Tag: Spotlight

Categories : Ethics and Law Medical IndustryTags :

Fight Not Yet over as Case Against Vertex is Dropped After Cystic Fibrosis Medicine Price Cut

On By ModernMedia
Cheri Nel launched a court case against Vertex to force them to allow their generic cystic fibrosis drug to be imported into South Africa. Credit: Spotlight

By Catherine Tomlinson

Last year a South African woman took a multibillion-dollar United States pharmaceutical company to court with the aim of securing access to life-changing cystic fibrosis medicines. That case has now been dropped following a reduction in the price charged for the medicines in South Africa.

Cheri Nel, a Johannesburg-based investment banker, has dropped a potentially landmark court case against Vertex Pharmaceuticals. Nel was asking the Gauteng Division of the High Court in Pretoria to grant a compulsory licence to allow generic versions of a cystic fibrosis medicine called Trikafta to be imported into South Africa. No such compulsory licences on medicines have ever been granted in South Africa.

Trikafta, which was registered in the United States in 2019, has been hailed as a “miracle” treatment for cystic fibrosis, which causes severe damage to the lungs, digestive system and other organs in the body. The medicine is effective in treating around 90 percent of people living with the condition. It significantly improves the quality of life of people living with cystic fibrosis, eliminating many of its debilitating symptoms, while also slowing the disease’s progression and extending survival.

In February 2023, when Nel launched her lawsuit against the Boston-headquartered pharmaceutical company, the only way people in South Africa could access Trikafta was by travelling to Argentina to buy it from an Argentinian company selling a generic version of the medicine.

This is because Vertex, the company that holds the patents on Trikafta in South Africa, refused to register the medicine with the South African Health Products Regulatory Authority (SAHPRA) or identify a local distributor that could import unregistered Trikafta via Section 21 authorisations – a mechanism allowing importation of unregistered medicines.

The United States list price for Trikafta is currently over $300 000 (around R5.5 million at the current rand/dollar exchange rate) per person per year, which South Africans feared they would also have to pay if or when Vertex finally started supplying its medicine in the country. Researchers in the United Kingdom have estimated that Trikafta can be produced for under $6000 (around R110 000 at the current rand/dollar exchange rate) per person per year.

When Nel filed the case, generic Trikafta from Argentina – called Trixacar – was much cheaper than Vertex’s product (but still prohibitively expensive for many) at around $60 000, or almost R1 million per person per year. But the Argentinian company selling generic Trixacar faced potential patent infringement challenges if it shipped Trixacar to South Africa. Thus, the only way to get the medicine into South Africa at the time was to travel to Argentina to collect it. People living with cystic fibrosis in South Africa learnt how to do this through an informal network or Buyers Club of people around the world that were reliant on the Argentinian product.

Launching a legal case

Nel argued that Vertex was abusing its patents in South Africa by refusing to make Trikafta available in the country on reasonable terms, while also blocking other manufacturers from supplying the medicine in the country. If successful, Nel’s case would have allowed generic Trikafta to be shipped directly to South Africa, removing the need for travel to Argentina to access the medicine.

According to Nel, Vertex argued in the company’s answering documents to her legal filing that, as she was the only named applicant in the case, a compulsory licence for importation could only be considered for her.

Nel then worked with the South African Cystic Fibrosis Association (SACFA) to get other people living with cystic fibrosis admitted as co-applicants in the case. This process of seeking more people to join her case, she said, was time-consuming, difficult, and expensive, but more than 100 people were working towards being admitted as co-applicants before the case was dropped.

Under pressure, Vertex starts providing Trikafta in South Africa

As the case gained momentum and made headlines around the world, Vertex finally opened the door to allow some people living in South Africa to access their product.

In May 2024, Vertex identified Equity Pharmaceuticals as the local company through which Trikafta could be imported into South Africa via Section 21 authorisations. These authorisations are granted by SAHPRA to enable importation of an unregistered medicine and are meant to be used in exceptional circumstances to remedy the need for an unregistered medicine, such as when there is a shortage of the registered product.

While Vertex has not confirmed to Spotlight or stated publicly the price of Trikafta for people living in South Africa, Nel and Doctors Without Borders’ Candice Sehoma told us that the company is charging around R400 000 ($22 000) for a year’s supply of the medicine.

While still unaffordable for many and much higher than the estimated cost of manufacturing, the R400 000 price is drastically lower than the R5.5 million price charged in the United States and originally feared for South Africa.

It seems improbable that Vertex would have offered the much reduced price to people living in South Africa had Nel not launched the court case

Some medical schemes now paying for Trikafta

As emerged in April this year, Vertex reached an agreement with some medical schemes in South Africa to provide the medicine for people on top-end plans.

“Four private healthcare providers are currently funding Trikafta for eligible patients and we are open for conversations with more insurance companies,” Vertex’s spokesperson Daria Munsel confirmed to Spotlight.

The exact nature of the conversations and/or agreements between Vertex and medical schemes in South Africa however remains somewhat unclear.

Discovery Health‘s CEO, Dr Ron Whelan, told Spotlight it has engaged Vertex about the “benefits available” and “affordable access” of the class of medications that Trikafta falls in but there is “no specific commercial agreement in place” in South Africa.

He noted that Discovery Health Medical Scheme members on the comprehensive and executive plans have a suite of benefits available for the treatment of cystic fibrosis with medicines like Trikafta “of up to R400 000 per annum” for eligible people.

According to Vertex, uptake of its product has been swift and is already starting to make a difference in the lives of people living with cystic fibrosis in South Africa. “Over 100 South Africans with CF [cystic fibrosis] have been prescribed our triple combination treatment in just the first two months of the medicine being available,” said Munsel.

The cystic fibrosis registry, an initiative which seeks to identify and collect data on the outcomes of people living with cystic fibrosis in South Africa, identified 525 people living with cystic fibrosis in the country as of December 2020. Experts believe there are many more undiagnosed cases.

Why did Nel drop the case?

Not only is Vertex’s price for people in South Africa now lower than the 2023 price of Argentinian generics, but the cost of a year’s supply of generic Trikafta from Argentina have increased from around $60 000 to around $100 000 due to hyperinflation in that country.

With Vertex now offering a price lower than the cost of Argentinian generics, Nel decided that her legal case was no longer the best avenue to enhance access to the medicine. The aim of the case “was to get access to the medication… to put pills in patients’ mouths”, she told Spotlight.

Nel said it is now probably better to redirect efforts to getting government at national or provincial levels to buy the medicine for patients in the public sector.

“There is a lot of work still to be done… my efforts are still there, it’s just being redirected,” she said.

“The fact that Trikafta will now be available in South Africa at a much lower price compared to generic versions globally, certainly undercuts the legal case for a compulsory license,” said Tendai Mafuma of SECTION27, a public interest law centre. The Treatment Action Campaign and Doctors Without Borders, represented by SECTION27, were admitted as friends of the court in the case.

Why won’t Vertex register its product in SA?

While much has changed because of Nel’s legal action, Vertex has held fast on its refusal to register Trikafta with SAHPRA.

When asked about Vertex’s plans to register Trikafta in South Africa, Munsel said: “We strongly believe that this [Section 21 Authorisation] is the fastest and most efficient route to sustainable access in South Africa, which does not require a regulatory filing.”

While registering medicines can be onerous and time consuming, it is a routine practice required for pharmaceutical companies to operate around the world. Full registration also typically requires that safety, effectiveness and quality is more closely scrutinised than is the case with Section 21 authorisations.

Nel believes that Vertex has chosen not to register Trikafta in South Africa because of the price transparency requirements embedded in South African law. If other countries know what price South Africa is paying then they may also demand a lower price, she said.

The law requires that there is a transparent pricing system for medicines sold in the private sector, but these requirements do not extend to unregistered medicines imported through Section 21 authorisations, explained Mafuma.

Note: SECTION27 was involved in the court case that is the subject of this article. Spotlight is published by SECTION27, but is editorially independent – and independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons licence.

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Categories : Paediatrics VaccinesTags :

Childhood Vaccine Coverage in SA Declined in 2023, Finds WHO Report

On By ModernMedia
A marker used to measure immunisation coverage is to look at whether children received three doses of the vaccine against diphtheria, tetanus and pertussis. Photo by Mufid Majnun on Unsplash

By Elri Voigt

New data from the World Health Organization (WHO) and UNICEF show that globally childhood immunisation coverage stalled in 2023, while in South Africa it decreased. Elri Voigt unpacks the new data and asks local experts to put it in context.

A new report found that vaccination coverage rates around the world have not yet returned to levels seen in 2019, before the COVID-19 pandemic disrupted immunisation programmes.

There has been no meaningful change in immunisation coverage between 2022 and 2023, according to the WHO and UNICEF report published in July. It means progress in immunisation coverage has effectively stalled, leaving 2.7 million additional children who are either unvaccinated or under-vaccinated compared to pre-pandemic levels in 2019.

A marker used to measure immunisation coverage is to look at whether children received three doses of the vaccine against diphtheria, tetanus and pertussis – referred to as DTP3. Global coverage for DTP3 stalled at 84% in 2023, according to the report.

At the same time, the number of children worldwide who have not received any vaccinations has increased. We refer to these kids as zero-dose children. Ten countries account for 59% of all zero-dose children, with the global number in 2023 rising to 14.5 million compared to 13.9 million in 2022, according to the report.

Coverage slightly down in SA

Data from the report showed a slight decrease for a number of outcome measures in South Africa between 2022 and 2023. It was one of 14 countries in the African region that saw a decrease in coverage for DTP1 (the first dose of the vaccine for diphtheria, tetanus and pertussis), slipping from 87% in 2022 to 81% in 2023. Coverage for DTP3 also decreased, falling from 85% in 2022 to 79% in 2023.

South Africa was also one of 10 countries in the African region that saw a decrease in coverage for the first dose of the measles vaccine, and was singled out by the report as having the sharpest decline in coverage in the region between 2022 and 2023. Measles coverage dropped from 86% in 2022 to 80% in 2023.

