Team JGJ

Nov 11, 2024 The cyberattack, reported on Feb. 21, knocked the UnitedHealth Group subsidiary offline, cutting off billions of dollars in payments to medical practices and jeopardizing sensitive information for millions of patients. In an interview with NBC News, Rick Pollack, CEO of American Hospital Association, described the attack as the most serious incident of its kind leveled against a U.S. health care organization. However, it was not an isolated incident. An estimated 725 HIPAA data breaches occurred in 2023, according to the Health Sector Coordinating Council Cybersecurity Working Group, a coalition of health care providers, medical technology companies and other entities that work with the government to mitigate cyber threats to the health care system. Another 141 ransomware attacks struck hospitals, with an average ransom of $1.5 million per institution, according to the working group. On May 8, the Ascension health care organization was struck by the same cybercriminals behind the Change Healthcare event. The attack disrupted Ascension’s 140 hospitals in at least 10 states for more than a month. “It was a single individual who downloaded the wrong software on an email that set off this infiltration of ransomware,” Keith A. Bellovich, DO, chief medical officer at Ascension St. John Hospital in Detroit, told Healio I Nephrology News & Issues. “It could happen anywhere; it could happen to any of us. Yes, we get frustrated with our IT teams for always trying to educate us. But we have to pay attention because this isn’t the end, Bellovich, who is a Healio I Nephrology News & Issues Editorial Advisory Board member, said. The health care sector is ripe for attack because of the amount of money, sensitive data and personal information cybercriminals can steal and exploit, according to experts interviewed for this article. “We have seen it in large health organizations, smaller health systems and in individual practices,” Margaret Lozovatsky, MD, FAMIA, AMA vice president of digital health innovations, said in an interview. “That just speaks to the fact that technology has become such an integral part of care delivery. Every area where we are providing clinical care has the potential to be impacted, and there’s a lot of vulnerabilities in those spaces.” Everyone is a target Change Healthcare paid a $22 million ransom to the hacker to regain control of its system. However, the payment did not prevent myriad disruptions to providers and patients. In a survey about of nearly 1,000 U.S. hospitals conducted by the American Hospital Association (AHA) on March 9-12, nearly all respondents (94%) reported financial impacts, with more than half characterizing these as “serious” or “significant.” Nearly 60% of respondents reported the impact to their revenue totaled $1 million or more per day. “We haven’t even discussed the ongoing damage from records being released, Theresa Payton, CEO of Fortalice Solutions, a boutique cyber firm that serves the Fortune 100 and other large privately held  firms, said in an interview. “Depending on what’s in these records, there could be information that could be used for extortion and blackmail. One-third of all Americans — or more than 110 million people — could have had their personal data compromised in the Change Healthcare ransomware attack, UnitedHealth CEO Andrew Witty told Congress in May. The success of the Change Healthcare attack appears to have prompted a new wave of similar threats. “It is vitally important for organizations to prepare for this reality, ” Payton, who served as the White House chief information officer from 2006 to 2008, said. “When impacted by a cybercriminal syndicate — whether they take a system offline, lock files or steal data — organizations must focus on minimizing and mitigating damages. They need to ensure they can continue to function even while dealing with a cyber incident. It’s easier said than done, but it’s the crucial question every health care organization must address.” Source: Healio

Oct 25, 2024 India’s pharmaceutical landscape is a double-edged sword. On one side, it boasts a vast ecosystem of compliance, with over 69,000 unique regulations governing pharmaceutical companies. On the other hand, the regulatory enforcement capacity struggles to keep pace with industry demands, resulting in significant gaps in oversight. Agrawal highlights the importance of regulatory compliance and the responsibility of manufacturers in maintaining quality control. He emphasised that while counterfeit drugs are manufactured with the intent to deceive, not of standard quality (NSQ) drugs may originate from legitimate sources yet fail to meet required standards due to various factors like poor storage or inadequate testing. Agrawal advocates for a more robust regulatory framework, emphasising the need for a targeted approach to enforcement. He suggests that the 10% of manufacturers engaged in illegal practices should face stringent consequences, while the remaining 90%—the law-abiding companies—should not be burdened with excessive compliance demands. As consumers navigate the choices between local chemists and online pharmacies, the podcast highlights the need for assurance in the quality of medications regardless of the purchasing avenue. Agrawal firmly asserts that the onus of accountability lies with regulators and manufacturers to ensure that all medicines meet safety and efficacy standards, regardless of price. Source: The Hindu Business Line

