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Inside The Box with Dr Andy Gray | How Should the Compounding of Medicines Be Regulated?

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Andy Gray

The South African Health Products Regulatory Authority, with the South African Pharmacy Council, recently announced what was described as a crackdown on a compounding pharmacy. They allege “critical regulatory non-compliance” in relation to the compounding of unregistered medicines. In his latest Inside The Box column, Dr Andy Gray provides some background to the issues at stake, while recognising that some key elements remain contested.

Until the 20th century, medicines dispensed by pharmacists were all compounded (mixed) from raw ingredients, most of which were inorganic chemicals and herbal products. The gilded majolica jars displayed in pharmacies and museums depict the names of those common ingredients, often in Latin. Hence, a jar labelled as “Paraf mol alb” would contain “paraffinum molle album”, or white soft paraffin (white petroleum jelly), more commonly known as Vaseline.

The market for finished pharmaceutical products, in the form of modern tablets, capsules and the like, has grown dramatically over the last century. Even so, the need for the preparation of medicines in a pharmacy, from either raw ingredients or existing products, has not entirely disappeared.

#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)

There has always been a need for the preparation of particular products for individual patients in cases where a commercial product does not exist or is not suitable. For example, a pharmacist may be asked to produce an eye drop when no commercial products exist, using an injection as the starting material. Similarly, where a patient is unable to swallow tablets or capsules, an oral liquid preparation may be compounded. In many cases, the preparation is done extemporaneously, meaning that it is done specifically for that patient at a point in time. Such medicines are compounded by pharmacists as part of their usual professional practice in community and hospital pharmacies.

Exceptions, limitations and contestation

Modern medicines regulatory practice is based on the concept of registration or marketing authorisation. This is where a manufacturer is required to provide evidence to the national medicines regulatory authority of the quality, safety and efficacy of a medicine, before it can be sold. However, an exception has been created, allowing for compounding of medicines. In the South African medicines legislation, this is provided by section 14(4) of the Medicines and Related Substances Act (Act 101 of 1965).

The usual approach is described in section 14(1) of the Act, which states that “no person shall sell any medicine … which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered”. The declaration in this regard refers to the call-up notices issued for different pharmacological classifications of medicines since 1967, when the Act came into operation. All pharmacological classifications have now been made subject to registration.

The exception is provided by section 14(4), which states that subsection 14(1) will not apply when a medicine is “compounded in the course of carrying on his or her professional activities by a pharmacist”. A similar exception applies to licensed dispensing and compounding practitioners and veterinarians. Two scenarios are envisaged: compounding a preparation in accordance with a prescription for a particular patient, or compounding by a pharmacist for the retail trade.

However, there are three critical additional restrictions: a compounded medicines shall “not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected”, the compounded medicine “is not or has not been advertised”, and the “the active components of such medicine appear in another medicine which has been registered”. Thus, unless declared undesirable or never before registered, an active ingredient may be compounded and sold without being registered. A compounded medicine may also not be advertised to the public or to health professionals.

Further details were provided by the General Regulations to the Medicines and Related Substances Act, which were published in 2017. The initial version of those regulations added some additional restrictions, for example restricting the quantity to be compounded to the “quantity that is intended to be used by a patient for not more than 30 consecutive days from the date of compounding”. More importantly, sub-regulation 3(3)(a) prohibited compounding that was intended “to circumvent the provisions of section 14 of the Act”, the requirement for registration.

Legal challenge

In December 2021, the North Gauteng High Court in Pretoria ruled in a case brought by The Association of Compounding Pharmacists of South Africa, challenging the regulations. While noting that “[w]hat constitutes pharmacy compounding is not well defined”, Judge Norman Manoim ordered that the regulations be redrafted and that a draft guideline on good compounding practice be published. In particular, the judgment recognised the need to clarify what was needed for “anticipatory compounding”, where medicines were compounded in anticipation of a prescription or for sale by a pharmacist.

In accordance with the court judgment, amended regulations were published for comment and finalised in 2022, deleting sub-regulation 3(3)(a), and recognising that a pharmacist could “based on the amount of medicine compounded previously for a particular period, compound such medicine in anticipation of supply thereof within such particular period”. Lastly, the regulations required that draft guidelines on good compounding practice be published within 6 months, for public comment. These draft guidelines were published for comment in June 2023, but have not been issued in final form. The draft guidelines are no longer accessible on the South African Health Products Regulatory Authority (SAHPRA) website.

Compounding pharmacies

While the extemporaneous compounding of medicines for individual patients is routinely performed in most community and hospital pharmacies, “anticipatory compounding” has emerged as a speciality practice.

Compounding pharmacies are not recognised as a specific category of pharmacies licensed by the Department of Health and recorded as such by the South African Pharmacy Council (SAPC). The current regulations to the Pharmacy Act only recognise community, institutional (hospital), wholesale, manufacturing and consultant pharmacies. The services that each category of pharmacy can deliver are regulated, with both community and institutional pharmacies enabled to perform “compounding, manipulation or preparation of any medicine or scheduled substance”. Specialist compounding pharmacies are thus licensed as community pharmacies.

SAHPRA licenses manufacturers and wholesalers of medicines, not community pharmacies. Section 22C(1)(b) of the Medicines and Related Substances Act states that the Authority “may … issue to a … manufacturer, wholesaler or distributor of a medicine … a licence to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine … upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine”.

