Pub Date : 2021-07-09DOI: 10.5772/INTECHOPEN.98583
Md. Shah Amran
The discovery of a new drug usually takes 10-15 years. Within this time period, the candidate drug is thoroughly screened for its beneficial as well as side effects. But the side, adverse or toxic effects cannot be detected to a full scale due to some special reasons. The beneficial effects and toxicity of new drugs and vaccines are usually studied by “Clinical trials”, which are divided into four categories ranging from clinical trial phases I to IV. During clinical trial phase-III, about 4,000-10,000 patients are involved and after passing this phase, the drug is allowed to enter into the global market. Then, billions of people, including those who were excluded in phase-III, may be administered with this drug. It is worthy to mention that these 4,000-10,000 patients may not show many of the side effects or toxic actions. The undetected adverse drug reactions (ADRs) are studied in clinical trial phase-IV, which is also known as post market surveillance. For this reason, the ADRs are compared with the tip of the iceberg, as it indicates the minor part of a major event. This phenomenon gave birth to a new branch of the pharmacology known as Pharmacovigilance.
{"title":"Adverse Drug Reactions and Pharmacovigilance","authors":"Md. Shah Amran","doi":"10.5772/INTECHOPEN.98583","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.98583","url":null,"abstract":"The discovery of a new drug usually takes 10-15 years. Within this time period, the candidate drug is thoroughly screened for its beneficial as well as side effects. But the side, adverse or toxic effects cannot be detected to a full scale due to some special reasons. The beneficial effects and toxicity of new drugs and vaccines are usually studied by “Clinical trials”, which are divided into four categories ranging from clinical trial phases I to IV. During clinical trial phase-III, about 4,000-10,000 patients are involved and after passing this phase, the drug is allowed to enter into the global market. Then, billions of people, including those who were excluded in phase-III, may be administered with this drug. It is worthy to mention that these 4,000-10,000 patients may not show many of the side effects or toxic actions. The undetected adverse drug reactions (ADRs) are studied in clinical trial phase-IV, which is also known as post market surveillance. For this reason, the ADRs are compared with the tip of the iceberg, as it indicates the minor part of a major event. This phenomenon gave birth to a new branch of the pharmacology known as Pharmacovigilance.","PeriodicalId":130195,"journal":{"name":"New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129840332","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 : 2021-06-26DOI: 10.5772/intechopen.98665
Daniel Gomes, E. Gomes, I. Ribeiro-Vaz, M. T. Herdeiro, F. Roque
Polypharmacy and physiological changes inherent to the aging process can cause significant modifications in the pharmacokinetic and dynamic regimens of drugs, making the elderly more susceptible to adverse drug effects. Adverse drug reactions (ADR) in older adults have a significant impact on hospital admissions, increasing hospital stay and healthcare costs. Most common ADR in this population are dose-related and predictable. However, they can be difficult to diagnose as they often have nonspecific symptoms. This could be minimized by decreasing the use and prescription of potentially inappropriate medication and being aware of possible drug interactions. Besides, being older patients underrepresented in clinical trials and due to their physiological modifications, serious or atypical ADR are more common in this age range. To minimize harm in older adults, effective pharmacovigilance must be encouraged.
{"title":"Pharmacovigilance in Older Adults","authors":"Daniel Gomes, E. Gomes, I. Ribeiro-Vaz, M. T. Herdeiro, F. Roque","doi":"10.5772/intechopen.98665","DOIUrl":"https://doi.org/10.5772/intechopen.98665","url":null,"abstract":"Polypharmacy and physiological changes inherent to the aging process can cause significant modifications in the pharmacokinetic and dynamic regimens of drugs, making the elderly more susceptible to adverse drug effects. Adverse drug reactions (ADR) in older adults have a significant impact on hospital admissions, increasing hospital stay and healthcare costs. Most common ADR in this population are dose-related and predictable. However, they can be difficult to diagnose as they often have nonspecific symptoms. This could be minimized by decreasing the use and prescription of potentially inappropriate medication and being aware of possible drug interactions. Besides, being older patients underrepresented in clinical trials and due to their physiological modifications, serious or atypical ADR are more common in this age range. To minimize harm in older adults, effective pharmacovigilance must be encouraged.","PeriodicalId":130195,"journal":{"name":"New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129424512","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 : 2021-05-20DOI: 10.5772/INTECHOPEN.95293
M. T. Herdeiro, T. Silva, I. Ribeiro-Vaz, E. Gomes, A. Figueiras, F. Roque
{"title":"Introductory Chapter: Pharmacovigilance and Public Health Safety","authors":"M. T. Herdeiro, T. Silva, I. Ribeiro-Vaz, E. Gomes, A. Figueiras, F. Roque","doi":"10.5772/INTECHOPEN.95293","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.95293","url":null,"abstract":"<jats:p />","PeriodicalId":130195,"journal":{"name":"New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125325130","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 : 2021-04-23DOI: 10.5772/INTECHOPEN.97248
Vivekanandan Kalaiselven, S. Shukla, N. Mishra, Pawan Kumar
Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.