Oct 06, 2024 New Delhi: India’s apex health research body, ICMR, will undertake a study to evaluate the efficacy of two Polycystic Ovarian Syndrome (PCOS) drugs in improving fertility and bilth outcomes among women suffering from the ovarian condition. The drugs that have been recommended by experts for this purpose are Metformin and Inositol which are used in the treatment of the condition. The ICMR has recently invited expression of interest (EOI): “To undertake a multi-centric randomised controlled trial for evaluating the efficacy of Metformin vs Inositol to improve fertility and birth outcomes among PCOS women”. Polycystic Ovarian Syndrome (PCOS) is a complex disorder ranging from mild to severe disruptions in reproductive, endocrine and metabolic functions, with key features including irregular menstrual periods (anovulation), hyperandrogenism, insulin resistance and abnormal gonadotropin secretion. The prevalence of infertility in women with PCOS is high, varying between 70 and 80 per cent, the ICMR said in the Eol document. Moreover, PCOS women have been found to have increased prevalence of pregnancy complications and less favourable pregnancy outcomes (live births, miscarriage, pregnancy rate) compared with women without PCOS, it stated. In contemporary practice, the use of Metformin and Inositol for the treatment of PCOS is widespread. “However, present evidence on the efficacy of these two drugs in terms of improvement in fertility and other related outcomes is insufficient,” the ICMR said in a document. A Finnish study suggested that, as compared to placebo, metformin improved the pregnancy rate, live birth rate and ovulation rate in the studied population, the document said. However, a Cochrane review with meta-analysis including three other smaller studies reported that as compared with placebo, metformin may have only marginal benefit for live birth rate outcome. Additionally, there is very limited data available globally on the effectiveness of Inositol for PCOS women, especially for birth outcome and cycle regulation. “Evidence on the efficacy of both metformin and inositol in the Indian context is almost non-existent. To address the knowledge gap and to generate evidence on the management of PCOS for improving birth outcomes in the Indian context, the current ICMR call is being proposed,” the document said. The ICMR is looking to partner with interested researchers for the development of a multicentre randomised controlled trial for the management of PCOS in Indian women. The selected researchers shall be invited to join the research team and shall collaborate to develop a full research proposal and roll out the multi-centre research project which will be coordinated by ICMR, the document said. The research question is “Among women with Polycystic Ovary Syndrome (PCOS), how does inositol in comparison to metformin work in terms of efficacy and safety on outcomes including pregnancy conception, menstrual cycle regularisation, and improvement in endocrinological and metabolic parameters?” Source: Economic Times

Nov 11, 2024 In October 2024, approximately 480 Indian students participated in counselling sessions conducted by the Medical Education Commission (MEC) under the government of Nepal. But, now most of them are in a fix due to changing policies introduced by the Nepal Medical Council in April 2023. This implies that Indian students who have enrolled in Nepal after 2021 or are planning to move there for an MBBS or BDS degree will not be granted a license to practice in Nepal. Due to the change in policies international students from the 2021, 2022, and 2023 MBBS batches are considering abandoning their courses and planning to protest against private colleges and the Nepal Medical Council (NMC) over the uncertainty created by licensing regulations. The Global Medical Society (GMS), an association representing Indian MBBS students in Nepal, has informed Education Times that they will soon protest, demanding amendments to NMC Regulations, 2024 (especially to the section 21 f). A student from Muzaffarpur, Bihar, studying at Kathmandu University, on the condition of anonymity says, “After the NMC’s ambiguous notifications released in April 2023 and October 2024, foreign students are struggling to ensure if their medical education will remain valid in India. Since Nepal does not grant licenses to foreign students, it is unclear why we are still expected to take the licensing exam. Without the license to practice in Nepal, our careers are at risk, as we will not be able to qualify for the FMGE or NExT exams in India.” Another student from Gorakhpur, studying at Tribhuvan University, Nepal, says, “Nepal’s medical education is also not yet recognised by the United States Medical Licensing Examination (USMLE), which limits our opportunities worldwide. We have reached out to the Indian Embassy in Nepal for clarifications as well and are awaiting their response. If the NMC does not provide us with a practising license for at least 10 years, we will be forced to return to India.” Around 1,338 Indian students could face severe career setbacks if amendments or special provisions are not made for currently enrolled students in Nepal. “We also do not want more Indian students to get into this entrapment, thus we have asked the authorities to delay the last date of the ongoing admission process so that these students can make an informed decision,” adds the student. Indian students have faced the potential loss of at least Rs 5 lakh each, which was illegally collected by consulting agencies as a pre-booking fee. Dr Kumar from a private medical college in Nepal says, “This year, around 845 students registered for counselling, and 480 students were selected based on the MEC merit list. Following awareness regarding the licensing issue, nearly 50% have withdrawn their applications. Most registrants this year were from Maharashtra, Uttar Pradesh, Bihar, West Bengal, and Gujarat. Many students paid pre-booking fees to agents, ranging from Rs 5 to 15 lakh, despite the NMC’s clear statement that such fees are illegal. Consultants/ agents often mislead students and parents.” Anuj Goyal, co-founder, Get My University, says, “The young Indian medical aspirants are draining their finances due to misleading information from certain consultants and private medical colleges in Nepal. From 2021 to 2024, over 1 ,400 students travelled to Nepal to pursue medical degrees, each investing an average of Rs 30 lakh in tuition fees—a combined total of Rs 400 crore. However, following a circular issued by the MEC on October 17, 2024, these students are now in severe distress, as their education in Nepal risks being invalidated, potentially costing them their savings and jeopardising their futures.” Source: Education Times

