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Solving the problem of access to cardiovascular medicines: Revolving fund pharmacy models in rural western Kenya

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Availability of medicines for treatment of cardiovascular disease (CVD) is low in low-income and middle-income countries (LMIC). Supply chain models to improve the availability of quality CVD medicines in LMIC communities are urgently required. Our team established contextualised revolving fund pharmacies (RFPs) in rural western Kenya, whereby an initial stock of essential medicines was obtained through donations or purchase and then sold at a small mark-up price sufficient to replenish drug stock and ensure sustainability. In response to different contexts and levels of the public health system in Kenya (eg, primary versus tertiary), we developed and implemented three contextualised models of RFPs over the past decade, creating a network of 72 RFPs across western Kenya, that supplied 22 categories of CVD medicines and increased availability of essential CVD medications from <30% to 90% or higher. In one representative year, we were able to successfully supply 5 793 981 units of CVD and diabetes medicines to patients in western Kenya. The estimated programme running cost was US$6.5–25 per patient, serving as a useful benchmark for public governments to invest in medication supply chain systems in LMICs going forward. One important lesson that we have learnt from implementing three different RFP models over the past 10 years has been that each model has its own advantages and disadvantages, and we must continue to stay nimble and modify as needed to determine the optimal supply chain model while ensuring consistent access to essential CVD medications for patients living in these settings.
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TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
Solving the problem of access to
cardiovascular medicines: revolving
fund pharmacy models in rural
western Kenya
Dan N Tran ,1,2,3 Imran Manji,4 Benson Njuguna,4 Jemima Kamano,3,5
Jeremiah Laktabai,3,6 Edith Tonui,7 Rajesh Vedanthan ,3,8 Sonak Pastakia 1,2,3
Original research
To cite: TranDN, ManjiI,
NjugunaB, etal. Solving
the problem of access to
cardiovascular medicines:
revolving fund pharmacy
models in rural western
Kenya. BMJ Global Health
2020;5:e003116. doi:10.1136/
bmjgh-2020-003116
Handling editor Seye Abimbola
DNT and IM contributed equally.,
RV and SP contributed equally.
DNT and IM are joint rst
authors.
RV and SP are joint senior
authors.
Received 9 June 2020
Revised 17 September 2020
Accepted 20 September 2020
For numbered afliations see
end of article.
Correspondence to
Dr Dan N Tran;
tran. nk. tina@ gmail. com
© Author(s) (or their
employer(s)) 2020. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Availability of medicines for treatment of cardiovascular
disease (CVD) is low in low- income and middle- income
countries (LMIC). Supply chain models to improve the
availability of quality CVD medicines in LMIC communities
are urgently required. Our team established contextualised
revolving fund pharmacies (RFPs) in rural western Kenya,
whereby an initial stock of essential medicines was
obtained through donations or purchase and then sold at a
small mark- up price sufcient to replenish drug stock and
ensure sustainability. In response to different contexts and
levels of the public health system in Kenya (eg, primary
versus tertiary), we developed and implemented three
contextualised models of RFPs over the past decade,
creating a network of 72 RFPs across western Kenya, that
supplied 22 categories of CVD medicines and increased
availability of essential CVD medications from <30% to
90% or higher. In one representative year, we were able to
successfully supply 5 793 981 units of CVD and diabetes
medicines to patients in western Kenya. The estimated
programme running cost was US$6.5–25 per patient,
serving as a useful benchmark for public governments to
invest in medication supply chain systems in LMICs going
forward. One important lesson that we have learnt from
implementing three different RFP models over the past 10
years has been that each model has its own advantages
and disadvantages, and we must continue to stay nimble
and modify as needed to determine the optimal supply
chain model while ensuring consistent access to essential
CVD medications for patients living in these settings.
INTRODUCTION
Availability of medicines for treatment of
cardiovascular disease (CVD) is still consid-
ered suboptimal across many low- income
and middle- income countries (LMIC) world-
wide.1 In rural communities of low- income
and lower- middle income countries, avail-
ability of CVD medicines was estimated to
be between 3% and 37%, with up to 60%
of these medicines being unaffordable to
patients who need them.1 Limited access to
Key questions
What is already known?
Availability of medicines for treatment of cardio-
vascular disease (CVD) is still suboptimal across
many rural communities of low- income and
middle- income countries (LMIC) worldwide.
Limited access to CVD medicines for LMIC pa-
tient populations significantly hinders adherence
and increases morbidity and mortality, with sub-
sequent detrimental impact on economic produc-
tivity and development, poverty and inequality.
The revolving fund pharmacy (RFP) concept
represents a promising, pragmatic, affordable
and sustainable supply chain model for CVD
medicines.
What are the new ndings?
We developed and implemented three contex-
tualised models of RFPs over the past decade,
creating a network of 72 RFPs across western
Kenya that supplied 22 categories of CVD medi-
cines and increased availability of essential CVD
medications from <30% to 90% or higher.
In one representative year, we were able to suc-
cessfully supply 5 793 981 units of CVD and di-
abetes medicines to patients in western Kenya.
The estimated programme running cost was
US$6.5–25 per patient, serving as a useful
benchmark for public governments to invest in
medication supply chain systems in LMICs going
forward.
What do the new ndings imply?
The RFP model has the potential to significantly
improve access to CVD medicines for patients
and can be adapted and implemented in other
similar low- resource settings.
It is important to note that each supply chain
model has its own advantages and disadvan-
tages, and we must continue to stay nimble and
modify as needed to determine the optimal sup-
ply chain model while ensuring consistent ac-
cess to essential CVD medications for patients
living in these settings.
2TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
BMJ Global Health
CVD medicines for LMIC patient populations signifi-
cantly hinders adherence2 and increases morbidity and
mortality,3–5 with subsequent detrimental impact on
economic productivity and development, poverty and
inequality.6–11
The search for programmes to provide cost- effective
CVD prevention and treatment services in LMICs has
intensified over the last decade, but gaps persist in
ensuring reliable access to CVD medicines in resource-
limited settings, particularly in rural LMIC communi-
ties.2 12–15 In our practice setting in rural western Kenya,
the availability of CVD medicines is low, with availability
of originator- brand CVD medicines reported to be as
low as <5% and availability of generic CVD medicines
was <30% in the public sector,16 while the rise of falsi-
fied and substandard medicines remained concerning
to both consumers and the health system.17 These chal-
lenges are not unique to Kenya and are present in LMICs
worldwide. Thus, contextualised supply chain models to
deliver consistent and quality CVD medicines in Kenya
and similar LMIC communities are urgently required.2 18
The revolving drug fund concept represents a prom-
ising, pragmatic, affordable and sustainable supply chain
model for CVD medicines. In this model, an initial stock
of essential medicines is obtained through seed funding
and then sold at a small mark- up price that is sufficient to
replenish drug stock and ensure sustainability of the model
operation.19 20 Our investigator team has leveraged this
concept to successfully establish revolving fund pharma-
cies (RFPs) as a backup supply chain system for the Kenya
Ministry of Health (MOH), specifically in government-
owned/public sector health facilities. Starting with three
pilot RFPs, we have previously reported an increase in
availability of essential medicines from <10% pre- RFP
to >90% post- RFP.18 Despite this success, we recognised
that our initial efforts did not immediately reach the
more remote rural areas where a significant proportion
of our CVD patient population reside. Therefore, over
the past 9 years, we have continued to refine and build
on our pilot success to fill in this care gap, specifically
in public/governmental health facilities. Our previously
published RFP evaluation was primarily limited to non-
CVD essential medicines.18 Thus, this current evaluation
focuses specifically on how the RFP has been expanded
to address the needs for CVD and diabetes mellitus essen-
tial medicines and access.
In this paper, we describe our experience with
extending the RFP model to the lower- level public- sector
health facilities in the most rural areas of our western
Kenyan catchment area, in order to deliver medicines
for CVD and diabetes mellitus. We also describe how
we adjusted and calibrated according to local contexts,
ultimately remaining nimble and developing three
different models that were context- specific and allowed
for successful supply of CVD medicines. In addition, we
highlight the rationale for using each model in its respec-
tive context, an in- depth description of operations and
costs and a summary of impact on increasing medication
access. Last, we reflect on lessons learnt and future plans
in expanding our RFPs to other similar low- resource
settings.
METHODS
Programme setting
The Academic Model Providing Access to Healthcare
(AMPATH) programme is an academic partnership
between Moi University College of Health Sciences
(MUCHS), Moi Teaching and Referral Hospital and a
consortium of North American universities.21 In 2011,
AMPATH established a chronic disease management
(CDM) programme in collaboration with the Kenya
MOH to provide care for non- communicable diseases
such as hypertension and diabetes across seven different
counties in western Kenya, and we have enrolled over
50 000 patients since that time.17 The RFPs have played
a vital role within the AMPATH CDM programme by
ensuring reliable access to medication supplies for these
patients across MOH- supported county health facilities
in rural western Kenya.22
The original Model 1 RFPs were first established in 2011
to address the inadequate access to essential medicines,
particularly for patients living with chronic diseases at the
time.18 This model was referred to as the ‘community-
managed RFP model’ due to its significant engagement
with community stakeholders in its governance and
financial management. During the course of implemen-
tation over the past decade, our programme recognised
that we needed to be flexible and compliant with local
contexts in terms of geographical area, supervision, oper-
ation, financial accountancy and patient population.
As a result, we developed two additional RFP models
to address those needs. Model 2 RFPs were known as
‘AMPATH- managed RFPs’, having their governance and
finances being overseen by AMPATH, while Model 3 RFPs
were ‘facility- managed RFPs’, with their operation being
managed directly by health facilities in which these RFPs
existed. Thus far, we have implemented a network of 72
RFPs across all levels of the health system in Kenya, from
level 1 (community), level 2 (health dispensaries), level
3 (health centres), level 4 (subcounty hospitals), level 5
(county hospitals), to level 6 (tertiary referral hospitals).
