Edmondo Aimee PHA Final Spring 2014
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Transcript of Edmondo Aimee PHA Final Spring 2014
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 1
T u l a n e U n i v e r s i t y S c h o o l o f P u b l i c H e a l t h a n d T r o p i c a l M e d i c i n e
Innovations in Access to Essential Medicines: Focus on South Africa Aimee Edmondo MPH Candidate
Spring
2014
08 Fall
Public Health Analysis Culminating Experience
Department: Global Health Systems and Development Focus: Program Design and Implementation Advisor: Nathan Morrow
List of Acronyms ANC – African National Congress ARV – Anti Retro Virals CHW – Community Health Worker DoH – Department of Health EDL – Essential Drugs List EDP – Essential Drugs Programme eHealth – Electronic Health Informatics EML – Essential Medicines List EMR – Electronic Medical Records FDC – Fixed Dose Combination HIS – Health Information System HIM – Health Information for Management HIV – Human Immunodeficiency Virus HST – Health Systems Trust ICT – Information and Communications Technology iDART – Intelligent Dispensing of Anti-‐Retroviral Treatment KEMSA – Kenya Medical Supplies Agency LMIC – Low and Middle-‐Income Countries LMIS – Logistics Management Information System MatCH – Maternal Adolescent and Child Health mHealth – Mobile health technology MSF – Medecins Sans Frontieres / Doctors Without Borders MSH – Management Sciences for Health NCD – Non-‐Communicable Disease NDP – National Drug Policy NDoH – National Department of Health NGO – Non-‐governmental Organization PHC – Primary Health Care PTC – Pharmacy and Therapeutics Committee RCT – Randomized Controlled Trial SMS – Short Message Service SSA – Sub Saharan Africa STG – Standard Treatment Guidelines TB – Tuberculosis WHO – World Health Organization
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 1
Abstract South Africa instituted no cost public healthcare services in 1994, despite this, South Africa suffers from
a quadruple health burden, which includes communicable disease, non-‐communicable disease, poor
maternal and child health, and injury and death due to violence. Additionally, South Africa is home to
the largest populations of HIV and TB infected individuals in the world. Satisfactory health outcomes are
dependent upon reliable access to health care and uninterrupted supplies of essential medicines.
Recently, advocacy organizations have reported regular stock outs of essential medicines, and reviews
of patient experiences in the public healthcare delivery system indicate that patients are required to
repeatedly return to health facilities to collect medications. Consequently, impoverished patients are
often demoralized and experience catastrophic out of pocket expenses. In this analysis mobile
technology is explored as a potential intervention to empower patients and simultaneously improve
access to essential medicines in South Africa.
A qualitative review of literature from the last decade was conducted to explore essential drugs access
and the pharmaceutical supply chain management system in South Africa. Additionally, mobile health
technology interventions in sub Saharan Africa were reviewed for their feasibility and potential to
improve supply chains. Policy documents and reports from advocacy organizations were also used to
inform this analysis.
Over 20 documents were identified for this public health analysis. Findings related to access to
medicines and care, pharmaceutical supply chain systems, and the role of mobile health technology
indicate that little comprehensive research has been conducted in South Africa on these topics and the
relationships between them. Furthermore, few peer-‐reviewed studies have explored the impact of
healthcare access barriers and essential medicine shortages in South Africa on treatment adherence or
overall health outcomes.
Widespread mobile phone use, advanced ICT systems, and government-‐initiated health technology
policies suggest that South Africa has an enabling environment to facilitate the implementation mHealth
to improve essential medicines access. It should be noted, however, that limited stewardship, poor
leadership, resource constraints, and an ineffective culture of service delivery will need to be
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 2
ameliorated in order to implement beneficial mHealth innovations to improve pharmaceutical supply
chain management.
Background
WHO and the Model List of Essential Medicines
In 1975 global concerns about the availability of important lifesaving medicines in the public sector,
particularly in developing countries, led to a request by the World Health Assembly for the World Health
Organization (WHO) to establish a model list of essential medicines. The first essential medicines list
(EML) was released in 1977. Challenges to the EML and changing patterns of health and evidenced-‐
based practices have led to several revisions of this list (Laing et al. 2003). Today, the WHO EML is in its
18th edition. Essential medicines are defined by WHO as:
“Those drugs that satisfy the priority health care needs of the of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-‐effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, appropriate dosage forms, with assured quality and adequate information, and at a price the individual and community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility (2002).”
