Pub Date : 2019-02-09DOI: 10.5772/INTECHOPEN.82253
Roxana De Las Salas, C. Soto
Pharmacology in pediatric population has specific needs in pharmacovigilance. The lack of studies in children leads mostly to “off-label” prescribing and to an increased frequency of adverse drug reactions. Additionally, younger ages, male sex, prolonged and previous hospitalization, indication of antibiotics, and the number of prescribed drugs are factors associated with a higher risk of ADRs. Consequently, ADRs represent an additional burden of morbidity. This chapter will be focused on the most common adverse drug reactions in children (including infants and newborns), challenges, and new legislative tools in pediatric pharmacovigilance by using the Word Health Organization global individual case safety report database (VigiAccess) and results from a Latin American study.
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Pub Date : 2018-12-20DOI: 10.5772/INTECHOPEN.82623
C. Kothari, M. Shah, Rajvi Patel
Consuming a drug is equivalent to consume a risk. It is only when the benefit associated with the drugs are more than the risk, that the consumption of a drug is justified. Thus, it is benefit versus risk ratio of the drug which decides whether a drug is to be taken or not. The next question is how to measure risks and how to measure the benefits. Due to individualization of drugs to patients, it is the clinical judgment of the physician to identify what will benefit the patient. At the same time, risk associated with the drug can be ascertained by observations related to pharmacovigilance. The studies related to pharmacovigilance indicate what are the possible risks associated with the drug. Even drug can be associated with possible adverse reactions, intended or unintended. The only exception to this generality is the case of drug which is given in case of deficiency of specific components like vitamins or minerals. It is the study of possible adverse reactions of drugs which constitutes the essential content of Pharmacovigilance. This takes us to the definition of Pharmacovigilance. Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drugrelated problems. [1] Spontaneous reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data. Major aims of pharmacovigilance are as follows:
{"title":"Introductory Chapter: Pharmacovigilance","authors":"C. Kothari, M. Shah, Rajvi Patel","doi":"10.5772/INTECHOPEN.82623","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.82623","url":null,"abstract":"Consuming a drug is equivalent to consume a risk. It is only when the benefit associated with the drugs are more than the risk, that the consumption of a drug is justified. Thus, it is benefit versus risk ratio of the drug which decides whether a drug is to be taken or not. The next question is how to measure risks and how to measure the benefits. Due to individualization of drugs to patients, it is the clinical judgment of the physician to identify what will benefit the patient. At the same time, risk associated with the drug can be ascertained by observations related to pharmacovigilance. The studies related to pharmacovigilance indicate what are the possible risks associated with the drug. Even drug can be associated with possible adverse reactions, intended or unintended. The only exception to this generality is the case of drug which is given in case of deficiency of specific components like vitamins or minerals. It is the study of possible adverse reactions of drugs which constitutes the essential content of Pharmacovigilance. This takes us to the definition of Pharmacovigilance. Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drugrelated problems. [1] Spontaneous reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data. Major aims of pharmacovigilance are as follows:","PeriodicalId":39098,"journal":{"name":"PharmacoVigilance Review","volume":"463 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82991506","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 : 2018-11-05DOI: 10.5772/INTECHOPEN.79986
E. Raschi, U. Moretti, F. Salvo, A. Pariente, I. Antonazzo, F. Ponti, E. Poluzzi
This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient’s reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.
{"title":"Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety","authors":"E. Raschi, U. Moretti, F. Salvo, A. Pariente, I. Antonazzo, F. Ponti, E. Poluzzi","doi":"10.5772/INTECHOPEN.79986","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.79986","url":null,"abstract":"This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient’s reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.","PeriodicalId":39098,"journal":{"name":"PharmacoVigilance Review","volume":"47 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79033890","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 : 2018-11-05DOI: 10.5772/INTECHOPEN.80295
M. Vázquez, P. Fagiolino, Cecilia Maldonado, Natalia Guevara, M. Ibarra, I. Rega, A. Gómez, A. Carozzi, C. Azambuja
Despite the introduction of new and more expensive anticonvulsant drugs, phenytoin (PHT) is still a first-line medication for common types of epilepsy such as tonic-clonic and complex partial seizures but not for absence seizures. PHT shows a nonlinear kinetics and a narrow therapeutic range, thus a fine balance must be found between efficacy and toxic effects. Since the free (unbound) drug is responsible for producing the pharmacological effect, the concentration in a novel biological fluid more closely related to arterial free plasma drug concentration— saliva—is used in this study as part of the monitoring strategy. Therefore, in order to optimize therapy in epileptic patients under PHT treatment, plasma and saliva concentrations of PHT were measured, and adverse drug reactions were registered during a 2-year follow-up. CYP2C9, CYP2C19, and epoxide hydrolase polymorphisms (enzymes involved in PHT metabolism) were also analyzed using, in this way, pharmacogenetics for drug safety. The two PHT brands commercially available in our country and used in this study demonstrated similar pattern of efficacy and safety.
{"title":"Active Pharmacovigilance in Epileptic Patients: A Deep Insight into Phenytoin Behaviour","authors":"M. Vázquez, P. Fagiolino, Cecilia Maldonado, Natalia Guevara, M. Ibarra, I. Rega, A. Gómez, A. Carozzi, C. Azambuja","doi":"10.5772/INTECHOPEN.80295","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.80295","url":null,"abstract":"Despite the introduction of new and more expensive anticonvulsant drugs, phenytoin (PHT) is still a first-line medication for common types of epilepsy such as tonic-clonic and complex partial seizures but not for absence seizures. PHT shows a nonlinear kinetics and a narrow therapeutic range, thus a fine balance must be found between efficacy and toxic effects. Since the free (unbound) drug is responsible for producing the pharmacological effect, the concentration in a novel biological fluid more closely related to arterial free plasma drug concentration— saliva—is used in this study as part of the monitoring strategy. Therefore, in order to optimize therapy in epileptic patients under PHT treatment, plasma and saliva concentrations of PHT were measured, and adverse drug reactions were registered during a 2-year follow-up. CYP2C9, CYP2C19, and epoxide hydrolase polymorphisms (enzymes involved in PHT metabolism) were also analyzed using, in this way, pharmacogenetics for drug safety. The two PHT brands commercially available in our country and used in this study demonstrated similar pattern of efficacy and safety.","PeriodicalId":39098,"journal":{"name":"PharmacoVigilance Review","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72892188","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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