ARV prescribing

The gap between judicial authority and clinical practice has left a significant portion of the HIV-positive population in South Africa waiting for expanded access to medication. While the court determined that the current restriction on pharmacist prescribing inhibits the constitutional right to healthcare, the administrative machinery required to operationalize this decision has stalled.

The Disconnect Between Judicial Mandate and Regulatory Action

The legal challenge focused on the necessity of task-shifting to alleviate the pressure on the country’s overburdened primary healthcare system. By allowing pharmacists—who are already trained in pharmacology and drug interactions—to manage the prescriptions of stable patients, the court intended to reduce clinic wait times and improve adherence. A stable patient is generally defined within the South African clinical framework as an individual with a suppressed viral load and a consistent history of medication adherence.

However, a court ruling does not automatically change the professional regulations governing healthcare workers. For a pharmacist to legally prescribe, the South African Pharmacy Council (SAPC) must formally amend the professional scope of practice. Without this amendment, any pharmacist attempting to issue ARV prescriptions could face disciplinary action for practicing outside their legal mandate. This regulatory vacuum has created a period of uncertainty where the legal right to prescribe exists in theory, but the professional permission to do so does not exist in practice.

The Role of the South African Pharmacy Council

The South African Pharmacy Council is the statutory body responsible for regulating the pharmacy profession. While the court has provided the legal signal, the SAPC is tasked with the technical work of defining how this new authority will be exercised. This includes determining the specific training requirements, the types of ARV regimens pharmacists may manage, and the monitoring protocols they must follow.

The delay in updating the scope of practice has been attributed to the complexity of integrating new clinical responsibilities into existing professional standards. The SAPC must ensure that the expansion of duties does not compromise patient safety or the integrity of the pharmaceutical profession. This process involves extensive consultation with various stakeholders, including pharmacy educators and healthcare regulators.

The transition from dispensing to prescribing requires a rigorous assessment of competency frameworks to ensure that patient care remains the priority during this shift in responsibility.

A spokesperson for the South African Pharmacy Council

Until the SAPC publishes the updated scope of practice, pharmacists remain legally tethered to their traditional role of dispensing medication rather than managing the clinical decisions that lead to those prescriptions.

Clinical Guidelines and the National Department of Health

Even if the SAPC completes its regulatory updates, a second hurdle remains: the National Department of Health (NDoH) must provide the clinical guidelines. In the South African healthcare system, prescribing is not a matter of individual discretion but is governed by strict national protocols. These protocols dictate which patients are considered stable, what specific antiretroviral combinations are permitted, and what the threshold for viral load suppression must be before a patient can be transitioned to pharmacist-led care.

The NDoH is responsible for ensuring that these guidelines are consistent with the national HIV treatment program. The absence of these specific protocols means that even a pharmacist with a revised scope of practice would lack the clinical roadmap necessary to treat patients safely. The development of these guidelines requires coordination between epidemiologists, clinicians, and public health officials to ensure that the task-shifting model does not lead to a rise in drug resistance or treatment failure.

The current stalemate places the burden of implementation on two separate agencies that must synchronize their efforts. The SAPC provides the professional authority, while the NDoH provides the clinical instructions. Without simultaneous action from both, the court’s decision remains a theoretical victory rather than a practical improvement for patients.

Professional Liability and Clinical Oversight

Beyond the regulatory and clinical hurdles, there is the issue of professional liability. Pharmacists have expressed concerns regarding the legal consequences of prescribing medication. In the event of an adverse drug reaction or a failure in treatment monitoring, the question of who holds responsibility—the pharmacist, the prescribing physician, or the state—remains unresolved.

The South African Medical Association (SAMA) has previously raised questions regarding the depth of clinical training provided to pharmacists compared to medical doctors. While the court recognized the benefits of task-shifting, the medical community has emphasized the need for clear lines of supervision and referral. If a pharmacist identifies a complication, such as a rising viral load or signs of opportunistic infection, there must be a seamless and immediate pathway to transfer that patient back to a medical doctor.

The implementation plan must therefore include a robust referral mechanism. This mechanism is intended to ensure that pharmacists act as a component of a broader healthcare team rather than as isolated providers. The lack of a clear, legally protected referral protocol contributes to the hesitation among pharmacy professionals to embrace the new prescribing authority.

The resolution of this impasse depends on the ability of the SAPC and the NDoH to move from legal acknowledgment to administrative execution. For the millions of South Africans living with HIV, the timeline for this transition will determine how quickly the benefits of task-shifting reach the community level.