Accordingly, South Africa also has its own essential drugs list (EDL) and associated treatment guidelines,
though the evolution of this list has been fraught with controversy and heavily influenced by a host of
growing epidemics such as HIV and TB (Laing et al. 2003).
Primary Health Care and the Essential Drugs List in South Africa
Following democratic transition in South Africa in 1994, the African National Congress (ANC) proposed a
plan for national health services based on the concept of primary health care (PHC) promoted at Alma
Ata. Through this plan, the National Department of Health (NDoH) sought to address the unequal
distribution of health services, infrastructure, monetary, and human resources resulting from Apartheid.
No cost PHC became available to the public though a district health system following the construction
and upgrading of over 1,500 clinics (Coovadia et al. 2009). In 1996 South Africa released the National
Drug Policy (NDP), which outlined changes in drug management and detailed a host of legislative and
regulatory priorities. One of these priorities involved the establishment of a representative committee
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 3
to produce standard treatment guidelines (STGs) from which the medicines to be included in the PHC
EDL would be extracted. The first editions of these documents were released in April of 1996 (Gray &
Suleman 2000, Essack et al. 2011).
Though the national PHC EDL and STGs are regularly reviewed and updated, limited political will, patent
policies, and inequitable resources mean that some essential drugs are less accessible than others. HIV
has been a prominent issue in the EDL process. Today there are clear STGs for HIV and TB and policy-‐
based strategic plans at the national and provincial level in South Africa, but at one time anti-‐retrovirals
(ARVs) were considered too expensive for public use. For example, in the 1998 PHC EDL it is noted that
“these medicines are very costly and cannot be provided on a mass scale by the public health services…
they may only be provided on a limited and selected basis or for academic and research purposes only”
(Laing et al. 2003). Fortunately, the World Health Assembly approved a Revised Drug Strategy in May of
1999, which allows for interpretation of the World Trade Organization (WTO) TRIPS agreement based on
priority global health concerns (Hoen et al. 2011). This has greatly reduced the cost of ARVs and allowed
South Africa to establish a national ARV program in 2003 with assistance from foreign donors. With
over 2.1 million people initiating ARV treatment in South Africa in 2012, it is the largest program of its
kind.
Health Service Delivery and the Health Status of South Africa
Multiple reviews on the process of implementing post-‐Apartheid national health services in South Africa
have indicated that progress is slow, uneven, and faces multiple difficulties. (Gray & Suleman 2000,
Coovadia et al. 2009, Levitt N, 2011). Major setbacks in implementation have included confusion about
responsibilities within the district health system. In the 2004 National Health Act, the NDoH is identified
as the sole responsible party for national health policy, while public health service delivery was deemed
a provincial responsibility. Within the national pharmaceutical program, NDoH is responsible for the
tender process, while provincial governments are responsible for ordering, storage, and distribution of
medicines. Additional national health care challenges include skilled human resource shortages,
unequal distribution of resources – with very few at the rural community or primary level, and poor
human resource management. Though perhaps more damaging has been a historical lack of
stewardship and leadership within the health system at a national level (Coovadia et al. 2009).
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 4
Though South Africa is considered a high-‐middle income country, its health outcomes are worse than
many low-‐income countries. Currently South Africa faces a quadruple epidemic, which includes
communicable disease (such as HIV and TB), injury and death due to violence, diseases of poverty (such
as poor maternal and child mortality and morbidity), and rising non-‐communicable chronic diseases
related to diet and lifestyle. South Africa is home to the largest number of HIV infected individuals in
the world, with an estimated 6.1 million infected. Additionally, over 60% of TB patients are found to be
co-‐infected with HIV (UNAIDS 2012). The need for uninterrupted supplies of essential medicines,
particularly for South Africa’s growing burden of chronic communicable and non-‐communicable disease,
is evident.
Rationale South Africa’s overburdened and under-‐resourced public healthcare system regularly struggles to meet
the demands of the public. In addition, poor pharmaceutical logistics and supply chain management
impedes the ability of patients to adhere to treatment regimes, and when combined with poverty, often
deters highly vulnerable households from engaging in health seeking behavior (Goudge et al. 2009).
Regular stock outs of essential medicines at the facility and depot level put patients at risk of developing
poor health outcomes and increase the probability of drug resistance. Moreover, smaller rural clinics
serving traditionally impoverished areas are particularly vulnerable to stock outs because they are
downstream recipients of medicines from larger facilities such as municipal and district hospitals (MSF et
al. 2013). Multiple reviews on access to care in South Africa indicate that poverty, poor healthcare
service delivery, and a lack of clear information from providers disempower patients. In order to
improve the disease burden in South Africa these reviews indicate that novel and innovative approaches
to improve health services are needed (Goudge et al. 2009, Coovadia et al. 2009, Mayosi et al. 2009,
Schneider et al. 2006).
