PSM News

July 06,2024 New Delhi: Drug standards body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert on commonly used drugs amlodipine and acetazolamide, saying both these medicines cause adverse reactions. Amlodipine – used for treatment of fatal coronary heart disease and non-fatal myocardial infarction and to reduce the risk of stroke – causes lichenoid keratosis, an inflammatory reaction, IPC said. According to IPC, amlodipine is also used to reduce the risk of coronary revascularisation procedures and need for hospitalisation due to angina in patients with coronary artery disease. The medicine is used alone or in combination with other medications. The lesions generally appear on the forearms, hands, chests of middle-aged women, or areas exposed to the sun, it said. Acetazolamide – a carbonic anhydrase inhibitor used to treat glaucoma- may lead to choroidal effusion or choroidal detachment, which is fluid buildup in the choroid layer of the eye. IPC, which comes under the health and family welfare ministry, has cautioned healthcare professionals to “diligently monitor” the potential occurrence of adverse drug reactions (ADRs) when administering these drugs. It has also advised patients and consumers to closely monitor the possibility of the above ADRs when using the suspected drugs. “Companies manufacturing these drugs may be asked to insert warnings in their package so that patients and doctors know about the adverse event,” a government official said on the condition of anonymity. The IPC warning is based on preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database. Source: Pharma

July 06,2024 London: Patients with type 2 diabetes taking GLP-1 treatments, which include Ozempic, have a lower chance of developing 10 types of obesity-related cancers than those taking insulin and other diabetes drugs, according to a study published on Friday. GLP-1 treatments for type 2 diabetes have been on the market for nearly 20 years. The newer generation – such as Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro – are far more effective at controlling blood sugar levels and inducing weight loss. Ozempic was the first of the newer generation in the class to be approved, in 2017. In the study published on Friday in medical journal JAMA Network Open, researchers examined the medical records of 1.6 million patients with type 2 diabetes who had no prior history of 13 types of obesity-related cancers including gallbladder cancer and kidney cancer. The study did not specify which GLP-1 medicines the patients took, but the records were for patients on these medicines or insulin or the diabetes drug metformin between March 2005 and November 2018. Ozempic was only approved by the U.S. Food and Drug Administration in December 2017. The study found that the patients treated with a GLP-1 therapy instead of insulin “had a significant risk reduction” in 10 of those cancers. The findings are “preliminary evidence of the potential benefit” of GLP-1 drugs for cancer prevention in high-risk population, the researchers concluded. They also said that studies of the newer generation of these medicines for their cancer preventative effects are warranted. The authors of the study did not report having received funds from drugmakers who market these medicines. The versions of these medicines that are approved to treat obesity, and have been shown to help patients lose as much as 20% of their weight on average, have exploded in popularity, leading to record profits for Novo and Lilly. Lilly’s Mounjaro and weight-loss therapy Zepbound, as well as Novo’s rival medicines Ozempic and Wegovy are already being studied to see whether they can improve health in many other ways, ranging from alcohol addiction to sleep apnea. In March, the U.S. Food and Drug Administration approved Wegovy for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes. (Reporting by Maggie Fick; Editing by Susan Fenton) Source: Healthworld

July 06,2024 Thiruvananthapuram: A day after a 14-year-old boy died due to amoebic meningoencephalitis, Kerala Chief Minister Pinarayi Vijayan held a meeting in which several suggestions, including not to bathe in unclean water bodies, were given to prevent further infections. Amoebic meningoencephalitis is a rare brain infection caused by a free-living amoeba found in contaminated waters and the suggestions to tackle it came during the meeting chaired by the CM, a statement issued by his office said. In the meeting, also attended by state Health Minister Veena George and various senior government officials including Chief Secretary Dr Venu V, it was also suggested that there should be proper chlorination of swimming pools and children should be careful when entering water bodies as they are mostly affected by this disease, the statement said. Using swimming nose clips to prevent infection by the free-living amoeba was also suggested in the meeting. The Chief Minister also said that everyone should take care to keep the water bodies clean. Besides the death of the 14-year-old boy on Wednesday night, two others — a five-year-old girl from Malappuram and a 13-year-old girl from Kannur died on May 21 and June 25, respectively, due to the rare brain infection. Medical experts said the infection occurs when free-living, non-parasitic amoebae bacteria enter the body through the nose from contaminated water. The health authorities have advised people to exercise caution against amoebic meningoencephalitis. The disease was earlier reported in coastal Alappuzha district in the state in 2023 and 2017. Source: Healthworld