Whether a compounding pharmacy, licensed as a community pharmacy, can import active pharmaceutical ingredients (APIs) for the purposes of compounding, is contested. It is the API which is responsible for the desired medicinal effect but can also be the cause of adverse events. Inactive excipients are added to produce the final dosage form administered to patients.

The question of quality

As was outlined in a previous column in this series, patients are assured of the quality of medicines on the South African market by virtue of their registration by SAHPRA and compliance with Good Manufacturing Practice (GMP) standards by licensed manufacturers. Compounded medicines are an exception to the rule – they are unregistered, and their preparation is not subject to GMP.

In the case of medicines compounded for individual patients, the risk is more manageable. Where larger quantities are prepared in anticipation of demand, and in particular where sterile preparations such as injections are made, the risks may be greater.

Equally, there is a need to ensure that APIs used for manufacturing or compounding medicines are of acceptable quality. A draft guideline on post-importation testing, published by SAHPRA for comment in May 2026, applies to all imported APIs.

Following a major incident in the United States, where contaminated compounded corticosteroid injections resulted in a number of serious fungal infections, US law was amended in 2013 to create a new category of outsourcing facilities regulated by the Food and Drug Administration (FDA), not by state pharmacy boards. State pharmacy boards were not considered to have the capacity to effectively regulate large scale compounding, especially for higher risk sterile preparations.

In South Africa, while the Good Pharmacy Practice standards issued by the SAPC cover the usual services delivered by community and hospital pharmacies, they are insufficient to cover larger scale anticipatory compounding or outsourcing services.

Ongoing contestation

Existing South African law may well be deficient in the way in which it regulates compounding pharmacies. How the current legal provisions are applied and interpreted is contested and will be the subject of a number of court challenges.

Patient safety must remain the key animating feature of any future regulatory process that is fit for purpose and effective.

*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of columns he is writing for Spotlight.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

| Republished from Spotlight under a Creative Commons licence.

Read the original article.

Categories : Expert Opinion IT in HealthcareTags : Leave a comment

Opinion Piece: Healthtech is Only as Strong as the Hands that Shape It

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By Vishal Barapatre, Group Chief Technology Officer at In2IT Technologies

| 17 June 2026

Healthcare is investing heavily in technology, but outcomes do not always improve at the same rate or deliver the desired effect. The issue is rarely a lack of tools. More often, it comes down to the way those tools are designed, connected, and maintained. Health technology, often referred to as Healthtech, delivers real value not just when systems exist, but also when expert IT partners shape them to turn health data into meaningful, useful intelligence throughout the entire care journey.

In many healthcare environments, technology has accelerated rapidly over the past decade. Hospitals and clinics have introduced electronic medical records, diagnostic platforms, and telehealth systems, with enormous potential, the benefits are often uneven when systems operate in isolation or fail to align with the realities of clinical workflows. The difference between technology investment and measurable clinical improvement often lies in the design and integration that happens behind the scenes.

The promise of healthtech lives in the data

At its core, healthtech is about data. This includes how data is captured, stored, presented, and analysed to support better patient care. Every interaction between a patient and the healthcare system generates information that can guide more informed decisions. From recognising early signals for preventive care, tracking progress during rehabilitation, to ensuring complete and accurate information during operative procedures, effective use of data underpins every stage of the healthcare journey.

Yet data alone is not enough. Without systems designed to bring clarity to complexity, information becomes fragmented, inconsistent, and largely underused. This is where expert IT partners are essential. They do not just implement platforms; they create the right conditions for data to support better patient care.

Another challenge lies in the diversity of healthcare data sources. Clinical records, laboratory results, imaging systems, wearable devices, and patient engagement platforms, all generate valuable information. However, without thoughtful integration and governance, these data streams can quickly become disconnected. When aligned, they allow clinicians to see a more complete picture of a patient’s health, enabling earlier intervention and more personalised treatment decisions.

Intuition does not happen by accident

There is a growing expectation that healthtech should feel intuitive, where insights emerge naturally without creating additional friction in already demanding clinical environments. However, intuitive technology does not happen by chance. It results from thoughtful choices about structure, integration, and user experience.

What needs to be understood is that a system’s value is not determined by its technical features but by how well it fits into clinical workflows. The data must be available at the right time, in the right context, and in a way that supports judgment instead of overwhelming it. Without this insight and expertise, even the most advanced systems may become obstacles instead of assets.

This is particularly important in high-pressure healthcare environments where time is limited, and decisions are critical. If systems require excessive navigation, duplicate data entry, or complicated interfaces, clinicians may spend more time interacting with technology than with the patients. Well-designed systems quietly support decision-making rather than compete for attention, ensuring that technology strengthens clinical practice of disrupting it.

Continuity of care requires continuity of systems

To add, preventive, rehabilitative, and operative care are often treated as separate areas, yet they are part of a single patient journey. The true value of healthtech emerges when data flows smoothly across these stages, creating continuity instead of hand-offs.

This continuity does not happen on its own. It relies on systems that preserve data integrity over time, integrate seamlessly across different care settings, and evolve as patient needs evolve. Without it, technology investments risk becoming isolated solutions rather than truly transformative tools.

When healthcare providers can access consistent patient information across departments and care phases, they gain a more holistic understanding of health outcomes. This continuity helps reduce redundant tests, prevent information gaps, and support coordinated treatment plans. Over time, it contributes to a healthcare environment where patients’ experiences feel more connected and less fragmented.

