June 2024

June 16,2024 New Delhi: Citing significant inconsistencies and lack of accountability in the referral process, the Union Health Ministry has for the first time issued interdepartmental referral guidelines for hospitals to facilitate better communication and cooperation. The ‘Guidelines for Inter-Departmental Referral (within hospitals)’ stress that referrals should be initiated promptly as and when patients require specialised care, diagnostic evaluations or consultations beyond scope of admitting department. The referral for a consultant’s opinion should only be written by consultants and that post graduate residents should not close referrals on their own without discussing with their consultants, the guidelines released on June 7 stated. Consultant on call should review the referral record attended to by his team the previous day, a step which will help improve patient care and enhance learning of residents. The referral process is a crucial component of high-quality patient care in any medical institution, Director General of Health Services, Union Health Ministry, Dr Atul Goel said in the document. Problems such as poor coordination and communication, unclear procedures, non-standardised formats, and inadequate training for healthcare professionals are common and they ultimately can potentially harm a patient, Dr Goel said. The roles of various professional levels are often undefined, resulting in gaps in patient care, he stated highlighting many patients who visit hospitals have multiple co-morbidities and need a multi-disciplinary approach. The document said a robust and efficient referral mechanism should be an essential part of training of residents as well. After residency as they enter a healthcare setup to practice, this training will be very useful for them. However, problems can arise in any inter-departmental referral process, including –delays in processing/attending of referrals, breakdown in communication, and variations in referral practices across departments, it said. To address these challenges, hospitals must implement standardised referral protocols, streamline referral work flows, and provide education and training to healthcare providers and staff involved in the referral process. “Currently, with no clear guidelines in place, it has been observed that there exist heterogeneous referral mechanisms. Every department and individual have their own way of sending and attending referrals. The documentation is also variable and inconsistent. “There are delays in attending to referrals which can affect patient care adversely. Mostly junior residents (first or second-year post-graduates) see referrals where higher order inputs may actually be required. There are conflicts between departments regarding referrals which are mostly rooted in lack of communication,” the document stated. The guidelines stated that departments can prepare a roster with names of officers in various units with contact numbers and availability of units on different days, time; place where referral needs to be sent. This should be available on website as well as circulated within the institution. The referral should help patient management without burdening the referring department with a huge list of investigations. Any investigation by the referral team should be completely justified from the diagnosis offered, the guidelines said. Among the Do’s, the guidelines said referrals should be documented accurately and comprehensively, including relevant clinical information, expected outcome from referral, patient preferences, and any other specific instructions. “Communicate clearly and effectively with receiving departments, providing necessary clinical information and patient context to facilitate appropriate evaluation and management,” it said. The guidelines emphasised following up on referrals and coordinating care transitions, ensuring that patients receive necessary follow-up appointments, treatments, and interventions. It also calls for seeking feedback from referring providers and receiving departments to identify areas for improvement and enhance the efficiency and effectiveness of the referral process and prioritising patient-centred care, considering patients’ preferences, values, and treatment goals in referral process and treatment planning. Source: Healthworld

June 16,2024 New Delhi: Bharat Biotech’s indigenous rotavirus vaccine Rotovac used in the government’s immunisation programme increases the risk of intussusception in infants, a new study found. Intussusception is a condition where the intestine telescopes into itself and can lead to gangrene of the bowel or death if not treated immediately. The study has been published in the International Journal of Risk and Safety in Medicine. Bharat Biotech has dismissed the findings claiming the vaccine has been evaluated for safety. The study, co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India, and Brian Hooker, chief scientific officer, Children’s Health Defense, found that there was a 1.6-fold increase in the risk of intussusception in the vaccinated, which was missed in the earlier analysis. “Additionally, the mean age of developing intussusception was lower in the vaccinated babies, putting them at risk of serious harm, including death,” it said. Puliyel told ET that those who are getting the vaccine must be told that there is a risk as they may easily mistake it for dysentery and take it lightly. “There is a terrible risk as this is a surgical emergency and must be treated. So, the parents need to be informed,” he said. In 2020, a New England Journal of Medicine analysis found there was no risk of intussusception from Rotavac, a live attenuated rotavirus vaccine. A statistical method called self-controlled case series (SCCS) determined that the risk of intussusception in the high-risk window (21 days after any dose of the vaccine) was comparable to the background risk. The company said that the data is not new, but it is reanalysis of old data that was “out of line with the experimental design and statistical plan. Hence, it cannot be interpreted in a meaningful manner to merit serious consideration,” it further said. “Rotovac is manufactured using human rotavirus strains and not from animal origin. Hence, the rate of intussusception is similar in vaccinated and non-vaccinated subjects,” the company said in a statement. Source: Pharma