Commenting on the accuracy of the new data, Professor Shabir Madhi, Dean at the Faculty of Health Sciences at the University of Witwatersrand (Wits), said it used administrative data, which can bias the estimates. He explained that the report bases vaccine coverage on the number of vaccines procured by government and deployed to facilities. For example, if a facility gets 100 doses of the measles vaccine and ends up discarding 50 doses, that doesn’t necessarily get reported.

The WHO acknowledges the potential for data inaccuracies. It stated that they calculate the estimated percentage of immunisation coverage by dividing the number of doses administered to a target population by the estimated number of people in that target population.

Madhi said a more accurate picture of childhood immunisation coverage in the country can be found in National Vaccine coverage surveys, like the Expanded Programme on Immunisation (EPI) National Coverage survey. Spotlight previously reported on results from the most recent EPI survey conducted in 2019.

Madhi said it appears the new report did not incorporate data from the EPI survey. However, even without this data, he said the WHO estimates are not too far off the local data. He remarked that he doesn’t feel “too strongly either way” about the accuracy of the WHO data since the bottom line is vaccine coverage in the country is lagging.

“Fluctuations in immunisation coverage are not uncommon,” Dr Haroon Saloojee, a professor of Child Health at Wits University told Spotlight. “One should not make too much of a fall or increase in coverage rates over one year, unless it is drastic.”

Data from the WHO report for vaccine coverage in South Africa between 2018 and 2022 had actually showed an overall upward trend, which was “promising”, according to Saloojee. However, he said the latest data from the report “holds no good news for South Africa” because the dip in coverage in 2023 was noteworthy.

How does SA compare?

“South Africa’s performance is moderate when compared globally, and poor compared to other high-middle income countries,” said Saloojee. “Considering that South Africa is a high-middle-income country, we should be performing much better in all our health indicators.”

He pointed out that countries in a similar bracket like Cuba and Uruguay have achieved high immunisation coverage through robust healthcare systems and effective public health policies.

Regarding zero-dose children, the report ranked South Africa 6th worst in the African region. In 2022, the country ranked 13th. With a total of 220 000 zero-dose children, the country accounted for 3% of all zero-dose children in the African region. Nigeria had the highest percentage at 32% of all zero-dosed children in the region, followed by Ethiopia with 14%.

‘Dysfunctionality of primary healthcare’

Apart from the international comparisons, Madhi pointed out that South Africa is not meeting its own targets of having at least 90% of children in each district fully vaccinated.

The EPI survey found that only seven of the 52 districts in the country were able to achieve the national target of 90% of children fully vaccinated under one year of age. Together, the data from the survey and the WHO clearly shows that childhood immunisation targets are not being met in the country.

For Madhi, the results from the EPI survey “speaks to dysfunctionality of primary health care in the country”. He said the immunisation of children, which is the bedrock of primary healthcare when it comes to children, acts as a “canary in the mine with regards to how well primary healthcare is working”.

He said South Africa is a leader in the field when it comes to evaluating and introducing vaccines to the public immunisation programme. But when it comes to implementation, for the vast majority of districts we “are falling completely flat on our face and coming short in terms of reaching our own targets”.

Implications for children

The health implications for children who are not unvaccinated or only partially vaccinated are significant.

“They are less protected against what can be life threatening diseases. And those life-threatening diseases include diseases such as measles, but also other life-threatening diseases such as pneumonia,” Madhi said.

“We’re selling ourselves short as a country in addition to actually compromising the health of children by not ensuring that we’re doing everything that’s possible to actually get children to be vaccinated,” Madhi added. “It also comes with other consequences, so it sort of lends South Africa to be more prone to outbreaks.”

Saloojee added that it is also likely that children who are not fully vaccinated are “not receiving many of the other health, education and social development services all children require and that is being provided by government, such as early childhood development services and child support grants”.

The reasons for immunisation coverage lagging are complex and the responsibility for fixing the problem lies with more than just one entity. Spotlight previously reported on some of the reasons children are remaining unvaccinated or under-immunised as identified by the EPI survey.

Madhi said there needs to be a fundamental relook at the country’s immunisation programme. Proper governance structures need to be put in place and the programme will need to be implemented all the way down to the sub-districts. There is also a need for real-time data and monitoring of that data so interventions can be done when children are missing their immunisations. He also suggested ring-fencing funds for vaccines, at either a national or provincial level, to ensure that money earmarked for vaccines are used for that purpose so as to ensure less stock-outs.

“The immunisation programme hasn’t changed much from what I can gather over the past 20 years, let alone the past 10 years. So we can’t expect a different outcome if the strategy that we’re using which has failed is the strategy that you continue pursuing,” Madhi said.

Saloojee said the National Department of Health can play a pivotal role in strengthening the immunisation programme by “providing leadership, resources, and policy support”. He said that to his knowledge the health department is currently preparing a national immunisation strategy to take us to 2030, but the draft is not up to scratch. The strategy, he says, will need to offer clear objectives, establish realistic indicators of, and targets for, measuring success, and attract a fully funded mandate.

Spotlight asked the National Department of Health for comment on the new WHO report and how it plans to respond to improve immunisation coverage. While the department acknowledged our questions, they did not provide comment by the time this article was first published.

Republished from Spotlight under a Creative Commons licence.

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Categories : HIVTags :

Medicines Stockouts Persist in North West as Tide Turns Slowly

On By ModernMedia
Photo by Miguel Á. Padriñán: https://www.pexels.com/photo/syringe-and-pills-on-blue-background-3936368/

By Nthusang Lefafa

Despite some improvement over the past three years, the North West province continues to experience medicine shortages, according to a survey by a community clinic monitoring initiative. We unpack the latest findings and ask why shortages persist in the province.

Some people in need of HIV or tuberculosis (TB) medicines were sent home empty handed after visiting clinics in the North West. This is according to the latest survey of public healthcare services in the province published by community-led clinic monitoring group Ritshidze. The survey data was collected in April and May this year.

Of the roughly 490 000 people living with HIV in North West, around 380 000 (77%) are on antiretroviral treatment, according to figures from Thembisa, the leading mathematical model of HIV in South Africa. Antiretroviral treatment is recommended for everyone living with the virus.

According to Ritshidze, besides HIV and TB medicines, other commonly reported stockouts at clinic-level include pain medicines (such as Paracetamol and Ibuprofen), cardiac medicines (such as Aspirin), contraceptives, dry stock (gauze, bandages, needles), maternal health medicines, psychiatric medicines, and different vaccines.

Out of the 72 facilities surveyed in the province, medicine stockouts lasting one to three months were reported at 20 and stockouts lasting three to six months were reported at six.

‘Failed to comply’

The North West health department, according to Ritshidze, has failed to comply with national guidelines recommending that people living with HIV should be provided with a three or more month supply of antiretrovirals at a time. They found that 71% of people surveyed in 2024 received antiretroviral refills of three to six months – in each of the previous three years this number was below 30%. There was large differences between districts, with 97% of people surveyed in Bojanala district reporting getting a 3 month supply of ARVs — compared to 37% in Dr Kenneth Kaunda.

Giving people longer antiretroviral refills like this means people do not have to visit health facilities as often to collect their medicines.

Various factors influence giving more people longer antiretroviral refills, Tebogo Lekgethwane, Director of Media and Communications in the province’s health department, told Spotlight.

A crucial factor, he said, is that patients must have a good track record of collecting their medication as well as a history of a documented undetectable viral load. “There’s therefore a criteria for multi-month supply which includes the fact that patients should have been on treatment for six months, they are compliant and clinically stable,” said Lekgethwane.

No “crisis” of medicine shortages

While the year-on-year comparisons should not be overinterpreted – Ritshidze themselves advise caution – the numbers nevertheless provide some indication that when it comes to medicines stockouts things are trending in the right direction. The total number of stockouts in the province reported to Ritshidze plunged from 895 in 2021 to 148 in 2024 – over the same period stockouts of HIV medicines went from 115 to 19 and stockouts of TB medicines from 28 to 7.

Lekgethwane was at pains to point out that Ritshidze’s findings do not necessarily represent the actual picture of the entire province. He said that the department believes that the Ritshidze report is subjective and relies on isolated incidents. These incidents, Lekgethwane said, are often quickly addressed.

“The current provincial medicine availability report shows that medicine availability has stabilised above 80%. As at the end of June 2024, ARV stock was at 89.5%, Expanded Programme on Immunisation and Contraceptives remained above 90%, TB treatment at 79%, Oncology treatment at 81.7% and Diabetes Mellitus at 85.8%. Therefore the province does not have a crisis of medicine shortages,” he said.

Asked what exactly these percentages mean, Lekgethwane said that it indicates the actual medicines stock available in the province in relation to what is required.

A pharmacy expert consulted by Spotlight further explained that the percentage indicates the percentage of medicines on a list or in a class that is available in the province.

The way these numbers are tracked is somewhat tricky. Firstly, if a clinic is supposed to have 10 different HIV medicines in stock, but they only have 8 in stock, then its HIV medicines availability would be at 80% (having a single pack of a medicine counts as having it in stock). When many facilities are considered together, as with an entire province like North West, the key indicator looks at what percentage of those facilities have medicines availability above 90%. We thus understand the figures shared by Lekgethwane to mean that 89.5% of facilities, depots and so on in the province have HIV medicines availability above 90%.

Catching up with payments

Past medicine shortages in the province were partly attributed to companies ceasing delivery of medicine due to non-payment of invoices. While the North West health department was under National Department of Health administration in 2020, the offices at the Mmabatho Medical Depot was raided. The search uncovered a number of unpaid invoices worth millions, some dating back to 2014. One unpaid invoice was for more than R16 million.

Bolstered by a Pharmaceutical Intervention Team to address medicine shortages, Lekgethwane said the department’s payments system is now in top shape.

“Payment of suppliers has remained a priority and the finance unit has assisted the team by making good progress on payments of supplier accounts. The unit continues to investigate and intervene when suppliers indicate their account status to the pharmacies.

“This has led to an increased number of deliveries from suppliers to the depot and increased direct deliveries to pharmacies from contracted companies as well as deliveries of main orders, allocation of orders and emergency orders from the depot to the pharmacies,” he said.

