Tag: 18/6/26

Categories : Healthcare Politics and RegulationsTags :

Why Pharmacists Still Can’t Prescribe ARVs, Months After Court Gave the Green Light

On By ModernMedia
Specially trained pharmacists will soon be allowed to dispense antiretrovirals without a doctor’s script. Photo by National Cancer Institute on Unsplash

By Catherine Tomlinson

A Supreme Court of Appeal ruling in October 2025 cleared the way for specially trained and permitted pharmacists to dispense antiretroviral medicines without a doctor’s script. Seven months later, no pharmacists are yet providing these services. Spotlight explores the reasons for the delay.

After a three-and a half year court battle between a group of private doctors and the South African Pharmacy Council (SAPC), the Supreme Court of Appeal (SCA) cleared the way for the SAPC to implement pharmacist-initiated management of antiretroviral treatment (PIMART) in October 2025.

The SAPC welcomed the ruling with a bullish press conference promising rapid implementation of PIMART. “The South African Pharmacy Council, together with stakeholders and the Department of Health, will work with speed to ensure that PIMART-trained pharmacists join other primary healthcare practitioners in providing primary care in relation to HIV and Aids,” said Mogologolo Phasha, president of the SAPC, at the time.

Vincent Tlala, CEO and Registrar of the SAPC, also in October 2025, said that the SAPC aimed to issue an e-note inviting pharmacists to apply for the PIMART permits in November. However, seven months later, this has still not happened and no pharmacists in the country are yet permitted to provide PIMART services.

What is PIMART?

PIMART stands for pharmacist-initiated management of antiretroviral treatment. It is a form of task-shifting that allows pharmacists to provide some limited HIV services that are currently only provided by doctors and nurses. The programme seeks to better utilise pharmacists in the country’s HIV response and relieve some of the burden on overcrowded and under resourced public clinics. It will also offer a route into treatment for people who are not willing or able to visit clinics.

It is intended that, under the PIMART programme, pharmacists that have completed a dedicated training programme and have received a special permit from the Director-General of Health will be authorised to provide first-line antiretroviral treatment to people with uncomplicated HIV without a doctor’s script. They will also be allowed to dispense HIV prevention medicines without a doctor’s script – this includes both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). PrEP is taken prior to sex to prevent potential infection while PEP is taken shortly after a possible HIV exposure to prevent infection.

Why is PIMART needed?

PIMART was proposed by the SAPC in response to a request from the health department for the SAPC to design an intervention to enable pharmacists to take on a greater role in the country’s HIV response.

South Africa has adopted the UNAIDS 95-95-95 targets that aim to ensure that 95% of people living with HIV know their status, 95% of people diagnosed with HIV are on treatment, and 95% of people on treatment are virally suppressed (and therefore cannot transmit HIV onwards).

According to new estimates from Thembisa, the leading mathematical model of South Africa’s HIV epidemic, 7.9 million people are living with HIV in South Africa. Ninety six percent of people living with HIV know their status, yet only 82% of people who know they are HIV positive are on antiretroviral treatment.

While South Africa’s health system should be commended for the fact that around 6.2 million people are taking HIV treatment, it is concerning that 1.7 million people living with HIV are not yet on treatment. In recognition of this problem, the health department has launched the “Close the Gap” campaign.

The thinking behind PIMART is that pharmacies can help close the gap by providing an important third option to people who are disinclined or unable to access HIV treatment from public clinics or private sector doctors.

More urgent than ever following US funding cuts

While PIMART was always intended to help identify patients falling through the gaps between South Africa’s public and private health sectors and to link them to care, the need for this third option is now more urgent than ever. US funding cuts over the last 15 months or so have led to the closure of many NGO-run clinics that previously provided HIV treatment and prevention services to populations at high risk of HIV who often face stigma at traditional health facilities. These groups include sex workers, men who have sex with men, and people who inject drugs.

