(Availability, Accountability, Adherence) of Supply ... - ACS Publications

Chapter 9

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Addressing the 3A’s (Availability, Accountability, Adherence) of Supply Chain Systems in Western Kenya Rakhi Karwa,1,2 Dan N. Tran,1,2 Mercy Maina,3 Benson Njuguna,3 Imran Manji,3 Paul Wasike,2 Edith Tonui,3 Gabriel Kigen,2,3 and Sonak D. Pastakia*,1,2 1Purdue University College of Pharmacy, West Lafayette, Indiana, 47907, United States 2Moi University, School of Medicine, Department of Pharmacology, Eldoret, Kenya 3Moi Teaching and Referral Hospital, Eldoret, Kenya *E-mail: [email protected].

The right to access essential medicines and medical technologies is crucial to attain the highest-quality health care for all citizens of the world. Unfortunately, in many low- and middle-income countries (LMICs) around the world, patients’ ability to access quality essential medicines still remains a critical challenge. Barriers that impact the quality of essential medicines from chronic communicable and chronic non-communicable diseases lie within three specific areas (3A’s): availability, accountability, and adherence. First, unnecessarily complex supply chain management, poor operational procedures, and inadequate financing for health lead to low availability of medicines. Second, corruption contributes to falsified and substandard medicines and low accountability of the supply chain to the patients who rely on it. Lastly, poor patient adherence to medicines is affected by low health literacy, lack of communication between providers and patients, and social stigma of diseases. Based on our on-the-ground experiences working in western Kenya, we propose solutions that target each of these challenges to improve access and quality of medicines.

© 2017 American Chemical Society Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

Through this chapter, we hope to compel chemists to apply and focus their efforts to create transformative chemical techniques with the potential to significantly improve quality of medicines, to improve patient outcomes, and to alter the delivery of care to patients all over the world.


Introduction Access to quality healthcare services has long been recognized as a human right. In 1948, the World Health Organization (WHO) Constitution stated: “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition (1).” As a result, the right to access essential medicines and medical technologies must also be recognized as a crucial part of attaining the highest-quality healthcare for all citizens of the world. Indeed, one of the United Nations’ Sustainable Development Goals (SDG) to transform our world identified the importance of achieving access to quality, safe, effective, and affordable essential medicines in SDG 3 by the year of 2030. Unfortunately, in many low- and middle-income countries (LMICs) around the world, patients’ ability to access quality essential medicines still remains a critical challenge. This challenge of access is further complicated by the penetration of low-quality medicines in LMIC healthcare systems and has become a significant public health problem, leading to drug resistance, inadequate treatment, and increased global morbidity and mortality (2). Past efforts to improve access to quality medicines have focused primarily on regulation and policy with the aim of strengthening healthcare systems and improving the supply chain for essential medicines. More importantly, technological innovations, including those in the field of applied chemistry, have also contributed to the expansion of access to quality medicines. The concept of transforming chemistry knowledge and bringing chemical analysis out of the laboratory settings and into the real world has begun to get healthcare providers more enthusiastic about scalable, implementable, and affordable new technologies that can impact patient lives all over the world. The need for new technologies and interventions must involve a deep understanding of the supply system in which these technologies aim to address. Consequently, in this book chapter, we aim to provide a practical example of the supply chain system primarily within which we have been working in for the past two decades through the Academic Model Providing Access To Healthcare (AMPATH) in western Kenya. AMPATH has established themselves as pioneers in service delivery as they have leveraged their unique academic model supported by Moi University, Moi Teaching Referral Hospital, and a consortium of North American Universities to provide care services to a population of over 4 million people living in western Kenya. Through our team’s experiences working within the AMPATH program, we propose that the barriers that impact the quality of essential medicines from chronic communicable and chronic non- communicable diseases lie within three specific areas (3A’s): availability, accountability, and 130 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.


adherence as illustrated in Figure 1. In this chapter, we further describe solutions that have been implemented to address the barriers each of the identified areas.

Figure 1. Barriers to the 3A’s of supply chain systems in Kenya.

