Courts to decide whether pharmacists can start HIV medicines without a doctor’s script

Courts to decide whether pharmacists can start HIV medicines without a doctor’s scriptA study recently published in the Lancet found that those who initiated ART treatment on a dolutegravir based regimen were more likely to be retained in care and virologically suppressed than those who were initiated on a non-dolutegravir regimen. PHOTO: Spotlight
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In August 2021, the South African Pharmacy Council (SAPC) published legislation in the Government Gazette to enable pharmacists to prescribe and dispense antiretroviral medicines (ART) for the treatment and prevention of HIV. The initiative, known as Pharmacist-Initiated Management of ART, or PIMART, aims to address the low rates of uptake of ART prophylactic treatment in South Africa and close the gap between the numbers of people diagnosed with HIV and those initiated onto treatment. (At the time Spotlight reported on PIMART here.)

Yet, almost two years after the legislation was published, pharmacists remain unable to initiate ART in South Africa. This is because a legal challenge has been brought against the PIMART legislation and its introduction by the Independent Practitioners Association (IPA) Foundation.

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The SAPC wrote in the December 2022 issue of its online Pharmaciae publication, “All processes relating to Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) are currently on hold, pending the outcomes of a court case.”

The IPA Foundation, which represents a group of private GPs in South Africa, filed a Notice of Motion with the Gauteng Division of the High Court in February 2022, requesting that the court stops the implementation of PIMART by setting aside the SAPC’s decision to implement PIMART and the legislation (Board Notice 101 of 2021) providing for its implementation.

The case brought by the IPA Foundation challenges the SAPC’s legislative mandate to implement PIMART, the need for PIMART, and the adequacy of the reasons put forward by the SAPC for the intervention. The IPA Foundation also asserts that the procedures by which the SAPC engaged stakeholders on PIMART’s legislation did not meet legally required standards. Finally, the IPA Foundation claims that pharmacists do not have the required expertise to initiate ART and that PIMART’s implementation will endanger patients.

In response to the arguments put forward by the IPA Foundation, the SAPC has filed a responding affidavit with the courts rejecting the IPA Foundation’s claims. The SAPC’s affidavit outlines the legislative powers held by SAPC, the need and reasons for PIMART, and the competency of pharmacists to initiate ART with supplementary training that is required under the PIMART programme. The SAPC further provides detail in its affidavit on the stakeholder engagements that were undertaken in designing PIMART’s legislation and supplementary training curriculum and argues that its procedures met all legal requirements for stakeholder engagement.

The hearing is scheduled to take place in the Gauteng Division of the High Court on Tuesday 23 May. The court’s ruling in this case is likely to have broad ramifications for how HIV treatment and prevention services are provided in South Africa.

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Over 175 000 people acquired HIV in South Africa in 2021 yet less than one percent of sexually active individuals in the country were using PrEP to protect themselves from HIV in 2022. PHOTO: Rodrigo Nunes/MS

What’s at stake?

A key objective of PIMART is to reduce new HIV infections by expanding the use of antiretrovirals to prevent HIV infection – known as pre-exposure and post-exposure prophylaxis (PrEP and PEP).

PIMART aims to expand uptake of PrEP by allowing pharmacists to prescribe and dispense PrEP, which is taken as a daily tablet, without requiring that people first attend and pay for a doctor’s visit and script or first have to visit a public sector clinic. PrEP is available free of charge in designated public sector healthcare facilities.

PrEP, which can be used on an ongoing basis for long-term protection or over an anticipated period of risky sexual behaviour, is highly effective in preventing HIV. Yet, use of PrEP in South Africa remains extremely low despite the ongoing high rates of new HIV infections in the country.

According to the latest data from Thembisa, the leading mathematical model of HIV in South Africa, over 175 000 people acquired HIV in South Africa in 2021. Yet less than one percent of sexually active individuals in the country were using PrEP to protect themselves from HIV in 2022.

In addition to expanding access to PrEP, PIMART seeks to expand access to PEP – a 28-day ART regimen taken to prevent HIV infection after exposure. While SAPC’s answering affidavit notes that pharmacists can already initiate healthcare workers on PEP following occupational exposure to HIV, the PIMART initiative would also allow pharmacists to initiate PEP among members of the public.

PIMART also seeks to improve treatment linkage amongst people living with HIV. Despite the adoption of a universal test and treat policy in South Africa in 2016, many people who have been diagnosed with HIV in the country have never started treatment, or have started and then stopped.

According to Thembisa data, 94.5% of the almost 8 million individuals living with HIV in South Africa have been diagnosed, yet only 73.2% of people living with HIV are on treatment.

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Antiretroviral HIV medication PHOTO: NIAID

PIMART would build on another initiative called Nurse-Initiated Management of ART (NIMART). Introduced in South Africa in 2010, NIMART allowed qualifying nurses to start people on HIV treatment without a doctor’s script, an arrangement that facilitated the rapid growth of South Africa’s ART programme. As NIMART shifted certain tasks from doctors to qualifying nurses, PIMART would shift certain tasks from doctors and nurses to pharmacists. The SAPC argues that shortages of healthcare workers and budget constraints require this further task-shifting to reach those who are missed by current interventions.