{"title":"Basics and Essentials of Medical Devices Safety Surveillance","authors":"Vivekanandan Kalaiselven, S. Shukla, N. Mishra, Pawan Kumar","doi":"10.5772/INTECHOPEN.97248","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.97248","url":null,"abstract":"Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.","PeriodicalId":130195,"journal":{"name":"New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129008556","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 : 2021-01-05DOI: 10.5772/INTECHOPEN.95470
F. Varallo, Alan Maicon de Oliveira, Ariane Cristina Barbosa Zanetti, H. C. Capucho, L. R. Pereira, Lucas Borges Pereira, Maria O.B. Zanetti, Thalita Zago Oliveira, V. D. Lopes
Although underdiagnosed, delirium is a common and potentially preventable problem in older patients, being associated with morbimortality. Drugs have been associated with the development of delirium in the geriatric population and may be considered the most easily reversible trigger. Polypharmacy, prescription of deliriogenic, anticholinergic and potentially inappropriate drugs are contributing factors for the occurrence of the disturb. Furthermore, changes in pharmacokinetic and pharmacodynamic parameters, which are intrinsic of the aged process, may contribute for cognitive impairment. Identification and reversal of clinical conditions associated with delirium are the first step to treat the disturbance, as well as mitigation of environmental factors and the exposition to deliriogenic drugs. Current evidence does not support the prescription of antipsychotics and benzodiazepines for the treatment of delirium. However, the judicious use of first- or second-generation antipsychotics can be considered in severe cases. Multi-component non-pharmacological, software-based intervention to identify medications that could contribute to delirium, predictive models, tools, training of health professionals and active actions of pharmacovigilance may contribute to the screening, prevention, and management of delirium in older people. Besides, it is also important to improve the report of drug-induced delirium in medical records, to develop properly risk management plans and avoid cascade iatrogenesis.
{"title":"Drug-Induced Delirium among Older People","authors":"F. Varallo, Alan Maicon de Oliveira, Ariane Cristina Barbosa Zanetti, H. C. Capucho, L. R. Pereira, Lucas Borges Pereira, Maria O.B. Zanetti, Thalita Zago Oliveira, V. D. Lopes","doi":"10.5772/INTECHOPEN.95470","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.95470","url":null,"abstract":"Although underdiagnosed, delirium is a common and potentially preventable problem in older patients, being associated with morbimortality. Drugs have been associated with the development of delirium in the geriatric population and may be considered the most easily reversible trigger. Polypharmacy, prescription of deliriogenic, anticholinergic and potentially inappropriate drugs are contributing factors for the occurrence of the disturb. Furthermore, changes in pharmacokinetic and pharmacodynamic parameters, which are intrinsic of the aged process, may contribute for cognitive impairment. Identification and reversal of clinical conditions associated with delirium are the first step to treat the disturbance, as well as mitigation of environmental factors and the exposition to deliriogenic drugs. Current evidence does not support the prescription of antipsychotics and benzodiazepines for the treatment of delirium. However, the judicious use of first- or second-generation antipsychotics can be considered in severe cases. Multi-component non-pharmacological, software-based intervention to identify medications that could contribute to delirium, predictive models, tools, training of health professionals and active actions of pharmacovigilance may contribute to the screening, prevention, and management of delirium in older people. Besides, it is also important to improve the report of drug-induced delirium in medical records, to develop properly risk management plans and avoid cascade iatrogenesis.","PeriodicalId":130195,"journal":{"name":"New Insights into the Future of Pharmacoepidemiology and Drug Safety [Working Title]","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125794862","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}
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