Novel models to improve access to medicines for chronic diseases in South Africa: an analysis of stakeholder perspectives on community-based distribution models

This section starts by presenting an overview of how CBD services are organised (Typology of CBD models) then presents the remaining findings according to the elements of the framework
(human resources, medicines, infrastructure and population). Finally, we present our findings related to governance, taking into account the implementation context.

Typology of CBD models

From the interviews with key informants, we found variation in focus and structure
of CBD models implemented in the Western Cape Province. Regarding geographical spread,
some areas had a single model while others had a combination of models. The mix of
models available in an area was primarily dependant on the presence and mandate or
interests of particular stakeholders whose activities tended to be geographically
demarcated. However, they were all linked to nearby PHC facilities for medicines supply.
In this article, we categorised them as formal and informal as explained below:

I.?Formal: Models officially recognised and approved by the WCDoH. Services were provided free
of charge to the patient. Formally recognised providers were expected to facilitate
referrals and linkage to care for patients at risk who require consultation with the
health provider. Some models were based on direct involvement of trained HCPs (i.e.
nurses and/or post-basic pharmacists), while others were driven by community health
workers (CHWs) with some basic health training, linked to NGOs.

II.?Informal: Models driven by entrepreneurs with no basic training in health. They charged a service
fee to the patient and were not officially recognised by the WCDoH. Informal providers
could be described in two ways: either operating under the ‘approval’ of mid-level
management or known anecdotally, but not easily identifiable. The latter operated
on a small-scale and could not be easily distinguished from a relative or friend collecting
medicines on behalf of the patient. At the time of research, service fees charged
by the known informal providers ranged from ZAR10.00–20.00, which was equivalent to
approximately US$1.00-2.00. It was unclear how informal providers market their services
or initiate services in the absence of the approval of senior provincial leadership.

Patient enrolment in all the CBD models was facilitated by nurses and health promoters
during club sessions (group-based education), and patients were asked to provide consent
for their information to be supplied to the service provider of their choice. Table 2 shows the range of models that we identified at our study sites. We acknowledge that
this list may not be exhaustive for the Cape Town metropolitan area.

Table 2. Overview of models for community based distribution of medicines

Resources

Human resources

As illustrated in Table 2, task shifting from pharmacists to other HCPs and Non-Health Professionals (NHPs)
is a common feature in CBD models. There was contention between participants about
the involvement of NHPs and their permitted scope of practice.

Proponents for task-shifting in CBD models argued that this mechanism could address
existing human resource shortages in the South African public sector by “de-medicalising”
treatment to ensure sustainability of models. Informants cited a situation illustrating
lack of sustainability of medicalised models: a clinical nurse practitioner was asked
to urgently return to the health facility from a CBD site leaving patients unattended
and necessitating their referral back to the health facility.

Another stakeholder (academic) argued that patient counselling by pharmacists, though
desired, was in most cases impractical. The informant’s own research showed that pharmacists
in the Western Cape spend an average of only three minutes (range: 2–4 min) of face-to-face
contact with a patient due to workload pressures. In light of these health workforce
issues, stakeholders suggested the need for greater efforts towards empowering patients
to manage their own therapy thereby reducing the need for regular contact with HCPs.

Those who opposed involvement of NHPs in CBD cited their lack of accountability to
statutory bodies as a major concern in delivering pharmaceutical services. This is
currently a grey area in the task-shifting discourse because statutory bodies only
regulate personnel who are registered with them.

Other concerns raised by participants related to the capacity of NHPs to: (i) conduct
quality assurance (QA) processes (e.g. verifying medicines before handing them over
to the patient), (ii) monitor therapeutic outcomes and (iii) link at-risk patients
to appropriate care. These tasks are outside their scope of practice therefore, perhaps
a more pertinent question is: which tasks should NHPs be expected to carry out? Many
informants argued that QA processes should be ensured by the Chronic Dispensing Unit
(CDU), a centralised dispensary responsible for dispensing and pre-packing of medicines
in the public sector in this province. If performed optimally by ensuring minimal
prescribing and dispensing errors, this would eliminate the need for checking parcels
at the distribution point upon issue to patients. With QA processes out of the way,
this would technically not be a full dispensing process, allowing NHPs to comfortably
participate in the process.

