The Independent Uganda: You get the Truth we Pay the Price
The case of Uganda
The latest `Essential Medicines and Health Supplies List for Uganda (EMHSLU)’ that was released in 2016 is a 217-page document. It follows one that was released in 2012. The 2016 list has been harmonised with the Uganda Clinical Guidelines 2016, so as to reflect medicines and diagnostic requirements for management of common conditions affecting the Ugandan population.
The process of update involved consultations from multiple stakeholders to ensure comprehensive review, and was based on principles of evidence-based medicine, cost-effectiveness, and current ministry of health policies. The 2016 is a list of safe, efficacious, and cost-effective medicines and health supplies that suit the health care needs of the majority of the Ugandan population.
The EMHSLU list is designed for use in a resource-limited setting. It is intended to provide a basis for efficient supply chain management, planning and procurement of supplies by the health facilities and procurement agencies.
But the experts cite one study in Uganda which showed that almost half (49%) of essential medicines were not registered for use in the country.
The findings of the study entitled ‘The Registration and local production of essential medicines in Uganda’ were published in the Journal of Pharmaceutical Policy and Practice on August 11, 2020. The study was conducted by Professors Petra Brhlikova and Allyson Pollock from Newcastle University, Amon Ganafa from Mbarara University of Science & Technology (MUST) Department of Pharmacology, and Jonans Tusiimire from Kampala International University (KIU) School of Pharmacy and others.
They compared Uganda Essential Medicines List (EML) against the National Drug Register (NDR) of Uganda and recorded the number and names of foreign and local manufacturers of essential medicines. They looked to see which essential medicines had a WHO prequalified manufacturer/product as of November 2012.
Of the 3130 brands of human medicines and vaccines registered on the 2012 NDR, 880 (28%) corresponded to medicines and vaccines listed on the Ugandan EML. The 2012 version of the EML contained 566 essential medicines and vaccines (unique INN/dosage form/strength) but 275 (49%) were not registered with the NDA. Of the 291 (51%) registered medicines, 37 were listed as a different salt, dosage form, or strength but were considered to be reasonable/practical substitutes. Of the 275 essential medicines that were not registered, 166 (60%) were listed as general medicines and 109 (40%) as specialist medicines. One quarter (42/166) of the general medicines were classified as vital and included: BCG vaccine, lignocaine, morphine, rifampicin combinations, diphtheria-pertussis-tetanus vaccine, and warfarin.
They noted that almost half of essential medicines had no registered product with the Ugandan regulator, the National Drug Authority (NDA) in 2012 and more than 70% of products on the Ugandan 2012 NDR were non-essential. According to them, this has the effect of using scarce regulatory resources and enabling the private market where patients pay out-of-pocket.
“Regulatory resources could be used more effectively if essential medicines are prioritised. Use of restricted lists of medicines also improves prescribing practices and contributes to appropriate use of medicines,” they say.
They add: “Essential medicines should be prioritised by the regulatory system and continuous monitoring of registration of essential medicines is necessary. Uganda’s pharmaceutical sector development plan should address the issue of unregistered essential medicines and the implications for availability and use”.
According to the researchers, Uganda imported 96% pharmaceuticals on its 2012 NDR. Up to 60% were from India and only about 20% of registered products were manufactured in countries with well-established authorities or members of Pharmaceutical Inspection Cooperation/Scheme (PIC/S). The PIC/S countries were Germany, UK, Cyprus, South Africa, Belgium, France, Malaysia, Switzerland, Indonesia, Italy, Sweden, Canada, The Netherlands, Greece, Spain, USA, Portugal, Denmark, Hungary, Slovenia, Korea, Finland, and Japan. Meanwhile Non-PIC/S countries (importing < 4% of products into Uganda) were Pakistan, Egypt, Jordan, Morocco, Turkey, Bangladesh, Iran, and UAE.
“Our interviews with local producers highlighted two challenges – stringent international production standards such as GMP (Good Manufacturing Practice), and funding,” the researchers say.
Only one manufacturer, Cipla Quality Chemical Industries Limited (CQCI), gained a WHO prequalification as an alternative manufacturing site for Cipla’s (India) lamivudine, nevirapine and zidovudine fixed dose tablet preparations.
Comparing with Kenya, Tanzania
Looking to fill a gap in information about these mismatches, we conducted a study in Kenya, Uganda and Tanzania. We compared the antimicrobial products on national drug registers with those on the three countries’ essential medicine lists.
The researchers set out to establish the extent to which medicines prioritised for use on the essential medicine lists are registered for use in Kenya, Tanzania and Uganda.
They found many antimicrobials on the essential medicine list of each country that were not registered for use. In Kenya, 33 of 160 (20.6%) of antimicrobial medicines on the essential list were not registered. For Uganda and Tanzania the proportions were 50 out of 187 (26.7%) and 52 out of 182 (28.6%) respectively. The medicines weren’t registered because no manufacturer had successfully applied for a licence to market them.
Of equal concern is that they found hundreds of antimicrobial products on the register of each country which were not on the essential medicine lists. In Kenya only 36% of the 2,105 registered antimicrobial products corresponded to antimicrobials on the essential medicine list. In Uganda only 49% of the 1,563 registered antimicrobial products were essential medicine products and in Tanzania, only 47% of the 1,327 registered antimicrobial products were essential medicine products. Over half of all registered antimicrobial products, therefore, are non-essential.
In 2017 the WHO introduced a new classification system within the Essential Medicine Lists to help tackle antimicrobial resistance: the AWaRe classification. It classifies antibiotics into three categories: Access, Watch and Reserve.
Access antibiotics are the treatments of choice for common infections and must be readily available. They are at low risk of causing antimicrobial resistance. Watch antibiotics come with a higher risk of causing resistance and should only be used in selected circumstances. Reserve antibiotics are last-resort options, only to be used once all other antibiotics have failed. These categories are used in health systems to decide where antibiotics should be available, for example in very basic healthcare centres or in hospitals.
The researchers found that in all three countries they studied, the highest proportion of registered antibiotics was in the Access group, and the lowest proportion was in the Reserve group. This is as it should be.
Setting priorities
But the high numbers of non-essential antimicrobials registered for use are of great concern. Registered medicines which are not on the essential medicine lists are not included in treatment guidelines. They are likely to be used inappropriately and contribute to antimicrobial resistance. At the same time, the lack of registration of around three quarters of the antimicrobials listed on the essential medicine of each country is very worrying as these are vital for treating infections.
Governments should ensure that the regulatory agencies responsible for registering medicines prioritise and restrict the registration of antimicrobials to only those that are on the lists of essential medicines. In tandem with standard treatment guidelines, this would help healthcare professionals to prescribe them appropriately. It would also ensure that priority medicines are available to the population.
Future work must also focus on updating essential medicines lists based on local antimicrobial resistance data and monitoring the use of registered antimicrobial medicines.