In addition to expanding access to HIV treatment, PIMART aims to increase access to PrEP and PEP to prevent new HIV infections. While the full impact of US funding cuts on these services remains unclear, the cuts likely contributed to the slight decline in PrEP use in South Africa seen in 2025, following seven years of steady growth in PrEP uptake.

Graph by Spotlight. Data courtesy of the Thembisa model.

Finger pointing and lack of accountability

Seven months after the Supreme Court of Appeal ruled that the SAPC could implement PIMART and the SAPC promised to move rapidly in implementing PIMART, pharmacists have still not been invited to apply for permits and no PIMART permits have yet been issued to pharmacists.

When asked why the programme remains unimplemented, the SAPC pointed to the Southern African HIV Clinicians Society’s (SAHCS) PIMART training course as the cause of the delay.

SAHCS is the only entity in the country providing PIMART training to pharmacists. In October 2025, Mokoena said several groups had expressed interest in becoming accredited to provide PIMART training. However, on 14 May 2026, Tlala told Spotlight: “While we have invited existing providers of pharmacy education in South Africa to offer (the course), the South African Pharmacy Council is yet to receive applications for the accreditation of the PIMART supplementary training course.”

He added: “Currently, the Southern African HIV Clinicians Society are the only approved provider for the PIMART short course.”

So, what’s going on with SAHCS’ PIMART training?

PIMART used to be on a very different timeline before it got tangled up in the court processes that led to the October 2025 SCA judgment. Back in July 2021, Spotlight reported that the launch of PIMART was imminent, and indeed, that was roughly the timeline the SAHCS training had been working toward.

In fact, the SAHCS has offered a PIMART training course for pharmacists that want to provide PIMART services since 2019. Professor Natalie Shellack, chairperson of the SAPC Education Committee, said in October 2025 that this course was developed jointly by SAHCS and SAPC.

Over a thousand pharmacists have completed SAHCS’s original PIMART training course as continuous professional development (CPD) training. But after the October 2025 SCA ruling, Lizeth Kruger, Dischem’s Clinical Executive, told Spotlight that due to the time lapse between the initial training and court ruling, Dischem pharmacists “will need to do a refresher course to ensure compliance and up-to-date knowledge”.

While SAHCS’s PIMART course has not yet been accredited by the SAPC as a PIMART course, it is accredited as a CPD course for pharmacists. Tlala told Spotlight in May that it has not been accredited as a PIMART course because of an identified “gap” in the course.

“The gap identified between the short course and the approved qualification standard meant that the approved provider of the short course, the Southern African HIV Clinicians Society, had to conduct a gap analysis and develop a bridging course to enable pharmacists trained in the short course to access the full PIMART scope of services,” said Tlala.

In response to questions about the “gap” in their training course identified by the SAPC, SAHCS’s CEO Dr Fiona Storie told Spotlight on 19 May: “SAHCS has completed a full review and update of the PIMART training course in line with the requirements for accreditation as a supplementary training course (i.e. not just a CPD accredited course).”

“As PIMART training was originally provided from 2019, there is a need for pharmacists to undergo refresher training since the field of HIV medicine is evolving and clinical recommendations change over time,” said Storie. She added: “SAHCS’ recommendation is that pharmacists undertake the newly updated PIMART training course as either a refresher/bridging course or, if not previously trained, as a new course.”

“SAHCS is engaging with SAPC to finalise the accreditation of the updated PIMART course as a refresher course and a new supplementary training course to make it available as soon as possible,” Storie said.

Limiting PIMART’s scope

Tlala told Spotlight that because of the “gap” in SAHCS’s training course, the SAPC has asked the Director-General of Health to grant limited scope PIMART permits.

“The Director-General: Health has been requested to issue a limited scope permit granting PIMART-trained pharmacists’ access to those services fully addressed in the short course previously delivered by the South African HIV Clinicians Society,” he said.

The health department confirmed to Spotlight that this request was received on 23 April 2026.

Neither the SAPC nor the Department of Health responded to Spotlight’s requests for clarification on which PIMART services the SAPC had proposed for inclusion in the limited-scope permits.