Availability Problem Statement Well-functioning supply chain systems for medicines must be consistently reliable and responsive to the priority health care needs of the patient populations that they serve. Ideally, at any health service delivery point, patients should be able to access all necessary medicines in a reliable, affordable and high-quality manner. In 1977, the WHO published its first Model List of Essential Drugs in which it identified 208 medicines deemed to provide safe and effective treatment for communicable as well as non-communicable diseases worldwide. Since then, the Essential Medicines List (EML) has continued to evolve to include more than 300 medicines (3). The EML is meant to serve as a guide for the procurement and 131 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.


supply of medicines in the public sector, medicine reimbursement, donations, and local drug production (4). Despite this effort, in 1999, the WHO still showed that a large fraction of the world’s population still had poor access to appropriate, affordable, and high-quality essential medicines, with the limitations being especially pronounced in remote, rural areas where many resource constrained populations reside (5). In the public sector, the median availability of essential medicines was reported to be 40%, much lower when compared to 78.1% in the private sector (6). In many LMICs, stock-outs of essential medicines are common occurrences in public health facilities. The WHO and Health Action International also reported that the availability of essential generic medicines in low-income countries as being at an average of 36.1% in the public sector, with countries in Africa having a mean availability of 29.4% in public health facilities (7). The availability of medicines for chronic conditions in LMICs is even less. Medicines for cardiovascular diseases, for example, have been reported to have availability as low as 3% in some settings (8). Low medicine availability makes it difficult for patients with chronic conditions to have routine access to chronic disease medicines that they are meant to take on a long-term basis and could potentially affect medication adherence as well as adherence to clinic visits. In Kenya, a survey carried out by the WHO in 2009 showed a median availability of essential medicines of only 67% in public hospitals countrywide (9). In this section, we analyze the gaps within the supply chain system from a pharmaceutical policy as well as an on-the-ground perspective. Drawing from our practical experiences in Kenya, we further describe examples of successful programs where attempts have been made to fill these gaps. Obstacles to Efficient Supply Chain Systems in Kenya and LMICs Dysfunctional Supply Chain Management In most LMICs, drug supply is coordinated by the government using Central Medical Stores (CMS), which procures and distributes medicines to public health facilities for dispensing (10). In Kenya, the CMS is known as the Kenya Medical Supplies Authority (KEMSA) and is a state corporation under the Ministry of Health (MOH) (11). Previously, KEMSA was financed by the central MOH to procure and distribute medicines across the country based on individual facility orders; however, health financing was transferred from the central government to the county governments in 2013. Currently, KEMSA supplies individual counties based on orders made by the county health ministries who pay for the subsidized costs of medicines and their distribution (10, 12). Unlike many other LMICs, KEMSA contracts with several transport companies to distribute the medicines directly to the health facility. In other countries, the government typically owns a transport fleet that distributes to regional warehouses that then transport the supplies to the individual facilities or the facilities are expected to collect their orders from the regional warehouses which is challenging when facilities have limited vehicles or limited funds for fuel or vehicle maintenances (10). This unnecessarily complex design coupled with multiple tiers of stock 132 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

management leads to increased opportunities for the system to break down causing interruptions in supply chain. In addition to government-coordinated procurement and distribution of essential medicines, developing countries have a large private pharmacy sector, with a number of private wholesalers and importers who regularly distribute medicines to retail outlets (13). Non-governmental and faith-based organizations also play a role in the supply of medicines in developing countries.


Inadequate Financing for Health Uncertainties and inefficiencies in health financing can lead to ineffective supply chains. The complex bureaucratic procedures and inefficiencies in the health and finance ministries of most LMICs result in long lead times before funds are even disbursed from the government treasury to procure medicines (10). In Kenya, this complexity has been further complicated by the devolved structure of government. Specifically, each of the 47 counties requests for funds from the government, which they then have to allocate to various functions other than healthcare. A specific amount from these funds are then used to purchase medicines from KEMSA. Consequently, there may be large variability in the budgetary allocation for drug procurement across the counties because each county may have differing priorities and political agendas (14). The entire procedure adds yet more inefficiency in ensuring medicines are made available in good time to various health facilities (14).

Inefficient Health Information Systems Another challenge with government-coordinated supply chains lies with the inefficient health information systems that should provide adequate data to allow for planning and forecasting of needs. Yadav describes a phenomenon known as “the bullwhip effect” in which small variations in the information communicated across the various levels of the supply chain end up being amplified, resulting in too large or too small quantities of medicines being supplied to health facilities (10). One reason for this is insufficient and weak communication across multi-tiered distribution systems. These systems use a funnel model of communication such that multiple lower tiers (i.e. primary care centers) funnel their drug orders to a middle tier (i.e. secondary care facilities), which then make orders for them to the central drug supplier. Various primary care centers have no real-time knowledge on each other’s drug stocks. One facility may be having a shortage of crucial drugs, but these drugs may be available at another facility in large quantities where they are not been consumed. This is further complicated by the fact that there are long intervals between delivering supplies to individual facilities; with the aim of reducing transport costs, most CMS distribute medicines on a quarterly basis. However, with its long lead time, it is difficult to forecast the needs leading to stock-outs or wastage (10). Furthermore, not enough data is collected at the health facility level that could provide accurate information about utilization for 133 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.

appropriate planning and ordering. Hence, there is a disconnect between the actual need and what is supplied to the facility. Much of this stems from inadequate funding of operating costs for the supply chain including the lack of systematic investment in supply chain data management systems in the pharmaceutical sector (9, 15).


