The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.
The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
Areas of cooperation
SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.
According to SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, the agreement with the TGA expands the geographical reach for both regulators’ pharmacovigilance programmes and augments their internal expertise.
“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” says Dr Semete-Makokotlela.
Deputy Secretary at the Australian Government Department of Health and Aged Care and head of the TGA, Professor Anthony Lawler, said: “TGA is very pleased to have strengthened our collaborative relationship with SAHPRA with the signing of this international agreement. We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market.”
Hypertension has contributed at least 44% to CVD deaths over thirty years, more than dietary factors and tobacco
Raised blood pressure has been the leading risk factor for death in Australia for the past three decades, according to a study published February 21, 2024, in the open-access journal PLOS ONE led by Alta Schutte and Xiaoyue Xu from The George Institute for Global Health and UNSW, Sydney, with colleagues across Australia. It is also the main contributor to deaths from cardiovascular disease (CVD) specifically.
Raised blood pressure has long been recognized as a contributing factor to CVD and death, but is not always prioritized in national health plans. In this study, researchers focused on Australia, which lags behind other high-income countries in hypertension control. Data on how raised blood pressure compares to other risk factors for CVD burden – and how this changes over time – can help to guide public health agendas and inform the effectiveness of public health policies.
Researchers analysed epidemiologic data from the Global Burden of Disease (GBD) study between 1990 and 2019 to determine the leading risk factors associated with both all-cause and CVD deaths, over time and between gender and age groups. The GBD study provides data on nearly 400 diseases and 87 risk factors across 204 countries.
They found that while the contribution of raised blood pressure to these outcomes declined early in the study period (from around 54% to around 44%), it persisted as the leading risk factor for all-cause and CVD deaths. Dietary factors and tobacco use rounded out the top three risk factors. These findings strongly align with the recently established National Hypertension Taskforce of Australia, which aims to improve Australia’s blood pressure control rates from 32% to 70% by 2030 (Hypertension – Australian Cardiovascular Alliance [ozheart.org]). The research findings further advocate for the prioritisation of blood pressure control on the public health agenda.
Differences by gender and age were also seen. For example, the contribution of raised blood pressure to stroke-related deaths in males aged 25–49 years were higher than other age groups, exceeding 60% and increasing steeply over time.
The study reinforces the importance of blood pressure control and awareness. The researchers hope that the data will urge policymakers to prioritise blood pressure control efforts in Australia and will provide insight into age groups and populations that would benefit from more targeted action.
The authors add: “There is no doubt that raised blood pressure has remained the leading risk factor for all-cause and cardiovascular deaths in Australia across the past three decades. Our findings support actions to strengthen primary care and to improve the prevention, detection, treatment and control of raised blood pressure, with the goal of significantly reducing all-cause and cardiovascular deaths in Australia over the next decade.”
Detection of Ophidascaris robertsi nematode infection in a 64-year-old woman from southeastern New South Wales, Australia. A) Magnetic resonance image of patient’s brain by fluid-attenuated inversion recovery demonstrating an enhancing right frontal lobe lesion, 13 × 10 mm. B) Live third-stage larval form of Ophidascaris robertsi (80 mm long, 1 mm diameter) removed from the patient’s right frontal lobe. C) Live third-stage larval form of O. robertsi (80 mm long, 1 mm diameter) under stereomicroscope (original magnification ×10). Source: Hossain et al. 2023
Australian researchers have discovered the world’s first case of a new parasitic infection in humans after they detected a live eight-centimetre roundworm from a carpet python in the brain of a 64- year-old Australian woman. The researchers at the Australian National University (ANU) and the Canberra Hospital described the novel case in the journal Emerging Infectious Diseases.
The Ophidascaris robertsi roundworm was pulled from the patient after brain surgery – still alive and squirming. It is suspected that larvae, or juveniles, were also present in other organs in the woman’s body, including the lungs and liver.
“This is the first-ever human case of Ophidascaris to be described in the world,” leading ANU and Canberra Hospital said Associate Professor Sanjaya Senanayake, infectious disease expert and co-author of the study.
“To our knowledge, this is also the first case to involve the brain of any mammalian species, human or otherwise.
“Normally the larvae from the roundworm are found in small mammals and marsupials, which are eaten by the python, allowing the life cycle to complete itself in the snake.”
Ophidascaris robertsi roundworms are common to carpet pythons. It typically lives in a python’s oesophagus and stomach, and sheds its eggs in the host’s faeces. Humans infected with Ophidascaris robertsi larvae would be considered accidental hosts.