Angela Tembo, director of pharmacy health at the research centre Ezintsha, told Spotlight that she understands that the limited scope permits that the SAPC has requested the Director-General of Health to grant “will be limited to HIV prevention (PrEP and PEP) and not treatment”.

“Our understanding is that the delays [in implementing PIMART] relate to ongoing discussions around training requirements, accreditation processes, and the practical implementation pathway following the SCA ruling,” she added.

Tlala said as soon as the Director-General of Health approves the limited-scope permits, the SAPC will publicly communicate the launch of the PIMART programme and the services that may be accessed under such a permit.

“The full PIMART scope of services will only be available once the Southern African HIV Clinicians Society has finalised and submitted a bridging course following gap analysis or, alternatively, once another training provider is accredited to provide the PIMART Supplementary Training course,” he added.

Republished from Sptolight under a Creative Commons licence.

Read the original article.

Categories : CancerTags :

Which Genes Contribute to Early-onset Breast Cancer in Black Women?

On By ModernMedia
Photo by National Cancer Institute

Black women experience disproportionately elevated risks of developing and dying from early-onset breast cancer. New research published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society, reveals the genes that are most likely to be mutated to contribute to these increased risks.

In the study of 686 young Black women diagnosed in Florida and Tennessee with invasive breast cancer at age 50 or younger in 2005–2018, genetic testing showed that 15.3% of the women carried a gene variant with a suspected link to breast and/or ovarian cancer, with most occurring in the BRCA1 and BRCA2 genes and fewer in PALB2, ATM, and other genes. A family history of breast cancer was common in women with mutations in BRCA1, BRCA2, and PALB2. Triple-negative breast cancers (one of the most aggressive forms) were most often seen in women with BRCA1 mutations. Also, most of the women with BRCA1 mutations were diagnosed at or below age 40, whereas the age at diagnosis was more evenly distributed up to age 50 for women with variants in the other genes.

The study’s findings point to the importance of breast cancer genetic testing for young Black women, a group that is less likely to receive such screening compared with other racial and ethnic groups. Such tests could identify women most likely to benefit from more frequent screening and preventive measures to safeguard their health.

“We must test at-risk women across all populations – testing is essential to personalise treatment strategies and enable life-saving prevention for future cancers, and it may empower at-risk family members to get tested so they too can benefit from this information,” said senior author Tuya Pal, MD, of Vanderbilt University Medical Center. “Equitable access to inherited cancer testing ensures that all women, regardless of race, can benefit from precision medicine and take control of their genetic health.”

Source: Wiley

Categories : UrologyTags :

A 1940s-era Drug Reveals a New Renal Water Regulation Pathway

On By ModernMedia

Marla Broadfoot, PhD

Human kidney. Credit: Scientific Animations CC0

Mayo Clinic researchers have identified a previously unrecognised way the kidneys regulate water balance – an advance that could lead to improved treatments for polycystic kidney disease (PKD) and other disorders. The study, led by Fouad Chebib, MD, a nephrologist at Mayo Clinic, is published in the Journal of Clinical Investigation.

The findings build on decades of scientific understanding by revealing an additional pathway the kidney uses to control water balance. Until now, the body’s ability to concentrate urine – and prevent dehydration – has been thought to depend primarily on the hormone vasopressin. Dr Chebib’s team discovered an alternative mechanism that operates independently of that system.

“The kidney’s ability to regulate water is one of the most fundamental processes in the body,” Dr Chebib says. “It’s not every day that you uncover a new way it carries out that function.”

Polycystic kidney disease is a common inherited condition that causes fluid-filled cysts to grow in the kidneys over time, gradually reducing kidney function and often leading to kidney failure. It affects millions of people worldwide, including an estimated 140 000 people in the US with the most common form, autosomal dominant PKD (ADPKD). Many patients eventually require dialysis or a kidney transplant.

