In-depth: SA pharmacists will soon be able to prescribe HIV treatment

South African pharmacists will soon be able to prescribe HIV treatment.

South Africa is on the brink of allowing pharmacists holding the required permits to prescribe and initiate HIV medicines without people first having to get scripts from doctors or nurses.

The initiative, known as Pharmacist-Initiated Management of ART or PIMART, seeks to improve linkage to HIV treatment and prevention therapy among under-reached and underserved groups and communities. South Africa’s PIMART programme will be the first of its kind globally – potentially paving the way for other countries to follow suit.

Linking men to treatment earlier

South Africa has the largest HIV antiretroviral treatment (ART) programme in the world. Over seven million people in the country are living with HIV – over five million of whom are on ART.

South Africa’s success in scaling up ART to treat millions is partly due to the introduction of Nurse-Initiated Management of ART, or NIMART, in 2010 – which allowed for the screening and initiation of HIV-positive people onto ART by nurses at primary health care clinics across the country. Prior to the introduction of NIMART, initiation of ART could only be done by clinicians and was largely hospital-based.

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While NIMART has allowed for the massive expansion of South Africa’s public ART treatment programme, many people still only get diagnosed and started on treatment very late after they have experienced HIV-related illnesses and are at risk of dying of opportunistic infections. According to data from Thembisa (the leading mathematical model for HIV in South Africa), around a quarter of adults who started ART in 2019 had CD4 counts below 200 – meaning their immune systems had already been severely compromised, among others making them vulnerable to tuberculosis (TB).

Men in particular tend to wait too long before testing and starting treatment. This is one group that pharmacists and HIV clinicians hope can be better reached through PIMART, which will allow pharmacists to initiate HIV-positive men onto ART at pharmacies.

Francois Venter, an infectious diseases professor at the University of the Witwatersrand, explains that private pharmacies are a first port of call for many people seeking health services in South Africa, including men seeking treatment for sexually transmitted infections (STIs). Venter adds that each of these visits provides an opportunity to offer men HIV testing services and initiate HIV-positive men onto ART, or offer PrEP (medicines to prevent HIV infection) to men who test negative.

“We have men coming in [to pharmacies] for chronic medicine, we have men coming in for libido boosters who don’t go to doctors,” says Jackie Maimin, CEO of the Independent Community Pharmacy Association (ICPA). “We have men coming in for all sorts of over-the-counter stuff. Men don’t like to go to clinics and don’t like to go and see the doctor, but they will pop into the pharmacy,” says Maimin.

“Pharmacies are really in the communities, they are even pharmacies in the most rural of areas.” She adds that because men come in for a whole range of services, from collecting chronic medicines to buying shaving cream, there is little stigma around visiting pharmacies, and they can provide a high level of anonymity to men who are reluctant to visit primary health care clinics in their communities.

Venter adds, “Unlike primary clinics and GPs, pharmacies are open after hours and on weekends.”

Preventing HIV among girls and young women

Besides helping men living with HIV to start treatment earlier, HIV clinicians and pharmacists are enthusiastic that PIMART can substantially expand uptake of PrEP – a combination of two antiretroviral medicines taken daily on an ongoing basis to prevent HIV infection.

Current usage of PrEP is dismally low in South Africa. Department of Health spokesperson Popo Maja told Spotlight in early 2021 that only 107 081 people have initiated PrEP in the public sector by that date. It is unclear how many of these people have remained on PrEP continuously. According to Venter, PrEP usage rates are even worse in the private sector.

PIMART holds massive potential to help scale up PrEP usage according to Maimin, who explains that every month around 100 000 girls and young women seek emergency contraception in private pharmacies in South Africa.

“We see so many young women coming in for the morning after [pill] – we know this is a group that is hard to reach… we do use this opportunity to say ‘Have you been tested? Do you know your status?’. If we find out they are negative, surely it’s logical that the next thing we say to them is ‘you need to remain negative, have you considered PrEP?’”, says Maimin.

Besides seeking emergency contraception, Maimin says young women commonly visit pharmacies for family planning services and to vaccinate their infants and young children which provides further opportunities to discuss and offer PrEP.

The public ARV programme has reached a “ceiling” 

According to Venter, the public ARV programme has reached a “ceiling” in its ability to recruit and link patients into care and many people are being left behind. He says that new innovative strategies such as PIMART are critical to recruiting hard-to-reach groups into care.

Natalie Martyn, former EPIC programme manager for the Southern African HIV Clinician’s Society (SAHCS), says that interviews conducted with pharmacists, other healthcare workers, and patients have shown that there is a preference among under-reached groups such as men, girls, and young women to access sexual health services, including ART, at pharmacies rather than at primary clinics or GPs.

“Pharmacists are seen as less judgmental and nicer to engage with [than other health care workers] – nothing shocks them, they have heard it all”, says Martyn. She adds that pharmacies are typically more accessible from people’s homes, schools, and workplaces, have better opening hours than clinics and GPs, and can provide greater anonymity to their clients.

