Proposed lower cost of medicines and quality assurance; essential medicines list, including those for non-communicable diseases

Lowering the cost of medicines in Kenya has been an uphill task, thus becoming one of the stumbling blocks to achieving UHC. According to WHO, 100 million people across the world fall into poverty because of out-of-pocket payments for medicines and related health services. In May 2019, Kenya’s Cabinet Secretary for Health, cognisant of this problem, alluded to the need to develop an essential drugs list with fixed prices for each health commodity to guide the pricing of essential medicines.

The National Hospital Insurance Fund (NHIF) provides health insurance coverage to members (contributors) and their dependants. However, being a contributory scheme, it means the majority of non-members cannot benefit from it. According to the NHIF strategic plan 2018-2022, the Fund had seven million principal members in 2018, and projects to increase its membership to 19 million by 2022. The NHIF has also introduced a health insurance cover for chronic conditions and vulnerable populations.

Furthermore, the Government of Kenya, through the Third Medium Term Plan 2018–2022, plans to expand social health protection by implementing schemes aimed at benefiting target populations. The Government has lined up key flagship projects that will enhance social health protection and contribute towards the achievement of UHC by 2022. It is projected that Health Insurance Project for Elderly People and Persons with Severe Disabilities (PWSD) will cover about 1.7 million people by 2022. This is expected to cushion the elderly and PWSDs from financial hardship. The government also plans to eliminate user fees in primary healthcare facilities, as well as expand the Health Insurance Subsidy Programme (HISP) for orphans and the poor to cover about 1.5 million people by 2022. Most of the poor either avoid seeking healthcare because it is unaffordable or seek it and experience financial hardship. Other flagship projects include: Linda Mama Project (free maternity programme), which aims at covering 1.36 million mothers and babies by 2022; Informal Sector Health Insurance programme to cover 12 million informal sector workers by 2022; and, Formal Sector Medical Insurance Coverage (medical insurance cover for retired civil servants), which targets 4.2 million people by 2022.

Medicines quality assurance

Quality assurance is a concept that covers all matters that influence, either individually or collectively, the quality of a product. Medicines quality assurance is critically important as it contributes to providing quality public health services by ensuring quality medicines reach patients. According to WHO, quality assurance in pharmaceuticals can be categorised in the following areas: development, quality control, production, distribution, and inspection.

The National Quality Control Laboratory’s role in medicines quality assurance

In Kenya, quality assurance of medicines falls within the docket of the National Quality Control Laboratory (NQCL) and the Pharmacy and Poisons Board. The NQCL carries out tests and analyses and conducts research to ensure quality control for essential human medicines; and medicine devices used in Kenya, to meet international quality standards in order to guarantee patient safety. The laboratory also controls the quality of veterinary medicines. The NQCL was established in 1994 following an agreement between GTZ and the Kenya Government to renovate the existing facility and equip the laboratory at its present location. From 1994 to 1999, the NQCL was jointly run by GTZ and the Kenya Government.

In 1999, the operation of NQCL was fully handed over to the Kenya Government, attaining WHO prequalification in 2008 and retaining the WHO status in 2011 before receiving quality certification from the International Standardisation Organisation (ISO) — ISO 17025 accreditation — in 2015. The latter is expected to improve the international credibility of the results from NQCL. However, despite this sterling performance, Kenya is yet to win the war against poor quality of medicines. A survey conducted by Promoting the Quality of Medicines (PQM) programme revealed that poor quality of medicines was a threat to patients globally. The PQM is the United States Agency for International Development’s (USAID) intervention programme for ensuring quality, safety and efficacy of medicines.

To intensify the war against poor quality medicines, the NQCL attained international accreditation and received state-of-the-art laboratory equipment for testing the quality of medicines, a laboratory information management system and an upgraded website.  The PQM has committed itself to continue providing technical support to NQCL and the Ministry of Health with a view to building capacity for manufacturing and monitoring of quality medicines.

KEMSA’s role in medicines quality assurance

KEMSA also plays a role in ensuring quality assurance of medicines, pursuant to its mandate, and in implementing the goals of the National Medicines Policy (NMP). The NMP is grounded on both concepts of essential drugs and preventive healthcare to ensure pharmaceutical products meet the country’s requirement of prevention, diagnosis, and treatment of diseases using high quality, safe and cost-effective health products. According to KEMSA, their in-house quality assurance systems, including the Quality and Procedures Manual, ensure all medicines meet the highest standards possible. In addition, KEMSA uses other quality certification bodies such as the NQCL and the Kenya Bureau of Standards (KBS) to ensure the quality of medical products.