Unaffordable Drug Pricing The private pharmaceutical sector in most developing countries is a thriving one with wholesalers and distributors often having a monopoly for particular products (13). There may also be several tiers in the supply chain, with each tier adding a price mark up. Thus, prices of medicines in private pharmacies may be quite high and unaffordable to many. The analysis by Cameron et al. on prices and affordability of essential medicines in developing countries showed that private sector mark ups could range from 10% to more than 500% leading to exorbitant prices of medicines in the private sector (7). This can be attributed to poor drug pricing policies that allow private sector players to mark-up prices.

Poor Outreach to Rural Areas Another challenge with private sector supply is that it has poor reach into rural areas (10, 13). Most wholesalers distribute to cities and towns but not to densely populate villages. This then forces retailers in rural areas to find their own means of purchasing and transporting medicines from larger towns. This also has a negative impact on the price of the medicines because the additional transport cost is added to the mark up. Therefore, patients in rural areas, who are typically facing greater financial constraints to begin with, end up paying much more for essential medicines in comparison to urban residents. The resulting situation from all these barriers is that a large proportion of the population, consisting particularly of lowincome earners in rural areas, is unable to access medicines in both public health facilities, because of poor availability, and from private pharmacies because of the high costs. It is for this population that targeted innovative solutions improving access to essential medicines are needed.

Proposed Solutions In order to mitigate some of the most pressing challenges of the supply chain system, in Kenya, several efforts have been conducted to bridge the gaps within the public health sector to improve the availability of medicines for chronic communicable and non-communicable diseases. In this section, we document two successful programs in Kenya that highlight the process of implementation, evaluation, outcomes, and their significant impact on patient lives.

134 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.


The KEMSA Case Study: The Push and Pull System As generally states above, KEMSA is the entity within the Kenyan government, which is responsible for sourcing, storing and supply of medicines and other health related products to both government hospitals and some selected non-governmental organizations. Despite facing many challenges, KEMSA has managed to supply commodities to more than 4000 health institutions in Kenya (16). Because of the lack of accurate projections of needs and poor record keeping, KEMSA relied primarily on the “push” model of distribution, where predefined amounts of medications were periodically distributed to health facilities based on somewhat arbitrary allocation rules and catchment populations (10). The push system often results in a mismatch between supply and demand leading to the wastage of many unnecessary medications and shortage of medications that have higher consumption. The difficulties with the push system coupled with increased demand for timely deliveries have led to change in policies pertaining to medicines supply within KEMSA. As a result, recently, KEMSA has utilized new approaches that aim to improve the supply chain within Kenya. One such intervention is the utilization of the pull system, which involves fulfilling orders based on the clients’ (hospitals) demands. Through the pull system, KEMSA utilizes an in-house Logistics Management Information System (LMIS) in inventory tracking and management. Facilities can also place orders via KEMSA’s, e-mobile platform. KEMSA has also incorporated Zidi™, a phone-based model that tracks stock movement in real time in addition to making estimates for reorder quantities before the next ordering cycle (16). All these interventions have led to improved pharmaceutical supply chain performance especially in the public sector leading to improved stock monitoring, reduction in quantities of expired medicines and overall reduction in overstocking of medicines (16).

HIV Drug Procurement at AMPATH AMPATH was created initially as an HIV focused care program that was established in 2001 through a partnership between Moi Teaching and Referral Hospital (MTRH), Moi University College of Health Sciences, and a consortium of North American universities and academic medical centers (17). AMPATH has a tripartite mission of care, education and research, serving a catchment population of 4 million people in western Kenya. Through close partnership and collaboration with the Kenyan MOH, AMPATH has worked closely with Kenya’s MOH, the United States Agency for International Development (USAID), and the President’s Emergency Plan for AIDS Relief (PEPFAR) to build a reliable supply chain system for antiretroviral (ARV) drugs and to provide comprehensive care and treatment for HIV-infected patients in Kenya. Many lessons can be learned from understanding the supply chain management of ARV drugs at AMPATH as a case example. With funding from USAID and PEPFAR, Kenya Pharma was established to create a reliable and uninterrupted supply chain for ARV drugs to ensure 135 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.


