Medical devices, being life-saving tools, are considered to be a boon for healthcare system. However, in addition to their therapeutic effects, there are several ill consequences that are caused by these devices. An effective cohort vigilant system was needed to manage such adverse effects. This had led to the introduction of materiovigilance. Materiovigilance is the study and follow-up of occurrences that arise as a result from the usage of the medical equipment. It not only manages adverse events (AE) but also creates harmonization among countries. Keeping these objectives in focus, the principles, perspectives, and practices with regard to materiovigilance that are followed in the USA, Europe, China, Japan, Australia, Canada, and India are being compared. Such a comparison is essential, which will help us to understand the gaps in the current regulatory systems in the above-mentioned countries and furthermore will provide a comprehensive picture to the regulatory authorities to amend any existing laws if required. These amendments may ensure optimal patient safety by providing them a benign experience from the use of medical devices.
Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe’s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars.
Adverse drug reactions (ADRs) are one of the major causes of mortality as well as morbidity. They do have a substantial influence on human health, lowering quality of life for patients, and increasing morbidity and mortality rates, while also putting a significant financial strain on health-care systems. According to a 1998 study, ADRs are the 4th leading cause of death in the United States, accounting for up to 7 percent on average of all hospitalizations. In India, a similar situation, where physicians' inability to diagnose ADRs has caused a lot of hospitalizations and fatality cases. There are many observational studies and KAP (Knowledge, Attitude, and Practices) studies performed across the country to evaluate this issue, but none has summarized the important points at one platform to give the readers, regulatory agencies, and policymakers an idea to improvise the ADR reporting process. This comprehensive review has revealed a major KAP gap in India, and has summarized the different reasons for this gap, as well as their relevant solutions. The provided solutions help to achieve the sustainable goal of ‘good health and well-being.’
Aim: Analysis of the percentage price differences among the widely prescribed antihypertensive drugs available on the Indian retail market and under the Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP) or the Jan Aushadhi scheme. Materials and Methods: The prices of frequently prescribed various antihypertensive brands were collected and organized by using latest Monthly Index of Medical Specialties. The price of 1 dosage form in INR of each brand was extracted. Based on the price of various brands, average price of each drug was calculated and compared with the price of PMBJP drugs. Additionally, literature review was performed to place the results in perspective. Results: The prices of prescribed antihypertensive medicines were analyzed and compared with PMBJP drugs. In monotherapy, Metoprolol 25 mg showed a maximum price difference of 89.08%; in combination therapy, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg indicates maximum price difference of 90.76%. In addition, Telmisartan 40 mg demonstrate 88.59%, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg demonstrate 90.76%, Ramipril 5 mg plus Hydrochlorothiazide 12.5 mg and Amlodipine 5 mg indicates 90.38% price variation in one treatment course based on the grading of hypertension. Further, on literature review 11 relevant articles were found which were consistent with the results of this study. Conclusion: The results of our study show huge differences between the prices of PMBJP drugs and branded drugs available in India. It suggests that moving towards PMBJP drugs may lessen the financial strain on the patients and their caregivers. The prescriber should make an informed decision and choose the cheaper antihypertensive drugs to lessen the financial burden on the patient leading to maximum patient adherence.
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