scholarly journals The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK

Drug Safety ◽  
2019 ◽  
Vol 43 (3) ◽  
pp. 255-263 ◽  
Author(s):  
Kevin Klein ◽  
Lorna Hazell ◽  
Pieter Stolk ◽  
Saad Shakir
2017 ◽  
Vol 53 (3) ◽  
pp. 177-187 ◽  
Author(s):  
Hussen Shanko ◽  
Jemal Abdela

Aims: This study was designed to assess knowledge, attitude and practices of adverse drug reaction reporting among healthcare professionals in Hiwot Fana Specialized University Hospital (HFSUH). Method: Hospital based descriptive cross sectional study was conducted on healthcare professionals of HFSUH. Based on purposive sampling technique, all eligible healthcare professionals (nurses, physicians and pharmacists) were involved in the study. A pretested self-administered questionnaire was used to collect data. Data were coded, entered and analyzed using SPSS version 16. The test of association of selected categorical variables were done using cross tabulation and Pearson Chi-square test. Result: Our study indicated that about 297 participants provided their response to the distributed questionnaires which makes the response rate 91.4%. Of the total healthcare professionals involved in the study, 99 (33.6%) of them were able to understand the difference between adverse drug reaction (ADR) and side effects, of which pharmacists were significantly reported (95.24%, P<0.05). About 175(59.3%) of the respondents engaged in the study were reportedly knew the national ADR reporting system in Ethiopia. On the other hand, 181(61.36%) of the participants were recognized the presence of ADR reporting form while 114 (38.64%) of the respondents had no any information about its presence in the country. Conclusion: The study revealed that a gap in knowledge, awareness and practice of healthcare professionals on ADR reporting. Therefore, specific strategies should be designed in order to improve awareness, knowledge and practice of healthcare professionals to tackle issue related to under-reporting of ADR.


2017 ◽  
Vol 18 (10) ◽  
pp. 964-969 ◽  
Author(s):  
Ashish Sharma ◽  
Kumar G Chhabra ◽  
Chaya Chhabra ◽  
J Jyothirmai Reddy ◽  
Shravani G Deolia ◽  
...  

ABSTRACT Introduction This is a cross-sectional knowledge, attitude, and practices (KAPs) study on pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among dental students in a teaching hospital in India. Aim The aim of this study was to assess the KAP of dental students regarding PV, ADR reporting, and barriers toward the same. Materials and methods A cross-sectional survey using a selfadministered, investigator-developed, close-ended questionnaire was conducted in an academic dental hospital in India. All prescribers including third year students, final year students, and house surgeons of the same institute were included for assessment of KAP regarding PV using 16, 8, and 8 items respectively. Data regarding barriers toward ADR reporting and demographics were also collected. Mann–Whitney U-test and Kruskal–Wallis test were applied followed by post hoc test. Results A total of 241 of 275 respondents participated in the study with a response rate of 87.5%. Overall, 64% reported that they had no idea about the term PV. Age was significantly associated with knowledge (p = 0.045) and attitude (p = 0.016). Barriers contributing to underreporting were difficulty in deciding whether or not an ADR has occurred (52.0%), concerns that the report may be wrong (37%), lack of confidence to discuss ADR with colleagues (29%), and almost no financial benefits (24%). Conclusion Participants had a comparatively favorable attitude toward PV, but their knowledge and practice need considerable improvements. This study highlights the need for appropriate dental curriculum changes and further multicentric studies to shed more light on important issues of PV among dentists in India. Clinical significance This study explores dentists’ knowledge, attitude, and behavior regarding PV, which could help to improve patient's safety and care. The favorable attitude of dentists is an indication that PV could be added in depth in the curriculum and in general practice. Information on barriers for reporting the ADRs could help to find possible solutions for removing the barriers precisely. How to cite this article Chhabra KG, Sharma A, Chhabra C, Reddy JJ, Deolia SG, Mittal Y. Knowledge, Attitude, and Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional Study. J Contemp Dent Pract 2017;18(10):964-969.


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Manisha Bisht ◽  
Shruti Singh ◽  
D. C. Dhasmana

In India, the pharmacovigilance program is still in its infancy. National Pharmacovigilance Program of India was started for facilitating the pharmacovigilance activities. The ADR reporting rate is still below satisfactory in India. This cross-sectional questionnaire based study was carried out in a tertiary care teaching hospital in Uttarakhand, which is a peripheral ADR monitoring centre to assess the level of knowledge, attitude, and the practices of pharmacovigilance among the doctors and to compare it with the group of doctors attending educational CME for improving awareness of pharmacovigilance. The most important revelation of this study was that although adequate knowledge and the right attitude about adverse drug reaction reporting were instigated in the doctors after the educational intervention, the practice was still neglectful in both groups, emphasizing the need to design the strategies to develop adverse drug reaction reporting culture.


2021 ◽  
Vol 59 (233) ◽  
Author(s):  
Rekha Shah ◽  
Surya B. Parajuli ◽  
Suman Pokharel

Introduction: Doctors and nurses have a significant role in the detection of serious and unusual drug reactions. Effective implementation of an adverse drug reaction reporting system is required to ensure patient safety and quality care. This study’s objective was to find the prevalence of good knowledge of adverse drug reaction reporting among the Doctors and nurses working in a tertiary care hospital. Methods: A descriptive cross-sectional study was conducted among doctors and nurses from 15 February 2020 to 15 July 2020 at Birat Medical College and Teaching Hospital. The convenience sampling method was used to select 192 study participants. A semi-structured questionnaire was used to know the knowledge concept of adverse drug reaction reporting. Ethical clearance was taken from IRC (PA-047/2076-77) of Birat Medical College and Teaching Hospital. Written informed consent was taken from each study participant. Collected data were entered in Microsoft Excel 2010 and analyzed by Statistical Package for the Social Sciences v23. Results: In total, 192 doctors and nurses, the questionnaires were distributed to 52 (27.1%) doctors and 140 (72.9%) nurses. The mean age of study participants was 28.14 years (SD ±4.5). To know the prevalence of knowledge, 15 knowledge related questions of adverse drug reaction had asked. The majority of doctors and nurses had good knowledge about adverse drug reaction reporting, 75% and 64%, respectively. Conclusions: Overall, doctors and nurses have had good knowledge of adverse drug reaction reporting. Data shows there is still more gap in training and experience on adverse drug reaction reporting systems.


2016 ◽  
Vol 72 (5) ◽  
pp. 605-614 ◽  
Author(s):  
A. C. B. van Orten-Luiten ◽  
A. Janse ◽  
R. A. M. Dhonukshe-Rutten ◽  
R. F. Witkamp

Drug Safety ◽  
2017 ◽  
Vol 40 (7) ◽  
pp. 597-606 ◽  
Author(s):  
Nibu Parameswaran Nair ◽  
Leanne Chalmers ◽  
Bonnie J. Bereznicki ◽  
Colin Curtain ◽  
Gregory M. Peterson ◽  
...  

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