Pub Date : 2022-10-17DOI: 10.35248/2329-6887.22.10.385
Ketina Hirma Tchio-Nighie, Maurice Mbwe Mpoh, Herve Tchokomeni, Ingrid Marcelle Koutio Douanla, Paul Nyibio Ntsekendio, Frank Forex Kiadjieu Dieumo, Jerome Ateudjieu
Background: Data are needed to serve as evidence in planning the strengthening of pharmacovigilance in health programs administering drugs to populations. The present study was proposed to map the distribution of pharmacovigilance units in health programs, assess the availability of key resources, the implementation of key pharmacovigilance activities and identify needs of involved actors.
Methods: It was a cross sectional descriptive study targeting all health programs of the Cameroon Ministry of Public Health administering drugs/vaccines to the population. Data were collected using semi structured questionnaire administered face to face to key persons in charge of drug safety monitoring or drug management in health programs.
Results: Out of the 09 health programs involved in drug distribution, 07 consented to participate. Five out of them (71.4%) claimed to have existing pharmacovigilance units. Office space, computers, operating budget, data analysis software and a trained staff were available in 28.6%, 42.9%, 42.9%, 14.3%, 00.0%, and 42.9% of the health programs respectively. One of the 7 health programs (14.3%) declared conducting detection/notification of adverse events following exposure drugs, 2 (28.6%) conduct causality assessment and 3 (42.8%) conduct analysis of pharmacovigilance data. All health programs proposed to prioritize the allocation of budget and qualified personnel and the training of existing personnel as key interventions to improve drugs/vaccines safety monitoring in health programs.
Conclusion: The study reports limited coverage of Cameroon health programs with activities leading to drugs and vaccine safety monitoring. Suggested actions have to be taken into account when attempting to improve the situation.
{"title":"Drug Safety Monitoring in Health Programs of Cameroon.","authors":"Ketina Hirma Tchio-Nighie, Maurice Mbwe Mpoh, Herve Tchokomeni, Ingrid Marcelle Koutio Douanla, Paul Nyibio Ntsekendio, Frank Forex Kiadjieu Dieumo, Jerome Ateudjieu","doi":"10.35248/2329-6887.22.10.385","DOIUrl":"https://doi.org/10.35248/2329-6887.22.10.385","url":null,"abstract":"<p><strong>Background: </strong>Data are needed to serve as evidence in planning the strengthening of pharmacovigilance in health programs administering drugs to populations. The present study was proposed to map the distribution of pharmacovigilance units in health programs, assess the availability of key resources, the implementation of key pharmacovigilance activities and identify needs of involved actors.</p><p><strong>Methods: </strong>It was a cross sectional descriptive study targeting all health programs of the Cameroon Ministry of Public Health administering drugs/vaccines to the population. Data were collected using semi structured questionnaire administered face to face to key persons in charge of drug safety monitoring or drug management in health programs.</p><p><strong>Results: </strong>Out of the 09 health programs involved in drug distribution, 07 consented to participate. Five out of them (71.4%) claimed to have existing pharmacovigilance units. Office space, computers, operating budget, data analysis software and a trained staff were available in 28.6%, 42.9%, 42.9%, 14.3%, 00.0%, and 42.9% of the health programs respectively. One of the 7 health programs (14.3%) declared conducting detection/notification of adverse events following exposure drugs, 2 (28.6%) conduct causality assessment and 3 (42.8%) conduct analysis of pharmacovigilance data. All health programs proposed to prioritize the allocation of budget and qualified personnel and the training of existing personnel as key interventions to improve drugs/vaccines safety monitoring in health programs.</p><p><strong>Conclusion: </strong>The study reports limited coverage of Cameroon health programs with activities leading to drugs and vaccine safety monitoring. Suggested actions have to be taken into account when attempting to improve the situation.</p>","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7614915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9972776","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.330
A. Mishra
