A knowledge based approach for automated signal generation in pharmacovigilance
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Background: Pharmacovigilance experts detect new adverse drug reactions (ADR) by manually reviewing spontaneous reporting systems. Automated signal generation aims to focus the attention of experts on drug – adverse event associations which are disproportionally present in the database. Although adverse events are coded by means of controlled vocabularies such as the MedDRA dictionary, this semantic information is not taken into account for signal generation.Keywords:
SIGNAL (programming language)
Pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) have pivotal roles in drug safety. This study aimed to evaluate the knowledge, attitude and practice of health professionals towards pharmacovigilance in a university hospital in Turkey.An observational, cross-sectional study via a 25-item self-administered questionnaire was conducted among physicians (n=161) and nurses (n=321).Although 66% (320/482) of the subjects were aware of the 'pharmacovigilance' term, the awareness of the Turkish Pharmacovigilance Center was as low as 30% (161/482). Similarly, 41% (198/482) of the subjects did not know the pharmacovigilance contact point of the hospital. Defining and determining new ADRs and improving patient safety were associated with the importance of spontaneous reporting by the subjects. According to the physicians, unawareness of the national pharmacovigilance system was the first discouraging factor, as was the unawareness of the need for spontaneous reporting of ADRs for the nurses. Although the frequency with which the nurses encountered ADRs was lower than that of the physicians, their claimed reporting ratio (21%; 68/321) was more than the physicians (8%; 12/161).There is significant potential under-reporting of ADRs, which seems to be the result of several factors, including the lack of the knowledge of the national pharmacovigilance system.
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Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programs. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape the understanding of a drug’s safety profile in order to continually enhance patient safety
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of illness, disability and even death.In some countries, adverse drug reactions (ADRs) rank among the top 10 leading causes of mortality.In order to prevent or to reduce harm to patients and thus improve public health, mechanisms for evaluating and monitoring the safety of medicines in clinical use are vital. [1]Pharmacovigilance programs in the next 10 years, describe in brief the potential implications of such trends on the evolution of the science.These days pharmacovigilance is facing lots of challenges to develop better health care systems in this global pitch.Major challenges are globalization, web-based sales and information, broader safety concerns, public health versus pharmaceutical industry economic growth, monitoring of
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OBJECTIVE:With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs).The development of national pharmacovigilance systems is the responsibility of all health workers.The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. METHODS:This descriptive-cross sectional study was performed in 112 nurses working in a public hospital.The questionnaire was applied about pharmacovigilance and adverse drug reactions.The knowledge, attitudes and practices about adverse drug reactions were asked. RESULTS:The 74.1% of the nurses definition of "severe adverse effect" of drug therapy.The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%.Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM).Only 8% of nurses reported ADRs in their professionality. CONCLUSION:Although most of the participants knew the importance of ADR event reporting, event reporting was low.Thiese results showed that there is a lack of knowledge about pharmacovigilance.Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance.
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Signal detection is important and core activity of pharmacovigilance. The primary aims of pharmacovigilance are to collect, monitor, assess and evaluate information regarding adverse effects, especially those which are serious or unexpected; and also involve providing information about potential and investible hazards. The signal detection and its dissemination seem to be important utility of pharmacovigilance database. It has power to prevent the epidemics of serious adverse drug reaction before gross damage to community. The historical medical calamities could have been prevented if technique like signal detection and pharmacovigilance would have been practiced since that time.
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Introduction: Adverse Drug Reactions (ADRs) have presently been greatly contributing to the hospitaladmissions, prolongation of the hospital stays, visits to the emergency departments, in turn, contributingto the economic burden of healthcare management. Pharmacovigilance is predominantly concerned withADRs, and drug safety. The basic understanding about pharmacovigilance is essential for future medicalprofessionals as they will come in contact with the patients and can efficiently report the ADRs.Aim: To evaluate the basic understanding about pharmacovigilance and create awareness in medical studentsof a rural teaching hospital.Materials & Methods: This was a non-interventional questionnaire-based study, where medical studentsfrom a rural teaching hospital were included in the study. They were distributed a simple questionnairerelated to pharmacovigilance basic knowledge, through google form link, which they had submitted. Thedata was analysed.Results: Total 92 participants were included in the study. It was found that, 57.8% of these were female and42.2% were males. Moreover, regarding assessing the basic pharmacovigilance knowledge it was reportedthat 98.9% were aware about healthcare professionals who can report ADR. Nearly 83.5% were aware aboutpharmacovigilance. Nearly 70% of the participants had not heard about pharmacovigilance before joiningpharmacology lectures. Majority of the participants had never attended any seminar/workshops and agreedto attend in future.Conclusion: The results indicate that the basic understanding about pharmacovigilance is improving andmedical student shows interest about creating awareness related to pharmacovigilance, as it is an importantaspect of drug safety. However, to further improve their understanding awareness programs for medicalstudent can be conducted.
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Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is pharmacovigilance? What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India and their role in collecting the reports ADRs of medicines. Further discussion is about effectiveness and risk assessments of therapies, important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programme.
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Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is pharmacovigilance? What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India. Their role in collecting the reports ADRs of medicines. Further effectiveness and risk assessments of therapies are been discussed. The important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programme.
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