June 08,2024 New Delhi: Prominent spice brands failed quality tests conducted by the Rajasthan health department as part of the state’s campaign against food adulteration, with samples from reputed Indian companies – such as MDH, Everest, Gajanand, Shyam, and Sheeba Taza – found unfit for consumption. State health minister Gajendra Singh Khinvsar has directed stringent action against these companies under Indian Food Safety and Standards Act, including the immediate confiscation of the unsafe spices. MDH’s garam masala contained acetamiprid, thiamethoxam, and imidacloprid while its vegetable masala and chana masala had tricyclazole and profenofos. Shyam’s garam masala contained acetamiprid, Sheeba Taza’s raita masala had thiamethoxam and acetamiprid, Gajanand’s pickle masala had ethion, and Everest’s cumin masala contained azoxystrobin and thiamethoxam. The health department investigation revealed that pesticide/insecticide levels in these spices were significantly higher than permissible limits, posing serious health risks. A targeted operation was launched on May 8 to gather spice samples from all districts in the state. During this drive, 93 samples from various companies were collected. A report by the State Central Public Health Laboratory indicated that certain samples contained alarmingly high levels of pesticides and insecticides, Shubhra Singh, additional chief secretary (health) said, adding that letters had been sent to all designated officers and chief medical and health officers throughout the state, instructing them to seize the unsafe spices. Since MDH’s manufacturing units are in Haryana, that of Everest and Gajanand in Gujarat, letters have been sent to food safety commissioners of these states for necessary action. Additionally, a letter was sent to the chief executive officer of the Food Safety and Standards Authority of India in New Delhi, requesting their intervention. Food safety commissioner Iqbal Khan said samples of other spices from these companies – as well as additional batches of the unsafe batches – will also be collected. He has directed the chief medical and health officers to seize affected lots or batches of these spices from these brands, manufacturers, distributors, and wholesalers. Directives have also been issued to collect samples of other spices and spice powders from these brands. Source: Healthworld

June 22,2024 London: The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday. The approval under the agency’s accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with cetuximab. About 34 per cent of the patients who were given the combination treatment showed a partial or complete response to it during the study. The combination also helped increase the time patients lived without the disease worsening by 6.9 months. Colorectal cancer is the third most common cancer worldwide, accounting for about 10% of all cancer cases. It is the second leading cause of cancer-related deaths worldwide, according to the World Health Organization. Bristol Myers added Krazati to its portfolio after it completed its up to $5.8 billion acquisition of Mirati Therapeutics in January. Krazati works by targeting a mutated form of the gene known as KRAS that occurs in 3 per cent to 5 per cent of colorectal cancers. It targets specific gene mutations that drive cancer cell count up regardless of the organ in which the disease originated. “The approval helps justify Bristol’s decision to buy Mirati,” Morningstar analyst Damien Conover said. He estimates just over a billion dollars in annual sales for Krazati. Bristol recorded $21 million in U.S. sales of Krazati for the quarter ended March 31, 2024. The FDA’s decision adds on to Bristol’s goal to diversify its oncology business as the company faces pressure from declining demand for two of its top drugs – the blood cancer treatment Revlimid and blood thinner Eliquis, which face generic competition. Krazati had received accelerated approval from the FDA in 2022 for the treatment of a type of advanced lung cancer with the mutated form of the gene known as KRAS. Source: Pharma