“The Department can confidently confirm that the financial management of pharmaceuticals has been improved resulting in 97% of 2024/2025 accruals being paid and remaining with only two accounts that are on hold. The two accounts that are on hold will only be paid once their compliance requirements are sorted,” said Lekgethwane.

He said that the intervention team has the capacity to assess and intervene, in among others, pharmaceutical supply chain issues, system effectiveness, distribution and delivery processes, storage capacity, human resource capacity and safety issues.

Lekgethwane said the team’s first priority was to assess the Mmabatho Medical Depot before moving onto pharmacies in hospitals and clinics across the province.

Getting medicines to rural areas

While Ritshidze also raised concern around transportation for the delivery of medicines, the department said transportation has never been a challenge.

“There are contracted service providers who deliver to the Mmabatho Medical Depot and the depot delivers to hospitals. Clinics receive their medicine from their referral hospital,” said Lekgethwane.

“However, the department is currently implementing the bulk pharmacies for districts to bring medicines closer to facilities”, he added. A bulk pharmacy is a medicine storage facility which serves as a medical depot. It is situated in the districts and helps with bringing medicines closer to rural areas so that medicines do not have to be transported from major towns.

In this regard, Lekgethwane said the Dr Kenneth District Bulk Pharmacy was recently opened and soon the General De la Rey Bulk Pharmacy will open.

He said the department is confident that the use of these bulk pharmacies will improve medicine storage and distribution capacity.

Shortage of pharmacists and pharmacy assistants

The Ritshidze report found that only 9% of surveyed facilities had a pharmacist and only 18% had a pharmacist assistant. Government regulations state that either pharmacists or pharmacy assistants should be responsible for stock receiving orders and updating the stock visibility system. However, Ritshidze found that enrolled nurses, enrolled nurse assistants, facility managers, and even cleaners acted in that capacity at some clinics.

The province has a 6% vacancy rate for pharmacists while 342 are currently employed, according to the 2024/2025 health department annual performance plan tabled in the North West Provincial Legislature earlier this month. The plan states that the department’s organisational structure makes provision for 10 pharmacists to be appointed in the province for every 100 000 uninsured individuals.

The DA’s Hendriette van Huyssteen says there is a challenge of pharmacists and pharmacy assistants where there are clusters of less than 10 000 uninsured individuals (where one pharmacist would be allocated for 10 000 uninsured individuals) and the clinics servicing them are far removed from one another.

“With the NHI [National Health Insurance] being signed into law, the number of pharmacists will become only a greater challenge. The cost per pharmacist employee stands at R765 000.00 per annum. It is unclear as to where the funding would come from for the remuneration of the additional pharmacists needed under the NHI, as even the NHI Act is unclear in this regard,” she said.

Notwithstanding the issue of budget constraints, the training of more pharmaceutical staff is integral to having fully functional health systems, said Professor Andrew Robinson. He is a deputy dean in the Faculty of Health Sciences at North West University (NWU). He was previously a deputy director general in the North West health department.

“To improve the pharmaceutical skills in the province, the NWU must ensure it aligns its pharmacy training to address the skill needs of the provincial health department to ensure equitable health service delivery to all, which is necessary for successful implementation of the NHI,” he said.

Republished from Spotlight under a Creative Commons licence.

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Categories : General Interest VaccinesTags :

“Not Being Afraid to Speak out, it does get me into Trouble Quite Often,” Says Prof Shabir Madhi

On By ModernMedia
Professor Shabir Madhi of Wits University. Photo: supplied.

By Biénne Huisman

Amid the uncertainty of the early days of the COVID-19 pandemic, Professor Shabir Madhi often stood out for his clarity of thought in making sense of rapidly evolving scientific evidence. Biénne Huisman chatted to Madhi about vaccines, ongoing challenges with the Gauteng health department, and being outspoken about issues such as the war in Gaza.

Professor Shabir Madhi became known to many in South Africa for leading the charge in two of the first COVID-19 vaccine clinical trials conducted in Africa – those for the AstraZeneca and Novavax vaccines. At a time of much scientific uncertainty, he was often quoted in the press – gaining a reputation for keeping his cool and calling things as he saw them based on available evidence.

He spoke out against the politicisation of science and was a staunch advocate for access to vaccines, especially for older people at higher risk of severe illness and death. He wasn’t afraid to ruffle feathers, openly criticising government’s COVID-19 vaccine communication efforts and arguing that government should take vaccines to the people, rather than the other way around. He called for the ending of strict lockdowns, before many others did so. Reflecting on his reputation for not holding back on his beliefs, he admits to “having a short fuse, especially when people are talking nonsense – or what I consider to be entirely off the mark”.

What may be less obvious to the public, is that Madhi’s healthcare impact precedes COVID by decades.

Internationally respected for his research into paediatric infectious diseases, his work has helped to save the lives of hundreds of thousands of children and informed World Health Organization policy (WHO) – notably relating to the pneumococcal conjugate vaccine (to prevent pneumonia and meningitis) and the rotavirus vaccine (to prevent diarrhoeal disease in young children).

His work continues. Just last year a landmark study, led in South Africa by Madhi’s Vaccines and Infectious Diseases Analytics Research Unit at the University of the Witwatersrand (Wits), found that immunisation of pregnant women safely protected their unborn babies from respiratory syncytial virus (RSV). As Spotlight reported at the time, researchers estimate the vaccine can save thousands of young lives.

Speaking to Spotlight over Zoom from Wits in Johannesburg, where he is Dean of Health Sciences, Madhi relays his love of treating kids – who “most importantly, don’t lie, and who are the most vulnerable”.

“Accidental vaccinologist”

Madhi has been described as an “accidental vaccinologist”. Shrugging inside a navy suit, he says he never intended to become a physician, let alone a professor in vaccinology. At medical school at Wits, he nearly dropped out after a month.

As a child, growing up in Lenasia, Madhi wanted to become an engineer. But born to a mathematics teacher father and a stay at home mum, money was tight. His only opportunity to attend university presented itself via a bursary in medicine.

“I only really started to enjoy medicine once I specialised in paediatrics,” he says. “But more importantly, that’s when I realised the huge potential that existed in medicine to make a difference, particularly the potential for vaccines to make a big difference over a short period of time – not on an individual level, but at a community level. And that’s what really drove me into the space of research.”

While doing his peadiatric training at Chris Hani Baragwanath Academic Hospital (he obtained a master’s degree in paediatrics from Wits in 1998), it struck him that the leading causes of death among children were entirely preventable.

“Back then, close to 750 000 children were dying of measles globally; half of those deaths were happening in Africa, despite the vaccine for measles being available since the 1970s. South Africa was one of the countries with a poor public immunisation programme; up until 1992 South Africa didn’t have a public immunisation programme.”

In 2009, in a first on the African continent, pneumococcal and rotavirus vaccines were finally officially rolled out in South Africa.

“While I was training at Baragwanath, there was a ward just for children with gastroenteritis or diarrhoea,” he recalls. “But six months after we introduced the rotavirus vaccine in South Africa [in 2009], we shut down the diarrhoea ward at Baragwanath and probably every other diarrhoea ward in the country.”

Contributing internationally

Today Madhi’s CV is long. He sits on scores of scientific advisory committees, attending conferences and delivering talks around the world.

Since 2019, he has served on a global panel of experts convened by the WHO, the Strategic Advisory Group of Experts on Immunization (SAGE), of which he now is deputy chair. He also chairs the SAGE working group on polio.

“I’m really enjoying SAGE at the moment,” he says. “This is where I think I am making a meaningful contribution. It really is an eye opener to the different types of research that’s taking place globally; but also the type of challenges we face in terms of ensuring that children are adequately immunised.

“It’s great to be working on new vaccines, coming up with new vaccines; but that’s a meaningless exercise unless you can ensure that those vaccines are getting into the arms of children – because that is what saves lives. So yes, dealing with issues around implementation and advocacy.”

SAGE requires frequent trips to Geneva, where the WHO is based.

Our discussion turns to business travel – the amount required for a researcher to remain “relevant and competitive”. With typical candour, Madhi outlines challenges faced by researchers from the global south.

“I think coming from South Africa, coming from the African continent, it’s more of a challenge for researchers to establish themselves, for a number of reasons. Firstly to become known in the international space, you probably need to deliver so much more than what is expected from our northern hemisphere counterparts.

“Then in addition to the inconvenience of needing to travel so often, there are subtle things which people in the northern hemisphere don’t have to deal with. Needing to get visas and dealing with customs officials when entering countries.

“It can become an extremely unpleasant experience, and you really need to swallow your pride given what is blatant racism at times. For example, nowadays I refuse to fly through Germany because the customs office in Frankfurt is probably the worst I have encountered. All of a sudden, they would keep me and question me for both arrival, as well as departure…”

Local challenges

The discussion turns back to South Africa, and health challenges in his home province of Gauteng. Here also Madhi has tried to make a difference, but it hasn’t been plain sailing.

Commenting on a floundered memorandum of agreement (MOA) signed between Wits and the Gauteng Department of Health in June 2022, Madhi says: “The bottom line unfortunately; the Gauteng Department of Health simply doesn’t have stability of leadership. At the level of the MEC in particular; I mean since I’ve been dean, there’s been about four or five heads of department. And it becomes difficult to follow through with any of these programmes.”

Madhi adds that Wits university executives had worked on the memorandum for seven years. The agreement set out a plan to combine university and government resources in “academic health complexes” for enhanced service delivery. But the Department of Health put it on hold three months later, following a related Public Service Commission inquiry.

He explains: “They convened this big workshop, spending probably a mini fortune, to basically facilitate the establishment of an MOA, not just between Wits and the Department of Health, but between the Department of Health and many other academic hospitals in the province. Because of the intervention, the Department of Health indicated that they weren’t going to implement our MOA until that particular commission concluded their work. But since then, there’s been absolutely no report from that meeting.”

Not afraid to speak out

On social media, Madhi speaks out about atrocities being committed in Gaza.

To Spotlight, he says leadership holds no place for neutrality.

“As part of leadership, and I do consider myself a leader in the different roles that I play – either in my research unit or currently as university dean – you need to be prepared to take a stance. You can’t remain neutral on positions. You need to interrogate facts. And once having interrogated the facts, you need to reach a conclusion; then follow through with what is required, if there’s anything that needs to be implemented.”