Currently, we have 15 community- managed RFPs (Model
1), 7 AMPATH- managed RFPs (Model 2) and 50 facility-
managed RFPs (Model 3).
Data sources
This is a retrospective study using administrative data
reports that were collected as part of the usual operation
of the RFPs in a predefined time period between 1 April
2011 through 31 December 2018. Our three primary
data sources included (1) memorandum of under-
standing (MOU) agreements with the county health
facilities (2011–2018), (2) inventory audit reports (2018)
and (3) financial reports (2011–2018). First, MOU agree-
ments provided historic descriptions of each of our
TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116 3
BMJ Global Health
RFP models, detailing how operational guidance, finan-
cial details, reporting mechanisms, accountability and
governance were established. Second, inventory audit
reports provided quantitative description of medication
supply (defined as total quantity of medications sold)
and availability (defined as average percentage of days
per year when the audited medications were present at
health facilities where the RFPs operated). RFP inventory
audits are carried out routinely for supervision purposes
and typically involve doing a physical stocktake, recon-
ciling cash collections, tallying prescriptions served and
calculating revenue earned at each RFP site. On average,
inventory audits are carried out on a quarterly basis, but
this can be as frequent as two times a month if the RFP is
new. Inventory audit reports include information related
to medication supply (for medications supplied to the
RFP) and availability (for selected tracer medications) per
reporting period. We purposefully chose to report data
from 2018 for two reasons. We began our data collection
process in 2019. As a result, we chose to report data up
to end of 2018 to have a complete annual/calendar- year
dataset. We could have reported data from 2011 up to
2018. However, our RFP programme is very much based
on an iterative process over a period of almost 10 years.
During this time period, new pharmacies were built while
some pharmacies were closed and/or acquired by larger
RFPs to more efficiently operate. Meanwhile, it took
several years for us to build a rigorous data reporting
system; as a result, there is a data scarcity in the first few
years of our operation. We believe that our data quality
in the year of 2018 best represents the current status of
where our programme is standing at the moment. Last,
financial reports for each of the three RFP models were
used to estimate costs associated with the establishment
of each RFP site, including setup costs, running costs and
administrative costs.
Data analysis
We qualitatively reviewed established MOUs and catego-
rised the content of all MOUs for each RFP model into
governance, operations and inventory, accounting and
financial reporting mechanisms. Two pharmacists (IM
and DT) worked together to review all inventory audit
reports. On average, there were a total of four audit
reports per RFP site in 2018. Essential CVD medicines
were selected from the list of medications audited and
categorised based on (1) pharmacological categories,
(2) level of health facility at which medications were
dispensed and (3) the model of the RFP. We calculated
supply by summating the number of medication units
(ie, tablets, capsules or vials) supplied and dispensed for
each medicine over a 12- month period.
For availability, frequencies were calculated for each
medicine and averaged over a period of 12 months. We
included availability data for only Models 1 and 2 as these
audit reports were most consistently available during our
predefined time period. Model 3 reports were not consis-
tently available as these audits were not formally carried
out on a scheduled basis by MOH health facilities; there-
fore, Model 3 was not included in the availability analysis.
Historical financial reports for all RFPs at the time of
their establishment and financial reports in the year of
2018 were compiled. For each RFP model, we recorded
one- time setup cost and annual running costs per phar-
macy in that model. One- time setting- up costs included
facility renovation, seed stock of drugs and travel costs.
Annual running costs included personnel, supervi-
sion, transportation, cost waivers for indigent patients,
programme leadership and management. Individual
pharmacy costs were summated per RFP, and total costs
were calculated by multiplying individual costs per phar-
macy by the total number of RFPs in each model. Total
costs were reported in terms of total setting- up cost in
the first year of operation (ie, one- time cost) and total
running cost per year in subsequent years per RFP model.
To estimate the running cost per patient, we divided the
total running costs by an estimated number of patients
receiving one medication unit per day in a year.
Patient and public involvement
Because this was a retrospective using programmatic
and administrative data reports, patients or the public
were not directly involved in the design or conduct of
the research. However, our patients have been intimately
engaged and their needs have been the inspiration of the
implementation of the RFP model since the inception
of this programme in 2011. Results from this published
study will be reported and disseminated widely with the
local health facility in- charges, the AMPATH Leadership,
as well as the Ministry of Health of Kenya in order to
advocate for further expansion of this impactful supply
chain model to improve access to CVD and diabetes
medications for the public.
RESULTS
Description of revolving fund pharmacy (RFP) models
We describe similarities and differences for RFP Models
1–3 in detail to shed light on the evolution of the
different models we have developed as well as how they
are managed. Table 1 provides a summary of this infor-
mation.
Model 1: Community-managed RFP
This was the original RFP model in which a separate
and parallel pharmacy was set up within the County
health facility, as a backup to the existing facility phar-
macy in case of stockouts and patients were not able to
access essential medicines from the facility pharmacy.
While we were working to strengthen the county medi-
cation supplies through the main facility pharmacies, we
recognised that this would take time to fully implement.
Therefore, the Model 1 RFPs formed a backup system
to address immediate medication access needs while we
continued to work with county governments and facili-
ties to address systemic supply chain challenges. As a
result, the following stakeholders, the MOH, the facility
4TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
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in- charge personnel, local community representatives
and AMPATH, managed the RFPs.18 Drug procurement
was done centrally by the AMPATH programme to get
the best possible pricing for medicines through bulk
procurement. Because Kenyan national health insurance
did not cover outpatient CVD medication costs, phar-
macies within the public- sector health system charged
copays for medications. Thus, the community- managed
RFP model also charged copays for medications, but
with a minimal average 10% markup above the facility
price. The markup served two purposes: (1) we ensured
preferential refill of drugs in the county pharmacy if in
stock, hence encouraging the RFP’s sustainability and
growth rather than competition and (2) the additional
RFP revenue helped maintain the pharmacy and offset
other expenses. For a small subset of patients who were
unable to afford copays, a waiver system was in place to
support those patients. Essentially, a social worker inde-
pendently assessed a patient’s ability to pay and recom-
mended a full or partial waiver, where applicable.18
Revenue was collected into a bank account separate
from the health facility account and representatives from
each stakeholder were assigned as joint signatories to the
account. In this model, the pharmacy had a full formu-
lary of essential medicines and was run daily either by an
existing facility pharmaceutical technologist or an RFP-
hired pharmaceutical technologist using the revenue
generated from the sale of medicines. These RFPs were
Table 1 Summary of all RFP Models 1–3
General characteristics
and overall management
mechanisms
Model 1
Community- managed RFP
Model 2
AMPATH- managed RFP
Model 3
Facility- managed RFP
Year established 2011 2012 2013
Total number of RFPs
established as of 2018
15 7 50
Total number of health
facilities with RFPs by
levels of care (level 1–6)*
as of 2018
Level 2: 3 facilities
Level 3: 5 facilities
Level 4: 6 facilities
Level 5: 1 facility
Level 3: 1 facility
Level 4: 3 facilities
Level 5: 2 facilities
Level 6: 1 facility
Level 2: 31 facilities
Level 3: 11 facilities
Level 4: 8 facilities
Cumulative number of
patients served between
2011 and 2018
Hypertension: 10 622
Diabetes: 4231
Hypertension: 13 916
Diabetes: 10 943
Hypertension: 11 239
Diabetes: 2598
Total: 14 853 Total: 24 859 Total: 13 837
Copay waiver system Yes Yes Minimal
Governance and
stakeholders County MOH and facility
leadership
Local community representatives
AMPATH
County MOH and facility
leadership
Local community
representatives
AMPATH
County MOH and facility
leadership
AMPATH CDMprogramme
Operation
Existing MOH pharmaceutical
technologist
OR
Occasional newly RFP- hired
pharmaceutical technologist
New RFP- hired
pharmaceutical technologist Nurse in- charge or clinical
ofcer in- charge
OR
Occasional support from the
AMPATH CDM programme
Medicine procurement Direct bulk procurement through
AMPATH programme
Direct bulk procurement through
AMPATH programme
Indirectly through regional
Model 1 and 2 RFPs
Medicine inventory report Carried out by RFP supervisors on a
quarterly basis
Carried out by RFP supervisors
on a quarterly basis
Carried out by MOH health
facilities on a needs- based
schedule
Financial and accounting
reports
Carried out by RFP supervisors on a
quarterly basis (via RFP developed
electronic databases including an
internally designed Excel database
and QuickBooks)
Carried out by RFP supervisors
on a quarterly basis (via
RFP developed electronic
databases including an internally
designed Excel database and
QuickBooks))
Carried out by health facilities
and AMPATH CDM programme
on a needs- based schedule
(via existing health facility
databases including paper-
based bin cards)
Management of revenue Jointly by County MOH, local
community and AMPATH
Only by AMPATH Research and
Sponsored Projects Ofce
Only by health facility
*Level 1=community- based care, Level 2=health dispensaries, Level 3=health centres, Level 4=subcounty hospitals, Level 5=county
hospitals, Level 6=tertiary/referral hospitals.
AMPATH, The Academic Model Providing Access to Healthcare; CDM, chronic disease management; RFP, revolving fund pharmacy.
TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116 5
BMJ Global Health
supervised by staff from AMPATH who routinely carry out
stocktakes and financial audits. During the initial evalu-
ation of RFP implementation, the availability of essen-
tial medicines improved from an average of 30%–40%
to >90%.18 In the period of the current analysis (2018),
this model was run in 15 facilities within the AMPATH
catchment area. These facilities had 10 662 patients who
were hypertensive and 4231 patients who were diabetic
cumulatively enrolled into care between 2011 and 2018.