Mobile health technology (mHealth) is a growing field. Innovative uses of technology have improved
information flow, allowed for timely and accurate methods of data collection, and have connected
consumers with providers. Recent pilot programs have looked at how mobile technology can increase
access to medicines by improving accountability within the supply chain of pharmaceuticals (Barrington
et al. 2010). Given that there are 29 million mobile phone users in South Africa, a noted increase from
17% to 76% amongst adults in the past decade, it would be advantageous to explore the ways in which
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 5
mHealth can both empower patients and improve access to medicines in low resource settings in South
Africa (KMPG South Africa 2013).
Competencies The competencies to be developed by this analysis into essential medicines access in South Africa are as
follows:
Program Design and Implementation competencies:
• Identify program/project goals, objectives, strategies, activities and resource requirements for interventions that target key global health problems.
• Develop management systems for interventions that address priority global health problems. • Identify information requirements for design, implementation, and evaluation of global health
programs. • Apply design and implementation principals and approaches to a specific program area within
global health.
Topic-‐specific competencies:
• Develop an understanding of the supply chain management system for essential medicines on the national, provincial, and district level in South Africa.
• Conduct a landscape analysis of the current health issues in South Africa as they relate to essential medicines access.
• Review the existing systemic and social challenges to essential medicine access. • Research and compile best practices regarding the use of mobile technology in low-‐resource
setting to improve health outcomes and access to essential medicines.
Methodology Literature in this analysis was located utilizing the databases PubMed and Google Scholar. Peer
reviewed journal articles were limited to the past decade (2004 to 2014), with some exceptions such as
those related to policies implemented prior to 2004. Database searches included the following terms
and phrases:
• South African drug policy • Pharmaceutical supply chain management in South Africa • Access to essential medicines in South Africa • Access to health care in South Africa • Medication stock outs in South Africa
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 6
• Mobile technology and medicines access • Mobile health in South Africa • Monitoring distribution of essential medicines • Health impacts of medication stock outs in South Africa
Publications regarding essential medicines and pharmaceutical supply chain systems from multilateral
institutions such as the World Health Organization (WHO) and international agencies were also
considered in this analysis. In addition, applicable policy briefs, news stories, information regarding
mobile health technology programs, and government documents were accessed via the online websites
of the South African National Department of Health (NDoH), associated press, private technology
enterprises, and advocacy organizations.
Results and Discussion Findings from a review of literature related to access to medicines and care, pharmaceutical supply
chain systems, and the role of mobile health technology indicate that little comprehensive research has
been conducted in South Africa on these topics and the relationships between them. Furthermore, few
peer-‐reviewed studies have explored the impact of healthcare access barriers and essential medicine
shortages in South Africa on treatment adherence or overall health outcomes. Topics that repeatedly
appeared in literature searches regarding access to care in the context of South Africa included human
resource challenges and the role of leadership and stewardship in health systems strengthening.
Table 1: Literature sources by topic
Document Year Location Source Type
Access to Care
Access to Medicines
Pharmaceutical Supply Chain
Mobile Health
Technology
Health Outcomes
Aronovich & Kinzett 2001 Kenya Report X
Barnighausen et al 2012 N/A
Peer Reviewed Journal
X
Barrington et al 2010 Tanzania
Peer Reviewed Journal
X X X
Demiris et al 2008 USA Peer
Reviewed Journal
X X
Embrey et al 2009 Global Peer
Reviwed Journal
X
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 7
Essack et al 2011 South Africa
Peer Reviewed Journal
X
Goudge et al 2009 South Africa
Peer Reviewed Journal
X X
Gray & Suleman 2000 South
Africa Report X
Harris et al. 2011 South Africa
Peer Reviewed Journal
X
Hozerzeil et al. 2013 Global
Peer Reviewed Journal
X
Kaplan 2006 Global Peer
Reviewed Journal
X X
Leon et al. 2012 South Africa
Peer Reviewed Journal
X
Levitt et al 2011 South Africa
Peer Reviewed Journal
X X
MSF et al 2013 South Africa Report X X X
MSF et al. 2013 South Africa Report X X
NDoH 2012 South Africa Report X
NDoH 2011 South Africa Report X X
Pharasi & Miot 2013 South
Africa Report X
Schneider et al 2006
Southern Africa Region
Peer Reviewed Journal
X X X
Steyn et al. 2009 South Africa
Peer Reviewed Journal
X X
Access to Medicines and Health Care in South Africa
An initial search for literature related to access to medicines in South Africa yielded few results.