“The very point underpinning PIMART is the absence of medical practitioners available and willing to provide appropriate treatment to people in areas where they require it and at a cost they can afford. If the members of the IPA were providing the necessary treatment then there might not be a need for PIMART,” says the SAPC in its answering affidavit in the court case.

In addition to prescribing and dispensing ART for HIV treatment and prevention, PIMART would allow accredited pharmacists to prescribe and dispense tuberculosis preventive therapy (TPT). Despite South Africa’s high TB rates and the proven efficacy of TPT, uptake of these therapies has been low. (The Department of Health recently published new TB prevention guidelines, which Spotlight both reported on and assessed in an editorial.)

neon sign that reads Pharmacy
Pharmacist-Initiated Management of ART, or PIMART, aims to address the low rates of uptake of ART prophylactic treatment in South Africa. PHOTO: Marcus Quigmire/Flickr

How did PIMART come about?

In their responding affidavit to the IPA Foundation’s Notice of Motion, the SAPC explains that the PIMART initiative was designed in response to a request from the National Department of Health for the SAPC to develop and implement an intervention to enable pharmacists to assist in scaling up PEP and PrEP in the country.

“At the time, the department proposed that the SAPC, as the regulator of pharmacists, petition the South African Health Products Regulatory Authority to potentially down-schedule certain medicines indicated for the treatment of HIV, for the purposes of PrEP and PEP,” states SAPC’s answering affidavit.

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A key objective of PIMART is to reduce new HIV infections by expanding the use of antiretrovirals to prevent HIV infection. PHOTO: Samantha Reinders/MSF

“Down-scheduling” ART could allow pharmacists in South Africa to prescribe and dispense ART for HIV treatment, PEP, and PrEP without a doctor’s script. Yet, after consideration of potential risks associated with down-scheduling ART, the SAPC proposed the implementation of PIMART as an alternative – which would provide supplementary training as well as an accreditation process for pharmacists to initiate ART.

In August 2018, the SAPC wrote to the Director General of the Department of Health stating, “Following consultation and deliberations with representatives from organisations such as the South African HIV Clinicians Society (SAHCS), [the SAPC] is of the opinion that the public would benefit from having pharmacist with supplementary training on PrEP and PEP.”

Between August 2018 and August 2021 (when legislation for PIMART’s implementation was published), the SAPC worked together with the SAHCS and the School of Pharmacy at North-West University to develop processes, guidelines, and relevant legislation for PIMART. SAPC published draft legislation for public comment in March 2021. SAPC and SAHCS also worked with a consortium of partners to pilot the intervention in several pharmacies.

The SAPC says in its answering affidavit to the IPA Foundation’s Notice of Motion that “the IPA Foundation did not participate in this process, but now seeks to undo it. It does this despite the enormous harm that this might cause and without offering an alternative.”

Why are many private practitioners opposing PIMART?

While the IPA Foundation is the only group that has taken legal action, other associations representing doctors, including the South African Medical Association, the Unity Forum for Family Practitioners, and the South African Private Practitioners Forum (SAPPF) have published statements opposing PIMART.

These professional associations argue that pharmacists do not have the competencies and training required to initiate ART and that the PIMART programme would compromise the quality of care available to patients.

“Pharmacists are not educated, trained, or experienced in treating patients, and their focus is on medicines only. Diagnosis and treatment choices are within the domain of healthcare professionals registered as such,” said SAMA. While the SAPPF noted, “If patients are not optimally managed according to best practice with appropriate clinical experience, then the safety, comorbidity, and death rates will inevitably increase.”

There are also concerns that the initiative could divert patients and income away from private practitioners. “Put bluntly – allowing pharmacists to compete with general practitioners and others, whilst not having the necessary qualifications, experience, and registration – presumably at much lower rates – can only be described as unfair competition,” said former SAMA chairperson Dr Angelique Coetzee in a 2021 SAMA media release.

Not a ‘perfect world’

In October 2021, a collective of pharmacy researchers, practitioners, and academics wrote to the Minister of Health responding to the concerns raised by those opposing PIMART. The letter, which was published in the South African Medical Journal in December 2021, highlighted existing precedents for pharmacist-initiated therapy in South Africa and the extensive training that pharmacists undergo, which they argue is more than adequate to enable pharmacists to safely initiate ART.

They also make the case that PIMART is in the best interest of patients. “In a perfect world, every patient with HIV would be treated by an adult or paediatric infectious disease specialist and prescribed an individualised regimen based on pre-treatment genotyping. However, to impose that standard of care in resource-constrained settings would result in compromised access to care for many patients and a net loss in health benefits,” they wrote.