HIV patients across the country could continue to derive the benefits from PEPFAR supported HIV programs (18). Since 2009, Kenya Pharma has worked in multiple cross-cutting areas to achieve these aims. Besides conducting regular quality assurance performance reviews and making sure that medicines are properly stored, the project has managed to strengthen the ARV supply chain by prioritizing these following activities: (1) quantifying antiretroviral and opportunistic infection drugs, (2) analyzing consumption patterns, (3) forecasting needs based on the most updated data, (4) procuring required pharmaceuticals, and (5) distributing medicines to all sites in a timely, efficient, and consistent manner (19). The creation of a reliable supply chain system for ARV drugs has helped ensure that patients sustain the life-saving benefits of HIV treatment. Through this program, AMPATH has been able to ensure medication access for ARV drugs and medications for AIDS-related opportunistic infections for more than 150,000 ever-enrolled HIV patients across western Kenya without any reported stock-outs at more than 500 MOH facilities across western Kenya (20). As PEPFAR/USAID continue to emphasize the importance of country owned and operated programs, PEPFAR is currently transitioning responsibility for supply chain to KEMSA. Revolving Fund Pharmacies History In 2011, revolving fund pharmacies (RFPs) were developed by AMPATH with the aim of ensuring sustainable and reliable access to quality and affordable medicines for patients with chronic diseases outside of HIV (21). The idea behind this RFP model came from the revolving drug fund (RDF) concept, which dated back to 1989 when an RDF was introduced in Ghana (22). In the RDF model, seed funding was obtained for the purpose of procuring an initial stock of essential medicines. These medicines are later sold at a slightly higher price, in order to generate sufficient profit that can be used to replenish drugs and to support administrative costs. Learning from criticism, challenges, and successes of RDF projects in various other settings, Kenya’s RFPs were set up to address the unmet needs of the public sector to consistently access essential medications (23, 24).

Guiding Principles for Setting Up RFPs RFPs are located within public health facilities, however, the operational aspects of the pharmacy are separated from that of the government pharmacies. Indeed, RFPs serve as “backup” pharmacies to the government facility, with the medicines being sold to patients only when the government pharmacies are not able to supply patients with the essential medications that they need. Revolving fund pharmacies are typically initiated in a stepwise fashion with the process starting with a thorough needs assessment of the medication availability, supply chain issues, staffing and security issues at each site. Based on collected data and documented needs, key stakeholders including the MOH 136 Grosse; Mobilizing Chemistry Expertise To Solve Humanitarian Problems Volume 1 ACS Symposium Series; American Chemical Society: Washington, DC, 2017.


Facility Management team, the AMPATH RFP team, and members of the local community in which the public health facility is located, are engaged and form a management committee. As a unified team, the three parties create a memorandum of understanding that governs daily operations to ensure patient needs, patient safety, and optimal workflow. Specifically, the MOH facility management team avails RFP space and offer day to day oversight of activities, including if necessary, shifting staff members already employed by the facility to manage the RFPs to minimize cost of hiring new staff. The AMPATH RFP team is responsible for stocks management including regular audits, report generation, and drug re-supply. The local community representatives ensure that community needs are continuously met and any community concerns are allayed. The novelty in the RFP model, and why it has been functioning well in our setting, is based on several guiding principles, as summarized in Table 1. The MOH serves as the primary supplier of drugs for patients seeking care at the facility while the RFP serves as a back-up for patients in the case of MOH facility stock-outs. All prescriptions filled in the RFPs represent drugs that otherwise would have been inaccessible, of possible poor quality or unaffordable to patients. Autonomy and sustainability are of utmost importance to the RFP model. An operational procedure, distinct from the MOH’s system is put in place to ensure separation of medication stocks, records and cash, which are all under the management of the above mentioned committee. As accountability is of utmost importance to maintain the RFP implementation all RFPs are audited by a member of the AMPATH staff on a weekly basis during the first 1-2 months of operation, followed by a monthly or bi-monthly basis. This procedure facilitates not only transparency in cash collection, but also efficient and timely procurement of drugs. Most importantly, RFPs operate in an access-maximization model where patients should not be denied life-saving medications. A waiver system is established to identify patients who are unable to pay.

Outcomes Availability of essential medicines in the three initial pilot RFPs increased from 40%, 36% and

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