July 07,2024 Pune: The city is witnessing a sudden spike in typhoid cases, putting local medical professionals on alert. Adults as well as children have been affected by this recent outbreak, Pune Municipal Corporation Pune Municipal Corporation (PMC) health department officials said, and added that the situation is under control. PMC assistant health officer Dr Rajesh Dighe said there was an outbreak recently in a society in Sadanandnagar, where the water tanks had not been cleaned for some time. “Once typhoid patients started being reported from the society, we took water samples from the tanks as well as the civic body water supply taps in the area and sent them for testing,” Dighe said. “We found that the water in the tanks was contaminated, and the society was intimated about it and asked to clean the tanks or face action,” Dighe said. As many as 21 people had tested positive from the society, he said, and added that they have all now recovered. “We had found two more patients from other areas such as Kondhwa,” he said, and emphasised that hospitals should immediately notify the civic administration of any cases. He warned that they could face action for failing to do so. Dr Amita Kaul, head of the department and senior paediatrics consultant at Surya Mother and Child Super Speciality Hospital, told TOI, “We’ve seen a marked increase in enteric fever cases over the past month. Our institute is admitting two to three children daily with high fever, vomiting, and in some instances, severe abdominal pain and dehydration.” The bacterial infection, caused by Salmonella typhi and Salmonella paratyphi A, enters the body through contaminated food and water. Kaul said that many patients’ blood cultures have tested positive for Salmonella typhi, with some children presenting low blood counts and platelet levels. “We suspect the surge may be linked to sewage contamination in water lines or increased coliform content in rivers. This systemic infection in most cases is not responding to oral antibiotics and needs hospitalisation and IV antibiotics,” Dr Kaul said. Typhoid is a vaccine-preventable disease. “However, this year has seen a rise in cases caused by the paratyphoid strain, which is not covered by the current vaccine,” she added. Dr Ameet Dravid, an infectious diseases specialist from Noble Hospital, agreed that there has been a significant surge in typhoid cases. Dravid added that the majority of patients presented with prolonged fever and tested positive for Salmonella in blood cultures. Doctors have noticed that it is taking longer for the fever to subside, typically seven to 10 days, indicating a prolonged fever feature in the current cases. “In some cases, diagnosis was initially challenging as patients had taken over-the-counter antibiotics. This can prevent Salmonella from growing in blood cultures, obscuring the diagnosis. As a result, some patients had a history of fever for a month but weren’t diagnosed with typhoid initially,” he said. Source: Healthworld

July 07,2024 New Delhi: The Indian Medical Association has demanded increased allocation of financial resources in the budget, advocating a tax-based system of health financing, the medical body said in a letter written to Finance Minister Nirmala Sitharaman on Saturday. Indicating that government spending on health was low, the medical body said that allocations varying from 1.1 to 1.6 per cent of GDP by the various governments are among the lowest in the world. The body demanded an increased allocation of financial resources for the health sector. Urging the Finance Ministry for this year’s union budget, it further demanded that the expenditure incurred on health determinants like drinking water and sanitation should be provided separately. “A minimum allocation for health alone should be around 2.5 per cent of the GDP, the medical body demanded. India’s overall health spending (public and private) is currently estimated to be 3.8 per cent of its GDP, lower than the low- or middle-income country’s (LMIC) average health spending share of GDP of around 5.2 per cent, as per the IMA. Among the major demands, the body urged for tax-funded universal healthcare with a basic package for all citizens. It demanded investments in public sector hospitals, an allocation of 5 per cent of GDP for health, a re-envision of PMJAY to cover outpatient care and the cost of drugs, and facilities for direct patient transfer, copayment, and reimbursement models, among others. IMA suggested that to achieve the goals of Viksit Bharat 2047, “the health sector has to be promoted judiciously and made a priority sector, like industries, education, and agriculture.” “New hospital projects capital equity financing support through SIDBI/NationalInfrastructure fund/infrastructure grants/state infrastructure,” it suggested. The IMA also suggested working capital loan subsidies as a supply-side financing mechanism to help with cash flow issues in PMJAY. Highlighting the complexities of the third-party payer system under PMJAY, it said that the system is creating serious fault lines in India.medical care system. Third-party payor system making medical care complex and creating serious fault lines in Indian medical care system (like US Healthcare), distorting its Indian values and USPs and leading to Burocratisation of medical care: “Third-party payors are bringing indirect price control, and their predatory suboptimal pricing is killing the quality of medical care and creating moral and ethical distortions in medical care, illegalOOPE and undermining the trust relationships between patient-providers and payor-providers, the IMA said. The body also emphasised the need to review the health insurance regulations and GST. Source: Healthworld