It seemed even pharmacists who were responsible for checking the pre-packed medicine
packages felt that the QA demands were time consuming and detracted from the intended
benefits of both the CDU (which was established to reduce pharmacists’ workload) and
of CBD (which was established to take the pressure off health facilities and to improve
access for patients).

While some informants mentioned that they would feel comfortable relying on CHWs to
issue medicines that were already checked at the CDU, some clinicians were still reluctant.
They suggested that CBD activities be placed under the responsibility of registered
pharmacy mid-level workers known as pharmacist’s assistants (PAs) as opposed to CHWs.
A further suggestion was engagement of private-sector pharmacies to distribute public-sector
medicines. In subsequent years, this model was proposed under the NHI scheme 37].

Medicines supply management

Our findings show that inefficiencies in procurement (a macro-level issue) affected
medicines availability at the CDU where dispensing for CBD programmes takes place.
As such, medicines omitted from parcels would require manual dispensing at health
facilities, another reason why informants were sceptical about NHPs involvement as
the final link to patients. As stated by a senior manager:

“I wouldn’t like at this stage for community health workers to give medication, because,
once in a while, something is missing, because of the out-of-stock situation. Now
we got a serious situation as well…the Cape Medical Depot cannot always supply because
of change of tender.”

Another contentious issue raised was the handling and storage of “non-collected” medicines,
i.e. parcels not collected by the patient on the appointment date. The handling of
medicines by untrained personnel and their storage in transient unregistered sites
casts doubt on the integrity of non-collected medicines and as such, these medicines
are usually disposed of with resultant cost implications. Informants were of the opinion
that some of these risks could be obviated if sites met minimum standards for medicine
storage.

Infrastructure and logistics

Securing reliable venues for CBD activities emerged as another important aspect of
CBD. During the time of our study, services were interrupted at one site because it
was no longer available for CBD. The PA at the site expressed concern about the potential
loss of confidence by patients experiencing service disruption. In addition to securing
venues, opening times for the venues needed careful consideration. This often called
for negotiation with the owners of the venue to ensure that times were suitable for
the patients.

Reliable transportation for medicine delivery to CBD sites was also identified as
a need. Government vehicles could be requested by PAs linked to formal CBD models,
but this transportation mode was not accessible to CHWs who often walked to sites
and carried the supplies. According to informants, the latter not only posed security
risks and environmental risks for the medicines, but created inefficiencies for CHWs
with home-based care duties who were often late for CBD activities. Informal providers
used bicycles and this was also feared to potentially render medicines vulnerable
to environmental risks.

Outcomes

Acceptability of CBD models and accommodation to clients’ practical circumstances

We used our observation data related to patient-provider and patient-patient interactions
during the CBD process to look into the acceptability of the models. Interactions between patients and providers and between patients were
largely positive. Patients showed no restraint in engaging with the providers involved
in CBD (both HPs and NHPs) even when they presented late for their appointments. In
some cases, CHWs reported taking the initiative to deliver medicines to patients’
homes when they failed to collect at community venues, a means of accommodating patients’ practical circumstances. These deviations from formal processes were merely
acts of goodwill facilitated by positive patient-provider relationships, but were
noted to contribute to acceptability. Furthermore, CHWs reported using cost-effective social media methods such as the
instant messaging application “WhatsApp” to remind patients of their appointments
and to follow-up with those who missed appointments. In this regard, the close patient-provider
interactions allowed for some degree of patient follow-up where there had been limited
to no follow-up mechanisms in the health system. These experiences also reveal a form
of grassroots innovation that could improve patient retention-in-care in the long-run.