Madhi says his leadership style was honed during childhood. “Not being afraid to speak out, it does get me into trouble quite often,” he says, laughing. “I think that’s just part of my upbringing, being an activist during apartheid in the Lenasia Youth League and other activist organisations. My upbringing was, when things are not what it’s meant to be, you speak out; you champion the right cause.”

These days Madhi lives in Northcliff with his wife, with whom he has two children. His favourite football team is Arsenal and a book he says he recently enjoyed was The Covenant of Water – a three generation family account set in India, by physician and author Abraham Verghese.

Republished from Spotlight under a Creative Commons licence.

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Categories : Lab Tests and Imaging Respiratory DiseasesTags :

“We Were the First Ones to Do It”: Innovative SA Study Takes TB Testing to People’s Homes

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

By Tiyese Jeranji

Most tuberculosis (TB) tests still require a trip to the clinic. Now, new technology has made it possible to test people at home. This could be a big deal for South Africa, where much TB goes undiagnosed. We unpack the findings and implications of a recent study into such TB home testing.

One of the biggest challenges in combatting TB in South Africa is that many people who fall ill with the disease are diagnosed late, or not diagnosed at all.

The World Health Organization (WHO) estimates that 280 000 people fell ill with TB in the country in 2022. Of these, roughly 66 000 were not diagnosed, and accordingly also not treated. Apart from the damage to the health of the people who are not diagnosed and treated, this also has implications for the further spread of TB since untreated TB is often infectious TB – people become non-infectious within a few weeks of starting TB treatment.

Typically, people who fall ill with TB only get diagnosed once they turn up at clinics with TB symptoms – this is called passive case-finding. In recent years, there has been a growing recognition that passive case-finding alone is not good enough if we want to diagnose more people more quickly. As a result, many people in South Africa considered to be at high risk of TB are now offered TB tests whether or not they have symptoms – an approach called targeted universal testing. Screening for TB using new mobile X-ray technology has also been piloted in the country.

Now, in the latest such active case-finding innovation, researchers have been offering people TB tests in the comfort of their own homes.

Dr Andrew Medina-Marino, a senior investigator at the Desmond Tutu Health Foundation (DTHF), tells Spotlight no one in the world was testing for TB at home until they recently started doing so at the DTHF’s new research site in the Eastern Cape.

The testing is done using a molecular testing device, roughly the size of a two litre Coke bottle, called the GeneXpert Edge. The GeneXpert Edge is a portable version of the GeneXpert machines that have been used in labs across the country to diagnose TB for over a decade.

The GeneXpert Edge is a standardised testing device that detects TB DNA in sputum. (Photo: Nasief Manie/Spotlight)

One challenge with the device was that it needed to be plugged into a power outlet in a wall and not all homes in the area have power. “So what we did is, we hooked up a car-like battery to the device and we were able to take it into people’s homes,” says Medina-Marino.

‘Acceptable and feasible’

A study lead by Medina-Marino, and recently published in Open Forum Infectious Diseases, set out to determine the acceptability and feasibility of in-home testing of household contacts of people with TB.

The study was conducted among 84 households in Duncan Village, a township in the Buffalo City Metropolitan Municipality in the Eastern Cape. The Metro had an estimated TB incidence of 876 cases per 100 000 population in 2019, according to the National Institute for Communicable Diseases. This number is much higher than the latest WHO estimate of 468  per 100 000 for South Africa as a whole.

From July 2018 to May 2019, people diagnosed with pulmonary TB were recruited from six government health clinics in the area. They were asked for permission to visit their homes to screen their household contacts for TB. Household contacts were verbally assessed for signs or symptoms of TB, including night sweats, weight loss, persistent cough and a fever.

Households where people had any signs or symptoms of TB were randomised to either be referred to a local clinic for TB testing or tested immediately in their home. Of the eighty-four randomised households, 51 household contacts were offered in-home testing. Everyone accepted the offer for in-home testing.

For the test with the GeneXpert Edge, Medina-Marino says household contacts had to produce a sputum sample. About 47% (24/51) were able to produce sputum. This was then mixed with a reagent containing the required components for a polymerase chain reaction test. This solution was then loaded into a disposable cartridge/test module and inserted into the Edge device. Results were available in about 90 minutes. Anyone who received a positive test result in their home were immediately referred to a clinic for TB treatment.

Regarding the 47 household contacts referred for testing at the clinic, only 15% (7 people) presented for clinic-based TB evaluation, 6 were tested, and 4 out of 6 returned for their results.

Ultimately, the study found that in-home testing of household contacts for TB was acceptable and feasible.

“It’s feasible. If you compare the rate of uptake of treatment versus the rate of uptake for testing, it looks like it’s performing much better when you do home based testing versus referral for testing at the clinic,” says Medina-Marino.

Risk of stigma?

Similar to when HIV home-based testing studies were carried out, Medina-Marino says prior to their study, community members expressed concerns about stigmatising houses that were visited. “[A] lot of people were saying: ‘If you go to people’s houses, you’re going to stigmatise the household.’”

But what they actually found was that people didn’t feel stigmatised. Household contacts of people with TB felt that coming to the house to test people brought a sense of security in the home. He adds that it was easy for people to believe the results because everything was done in front of them.

In instances where people didn’t have TB, Medina-Marino says household contacts were comforted that they didn’t have to be scared of the person tested. In instances where people did have TB, he says the attitude of household contacts was supportive to start treatment.

How the test compares to other tests

Apart from testing for TB, the GeneXpert Edge can also detect whether someone’s TB is resistant to rifampicin. This is one of the medicines in the standard four-drug combination used to treat TB.

Unlike the latest lab-base GeneXpert tests, the GeneXpert Edge does not detect resistance to any TB medicines other than rifampacin. “It is hard to fit the probes needed to detect other forms of resistance into the cartridge,” says study co-author Professor Grant Theron, head of the Clinical Mycobacteriology and Epidemiology Research group at Stellenbosch University’s Molecular Biology and Human Genetics Unit.

Theron notes that the sensitivity and specificity of GeneXpert Edge is similar to that of lab-based GeneXpert machines if the tests are done on specimens from the same type of patient and the same test cartridge. (High sensitivity means the likelihood of false negatives is low wile high specificity means the likelihood of false positives is low.)

Performance may however differ because of differences between people who test at home and people who test at the clinic. Theron explains that in their study they tested people who did not yet feel sick enough to go to get tested at the clinic. People who are sicker, and who are accordingly more likely to go to the clinic, are likely to have more pathogen in their sputum samples and be easier to diagnose.

‘A breakthrough for TB’

Home-based tests is a significant breakthrough in TB because of its crucial role in detecting cases early and enabling timely tracing and testing of household contacts, says Dr Ntokozo Mzimela, a lecturer in integrated pathology in the Faculty of Health Sciences at Nelson Mandela University.

She tells Spotlight it also offers several advantages over clinic-based tests. “They are highly accessible, facilitate mass testing, reduce the risk of disease transmission, and address patient reluctance by allowing testing in the comfort and privacy of one’s home.”

Mzimela adds the GeneXpert Edge and portable X-ray screening serve complementary roles in TB diagnosis. “While the X-ray reveals lung abnormalities, the Edge confirms the presence of TB bacteria. Both tools are essential and should be used in conjunction to provide comprehensive diagnostic insights and ensure accurate and timely treatment for patients,” she says.

Professor Keertan Dheda agrees that home-based testing could link up neatly with portable X-ray, but adds it is still too early to determine where home-based TB testing will fit into the country’s TB testing programme. Dheda heads up the Division of Pulmonology at Groote Schuur Hospital and the University of Cape Town.

“We don’t yet know whether testing everyone is the right approach or whether reflex testing based on chest x-ray abnormalities is the right approach,” Dheda says. “Now that feasibility has been established, it means that more studies can be undertaken, and operational research can be commenced.”

Further studies are already underway, Medina-Marino tells Spotlight.

He says the study in Duncan Village found that about 60% of household contacts who had TB symptoms could not cough up a sputum sample. His team therefore decided to combine in-home testing with an oral swab.

“So in the study that we’re doing now in households, we found an additional 12 people who cannot produce sputum but on their swab test, they showed a positive swab result. Tongue swabs increase yield of case finding among those unable to produce sputum,” he says.

Republished from Spotlight under a Creative Commons licence.

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Categories : PaediatricsTags :

How ‘NHI on Wheels’ is Bringing Life-changing Healthcare to Young People in Rural Eastern Cape

On By ModernMedia
Children lining up to see the dentist at the Ekuphumleni Community Hall, near Whittlesea. (Photo: Sue Segar/Spotlight)

By Sue Segar

The Keready project uses mobile clinics to take healthcare services to rural areas. Sue Segar spent time with the project as they took eye, dental, and other healthcare services to communities in the Eastern Cape.

In the small Eastern Cape town of Bizana, hundreds of children stream into a large hall at the Oliver and Adelaide Tambo Regional Hospital on a brisk Tuesday morning in May. There’s a festive but orderly vibrancy in the air – the scene made all the more colourful by different school uniforms and young voices from tiny six-year-olds to learners in their late teens.

They’ll be assessed, and helped by doctors from Keready – an organisation offering mobile health services in many far-flung communities lacking healthcare services.

For weeks leading up to today, outreach teams from Keready’s mobile clinic operation have gone from school to school, asking teachers to identify children with eye problems. Today they arrived on various forms of transport – some on the back of a bakkie – from deeply rural communities as far as 100 kms away. Most of the children have little access to health services, particularly eye care, so the response is substantial.

I have travelled here with three doctors and an admin assistant from Keready’s East London office. They join other healthcare staff, including from the health department, for this two-day mega outreach in partnership with the Umbono Eye Project.

“Over the past three months, school educators identified 492 learners from 26 schools who have impaired vision,” says Ewan Harris, a pharmacist and consultant by training and a former deputy director-general of education in the Eastern Cape, who heads up Keready’s Eastern Cape team. “We will attend to these learners and if necessary, provide them with prescription spectacles and meds.”