Watch: 1940s-era drug shows new promise for kidney disease

Dr Chebib’s team studies how kidney cysts grow in PKD using lab-grown cell models. As part of that work, they tested compounds expected to worsen the disease process by increasing cellular signals linked to cyst growth. One of those compounds was probenecid, a drug first used in the 1940s to conserve limited supplies of penicillin by reducing its urinary excretion.

“We thought this drug would make the disease process worse,” Dr Chebib says. “Instead, it did the opposite.”

Rather than promoting cyst growth, the drug slowed it. After repeating the experiments multiple times, the team realised they had uncovered something important.

Further investigation revealed that probenecid affects how kidney cells handle urate, a molecule commonly associated with gout. Inside the cell, urate acts as a signal – triggering a chain of events that helps move water channels to the cell surface. This allows the kidney to reabsorb water and concentrate urine without relying on vasopressin, the hormone traditionally thought to control this process.

“This represents a distinct pathway from what is described in traditional physiology models,” Dr Chebib says. “It demonstrates that the kidney has an additional mechanism to preserve water.”

For patients with PKD, the discovery could address one of the biggest challenges of current treatment. The only approved therapy, tolvaptan, works by blocking vasopressin, which slows cyst growth but causes patients to produce very large amounts of urine – often 6 to 7 litres a day. That side effect can be difficult to live with and leads some patients to stop treatment.

In preclinical studies and a small clinical trial, adding probenecid reduced urine volume and nighttime urination while preserving the treatment’s effectiveness.

After taking probenecid, patients’ urine volume dropped by about 30% on average, and they went from waking up several times a night to urinate to about once per night. Many also reported improved quality of life.

“The goal is to preserve the therapeutic benefit of tolvaptan while reducing its burden,” Dr. Chebib says.

Despite these promising results, researchers are not planning to rely on probenecid as a long-term solution. The drug is decades old, affects multiple systems in the body and is not widely available today. Instead, the team is using what they learned to design more targeted therapies.

“Probenecid helped us uncover the mechanism,” Dr Chebib says. “Our goal is to take this insight and develop therapies designed specifically for this pathway.”

For Dr Chebib, the work is rooted in early inspiration. He was drawn to kidney research after his father developed PKD.

“This has been a long and deeply purposeful journey,” he says. “It started with a personal motivation and led to something that could ultimately benefit patients.”

For a complete list of authors, disclosures and funding, see the study.

Source: Mayo Clinic

Categories : Substance UseTags :

Even Low Alcohol Consumption Linked to Cancer and Heart Risks

On By ModernMedia

Study provides much-needed benchmark with finding that alcohol consumption is associated with increased risk above one drink per day for both men and women

Photo by Pavel Danilyuk on Pexels

Even what many consider to be moderate drinking is linked to an increased risk of death, disability, and chronic diseases such as cancer and heart disease, according to a new study published in the Journal of Studies on Alcohol and Drugs.

“This study provides the most comprehensive US estimates to date of lifetime risks of alcohol-attributable mortality and morbidity, showing that even moderate levels of consumption increase the risk of premature death and disability,” said study co-author Katherine M. Keyes, PhD, professor of Epidemiology at Columbia University Mailman School of Public Health. “No protective effect of drinking was observed even at low levels,” noted Keyes, whose research focuses on alcohol use and other substances epidemiology across the life course.

The findings show mortality risk from alcohol of 1 in 25 for people who consumed an average of 14 drinks per week. In contrast, drinking up to 7 drinks per week was associated with only minimally elevated risks for most conditions.

“Even low levels of alcohol use come with health risks,” says first study author Kevin Shield, PhD, an associate professor at the University of Toronto and a senior scientist who leads the World Health Organization (WHO)/Pan American Health Organization (PAHO) Collaborating Centre in Addiction and Mental Health. “And that risk continues to increase the more someone drinks.”

The researchers, from the United States and Canada, aimed to estimate how lifetime drinking habits affect Americans’ risk of illness and death related to alcohol. After medical experts reviewed more than 7200 scientific articles on alcohol-related diseases and injuries to determine the level of risk for each condition, the researchers applied those risks to large national health data sets. They then used statistical modelling to estimate how different drinking levels influence long-term health outcomes.