Model 2: AMPATH-managed RFP
Due to restrictions in a few counties with regard to the
ability to open separate accounts for financial manage-
ment, in 2012, our programme developed the second
RFP model, in which the AMPATH programme directly
managed the RFP’s finances. The other stakeholders
(ie, county, local community representatives) were still
involved in the management of other aspects of the phar-
macy, such as staffing, inventory control and drug formu-
lary determination similar to Model 1. Drug procurement
was also done centrally by the AMPATH programme
in order to get the best possible pricing for medicines
through bulk procurement. Similar to Model 1, Model
2 RFPs were also set up as a separate and parallel to the
health facility pharmacy, for the same reason as described
above. However, the revenue collected was deposited
into an account administered by AMPATH’s Research
and Sponsored Projects Office. In 2018, there were
seven RFPs that used this model of operation. Facilities
using this model had 13 916 patients who were hyperten-
sive and 10 943 patients who were diabetic cumulatively
enrolled into care between 2012 and 2018.
In both Models 1 and 2, there were significant operating
costs associated with running the pharmacies including staff,
copay waivers, supervisory audits and transportation of medi-
cines and supervisors. For this reason, these models could
only be implemented in facilities that had a high patient
volume to generate sufficient revenues to sustain the fixed
operating costs of the RFP. It was difficult to implement these
models with relatively higher fixed costs in facilities with
lower patient volumes, which were generally located in the
more rural areas in closer proximity to communities and
villages. Because of AMPATH’s efforts to bring care as close
to patients as possible, another contextualised approach was
needed to increase medication access in remote rural areas
with limited patient densities. Model 3 was developed to
address this need.
Model 3: Facility-managed RFP
In 2013, as our AMPATH CDM programme expanded its
patient care effort to community- based and facility- based
care in the most rural community and the lowest- level
health facilities (ie, levels 1–3), we needed to develop
a supply chain system that could serve patients living in
close proximity to those very rural health facilities.17 23 24
At the time that AMPATH expanded its CDM programme
to the more rural areas and geographically decentral-
ised health facilities, historical MOH policies and proce-
dures for supplying medicines to these lower- level health
facilities did not include CVD medicines. For example,
the Kenya Essential Medicines List (KEML) 2016 and
previous versions limited CVD and diabetes medicines
to be stocked only in level 4 facilities or higher.25 All
seven antihypertensive medications (ie, amlodipine,
carvedilol, enalapril, hydralazine, hydrochlorothiazide,
losartan, methyldopa) and all antidiabetic medications
(ie, metformin and insulin preparations) had only been
designated to be used in level 4 or higher.25 Thus, health
facilities in levels 1–3 did not have a supply of these medi-
cines prior to the establishment of our RFP programme.
Therefore, level 1–3 facilities historically have never
stocked CVD and diabetes medicines. Because the
demand for CVD medicines at these facilities had histor-
ically not been met, the utilisation of the RFP framework
as a supply chain for these facilities was justified.2 17 18 25
We secured the approval of the Kenya MOH, local lead-
ership and facility administrators to integrate CVD and
diabetes clinical services as well as essential medications
into the lower primary care- level facilities. As such, the
RFP was also permitted to supply essential medications
for these conditions at the appropriate lower levels to
ensure medication access for patients. However, the
patient volumes at each of these lower- level facilities were
not sufficient to sustain a full RFP as described above in
Models 1 and 2.
The RFP Model 3 was therefore employed for these
low- volume facilities, in which dispensaries were supplied
with a limited formulary of CVD medications. Model 3
facilities got drugs procured indirectly through regional
Model 1 and 2 RFPs. In a few facilities, clinical officers
or nurses were too overwhelmed to dispense and main-
tain the inventory of RFP medicines. For these facili-
ties, pharmaceutical technologists from the AMPATH
CDM programme would accompany clinicians on clinic
days to the facility and dispensed the medicines from
tackle boxes stocked from the nearest Model 1 or 2 RFP.
Small quantities of the medicines were retained at the
facility in the event that patients dropped in for refills
before the next clinic day. Because of the small quanti-
ties of medicines and the fact that they were managed by
officers- in- charge of the facilities, there were no physical
and parallel pharmacies opened in these facilities. Medi-
cations were kept in tackle boxes or in a separate area
within the existing government pharmacies, and medi-
cine inventory audits were conducted by the health facili-
ties on a needs- based schedule. As of 2018, this model was
being used in 50 facilities, mostly dispensaries and some
health centres. These facilities had 11 239 patients who
were hypertensive and 2598 patients who were diabetic
cumulatively enrolled into care between 2013 and 2018.
Supply of CVD medications across RFP models
In 2018, a total of 5 793 981 CVD and diabetes medicine
units (ie, tablets, capsules, vials) were supplied to the RFPs
and purchased by patients across all three RFP models
and across all levels of the health system in western Kenya
(figure 1). RFP Model 2 supplied the highest number of
6TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
BMJ Global Health
medicines (2 640 563), primarily to county and tertiary
referral hospitals (levels 5 and 6). RFP Model 3 supplied
the second highest number of medicines (1 900 645),
primarily to the community- based care programme,
dispensaries and health centres (levels 1, 2 and 3). Last,
RFP Model 1 supplied 1 252 773 medicine units primarily
to dispensaries, health centre and subcounty hospi-
tals (levels 2, 3 and 4). The RFPs supplied a total of 22
different categories of CVD medicines: calcium channel
blockers, thiazide diuretics, loop diuretics, angiotensin-
converting enzymes inhibitors/angiotensin II receptor
blockers, beta blockers, antiplatelet agents, statins, oral
diabetes medications, insulin and other CVD medicines
(cardiac glycosides, potassium- sparing diuretic and fixed-
dose combination CVD medicines) (table 2).
Availability of tracer CVD medications across different levels
of health facilities and RFP models
As recommended by the Kenya MOH, eight tracer CVD
medicines (nifedipine, hydrochlorothiazide, enalapril,
furosemide (intravenous injection solution and tablets),
metformin, glibenclamide and insulin) were selected and
tracked in 2018 to determine how consistently available
essential CVD medicines were at all Model 1 and 2 RFP
sites.26 These eight medicines were selected because they
were represented on the KEML (2018), the Kenya National
Guidelines for Cardiovascular Disease Management
(2018), the National Clinical Guidelines for Management
of Diabetes (2010) and the local AMPATH guidelines for
management of hypertension and diabetes (2018). Overall,
by health system level, a majority of tracer medicines were
present 94%–100% of the time at health facilities across
levels 2–6 (figure 2). The availability of insulin (Humulin
70/30) at levels 5 and 6 were 97% and 100%, respectively,
and 81%–85% at levels 2–4. These results were consistent
with the appropriateness of insulin prescribing practices in
Kenya, being more appropriate at the county (level 5) and
referral (level 6) hospitals where blood sugar monitoring
for patients could be more regularly done. By RFP model,
availability was also consistently above 95% in both RFP
models 1 and 2 (figure 3). One exception was injectable
furosemide 20 mg/2 mL being available at 88%, a relatively
lower rate in Model 2. This was due to one facility with low
availability that impacted the overall the average value for
Model 2.
Setting up cost, running cost, and patient cost associated
with each RFP model
Using financial reports collected when each RFP was
established and in 2018, we compiled a detailed cost
description to compare RFP model- specific average
cost per individual RFPs as well as total cost for all
Figure 1 A schematic description of the ow of RFP- supplied CVD medications across different levels of health facilities.
The above numbers represent medication units (ie, tablets, capsules or vials for insulin). Model 1=community- managed
RFPs, Model 2=AMPATH- managed RFPs, Model 3=facility- managed RFPs. Level 1=community- based care program, Level
2=dispensaries, Level 3=health centres, Level 4=subcounty hospitals, Level 5=county hospitals, Level 6=tertiary referral
hospitals. ACEIs, angiotensin- converting enzymes inhibitors; AMPATH, The Academic Model Providing Access to Healthcare;
APA, antiplatelet agents; ARBs, angiotensin- II receptor blockers; BB, beta blockers; CCB, calcium channel blockers; CVD,
cardiovascular disease; INS, insulin; LD, loop diuretics; OHA, oral hypoglycaemia agents; RFP, revolving fund pharmacy; STA,
statin; TD, thiazide diuretics.
TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116 7
BMJ Global Health
model- specific RFPs. Table 3 summarises the cost for
individual RFPs, the total cost for each RFP model and
the cost per patient. The ‘setting up cost’ to start an RFP
was $4100 per RFP for Models 1 and 2, and $110 per RFP
in Model 3. Annual running costs were $5820 per RFP
in Model 1, $6900 per RFP for Model 2 and $672 per
RFP in Model 3. Due to differences in the total number
of RFPs per model as summarised above, the total setup
and running costs were highest for Model 1, followed by
Model 2, then Model 3. Using 2018 running cost data
as well as the number of medication units dispensed to
patients in 2018, we estimated the annual programme
running cost per patient served. Our calculations yielded
an annual cost of approximately $25 per patient in Model
1, $6.7 per patient in Model 2 and $6.5 per patient in
Model 3.
DISCUSSION
This paper describes the evolution of our RFP programme
to increase access to essential CVD medications for patients
across different levels of the public sector healthcare
system in western Kenya. The RFP models evolved along-
side the Kenya MOH’s and the AMPATH CDM’s efforts to
decentralise and expand quality and affordable CVD care
to all patients within the public sector in western Kenya,
particularly in remote geographical regions where CVD
care and medications had never been delivered before.
Our experience with the various RFP models illustrates
that by staying adaptable, nimble and contextualised to
each of our patient populations and the environment in
which the RFP was being implemented, we were able to
ensure medication availability for different levels of care
and care needs.