Ntombizedumo Bhekizulu, a teacher at the Mhlabuvelile Senior Primary School at Ludeke Mission, has come with 16 children, “the ones who struggle to see what we write on the chalkboard”.

Bulelwa Mqhayi from Nomathebe Primary School in Isithukutezi adds: “It’s great that they can help these kids. Most of the parents are unemployed and on social grants and don’t have the money to take the kids to specialists. The clinics don’t help us with eye problems.”

The youngsters will also have a range of other health checks and will be sent to see one of the doctors on site if found to be in need of further health assistance. The health department has deployed a mobile dental unit, an audiologist, as well as a medic to provide advice on family planning and reproductive health.

A child being signed in for a health check at Bizana. (Photo: Sue Segar/Spotlight)

Before arriving at the registration desk, the children have already been given deworming tablets and a Vitamin A supplement, provided by the health department, while each group is given a health talk on age-dependent topics ranging from hand hygiene, to TB and HIV.

After handing in their registration and consent forms, the children go through basic vision screening tests by a team of “eye care ambassadors” – young people supported with employment opportunities through the Social Employment Fund, which is managed by the Industrial Development Corporation.

If the school children fail the eye screening test, they are sent to see optometrist Johan van der Merwe.

In between patients, he tells Spotlight he’s already found a number of “low vision candidates” and one who might need to be placed in a special school. “I’ve just done a full refraction on one child … It’s clear that he has a lens defect,” says Van der Merwe. Placing his hand on the head of another small boy, he continues: “This little one has been very quiet … he’s struggling to communicate. He needs thick lenses, or an operation by a specialist.”

Van der Merwe, who has been an optometrist for 22 years, joined the Umbono Eye Project permanently almost two years ago after volunteering his services once a week. “Before I joined, I was working in a mall in East London. I never saw sunlight.” He adds: “It has been very rewarding to make a difference to these children.”

Optometrist Johan van der Merwe assesses a child at Bizana. (Photo: Sue Segar/Spotlight)

At another mobile site, health department dentist, Dr Unathi Mponco, has been busy with youngsters suffering from a range of dental ailments. “There were sore teeth, rotten teeth, mobile teeth, and some children had very swollen gums…. Whatever I can treat on the mobile truck, I deal with here – otherwise if they need X-rays or the cases are more serious, I refer them to the hospital’s dental unit for a comprehensive exam,” she says.

In a mobile van outside the hall, health department medic Siyabonga Chonco has been consulting teenage girls all day offering family planning services. “The Alfred Nzo district has the highest rate of teen pregnancies in the Eastern Cape. We are trying hard to curb teenage pregnancy,” he says.

The teens are invited to ask any questions and to say whether they are sexually active and ready to take contraceptives. Chonco says in almost every case, he senses great relief from the learners to speak to an impartial young person. “They tell me that, at the clinics, the older nurses can be quite harsh…. They open up to me, especially with questions about contraceptives.”

He says broadly, young people are interested in long-term contraceptives. “They don’t want to have to go to clinics all the time.” Some will walk away with a contraceptive implant – a flexible plastic rod about the size of a matchstick that is placed under the skin of the upper arm to prevent pregnancy over three years – while others will choose injectables or pills.

At the end of two days in Bizana, the team has seen nearly 750 youngsters from about 40 schools, with 432 having had their eyes screened and 52 eligible for specs. For six of those children, the spectacles will be life-changing, says Van der Merwe.

Doctors Eileen Kaba and Anda Gxolo consulting with their little patients. (Photo: Sue Segar/Spotlight)

Apart from a few “high” prescriptions that might have to be ordered from overseas, a member of the team will deliver the specs personally to each learner, an occasion which is a highlight for the team. “When we first put the glasses on their faces, you just see smiles. The parents are so thankful. It makes this so worthwhile,” says Van der Merwe.

Keready is working closely with the provincial departments of health and education. The NGO recently received the Eastern Cape’s Batho Pele Award for enhancing healthcare in the province.

“We could never reach all these children as government,” says TD Mafumbatha, mayor of the Winnie Madikizela-Mandela municipality, adding “this is what collaboration looks like”.

But where did it all begin?

Keready, loosely translated as “We are ready”, was set up in February 2022 to encourage young people to vaccinate against COVID-19.

One of the people behind Keready is Harris, a pharmacist and consultant by training and a former deputy director-general of education in the Eastern Cape. Harris was working as a consultant for the Fort Hare Institute of Health, when he was asked to help design the Eastern Cape’s COVID vaccine rollout strategy.

“The COVID programme was a success because, through advanced digitisation, we were able to map the 84 000 communities in South Africa to their nearest schools, clinics and hospitals,” he says.

And it is out of that awareness of the spatial distribution of healthcare needs that Keready was born.

After the COVID programme ended, Harris, as national lead for the project, was tasked with setting up Keready’s offices in  four provinces, including employing provincial leads, and staff as well as doctors and nurses. “Our vision was to give young doctors the opportunity to manage at the highest level, under our guidance.”

Implemented by DG Murray Trust (a South African philanthropic foundation) in partnership with the National Department of Health, Keready is funded by the German government through the KfW Development Bank.

The project reached full scale late last year with 46 mobile health clinics in four provinces:  Eastern Cape (8), Gauteng (16), KwaZulu-Natal (13), and the Western Cape (9).

These mobile clinics move into different communities every day. At times they use a loud-hailer to attract people. Sometimes they are based at schools, other times at taxi ranks and other hubs of activity.

People of all ages who visit the clinics are provided with a range of health services, including screenings and tests for HIV, TB and diabetes, as well as given family planning advice and immunisations. Medication is prescribed, and, where possible, dispensed on the spot.

Keready also runs a WhatsApp line where youth can ask young doctors and nurses any health-related questions and get straightforward, non-judgemental answers.

When learning about Keready during a walkthrough of exhibition stands set up at the Birchwood Hotel in Boksburg during the 2023 Presidential Health Summit, President Cyril Ramaphosa described the movement as “NHI on Wheels” because of its efforts in addressing universal health coverage.

From Bizana to Whittlesea

Two weeks later, I am again travelling with the same Keready team – this time to Whittlesea, outside Queenstown. Over two days, we visit the Ekuphumleni Community Hall and Kopana School in Ntabethemba. A highlight of this outreach is that teenage girls will be supplied with sanitary pads, thanks to a collaboration with pharmaceutical and healthcare company Johnson & Johnson.

On day one, hundreds more pupils than anticipated arrive. School principals were over-enthusiastic in spreading the word of the outreach resulting in taxi-loads of pupils from unexpected schools arriving. Irate teachers try to negotiate a way for their pupils to be seen.

Teacher Nolitha Tuta tells me many of the children she’s brought are from child-headed households and some have had little to no access to healthcare services.

While waiting in the queue, a mother of a child from Bhongolethu Primary School describes how she walked for hours to bring her child for eye testing.

Children line up for their health checks at the Kopana School in Ntabethemba. (Photo: Sue Segar/Spotlight)

Despite having waited until the end of the day, students from Zweledinga High end up being driven back home at sunset without being assisted.

After two days in Whittlesea, nearly 1 200 pupils from 36 schools have arrived. Nine schools were turned away. Nearly 700 learners have been screened for eye conditions, with 88 eligible for specs and four referred to an ophthalmologist.

The doctors look exhausted. Dr Anda Gxolo says over the past two days numerous children presented with ear problems. There were also long lines for dental care this time.

Despite the long hours, Dr Phumelele Sambumbu, who manages five of the eight Keready mobile clinics in the Eastern Cape, says she loves her work. “I come from these parts – from a village between Cofimvaba and Tsomo. My old grandmother is bedridden. I know first-hand how difficult it is to have access to care when you’re from a village like that and when you suffer from ailments like that. The idea of bringing health services to people who would otherwise struggle to access them is what drives me,” she says.

Mapping the need

Based on its relationship with the department of health, Keready has ambitious plans to expand its grassroots outreach programmes to help narrow the gaps in healthcare nationally.

A map on the wall of Keready’s office shows the number of government clinics in the Eastern Cape relative to schools. There are around 700 clinics in the province, but over 5000 schools (which works out to more than seven schools per clinic). Nationally, the ratio is similar with around 3 400 clinics and 25 000 schools.

It’s no surprise then that, according to Harris, staff on Keready’s 46 mobile clinics in the four provinces where it operates cannot keep up with demand for their services.

“Based on our mapping of the national population, we know there are 2 500 communities that don’t have reasonable access to a clinic. Just to deal with the gaps, we need 2 500 mobile clinics. We can tell you exactly where in the country to put them,” says Harris.

To reach ill people who are ill but don’t know it, Keready aims for nurse-supervised ambassadors to do door to door visits in communities to check who has TB, HIV and hypertension. “We have digitised every street and every house by satellite. Each house would be marked off; if TB’s picked up, it is mapped,” says Harris.

Plans for the door to door programme are well under way, he says. “In the Eastern Cape, Keready has partnered with the Small Projects Foundation to train 80 young people [as nurse-supervised ambassadors] from the Industrial Development Corporation’s Social Employment Fund to do health testing house to house.”

Eventually, says Harris, there could be 80 people linked to each of the 46 mobile clinics, meaning that a total of 3 680 trained people could be going from door to door.

“Going forward we’d want to find the disease before the disease finds us – TB, HIV, hypertension, diabetes and general growth issues [in children] are the core areas we will address in this programme,” he says.

But the extent to which Keready can deliver on its ambitious expansion plans will depend on funding and to what extent government continues to implement services using mobile clinic outreach programmes. The German financial contribution to the Keready project comes to an end in September. “We are working day and night to get more funding,” says Harris. He says they will soon be meeting with potential donors.

Disclosure: Segar was hosted by the Keready team.

Republished from Spotlight under a Creative Commons licence.

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Categories : Substance UseTags : 1 Comment

Codeine Addiction in SA: New Guideline Aims to Curb Abuse

On By ModernMedia
Photo by cottonbro studio

By Jesse Copelyn

Rehab centres in South Africa have been admitting an increasing number of codeine users in recent years. Now, the country’s medicines regulator has published a draft guideline as part of a broader effort to track suspicious codeine sales.