Before 2008, KEMSA had only one member of staff for quality assurance, but it now has a fully-fledged Quality Assurance Department with an in-house mini laboratory. The department ensures that commodities in transit to health facilities are of high quality. KEMSA also conducts supplier audits and liaises with partners to carry out post-distribution surveillance to maintain the quality of products. The Authority also has Standard Operating Procedures (SOPs) for outsourced transporters to guarantee good storage and distribution practices for medicines and other health commodities. Furthermore, the Third Medium Term Plan 2018-2022 provides for construction and equipping of an ultra-modern laboratory complex for NQCL to upscale its capabilities.

Essential Medicines List, including those for non-communicable diseases

The WHO defines essential medicines as those that satisfy the priority healthcare needs of the population. The selection criteria of essential medicines is based on disease prevalence and public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness. The WHO usually updates its list of essential medicines every two years and is used as a reference guide for governments and institutions around the world in developing their own essential medicines list.

Globally, the concept of essential medicines incorporates the need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure drug quality; and the need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns.

Once thought of as relevant only in resource-constrained settings, the WHO Model Lists are now seen as equally relevant to high, middle and low-income countries, particularly with the inclusion of new, highly effective and expensive medicines in more recent years.

Kenya developed its first Essential Medicines List in 1981. Over the years, the Essential Medicines List (EML) concept has become increasingly entrenched into the health system, with successive revisions of  the Kenya Essential Medicines List (KEML) in 1993, 2003 and 2010. However, it should be noted that KEML 2010 lacked effective mechanisms for promoting and monitoring its use, and for subsequent regular review and revision.

The evidence for listing medicines on the KEML 2016 was derived from a globally coordinated process of the WHO, which develops the Model List of Essential Medicines, and makes the relevant information and knowledge available to countries for their own adaptation.

According to the Ministry of Health, the KEML 2016, which is the latest, was revised in 2016 and is a key tool for promoting access to essential medicines. If properly managed, it can enhance therapeutic benefits.

The KEML 2016 provides guidance to investments in medicines by all relevant actors in Kenya. It is developed based on evidence, thus provides a basis for best practice in the selection of medicines. According to the Ministry of Health, the list is recommended for use by public sector health service providers at national and county levels; policymakers; private, faith-based organisations and NGO health facilities; as well as development partners.

Non-communicable diseases (NCDs)

The KEML 2016 provides good guidance to adequately address communicable diseases such as malaria, TB, and HIV. Furthermore, KEML 2016 pays attention to the management of the ever-increasing numbers of non-communicable disease (NCDs), namely; heart diseases, diabetes, cancers and chronic respiratory diseases. According to WHO, NCDs contribute to the mortality rate of 182 per 100,000 people. On the other hand, a stepwise survey carried out in 2015 showed that 27 percent of adult Kenyans are overweight/obese, while 23.8 percent of Kenyans are hypertensive.

Overall, there is a high incidence of NCDs in Kenya, such as heart disease, diabetes, hypertension, and cancer. This is exacerbated by poor surveillance systems for NCDs. However, the inclusion of essential medicines for NCDs in the KEML 2016 is a good move towards addressing this problem. Essential medicines for neglected, yet key areas of public health, such as albinism and jiggers, have also been included on the list. In addition, the list has medicines for heart diseases, respiratory disorders (anti-asthmatics and medicines for chronic obstructive and pulmonary disease), and hypertensive conditions.

Main changes in KEML 2016

Simon Gachoka, KEMSA Laboratory Analyst, performs a dissolution test for efficacy at KEMSA Embakasi Warehouse in Nairobi on 13th June 2018.

KEML 2016 includes additions of medicines that were previously not on the list, deletions of medicines that are either considered obsolete or evidently less cost-effective, and changes to facilitate better administration.

KEML 2016 is a cornerstone of the national healthcare system, and a key component of both the national health and national pharmaceutical policies. It is a vitally-important tool and reference source for guiding the management of common health conditions in the country, as well as the management and utilisation of medicines at national, county and institutional (health facility) levels. KEML aims to support the smooth functioning of the healthcare system and radically improve the availability and appropriate use of medicines for improved health status of the population. It is also an investment guide of healthcare funds in financing essential medicines to respond to prioritised public health needs.

While launching the KEML 2016, then Ministry of Health Cabinet Secretary Cleopa Mailu said KEML provides a key tool in efforts to attain equity and high standards in healthcare. Mailu said the tool was intended to guide medicines development, production, procurement and supply, prescribing, dispensing and use, as well as the development, monitoring and evaluation of strategies, thereby enhancing Appropriate Medicines Use (AMU).

To provide comprehensive healthcare services to the population, heavy investments are required, which constitute a major and ever-increasing cost to governments, households and individuals. Therefore, effective mechanisms are needed to prioritise the various health interventions and products in order to maximise therapeutic benefits and optimise patient outcomes.