The successful scalability of each of our RFP model in
the appropriate setting depended on three key compo-
nents which can be summarised as follows: (1) our ability
to define pharmaceutical gaps for CVD care by focusing
on the patients’ needs, (2) our priority to create local
adoption mechanisms by establishing governance and
engaging key stakeholders early in the process and (3)
our efforts to create support systems and ensure sustain-
ability by developing affordable patient copays, waivers
and accountability mechanisms through inventory,
financial and accounting systems. In addition, all reve-
nues remained within our funding pool to sustain and
expand more RFPs to other geographical locations to
Table 2 List of CVD medicines supplied by the RFP
Pharmacological
category Abbreviation Example
Calcium channel blockers CCB Amlodipine
Nifedipine
Felodipine
Thiazide diuretics TD Hydrochlorothiazide
Loop diuretics LD Furosemide
Angiotensin- converting
enzymes inhibitors/
Angiotensin- II receptor
blockers
ACEIs/ARBs Enalapril
Losartan
Beta blockers BB Atenolol
Metoprolol
Propranolol
Carvedilol
Antiplatelet agents APA Aspirin
Clopidogrel
Statins STA Atorvastatin
Oral diabetes medications OHA Metformin
Glibenclamide
Insulin INS Insulin Lispro
Insulin NPH
Insulin 70/30
Others Others Digoxin
Spironolactone
Lisinopril/
hydrochlorothiazide
CVD, cardiovascular disease; RFP, revolving fund pharmacy.
Figure 2 Average availability of tracer CVD medicines across different levels of health facilities for RFP Model 1 (community-
managed RFPs) and Model 2 (AMPATH- managed RFPs). Level 2=dispensaries, Level 3=health centres, Level 4=subcounty
hospitals, Level 5=county hospitals, Level 6=tertiary referral hospitals. AMPATH, The Academic Model Providing Access to
Healthcare; CVD, cardiovascular disease; RFP, revolving fund pharmacy.
8TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
BMJ Global Health
support patients. This would not have been possible
without predefined accountability mechanisms such
as the early establishment of governance and memo-
randa of understanding with key stakeholders, sched-
uled medicine inventory reports as well as financial and
accounting reports. These scale- up strategies are similar
to what have been described in previous literature and
frameworks.27 From a sustainability standpoint, all three
RFP models have made tremendous progress towards
self- sustainability over the past decade, as demonstrated
through the expansion of the model from 3 pilot sites
to 72 health facilities supported by the RFP programme;
the revenue recovered from drugs sold to maintain our
current operation and continuous expansion; and the
cost- sharing agreements between the Ministry of Health,
the local health facilities, and AMPATH/RFP.
We presented the three RFP models as distinct and
independent of each other; however, there is consider-
able overlap in the infrastructure on which each model
relies. It is worth noting that the implementation of the
original community- managed RFP model (ie, Model 1)
was essentially a prerequisite for the development of alter-
native RFP models (ie, models 2 and 3) in the following
years. In addition, by strategically leveraging a network of
RFPs that we have built across the entire health system,
our programme has the unique advantage to conduct
coordinated redistribution of medication stocks between
RFPs during the events of unplanned stock- outs or over-
stocks. Our ability to adapt to urgent supply chain issues
such as these ensures rational medication allocation,
adequate medications and other supplies to manage
patients from the healthcare providers’ standpoint, and
consistent access to CVD medications from the patients’
perspective. The lesson that we have learnt from imple-
menting three different RFP models over the past 10
years has been that each model has its own advantages
and disadvantages, and we must continue to stay nimble
and modify as needed to determine which model might
work best for the setting in which we are operating.
Through our network of RFPs, we were able to consis-
tently and adequately supply CVD medications to meet
the demand of our patients. In the year of 2018 alone, we
supplied close to 6 million medication units to patients
who would otherwise not have had access to affordable
CVD medications. This quantity of medications is equiv-
alent to supplying approximately 16 000 patients at least
one medication unit per day for the entire year. Critical
to being able to accomplish this was the utilisation of
core supply chain management strategies including pull
strategies (ie, medications provided are driven by our
patients’ demand) and push strategies (ie, ability to fore-
cast demand based on an understanding of local needs).
As a result, we have been able to increase availability of
generic CVD medications from the historical 30% or less
to 90% or higher across all levels of the health system.
We explicitly described the programme’s operational
costs in detail, per RFP and specific to each model. By
doing so, our goal was to widely disseminate useful and
practical information to other programmes around the
world that may be looking into replicating this innovative
supply chain model. Furthermore, this cost data profile
serves as a benchmark for future comparison for quality
improvement within our own programme as well as for
other similar supply chain programmes in similar LMIC
settings. Finally, these cost data can be helpful in providing
local government with cost information to better invest
and support an adequate government- led supply chain
system. We recognise, however, that these programmatic
cost data do not necessarily reflect affordability from the
patient’s perspective. More economic analyses will be
required to better understand patient- experienced costs.
It is notable that, in Kenya (as in other LMICs), there has
been a deliberate move towards universal healthcare,22
including a benefits package that includes outpatient
Figure 3 Average availability of tracer CVD medicines across RFP Model 1 (community- managed RFPs) and Model 2
(AMPATH- managed RFPs). AMPATH, The Academic Model Providing Access to Healthcare; CVD, cardiovascular disease; RFP,
revolving fund pharmacy.
TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116 9
BMJ Global Health
chronic disease medications, which represents the key
pillar to offset the medication cost realities that are a key
hindrance to adherence in low- resource settings.
Finally, our experiences with RFPs have highlighted
other persistent barriers that need to be addressed, such
as transportation costs, opportunity cost of missed work
and distance from health facilities. Building on the foun-
dation of our RFPs, we are currently testing an innova-
tive model of CVD medication refills whereby trained
peers with hypertension serve as drug delivery agents. In
addition to overcoming the above patient barriers, the
trained peers can provide psychosocial support, perform
simple screening for medication adherence, elicit
patient- reported adverse drug effects and health- seeking
behaviours specific to chronic asymptomatic CVD, all
of which can be immediately relayed to clinicians for
appropriate action.28 Our existing RFPs can be leveraged
to test new supply chain models to improve access from
both the supply and demand side for CVD medicines.2
Limitations
We acknowledge several key limitations to consider. First,
we were not able to analyse the medicine availability
profile for Model 3 RFPs due to the lack of consistent
reports from these sites. However, because these RFPs
received their medication supplies from nearby Model 1
or Model 2 RFPs, we can extrapolate the assumption that
Model 3 availability was similar to that seen in Model 1
and 2 (approximately 90% or above). Another key limi-
tation is that discrete patient- specific data could not be
analysed to show more detailed trends in terms of number
of patient visits, patient- specific medication refills,
Table 3 Programme setting up cost, programme running cost and programme running cost per patient served across RFP
models (in US$)
Category Type of cost Cost description
Model 1
Community- managed
RFP
Model 2
AMPATH- managed
RFP
Model 3
Facility- managed RFP
Cost per
RFP Total cost
Cost per
RFP Total cost
Cost per
RFP Total cost
Setting up
costs (one-
time costs)
Renovation Identied rooms are renovated
to meet specications of a
pharmacy
2000 30 000 2000 14 000 n/a n/a
Seed stock Initial drug stock plus
miscellaneous pharmacy
supplies (stationery, pill
counters and so on)
2000 30 000 2000 14 000 100 5000
Travel Meetings with facility
leadership, oversight of
renovations, delivery of seed
stock of drugs
100 1500 100 700 10 500
Total programme setting up cost (one- time cost) 4100 61 500 4100 28 700 110 5500
Running
costs (per
year)
Personnel Pharmaceutical technologist 2400 36 000 3000 21 000 240 12 000
Supervision Inventory management,
supervision and mentorship of
site staff
720 10 800 720 5040 120 6000
Transportation Transportation of supplies,
drugs, supervisory personnel
900 13 500 900 6300 72 3600
Waivers For indigent patients who are
unable to afford medications
360 5400 360 2520 Minimal Minimal
Programme
leadership and
management
Overall strategy planning,
oversight, audit, procurement
and nancial management
1440 21 600 1920 13 440 240 12 000
Total programme running cost (per year) 5820 87 300 6900 48 300 672 33 600
Quantity of medication units supplied (2018) 1 252 773 units 2 640 563 units 1 900 645 units
Estimated number of patients receiving at least one
medication unit per day for the entire year*
3432 patients 7234 patients 5207 patients
Programme running cost per patient served (per year)† 25 6.7 6.5
Programme average running cost per patient served (per
year)
10.6
*Estimated number of patients receiving at least one medication unit per day for the entire year=Quantity of medication units supplied in 2018÷365
days.
†Programme running cost per patient served=(Total running cost per model per year)÷(Estimated number of patients receiving at least one
medication unit per day for the entire year).
AMPATH, The Academic Model Providing Access to Healthcare; RFP, revolving fund pharmacy.
10 TranDN, etal. BMJ Global Health 2020;5:e003116. doi:10.1136/bmjgh-2020-003116
BMJ Global Health
adherence patterns and respective clinical outcomes
within the different models. While clinical outcomes
could not be described in this paper, AMPATH has a large
body of previously published papers describing the clin-
ical effectiveness of the overarching CDM care model, a
central component of which includes the RFP approach
to ensuring medication availability.13 29–31 Last, our
assessment was done from the perspective of the patient
and their needs. While it is possible that introducing a
backup pharmacy system may have unintended negative
consequences on the impetus for improving the MOH
pharmacies, it is our hope that this analysis provides the
evidence to support the ongoing advocacy and adoption
of RFP supply chain principles to ultimately improve the
MOH supply chain systems.
CONCLUSION
In this paper, we have described our implementation
experience and provide consumption and availability
data as well as initial and maintenance costs per RFP
model. We have described our iterative and contextual-
ised solutions that adapt to local conditions and settings.