July 06,2024 New Delhi: Obesity can no longer be just defined by body mass index (BMI) and rather should be about how body fat is distributed throughout one’s body, researchers said while launching a new framework for diagnosing and managing obesity. Published in the journal Nature Medicine, the framework looks specifically at fat accumulated in the abdomen, measured as ‘waist-to-height ratio’ — an increased value of which is related to a higher risk of developing cardiometabolic complications, according to the researchers. An “important novelty” of the framework is including a waist-to-height ratio higher than 0.5, along with a BMI of 25-30, for diagnosing obesity, the authors, representing the European Association for the Study of Obesity (EASO), said. “The choice of introducing waist-to-height ratio, instead of waist circumference, in the diagnostic process is due to its superiority as a cardiometabolic disease risk marker,” they wrote. Accumulation of abdominal fat is a more reliable predictor of health deterioration, compared to BMI, even for individuals not meeting the current standard cut-off value for obesity diagnosis, which is a BMI of 30, the authors said. They said that the current guidelines are based on evidence from studies in which participants meeting cut-off values were included for analysis, rather than on a “complete clinical evaluation”. “The basis for this change is the recognition that BMI alone is insufficient as a diagnostic criterion, and that body fat distribution has a substantial effect on health,” they wrote. The researchers said that introducing the suggested changes in the diagnostic processes could reduce risk of undertreatment in this particular group of patients — low BMI and high abdominal fat — in comparison to the current BMI-based definition of obesity. Source: Healthworld

June 26,2024 New Delhi: Almost 50 per cent of adults in India engaged in insufficient levels of physical activity in 2022, according to a study published in The Lancet Global Health journal. Far more women in India (57 per cent) were found to be insufficiently physically active, compared to men (42 per cent), in line with trends across the South Asian region, the study found. The insufficient levels of physical activity in women in the region were, on average, 14 per cent higher than those in men, it said. The South Asian region also ranked the second highest in terms of adults being insufficiently physically active after high-income Asia Pacific region, an international team of researchers, including those from the World Health Organization (WHO), said. Globally, the authors found that about a third of the adults (31.3 per cent) were insufficiently physically active — defined as not performing at least 150 minutes of moderate-intensity physical activity per week or 75 minutes of vigourous-intensity physical activity per week. This was up by five per cent from 26.4 per cent of the adults worldwide insufficiently engaging in physical activity in 2010, they found, and if the 2010-2022 trends continued, the authors said that the global target of improving physical activity engagement by 15 per cent would not be met. In India, a little over 22 per cent of the adults engaged in insufficient physical activity in the year 2000, while in 2010, close to 34 per cent of the adults were insufficiently physically active, the researchers found. They projected that in 2030, 60 per cent of the adults could be insufficiently engaging in physical activity, should current trends continue. For the study, the researchers analysed data of physical activity reported by adults (aged at least 18 years) in population-based surveys to estimate the number of adults performing insufficient physical activity for 197 countries and territories from 2000 to 2022. The team also found that around the world, older adults, both men and women, aged 60 years and above, were increasingly engaging in insufficient physical activity. Physical inactivity is known to heighten risk of developing non-communicable diseases, including diabetes and heart disease. Rising levels of physical activity, along with an increasingly sedentary lifestyle, are contributing to increase in cases of these diseases and burdening healthcare systems around the world, according to the WHO. A 2023 Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study, published in The Lancet Diabetes and Endocrinology journal, estimated that 101 million people in India were diabetic in 2021, and about 315 million had hypertension the same year. Further, 254 million were estimated to have obesity and 185 million estimated to have high levels of LDL or ‘bad’ cholesterol, according to the study. Source: Healthworld

June 27,2024 New Delhi: All citizens aged above 70 years will be provided free treatment under the Ayushman Bharat health insurance scheme, President Droupadi Murmu said on Thursday. The opening of 25,000 Jan Aushadhi Kendras in the country is also progressing at a fast pace, she said while addressing the joint sitting of Parliament. Under the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), free health services are being provided to 55 crore beneficiaries, Murmu said. “Further, the Government is going to take yet another decision in this area. Now all the elderly above 70 years of age will also be covered and get the benefit of free treatment under Ayushman Bharat Yojana,” the President said. The AB-PMJAY, the largest publicly funded health insurance scheme in the world, aims to provide health cover of Rs 5 lakh per family per year for secondary and tertiary care hospitalisation to 12 crore families. Hospital Empanelment and Management (HEM) guidelines for empanelment of hospitals under AB-PMJAY mandates the State Health Agencies (SHAs) with the responsibility of empanelling hospitals under the scheme. Source: Healthworld