The study offers more concrete guidance than the new US Dietary Guidelines, which currently advise Americans to “limit alcoholic beverages” without specifying how much alcohol is safe to drink. Previous guidelines recommended a daily limit of two alcoholic drinks for men and one for women. The definition of a ‘drink’ varies by beverage type, typically 12 ounces (340mL) for beer, 5 ounces (140mL) for wine, and 1.5 ounces (40mL)for spirits, although that too can vary by alcohol concentration.

While the new US Dietary Guidelines contain a useful ‘less-is-best’ message, they provide no quantitative framework, according to the authors. This study was designed to do just that across the drinking spectrum. 

It turns out that an average of two drinks per day, which might be considered ‘moderate’ from a social standpoint, is associated with a substantially elevated risk of a premature death caused by alcohol, they explain.

In addition to mortality risk, researchers examined how drinking patterns influence chronic and acute alcohol-related conditions such as cancer – including oesophageal, oral, and breast – cardiovascular disease, liver disease, and injury. 

The study overturns a common misconception that alcohol can protect health. The researchers did not observe a significant protective effect of alcohol on overall health at any level of consumption. They noted that at low levels, alcohol may be associated with a reduced risk of ischemic heart disease and stroke. But when you look across the full range of health outcomes, including cancer and other chronic diseases, those potential benefits are outweighed by the risks even at 7 drinks per week.

Statistical modelling used in the study to determine health risks was based on “the best possible data,” according to the team. But they caution one should not assume that means one person’s individual health risk is the same as what is reported here – that depends on other factors like lifestyle, genetics, drinking patterns, and other choices that differ person to person.

The researchers estimated risk for all health conditions known to be causally related to alcohol and then aggregated these estimates to determine the total health risk. Yet, new research continues to emerge that links alcohol with additional health conditions, such as pancreatic cancer. “Understanding those relationships, and how much alcohol contributes to those risks, is an area that still needs further work,” says Keyes and Shield.

By finding that alcohol consumption is associated with increased risk above one drink per day for both men and women, the study offers a much-needed benchmark.

“Having a clearer threshold helps people better understand what level of drinking is associated with increased risk and make more informed decisions when drinking.”

In an accompanying editorial, Robert M. Vincent, a former associate administrator for the US Substance Abuse and Mental Health Services Administration, discusses his view of the behind-the-scenes environment in which the study was produced. “The Alcohol Intake and Health report was explicitly invited to inform alcohol guidance during development of the Dietary Guidelines for Americans, 2025–2030,” he writes. “Despite the study’s adherence to its mandate, its findings were sidelined.”

See the paper for a full list of co-authors and their institutions.

Source: Columbia University Mailman School of Public Health

Categories : Mental HealthTags :

A New Diagnosis of ‘Profound Autism’ Is on the Cards. Here’s What Could Change

On By ModernMedia

Kelsie Boulton, University of Sydney; Marie Antoinette Hodge, University of Sydney, and Rebecca Sutherland, University of Sydney

Photo by Peter Burdon on Unsplash

When it comes to autism, few questions spark as much debate as how best to support autistic people with the greatest needs.

This prompted The Lancet medical journal to commission a group of international experts to propose a new category of “profound autism”.

This category describes autistic people who have little or no language (spoken, written, signed or via a communication device), who have an IQ of less than 50, and who require 24-hour supervision and support.

It would only apply to children aged eight and over, when their cognitive and communication abilities are considered more stable.

In our new study, we considered how the category could impact autism assessments. We found 24% of autistic children met, or were at risk of meeting, the criteria for profound autism.

Why the debate?

The category is intended to help governments and service providers plan and deliver supports, so autistic people with the highest needs aren’t overlooked. It also aims to re-balance their under-representation in mainstream autism research.

This new category may be helpful for advocating for a greater level of support, research and evidence for this group.