Another advantage of the PIMART programme, according to SAHCS CEO Lauren Jankelowitz, is that once you have enrolled in the programme, you can go to any participating pharmacy in the country to seek treatment. Jankelowitz adds that a patient app created for the programme enables participants to access their own medical records, and share them with other healthcare providers. “As [an] individual you own your own medical records”, says Jankelowitz.

Jankelowitz notes, however, that certain groups will not be eligible for treatment initiation in pharmacies under the PIMART programme and must be referred by pharmacists to state or private facilities given the complexities involved in their care. These groups include people with TB, cryptococcal meningitis, pregnant women, and children.

Laying the groundwork for PIMART

SAHCS has been working with the ICPA since 2018 towards the implementation of PIMART in South Africa with support from Ezintsha, Digital Health Cape Town, and Vula Mobile under the ‘Expanding Access to PrEP and ARVs Innovation Consortium (EPIC)’.

While pharmacists have not yet been authorised to prescribe ART, PEP (post-exposure prophylaxis), or PrEP in South Africa, the EPIC consortium has piloted the initiation of ART, PEP, and PrEP at multiple pharmacies across the country – including in both independent and corporate pharmacies.

At pilot sites, trained pharmacists counsel and screen individuals for ART, PEP, or PrEP, while on-site nurses or off-site clinicians contacted via a telemedicine system set up for the programme provide final sign-off on scripts. (While NIMART has been in place since 2010, this programme only allows for the initiation of ART by public sector nurses, and special authorisation was sought from the Department of Health to allow nurses in private pharmacies to script antiretroviral medicines at pilot sites).

SAHCS has developed a curriculum and online training course to enable pharmacists and pharmacy nurses to prescribe and initiate ART, PEP, and PrEP, which, due to COVID-19, can now be completed online. According to SAHCS, 787 pharmacists and pharmacy nurses have already completed the course and 419 scripts for ART, PEP, or PrEP have been written at PIMART pilot sites around the country.

Special permits required

Martyn notes that the piloting and roll-out of PIMART have been slower than expected due to delays in the granting of permits to enable pharmacists to prescribe antiretroviral medicines. For pharmacists to prescribe ART, PEP, or PrEP, they must apply for and receive a PIMART permit granted under Section 22(A)15 of the Medicines and Related Substances Act.

The granting of these permits has been put on hold while the South African Pharmacy Council has developed and sought public comment on the scope of practice, competency standards, and accreditation requirements for pharmacist-initiated management of ART. A board notice outlining these requirements was gazetted for public comment on 22 March 2021. The public comment period has now closed and, according to Maimin, a document outlining the scope of practice, competency standards, and accreditation requirements has been approved by the Pharmacy Council.

Once this document is published for implementation by the Department of Health, pharmacists can begin applying for PIMART permits. “We are quite far down the road, the only hold up now is the publishing works for the government have a backlog because of COVID,” says Maimin.

Following the publication of PIMART standards and requirements by the Department of Health, the granting of PIMART permits to trained pharmacists should be a relatively quick and seamless process as, due to COVID-19, applications for Section 22(A)15 permits are now electronic. Maimin notes that while accessing Section 22(A)15 permits used to be a long-winded process, under the new electronic system permits are being processed and granted within 48 hours.

Section 22(A)15 permits are currently being used to enable pharmacists to participate in the rollout of COVID-19 vaccines, as they have been granted to enable pharmacists to prescribe and deliver adrenaline and hydrocortisone to individuals that experience severe allergic reactions following vaccination. (Pharmacists are already permitted to deliver certain vaccines).

Who will pay for PIMART services?

People seeking PIMART services will initially be required to pay for these services out-of-pocket. Equivalent services provided at public clinics are free or when sought from private GPs, covered for those holding private medical insurance.

As PIMART services will be provided from private pharmacies that do not hold government ARV stock, users will be required to pay private sector costs for ARVs. One month’s supply of a generic first-line dolutegravir-based regimen (the combination most newly diagnosed people will start with) costs around R350 per month in the private sector.

Martyn notes that interviews conducted with patients and healthcare workers indicate that people will pay to access these services from pharmacies and that the cost to uninsured individuals of accessing these services at pharmacies is lower than doing so at GPs.

“South Africans are willing to pay for their reproductive and sexual health services”, Venter adds, noting that while free condoms are widely available through public sector initiatives, half of the condoms used in the country continue to be bought from commercial sources.

While PIMART will initially require out-of-pocket payments, its proponents hope that eventually, partnerships with the government will enable private pharmacies to hold stock of government procured antiretroviral medicines that can be given to uninsured individuals.

“Here in the Western Cape and in patches in other provinces, we have been doing state family planning and EPI for a while. It works extremely well. We give the stock for free and we charge a consultation fee [~R75] to see the pharmacist,” says Maimin. “I think that when we can show the value of what pharmacist-initiated management of ART can do, I think we will be able to start discussions with the Department of Health and access that [public ARV] stock [for pharmacies]”.

She adds, “It is really exciting that we will be the first in the world [to initiate PIMART], but it makes sense since we have the biggest HIV population in the world… I am sure that we will then show the world that this is the way to go.” 

To learn more about pharmacies initiating ART, visit the #4eachother webpage or Facebook page.