We believe the RFP model has the potential to signifi-
cantly improve access to CVD medicines for patients and
can be adapted and implemented in other similar low-
resource settings.
Author afliations
1Pharmacy Practice, Purdue University College of Pharmacy, Indianapolis, IN, USA
2Pharmacology and Toxicology, Moi University College of Health Sciences, Eldoret,
Kenya
3Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya
4Pharmacy, Moi Teaching and Referral Hospital, Eldoret, Kenya
5Medicine, Moi University College of Health Sciences, School of Medicine, Eldoret,
Kenya
6Family Medicine, Moi University College of Health Sciences, School of Medicine,
Eldoret, Kenya
7Pharmacy, Kericho County Referral Hospital, Kericho, Kenya
8Department of Population Health, New York University Grossman School of
Medicine, New York, NY, USA
Twitter Rajesh Vedanthan @rvedanthan
Acknowledgements We thank Eunice Kosgei, Phelix Were, Kenneth Too, James
Kamadi, Rogers Boit, Maureen Tuei, Moses Rotich, Kennedy Nabongo, Sabinah
Atieno, Carren Soita, Amos Kiplagat, Caren Chepngetich and Elizabeth O’Hara
for their direct technical assistance and intellectual discussions over the years
to support the Revolving Fund Pharmacy programme. We also thank Abbott
Diabetes Care for providing glucose testing supplies, Eli Lilly and Company
for donating insulin, AstraZeneca and Abvie for providing nancial support
to the CDM programme and the Pzer Global Health Fellows programme for
providing volunteer staff. The work described in this article was supported in
part by the President’s Emergency Plan for AIDS Relief through the U.S. Agency
for International Development under the terms of Cooperative Agreement No.
AID-623- A-12–0001.
Contributors DNT and IM conceived and designed the work; acquired, analysed
and interpreted the data; drafted, revised and approved the nal manuscript. RV
and SP conceived and designed the work; interpreted the data; drafted, revised and
approved the nal manuscript. BN conceived and designed the work; interpreted
the data; drafted and approved the nal manuscript. JK and JL conceived the work;
interpreted the data; revised and approved the nal manuscript. ET conceived and
designed the work; interpreted the data; drafted and approved the nal manuscript.
Funding The authors have not declared a specic grant for this research from any
funding agency in the public, commercial or not- for- prot sectors.
Disclaimer The contents of this article are the sole responsibility of AMPATH and do
not necessarily reect the views of USAID or the US government.
Competing interests Sonak Pastakia serves as a consultant for Abbott and
Becton Dickinson on work unrelated to the study being presented here. The other
authors declare that they have no competing interests.
Patient and public involvement Patients and/or the public were not involved in
the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the
article. Original data are available on request.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the
use is non- commercial. See:http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
ORCID iDs
Dan NTran http:// orcid. org/ 0000- 0002- 8332- 8196
RajeshVedanthan http:// orcid. org/ 0000- 0001- 7138- 2382
SonakPastakia http:// orcid. org/ 0000- 0003- 4259- 695X
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... A well-functioning supply chain system for antihypertensive medications is crucial in ensuring optimal medication possession and adherence for hypertensive patients [19]. Our team at the Academic Model Providing Access to Healthcare (AMPATH) partnership has implemented numerous community-centric and health system-responsive strategies over the past decade to establish a reliable, consistent, and accountable supply chain system for essential cardiovascular disease medications [20][21][22][23]. We have improved the availability of essential CVD medications from <30% to >90% across our catchment area in western Kenya [20]. ...
... Our team at the Academic Model Providing Access to Healthcare (AMPATH) partnership has implemented numerous community-centric and health system-responsive strategies over the past decade to establish a reliable, consistent, and accountable supply chain system for essential cardiovascular disease medications [20][21][22][23]. We have improved the availability of essential CVD medications from <30% to >90% across our catchment area in western Kenya [20]. However, despite these successes in system-level supply, gaps remain with respect to patientlevel possession of antihypertensive medications, leading to suboptimal adherence and worse blood pressure control [21]. ...
... In 2011, AMPATH established a Chronic Disease Management (CDM) program in collaboration with the Kenya Ministry of Health (MOH) to provide care for non-communicable diseases in western Kenya, enrolling over 50,000 patients since that time [27]. The CDM program provides multi-component clinical care for patients primarily at health facilities [20,[28][29][30][31], and also at the community level through a group medical visit model entitled Bridging Income Generation with grouP Integrated Care (BIGPIC) [32,33]. BIGPIC Family extends the BIGPIC model of care to encompass comprehensive primary care to be provided by family medicine-trained clinicians in the community. ...
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Non-adherence to antihypertensive medications is a major cause of uncontrolled hypertension, leading to cardiovascular morbidity and mortality. Ensuring consistent medication possession is crucial in addressing non-adherence. Community-based medication delivery is a strategy that may improve medication possession, adherence, and blood pressure (BP) reduction. Our program in Kenya piloted a community medication delivery program, coupled with blood pressure monitoring and adherence evaluation. Between September 2019 and March 2020, patients who received hypertension care from our chronic disease management program also received community-based delivery of antihypertensive medications. We calculated number of days during which each patient had possession of medications and analyzed the relationship between successful medication delivery and self-reported medication adherence and BP. A total of 128 patient records (80.5% female) were reviewed. At baseline, mean systolic blood pressure (SBP) was 155.7 mmHg and mean self-reported adherence score was 2.7. Sixty-eight (53.1%) patients received at least 1 successful medication delivery. Our pharmacy dispensing records demonstrated that medication possession was greater among patients receiving medication deliveries. Change in self-reported medication adherence from baseline worsened in patients who did not receive any medication delivery (+0.5), but improved in patients receiving 1 delivery (-0.3) and 2 or more deliveries (-0.8). There was an SBP reduction of 1.9, 6.1, and 15.5 mmHg among patients who did not receive any deliveries, those who received 1 delivery, and those who received 2 or more medication deliveries, respectively. Adjusted mixed-effect model estimates revealed that mean SBP reduction and self-reported medication adherence were improved among individuals who successfully received medication deliveries, compared to those who did not. A community medication delivery program in western Kenya was shown to be implementable and enhanced medication possession, reduced SBP, and significantly improved self-reported adherence. This is a promising strategy to improve health outcomes for patients with uncontrolled hypertension that warrants further investigation.
... Medicine pricing policies sought to achieve two main aims: a) control or reduce the prices of medicines and b) improve access to essential medicines. Some studies reported separate effects on medicine prices (37, 38, 40-42, 44, 46, 49, 54), or improved access to essential medicines (39,50,51,66). However, as shown in Table 3, many studies reported on both effects (45,47,48,(55)(56)(57)(58)(59)(60)(61)(62)(63)(64). ...
... Fifteen studies reported evidence of policy effect on improved availability and affordability to essential medicines (45, 48, 50, 51, 55-63, 66, 67). In Kenya, implementation of a revolving fund pharmacy model improved the availability of essential medicines from 30% to 40% to over 90% in 15 health facilities (66). In South Africa, when generic reference pricing was implemented, the use of generic rosuvastatin increased from 24% to 63.9% in the subsequent year and to 76.4% a year later (56). ...
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Background: High medicine prices contribute to increasing cost of healthcare worldwide. Many patients with limited resources in sub-Saharan Africa (SSA), are confronted with out-of-pocket charges, constraining their access to medicines. Different medicine pricing policies are implemented to improve affordability and availability. However, evidence on the experiences of implementations of these policies in SSA settings appears limited. To bridge this knowledge gap, we reviewed published evidence and answered the question: what are the key determinants of implementation of medicines pricing policies in SSA countries? Methods: We identified policies, examined implementation processes, key actors involved, contextual influences on and impact of these policies. We searched five databases and grey literature; screening was done in two stages following clear inclusion criteria. A structured template guided the data extraction and data analysis followed thematic narrative synthesis. The review followed best practices and reported using PRISMA guidelines. Results: Of the 5595 studies identified, 32 met the inclusion criteria. The results showed fourteen pricing policies were implemented across SSA between 2003 and 2020. These were in four domains: targeted public subsides, regulatory frameworks and direct price control, generic medicine policies and purchasing policies. Main actors involved were government, wholesalers, manufacturers, retailers, professional bodies, community members and private and public health facilities. Key contextual barriers to implementation were: limited awareness about policies, lack of regulatory capacity, and lack of price transparency in external reference pricing process. Key facilitators were: favourable policy environment on essential medicines, strong political will, and international support. Evidence on effectiveness of these policies on reducing prices of, and improving access to, medicines were mixed. Reductions in prices were reported occasionally and implementation of medicine pricing policy sometimes led to improved availability and affordability to essential medicines. Conclusions: Implementation of medicine pricing policies in SSA shows some mixed evidence of improved availability and affordability to essential medicines. It is important to understand country-specific experiences, diversity of policy actors and contextual barriers and facilitators to policy implementation. Our study suggests three policy implications: avoiding ‘one-size-fits-all’ approach, engaging both private and public sector policy actors in policy implementation and continuously monitor implementation and effects of policies. Systematic review protocol registration: PROSPERO registration number CRD42020178166.
... In recognition of the growing NCD burden in Kenya, AMPATH has established a chronic disease management program in collaboration with the Kenya Ministry of Health (MOH), operating in over 150 health facilities spanning all levels of the public sector health care system in western Kenya [3]. Over the past decade, the program has provided multicomponent care to over 40,000 individuals with hypertension and/or diabetes, grounded in the following principles: partnership with communities and governments [4], geographic decentralization of care, task redistribution [5], continuous supply of medications [6], group medical visits [7], and incorporation of social determinants of health into care delivery [8]. ...