Informants collectively felt that CBD models are suitable for patients who are empowered
to take responsibility for the management of their illness. From observation during
CBD operations, some patients were able to accurately identify their medicines, including
identifying any missing medicines when there were medicines availability challenges.

Despite the positive aforementioned aspects, there were some concerns with stigma.
At one site (a small municipal clinic which traditionally offered HIV services and
was later also used as a distribution site for NCD medicines), patients on ART raised
concerns about privacy because their appointments overlapped with patients enrolled
in NCD programmes. With medicine collection points for ART being distinct, patients
with HIV were easily identifiable and this was a huge concern for those who had not
disclosed to family and friends. This raised questions about the appropriateness of
integrating HIV and NCDs in the design of CBD models.

At a second site, providers also noticed similar reluctance from clients on ART. The
pharmacist’s assistant in charge of CBD at the site said:

“…we told them that it’s only them who are going there; there are a lot of offices
so no one will know why you are walking through that building, what you are going
to do there…”

While in principle, patients should be offered the choice to collect medicines at
CBD sites or at the health facility, in practice there seemed to be pressure to enrol
all patients onto CBD models, because of the perceived benefits for both the health
system and the patients. Asked if patients had a choice regarding their collection
point, one PA stated “…we don’t prioritise that freedom”. In their view, once patients experienced the benefits of CBD, they appreciated the
system and in most cases were no longer interested in the facility-based model.

Affordability to patients: to pay or not to pay for CBD services?

As stated earlier, the critical difference between the formal and informal CBD models
was that the former provides services at no charge to the patient while the latter
levies a user-fee. Many stakeholders grappled with the issue of paid services: some
senior managers expressed disapproval of imposing out-of-pocket payments on the premise
that medication was free and no direct charges should be introduced to the patients,
while others feared that the absence of regulation on levying fees could result in
patient exploitation. Indeed, some patients had apparently mentioned to informants
that the services were expensive for them but some HCPs still argued that paid services
were demand-driven and that many patients were willing to pay for a service offering
convenience. One nurse and PA were of the opinion that the elderly derived particular
benefits since they often have impaired mobility, lack family and other support to
collect medicine on their behalf and many stayed in areas that are not served by formal
models. Also, the formal models had limited capacity to serve a large population.
Some respondents felt that paid services offset the usual indirect costs for transport
fees to the health facility and thus had no objection to charging fees for CBD services.

At the time of our study, one of the four study sites had no history of “fee-for”
services, a second site still charged a fee and the remaining two sites had been mandated
to cease services that attached a fee. Although some frontline HCPs approved of services
levied for a fee at the second site, senior managers had strong reservations. However,
HCPs reported that some patients still enquired about the service and attributed increased
non-collection of medicines to the management’s decision to stop these paid services.
One pharmacist elaborated as follows:

“A few years ago, we had a courier service that was privately run and we had an objection
from the government that it’s unconstitutional to charge patients from a primary health
care level. Then we stopped it. The patients benefited a lot from it and up to this
day, patients are still asking “When is it coming back and why can’t we have it back?”,
because they were prepared to pay. But the department said it is criminal for patients
who can’t afford the service. It didn’t make sense to us but it came from the top
level to be stopped basically, but it was working well and we were pushing almost
200 parcels a day from the facility.” [Pharmacist]

In essence, views on paid services were quite divergent, with provincial managers
expressing the need to safeguard patients against exploitation and with some frontline
HCPs indicating that paid for services are demand-driven and should remain an option
to patients.

Governance: Policy and regulatory issues

As stated earlier, for any service delivery model to function effectively, all health
system elements require good governance in the form of policies and regulatory frameworks
which consider the population’s needs and demands.