June 27,2024 New Delhi: Throwing expired medicines with household trash is not an ideal way to get rid of them. The country’s drug controller is working on a guidance document detailing methods to be followed for safe disposal of unused and expired medicines. “The need was felt for safe and proper disposal of expired/unused medicines/drugs for protecting the environment and public health,” a government official aware of the development told ET. The document is in the final stages of completion. It will include procedures to be followed for disposal, collection, storage and transportation of expired and unused drugs. Improper disposal of medications that have crossed the expiry date mentioned on the label or not used by the individual for whom they were prescribed and purchased may be hazardous to public health, animal health and environment, officials said. The recently notified Schedule M under Drug Rules prescribed the requirements for manufacturers for proper and safe storage of waste material awaiting disposal. The guidance document in works has been prepared to provide the best practices that may be followed for safe and proper disposal of expired/unused drugs, the official cited above said. The document has been prepared keeping in view various international guidelines including those issued by the World Health Organisation (WHO) and the US Food and Drug Administration (USFDA). The Biomedical Waste (Management and Handling) Rules, 2016, have also been considered, officials said. The Central Drugs Standard Control Organisation (CDSCO) had received a letter from researchers, referring to an article regarding a study aimed to assess the extent of exposure of active pharmaceutical compounds (APCs) in the hydrologic cycle in and around New Delhi. The study stated the role of ecological exposure due to the disposal of unused and expired pharmaceutical compounds into landfills and indicated that un-segregated drug disposal could be a reason for the emergence of drug resistance with special reference to antibiotics. Discussions to make sure proper disposal of these medications have been going on for long. The guidance documents will have methods for disposal of expired/unused medicines in landfills. It will also specify ways to dump antineoplastic drugs, officials said. Source: Pharma

June 29,2024 New Delhi: Nearly 80 per cent of public health facilities in India do not meet the minimum essential standards for infrastructure, manpower, equipment and other benchmarks set by govt. This shocking detail has emerged from a self-assessment exercise carried out by govt in which public health facilities from states and UTs covered under the National Health Mission (NHM) were asked to fill in details, such as the number of doctors, nurses or basic medical equipment they have. There are more than two lakh public healthcare facilities, including district hospitals, sub-district hospitals, community health centres, primary health centers, and Ayushman Arogya Mandir (erstwhile sub health centres) that are covered under NHM – a flagship scheme of govt. Of them, data shared by govt on the Indian Public Health Standards (IPHS) dashboard shows, 40,451 filled in key statistics about their respective facilities in the Open Data Kit – a digital tool – developed by the health ministry. When the scoring was done based on the statistics shared, it was revealed that only 8,089, approximately 20% of the facilities, scored 80% or higher which is needed to qualify as IPHS compliant. Simply put, these facilities had the required infrastructure, human resources, drugs, diagnostics and equipment available to provide essential services as desired. Total 17,190 (42%) of the facilities that participated in the self-assessment exercise scored less than 50% while the rest, 15,172 facilities, scored anywhere between 50 to 80%. All these details have been put out in public domain on the IPHS dashboard. A senior health ministry official said the self-assessment and its real time monitoring has been started to ensure that the health facilities maintain the required standards of infrastructure, equipment, and human resources, leading to better health outcomes and fostering a healthier and more equitable society. The Centre, an official said, is aiming to make 70,000 health institutions IPHS compliant within the first 100 days of the new govt’s formation. “The aim of this self-assessment exercise is to identify the gaps and push the states/UTs to fill them with full support from the Centre so that quality of services provided to the public improves,” a senior health ministry official said. She added that self-assessment is the first step and the Centre also plans to carry out surprise inspections to verify the claims being made by health facilities against the benchmarks set by IPHS. While the IPHS assesses health facilities for basic services, National Quality Assurance Standards (NQAS) is another higher level of evaluation which rates them on the basis of best practices followed such as availability of essential medicines, equipment, waste management, infection control practices, support services and patient’s rights. The official said that while NQAS assessment for district hospitals, sub-district hospitals, community health centres and primary health centers will continue to be carried out physically, they have introduced a new provision of virtual assessment for the Ayushman Arogya Mandir that constitute the highest number of public health facilities under NHM. The Centre bears 60 per cent of the expenditure in a public health facilities under the NHM while the rest of the expenditure is borne by the state. Source: Healthworld