Trust is built behind the scenes

To truly be transformative, healthcare must rely on trust between patients and clinicians, as well as between clinicians and the systems they depend on. Yet, this trust is fragile, as a single system failure, data inconsistency, or security issue can erode confidence across a healthcare facility.

Trust is built on reliability, resilience, and strong governance. Systems must perform well under pressure, safeguard sensitive information, and evolve safely over time. Although this foundation work often goes unnoticed, its impact is felt every time clinicians use technology with confidence and ease.

The growing digitisation of healthcare has also made cybersecurity and data protection essential pillars of trust. Healthcare data is among the most sensitive information an organisation can manage. Protecting it requires robust security architecture, continuous monitoring, and governance practices that evolve as threats emerge. When these safeguards are embedded into the system architecture, healthcare organisations can innovate confidently without compromising patient privacy.

The real differentiator is partnership, not platforms

As healthtech continues to evolve, access to tools will be less of a significant differentiator. What will matter more is how those tools are shaped, connected, and sustained. Technology alone cannot provide better care. It requires partners who understand both the technical and human aspects of healthcare.

This is where an IT partner can navigate and guide healthcare organisations through complexity, turning possibilities into practice and ambitions into results. Their role is not just supportive but foundational in demonstrating the true value of healthtech. The future of healthcare will belong not to those who adopt the most technology, but to those who build it wisely.

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Why Medical Schemes Must Own Healthcare Reform

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“Medical schemes have an enormous amount of power to change the trajectory of healthcare in this country – but only if they are willing to use it,” Lungile Kasapato, CEO of PPO Serve.

South African medical schemes have long borne the brunt of public frustration. Contribution increases have outpaced both wages and inflation, forcing many members to choose between healthcare cover and basic needs. But according to Lungile Kasapato, CEO of PPO Serve, a healthcare management company that has been implementing value-based care in South Africa for more than a decade, rising premiums and shrinking benefits are symptoms, not causes. The real problem is structural: the industry has been operating as a passive payer when it should be commissioning a better functioning healthcare system.

“The conversation we keep having – about contribution levels, affordability, and who is to blame – is only half the conversation,” says Kasapato. “What is missing is the question of why costs keep escalating and what schemes are actively doing about it.

The World Health Organisation is clear on what that answer should look like: schemes purchasing value for their members, managing the quality and cost of care, and correcting the incentives that keep a poorly functioning system in place. “Until that happens, we will be back here next year, at a higher number, with the same grievances,” she says.

South Africa’s healthcare system rewards providers for the volume of services delivered, not patient outcomes achieved; “More tests, more procedures, more bed days: each generates revenue regardless of clinical necessity. The Health Market Inquiry identified this as a structural failing – schemes, unable to control what providers charge, absorb the pressure by eroding the benefits members thought they were paying for,” says Kasapato.

On average, schemes are currently spending three cents more for every rand they collect; “Even the best-capitalised ones are drawing down their historical reserves. Without meaningful intervention, that gap does not close on its own – it widens. And yet the industry continues to treat this as a pricing problem rather than the systemic one it actually is,” she says.

PPO Serve’s The Value Care Team programme, implemented in partnership with the Government Employees Medical Scheme (GEMS), demonstrates what a different approach looks like in practice. The programme segments members by clinical need – from high-risk complex cases to those currently healthy – and aligns care accordingly. GPs are equipped with real-time data, including visibility of planned admissions from other providers, enabling early intervention before costs escalate. Clinicians are rewarded for measurable patient outcomes rather than the volume of services delivered.

“When patients are well-managed at primary care level, unnecessary hospital admissions fall – and that is exactly what we are seeing,” says Kasapato. “Early pilot data shows a 29% reduction in hospitalisations over three years.  Those savings can then be reinvested into better care. That is what purchasing value looks like in practice.”

For lower-income members, who have historically faced benefit structures favouring hospital care over preventative and primary care, The Value Care Team operates outside discretionary benefit allocations. This preserves out-of-hospital benefits while ensuring members receive coordinated care throughout the year.

“The evidence is already there, globally and in our own programme: investing in primary healthcare costs more today but far less tomorrow. A scheme that cannot absorb the short-term cost of prevention will not survive the long-term cost of inaction. Medical schemes have an enormous amount of power to change the trajectory of healthcare in this country – but only if they are willing to use it. At PPO Serve, we are not waiting for the system to fix itself – we are doing the work,” says Kasapato.

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Inside The Box with Dr Andy Gray | How Can We Know that Medicines Sold in Pharmacies Are of Good Quality?

On By ModernMedia
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)

8th May 2026 | Andy Gray

We can generally trust that the medicines we buy at pharmacies contain what they are supposed to and that they were manufactured according to good quality standards. In his latest column, Dr Andy Gray zooms in on the regulatory scaffolding that enables this trust.

One of the health-related Sustainable Development Goal targets is to achieve “universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. The word “quality” appears twice in that target description, as a requirement for the healthcare services delivered, and as an essential element of the medicines and vaccines made available.

‘Quality cannot be tested into a product’

There is a truism in the pharmaceutical industry that quality cannot be tested into a product. Instead, quality is assured by the implementation of a pharmaceutical quality system, referred to as current Good Manufacturing Practice (cGMP).