{"title":"A Brief Review on Pre-Clinical Studies and Phases of Clinical Trials","authors":"A. Mishra","doi":"10.35248/2329-6887.21.9.330","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.330","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78789855","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 : 2021-01-01DOI: 10.35248/2329-6887.20.8.294
R. Odesanya, J. Ofeimun, Sofa Meshach Fanjip
Background: Pharmacovigilance is a post-marketing surveillance of medicine use. Studies show that adverse drug reactions lead to acute hospitalizations. We noticed a decline in pharmacovigilance activities in our Centre, thus we aim to determine the knowledge, attitude and practice of pharmacovigilance in Jos University Teaching Hospital (JUTH). Method: It was a cross-sectional questionnaire-based study design using stratified sampling method in administering 183 questionnaires to Pharmacists, Doctors and Nurses in JUTH from May to June, 2019. Results were presented in proportions and a p value of <0.05 was considered statistically significant. Result: The modal age of respondents was 26-35 years. On sources of information on pharmacovigilance, 39.9% got information from Journal texts, 3.3% through television/Radio set, 29.5% from combination of Journals, Television/Radio, Colleagues, Seminars and lectures. The overall good knowledge of pharmacovigilance was 62.3%, majority (84.7%) had good attitude while most (63.4%) had poor practice of Pharmacovigilance. There were statistical significant differences in knowledge, attitude and practice of Pharmacovigilance in relation to the three professions (p=0.000). Conclusion: This study shows that health care professionals in Jos university teaching hospital had good knowledge and attitude towards pharmacovigilance but had very poor practice.
{"title":"Knowledge, Attitude and Practice of Pharmacovigilance among Health Care Professionals in Jos University Teaching Hospital, Nigeria","authors":"R. Odesanya, J. Ofeimun, Sofa Meshach Fanjip","doi":"10.35248/2329-6887.20.8.294","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.294","url":null,"abstract":"Background: Pharmacovigilance is a post-marketing surveillance of medicine use. Studies show that adverse drug reactions lead to acute hospitalizations. We noticed a decline in pharmacovigilance activities in our Centre, thus we aim to determine the knowledge, attitude and practice of pharmacovigilance in Jos University Teaching Hospital (JUTH). Method: It was a cross-sectional questionnaire-based study design using stratified sampling method in administering 183 questionnaires to Pharmacists, Doctors and Nurses in JUTH from May to June, 2019. Results were presented in proportions and a p value of <0.05 was considered statistically significant. Result: The modal age of respondents was 26-35 years. On sources of information on pharmacovigilance, 39.9% got information from Journal texts, 3.3% through television/Radio set, 29.5% from combination of Journals, Television/Radio, Colleagues, Seminars and lectures. The overall good knowledge of pharmacovigilance was 62.3%, majority (84.7%) had good attitude while most (63.4%) had poor practice of Pharmacovigilance. There were statistical significant differences in knowledge, attitude and practice of Pharmacovigilance in relation to the three professions (p=0.000). Conclusion: This study shows that health care professionals in Jos university teaching hospital had good knowledge and attitude towards pharmacovigilance but had very poor practice.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87337578","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.311
Kaumudi Nalla
{"title":"An Overview on Primary and Secondary Research of Clinical Trails","authors":"Kaumudi Nalla","doi":"10.35248/2329-6887.21.9.311","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.311","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74792346","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.317
N. Deepthi, A. Nalla
Observational studies are an essential class of examine designs. To deal with a few investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. As an alternative, observational research can be the next exceptional method to deal with those types of questions. Properlydesigned observational studies were shown to provide results just like randomized controlled trials, challenging the belief that observational studies are 2d-rate [1].