June 20,2024 New Delhi: Last year, Google-owned YouTube announced partnership and product updates to support wellbeing and mental health of teens on the platform. It is now rolling out those features, which include limiting the recommendation of videos that could be negative if watched repeatedly, in more countries. James Beser, director, product management, recently spoke about how teens can navigate their growing individual interests. He emphasised that YouTube’s updates will help teens put their safety, privacy and wellbeing on priority. Additional safeguards for teen content recommendations Beser explained how YouTube is limiting repeated content recommendations for teens of videos featuring social comparison and aggression. The company worked with an Advisory Committee to identify “categories of content that may be innocuous as a single video, but could be problematic for some teens if viewed in repetition.” “These categories include content that compares physical features and idealises some types over others, idealises specific fitness levels or body weights, or displays social aggression in the form of non-contact fights and intimidation,” the company said in a blog post when it announced the features in November To help teens manage their screen time, YouTube notifies them with “Take a Break reminders”. These reminders will help teens set boundaries to manage time spent online and disconnect when needed. The feature is available since 2018, and is on by default for teens users (for every 60 minutes) but will now be visually prominent in viewers’ feeds across long-form and Shorts. Beser also said that these reminders will now appear more frequently. YouTube is also expanding crisis resource panels into a new full-page experience. When teens search for sensitive topics such as related to suicide, self-harm, and eating disorders on YouTube, a new full-page experience will help viewers pause for a moment and explore health topics. “Viewers will more prominently see resources for third-party crisis hotlines as well as suggested prompts to steer search queries towards topics like ‘self-compassion’ or ‘grounding exercises’, the company said. This feature has also rolled out for viewers of all ages where crisis resource panels are available. Source: Healthworld

June 18,2024 Washington: Erin Fox has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has become a record run. Total active shortages hit an all-time high of 323 in this year’s first quarter, according to the University of Utah Drug Information Service. That’s up about 86 per cent from a 10-year low of 174 last reached in 2017. There were 48 new shortages recorded this year through March, according to the data, published by the American Society of Health-System Pharmacists. Still, Fox also sees positive news developing. The associate chief pharmacy officer at University of Utah Health spoke recently with The Associated Press. The conversation has been edited for clarity and length. Q: Are there any signs that this is letting up? A: Unfortunately, no. We haven’t necessarily solved some of the root causes. We have, overall, relatively few manufacturers. (The U.S. Food and Drug Administration) halted inspections during COVID. Now they’re back, at factories that maybe haven’t been inspected for five or six years. They’re finding some things to fix. Those fixes can take anywhere from 6 to 18 months for production to get fully back on schedule. Meanwhile, other companies don’t necessarily have the capacity to ramp up production to make up the difference. It’s not the FDA’s fault. We want them to find those quality deficits. But when FDA goes out looking all at once, it can be pretty disruptive. Q: What are the typical drugs that land on the shortage list? A: Generic, injectable hospital drugs or older drugs. They are usually pretty low cost. There’s not a lot of resilience in the supply chain for another company to make up the difference. We saw all those chemotherapy shortages last year in part because a large factory in India, (the FDA) found quality problems there. They made a large amount of the U.S. supply. The other companies were unable to quickly make up the difference. Things have definitely improved, but that factory is still not running. Q: What is one thing about shortages that patients underestimate? A: They shouldn’t automatically assume they won’t be able to get that treatment. It might be delayed or they might have to take a capsule instead of a pill. They might have to call their insurance company to ask if they will cover the brand because sometimes (that) is available while the generic is not. Don’t panic. It’s frustrating to have to do a little bit of work, but usually you will still be able to get a treatment. Source: Pharma

June 20,2024 New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday said it has received a warning letter from the US health regulator for its Dadra facility over violation of manufacturing norms. The warning letter by the US Food and Drug Administration (USFDA) summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, Sun Pharma said in a regulatory filing. The contents of the warning letter shall be made public by the USFDA in due course, it added. This intimation is further to our communication dated April 11, 2024, about Dadra facility receiving OAI status by the USFDA. On April 11, Sun Pharma had informed stock exchanges that its Dadra facility had received Official Action Indicated (OAI) status from the USFDA. It followed an inspection at the company’s Dadra facility from December 4 to December 15, 2023. Source: Pharma