Therefore, studies related to public sector health care access in South Africa have been used as a proxy
for essential medicines access. These works have been combined with reports from advocacy
organizations that address nationwide pharmaceutical stock outs.
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 8
Despite the great strides that South Africa has made since its democratic transition from Apartheid in
1994, health outcomes remain unsatisfactory. While the South African constitution assures state
sponsored PHC for all, uneven resource allocation, inadequate infrastructure, and skilled human
resource shortages continue to plague the system. It is recognized that equitable universal health care
must be affordable, available, and acceptable to recipients of services. The public health care system in
South Africa rarely meets these requirements, particularly for chronically ill patients (Harris et al. 2011,
Goudge et al. 2009).
Affordability
Affordability is a key component of accessible health care. While PHC services are offered to the public
at no cost, there are often catastrophic out of pocket expenses that affect the most vulnerable and
impoverished populations in South Africa. Due to an inequitable distribution of infrastructure and
resources many individuals, especially those in rural areas, are unable to access care due to public
transport costs. For individuals in lower wealth quintiles in South Africa, transport costs and distance to
PHC clinics are likely to be higher than those for individuals in the uppermost quintiles -‐ who are
generally closer to secondary and tertiary facilities and are more likely to utilize private modes of
transportation. With high rates of unemployment (currently 24.5% nationally), many households in
rural areas are reliant upon government funded social grants as a sole source of income. When
transport costs are combined with limited availability of services and interrupted drug supplies, these
cost burdens can account for 6% to 60% of household expenditure in any given month depending on the
number of repeated trips to obtain medicines and care. Private healthcare services are also frequently
secondary sources of out of pocket expenses for vulnerable groups that are dissatisfied with publicly
funded PHC. In South Africa private healthcare services function alongside public services, delivering
care to those with private insurance schemes or individuals with the ability to pay. These catastrophic
costs can increase household vulnerabilities and food insecurity for low-‐income families. For individuals
without sufficient financial resources, care is often sought intermittently, despite higher rates of
infectious and non-‐communicable disease (NCD) within these lower wealth quintiles (Harris et al. 2011,
Goudge et al. 2009, MSF et al. 2013).
Availability
Availability of healthcare refers to the quantity of fully functioning public facilities, goods, and services.
In an effort to bolster PHC services, several hundred rural primary clinics were built to improve access
for underserved areas. Unfortunately, these rural clinics are plagued with health system weaknesses
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 9
and frequently lack adequate infrastructure and skilled service providers. In South Africa the number of
doctors, pharmacists, and nurses required for the public healthcare system to function outstrip the
number of available professionals. Furthermore many of the national human resource challenges do
not reflect the disparities within South Africa – many of these healthcare professionals work in urban
areas, leave the government system to provide care in the for-‐profit private sector, or choose to practice
outside of the country. Over 85% of the South African population is reliant upon public services, and yet
the private system employs 70% of the doctors in the country. Similarly, only 29% of registered
pharmacists work in the public sector. National public sector vacancy rates for doctors and nurses are
currently 56% and 46% respectively, and there are roughly 8 pharmacists providing services per 100,000
people (George et al. 2009, FIP 2012, Gray & Suleman 2000, Schneider et al. 2006).
Few studies have explored healthcare service availability from a beneficiary perspective, of those that
have, drug stock outs were frequently noted as deterrents to care (Schnieder et al. 2006, Goudge et al.
2009, MSF et al. 2013). Two of the national core standards for pharmaceutical services at health
facilities in South Africa ensure that, “medicines and medical supplies are in stock and their delivery is
reliable, and that stock levels and storage are managed appropriately” (NDoH 2011). In surveys
performed by patient advocacy organizations, it was found that 21% of facilities nationwide had
experienced shortages or stock outs of HIV and TB medication, with some rural provinces reporting
stock out rates of over 50%. Vaccine availability was surveyed as a proxy for other essential medicines.
Nationally, 14.7% of facilities had experienced shortages and stock outs of vaccines. Again, rural
provinces experienced higher vaccine stock out rates at over 30% (MSF et al. 2013). Similarly, in a 2011
baseline audit of national health care facilities 77% of clinics, 70% of community health centers, and 98%
of hospitals did not have EDL tracer medications available in the pharmacy or medication storage room
(HST et al. 2012). Patients utilizing the public PHC system report that they are frequently sent home
from health facilities without medication or told to return at a later date. Some patients who are reliant
on lifesaving medications resort to paying out of pocket for essential medicines at private pharmacies.