The primary legal enablement is provided by the Medicines and Related Substances Act, 1965. Section 1(3) of the Act states: “In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be.” Evidence for safety and therapeutic efficacy is provided by well-conducted clinical trials. There is a difference, however, between registered medicines and complementary medicines. The latter require a warning on their labels stating: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. Complementary medicine manufacturers are being progressively brought in line with GMP.

Evidence of quality is not reliant only on retrospective data, on tests conducted on the medicines used in the clinical trials, and the design of the dosage form to be sold, but also on the means to ensure that every batch made will deliver the same results. By requiring that every manufacturer of a medicine is licensed by the South African Health Products Regulatory Authority (SAHPRA), the Authority can ensure compliance with GMP. The ultimate sanction for not meeting GMP standards is withdrawal of licensure and therefore an immediate stop to all manufacturing activities.

New guidelines

SAHPRA updated its GMP guidelines in April 2026. The guideline defines GMP as “a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy”, and as a “system that ensures medical products are consistently produced and controlled according to quality standards”. Echoing the truism, it states that GMP is “designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.

GMP requires the manufacturer to provide detailed description of the systems to be implemented to document every step in the manufacturing process and the control measures in place to ensure quality. These step-by-step descriptions have to cover every component included in the medicine and its packaging, the premises and equipment used, as well as the training and accreditation of the staff involved in the production process. A risk-based approach is used, for example differentiating between sterile and non-sterile production processes. Quality control testing during the production process is critically important.

GMP places a lot of emphasis on the capability of key personnel, but also the way in which authority and responsibility is assigned, accepted and documented, and how each person fits into the management decision-making process. For example, SAHPRA’s GMP guidelines differentiate between the Head of Quality Control, who “should have the authority to establish, verify and implement all quality control procedures such as authority over quality decisions, oversight of testing and results, approval of quality control documentation, laboratory management, validation and method control”, and the Head of Quality Assurance, who “should be part of the decision-making process in all matters that affect the quality of products including development, laboratory, storage, distribution, vendors and third-party contractors”. All staff engaged in production have to be trained on the principles of GMP and the specific duties assigned to them. Continuing training is required, with documented training programmes, training records, and checks to confirm that procedures are being followed.

What if medicines are made outside of SA?

That all sounds straightforward, if the manufacturer is located in South Africa and can easily be accessed by a SAHPRA GMP inspector. However, the majority of medicines consumed in South Africa are imported, and even those that are made locally mostly rely on imported active pharmaceutical ingredients or drug substances.

International standards for GMP have a long history. The first draft document was prepared by the World Health Organization (WHO) in 1968. Since 1969, compliance with WHO GMP has been the basis for the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. However, there has been criticism of the scheme, as certificates can be issued by national regulators that are not considered to meet acceptable maturity standards.

Although there is provision for exceptions, medicines imported into South Africa have to be subjected to post-importation identification and assay (testing of what it contains) by a local, accredited laboratory, or samples have to be returned to the manufacturer or an overseas testing laboratory.

SAHPRA is a member of two key organisations that are advancing harmonisation of regulatory standards. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) publishes extensive quality guidelines. ICH Q10, for instance, describes the requirements for a Pharmaceutical Quality System.

SAHPRA is also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which aims to pursue the “development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates”. Apart from its work on harmonising GMP standards, PIC/S enables the training of GMP inspectors and the voluntary sharing of GMP inspection reports. PIC/S membership requires an assessment of a regulator’s inspectorate systems and procedures, so provides a quality check at that level. South African GMP adopted the PIC/S GMP guide in 2006, updating that status in 2017.

SAHPRA’s GMP inspectors are not confined to working only within the boundaries of the country. They also inspect pharmaceutical production plants in other countries and work together with the WHO prequalification programme to extend their reach. That said, even the best-resourced regulatory authorities are struggling to cover a globalised pharmaceutical industry, with many facilities located in China and India. A recent commentary in the New England Journal of Medicine pointed out how few foreign plants making generic medicines had been inspected by the Food and Drug Administration, and the problems they encountered when conducting inspections, calling for improved post-marketing surveillance.

The public, patients and health professionals can therefore make a reasonable assumption that medicines produced in a cGMP-compliant production facility meet the required quality standards. However, that is insufficient on its own. Mature regulators are also required to have effective post-marketing vigilance systems in place. Apart from adverse event reporting, these systems should also enable the reporting of quality problems with medicines.

Substandard or falsified medicines

Effective surveillance of the pharmaceutical market assists in the identification of substandard or falsified (SF) medicines. The necessary control measures also have to be in place to enable recalls and the destruction of identified SF medicines.

The WHO Global Benchmarking Tool (GBT) requires evidence that “Legal provisions and regulations authorize market surveillance and control activities which include product sampling from different points of the supply chain.” SAHPRA does not operate its own testing laboratory, but contracts with a WHO -prequalified facility at North-West University. Proactive sampling of medicines from all points in the distribution chain needs to be strengthened, as part of the National Action Plan to combat SF medicines.

Despite the existence of a Global Surveillance and Monitoring System for SF medical products (both medicines and devices), quantifying the scale of the problem remains challenging. Medical product alerts have been issued in every WHO region, affecting every type of medical product, not only generic medicines. They have been identified in countries with well-resourced, mature regulatory systems and in countries that lack such capacity. Nonetheless, transparent reporting of problems identified, corrective actions taken and regulatory interventions can help to build confidence that quality assurance systems are not only working, but are seen to be working. Quality should not have to be assumed without assurance that effective systems are in place and appropriately monitored.