Roundworms are incredibly resilient and able to thrive in a wide range of environments. In humans, they can cause stomach pain, vomiting, diarrhoea, appetite and weight loss, fever and tiredness.
The researchers say the woman, from southeastern New South Wales in Australia, likely caught the roundworm after collecting a type of native grass, Warrigal greens, beside a lake near where she lived in which the python had shed the parasite via its faeces.
The patient used the Warrigal greens for cooking and was probably infected with the parasite directly from touching the native grass or after eating the greens.
Canberra Hospital’s Director of Clinical Microbiology and Associate Professor at the ANU Medical School, Karina Kennedy, said her symptoms first started in January 2021.
“She initially developed abdominal pain and diarrhoea, followed by fever, cough and shortness of breath. In retrospect, these symptoms were likely due to migration of roundworm larvae from the bowel and into other organs, such as the liver and the lungs. Respiratory samples and a lung biopsy were performed; however, no parasites were identified in these specimens,” she said.
“At that time, trying to identify the microscopic larvae, which had never previously been identified as causing human infection, was a bit like trying to find a needle in a haystack.”
The patient was first admitted to a local hospital in late January 2021 after suffering three weeks of abdominal pain and diarrhoea, followed by a constant dry cough, fever and night sweats. By 2022, the patient was experiencing forgetfulness and depression, prompting an MRI scan. It revealed an atypical lesion within the right frontal lobe of the brain, Associate Professor Kennedy said.
A neurosurgeon at Canberra Hospital explored the abnormality and it was then that the unexpected eight-centimetre roundworm was found. Its identity was later confirmed through parasitology experts, initially through its appearance and then through molecular studies.
Associate Professor Senanayake said the world-first case highlighted the danger of diseases and infections passing from animals to humans, especially as we start to live more closely together and our habitats overlap more and more.
“There have been about 30 new infections in the world in the last 30 years. Of the emerging infections globally, about 75 per cent are zoonotic, meaning there has been transmission from the animal world to the human world. This includes coronaviruses,” he said.
He added that “the snake and parasite are found in other parts of the world, so it is likely that other cases will be recognised in coming years in other countries.”
The patient continues to be monitored by the team of infectious diseases and brain specialists.
“It is never easy or desirable to be the first patient in the world for anything. I can’t state enough our admiration for this woman who has shown patience and courage through this process,” Associate Professor Senanayake said.
Australian researchers have found SARS-CoV-2 virus in wastewater samples from long haul flights arriving from outside the country, demonstrating that they can detect it even before passengers show symptoms.
The CSIRO and University of Queensland scientists worked with Qantas to show that wastewater surveillance can provide valuable data for public health agencies.
CSIRO lead author Dr Warish Ahmed said as global travel returns, testing wastewater of incoming flights could screen incoming passengers for COVID at points of entry.
“It provides an extra layer of data, if there is a possible lag in viral detection in deep nasal and throat samples and if passengers are yet to show symptoms,” Dr Ahmed said.
“The rapid on-site surveillance of wastewater at points of entry may be effective for detecting and monitoring other infectious agents that are circulating globally and provide alert to future pandemics.”
Co-author Professor Jochen Mueller from UQ’s Queensland Alliance for Environmental Health Sciences said wastewater testing could be a useful extra tool.
“The paper recommends that wastewater surveillance be used as part of an efficient clinical surveillance and quarantine system – providing multiple lines of evidence of the COVID infection status of passengers during international travel,” Professor Mueller said.
The study, published in Environment International, analysed wastewater samples from 37 Australian Government repatriation flights from COVID hotspots including India, France, UK, South Africa, Canada and Germany between December 2020 and March 2021.
The research found SARS-CoV-2 in wastewater samples from 24 of the 37 repatriation flights (65%) despite all passengers (except children under age five) having tested negative to the virus 48 hours before boarding. Virus is shed in the faeces of infected people about two to five days before showing symptoms.
Traces of SARS-CoV-2 can also be detected in wastewater from previously infected people who still shed the coronavirus, but are no longer infectious – although typically a weaker signal.
During 14 days of the passengers’ mandatory quarantine upon arrival in Australia, clinical tests identified only 112 COVID cases among the 6570 passengers (1.7%).
Monitoring of wastewater has a number of applications. Through its wastewater monitoring programme, the Durban University of Technology found that the recent unrest in South Africa was a superspreader event that drove up cases in KwaZulu-Natal.