... The authors affirm that we have not entered into an agreement with the funder that may have limited our ability to complete the research and we have had full control of all primary data. Figure 1: distribution of length to follow-up appointments for patients with diabetes seen from Feb-April 2020 Figure 2: number of clinic sessions (vertical bars) and patients seen (line graph) at PIC4C facilities from February to July 2020; solid horizontal bars indicate periods of COVID-19 public measures put into place by the government of Kenya; a ban on group gatherings was instated from March 15-July 7; curfew was enforced from March 27 and is ongoing; restrictions on movement started on April 6 and was lifted in phases starting July 7 Figure 3: number of screening visits for hypertension and diabetes from February to July 2020; solid horizontal bars indicate periods of COVID-19 public measures put into place by the Government of Kenya; a ban on group gatherings was instated from March 15-July 7; curfew was enforced from March 27 and is ongoing; restrictions on movement started on April 6 and was lifted in phases starting July 7 6 8. Rosenberg M, Amisi JA, Szkwarko D, Tran ...
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The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide, gravely threatening continuity of care for non-communicable diseases (NCDs), particularly in low-resource settings. We describe our efforts to maintain the continuity of care for patients with NCDs in rural western Kenya during the COVID-19 pandemic, using a five-component approach: 1) Protect: protect staff and patients; 2) Preserve: ensure medication availability and clinical services; 3) Promote: conduct health education and screenings for NCDs and COVID-19; 4) Process: collect process indicators and implement iterative quality improvement; and 5) Plan: plan for the future and ensure financial risk protection in the face of a potentially overwhelming health and economic catastrophe. As the pandemic continues to evolve, we must continue to pursue new avenues for improvement and expansion. We anticipate continuing to learn from the evolving local context and our global partners as we proceed with our efforts.
... 83 Lastly, creating innovative pharmacy models and distribution strategies at all levels of the health-care system will improve availability and patient-level access, leading to better patient adherence and clinical outcomes than is currently the case. [85][86][87] Financing Investments in HIV and AIDS specific programmes over the past few decades have inadvertently diverted needed financial resources to address the needs of other non-HIV programmes. 69,88,89 To mitigate against siloed funding that can result in the fragmentation of services, increased funding streams that support integration and align with national disease burdens and priorities are needed. ...
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As people age with HIV, their needs increase beyond solely managing HIV care. Ageing people with HIV, defined as people with HIV who are 50 years or older, face increased risk of both age-regulated comorbidities and ageing-related issues. Globally, health-care systems have struggled to meet these changing needs of ageing people with HIV. We argue that health systems need to rethink care strategies to meet the growing needs of this population and propose models of care that meet these needs using the WHO health system building blocks. We focus on care provision for ageing people with HIV in the three different funding mechanisms: President's Emergency Plan for AIDS Relief and Global Fund funded nations, the USA, and single-payer government health-care systems. Although our categorisation is necessarily incomplete, our efforts provide a valuable contribution to the debate on health systems strengthening as the need for integrated, people-centred, health services increase.
... In collaboration with the Kenyan Ministry of Health, AMPATH has established a Chronic Disease Management (CDM) Program, which has enrolled over 40,000 patients with hypertension at over 70 health facilities spanning all levels of the health system [20,21]. The multicomponent CDM care delivery package includes task redistribution [22], clinical decision support using HIT [23], consistent and secure medication supply [24], linkage and retention activities [25], community and stakeholder engagement [26], and social support for patients. ...
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Background Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study ( St rengthening Re ferral N etworks for Mana g ement of Hyper t ension Across the H ealth S ystem), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial. Methods We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey. Results The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions. Conclusions The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings. Trial registration Clinicaltrials.gov, NCT02501746 , registration date: July 17, 2015
... In collaboration with the Kenyan Ministry of Health, AMPATH has established a Chronic Disease Management (CDM) Program, which has enrolled over 40,000 patients with hypertension at over 70 health facilities spanning all levels of the health system (20,21). The multicomponent CDM care delivery package includes task redistribution (22), clinical decision support using HIT (23), consistent and secure medication supply (24), linkage and retention activities (25), community and stakeholder engagement (26), and social support for patients. ...
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Background Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study (Strengthening Referral Networks for Management of Hypertension Across the Health System), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial. Methods We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey. Results The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions. Conclusions The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings. Trial registration: Clinicaltrials.gov, NCT02501746, registration date: July 17, 2015, https://clinicaltrials.gov/ct2/show/NCT02501746
... Over the past decade the revolving fund pharmacy model has successfully addressed many supply-chain needs for essential medicines in alignment with the Kenya essential medicines list. [8][9][10] The scheme operates within the catchment area of the Academic Model Providing Access to Healthcare partnership, spanning across seven counties and serving a population of 8 million people in western Kenya. ...
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Problem: The coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide and threatened the supply of essential medicines. Especially affected are vulnerable patients in low- and middle-income countries who can only afford access to public health systems. Approach: Soon after physical distancing and curfew orders began on 15 March 2020 in Kenya, we rapidly implemented three supply-chain strategies to ensure a continuous supply of essential medicines while minimizing patients' COVID-19 exposure risks. We redistributed central stocks of medicines to peripheral health facilities to ensure local availability for several months. We equipped smaller, remote health facilities with medicine tackle boxes. We also made deliveries of medicines to patients with difficulty reaching facilities. Local setting: Τo implement these strategies we leveraged our 30-year partnership with local health authorities in rural western Kenya and the existing revolving fund pharmacy scheme serving 85 peripheral health centres. Relevant changes: In April 2020, stocks of essential chronic and non-chronic disease medicines redistributed to peripheral health facilities increased to 835 140 units, as compared with 316 330 units in April 2019. We provided medicine tackle boxes to an additional 46 health facilities. Our team successfully delivered medications to 264 out of 311 patients (84.9%) with noncommunicable diseases whom we were able to reach. Lessons learnt: Our revolving fund pharmacy model has ensured that patients' access to essential medicines has not been interrupted during the pandemic. Success was built on a community approach to extend pharmaceutical services, adapting our current supply-chain infrastructure and working quickly in partnership with local health authorities.
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Background Implementation science has been primarily focused on adoption of evidence-based interventions, and less so on sustainability, creating a gap in the field. The Global Research on Implementation and Translation Science (GRIT) Consortium is funded by the National Heart Lung and Blood Institute (NHBLI) to support the planning, implementation, and sustainability of Late-Stage Phase 4 Translational Research (T4TR) and capacity building for NCD prevention and control in eight low-and middle-income countries (LMICs). This paper highlights perspectives, including barriers, facilitators, opportunities, and motivators for sustaining capacity building and evidence-based hypertension interventions within LMICs. Methods Guided by the Capacity, Opportunity, Motivation, Behavior (COM-B) Model, this study surveyed GRIT consortium members on the barriers, facilitators, key motivators, and opportunities for sustaining capacity building and evidence-based hypertension interventions in LMICs. Thematic analysis was used to identify themes and patterns across responses. Results Twenty-five consortium members across all eight sites and from various research levels responded to the survey. Overarching themes identifying facilitators, key motivators and opportunities for sustainability included: (1) access to structured and continuous training and mentorship; (2) project integration with existing systems (i.e., political systems and health systems); (3) adaption to the local context of studies (i.e., accounting for policies, resources, and utilizing stakeholder engagement); and (4) development of interventions with decision makers and implementers. Barriers to sustainability included local policies and lack of infrastructure, unreliable access to hypertension medications, and lack of sufficient staff, time, and funding. Conclusion Sustainability is an important implementation outcome to address in public health interventions, particularly as it pertains to the success of these initiatives. This study provides perspectives on the sustainability of NCD interventions with a focus on mitigating their NCD burden in LMICs. Addressing multilevel factors that influence the sustainability of capacity building and interventions will have notable implications for other global NCD efforts going forward. Current and future studies, as well as consortium networks, should account for sustainability barriers outlined as it will strengthen program implementation, and long-term outcomes.
Chapter
The burden of cardiovascular disease (CVD) is increasing in low-and middle-income countries (LMICs), and it is estimated that nearly one-third of the CVD burden requires cardiac surgery as a component of management. Establishing an effective system for delivery of cardiac surgery in LMICs requires a team-based approach to CVD care. Non-surgical team members include cardiologists, internists, general practitioners, advanced practice providers, pharmacists, nurses, and community health workers. A multidisciplinary approach to CVD care promotes shared decision-making among these providers and results in improved outcomes for patients. Team members are involved throughout the care cascade which includes primordial, primary, secondary, and tertiary prevention, in addition to acute perioperative care and long-term follow-up. Though challenges may arise in implementing the team-based model in LMICs, many can be addressed through health systems strengthening. Ultimately, the team-based model can effectively leverage the healthcare workforce and provide integrated and effective care to cardiac surgical patients in LMICs.
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Background Incorporating social determinants of health into care delivery for chronic diseases is a priority. Objectives The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction. Methods The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes. Results A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined −11.4, −14.8, −14.7, and −16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (−8.5 to 0.7), 3.3 mm Hg (−7.8 to 1.2), and 2.3 mm Hg (−7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit. Conclusions A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746)
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Background: As the noncommunicable disease (NCD) burden is rising in regions with high HIV prevalence, patients with comorbid HIV and chronic NCDs may benefit from integrated chronic disease care. There are few evaluations of the effectiveness of such strategies, especially those that directly leverage and extend the existing HIV care system to provide co-located care for NCDs. Setting: Academic Model of Providing Access to Healthcare, Kenya, provides care to over 160,000 actively enrolled patients in catchment area of 4 million people. Methods: Using a difference-in-differences design, we analyzed retrospective clinical records of 3603 patients with comorbid HIV and hypertension during 2009-2016 to evaluate the addition of chronic disease management (CDM) to an existing HIV care program. Outcomes were blood pressure (BP), hypertension control, and adherence to HIV care. Results: Compared with the HIV standard of care, the addition of CDM produced statistically significant, although clinically small improvements in hypertension control, decreasing systolic BP by 0.76 mm Hg (P < 0.001), diastolic BP by 1.28 mm Hg (P < 0.001), and increasing the probability of BP <140/90 mm Hg by 1.51 percentage points (P < 0.001). However, sustained control of hypertension for >1 year improved by 7 percentage points (P < 0.001), adherence to HIV care improved by 6.8 percentage points (P < 0.001) and retention in HIV care with no gaps >6 months increased by 10.5 percentage points (P < 0.001). Conclusion: A CDM program that co-locates NCD and HIV care shows potential to improve BP and retention in care. Further evaluation of program implementation across settings can inform how to maximize hypertension control among patients with comorbid HIV, and better understand the effect on adherence.