South Africa’s medicines regulator – the South African Health Products Regulatory Authority (SAHPRA) – has released a new draft guideline which it says will help stem the misuse of codeine. The opioid, which is found in certain pain relief medicines and cough syrups, is used by some people in large doses to get high.

Under the new draft guideline, the regulator can request sales data (and other information) from manufacturers, suppliers or distributors of any scheduled medicines. This would allow them to track the flow of codeine all the way “from the manufacturer to the dispensary, be it a clinic, pharmacy, hospital, or doctor’s practice”, SAHPRA’s communications officer, Nthabi Moloi, told Spotlight.

Why is this important? Until now, health authorities have struggled to detect suspicious sales of codeine, which is found in both prescription and over-the-counter medicines. This problem manifests in two ways. For one, recreational users can often get a continuous supply of codeine directly from pharmacies. While people are only permitted to purchase a limited amount of the drug, many bypass this simply by buying from different pharmacies. It’s largely impossible to flag these individuals since there is no centralised data on what medicines people buy across vendors (though attempts have been made to address this).

The second issue relates to wholesale supply. Following a Carte Blanche investigation flighted last year, SAHPRA confirmed that a pharmacy group was making illicit bulk sales of codeine-based cough syrups. While patients are only allowed to get codeine from a licensed health worker or pharmacist, it’s thus no surprise that it can also be found on the black market.

The new draft guideline aims to tackle both of these problems by allowing SAHPRA to request information from companies and health workers about how much codeine they’re producing, selling or dispensing and who it is being provided to. This would “enable SAHPRA to detect anomalies in the distribution of medicines prone to abuse, such as abnormally large orders by dispensaries” Moloi explains.

It is the “first phase”, she says, of the codeine care initiative – which is an effort to centralise data on all codeine sales along the entire supply chain nationally. The plan is to ensure that the regulator can flag anything from an individual who is buying large amounts of codeine from multiple vendors to a wholesaler who is selling the drug to illicit dealers.

Codeine rehab admissions triple since 2019

The draft guideline, which is now available for public comment, comes at a time in which rates of codeine addiction are soaring throughout South Africa, according to admissions data from drug and alcohol treatment facilities. Most rehabilitation centres around the country are connected to a programme called the South African Community Epidemiology Network on Drug Use (SACENDU), which collects anonymised patient data from the different centres. Professor Nadine Harker, who oversees this project says “if you look at treatment admissions over time, there has been an increase [in codeine-related admissions] over the years – steadily but definitely”.

Indeed, SACENDU’s bi-annual reports show that in the first half of 2019, 277 people who went to SACENDU-linked rehab sites said they had been misusing codeine. This amounted to 3% of all admissions. But by the first half of 2023, this percentage had tripled to 9% – totalling 749 people. (In absolute terms the number slightly less than tripled).

Even before this uptick, health workers were concerned. In the mid-2010s, a survey of 238 (mostly private sector) doctors was conducted across South Africa. It found that 85% of these practitioners were worried about the easy availability of codeine in pharmacies.

Part of the concern is driven by the fact that people who use codeine-based medicines over a long time can develop a range of health complications, including stomach ulcers and liver damage (this is particularly when the medicines contain additional substances like paracetamol). And some people are more vulnerable than others, as genetic factors play a big role in how codeine affects a person.

Why is the problem getting worse?

Part of the spike in codeine use appears to be driven by a trend among young people, who sometimes mix codeine-based cough syrups with cooldrinks. The combination is often referred to as lean, and has become a popular party drug among high school students. Research shows that codeine’s low price and general accessibility is one reason for its popularity. Harker for instance notes that it’s often available at home, where kids “can pick it up out of their mom’s medicine cabinet”.

In other cases, people appear to be relying on the drug not for recreation but to cope with psychological distress. For instance, a 2022 study for which women were interviewed at rehab centres in the Western Cape and Eastern Cape found that many had turned to pharmaceutical products to deal with everything from trauma caused by physical abuse to grief over the loss of a child.

“I just wanted the pain to go away. I wanted my mind to switch off… [the tablets] actually made me dead inside if I can say that,” one woman explained.

A lack of awareness about the dangers of codeine also seems to play a role: 94% of doctors who were surveyed agreed that patients “do not fully understand the risk of dependence in taking over-the-counter medicines containing codeine”. The lack of regulatory control may contribute to this impression: one study at South African rehab centres found that “many participants were of the view that [over-the-counter] codeine-containing medicines were not drug[s] per se due to their free availability to purchase without any real regulations or protocols guiding their sale”.

Shouldn’t we just make codeine prescription-only?

Currently, the law states that codeine-based pills can be bought over the counter only under specific conditions. For one, they have to contain another active ingredient like paracetamol or ibuprofen, and each pill can contain a maximum of 10 milligrams of codeine. A person can only buy one pack and it must contain at most 5 days’ worth of medicine (with no more than 80 milligrams a day). Anything more and a script is needed.

Liquid codeine, like cough syrups, can be bought without a script if it contains no more than 10 milligrams of codeine per teaspoon (the maximum daily dose is 80 milligrams). The bottle itself may not contain more than 100 millilitres of syrup.

Products like Gen-payne, Myprodol, and Stopayne all contain small amounts of codeine – typically in combination with other painkillers such as paracetamol or ibuprofen. (Photo: Towfiqu Barbhuiya/Unsplash)

Some researchers that spoke to Spotlight argue these restrictions are too lenient, and that codeine should be ‘up-scheduled’, meaning that it would only be available if a patient has a script, regardless of the dose or combination. By doing this, children may find it harder to get a hold of cough syrups for lean, and people may generally become more aware of the addictiveness of the drug when used over the long-term.

Indeed, there are some studies which have found this approach to be effective in other countries. Research published in the journal Addiction found that when authorities in Australia made codeine prescription-only in 2018, a large poisoning information centre in the country began to receive significantly fewer calls about codeine-related incidents (both from health workers and members of the public).

But there are also potential downsides to this strategy. For one, as Spotlight has previously reported, increased regulation may make life harder for poorer patients seeking pain relief. This is given that they would have to spend more money for a consultation and prescription if they needed codeine-based painkillers.

Andy Gray, who chairs an advisory scheduling committee at SAHPRA, details a second issue: “I’m not convinced that up-scheduling would solve the issue if what we’re dealing with [in South Africa] is illegal behaviour… If [codeine] is being smuggled out of manufacturers or wholesalers, scheduling is not going to make a difference”.

Dr Andrew Scheibe, a harm reduction researcher at the University of Pretoria, notes a third related problem that may occur. “If people do have codeine-dependence and they’re unable to access the codeine, they might likely shift to accessing opioids… on the black market”.

Scheibe highlights the United States as an example, where prescription opioids like oxycodone and fentanyl have been at the centre of a major drug epidemic. “When they tried to increase restrictions on access to those opioids then people started using heroin,” he notes. A 2022 study found that this had taken place among opioid users interviewed in Connecticut, Kentucky and Wisconsin.

Whatever the answer, researchers agree that some basic steps need to be taken to educate the public. Harker says “a lot of awareness raising needs to happen at various levels, for instance at pharmacies”. She notes that “when someone purchases codeine over the counter, it’s important for a pharmacist to engage [with them and] make the consequences known to the individual if they use it outside of the dosages indicated… And we don’t do that enough from the medical or pharmacist’s side”.

Republished from Spotlight under a Creative Commons licence.

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Categories : Cardiovascular Disease HIVTags :

Why a Major Finding on HIV and Statins may not be That Relevant in SA

On By ModernMedia
Photo by Miguel Á. Padriñán

By Elri Voigt

One of the biggest stories in HIV in the last year was that a class of medicines called statins could help reduce cardiovascular disease in people living with the virus. In response, treatment guidelines in the United States were quickly updated, but the picture is more complicated in South Africa. Spotlight’s Elri Voigt explores why the case for widespread use of statins by people living with HIV is less compelling in South Africa than in some other countries.

People living with HIV, provided they are stable on antiretroviral therapy, are affected by the same diseases as those who don’t have HIV, including cardiovascular disease, says Professor Mpiko Ntsekhe, head of Cardiology at Groote Schuur Hospital in Cape Town.

The key difference, he says, is that although both groups of people get the same spectrum of diseases, people living with HIV get those diseases more frequently and earlier. One way to think about this, he explains, is to imagine twins who are identical in every way except one is living with HIV. The twin living with HIV is more likely to get cardiovascular disease than the other twin.

And these differences can be substantial. Current evidence shows that people living with HIV have a twofold increased risk of developing cardiovascular disease compared to people not living with HIV, says Professor Hans Strijdom. He is the Head of the Division of Medical Physiology and Deputy Director of the Centre for Cardio-Metabolic Research in Africa (CARMA) at Stellenbosch University.  The cardiovascular risk attributable to HIV, Strijdom adds, is now believed to be equivalent to that posed by traditional risk factors such as smoking. This prompted an editorial in 2018 in one of the top cardiovascular journals, Circulation, advocating for HIV to be recognised as a major cardiovascular risk factor.

He explains that people living with HIV who are stable on treatment are living longer, making them susceptible to the normal risk posed by older age. They also have “modifiable risk factors, in other words lifestyle risk factors”, like a higher smoking and alcohol use incidence, as well as increasing rates of being overweight and obesity. Strijdom says that living with HIV, even when someone is stable on treatment, causes low-grade inflammation, which over time increases a person’s risk for cardiovascular disease. “That all in combination are the current theories [of] why we think that they have a bigger risk of cardiovascular disease,” he says.

Important study findings

Arguably, the biggest news from last year’s International AIDS Society (IAS) Conference in Australia was findings from a study on heart disease in people living with HIV. The trial, called REPRIEVE, showed that a class of cholesterol-busting drugs called statins can prevent a lot of cardiovascular disease events in people living with HIV whose cardiovascular disease (CVD) risk score meets a certain threshold. Spotlight previously reported on these findings, which showed that compared to placebo, daily treatment with 4mg oral pitavastatin – a specific statin – led to a 35% reduction in major adverse cardiovascular events (MACE) in people living with HIV classified to be at risk of cardiovascular disease.

