016/S2214-109X(19)30426-7), a systematic review and meta-analysis estimated that 12·4% of antibiotics and 19·1% of antimalarials in low-income and middle-income countries (LMICs) were substandard or falsified, and the SEVEN study in sub-Saharan Africa found that 16·3% of 1530 randomly sampled cardiovascular medications (anticoagulants, antihypertensives, and statins) failed Active PharmaceuticaI Ingredient content analysis. The extent to which drugs used to treat cancer in Africa are substandard or falsified is not known, but there are well-documented examples.
The aims of this workshop are to discuss the challenges of identifying substandard and falsified cancer chemotherapeutic agents in Africa, the regulatory processes involved in approving and procuring cancer chemotherapeutic drugs for use in various African countries, the impact of cancer drug quality on patient outcomes from the standpoint of African oncologists, and potential methods to better ensure cancer drug potency, purity, and sterility throughout Africa.

Systemic therapies play an important part in curative and palliative therapies in most cancers in Zimbabwe. Whilst poorer outcomes of treatment are attributed to late presentation in Africa, this is not the only contributor. Other factors such as safe chemotherapy administration have been considered to positively impact outcomes. However, no matter how safe the administration of the drug is, safety and efficacy begin with quality of the drug and its handling from source to the patient. Application of evidence-based therapies become irrelevant as poor quality medicines lead to poor response to therapy and increased drug toxicity. Adverse events lead to patient drop out from therapy which results in high morbidity and mortality. Costs of treatment therefore increase for impoverished of clients who mostly pay out of pocket.

There are several challenges to identifying “substandard” or “spurious” cancer chemotherapy. Sophisticated manufacturing of counterfeit drugs makes it difficult to identify counterfeit medicines. Shortages of medicines encourage parallel imports that are difficult to detect from neighboring countries. There are inadequate resources and capacity for post market surveillance activities. It is costly to adopt track and trace systems for medicines including chemotherapy medicines.

Medicines marketed for use in Zimbabwe are registered through the Medicines Control Authority of Zimbabwe (MCAZ). Registration involves submission of a dossier, samples and paying the relevant fee. Manufacturing site assessments are done to check compliance with Good Manufacturing Practices. Two special permits, a Bulk Section 75 Permit and Section 75 Permit allow for import of unregistered medicines as required. Such medicines should be registered in the country of origin. Procurement is regulated through several processes by the MCAZ. Potential options for monitoring cancer drug potency, purity and sterility in Zimbabwe and Africa exist must continue to be explored and implemented.

With more than 1million new cases in 2020, cancer is a major public health problem in Africa. For some cancers, such as breast cancer, although incidence rates are among the lowest worldwide, the continent has the highest mortality rates, reflecting a particularly poor survival. In fact, cancer mortality rates in African countries are reaching unacceptably high proportions. Delayed diagnosis and poor access to treatment are the most frequently cited causes.
Despite its rising in recent years, the number of publications documenting experiences with systemic therapies such as chemotherapy for cancer management in Africa are scare.
However, there is one certainty: for most of African countries, meager health budgets, dwindling donor financial support and, more recently, the health crisis linked to the Coronavirus pandemic are hindrances to accessing life-saving cancer medication.
With over 6,000 new cases and nearly 5,000 deaths of cancer in 2020, Benin, a West African country, is not an exception.
Our aim is to discuss the Benin Ministry of Health perspective to ensure quality chemotherapy.
This requires the availability of quality medicines administered in adequate facilities, by specialised personnel and at an affordable cost.