*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of columns he is writing for Spotlight.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

Read the original article.

Categories : Expert Opinion Metabolic DisordersTags :

South Africa’s Weight-loss Revolution is Testing Medical Discipline

On By ModernMedia
Photo by I Yunmai on Unsplash

One in every two South African adults is considered overweight or obese. It is not surprising, then, that potentially lifesaving prescription-based metabolic medicines are surging in popularity. The challenge: demand is rising faster than the clinical structure needed to support it, leaving many patients unsure what responsible, medically supervised care should look like.

It is a concern Dr Gerhard Vosloo, a prominent sports, exercise, and lifestyle physician, says he is encountering more frequently in clinical practice. “Expectations are becoming unreasonably high, while few understanding the level of medical oversight required to manage these therapies responsibly. It’s just not as simple as prescribing an aggressive regime and standing back.”

To address issues in today’s weight management sector, Dr Vosloo established Dr GL Vosloo Medical Practice, managed by BioWell, as a formal online medical practice built around sound clinical judgment, structured care, and meaningful patient oversight. He says, “We’re building a model – one that could serve as a stable structure for the wider industry, where sound medical judgment is consistently prioritised over the public’s growing appetite for weight loss drugs.”

The danger of normalising prescription therapy

Dr Vosloo cautions that the rapid rise of these medicines in the mainstream is oversimplifying a highly complex subject and making pharmaceutical use seem routine, when it should remain a final option after disciplined nutrition- and exercise-led approaches have been fully explored.

“Misinformation spreads like wildfire online. People are starting to view prescribed medicines as a routine diet option, when they should be a last resort. Pharmaceuticals are powerful tools for people who struggle to lose weight, but they should be introduced only when medically appropriate, and only after nutrition, exercise, and appropriate supplementation have been fully explored.”

He maintains that prescribed medicines should form part of a structured metabolic management programme that, when used correctly, will reduce cardiometabolic risk, improve insulin sensitivity, regulate appetite, and support meaningful body composition change. The goal is to improve metabolic health under disciplined supervision, and when treatment is not medically necessary, doctors must refuse to prescribe.

“Clinical eligibility must be determined by medical rationale,” he says. “A patient’s preference for medication, emotional pressure to start treatment, or the ability to pay cannot override clinical judgement. Where medical need is absent, a BioWell doctor will decline to prescribe and direct the patient to a non-pharmaceutical, doctor-supported metabolic management pathway.”

Dosing with discipline

Beyond unnecessary prescribing practices, Dr Vosloo stresses that the industry is undermined by over lenient dosing habits. As practiced on the BioWell platform, dosing decisions should instead follow a conservative model guided by clinical responses and tolerability rather than speed of weight loss. The objective is to protect overall health while supporting steady progress that the body can sustain.

“An unfortunate consequence of aggressive dosing is the loss of muscle mass. It’s easier for the body to draw from muscle than it is to mobilise fat, particularly when calories and protein are low – a hallmark of aggressive dosing protocols. The nutritional and training commitment needed to offset muscle loss under more radical regimens are difficult to manage for most people. It’s far safer and more sustainable to take low doses over a longer period.”

“BioWell doctors are more measured in our approach. Conservative dosing and escalation protocols help keep muscle loss to a minimum, while structured nutrition and exercise support plans strengthen the muscular system. This also reduces the risk of nutritional deficiency and limits the physiological stress that often accompanies poorly managed treatments.”

The end goal, Dr Vosloo explains, is to safely and gradually bring South Africa’s obesity crisis under control without creating any additional harm. “Prescription-based metabolic medicine is an undeniably powerful tool in the fight against obesity – one we cannot afford to lose. It’s a lifeline for people battling weight-related illness, but it’s also become a dangerous crutch for those willing to gamble with their health just to lose a few kilograms quickly. If we want to change the health trajectory of millions, we need to rein in aggressive dosing practices and establish a common-sense structure across the sector.”

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Beware the Salt Trap: Why South Africa’s Heart Health Depends on More Than Regulation

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Credit: Pixabay CC0

While South Africa was among the first countries to introduce mandatory salt reduction targets in processed foods, health experts warn that hypertension remains a major public health concern. The reason is increasingly clear, the problem is no longer only what is manufactured, but how people eat every day.

As World Salt and Hypertension Awareness Week (4–29 May) approaches, the focus should shift from reformulated products to daily behaviour change. High salt intake causes the body to retain excess fluid, which increases the volume of blood in the system and places greater pressure on the artery walls, directly leading to the development of hypertension.

“While the policy has successfully reduced hidden salt in many staple foods, it has not yet shifted South African taste preferences.,” says Lizeth Kruger, Clinic Executive at Dis-Chem. “We are still reaching for the shaker out of habit, and that’s where the real danger lies.”

Hypertension remains one of South Africa’s leading risk factors for heart disease and stroke, often progressing silently until complications arise. According to the Heart and Stroke Foundation South Africa, more than one in three adults lives with high blood pressure, a ‘silent killer’ that accounts for roughly half of all strokes and 40% of heart attacks in the country.

Kruger says a shift in everyday eating habits could reduce excess salt intake

1. Automatic salt shake

Many people add salt before tasting their food, even when meals have already been seasoned during cooking or processing.

2. Hidden salt in everyday staples

Stock cubes, processed meats, margarine and sauces remain significant sodium sources, especially when used frequently in daily cooking.

