Pub Date : 2022-11-08DOI: 10.2174/2667337109666221108141059
S. Gaikwad, Shrikant K. Ainor, Narayan B. Lande, Salunkhe
A tablet is a solid dosage form containing active pharmaceutical ingredients (API) and various excipients. Different procedures, such as direct compression of powder mixtures, and dry and wet granulation technologies, are used to create distinct types of tablets. Tablet development is aided by technological advancements in the form of modified-release tablets. The modified release dosage form can be manufactured to obtain a specific pharmaceutical profile, the specific site of action and reduce the number of dose administrations using a variety of coating technologies. For modified released drug delivery, various sorts of patents are explored. The review's primary goal is to provide information on modified release formulations, formulation methodologies, current active patents based on modified release, and tablet coating technologies. The tablet is a common and convenient pharmaceutical dosage form. Recently, modified release drug administration has largely supplanted traditional tablet drug delivery technologies. The chrono pharmaceutical drug delivery can also involve modified drug delivery. Modified release tablets are used to boost the therapeutic impact of medicine by targeting the location of action on the illness condition. Modified-release tablets are very handy, easy to create, cost-effective, and do not require high-cost equipment, and they are gaining in popularity these days. Patents for modified-release tablet dosage formulations that are currently active were also discussed.
{"title":"Review of Modified Oral Solid Drug Delivery System and Recent Active Patents","authors":"S. Gaikwad, Shrikant K. Ainor, Narayan B. Lande, Salunkhe","doi":"10.2174/2667337109666221108141059","DOIUrl":"https://doi.org/10.2174/2667337109666221108141059","url":null,"abstract":"\u0000\u0000A tablet is a solid dosage form containing active pharmaceutical ingredients (API) and various excipients. Different procedures, such as direct compression of powder mixtures, and dry and wet granulation technologies, are used to create distinct types of tablets. Tablet development is aided by technological advancements in the form of modified-release tablets.\u0000\u0000\u0000\u0000The modified release dosage form can be manufactured to obtain a specific pharmaceutical profile, the specific site of action and reduce the number of dose administrations using a variety of coating technologies. For modified released drug delivery, various sorts of patents are explored. The review's primary goal is to provide information on modified release formulations, formulation methodologies, current active patents based on modified release, and tablet coating technologies.\u0000\u0000\u0000\u0000The tablet is a common and convenient pharmaceutical dosage form. Recently, modified release drug administration has largely supplanted traditional tablet drug delivery technologies. The chrono pharmaceutical drug delivery can also involve modified drug delivery. Modified release tablets are used to boost the therapeutic impact of medicine by targeting the location of action on the illness condition. Modified-release tablets are very handy, easy to create, cost-effective, and do not require high-cost equipment, and they are gaining in popularity these days. Patents for modified-release tablet dosage formulations that are currently active were also discussed.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84862140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-29DOI: 10.2174/2667337109666220329180338
Beatriz H. Aristizabal-B, Clara I. Aristizabal-B, Bernardo Agudelo-J, Luis Miguel Gomez- O, Luz Elena Cano-R, Beatriz Estella Lopez-M, Juan Fernando Saldarriaga-F, Olga L. Rincon-C
It is urgent to adopt public health measures and implement a preventive approach, its contagiousness and alleviate severe COVID-19, by reducing excessive inflammation. To establish the efficacy and safety of the combined use of BlockACE2® oropharyngeal spray, and emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19. The clinical study includes 156 participants, ended with 125 adherent participants, 69 in the placebo group and 56 in the BlockACE2 group, with follow-up for 45 days. IgM seroconversion and confirmed with a RT-PCR test for COVID-19 were analyzed. the cases diagnosed in the placebo group were 5/64 = 0.078% and in the BlockACE2 group 1/55 = 0.018%. The practice of evidence-based medicine considers the randomized clinical trial as the standard to assess the efficacy of health technologies and recommends that decisions be made, with therapeutic options of proven efficacy. The recommended way to present the results of a randomized clinical trial and other types of study should include Relative risk reduction (RRR), Absolute Risk Reduction (RAR) and Necessary number of patients to treat to reduce an event (NNT). This way of presenting the results quantifies the effort to be made to achieve the reduction of an unfavorable event. Relative risk (RR) was 0.25, with a 95% CI (0.03 to 2.05) not statistically significant due to relatively small sample; however, other statistical measures from the clinical evidence were used, such as the Absolute Power, which was 0.753, which means that BlockACE2 could reduce the risk of coronavirus disease of any severity by 75.3%. The number needed to treat (NNT) is 18.31 people, Due to its characteristics as a food that has no indication for the treatment of diseases as a medicine, or as a nutritional supplement, it requires a rigorous stance to guarantee the validity of the findings from the conduct of the research protocol. In this way, a clinically relevant finding, although “not statistically significant”, appears as a signal to scale models of clinical experimentation in the area, for new indications or new presentations. These natural support products could improve the immune conditions to neutralize the entry of the virus into the body and stimulate the cellular immune response to control the aggression of the virus, support and help control the pandemic in an efficient way.