KEMSA is currently working with the Ministry of Health and have jointly produced the Health Technologies and Commodities (HPT) List, guided by the KEML 2019. KEMSA is currently supplying over 850 essential medicines and medical supplies in the country.

KEMSA is a critical partner for the success of UHC. The Authority has the mandate to procure warehousing and distribution of HPTs to all public health facilities in the country. KEMSA is also mandated to ensure timely supply of affordable and quality health products and technologies.

KEMSA Chief Executive Officer Jonah Manjari says the Authority has come up with enhanced strategies to increase efficiency, which will go a long way in supporting the Government’s UHC programme. KEMSA also supplies counties with the medical products they require from the essential supplies list.

“To achieve this, counties place orders of their supplies, which are processed in four quarters every year to address issues of storage and expiry. Through this, counties have been able to address the requirements of their patients,” Dr Manjari says.

The need for healthcare services in the four pilot counties has increased. Each of the four UHC pilot counties receives supplies on a quarterly basis. The rest of the counties get their supplies just in time before they run out of stocks. KEMSA works closely with the Ministry of Health to ensure the process of supplying essential medicines is effective and efficient.

The Authority’s central role in UHC has assisted in making healthcare products affordable. Dr Manjari says KEMSA is advocating for the establishment of a system that will capture consumption data. This will help in rational forecasting and quantification. A UHC scale-up roadmap has identified key areas that need improvement, and KEMSA has entered into framework contracts with its suppliers so that products are delivered as needed. This will accelerate the response to demand.

KEMSA has committed to deliver on its mandate to meet the demands of UHC scale-up. To this end, the Authority is set to introduce a suppliers performance tool to measure quality, consistency in pricing, and full delivery of commodities. This will promote best service and eliminate suppliers who fail to meet performance requirements. Dr Manjari says they will not entertain nonperforming suppliers.

The KEMSA CEO adds that they are committed to supporting local products that are affordable and meet high quality standards under UHC.  He says that 40 percent of the procurement budget has been reserved for locally-produced goods and services, as directed by the government. “We are committed and obligated to reserve 40 percent of our procurement budget for purchase of locally-produced goods and services,” says the KEMSA boss.

The CEO notes that counties expect KEMSA to fulfil 90 percent of the order fill rate, and therefore urged suppliers to be realistic and only accept tenders they can supply to avoid drug shortages in the country. “We have been given a good opportunity by UHC. Let us not bite more than we can chew,” he stressed. Dr Manjari says that with the introduction of UHC, the business model had changed and that if suppliers were not committed to the job, the achievement of UHC would be limited. He urges them to be strategic, understand the market, and be disciplined.

Teresa Muthoka, KEMSA Distribution Officer, records medicines leaving the KEMSA Embakasi Warehouse in Nairobi on 13th June 2018.

KEML in the context of devolved healthcare

KEML 2016 is derived from a robust and globally-recognised process of scientific assessment of efficacy, safety and quality, over and above cost-effectiveness evaluation. Such evaluations require massive investments, with processes requiring standardisation of evidence in order to promote uniformity in clinical care, disease control and public protection.

The KEML will guide the Authority on the products needed as per the level of care. These levels of care are categorised as follows; Community Health Services (Level One), Dispensary/Clinic (Level Two), Health Centres (Level Three), Primary Hospitals (Level Four), County (secondary) Referral Hospitals (Level Five), and Tertiary (national) Referral Hospitals (Level Six).

The KEML is a critical tool that can go a long way in ensuring the right to health by guaranteeing optimum therapeutic interventions. Therefore, for the National and County Governments, KEML 2016 provides the basis for selecting the medicines for procurement using public funds. The National and County Governments must ensure that essential medicines are available in terms of functioning health systems, adequate amounts, appropriate dosage, assured quality and adequate information, and at affordable prices to both individuals and the community.

KEMSA has come up with the Community Health Volunteers (CHV) kit to be used by care givers at the community level to respond to public needs. It is also constantly reviewing the demands of customers on life-saving products for non-communicable diseases such as oncology, hypertensive, renal, diabetes, nutrition and family planning.

Arising from a study from the four pilot counties, KEMSA has included orthopaedic implants on the list of essentials as a response to the high number of road accidents witnessed on highways in the country.

There is also a need for the Ministry of Health to come up with standardisation of lab equipment to address the requirements of laboratory reagents and consumables. KEMSA has faced various challenges as counties place all manner of requests for their laboratories, thus clogging the procurement and warehousing system. KEMSA is of the view that the ministry, apart from coming up with standards, should zone counties according to their unique needs for laboratory reagents and consumables.

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