3. Convenience meals and takeaways

Ultra-processed foods and fast meals are often high in sodium, with a single serving sometimes approaching or exceeding the recommended daily limit.

4. A conditioned taste for salt

Long-term high-salt diets have shaped taste preferences, making fresh, whole foods seem bland and reinforcing reliance on added seasoning.

5. Unnoticed snack intake

Savoury snacks, biltong and crackers contribute meaningful sodium but are often not counted in daily intake.

Small changes, meaningful impact

Kruger says reducing salt intake is less about strict diets and more about changing repeat behaviours.

“Small, consistent adjustments can make a real difference over time,” she explains.

  • Tasting food before adding salt is a simple first step, as many meals are already seasoned. Rinsing canned foods such as beans or corn can also reduce sodium content.
  • Flavour can be enhanced using alternatives such as garlic, lemon juice, herbs and black pepper, while checking labels for lower-sodium options helps guide better choices.

A shared responsibility

“Regulation has laid the foundation, but the final step is ours,” Kruger advises. “By becoming more aware of everyday habits, we can reduce the risk of hypertension, stroke and heart disease in our homes.”

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Joint Effort is Key to Sustainable Healthcare Reform

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By Gale Shabangu, Chairperson, Hospital Association of South Africa (HASA)

Recently, President Cyril Ramaphosa made an important decision: to pause the promulgation of the National Health Insurance (NHI) Act until the Constitutional Court has ruled on the pending challenges to Parliament’s role in passing the Act. In doing so, he affirmed that due process must guide reform.

It is a reminder that healthcare reform is not a race to the finish line, but a journey that requires careful pacing, broad consultation and respect for the voices of South Africans. Reform at this scale is like tending a vast garden: every seed must be planted with foresight, every path cleared with care, so that the harvest nourishes all.

Families already feel the strain of rising costs – electricity, food, borrowing – and medical contributions that climb steadily. Yet even in this pressure, there is resilience. South Africans have always found ways to adapt, to share, to build together. Healthcare reform must honour that spirit, ensuring affordability is not a privilege but a shared foundation.

The private healthcare system is a necessary and valuable part of the scaffolding of our healthcare system, sustaining capacity that millions rely on. Unfinished reforms, such as risk equalisation, mandatory membership, and base benefit packages, remain like bridges half‑built. Completing them would stabilise participation and strengthen the entire ecosystem.

If private participation declines, demand does not vanish – it shifts. Public hospitals, already carrying immense responsibility, would feel the weight. Yet here lies the opportunity: to recognise that public and private healthcare are not adversaries but allies. The public sector anchors universal access; the private sector provides funded capacity that absorbs demand and sustains innovation. Together, they form a single ecosystem, each part vital to the whole.

Healthcare reform is about weaving our systems together into a fabric strong enough to carry us all.

As the President recently noted, readiness is central to bringing legislation into effect. Readiness is not bureaucracy – it is the heartbeat of reform. It signals that change must be feasible, not forced; sustainable, not symbolic. That is a hopeful message, because it means reform will be paced by practicality, not politics.

The path forward is clear and promising: complete outstanding reforms in medical schemes, strengthen risk pooling, invest in primary care and prevention, and sequence structural changes responsibly. These steps are not obstacles – they are stepping stones toward a healthier, more equitable South Africa.

Healthcare reform is a national undertaking and a shared responsibility. Government, funders, providers, employers and civil society are all custodians of this commitment. What matters now is how we act, with realism, collaboration and a clear focus on strengthening what already works.

Equitable access to quality healthcare is our shared goal. Achieving it requires evidence, readiness, and respect for complementarity. With stability, sustainability and collaboration as our compass, South Africa can build a healthcare system that is workable and inspiring – a system that reflects the resilience, dignity and hope of its people.

Healthcare requires stewardship. With stability, sustainability, and collaboration guiding reform, South Africa can build a system that works for everyone. And with optimism guiding reform, I believe we can build a system that works for everyone – today, tomorrow and for generations to come.

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

Leadership, Transparency and Culture Shifts Are Key to Improving Public Sector Healthcare Quality

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COHSASA CEO, Jacqui Stewart (left), moderates the panel discussing “Quality in the Public Sector”. From left:  Dr Siphiwe Mndaweni, CEO of the Office of Health Standards Compliance (OHSC), Professor Sabelile Tenza, Associate Professor, Patient Safety and Healthcare Quality, North-West University, Professor Sibusiso Zuma, Chair of the Department of Health Studies at UNISA and Dr Arthur Manning, CEO of Rahima Moosa Women and Children’s Hospital.

Strong leadership, functional governance and an honest culture of reporting are among the critical factors needed to improve and sustain quality care in South Africa’s public health sector, experts said during a panel discussion at the Hospital Show Conference hosted by COHSASA in Sandton recently.

The session, moderated by COHSASA CEO Jacqui Stewart, brought together senior voices from regulation, academia and hospital management to unpack the persistent gaps – and opportunities – in public sector healthcare delivery.

Professor Sibusiso Zuma of UNISA set the tone, noting that quality varies widely across public hospitals and is often determined by how effectively leadership teams work together.

“In my experience, the level of care depends on how heads of departments—nursing, pharmacy and clinical leadership , function as a team,” he said. “They need to identify problems  and address them collectively. Management must also be visible, regularly engaging with what is happening on the ground.”

Dr Siphiwe Mndaweni, CEO of the Office of Health Standards Compliance (OHSC), reinforced the central role of leadership and governance structures, drawing on inspection findings.