{"title":"Preliminary results of the combined BlockACE2® Prevention and BlockACE2® functional food scheme for the prevention of COVID-19 in working population. Clinical trial , controlled, randomized, triple-blind, phase II.","authors":"Beatriz H. Aristizabal-B, Clara I. Aristizabal-B, Bernardo Agudelo-J, Luis Miguel Gomez- O, Luz Elena Cano-R, Beatriz Estella Lopez-M, Juan Fernando Saldarriaga-F, Olga L. Rincon-C","doi":"10.2174/2667337109666220329180338","DOIUrl":"https://doi.org/10.2174/2667337109666220329180338","url":null,"abstract":"\u0000\u0000It is urgent to adopt public health measures and implement a preventive approach, its contagiousness and alleviate severe COVID-19, by reducing excessive inflammation.\u0000\u0000\u0000\u0000To establish the efficacy and safety of the combined use of BlockACE2® oropharyngeal spray, and emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19.\u0000\u0000\u0000\u0000The clinical study includes 156 participants, ended with 125 adherent participants, 69 in the placebo group and 56 in the BlockACE2 group, with follow-up for 45 days. IgM seroconversion and confirmed with a RT-PCR test for COVID-19 were analyzed.\u0000\u0000\u0000\u0000the cases diagnosed in the placebo group were 5/64 = 0.078% and in the BlockACE2 group 1/55 = 0.018%. The practice of evidence-based medicine considers the randomized clinical trial as the standard to assess the efficacy of health technologies and recommends that decisions be made, with therapeutic options of proven efficacy. The recommended way to present the results of a randomized clinical trial and other types of study should include Relative risk reduction (RRR), Absolute Risk Reduction (RAR) and Necessary number of patients to treat to reduce an event (NNT). This way of presenting the results quantifies the effort to be made to achieve the reduction of an unfavorable event. Relative risk (RR) was 0.25, with a 95% CI (0.03 to 2.05) not statistically significant due to relatively small sample; however, other statistical measures from the clinical evidence were used, such as the Absolute Power, which was 0.753, which means that BlockACE2 could reduce the risk of coronavirus disease of any severity by 75.3%. The number needed to treat (NNT) is 18.31 people,\u0000\u0000\u0000\u0000Due to its characteristics as a food that has no indication for the treatment of diseases as a medicine, or as a nutritional supplement, it requires a rigorous stance to guarantee the validity of the findings from the conduct of the research protocol. In this way, a clinically relevant finding, although “not statistically significant”, appears as a signal to scale models of clinical experimentation in the area, for new indications or new presentations. These natural support products could improve the immune conditions to neutralize the entry of the virus into the body and stimulate the cellular immune response to control the aggression of the virus, support and help control the pandemic in an efficient way.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"506 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72433921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-01Epub Date: 2022-10-03DOI: 10.2174/2667337109666220615125134
Reva Bruns, Marietta Barton-Baxter, Roxane Poskin, Philip A Kern, William W Stoops
Background: A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices.
Objective: One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical and safe.
Methods: The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program's goal was to improve research design quality and from the start of the project, "find it, fix it", leading to improved PI education, without being viewed as punitive.
Results: Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth.
Conclusion: A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational and well accepted by all clinical research stakeholders.