{"title":"Cohort and Case-Control Studies","authors":"N. Deepthi, A. Nalla","doi":"10.35248/2329-6887.21.9.317","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.317","url":null,"abstract":"Observational studies are an essential class of examine designs. To deal with a few investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. As an alternative, observational research can be the next exceptional method to deal with those types of questions. Properlydesigned observational studies were shown to provide results just like randomized controlled trials, challenging the belief that observational studies are 2d-rate [1].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74599013","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.332
Ambica Saxena
{"title":"Adverse Drug Reactions and Their Danger Factors Among Indian Wandering Old Patients","authors":"Ambica Saxena","doi":"10.35248/2329-6887.21.9.332","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.332","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90340772","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.329
F. Steffen, C. Mühlen, Armin Nemani, T. Heidt, J. Schulte, C. Bode, M. Krohn-Grimberghe
Background: Direct oral anticoagulants (DOACs) are commonly used for treating or preventing thromboembolic events. At the same time anticoagulants are a notorious cause of medication errors. Such medication errors can jeopardize patients’ health and challenge the economy of healthcare systems. With the potential of e-health systems for reducing medication errors, our study investigates the effects of medication highlighting. Methods: To highlight medications with anticoagulatory properties in the electronic health records of cardiologic inpatients, a color scheme was introduced at our university hospital. We performed chart reviews of DOAC-related medication errors due to co-prescription of more than one anticoagulatory drug or omitted pausing of DOACs before interventions with increased bleeding risks. Chart reviews were performed before and after the introduction of medication highlighting. Patients having received a DOAC prescription at any point in time during their hospital stay were included. Results: 305 (out of 1.045) patients had received DOAC before and 277 (out of 1.062) received DOAC within a three-month period after the color scheme introduction. DOAC-related medication errors occurred in 25 of the 305 (8.2%) inpatients in total before medication highlighting, while 6 errors occurred in 277 inpatients (2.2%; p= 0.0013) afterwards. Conclusion: Highlighting anticoagulatory medications in the electronic medical record led to a reduction of DOACrelated prescription errors.
{"title":"Can Electronic Medical Record be used for Reducing DOAC Prescription Errors in Inpatients","authors":"F. Steffen, C. Mühlen, Armin Nemani, T. Heidt, J. Schulte, C. Bode, M. Krohn-Grimberghe","doi":"10.35248/2329-6887.21.9.329","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.329","url":null,"abstract":"Background: Direct oral anticoagulants (DOACs) are commonly used for treating or preventing thromboembolic events. At the same time anticoagulants are a notorious cause of medication errors. Such medication errors can jeopardize patients’ health and challenge the economy of healthcare systems. With the potential of e-health systems for reducing medication errors, our study investigates the effects of medication highlighting. Methods: To highlight medications with anticoagulatory properties in the electronic health records of cardiologic inpatients, a color scheme was introduced at our university hospital. We performed chart reviews of DOAC-related medication errors due to co-prescription of more than one anticoagulatory drug or omitted pausing of DOACs before interventions with increased bleeding risks. Chart reviews were performed before and after the introduction of medication highlighting. Patients having received a DOAC prescription at any point in time during their hospital stay were included. Results: 305 (out of 1.045) patients had received DOAC before and 277 (out of 1.062) received DOAC within a three-month period after the color scheme introduction. DOAC-related medication errors occurred in 25 of the 305 (8.2%) inpatients in total before medication highlighting, while 6 errors occurred in 277 inpatients (2.2%; p= 0.0013) afterwards. Conclusion: Highlighting anticoagulatory medications in the electronic medical record led to a reduction of DOACrelated prescription errors.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90315142","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 : 2021-01-01DOI: 10.35248/2329-6887.21.9.300
Archana Guyya
Causality assessment of ADRs is a technique utilized for assessing the strength of connection between drug(s) openness and event of antagonistic reaction(s). Causality assessment of ADRs might be embraced by clinicians, academics, the drug business and controllers, and in various settings, including clinical trials. At an individual level, medical care suppliers evaluate causality casually when managing ADRs in patients to settle on choices with respect to future treatment.
{"title":"Principles and Difficulties in Developing Causality Assesment","authors":"Archana Guyya","doi":"10.35248/2329-6887.21.9.300","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.300","url":null,"abstract":"Causality assessment of ADRs is a technique utilized for assessing the strength of connection between drug(s) openness and event of antagonistic reaction(s). Causality assessment of ADRs might be embraced by clinicians, academics, the drug business and controllers, and in various settings, including clinical trials. At an individual level, medical care suppliers evaluate causality casually when managing ADRs in patients to settle on choices with respect to future treatment.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86829825","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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