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Health systems in sub-Saharan Africa are facing an ongoing HIV epidemic and increasing burden of noncommunicable disease. With the focus shifting to the development of comprehensive primary health care and chronic disease treatment, multidisease modeling is integral to estimating future health care needs. We extended an established agent-based model of HIV transmission to include hypertension in two rural settings: KwaZulu-Natal, South Africa, and western Kenya. We estimated that from 2018 to 2028 hypertension prevalence would increase from 40 percent to 46 percent in KwaZulu-Natal and from 29 percent to 35 percent in western Kenya, while HIV prevalence is stabilizing and predicted to decrease. As the health system burden in sub-Saharan Africa is changing, innovative chronic disease treatment and the broadening of successful programs, such as integrated HIV and noncommunicable disease care, are necessary to reach universal health care coverage.
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Introduction Understanding context and how this can be systematically assessed and incorporated is crucial to successful implementation. We describe how context has been assessed (including exploration or evaluation) in Global Alliance for Chronic Diseases (GACD) implementation research projects focused on improving health in people with or at risk of chronic disease and how contextual lessons were incorporated into the intervention or the implementation process. Methods Using a web-based semi-structured questionnaire, we conducted a cross-sectional survey to collect quantitative and qualitative data across GACD projects (n = 20) focusing on hypertension, diabetes and lung diseases. The use of context-specific data from project planning to evaluation was analyzed using mixed methods and a multi-layered context framework across five levels; 1) individual and family, 2) community, 3) healthcare setting, 4) local or district level, and 5) state or national level. Results Project teams used both qualitative and mixed methods to assess multiple levels of context (avg. = 4). Methodological approaches to assess context were identified as formal and informal assessments, engagement of stakeholders, use of locally adapted resources and materials, and use of diverse data sources. Contextual lessons were incorporated directly into the intervention by informing or adapting the intervention, improving intervention participation or improving communication with participants/stakeholders. Provision of services, equipment or information, continuous engagement with stakeholders, feedback for personnel to address gaps, and promoting institutionalization were themes identified to describe how contextual lessons are incorporated into the implementation process. Conclusions Context is regarded as critical and influenced the design and implementation of the GACD funded chronic disease interventions. There are different approaches to assess and incorporate context as demonstrated by this study and further research is required to systematically evaluate contextual approaches in terms of how they contribute to effectiveness or implementation outcomes.
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Background Sub-Saharan Africa continues to face the highest rate of mortality from diabetes in the world due to limited access to quality diabetes care. We assessed the quality of diabetes care in a rural diabetes clinic in western Kenya. Methods To provide a comprehensive assessment, a set of clinical outcomes, process, and structure metrics were evaluated to assess the quality of diabetes care provided in the outpatient clinic at Webuye District Hospital. The primary clinical outcome measures were the change in HbA1c and point of care blood glucose. In assessing process metrics, the primary measure was the percentage of patients who were lost to follow up. The structure metrics were assessed by evaluating different facets of the operation of the clinic and their accordance with the International Diabetes Federation (IDF) guidelines. Results A total of 524 patients were enrolled into the diabetes clinic during the predefined period of evaluation. The overall clinic population demonstrated a statistically significant reduction in HbA1c and point of care blood glucose at all time points of evaluation after baseline. Patients had a mean baseline HbA1C of 10.2% which decreased to 8.4% amongst the patients who remained in care after 18 months. In terms of process measures, 38 patients (7.3%) were characterized as being lost to follow up as they missed clinic visits for more than 6 months. Through the assessment of structural metrics, the clinic met at least the minimal standards of care for 14 out of the 19 domains recommended by the IDF. Conclusion This analysis illustrates the gains made in various elements of diabetes care quality which can be used by other programs to guide diabetes care scale up across the region. Electronic supplementary material The online version of this article (10.1186/s12902-018-0324-5) contains supplementary material, which is available to authorized users.
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Background: The evidence on the economic burden of cardiovascular disease (CVD) in low- and middle- income countries (LMICs) remains scarce. We conducted a comprehensive systematic review to establish the magnitude and knowledge gaps in relation to the economic burden of CVD and hypertension on households, health systems and the society. Methods: We included studies using primary or secondary data to produce original economic estimates of the impact of CVD. We searched sixteen electronic databases from 1990 onwards without language restrictions. We appraised the quality of included studies using a seven-question assessment tool. Results: Eighty-three studies met the inclusion criteria, most of which were single centre retrospective cost studies conducted in secondary care settings. Studies in China, Brazil, India and Mexico contributed together 50% of the total number of economic estimates identified. The quality of the included studies was generally low. Reporting transparency, particularly for cost data sources and results, was poor. The costs per episode for hypertension and generic CVD were fairly homogeneous across studies; ranging between $500 and $1500. In contrast, for coronary heart disease (CHD) and stroke cost estimates were generally higher and more heterogeneous, with several estimates in excess of $5000 per episode. The economic perspective and scope of the study appeared to impact cost estimates for hypertension and generic CVD considerably less than estimates for stroke and CHD. Most studies reported monthly costs for hypertension treatment around $22. Average monthly treatment costs for stroke and CHD ranged between $300 and $1000, however variability across estimates was high. In most LMICs both the annual cost of care and the cost of an acute episode exceed many times the total health expenditure per capita. Conclusions: The existing evidence on the economic burden of CVD in LMICs does not appear aligned with policy priorities in terms of research volume, pathologies studied and methodological quality. Not only is more economic research needed to fill the existing gaps, but research quality needs to be drastically improved. More broadly, national-level studies with appropriate sample sizes and adequate incorporation of indirect costs need to replace small-scale, institutional, retrospective cost studies.
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Background: The Academic Model Providing Access to Healthcare (AMPATH) has been a model academic partnership in global health for nearly three decades, leveraging the power of a public-sector academic medical center and the tripartite academic mission - service, education, and research - to the challenges of delivering health care in a low-income setting. Drawing our mandate from the health needs of the population, we have scaled up service delivery for HIV care, and over the last decade, expanded our focus on non-communicable chronic diseases, health system strengthening, and population health more broadly. Success of such a transformative endeavor requires new partnerships, as well as a unification of vision and alignment of strategy among all partners involved. Leveraging the Power of Partnerships and Spreading the Vision for Population Health. We describe how AMPATH built on its collective experience as an academic partnership to support the public-sector health care system, with a major focus on scaling up HIV care in western Kenya, to a system poised to take responsibility for the health of an entire population. We highlight global trends and local contextual factors that led to the genesis of this new vision, and then describe the key tenets of AMPATH's population health care delivery model: comprehensive, integrated, community-centered, and financially sustainable with a path to universal health coverage. Finally, we share how AMPATH partnered with strategic planning and change management experts from the private sector to use a novel approach called a 'Learning Map®' to collaboratively develop and share a vision of population health, and achieve strategic alignment with key stakeholders at all levels of the public-sector health system in western Kenya. Conclusion: We describe how AMPATH has leveraged the power of partnerships to move beyond the traditional disease-specific silos in global health to a model focused on health systems strengthening and population health. Furthermore, we highlight a novel, collaborative tool to communicate our vision and achieve strategic alignment among stakeholders at all levels of the health system. We hope this paper can serve as a roadmap for other global health partners to develop and share transformative visions for improving population health globally.
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Background: There is an increasing recognition that non communicable diseases impose large economic costs on households, societies and nations. However, not much is known about the magnitude of diabetes expenditure in African countries and to the best of our knowledge no systematic assessment of the literature on diabetes costs in Africa has been conducted. The aim of this paper is to capture the evidence on the cost of diabetes in Africa, review the methods used to calculate costs and identify areas for future research. Methods: A desk search was conducted in Pubmed, Medline, Embase, and Science direct as well as through other databases, namely Google Scholar. The following eligibility criteria were used: peer reviewed English articles published between 2006 and 2016, articles that reported original research findings on the cost of illness in diabetes, and studies that covered at least one African country. Information was extracted using two data extraction sheets and results organized in tables. Costs presented in the studies under review are converted to 2015 international dollars prices (I$). Results: Twenty six articles are included in this review. Annual national direct costs of diabetes differed between countries and ranged from I$3.5 billion to I$4.5 billion per annum. Indirect costs per patient were generally higher than the direct costs per patient of diabetes. Outpatient costs varied by study design, data source, perspective and healthcare cost categories included in the total costs calculation. The most commonly included healthcare items were drug costs, followed by diagnostic costs, medical supply or disposable costs and consultation costs. In studies that reported both drug costs and total costs, drug costs took a significant portion of the total costs per patient. The highest burden due to the costs associated with diabetes was reported in individuals within the low income group. Conclusion: Estimation of the costs associated with diabetes is crucial to make progress towards meeting the targets laid out in Sustainable Development Goal 3 set for 2030. The studies included in this review show that the presence of diabetes leads to elevated costs of treatment which further increase in the presence of complications. The cost of drugs generally contributed the most to total direct costs of treatment. Various methods are used in the estimation of diabetes healthcare costs and the costs estimated between countries differ significantly. There is room to improve transparency and make the methodologies used standard in order to allow for cost comparisons across studies.