But some have raised concerns that autistic people who don’t fit into this category could be perceived as less in need and excluded from services and funding supports.

Others argue the category doesn’t sufficiently emphasise autistic people’s strengths and capabilities, and places too much emphasis on the challenges that are experienced.

What did we do?

We conducted the first Australian study to examine how the “profound autism” category might apply to children attending publicly funded diagnostic services for developmental conditions.

Drawing on the Australian Child Neurodevelopment Registry, we examined data from 513 autistic children assessed between 2019 and 2024. We asked:

  • how many children met the criteria for profound autism?
  • were there behavioural features that set this group apart?

Because we focused on children at the time of diagnosis, most (91%) were aged under eight years. We described these children as being “at risk of profound autism”.

What did we find?

Around 24% of autistic children in our study met, or were at risk of meeting, the criteria for profound autism. This is similar to the proportion of children internationally.

Almost half (49.6%) showed behaviours that were a safety risk, such as attempting to run away from carers, compared with one-third (31.2%) of other autistic children.

These challenges weren’t limited to children who met criteria for profound autism. Around one in five autistic children (22.5%) engaged in self-injury, and more than one-third (38.2%) showed aggression toward others.

So, while the category identified many children with very high needs, other children who didn’t meet these criteria also had significant needs.

Importantly, we found the definition of “profound autism” doesn’t always line up with the official diagnostic levels which determine the level of support and NDIS funding children receive.

In our study, 8% of children at risk of profound autism were classified as level 2, rather than level 3 (the highest level of support). Meanwhile, 17% of children classified as level 3 did not meet criteria for profound autism.

Our concern

We looked at children when they first received an autism diagnosis. Children were aged 18 months to 16 years, with more than 90% under the age of eight years.

This aligns with our earlier research, showing the average age of diagnosis in public settings is 6.6 years.

From a practical perspective, our biggest concern about the profound autism category is the age threshold of eight years.

Because most children are already assessed before age eight, introducing this category into assessment services would mean many families would need repeat assessments, placing additional strain on already stretched developmental services.

Second, modifications will be needed if this criteria is going to be used to inform funding decisions as it didn’t map perfectly onto level 3 support criteria.

On balance, however, our results suggest the profound autism category may provide a clear, measurable way to describe the needs of autistic people with the highest support requirements.

Every autistic child has individual strengths and needs. The term “profound autism” would need to be promoted with inclusive and supportive language, so as to not replace or diminish individual needs, but to help clinicians tailor supports and obtain additional resources when needed.

Including the category in future clinical guidelines, such as the national guideline for the assessment and diagnosis of autism, could help ensure governments, disability services and clinicians plan and deliver supports.

What can you do in the meantime?

If you’re concerned your child requires substantial support, here are some practical steps you can take to ensure their needs are recognised and addressed:

Explain your concerns

Not all clinicians have experience working with children with high support needs. Be as clear as possible about behaviours that affect your child’s safety or daily life, including self-injury, aggression or attempts to run away. These details, while difficult to share, help give a clearer picture of your child’s support needs.

It can also be a challenge to find and access clinicians with appropriate expertise. Another potential benefit of having a defined category is that it can better help families navigate care.

Ask about support for the whole family

Our studies show that many caregivers want more support for themselves but don’t always ask. Talk with clinicians about supports for yourself as well, including respite, or family support groups.

Reach out

Coming together with other carers and families can reduce your own isolation and normalise many of the unique challenges you face. Connecting with like-minded people can provide a supportive, empathetic and empowering community.

Plan for safety

For children with high support needs, prioritise safety planning with your child’s care team. This can include strategies to reduce risks, as well as planning how best to support your child’s interactions with health, education and disability services over time.

Kelsie Boulton, Senior Research Fellow in Child Neurodevelopment, Brain and Mind Centre, University of Sydney; Marie Antoinette Hodge, Clinical Lecturer, University of Sydney, and Rebecca Sutherland, Lecturer & Speech Pathologist, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.