For chronic patients living in poverty, availability is directly related to affordability, as out of pocket
expenses for repeated attempts to obtain medication can be devastating for the entire household.
Furthermore, a lack of medication and supplies is demoralizing for health workers who are unable to
provide necessary services. Stock outs cause relationships between patients and providers to become
strained, particularly because patients consider access to medication as an indicator of the overall state
of the public health system (Steyn et al. 2009, Goudge et al. 2009, Levitt et al. 2011, MSF et al. 2013).
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 10
Acceptability
Studies indicate that anticipated disrespect and ineffective care from providers counteracts health-‐
seeking behavior amongst patients accessing public services in South Africa. Long wait times, unsanitary
facilities, and a lack of privacy and confidentiality were also reported amongst patients expressing
dissatisfaction with public health services. Productive patient-‐provider relations are lacking in South
Africa largely due to overburdened health care professionals resulting from human resource constraints.
However, it should be noted that differences between sociocultural norms amongst providers and
patients also have a large role to play in the acceptability of services and the belief in the efficacy of
treatment regimes amongst patients. A lack of communication and understanding can also negatively
shape the patient-‐provider interaction. Without clear information patients feel that they are unable to
advocate for themselves and often feel disempowered. Such feelings, when combined with medicine
and supply shortages can potentially ruin the trust and relationship between provider and patients
(Schneider et al. 2006, Goudge et al. 2009, Harris et al. 2011, MSF et al. 2013).
Pharmaceutical Supply Chain Management in South Africa
The public sector drug regulatory system in South Africa is founded upon the National Drug Policy of
1996 (NDP). The NDP outlines objectives to improve the availability and accessibility of essential
medicines, quality assurance measures, and rational use of medicines. Initially, the primary goals of the
NDP were to establish an Essential Drugs Programme (EDP) and to develop an Essential Drugs List (EDL)
and Standard Treatment Guidelines (STGs). Compiled and reviewed regularly by experts on the EDL
committee, these documents serve as the foundation of essential medicines access at primary care and
hospital level facilities.
The process of procurement and distribution of medicines begins at the hospital level, where the
Pharmacy and Therapeutics Committee (PTC) at each hospital submits orders and expected drug needs
to the NDoH. Hospital demands form the basis of the medicine quantities requested in the tender
process. The NDoH then manages a competitive tender process with pharmaceutical suppliers. Once
tenders are awarded, suppliers distribute medicines to each of the nine provincial government
warehouse depots. The various provincial DoH offices manage tenders with private logistics companies
to run the pharmaceutical depots. In most provinces, medicines will also be distributed to smaller
district-‐level depots and hospitals, from which small rural PHC clinics will then request stock. These
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 11
steps can be visualized within the pharmaceutical management framework proposed by Management
Sciences for Health (MSH) (Figure 1) (Essack et al. 2011).
Figure 1: Pharmaceutical Management Framework (Source: MSH)
Various problems at every level of the supply chain compound medicine access issues for patients at the
rural PHC level. While selection is based on the South African EDL and STGs, government tenders are
often issued for several hundred other medicines that are not associated with the EDL (Gray & Suleman
2000). It is not clear whether this inefficiency is due to oversight or a need to evaluate the tender
process. In a review of tenders for antibiotics from 2007 to 2011 it was discovered that hospital PTC
requests for antibiotics have seen little change, despite expected increases (Essack et al. 2011).
Recently, there have been instances in which pharmaceutical suppliers have been unable to deliver on
tenders that have been offered to them. In early 2013, several thousand clinics reported shortages of
the newly introduced fixed dose combination (FDC) ARVs because the sole supplier could not produce
enough of the FDC pills according to the scheduled contract. In 2012, the Limpopo provincial
pharmaceutical depot was placed under administration and the private logistics company contract was
cancelled when it was discovered that millions of Rand in expired medication were destroyed because
they were not distributed to facilities. Also in 2012, staff at a district pharmaceutical depot in the
Eastern Cape staged a month long strike followed by DoH suspensions for 75% of the staff. A mere 10
working staff members remained to provide services to 300 medical facilities that provide ARVs to over
100,000 patients. Three months following the strike over 53% of facilities served by the depot reported
experiencing TB and ARV stock outs (MSF et al. 2013). At the distribution level, communication issues
between the provincial and district depots and facilities have resulted in drugs not ordered on time or
not ordered at all. These delays are particularly difficult for remote PHC facilities, where supply
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 12
deliveries occur on a monthly basis. Despite the use of human resources task shifting and sharing in the
public healthcare sector, these stock issues are made more difficult by a lack of skilled health
professionals such as pharmacists.