Nov 09, 2024 New Delhi: Many ethical concerns are raised when it comes to the In Vitro Fertilization (IVF). In vitro fertilization (IVF) is an innovative medical procedure that has transcended the boundaries of traditional conception methods, offering hope to countless couples who are battling infertility challenges. It is one of the common alternatives chosen by couples to conceive, especially in cases of blocked fallopian tubes in females, male factor infertility, recurrent miscarriages, endometriosis, or diminished ovarian resewe. During this procedure, the eggs and sperms are combined outside the body in a controlled laborat01Y environment, and the resulting embryo is transferred back into the uterus with the aim of fulfilling the dream of having a baby. When exploring the option of in vitro fertilization (IVF), one cannot overlook the ethical complexities that are linked to this popular technique and one such pertinent question which remains unanswered is— the optimum number of embryos to be transferred during IVF. More the number of embryos transferred, more are the chances of multiple pregnancies. This is done to maximize pregnancy rates in order to sustain the competition between IVF units, and making the treatment more cost- effective. The practice of multiple embryo transfer can pose serious risks to both the mother and the infants. Almost every obstetric complication happening in a singleton pregnancy is more common in multiple pregnancy and even routine life after delivery is more difficult for the parents with increased incidences of anxiety and depression. Risks to the children can be due to premature delivery, complications of intra- uterine growth retardation and all these can have short term and long term ill effects on the babies. Further, the health care costs related to the management of these complications increase and higher number of multiple pregnancies can be a public health issue. However simply stating that multiple pregnancy has potential risks to both the mother and child doesn’t mean that multiple embryo transfer should be prohibited. There is a need for proper legislation on the number of emblyos to be transferred to curtail both the parental and physician autonomy. The parents have the right to decide as to how many children they want in their family and the IVF specialist has a moral obligation towards both the parents and the future child. Hence a conscious decision regarding the number of embryos to be transferred has to be made considering many factors because any risk to either the parent or the child may be morally and ethically unacceptable. The key component of IVF treatment is informed consent. In order to make decisions that are consistent with their beliefs and goals, couples must have a thorough understanding of the physical, emotional, financial, medical and ethical components of the procedure. This covers the risks and benefits of single embryo transfer vs multiple embryo transfer and also their choices about cryopreservation, embryo selection and genetic testing. The decision regarding performance and possibility of multifetal reduction should also be discussed in length. The ethical dilemmas of reduction is perceived as a problem of abortion. Regardless of the education provided before treatment, people may still consider decision to reduce the number of emblyos as psychologically demanding and it is better not to go to that stage where couples have to take certain decisions which may jeopardize their present pursuit. Hence prevention of multiple pregnancies should be preferred to multifetal reduction of pregnancy. Age, parity, diagnostic criteria and co-existing medical conditions are examples of patient variables that affect the decision-making process. Couples should be informed about the potential dangers and how these factors may affect the treatment outcome, since they have an impact on the overall success of IVF. Technological advancement such as pre — implantation genetic testing (PGT-A) offers the parents an opportunity to screen for aneuploidy or genetic disorders and provide optimal pregnancy rates after elective transfer of a single normal embryo. Another factor to be considered is concerns of couples on cryopreservation of emblyos as many of them tend to experience emotional distress and this should be well addressed. Finally—the—prognosis – patients need to know about their chances of success depending on their particular medical/ obstetrical background, their profile as a patient — poor responders or poor implanters, their infertility treatment history, the quality of the embryos and the clinic’s experience. This aids them in reaching practical decisions. The treating physician and the couple reach an agreement on the modalities of treatment. Finally as adults, patients should have an ultimate say on the treatment that they would wish to receive within the framework of risks vs benefits and all the associated treatment alternatives prioritizing health outcomes. This article is written by Dr. Vandana Bhatia, Fertility Specialist , Nova Southend Fertility and IVF, Vasant Vihar. Source: Economic Times

Nov 11, 2024 The department conducts raids on pharmacies showing unusually high sales and inspects the outlets. So far, 470 pharmacies have been raided. While action has been taken against 73 of them, 10 have been shut down, and their permits have been revoked. Dr Umesh S, drugs controller of the Karnataka Drug Control Department, stated, “We received several complaints from the police department and have strictly instructed all pharmacies not to sell painkiller tablets without a prescription. We are closely monitoring their purchase and sale.” Ramesh, a retired officer from the drug control department, remarked, “Earlier, addicts preferred Tramadol tablets, followed by Diclofenac. Now, Tempetedol tablets are in high demand among addicts. When one tablet is controlled, they switch to similar tablets from other manufacturers. The Union government must implement stricter regulations.” Ravish R, a drug control officer, noted, “A patient might have purchased 100 painkiller tablets within a month. When sales increase, the department monitors the situation. By tracking sales details, locations, and outlets, more than 50% of the unauthorized use of painkillers has been curbed.” Karnataka has a total of 53,000 pharmacies, with a significant 25,600 located in Bengaluru. Source: Daiji World