When the findings were presented at the IAS conference, the study’s principal investigator, Dr Steven Grinspoon, said that while the researchers still have to assess more of the data collected to get a clearer picture of things, like the mechanisms driving cardiovascular disease across regions and conduct additional sub-group analyses, the study has already shown that using pitavastatin can save lives.

These sub-group analyses were discussed in greater detail at the Conference on Retroviruses and Opportunistic Infections (CROI) held in Denver in March this year. For the most part, the use of pitavastatin in the manner prescribed by REPRIEVE was considered a huge success, and the United States has since changed its guidelines to include the use of statins in the primary prevention of atherosclerotic cardiovascular disease.

Why it is different in South Africa

However, for low-and-middle-income countries like South Africa, the case for pitavastatin might not be as clear-cut. In fact, a panel discussion at CROI was dedicated to exploring the implications of the REPRIEVE findings for such countries.

Ntsekhe, who was a speaker on the CROI panel, tells Spotlight that data from REPRIEVE’s sub-group analyses reveal there was a striking difference in event rates – which in the case of the study are MACE in those who were getting the placebo – by country income status. He explains that as predicted in high-income countries, the event rates were high, while in low-and-middle income countries – particularly in Sub-Saharan Africa – event rates were very low.

He says one of the reasons for the difference in event rates was that the screening tool used in REPRIEVE worked well to identify those people living with HIV who might benefit from pitavastatin in high-income countries like the United States, but it did not work well in Sub-Saharan Africa.

This means using pitavastatin as part of a primary prevention strategy is a much more effective intervention in high-income countries than in low-and-middle income countries like in Sub-Saharan Africa because the cardiovascular disease profile is so different.

Ntsekhe explains the term cardiovascular disease itself is broad and all-encompassing and there are many forms, including valve disease, heart muscle disease, and vascular disease. The dominant form of cardiovascular disease in the high-income countries (which he refers to as the Global North) is known as atherosclerotic cardiovascular disease, which is characterised by a build-up of fatty deposits and plaque in the arteries.

In Sub-Saharan Africa though, Ntsekhe says “atherosclerotic cardiovascular disease is but one of many forms of cardiovascular disease”, taking the fourth or fifth place in the ranking of types of major heart disease.

Research conducted in high-income countries don’t always take differences in disease burden into account, according to Ntsekhe. This means that interventions researched in high-income countries and shown to be effective in that context won’t necessarily work as well in low-and-middle income countries like South Africa.

Strijdom concurs that while results from REPRIEVE in the global context were a game-changer, the findings are not easily transferable to South Africa’s context because pitavastatin is mainly aimed at reducing “bad cholesterol” and coronary artery disease (also called atherosclerosis).

‘Taking money away’

During the panel discussion at CROI, Ntsekhe asked whether Sub-Saharan Africa could justify taking money away from other health programmes that work in order to invest in pitavastatin.

“I said basically what should be a priority for us is a) finding tools that can better identify those at risk and b) continuing to focus on what our local data suggests are the priority areas,” Ntsekhe says.

“If your entire prevention strategy is aimed at atherosclerotic cardiovascular disease, but it isn’t the dominant cause of disease [in your country], you’re going to be treating a whole host of people to try and tackle this thing that affects very few in a sense,” he says.

“It was not anything about REPRIEVE, it was a wonderful study, the hypothesis was tested, and it was shown to be correct, the intervention we know works,” Ntsekhe says. “It really then comes down to regional areas to think very carefully about how best they’re going to get their biggest bang for their buck,” he says. “We have to carefully consider the local context, local burden, we have set local health priorities, and weigh benefit and cost before we adopt new interventions or recommendations.”

SA’s cardiovascular disease burden

While Strijdom says we don’t have great data, he points to a large systematic review and meta-analysis published in 2018 in Circulation, which estimates that around 15% of the total cardiovascular disease burden in South Africa is attributable to HIV. “It’s probably higher than that. I would say that probably about one in five people with heart disease have heart disease because of HIV in South Africa,” he says, adding “that figure is probably only going to increase”.

Because of this, he says, there is a need for proper and clear primary healthcare guidelines specifically aimed at managing cardiovascular disease in people living with HIV, which we don’t currently have.

Strijdom says what we have at the moment since the rollout of the 2019 National ART Clinical Guidelines is very basic guidelines. This involves screening someone who has just been diagnosed with HIV by taking their blood pressure, and testing urine for glucose and proteins, and an assessment of their general cardiovascular disease risk by taking their medical and family history. These guidelines, according to Strijdom, only make provision for routine screening at baseline, but screening guidelines at follow-up visits are insufficient.

“I am, however, aware of the fact that there is progress especially from the integrated chronic disease management model which is currently being piloted in South Africa – and hopefully with that will come much more definitive and universal guidelines,” he says. “The bottom line is that South Africa, in its public health [sector] especially, really very quickly needs to come up with very clear and more comprehensive guidelines to actively manage cardiovascular disease risk in people with HIV.”

Need for annual screening

Strijdom suggest that to improve screening for cardiovascular disease risk in people living with HIV, there needs to be annual screening of people’s weight, their measure of body fat based on height and weight, waist circumference, blood pressure, cholesterol and triglyceride levels as well as testing urine samples for kidney function. There also needs to be a thorough family and medical history conducted for each patient.

“It’s not really a very expensive or very exhaustive list of stuff that you have to do. Unless of course they have specific symptoms and signs that leads you in a specific direction that you then have to perhaps do an ECG [a test used to evaluate the functioning of the heart] or cardiac imaging but that is usually determined by what you get from their history and clinical examination,” he says.

Ntsekhe says public health strategies to combat the growing burden of non-communicable diseases (NCDs), including cardiovascular disease, in South Africa must be strengthened. These include screening and prevention tools like checking a patient’s blood pressure and blood glucose, advising against smoking and alcohol as well as promoting health lifestyle choices like exercise and weight loss. These interventions should be offered to everyone, regardless of whether they are living with HIV or not, he says.

“The thing about NCDs and cardiovascular disease, for the most part, they are diseases of lifestyle and behaviour. So, when you talk prevention, it’s not always about drug prevention,” he says. “It’s more about intensification of those [interventions] that are already in the public domain, are very effective, and cost very little. Many of the public health and primary healthcare guidelines do advise local ministries, local health authorities on what should be happening.”

In terms of public education, Stritjdom says people need to be aware that there is something like high blood pressure. “If people are aware they will come to the clinic and will say please measure my blood pressure,” he says.

“Our health system is understandably focused on infectious diseases, but if we are not careful, we will then be totally unprepared to tackle the epidemic that will have replaced it. Namely, cancer, heart disease, stroke, obesity, diabetes, and it will totally overwhelm our public healthcare system,” he says.

Republished from Spotlight under a Creative Commons licence.

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The Health Minister SA Needs: Astute Politician, Inspired Leader, Humble and Fair

On By ModernMedia

By Ufrieda Ho

By month end, South Africa will have a new Minister of Health. Ufrieda Ho asked some academics and activists what qualities that person should have to tackle the key health issues the country faces.

The precise health minister South Africa needs right now may not exist. But the portfolio still demands that the person appointed to this critical position be up to the job.

The appointment, when it happens, will come against a radically shifted political backdrop. Firstly, the elections results of the May 29 point to a coalition government for the first time in 30 years of democracy. The final configurations of a likely government of national unity is still anyone’s guess. And secondly, the National Health Insurance (NHI) bill is now an Act. President Cyril Ramaphosa signed off on the bill just a fortnight before the elections. It means by law, the work on the advancement of NHI must begin even as the contentions and contestations remain as thorny as ever.

Another reason why getting the right person matters is the money that comes with the portfolio. Annual government spending on health is in the region of R270 billion. Most of this spend is currently directed via provincial health departments, but flows under NHI will be nationalised and the NHI Act gives the minister extensive powers over NHI, and indirectly, the NHI fund.

At the same time, problems like entrenched health sector corruption and high levels of medico-legal claims against the state remain acute. Health budgets have been shrinking in real terms over the last decade. Financial shortfalls and shortages of healthcare workers in our health facilities are dire, while health needs enlarge.

Bridging ideological divides

Fatima Hassan, a human rights lawyer and founder of the Health Justice Initiative, says: “Policymaking in a coalition government is going to be so difficult – a Herculean task. And the place where you’re going to feel it most acutely is in health, because we have a dual health system and because NHI is sitting on the table.”

She says the role of minister will call for an astute politician. She says: “It must be someone who can work with different parties as well as constituencies in different sectors to try to bridge a number of these ideological divides.

“Health is a lightning rod for the differences between the different political parties; we saw this in how the parties campaigned for or against NHI,” she says.

Hassan says the worst case scenario will be someone in the position who is a “placeholder minister” who stalls on reforms, is a person more concerned with “calming the markets” and someone who will simply play the political long game waiting it out until the next elections.

“It must be someone who is able to work on creating a fairer system for access to proper healthcare services across the country, not just in specific provinces. They must invest in health infrastructure, invest in human resources for health, and invest in some of the more positive aspects of preparing for national health insurance,” she says. She adds that the person must prioritise fixing the “glaring issues in the NHI Act” to avert looming law suits.

In addition, Hassan says the minister must be someone who can stand up to the bullying of private sector power, including the likes of big pharma, and must be able to show leadership on domestic health issues while also being a strong Global South voice on international platforms to champion global health equity.

‘Health is more than a biomedical response’

Professor Scott Drimie is a researcher at the University of Stellenbosch and director of the Southern African Food Lab. Drimie works on food systems and food security and how these intersect with the social determinants of health.

For Drimie, South Africa’s health minister must be a person with an expansive leadership style; a person who is able to work across government departments and also be awake to the grassroots realities people face. Around 85% of people in South Africa rely on public healthcare.

“The minister must be able to grapple with the lived reality of most poor people and put in place a health system that supports the most vulnerable.

At the same time, that person should be someone who understands that health is more than a biomedical response – health is also issues like food security, sanitation, stable livelihoods and safety,” he says.

Another quality Drimie highlights is that the minister should be open to collaboration and experimentation. He says there has to be a “whole-of-government” approach and a “whole-of-society” approach. The Department of Health cannot achieve its key performance indicators on its own; it needs to collaborate with departments including social development, education and basic education.