“Where leadership is weak or absent, quality suffers,” she said. “Infrastructure is another major challenge. Many facilities are old, and maintenance budgets are often diverted elsewhere, meaning planned upkeep simply does not happen.”

She added that even basic resources remain a concern. “Without essentials like soap, effective infection prevention and control is impossible.”

Dr Mndaweni also highlighted shortcomings in clinical governance, linking these directly to rising litigation. “Facilities may have clinical committees on paper, but if they are not meeting to interrogate lapses in care, the system fails.”

Security risks, poor community engagement and underutilised strategic plans further compound the problem. “Too often, documents are developed and then filed away. Facilities lose sight of their strategy and have no real understanding of patient satisfaction.”

However, she noted that where leadership is engaged – actively interacting with staff and patients – outcomes improve significantly.

Responding to questions on balancing regulatory compliance with quality improvement, Dr Arthur Manning, CEO of Rahima Moosa Mother and Child Hospital, argued that compliance should be seen as a starting point rather than an endpoint.

“Standards are a benchmark, but they are not the ceiling,” he said. “Our experience shows that it is possible to move beyond them.”

Professor Zuma agreed, cautioning against a compliance-driven mindset that fades once certification is achieved. “Facilities often put in intense effort to meet regulatory requirements, then step back afterwards,” he said. “Quality improvement cannot be a once-off exercise or confined to a single ‘quality person’. It must be everyone’s responsibility.”

He advocated for broader training in Total Quality Management and regular six-monthly audits involving all staff. “Quality must be continuous,” he said.

Professor Sabelile Tenza of North-West University pointed to a deeper cultural issue undermining progress: performative compliance.

“There is a tendency to be compliant on paper rather than in practice,” she said, citing research in which hospitals borrowed equipment to pass inspections, only to return it afterwards.

She described a culture of concealment, where staff hesitate to report shortages or failures. “There is fear of exposing the truth, even to boards that could advocate for improvements,” she said. “If we remove that fear, we can move forward.”

Professor Tenza also raised concerns about the reporting of adverse events, stressing the need to protect healthcare workers. “Clinicians ask why they should report incidents when they see no feedback or improvement,” she said.

She criticised the gap between policy and practice around “Just Culture” frameworks. “We talk about it, but confidentiality is not adequately protected. Without anonymity, reporting systems will not work “The focus should be on the incident, not the individual,” she said. “That is how  a learning culture is created.”

Although the National Department of Health has developed free online reporting tools, uptake remains low. Professor Tenza said the system needs to be more user-friendly and accessible via mobile devices, with less duplication between paper and digital processes.

“The focus should be on the incident, not the individual,” she said. “That is how systems learn.”

Dr Mndaweni acknowledged that regulation can be perceived as punitive but stressed that enforcement is a last resort. “The OHSC is designed to support compliance and improvement, not punishment,” she said. “But where there is persistent non-compliance, enforcement becomes necessary—even to the point of revoking a facility’s licence to operate.”

She added that the regulator is repositioning itself to play a more active role in quality improvement, rather than acting solely as an enforcer.

Dr Manning rejected the notion that compliance and quality improvement are competing priorities. “Regulatory standards define the minimum acceptable level of care,” he said. “Meeting them should be business as usual. The real goal is to exceed them – there should be no trade-off.”

Categories : Expert Opinion Obstetrics & GynaecologyTags :

How Women Are Harmed When Clinicians Rely on the Lab More Than the Patient

On By ModernMedia
Photo by Karolina Grabowska on Pexels

Across the world, countless women enter perimenopause only to be told that “everything is normal” because their blood tests do not match their symptoms.

This is one of the most damaging failures in modern women’s health. Perimenopause is not a laboratory diagnosis. It is a clinical diagnosis, made by listening to the woman and recognising the pattern of hormonal transition. Yet many clinicians continue to rely on FSH, LH and oestrogen levels – tests that were never designed to diagnose perimenopause and are physiologically incapable of doing so.

1. Hormone levels in perimenopause are wildly erratic

Oestrogen does not decline smoothly. It surges, crashes, and oscillates unpredictably. FSH and LH follow the same chaotic pattern. A single blood test captures only a moment in this turbulence. It cannot represent the hormonal instability that defines the transition.

This is why women with severe vasomotor symptoms often have “normal” results, while women with mild symptoms may show “abnormal” ones.

Erratic physiology produces erratic numbers. The numbers do not reflect the suffering.

2. Lab ranges do not correlate with symptoms

Laboratory ranges were created for research and population studies – not for diagnosing perimenopause. They do not account for:

  • daily hormonal swings
  • stress
  • sleep deprivation
  • illness
  • cycle timing
  • individual sensitivity to hormonal change

A woman may be drenched in night sweats, unable to sleep, emotionally unstable, and struggling to function – yet her blood tests may look “normal”. This leads to the most common and harmful phrase in women’s health: “Your results are normal, so this is not hormonal.”

3. The harm of relying on lab results

When clinicians wait for “abnormal” results before offering help, women suffer. They are:

  • dismissed
  • misdiagnosed
  • told they are anxious or depressed
  • denied treatment
  • left to struggle through years of avoidable distress

Or are treated inappropriately for life with antidepressants, mood stabilisers, axyiolytics and sedatives. These do little to address the underlying problem but create another set of problems: addiction and a range of side effects. This is not medicine. This is neglect disguised as protocol.