{"title":"Building and implementing a quality assurance/quality improvement program for clinical research.","authors":"Reva Bruns, Marietta Barton-Baxter, Roxane Poskin, Philip A Kern, William W Stoops","doi":"10.2174/2667337109666220615125134","DOIUrl":"10.2174/2667337109666220615125134","url":null,"abstract":"<p><strong>Background: </strong>A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices.</p><p><strong>Objective: </strong>One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical and safe.</p><p><strong>Methods: </strong>The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program's goal was to improve research design quality and from the start of the project, \"find it, fix it\", leading to improved PI education, without being viewed as punitive.</p><p><strong>Results: </strong>Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth.</p><p><strong>Conclusion: </strong>A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational and well accepted by all clinical research stakeholders.</p>","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"9 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815204/pdf/nihms-1805204.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9475379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-06DOI: 10.2174/2667337108666211206151551
Sankha Bhattacharya
Artificial intelligence and robotics are two of the hottest and most recent technologies to emerge from the world of science. There is tremendous potential for these technologies to solve a wide range of pharmaceutical problems, including the reduction of the enormous amounts of money and time invested in the drug discovery and development process, technical solutions related to the quality of drug products, and an increase in the demand for pharmaceuticals. Nanorobotics is a new subfield that has emerged from the field of robotics itself. This technique makes use of robots that are as small as nano- or micron-sized to diagnose diseases and deliver drugs to the targeted organ, tissue, or cell. These techniques, as well as their various applications in the pharmacy sector, are extensively discussed throughout this article. Internationally renowned pharmaceutical companies are collaborating with Artificial Intelligence behemoths in order to revolutionise the discovery and development process of potential drug molecules and to ensure the highest possible quality in their products.
{"title":"A note on robotics and artificial intelligence in pharmacy","authors":"Sankha Bhattacharya","doi":"10.2174/2667337108666211206151551","DOIUrl":"https://doi.org/10.2174/2667337108666211206151551","url":null,"abstract":"\u0000\u0000Artificial intelligence and robotics are two of the hottest and most recent technologies to\u0000emerge from the world of science. There is tremendous potential for these technologies to solve a\u0000wide range of pharmaceutical problems, including the reduction of the enormous amounts of money and time invested in the drug discovery and development process, technical solutions related to\u0000the quality of drug products, and an increase in the demand for pharmaceuticals. Nanorobotics is a\u0000new subfield that has emerged from the field of robotics itself. This technique makes use of robots\u0000that are as small as nano- or micron-sized to diagnose diseases and deliver drugs to the targeted organ, tissue, or cell. These techniques, as well as their various applications in the pharmacy sector,\u0000are extensively discussed throughout this article. Internationally renowned pharmaceutical companies are collaborating with Artificial Intelligence behemoths in order to revolutionise the discovery\u0000and development process of potential drug molecules and to ensure the highest possible quality in\u0000their products.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83999020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-12DOI: 10.2174/2667337108666211112153807
Tanya Ralli, V. Kalaiselvan, Ritu Tiwari, S. Shukla, Kanchan Kholi
Silymarin is a mixture of 9 different active flavanolignans extracted from the seeds of the milk thistle (Silybum marianum) plant. It has been extensively used by local people and medicinal practitioners in European countries from around 2,000 years for the treatment of liver and biliary-related disorders. This review article documents and critically assesses, for the first time, up to date the regulatory status of the silymarin extract for the treatment of hepatic and other diseases. Information was collected systematically from electronic scientific databases including Google Scholar, Science Direct, PubMed, Web of Science, ACS Publications, Elsevier, SciFinder, and Wiley Online Library, as well as other literature sources (e.g., books). Additionally, various regulatory authority websites have been searched for exploring the data. Silymarin has been approved in different doses for the treatment or adjuvant therapy for liver disorders by the regulatory authorities of different countries. But, silymarin has still been used as a dietary supplement in the US, despite its high sales. The potential of silymarin to be approved for various other indications has been proved by assessing its efficacy in human patients. In addition to efficacy, it is found to be safe and well-tolerated. Phytochemical and pharmacological studies have demonstrated that silymarin is an important medicinal herb with prominent bioactivities. Thus, there is a need to conduct clinical trials in a larger number of patients to get approval for use in diseases like metabolic syndrome, diabetes mellitus, cancer, and many more.
