The lack of registration of some essential medicines in Kenya, Tanzania and Uganda is limiting access to safe, effective, and affordable healthcare, a new study has found.

Makerere University in Uganda and Newcastle University in the UK esearchers compared the essential medicines lists in each country with the products on each country's national drug registers, and found that a high proportion of essential medicines are not registered.

In Tanzania at least 50 percent of essential drugs are not registered as such, in Uganda 40 percent and Kenya 28 percent are unlisted, which acts as a barrier to availability.

According to the new analysis, published June 21, in the Journal of the Royal Society of Medicine, across all three countries between 80-100 percent of anti-Parkinsonism medicines were not registered along with 71-90 percent of antidotes/anti-poisoning medicines; this was true for up to 43 percent diuretics; between 28-41 percent antiepileptics; around one-fifth hormonal/endocrine meds; and approximately one-fifth anti-infective being unregistered.

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It is important to note that while there may be under-registration of necessary medication there could also be over-registration among non-essential ones.

For example, a recent analysis revealed that approximately two-thirds of antimicrobials authorised in Kenya, Tanzania and Uganda are not needed.

Furthermore, over-registration particularly among non-essential medications diverts regulatory resources towards registering sub-optimal or non-priority drugs.

Before a medicine can be made available in a country, manufacturers must apply to the medicine regulatory agency of the country for a licence to sell it and demonstrate the medicine is safe and effective. This is as market registration.

A significant proportion of those registered essential medicines had only 1–2 registered products: 45 percent, 38 percent, and 36 percent for Tanzania, Kenya and Uganda respectively.

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The recommendation

In Kenya, Tanzania and Uganda, 12 percent (29 of 242), 9 percent (18 of 207) and 10 percent (25 of 233) of registered essential medicines, respectively, had more than 15 registered products.

“Given that the WHO recommends at least three different manufacturers per medicine to ensure a stable supply, registration of less than three products is insufficient,” said Dr Moses Ocan, a senior lecturer in the department of Pharmacology & Therapeutics at Makerere University College of Health Sciences and co-author of the research.

A closer look at antimicrobials data within the research showed that there is an excessive number of antibiotics authorised within these countries. The experts viewed the high registration of non-essential antibiotics in the three countries as being likely to lead to inappropriate use while driving antimicrobial resistance rates upwards.

Dr Ocan added, “There are thousands of antibiotic medicine products in the market. This is because manufacturers may apply for licenses for the same medicine in different doses and formulations. We found 2,310 products for the 21 most highly registered antibiotics, of which, only 46 percent were essential medicines.”

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Prof Allyson Pollock of Newcastle University termed over-registration of non-essential medications diverts regulatory resources towards registering sub-optimal or non-priority drugs.

Registration in relation to essential medication availability is an under-researched area. A previous analysis of medicine registration within Uganda showed that only half (51 percent) of medicines listed as essential had a product registered with the National Regulatory Authority.

Manufacturers typically apply for licenses once they identify suitable markets for their products; this study has highlighted a gap between drug registrations and those required by populations prioritized by health needs while revealing oversupply issues concerning non-essential medication markets.

Another of the researchers, Prof Allyson Pollock, Clinical Professor of Public Health at Newcastle University, said, “Over-registration of medicines, particularly non-essential medicines, diverts regulatory resources towards registering non-priority and, sometimes, clinically sub-optimal medicines.

“The East African Community Medicines Registration Harmonisation Project has the potential to improve access to key medicines if registration of essential medicines is prioritised and registration of non-essential medicines is restricted.”