Two years after 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, there has still been no progress.
The objective of the initiative, published in August 2021 and known as Pharmacist-Initiated Management of ART, or PIMART, was to tackle the low rates of uptake of ART prophylactic treatment and reduce the gap between the number of people diagnosed with HIV and those on treatment.
However, 24 months later, pharmacists remain unable to initiate ART, writes Catherine Tomlinson in Spotlight, because a legal challenge has been brought against the PIMART legislation and its introduction by the Independent Practitioners Association (IPA) Foundation.
The IPA Foundation, representing a group of private GPs in South Africa, filed a notice of motion with the Gauteng High Court in February 2022 requesting the court stops the implementation of PIMART by setting aside the SAPC’s decision to implement it and the legislation (Board Notice 101 of 2021) providing for its implementation.
The case claims that not only do pharmacists not have the required expertise to initiate ART – and that PIMART’s implementation will endanger patients – but also challenges the SAPC’s legislative mandate to implement PIMART, and the adequacy of the reasons put forward by the SAPC for the intervention.
The IPA Foundation says the procedures by which the SAPC engaged stakeholders on PIMART’s legislation did not meet legally required standards.
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, while not having the necessary qualifications, experience and registration, presumably at much lower rates – can only be described as unfair competition,” said former South African Medical Association (Sama) chairperson Dr Angelique Coetzee in 2021.
The SAPC has filed a responding affidavit rejecting the claims and providing detail on stakeholder engagements, and the hearing is scheduled for 23 May.
What’s at stake?
PIMART’s aim is to slash new HIV infections by expanding the use of antiretrovirals to prevent HIV infection (pre-exposure and post-exposure prophylaxis, or PrEP and PEP).
The plan is to allow pharmacists to prescribe and dispense PrEP – a daily tablet – without people having to see and pay for a doctor’s visit and script or first visit a public sector clinic.
PrEP is available free in designated public sector healthcare facilities.
It can be used on an ongoing basis for long-term protection or over an anticipated period of risky sexual behaviour, and is highly effective in preventing HIV. Yet its use remains extremely low, despite the ongoing high rates of new HIV infections.
Thembisa, the leading mathematical model of HIV in South Africa, reports that more than 175 000 people acquired HIV in South Africa in 2021, but less than 1% of sexually active individuals were using PrEP in 2022.
Apart from expanding access to PrEP, PIMART also wants 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 after occupational exposure to HIV, the PIMART initiative would also allow pharmacists to initiate PEP to the public.
PIMART would build on another initiative called Nurse-Initiated Management of ART (NIMART), introduced in 2010 and which allows 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.
PIMART would also 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.
Why private practitioners oppose PIMART
While the IPA Foundation is the only group that has taken legal action, other associations representing doctors, including Sama, the Unity Forum for Family Practitioners, and the South African Private Practitioners Forum (SAPPF) have published statements opposing PIMART.
They don’t believe pharmacists have the competencies and training required to initiate ART and argue that the PIMART programme would compromise the quality of patient care.
“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.
And 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.”
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 undergone by pharmacists, which they argue is more than adequate to enable pharmacists to safely initiate ART.
They also said 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.
SAMJ letter
See more from MedicalBrief archives:
Doctors in new turf war with pharmacists over ‘unlawful and unfair’ competition
SA’s private pharmacies are Gollums, not trusted gatekeepers
Promising approaches to improving PrEP access