水飞蓟素是从水飞蓟植物的种子中提取的9种不同的活性黄烷脂素的混合物。大约2000年来，它被欧洲国家的当地人和医生广泛用于治疗肝脏和胆道相关疾病。这篇综述文章首次对水飞蓟素提取物用于治疗肝脏和其他疾病的最新监管状况进行了文献和批判性评估。系统地从电子科学数据库收集信息，包括Google Scholar、Science Direct、PubMed、Web of Science、ACS Publications、Elsevier、SciFinder和Wiley Online Library，以及其他文献来源(如书籍)。此外，人们还搜索了各种监管机构的网站，以探索这些数据。水飞蓟素已被不同国家的监管机构批准以不同剂量用于肝脏疾病的治疗或辅助治疗。但是，尽管水飞蓟素的销量很高，但它在美国仍被用作膳食补充剂。水飞蓟素被批准用于各种其他适应症的潜力已通过评估其在人类患者中的功效得到证实。除了疗效外，它还被发现是安全且耐受性良好的。植物化学和药理学研究表明，水飞蓟素是一种重要的中药，具有突出的生物活性。因此，有必要在更多的患者中进行临床试验，以获得批准用于代谢综合征、糖尿病、癌症等疾病。
{"title":"Clinical and Regulatory Status of Silymarin","authors":"Tanya Ralli, V. Kalaiselvan, Ritu Tiwari, S. Shukla, Kanchan Kholi","doi":"10.2174/2667337108666211112153807","DOIUrl":"https://doi.org/10.2174/2667337108666211112153807","url":null,"abstract":"\u0000\u0000Silymarin is a mixture of 9 different active flavanolignans extracted from the seeds of the milk thistle (Silybum marianum) plant. It has been extensively used by local people and medicinal practitioners in European countries from around 2,000 years for the treatment of liver and biliary-related disorders.\u0000\u0000\u0000\u0000This review article documents and critically assesses, for the first time, up to date the regulatory status of the silymarin extract for the treatment of hepatic and other diseases.\u0000\u0000\u0000\u0000Information was collected systematically from electronic scientific databases including Google Scholar, Science Direct, PubMed, Web of Science, ACS Publications, Elsevier, SciFinder, and Wiley Online Library, as well as other literature sources (e.g., books). Additionally, various regulatory authority websites have been searched for exploring the data.\u0000\u0000\u0000\u0000 Silymarin has been approved in different doses for the treatment or adjuvant therapy for liver disorders by the regulatory authorities of different countries. But, silymarin has still been used as a dietary supplement in the US, despite its high sales. The potential of silymarin to be approved for various other indications has been proved by assessing its efficacy in human patients. In addition to efficacy, it is found to be safe and well-tolerated.\u0000\u0000\u0000\u0000Phytochemical and pharmacological studies have demonstrated that silymarin is an important medicinal herb with prominent bioactivities. Thus, there is a need to conduct clinical trials in a larger number of patients to get approval for use in diseases like metabolic syndrome, diabetes mellitus, cancer, and many more.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85365704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-03DOI: 10.2174/2667337108666211103105845
Sankha Bhattacharya, Dnyanesh Saindane
Intellectual property rights (IPR) are intellectual privileges that allow authors and inventors to defend their original inventions from misuse or theft. With the assistance of algorithms, clinical science has taken on a different level in recent years. Various advanced tools can be used to investigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic effects, and so on. Computational scientists are making continuous efforts to figure out how to connect business models in pharmacology. However, software theft and security rights remain major concerns for all. In order to avoid such violations, IPR compliance for R&D as well as promoting machine applications is critical. This compilation will illustrate diverse software concepts, the latest patent data structures, copyright management laws for software, trade secrets, compliance rights, software patenting and contracts, artificial technology priorities and problems, licenses, and case studies relating to IPR violations in pharmaceutical and other fields.
{"title":"Intellectual Property Rights and computer applications for pharmaceutical research and development","authors":"Sankha Bhattacharya, Dnyanesh Saindane","doi":"10.2174/2667337108666211103105845","DOIUrl":"https://doi.org/10.2174/2667337108666211103105845","url":null,"abstract":"\u0000\u0000Intellectual property rights (IPR) are intellectual privileges that allow authors and inventors to defend their original inventions from misuse or theft. With the assistance of algorithms, clinical science has taken on a different level in recent years. Various advanced tools can be used to investigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic effects, and so on. Computational scientists are making continuous efforts to figure out how to connect business models in pharmacology. However, software theft and security rights remain major concerns for all. In order to avoid such violations, IPR compliance for R&D as well as promoting machine applications is critical. This compilation will illustrate diverse software concepts, the latest patent data structures, copyright management laws for software, trade secrets, compliance rights, software patenting and contracts, artificial technology priorities and problems, licenses, and case studies relating to IPR violations in pharmaceutical and other fields.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75458989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-10-29DOI: 10.2174/2667337108666211029122255
Q. Jahan, K. Pallavi, R. Hamshika, V. Talla, J. Rao, S. Pattnaik
Improper drug usages expose patients to drug-related problems (DRPs) and can be the cause of patient morbidity and even mortality, especially frequent in hospitalized patients and pediatric groups. The objective of the present study was to identify and assess the drug-related problems in the pediatric department of tertiary care hospitals. The cross-sectional, observational study was carried out for six months included pediatric in-patients of age ≤15 years of either gender in pediatric units of tertiary care hospitals of India. The enrolled pediatric patients were observed for any drug-related problem that were further recorded and classified using the DRP registration format taken from Cipolle et al. The assessment of therapy was done by using positional statements from standard organizations and guidelines. Main outcome measure: Incidences of drug-related problems and their assessment and root cause analysis. A total of 970 DRPs were identified in 296 patients, with an overall incidence of 49.3%. The incidence of DRPs was maximum in the age group of 2-12 years of children (51.2%). Patients who took six or more drugs were around eight (OR:8.41 , 95% CI: 5.22 to 13.55) times more likely to have DRPs compared to those patients who took less than six drugs. The incidences of DRPs were more in patients who were hospitalized for ≥ 7 days. The present study revealed significantly higher incidences of DRPs in hospitalized pediatric patients necessitating the involvement of clinical pharmacists in the pediatric department of tertiary care hospitals.