It is clear that national and provincial pharmaceutical supply chain management is fragmented. There
are no clear, cohesive, or systematic national standards or procedures for stock monitoring and
reporting. Many medicine shortages and stock-‐outs are underreported, which only exacerbates access
issues, puts patients at risk for poor health outcomes, and inadvertently leads to increased drug
resistance and communicable infections.
Mobile Technologies and Health
Globally, pervasive interest in information and communications technologies (ICT) in health and
development has grown considerably. Enthusiasm for mHealth is based upon the ability to rapidly
collect, store, and collate information in a short amount of time from remote locations. The widespread
use of basic mobile phones, and the limited level of skill or literacy required to use them, suggest that
they are convenient mediums for data collection or limited information transfer amongst diverse
populations in low resource settings (Kaplan 2006, Leon et al. 2012). Furthermore, the role of mHealth
as a means to engender a transition from the role of patients as passive recipients of health care
services to active participants suggests an opportunity for empowerment (Demiris et al. 2008).
Despite broad based policy and debate regarding ICT for health and development, many innovative uses
of mHealth have been confined to small pilot programs and studies conducted within the non-‐profit
sector. Due to the small scale of these studies and their diverse approaches to the use of mHealth, it is
difficult to generalize about the efficacy, value, and impact of scaled mHealth. With the exception of
small mHealth treatment adherence programs for HIV and TB, there is scant literature on the use of
mHealth to improve health outcomes for chronic communicable and non-‐communicable diseases in low
and middle-‐income countries (LMIC). Notwithstanding the success of several pilot projects, few studies
have researched the use of mobile technology to improve pharmaceutical stock levels on a large scale.
While there are small advocacy projects run by local and international civil society organizations that
encourage patient reporting of stock outs, there are no systems of accountability that allow for
bidirectional communication between patients and providers to manage pharmaceutical stock (Kaplan
2006, Barringson et al. 2010, Leon et al. 2012).
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 13
There is great potential for the implementation of mHealth technology in South Africa for the following
reasons: (1) At 76% saturation, mobile phone use in South Africa is prevalent in both rural and urban
settings. (2) In comparison to other LMICs, the ICT industry is relatively well developed and there are
diverse mobile network providers. (3) Lastly, there is an enabling policy environment for implementing
mHealth (Leon et al. 2012). In 2012 the National Department of Health released the eHealth Strategy
for South Africa. This document provides a review of policies and a strategic approach for the use of
electronic health informatics in South Africa’s public healthcare system. Within this report, a situational
analysis of South Africa’s capacity for eHealth is provided. The report also defines the ways in which
eHealth interventions can contribute to the strategic objectives of the NDoH. Suggested interventions
include a drug supply and logistics support system, an electronic medical records (EMR) and pharmacy
system interface, an SMS patient reminder system for appointments and medicines, and a
communication mechanism for community health workers (CHWs).
In a review of mHealth in South Africa, Leon et al. is critical of inherent health system challenges that
create barriers to successful implementation of mHealth interventions. These challenges include the
need for leadership and stewardship, the current culture of healthcare service delivery, requisite
systems of sustainable funding, and the ability to integrate mHealth interventions with existing health
information systems (HIS) (Figure 2).
Figure 2: Health systems framework for making decisions about mHealth (Source: Leon et al.)
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 14
In the context of mHealth for community-‐based health services, Leon et al. has the following points to
make about each health system dimension:
• Stewardship – The majority of mHealth interventions conducted in South Africa have been
initiated by non-‐governmental organizations (NGOs). Accordingly, they were conducted on a
small scale and did not involve the larger public health system, nor did they require policy
support from the government. Although the NDoH has released an eHealth strategy, there
remains a lack of high-‐level political and financial support from the government for
implementation of mHealth. Stewardship also requires a commitment to establishing public-‐
private partnerships, securing funding, and the identification of best practices for mHealth
interventions.
• Organizational – Although the goal of mHealth is to improve the efficiency of health systems,
the introduction of mHealth interventions present new management challenges. Poor health
outcomes in South Africa are largely attributed to organizational weaknesses, such as a lack of
management and accountability resulting in inadequate service delivery. Furthermore,
healthcare professionals at the district and provincial levels have demonstrated difficulties
utilizing existing health information for management (HIM).
