The currently available and ever improving pharmaceutical armamentarium and evidence based medicine (EBM) have enabled us to provide better care to our patients. However, evidence suggests the existence of a wide gap between EBM and actual clinical practices. In addition, available pharmaceutical armamentarium has also resulted in the risk of greater harm. Adverse drugs reactions (ADRs) are the most common cause of hospital admission and fourth to sixth leading cause of death. These findings increase the importance of pharmacoepidemiology which is defined as “study of the use of and effects of drugs in large number of people”. Pharmacovigilance (PV) is the science and activities concerned with the detection, understanding, and prevention of adverse effects or other drug-related issues. Vaccinovigilance is an activity that focuses on the prevention of adverse vaccine or immunization effects as well as the detection, assessment, understanding, and communication of adverse events following immunization and other vaccine-related problems. Whereas, phyto-vigilance is focused on side effects and interactions resulting from the use of herbal medicines, food supplements, cosmetics, and medicinal plants. Technovigilance (medical device vigilance) is also relevant as a policy to monitor the procedures of acquisition, use and quality control of health products and biomedical equipment.
Pharmacoepidemiological studies provide:
A) additional information on the better quantitation and incidence of known adverse and beneficial effects with higher precision, in patients not included in premarketing studies, in the presence of other drugs and diseases.
B) new types of information not available from the premarketing studies i.e., previously undetected adverse and beneficial effects, rare and delayed adverse effects, patterns of drug utilization and pharmaco-economics.
This Research Topic aims to closely look at pharmacoepidemiology and pharmacovigilance post-marketing drug safety studies including vaccines, herbs and medical device-related issues and the existing gap between the recommended and actual clinical practices and its impact on patients’ outcomes.
This Research Topic welcomes submissions on the following subjects:
1) Real-world data investigating drugs effectiveness and safety in the post-marketing setting.
2) Vaccinovigilance, Phyto-vigilance and Technovigilance based studies.
3) Rational drug use.
4) Implementation of clinical practice guidelines.
5) Healthcare professionals (medical doctors, dentists, pharmacists, nurses, paramedics, etc.) and various stakeholder perspectives on pharmacovigilance and other new concepts.
6) Risk management in Pharmacovigilance, Vaccinovigilance, Phyto-vigilance and Technovigilance.
7) All studies related to pharmacoepidemiology approaches, real-world evidence, and pharmacovigilance research.
The currently available and ever improving pharmaceutical armamentarium and evidence based medicine (EBM) have enabled us to provide better care to our patients. However, evidence suggests the existence of a wide gap between EBM and actual clinical practices. In addition, available pharmaceutical armamentarium has also resulted in the risk of greater harm. Adverse drugs reactions (ADRs) are the most common cause of hospital admission and fourth to sixth leading cause of death. These findings increase the importance of pharmacoepidemiology which is defined as “study of the use of and effects of drugs in large number of people”. Pharmacovigilance (PV) is the science and activities concerned with the detection, understanding, and prevention of adverse effects or other drug-related issues. Vaccinovigilance is an activity that focuses on the prevention of adverse vaccine or immunization effects as well as the detection, assessment, understanding, and communication of adverse events following immunization and other vaccine-related problems. Whereas, phyto-vigilance is focused on side effects and interactions resulting from the use of herbal medicines, food supplements, cosmetics, and medicinal plants. Technovigilance (medical device vigilance) is also relevant as a policy to monitor the procedures of acquisition, use and quality control of health products and biomedical equipment.
Pharmacoepidemiological studies provide:
A) additional information on the better quantitation and incidence of known adverse and beneficial effects with higher precision, in patients not included in premarketing studies, in the presence of other drugs and diseases.
B) new types of information not available from the premarketing studies i.e., previously undetected adverse and beneficial effects, rare and delayed adverse effects, patterns of drug utilization and pharmaco-economics.
This Research Topic aims to closely look at pharmacoepidemiology and pharmacovigilance post-marketing drug safety studies including vaccines, herbs and medical device-related issues and the existing gap between the recommended and actual clinical practices and its impact on patients’ outcomes.
This Research Topic welcomes submissions on the following subjects:
1) Real-world data investigating drugs effectiveness and safety in the post-marketing setting.
2) Vaccinovigilance, Phyto-vigilance and Technovigilance based studies.
3) Rational drug use.
4) Implementation of clinical practice guidelines.
5) Healthcare professionals (medical doctors, dentists, pharmacists, nurses, paramedics, etc.) and various stakeholder perspectives on pharmacovigilance and other new concepts.
6) Risk management in Pharmacovigilance, Vaccinovigilance, Phyto-vigilance and Technovigilance.
7) All studies related to pharmacoepidemiology approaches, real-world evidence, and pharmacovigilance research.