“It must also be able to be bold with programmes and work with communities directly as well as with civil society, health advocates and health activists,” he says.

Reform of bureaucracies in the health department must also be something the minister tackles, Drimie says. He says it means appointing effective managers who are not micro-managed or politically influenced. Effective implementers of policies and programme, he says, can be a counterweight to politics.

“Politicians can come with very short-term, very narrow party politics,” says Drimie. But, he adds, enduring and relevant health programmes survive beyond political tenure and are more likely to achieve positive health outcomes.

Put people first and ‘show humility’

For activist Anele Yawa, who is secretary general of the Treatment Action Campaign, we need someone who puts people first. He says the minister must serve the interests of people and show humility for the office.

“The minister must not be someone who pushes his or her agenda. A minister is appointed; he or she did not submit a CV to us. So a minister must understand that there will be times when we as citizens and civil society will disagree with them. It’s because we will continue to speak truth to power, we will continue to hold them accountable; whatever the new coalitions will look like,” he says.

“Our ministers must not be arrogant and think it’s because we hate them. We will disagree and we will fight because it is an effort to make sure that things are done the right way and we can bring health services to the majority – it’s that person who is working class, black and is a woman,” says Yawa.

He says it means a strong minister must be one who maintains an open-door policy; who arrives at community meetings in person; take calls personally and engages.

Yawa says it’s also critical that the seventh administration is one that works cohesively. “We voted on the 29 May for a contractual agreement with government; not a fashion show. It means that we don’t just need a good health minister, we need a good administration that delivers on water and sanitation, on education and on social development, and so on.”

Motivate and inspire

Professor Lucy Gilson is head of health policy and systems division in the School of Public Health at the University of Cape Town. Her top qualities for a good minister also centre on people skills. She says the health minister in South Africa must be an inspiring leader.

“The person must be able to motivate health workers and managers to be the best public servants they can be.

“The person must also inspire the public to trust in the public health sector,” Gilson says.

The new health minister must have strategic management skills, she says. These will be necessary to navigate the complexity of power and interests in a coalition government and to figure out how the NHI will take shape.

In the end, she says the person in the post should have patience and persistence. She adds: “Bringing change to the health system is a collective and sustained effort over time. The minister must be able to strengthen capacity, assemble coalitions and networks of learning, experience and mutual accountability.”

Republished from Spotlight under a Creative Commons licence.

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Categories : Respiratory DiseasesTags :

Slow Progress after Decision to Make TB Prevention Pills More Widely Available

On By ModernMedia
Tuberculosis bacteria. Credit: CDC

By Tiyese Jeranji

Besides preventing illness and death, tuberculosis prevention therapy is estimated to be highly cost effective. Yet, uptake of the medication is not what it could be in South Africa. Tiyese Jeranji asks how much has changed since the Department of Health last year decided to make TB prevention therapy much more widely available.

Many people who have the TB bug in their lungs are not ill with TB disease. Having the bug in your body, does mean however that you are at risk of falling ill, should the TB bacteria get the overhand in its battle with your immune system.

Fortunately, we have medications that can kill TB bacteria before one falls ill. A recent World Health Organization (WHO) investment case, suggests such TB prevention therapy, commonly called TPT, reduces the risk of falling ill with TB in those exposed to the bug by 60% to 90% compared to people who do not get the treatment.

In South Africa, TPT has been available in the public sector for years, but until the publication of new government guidelines last year, only kids aged five or younger and people living with HIV could get the medication. Under the new guidelines, everyone who has had close contact with someone with TB should be offered a TB test and if they test negative be offered TPT – if they test positive they should be offered TB treatment. These changes dramatically expanded the number of people in South Africa who are eligible for TPT.

The antibiotics used for TPT has also changed in recent years. For many years, the only option was a medication called isoniazid taken for six or more months. We now also have two three-month options – isoniazid and rifapentine given once weekly and rifampicin and isoniazid given daily. These shorter duration treatment courses should help more people complete the treatment.

Down and up?

Dr Norbert Ndjeka, Chief Director of TB Control and Management at the National Department of Health, tells Spotlight that in recent years, South Africa has seen a steady decline in the number of people initiated on TPT.

The decline has been substantial. In people living with HIV, initiation on TPT dropped from 454 000 in 2018 to around 241 000 in 2023. In children aged five and younger who have had contact with someone with TB, it fell from 25 357 in 2018 to 15 775 in 2023.

TPT enrolments per province for 2023

ProvincePeople living with HIVContacts < 5 YearsContacts > 5 Years
Eastern Cape34 6232 5514 771
Free State14 5355621 027
Gauteng67 3331 3684 241
KwaZulu-Natal62 3623 1688 519
Limpopo15 871391452
Mpumalanga25 6186692 006
Northern Cape3 1788551 595
North West9 4335961 425
Western Cape8 5325 6151 278
South Africa241 48515 77525 314
*Typically, provinces with higher numbers of people diagnosed with TB or those with high numbers of people living with HIV will report higher TPT initiations.

There are two significant reasons for this decline, according to Ndjeka. Firstly, declining TB incidence, and secondly, declining HIV incidence.

“With fewer people diagnosed with TB disease, fewer contacts will need TPT, and with fewer people being diagnosed with HIV, fewer people will initiate TPT regardless of TB exposure,” he says.

WHO figures have shown a significant downward trend in the estimated TB cases per year in South Africa and according to Thembisa, the leading mathematical model of HIV in South Africa, the number of people newly starting HIV treatment has dropped from a peak of over 700 000 in 2011, to well under 300 000 in 2023.

But the recent downward trend in people taking TPT may be coming to an end. “We believe that the implementation of the new guidelines within the current strategic framework will lead to increases in TPT enrolment,” says Ndjeka.

In line with the new guidelines, there are also changes to what TPT data is being collected. “For example, we never used to report on TPT provision to contacts 5 years and older, but now we do and in 2023 at least 25 314 TB contacts 5 years and older were initiated on TPT,” he says.

20% increase expected in 2024

Based on the data reported for January and February of this year, Ndjeka expects that overall TPT initiations will increase by at least 20% in 2024 compared to 2023. Moreover, as documented in the National Strategic Plan for HIV, TB and STIs 2023-2028, there is a plan to have a steady annual increase in TPT enrolments leading up to 2028.

Ndjeka says based on the NSP TPT targets, South Africa is exceeding TPT targets for people living with HIV, but reaching less than 25% of targets for TB contacts. He points out that performance varies by province, but that all provinces have a long way to go in terms of reaching TB contacts.

‘Cost saving over time’

“The aim of offering TPT is to reduce the TB incidence,” Ndjeka says. “So, if everyone eligible is offered TPT there will obviously be increased costs initially but cost saving over time. This looks at cost of treating people with TB, lives saved/ deaths prevented as well as costs to patients.”

For South Africa, he says, it is estimated that we can reduce the number of people with TB by 138 000 by 2050 at an estimated cost of R23 226.90 per TB episode prevented.

Ndjeka says it costs the health department an estimated at R1 498.51 to treat one person with drug-susceptible TB for 6 months and R16 612.82 to treat one person with the standard drug-resistant TB treatment for 6 months. “These costs are for medications alone, which can also go beyond R70 000 depending on the patient and the type of resistant TB. Moreover, when factoring in clinical consultations, hospitalisations, and costs to patients the costs go up considerably,” he says.

The cost of providing TPT also depends on the regimen. One person on TPT can cost as little as R608.77 for a course of three months of isoniazid and rifapentine given once weekly, and up to R1 358.02 for 12 months of isoniazid. “TPT also has much lower associated costs for example there is no hospitalisation, fewer clinic visits and consultations,” Ndjeka says.

“By preventing TB, the cost of TB treatment is avoided along with the costs of treating some of the acute and chronic conditions that someone with TB may experience even after being cured of TB. These include chronic obstructive pulmonary disease, bronchiectasis and pneumonia,” says Alison Best, communication manager at Cape Town-based NGO TB HIV Care.

“For children under five in particular, who are at increased risk of disseminated TB like TB meningitis, the cost of not preventing TB could be death or severe lifelong disability,” she says, adding that preventing TB in a single individual also prevents the costs associated with any onwards transmission of TB from that individual to others.

Questions over implementation

Expanded TPT eligibility has been widely welcomed, but questions have been raised over how well the new guidelines are being implemented.

Best says government austerity measures have made implementing new initiatives in the healthcare setting challenging.

“There is not much political will to implement the guidelines (to expand eligibility for TPT) at provincial and district levels and this has translated into the slow release of circulars, delays in training health workers, poor knowledge of the policy and its low prioritisation,” she says.

Ingrid Schoeman, Director of Advocacy and Strategy at TB Proof (a local advocacy group), says often when a national policy is released, there are delays at provincial-level in releasing circulars to enable health worker training.

“This results in these services not being available at district-level. In the Western Cape, civil society organisations, the [provincial] Department of Health, City of Cape Town and implementing partners are now all working together to support health worker training, and implementing community-led awareness campaigns so that all close TB contacts know they are eligible for TPT,” she says.

Best adds that tracking the data to show how many people are starting and completing TPT tends to be difficult. She notes there are many gaps in capturing the information. This includes, at times, the limited recording of information in patient folders by clinicians and suboptimal inputting of data by data capturers.

Ndjeka says the national department of health has been conducting training on the new guidelines with provincial and district TB and HIV programme managers, district support partners and other trainers.

“They are then responsible for training health care workers. The antiretroviral therapy guideline training also includes TPT. Webinars on the knowledge hub (an online training platform) have also conducted,” he says.

However, Ndjeka conceded that there is a lack of awareness about the value of TPT. “Additionally,” he says, “there is reluctance from clinicians to provide TPT. This result in poor demand for TPT. Treatment adherence is another problem especially for people on the long regimen (12 months)”.

Plans to address these challenges, among other things, include marketing TPT as treatment for TB infection rather than prevention, targeted communication strategies, community mobilisation, and ongoing training and mentoring of healthcare workers, says Ndjeka.

Republished from Spotlight under a Creative Commons licence.

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