• Technological – Implementing new large-‐scale mHealth programs require user-‐friendly
platforms for diverse stakeholder populations. Stakeholders at all levels must also believe in the
usefulness of the technology and the data it produces. It is important that a new intervention
have the ability to seamlessly integrate into existing HIS. This is a difficult obstacle to overcome
in South Africa, where patient management systems are different for each provincial DoH
(Figure 3).
Figure 3: Patient Management Systems by Province (Source: NDoH)
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 15
• Financial – As noted previously, most mHealth interventions in South Africa have been small-‐
scale pilot projects initiated by NGOs with independent funders. Establishing long-‐term funding
for large scale mHealth will be problematic in a system that already exhibits inadequate
stewardship.
Pharmaceutical Supply Chain Management mHealth Innovations in Sub Saharan Africa
SMS for Life
‘SMS for Life’ is a pilot study that was conducted in Tanzania for 21 weeks in 2009 and 2010. The
mHealth intervention focused on improving stock of anti-‐malarial medication at the health facility level
utilizing SMS messages and electronic mapping. Stock counts were conducted at each facility on a
weekly basis and then reported via SMS messages. District management teams were able to view stock
levels through a web-‐based reporting tool that assimilated data from SMS messages at each facility
(Figure 4).
Figure 4: Schematic of SMS system in 'SMS for Life' pilot (Source: Barrington et al.)
Weekly stock visibility allowed district medical officers to redistribute anti-‐malarial medications between
facilities, thereby reducing the risk of stock outs. The ‘SMS for Life’ pilot involved 129 health facilities in
three districts. At the beginning of the program 78% of facilities experienced stock outs of one or more
anti-‐malarial medication, and at the end of week 21 only 26% of facilities reported stock outs. Stock
reporting via SMS remained high at over 93% for the duration of the pilot, though this was likely due to
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 16
mobile credit incentives. ‘SMS for Life’ was a public-‐private partnership between the Ministry of Health
and Social Welfare’s National Malaria Control Programme, the Roll Back Malaria Partnership, Novartis
Pharma AG, Vodafone, and IBM. Barrington et al. credit government commitment, adequate mobile
telephone coverage, the use of personal phones, airtime credit incentives, effective training sessions,
and adequate health facility storerooms as project implementation success factors (2010). The ‘SMS for
Life’ model has expanded to include other medicines and is currently being piloted in other SSA
countries.
KEMSA
In 2001 the Kenyan government decided to create a parastatal agency to procure, store, manage, and
distribute medical supplies to public health facilities using private sector logistics and management
techniques (Aronovich & Kinzett 2001). This agency is known as the Kenyan Medical Supplies Agency
(KEMSA), and in 2013 it became a state corporation under the KEMSA Act of 2013. A decentralization of
health services funding and operations to the county level was one of the rationalizations in establishing
KEMSA. Under the new system KEMSA is responsible for procuring supplies with its own funds, ordering
from KEMSA is then completed by counties according to their needs. County governments pay KEMSA
for the supplies and are accountable for the cost of distribution. KEMSA replenishes stock through
profits from sales to counties. KEMSA start up costs were sponsored by the World Bank’s Health Sector
Support Project. Also in 2013, KEMSA announced the launch of KEMSA E-‐Mobile, a partnership between
the Center for Disease Control Foundation, mHealth Kenya, Safaricom, Fintech, Dazzle, and SafeMark.
KEMSA E-‐Mobile is a series of applications and platforms that allow public health facilities and Kenyan
Citizens to interact with KEMSA’s logistic management information system. At the health facility level,
consumption can be reported and supplies can be ordered via mobile phone, this facility level
information is then made available to county health management teams. For Kenyan Citizens, KEMSA’s
E-‐Mobile program provides a level of transparency and integrity, allowing them to anonymously report
suspicious or inappropriate supply issues at health facilities and to inquire about drug availability at their
closest facility via mobile phone. A comprehensive review of KEMSA’s E-‐Mobile initiative has not been
released due to the recent introduction of the program.
iDART by Cell Life
Intelligent dispensing for antiretroviral treatment (iDART) is a software program developed by Cell Life in
collaboration with the Desmond Tutu HIV Foundation, Cape Peninsula University of Technology, and the
University of Cape Town to improve the dispensing of ARVs and treatment adherence within the public
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 17
health care sector in South Africa. The system is intended to allow pharmacists to readily and accurately
dispense ARVs, manage EDL stock levels, and generate reports for a growing number of HIV patients.
iDART requires either direct dispensing of ARVs or pre-‐packaged remote dispensing with unique
barcodes that, when scanned, collect patient information. The iDART system is compatible with DoH
monitoring and evaluation mechanisms, thereby allowing for improved reporting for the government
and international donors. In 2010 the Canadian International Development Agency, in collaboration
with Maternal Adolescent and Child Health (MatCH) at the University of the Witwatersrand, designed a
randomized controlled trial to evaluate the introduction of an SMS component to iDART to reduce
treatment interruption and increase adherence amongst new ART patients. Four sites were chosen for
the RCT, which was completed in late 2013. To date results of this study have not been published.