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Background: Monitoring levels and trends in premature mortality is crucial to understanding how societies can address prominent sources of early death. The Global Burden of Disease 2016 Study (GBD 2016) provides a comprehensive assessment of cause-specific mortality for 264 causes in 195 locations from 1980 to 2016. This assessment includes evaluation of the expected epidemiological transition with changes in development and where local patterns deviate from these trends. Methods: We estimated cause-specific deaths and years of life lost (YLLs) by age, sex, geography, and year. YLLs were calculated from the sum of each death multiplied by the standard life expectancy at each age. We used the GBD cause of death database composed of: vital registration (VR) data corrected for under-registration and garbage coding; national and subnational verbal autopsy (VA) studies corrected for garbage coding; and other sources including surveys and surveillance systems for specific causes such as maternal mortality. To facilitate assessment of quality, we reported on the fraction of deaths assigned to GBD Level 1 or Level 2 causes that cannot be underlying causes of death (major garbage codes) by location and year. Based on completeness, garbage coding, cause list detail, and time periods covered, we provided an overall data quality rating for each location with scores ranging from 0 stars (worst) to 5 stars (best). We used robust statistical methods including the Cause of Death Ensemble model (CODEm) to generate estimates for each location, year, age, and sex. We assessed observed and expected levels and trends of cause-specific deaths in relation to the Socio-demographic Index (SDI), a summary indicator derived from measures of average income per capita, educational attainment, and total fertility, with locations grouped into quintiles by SDI. Relative to GBD 2015, we expanded the GBD cause hierarchy by 18 causes of death for GBD 2016. Findings: The quality of available data varied by location. Data quality in 25 countries rated in the highest category (5 stars), while 48, 30, 21, and 44 countries were rated at each of the succeeding data quality levels. Vital registration or verbal autopsy data were not available in 27 countries, resulting in the assignment of a zero value for data quality. Deaths from non-communicable diseases (NCDs) represented 72·3% (95% uncertainty interval [UI] 71·2–73·2) of deaths in 2016 with 19·3% (18·5–20·4) of deaths in that year occurring from communicable, maternal, neonatal, and nutritional (CMNN) diseases and a further 8·43% (8·00–8·67) from injuries. Although age-standardised rates of death from NCDs decreased globally between 2006 and 2016, total numbers of these deaths increased; both numbers and age-standardised rates of death from CMNN causes decreased in the decade 2006–16—age-standardised rates of deaths from injuries decreased but total numbers varied little. In 2016, the three leading global causes of death in children under-5 were lower respiratory infections, neonatal preterm birth complications, and neonatal encephalopathy due to birth asphyxia and trauma, combined resulting in 1·80 million deaths (95% UI 1·59 million to 1·89 million). Between 1990 and 2016, a profound shift toward deaths at older ages occurred with a 178% (95% UI 176–181) increase in deaths in ages 90–94 years and a 210% (208–212) increase in deaths older than age 95 years. The ten leading causes by rates of age-standardised YLL significantly decreased from 2006 to 2016 (median annualised rate of change was a decrease of 2·89%); the median annualised rate of change for all other causes was lower (a decrease of 1·59%) during the same interval. Globally, the five leading causes of total YLLs in 2016 were cardiovascular diseases; diarrhoea, lower respiratory infections, and other common infectious diseases; neoplasms; neonatal disorders; and HIV/AIDS and tuberculosis. At a finer level of disaggregation within cause groupings, the ten leading causes of total YLLs in 2016 were ischaemic heart disease, cerebrovascular disease, lower respiratory infections, diarrhoeal diseases, road injuries, malaria, neonatal preterm birth complications, HIV/AIDS, chronic obstructive pulmonary disease, and neonatal encephalopathy due to birth asphyxia and trauma. Ischaemic heart disease was the leading cause of total YLLs in 113 countries for men and 97 countries for women. Comparisons of observed levels of YLLs by countries, relative to the level of YLLs expected on the basis of SDI alone, highlighted distinct regional patterns including the greater than expected level of YLLs from malaria and from HIV/AIDS across sub-Saharan Africa; diabetes mellitus, especially in Oceania; interpersonal violence, notably within Latin America and the Caribbean; and cardiomyopathy and myocarditis, particularly in eastern and central Europe. The level of YLLs from ischaemic heart disease was less than expected in 117 of 195 locations. Other leading causes of YLLs for which YLLs were notably lower than expected included neonatal preterm birth complications in many locations in both south Asia and southeast Asia, and cerebrovascular disease in western Europe. Interpretation: The past 37 years have featured declining rates of communicable, maternal, neonatal, and nutritional diseases across all quintiles of SDI, with faster than expected gains for many locations relative to their SDI. A global shift towards deaths at older ages suggests success in reducing many causes of early death. YLLs have increased globally for causes such as diabetes mellitus or some neoplasms, and in some locations for causes such as drug use disorders, and conflict and terrorism. Increasing levels of YLLs might reflect outcomes from conditions that required high levels of care but for which effective treatments remain elusive, potentially increasing costs to health systems.
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Background: The UN's Sustainable Development Goals (SDGs) are grounded in the global ambition of “leaving no one behind”. Understanding today's gains and gaps for the health-related SDGs is essential for decision makers as they aim to improve the health of populations. As part of the Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016), we measured 37 of the 50 health-related SDG indicators over the period 1990–2016 for 188 countries, and then on the basis of these past trends, we projected indicators to 2030. Methods: We used standardised GBD 2016 methods to measure 37 health-related indicators from 1990 to 2016, an increase of four indicators since GBD 2015. We substantially revised the universal health coverage (UHC) measure, which focuses on coverage of essential health services, to also represent personal health-care access and quality for several non-communicable diseases. We transformed each indicator on a scale of 0–100, with 0 as the 2·5th percentile estimated between 1990 and 2030, and 100 as the 97·5th percentile during that time. An index representing all 37 health-related SDG indicators was constructed by taking the geometric mean of scaled indicators by target. On the basis of past trends, we produced projections of indicator values, using a weighted average of the indicator and country-specific annualised rates of change from 1990 to 2016 with weights for each annual rate of change based on out-of-sample validity. 24 of the currently measured health-related SDG indicators have defined SDG targets, against which we assessed attainment. Findings: Globally, the median health-related SDG index was 56·7 (IQR 31·9–66·8) in 2016 and country-level performance markedly varied, with Singapore (86·8, 95% uncertainty interval 84·6–88·9), Iceland (86·0, 84·1–87·6), and Sweden (85·6, 81·8–87·8) having the highest levels in 2016 and Afghanistan (10·9, 9·6–11·9), the Central African Republic (11·0, 8·8–13·8), and Somalia (11·3, 9·5–13·1) recording the lowest. Between 2000 and 2016, notable improvements in the UHC index were achieved by several countries, including Cambodia, Rwanda, Equatorial Guinea, Laos, Turkey, and China; however, a number of countries, such as Lesotho and the Central African Republic, but also high-income countries, such as the USA, showed minimal gains. Based on projections of past trends, the median number of SDG targets attained in 2030 was five (IQR 2–8) of the 24 defined targets currently measured. Globally, projected target attainment considerably varied by SDG indicator, ranging from more than 60% of countries projected to reach targets for under-5 mortality, neonatal mortality, maternal mortality ratio, and malaria, to less than 5% of countries projected to achieve targets linked to 11 indicator targets, including those for childhood overweight, tuberculosis, and road injury mortality. For several of the health-related SDGs, meeting defined targets hinges upon substantially faster progress than what most countries have achieved in the past. Interpretation: GBD 2016 provides an updated and expanded evidence base on where the world currently stands in terms of the health-related SDGs. Our improved measure of UHC offers a basis to monitor the expansion of health services necessary to meet the SDGs. Based on past rates of progress, many places are facing challenges in meeting defined health-related SDG targets, particularly among countries that are the worst off. In view of the early stages of SDG implementation, however, opportunity remains to take actions to accelerate progress, as shown by the catalytic effects of adopting the Millennium Development Goals after 2000. With the SDGs' broader, bolder development agenda, multisectoral commitments and investments are vital to make the health-related SDGs within reach of all populations.
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Background Access to medicines is important for long‐term care of cardiovascular diseases and hypertension. This study provides a cross‐country assessment of availability, prices, and affordability of cardiovascular disease and hypertension medicines to identify areas for improvement in access to medication treatment. Methods and Results We used the World Health Organization online repository of national essential medicines lists ( EML s) for 53 countries to transcribe the information on the inclusion of 12 cardiovascular disease/hypertension medications within each country's essential medicines list. Data on availability, price, and affordability were obtained from 84 surveys in 59 countries that used the World Health Organization's Health Action International survey methodology. We summarized and compared the indicators across lowest‐price generic and originator brand medicines in the public and private sectors and by country income groups. The average availability of the select medications was 54% in low‐ and lower‐middle‐income countries and 60% in high‐ and upper‐middle‐income countries, and was higher for generic (61%) than brand medicines (41%). The average patient median price ratio was 80.3 for brand and 16.7 for generic medicines and was higher for patients in low‐ and lower‐middle‐income countries compared with high‐ and upper‐middle‐income countries across all medicine categories. The costs of 1 month's antihypertensive medications were, on average, 6.0 days’ wage for brand medicine and 1.8 days’ wage for generics. Affordability was lower in low‐ and lower‐middle‐income countries than high‐ and upper‐middle‐income countries for both brand and generic medications. Conclusions The availability and accessibility of pharmaceuticals is an ongoing challenge for health systems. Low availability and high costs are major barriers to the use of and adherence to essential cardiovascular disease and antihypertensive medications worldwide, particularly in low‐ and lower‐middle‐income countries.