June 21,2024 Geneva: The World Health Organisation and drugmaker Eli Lilly and Co are warning people to be wary of fake versions of popular weight-loss and diabetes medicines. WHO said Thursday that it has fielded several reports of fake semaglutide – the active ingredient in Novo Nordisk’s Wegovy and Ozempic – in all geographic regions of the world since 2022. Lilly said in an open letter that it was “deeply concerned” about growing online sales and social media posts involving phony or compounded versions of tirzepatide, the active ingredient behind its drugs Mounjaro and Zepbound. The Indianapolis-based company said it was the only lawful supplier of those drugs, and it does not provide tirzepatide to compounding pharmacies, wellness centers or online retailers. Lilly said fake versions of its drugs frequently advertised or sold online are never safe to use. Novo Nordisk has issued similar warnings in the past about its medications. WHO said patients can protect themselves by using prescriptions from licensed physicians to buy the medications. The agency said patients also should avoid buying the drugs from unfamiliar sources. Lilly said any products marketed as tirzepatide and not Mounjaro or Zepbound were not made by the drugmaker and are not approved by the US Food and Drug Administration. (AP) SCY SCY. Source: Pharma

June 19,2024 New Delhi: An expert committee is likely to meet soon to deliberate on a contentious proposal to assess the feasibility of allowing generic substitutions for prescription drugs, said people familiar with the matter. The proposal has become a bone of contention between the Indian Pharmaceutical Alliance (IPA), which represents the country’s big drug makers, and the All India Drug Action Network (AIDAN), a network of several health organisations. The IPA is opposing the proposal to allow government-run Jan Aushadhi Kendras to dispense substitutes of prescription medications, claiming that it would open floodgates of similar demands by trade channels, such as general pharmacy stores, “which will not be in the interest of patients”. The IPA represents drugmakers such as Sun Pharmaceutical Industries, Dr Reddy’s Laboratories, Torrent Pharmaceuticals, Piramal Pharma, Aurobindo Pharma, Emcure Pharmaceuticals, Intas Pharmaceuticals, Glenmark Pharmaceuticals, Lupin, Cipla and Cadila Pharmaceuticals. The IPA has also said the absence of proper regulatory oversight could result in spurious drugs being dispensed to patients. AIDAN, on the other hand, said the permission to Jan Aushadhi Kendras to substitute brands with generic name medicines would be “in the interest of patients”. “A committee will take up this matter to deliberate the concerns of all stakeholders,” said one of the persons, who did not wish to be identified. AIDAN wrote to the health minister this week urging the government “to work for the consumer and leave no stone unturned towards making life saving medicines (available) at affordable price”. The Central Drugs Standard Control Organisation (CDSCO) has been mulling a proposal to make changes to the Drugs and Cosmetics Act, 1940, and its regulations to allow the substitution of drugs specified under schedules H, H1, and X with a view to promoting quality generic medicines at affordable prices. Source: Pharma

June 17, 2024 Mumbai : The FSSAI Western Region office has suspended the license of an ice cream manufacturer in Pune after a 26-year-old doctor from Malad West alleged that he found a human finger in an ice cream cone on Wednesday. “The premises of the ice cream manufacturer have been inspected by a team of FSSAI’s Western Region Office and its license has been suspended,” said FSSAI in a reply to ANI However, the report of the forensic lab is still pending. FSSAI further said that the ice cream manufacturer who delivered the ice cream is based in Indapur, Pune, and has a central license as well. “The manufacturer is based at Indapur, Pune and has a central license,” FSSAI said. For further investigation team FSSAI has collected samples from the premises of the seller. “The State FDA has also inspected the seller’s premises at Mumbai and samples of the batch have been taken,” the food safety body added. According to Branded Ferro, the complainant, his sister visited him, and he ordered three ice creams from Yumno through a grocery app, which arrived at 10:10 pm. In his Police complaint, he said, that as he took a byte from a cone he felt something unusual in his mouth and when he checked it properly then he got to see finger-like flesh. Later, he clicked the picture and shared it on the Instagram page of the company. Source: Healthworld