At the time of this study, there was no policy to institute CBD models and guide the
implementation efforts in the Western Cape. Stakeholders were not aware of policies
in other parts of the world enabling the use of non-registered sites for distribution
of medicines for chronic diseases and as an interim measure, they developed standard
operating procedures (SOPs), based loosely on available pharmacy and health regulations.
Stakeholder views on these SOPs varied. As one provincial manager explained:

“… this (CBD) is new … There was, like, really no definite law to guide the Pharmacy
Council. So, whatever has happened has been an interpretation of the law by someone
(provincial stakeholders) …”

We were informed by a key actor during this study that some engagement between provincial
and national stakeholders responsible for the policy making process had commenced
by 2014. The South African Pharmacy Council (SAPC), which is the statutory professional
body for pharmacy, together with the National Department of Health (NDoH) which has
oversight of health activities and legislation, were cited as the two governance bodies
responsible for drafting legislation. While recognising that CBD policy development
is a national priority and that the process of policy-making can be slow, stakeholders
insinuated that the process has not been altogether transparent. We found there was
limited consultation of frontline HCPs on the issue and that no feedback on progress
of the policy development process was given at this level. One senior manager had
some information on the process and reported that a task team had been set-up and
was steadily working on developing the policy.

Stakeholder perspectives on the future CBD policy

In general, informants envisaged that the policy will define organisation of CBD services
to ensure the delivery of quality pharmaceutical services as defined by the Good Pharmacy
Practice (GPP) standards 38]. There were some shared concerns that some aspects inherent to CBD models do not
meet GPP standards, inter alia, medicines handling and storage and possible lack of patient counselling.

Some stakeholders justified the current structure of CBD services while others showed
disfavour towards some aspects of CBD and offered suggestions for improved organisation
and structure. Despite varying opinions on what the content of the CBD policy ought
to be, a critical issue that was raised was the need for the policy to be context specific and pragmatic. There were concerns that existing CBD models could be jeopardised if the upcoming
policy prescribed the use of qualified personnel (HCPs) and/or distribution from health
sites only. It must be understood, however, that the call for flexibility is not akin
to accepting sub-standard service. Rather, it is a call to be realistic regarding
what is both feasible and sustainable in the local context. As one manager said:

“…they (regulators) need to draft the legislation to reflect pharmaceutical services
as they are delivered in 2015, and going forward not in 20 years ago and in 30 years
ago. Medicines are not ordinary commodities. The integrity of the medicine has to
be maintained… but our request collectively to council (SAPC) has been could one look
at a framework where one could legally issue the medicines that are not on a health
site… and have a set of norms and standards for the issuing of medicines … as long
as rules and standards are met and maintained and monitored.”

Furthermore, the call for regulators’ flexibility stemmed from the simple realisation
that more diversification is required if the province (and indeed the country at large)
is to truly expand ATM. A private-sector pharmacist elaborated on this aspect as follows:

“I said to somebody from council (SAPC): we are trying to put down first world standards
which is very noble, but we are a resource lacking third world, essentially, third
world country. We have a component of first world, but ninety per cent is third world.
We are a developing country. I hope it gets taken into consideration, because I think
it’s going to make implementation of a lot of what national health (insurance) wants
to do almost impossible to start.”

The quote above called into question the degree of alignment between the province’s
and country’s goals of improving ATM and the focus by professional statutory bodies
on what were sometimes perceived as rigid standards. There was also a prevailing view
that perhaps professional bodies were minimally consulted in the development of CBD
strategies and that subsequent disagreements are arising between policy stakeholders:

“…how much dialogue is actually happening between national, what national (NDOH) is
trying to bring through the National Health Insurance versus what Pharmacy Council
(SAPC) is saying and the statutes to everybody in terms of best policy. I don’t think
they are on the same page as to what the best practice is. (private-sector pharmacist)

On a positive note, despite a lack of consensus among stakeholders on certain issues,
there was notable commitment from the WCDoH leadership to engage with SAPC and eventually
align with the future CBD policy. Stakeholders also anticipated that CBD implementation
could eventually cost more than is currently envisaged if provinces have to invest
in training personnel and adapting venues to meet requirements for medicine handling
and storage for example.