{"title":"Pediatric Drug-Related Problems in an Indian Tertiary Care Hospital","authors":"Q. Jahan, K. Pallavi, R. Hamshika, V. Talla, J. Rao, S. Pattnaik","doi":"10.2174/2667337108666211029122255","DOIUrl":"https://doi.org/10.2174/2667337108666211029122255","url":null,"abstract":"\u0000\u0000 Improper drug usages expose patients to drug-related problems (DRPs) and can be the cause of patient morbidity and even mortality, especially frequent in hospitalized patients and pediatric groups. \u0000\u0000\u0000\u0000\u0000The objective of the present study was to identify and assess the drug-related problems in the pediatric department of tertiary care hospitals. \u0000\u0000\u0000\u0000\u0000The cross-sectional, observational study was carried out for six months included pediatric in-patients of age ≤15 years of either gender in pediatric units of tertiary care hospitals of India. The enrolled pediatric patients were observed for any drug-related problem that were further recorded and classified using the DRP registration format taken from Cipolle et al. The assessment of therapy was done by using positional statements from standard organizations and guidelines. Main outcome measure: Incidences of drug-related problems and their assessment and root cause analysis. \u0000\u0000\u0000\u0000\u0000 A total of 970 DRPs were identified in 296 patients, with an overall incidence of 49.3%. The incidence of DRPs was maximum in the age group of 2-12 years of children (51.2%). Patients who took six or more drugs were around eight (OR:8.41 , 95% CI: 5.22 to 13.55) times more likely to have DRPs compared to those patients who took less than six drugs. The incidences of DRPs were more in patients who were hospitalized for ≥ 7 days. \u0000\u0000\u0000\u0000\u0000The present study revealed significantly higher incidences of DRPs in hospitalized pediatric patients necessitating the involvement of clinical pharmacists in the pediatric department of tertiary care hospitals. \u0000\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90308979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-10-18DOI: 10.2174/2667337108666211018101106
A. Dang, Dimple Dang, P. Rane
The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.
{"title":"Regulations and Reimbursement of Digital Therapeutics: A Review of Current Global Practices and Future Prospects","authors":"A. Dang, Dimple Dang, P. Rane","doi":"10.2174/2667337108666211018101106","DOIUrl":"https://doi.org/10.2174/2667337108666211018101106","url":null,"abstract":"\u0000\u0000The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91250376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-05-28DOI: 10.2174/2213476x07999200918180556
S. Abouchacra, M. Yaman, S. Nair
The COVID19 pandemic has devastated the entire globe with an astounding death toll and various forms of human suffering worldwide. In its wake, it has uncovered serious flaws and shortcomings in healthcare systems and beyond. The objective of this perspective is to highlight the lessons learned from the catastrophic pandemic and propose recommendations for optimal future preparedness. Current literature was reviewed to identify common and serious challenges faced during and in the process of instituting solutions for addressing the COVID19 pandemic. The uncovered challenges appear to be similar in various countries across the globe, clearly demonstrating universal patterns in lack of preparedness. This spanned critical shortage in healthcare facilities, equipment, consumables and staffing along with technological gaps needs to keep up with the emerging needs. There are also major obstacles impeding the rapid development and implementation of diagnostics and therapeutics, and in addition, public awareness and international collaborations are immature to effectively handle the crisis. Fortunately many of these shortfalls lend themselves to intervention, however country- specific strategies must be preplanned with proactive readiness for rapid implementation during crisis situations. These go beyond readiness with physical space, essential equipment and consumables, and further involve proper capacity and manpower planning as well as local and global coordinated communication and cooperative collaborations. Moreover, self-sufficiency and sustainability are key to ensure the continuous provision of essential supplies and other needs. COVID19 has taught us that the world could never be too ready or prepared for such unexpected future events.
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