Suffering is prolonged because clinicians rely on lab results rather than the woman’s symptoms. Treating the lab instead of the woman is a betrayal of clinical responsibility.

4. The only test worth doing

There is one test that adds value: TSH and T4 – to exclude thyroid disease, which can mimic some perimenopausal symptoms. Beyond this, further hormone testing wastes time, money, and emotional energy.

5. The clinical truth

Perimenopause is diagnosed by listening to the woman, not by chasing fluctuating hormones. If she has:

• hot flushes

• night sweats

• irritability

• emotional instability

• sleep disturbance

• cycle changes

— she is in perimenopause, regardless of what the blood tests say.

The woman’s story is the evidence.

The numbers are often unreliable and misleading tools.

Dr E.V. Rapiti • April 2026

www.drrapiti.com

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

As NHI Stalls, the Real Debate Is About Trade Offs

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ANC President Cyril Ramaphosa, with Minister of Health, Dr Joe Phaahla and his deputy Dr Sibongiseni Dhlomo, during the signing into law of the National Health Insurance Bill. (Photo: @MYANC/Twitter)

By Thoneshan Naidoo

Healthcare funding is always about trade-offs, writes Thoneshan Naidoo, CEO of the Health Funders Association. The hardest question in healthcare is not what we would like to provide, he argues, but what we can provide sustainably, fairly and at scale.

South Africa’s healthcare debate is shifting and perhaps for the first time in years, it is becoming more honest.

With the National Health Insurance (NHI) Act tied up in legal processes and no credible funding pathway emerging from the 2026 Budget, the conversation is moving away from sweeping promises about the future to a more immediate and uncomfortable question. That is how do we fund healthcare today, and what trade-offs are we willing to accept?

At the centre of that reality is a part of the system that is often misunderstood and frequently criticised – medical schemes.

They are often portrayed as profit driven and exclusionary. In reality, they are not for profit, member owned entities built on a simple but powerful principle, social solidarity. Simply put, members pool their contributions so that those who are healthy today help fund the care of those who are sick.

In practice, around 80% of members claim less than they contribute in any given year. Their contributions help fund the care of the 20% who need it most. That is not exploitation. It is the very definition of risk pooling, and it is the same principle that underpins universal health coverage.

But solidarity comes with trade-offs.

Every Rand paid out in benefits in excess of a member’s monthly contributions is funded by other members. That means decisions about what is covered, how much is paid, and when limits apply are not arbitrary. They are the result of difficult choices about what the overall pool can afford.

These trade-offs become most visible in moments of tension, when a claim is limited, a treatment is excluded, or a dispute arises. To the individual, the system can feel uncaring. But at a system level, the alternative, unlimited funding for every possible intervention, is simply not sustainable.

Even prevention, often presented as an obvious solution, is not as straightforward as it seems.

Take colorectal cancer screening. An inexpensive test such as a faecal immunochemical test can help detect disease early. But many false-positive results lead to follow up procedures like colonoscopies, even when no serious condition is ultimately found. At the same time, some cases are still missed and only diagnosed later, when treatment is more complex and more expensive.

The question is not whether prevention is valuable, it is how to fund it at scale in a way that balances early detection, over treatment and cost.

These are not abstract policy debates but are real world funding decisions that affect millions of people.

And they are taking place in a system under pressure.

Medical scheme membership is voluntary, so younger and healthier individuals often delay joining until they need care. This drives up costs for those already in the system. At the same time, schemes are required to cover a comprehensive set of 270 Prescribed Minimum Benefits, which raises the baseline cost of cover.

The result is a system that works well for those inside it but remains out of reach for many.

This is South Africa’s so-called “missing middle” – millions of working people who earn too much to qualify for public support, but too little to afford private cover. They are left exposed, paying out of pocket, and navigating a fragmented system while waiting for reforms that may still be years away.

As the NHI debate continues, this gap can no longer be treated as a future problem. It is a present reality.

The risk is that the debate remains stuck in ideology. That private healthcare is painted as inherently problematic, or that structural reform alone will resolve access challenges.

Neither is true.

Healthcare funding is always about trade-offs. There are no perfect systems, only different ways of balancing access, quality and affordability within finite resources.

If South Africa is serious about expanding access to healthcare, the debate must move beyond rhetoric and toward practical solutions.

These include using spare capacity in private facilities to treat public patients, and allowing medical schemes, through targeted regulatory reform, to offer affordable primary healthcare cover for people who are currently excluded. Done properly, this could unlock access to private healthcare for more than 10 million uninsured South Africans at a cost of as little as R400 per person per month. Combined with existing tax credits, the impact on a family’s take home pay could be close to negligible. By providing access to preventive and primary care through the private sector, they would reduce pressure on overcrowded public facilities and ease waiting times. Importantly, a strong focus on prevention and early intervention would reduce the need for costly hospitalisation over time.

Medical schemes are well placed to deliver these options, given the principles of social solidarity, community rating and cross-subsidisation that underpin their design. This approach is aligned with the Sustainable Development Goals and the core principles of universal health coverage, and could serve as a practical transitional step as South Africa moves towards the full implementation of National Health Insurance.

After all, the hardest question in healthcare is not what we would like to provide. It is what we can provide sustainably, fairly, and at scale.

*Naidoo is CEO of the Health Funders Association, an industry group that represents several medical schemes and medical scheme administrators in South Africa.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

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