Limitations This analysis was limited by relatively scant literature on the role of mHealth to improve supply chain
management of essential medicines in low resource settings. Furthermore, the existing literature
generally features small scale mHealth interventions initiated by NGOs with fixed funding and project
time scales. There were difficulties finding comprehensive information on the process of
pharmaceutical supply chain management in South Africa because national LIMS are fragmented by the
decentralization of public healthcare services to the provincial level and the privatization of
pharmaceutical distribution. Lastly, very few studies have investigated patient perspectives on access to
medicines and healthcare in South Africa, or the potential to integrate bi-‐directional mHealth
communication systems with patients to improve supply chain management and access.
Conclusions and Recommendations Despite spending more money on healthcare than other LMICs, South Africa has unacceptably poor
health outcomes. Additionally, South Africa is also home to the largest populations of individuals
affected by HIV and TB -‐ considerable constituents of the quadruple disease burden, of which the other
three are NCD, poor maternal and child health, and violence. Human, financial, and physical resources
remain inequitably distributed within the South African health system in spite of the gains that have
been made in the public healthcare sector following democratic transition in 1994. Rural and
impoverished populations within South Africa consequently bear the brunt of these inequities.
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 18
With over 2.1 million individuals initiating treatment, South Africa operates the largest ARV program in
the world. However, tracking treatment compliance and loss to follow up remains an obstacle. South
Africa is also the epitome of a country in transition and chronic NCD is on the rise. The disease burden
in South Africa necessitates a regular and reliable supply of essential drugs for chronic illnesses.
Impoverished patients are constrained to utilizing PHC clinics with few resources. In reviews of the
South African PHC system patients report poor service delivery and regular shortages of medications.
Patients are often told to return to facilities at a later date to collect out of stock medications. Patients
within the public healthcare sector generally choose facilities based on distance in order to reduce the
economic impact of transport costs, however, repeated attempts to obtain medication can result in
catastrophic costs for the entire household. Inadequate access to medicines may lead to treatment non
adherence, potential development of resistant strains of TB, HIV reinfection, and poor health outcomes
overall – though there are no known studies to confirm this relationship. The economic impact of these
consequences are also unknown.
Pharmaceutical supply chain management within South Africa is controlled at the provincial level, with
NDoH heading the tender process for obtaining supplies and medicines. The quasi-‐provincial
implementation of drug delivery and public health services creates a difficult environment with which to
streamline HIM and data collection for improved decision-‐making. Multiple advocacy organizations
have documented essential drug stock outs resulting from the inefficiencies of supply chain
management in the public sector.
MHealth has the potential to empower South African patients by connecting them with necessary
information, such as facility-‐based drug availability. Additionally, bidirectional communication
transforms the traditional patient role from passive recipient to active participant in the health care
system. Initiating large-‐scale participatory mHealth in South Africa to improve the pharmaceutical
supply chain will require leadership and stewardship at all levels. Previous mHealth pilot projects have
demonstrated the importance of public-‐private partnerships. A scaled mHealth innovation will require
sustainable funding, the identification of stakeholders, and the involvement of multilateral agencies,
civil society organizations, academia, the private ICT industry, and the South African government. It
would be advantageous for the South African Government to build on the successes of existing
pharmaceutical supply chain management mHealth programs in SSA.
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 19
Widespread mobile phone use, an advanced ICT network, and an enabling policy environment suggest
that the potential to implement mHealth in South Africa to improve supply chain management is great.
However, it should be noted that introducing mHealth will likely create additional management
responsibilities. In South Africa there are skilled human resource shortages in the healthcare sector and
an unfavorable culture of service delivery. Until such resource constraints can be ameliorated, it is
unlikely that introducing innovative approaches will produce beneficial results.
INNOVATIONS IN ACCESS TO ESSENTIAL MEDICINES: FOCUS ON SOUTH AFRICA 20
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