scholarly journals Effectiveness of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Author(s):  
Nazuk Sharma ◽  
Taruna Sharma ◽  
Suman Bala

Background: Adverse drug reaction (ADR) under-reporting is a hindrance to the implementation of Pharmacovigilance Program of India. This is essentially due to lack of ADR reporting culture among healthcare professionals. Thus, study was conducted to assess and enhance awareness about ADRs and strengthen reporting among medical undergraduates.Methods: This is an interventional crossover study. A total of 140 students of 2nd professional, MBBS were included and divided into two groups of 70 each. In phase 1, group A was given a didactic lecture (DL) on ADR and pharmacovigilance. Group B was also given DL with an addition of a case narrative exercise and they were asked to fill an ADR form. Both groups were assessed based on an MCQ questionnaire for knowledge and skill. After 15 days of washout period, groups were crossed and reassessed. Feedback from students was taken on a 5 point Likert’s scale.Results: The mean scores of batch A without case was 17.5±3 out of a total score of 25 marks, which showed improvement with case narrative and mean increased to 19.6± 2.4 (p 0.05). Similarly, Batch B showed improvement as well and the mean 17.7±3.1 score without case narrative increased to 19.2±2.7 (p <0.05). Student’s perception of the effectiveness of module-based teaching was positive.Conclusions: Case narrative in addition to didactic lecture enhanced awareness and may strengthen ADR reporting culture among the medical students.

Author(s):  
Vibha Rani ◽  
Shyamala R ◽  
Simpson Gb

Objectives: Objectives of the study were (1) to evaluate the knowledge about pharmacovigilance and (2) to assess the attitude toward adverse drug reaction (ADR) reporting among undergraduate medical students.Methods: It is a cross-sectional, questionnaire-based study conducted in the Department of Pharmacology, Malla Reddy Medical College for Women, Hyderabad, Telangana, among fifth term Bachelor of Medicine, Bachelor of Surgery students (136). The questionnaire consisted of 16 questions dealing with knowledge, awareness, attitude about pharmacovigilance and ADR reporting. Data were analyzed and presented as percentage among respondents.Results: About 58.8% of students could not identify the proper definition of pharmacovigilance and 84.5% of undergraduates have not seen ADR form. It was agreed among 42.6% of students that ADR reporting is a professional obligation to them and 47.7% agreed that establishing ADR monitoring center in every hospital is compulsory.Conclusions: Our study revealed that though the attitude toward pharmacovigilance was appreciable among the medical students; there lies an insufficient knowledge and awareness about pharmacovigilance. Continued medical education programs and workshops may be helpful in the future to increase awareness and consequently to improve the rate of spontaneous ADR reporting among these upcoming doctors.


Pharmacy ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 222
Author(s):  
Md. Ashraful Islam ◽  
Aseel Fuad Al-Karasneh ◽  
Atta Abbas Naqvi ◽  
Dhfer Mahdi AlShayban ◽  
Fatimah Al-Hayek ◽  
...  

This study aimed to assess public knowledge about medicine information, safety, and adverse drug reaction reporting (ADR) in Dammam, Saudi Arabia. A cross sectional study was conducted using purposive stratified sampling in different settings of Dammam city for three months (January–March 2020). The target population was identified as consumers who had used the medicines in the last 3 months. The questionnaire was adopted from the literature and was validated. Content and face validities were established, and reliability was assessed. The study was approved by the concerned ethics committee. A total of 915 participants returned completed questionnaires. A total of 54.4% participants aged between 18 and 30 years, 65.8% were females and 53.1% had obtained bachelor level education. The mean score for knowledge of medicines (K1) was 5.46 ± 1.07. The mean score for knowledge regarding medication safety (K2) was 5.94 ± 1.73. The mean score for tendency to report a suspected ADR (T1) was 3.43 ± 1.57. Gender was a determinant of knowledge regarding medication safety (K2) (p < 0.01) and ADR reporting tendency (T1) (p < 0.01). The marital status of patients was a determinant for both knowledge of medicines (K1) (p < 0.01) and, knowledge regarding medication safety (K2) (p < 0.01). The results of this study highlighted that although the scores for knowledge of medicines, and tendency to report ADR were better, the score for knowledge regarding medication safety was unsatisfactory.


Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.


Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.


2021 ◽  
Vol 20 (2) ◽  
pp. 8-13
Author(s):  
Maliha Ata ◽  
Rozina Hoque ◽  
Asma Mostafa ◽  
Md Rakibul I Shakil ◽  
Rajat Sanker Roy Biswas ◽  
...  

Background: In order to improve the spontaneous Adverse Drug Reaction (ADR) reporting practice by the physicians, there is an obligatory need to investigate the current situation of ADR reporting by them. The study was conducted to observe the ADR reporting pattern among physicians in a tertiary medical college hospital. Materials and methods: This was a descriptive cross sectional study carried out in a tertiary medical college hospital during the study period of March 2020 to October 2020. Data were collected from 100 physicians working on different departments using self designed pretested questionnaire by convenient sampling technique. Results: Among the 100 respondents 70 provided response to questionnaire giving a response rate 70%. Most of the respondents (61.43%) had adequate knowledge on ADR reporting. A good number of respondents showed positive attitude but there is no practice of ADR reporting though most of the respondents (84.3%) had experienced it in last 1 year. Most of the respondents experienced ADR with antibiotic (81.35%), NSAIDs (33.89%) & anticonvulsants (15.25%) and maximum (44.06%) experienced ADR was with skin, 30.50% with GIT and 23.03% with respiratory system involvement. The cause of under reporting was mainly due to inaccessible ADR form, busy schedule, unaware of how and whom to report and lack of motivation to report. The respondents would be encouraged to report ADR if they were provided with simple & available reporting form, regular guideline & bulletin. Conclusion: There is an urgent need for educational training & seminar regarding our national online reporting system to emphasizing ADR reporting. Chatt Maa Shi Hosp Med Coll J; Vol.20 (2); July 2021; Page 8-13


2020 ◽  
pp. 001857872095796
Author(s):  
Theophilus A. Adegbuyi ◽  
Joseph O. Fadare ◽  
Ebisola J. Araromi ◽  
Abayomi O. Sijuade ◽  
Iyanu Bankole ◽  
...  

Background: Adverse drug reactions (ADRs) constitute a significant global healthcare challenge associated with increased morbidity, mortality and healthcare costs; however, there are concerns that ADRs are grossly under-reported by different categories of healthcare professionals (HCPs) in many countries. The main objective of this study was to assess the knowledge, attitude and practice of ADR reporting of HCPs working at the primary, secondary and tertiary levels of care in Ekiti State, Nigeria. Methodology: This was a self-administered questionnaire-based study conducted among HCPs working in Ekiti State, South-west Nigeria. The questionnaire which was adapted from ones used in similar studies was reviewed for content validity by experts in the field. Healthcare professionals (medical doctors, pharmacists, nurses, community health extension workers, and other allied HCPs) working in the 3 tiers of healthcare participated in the study. The questionnaire consisted of sections on the demographics of respondents, their knowledge, attitude and practice of ADR reporting. Data analysis was done using SPSS (version 25) employing t test, ANOVA and chi-square as appropriate with P-value < .05 accepted as being statistically significant. Results: Three hundred HCPs comprising of nurses (112; 37.3%), physicians (75; 25.0%), pharmacists (53; 17.7%), community health extension workers (40; 13.3%) and others (20; 6.7%) completed the questionnaire with 166 (55.3%) of them working in tertiary healthcare facilities. Male respondents (6.3 ± 1.7; P = .003), pharmacists (7.0 ± 1.6; P < .0001), HCPs and those from tertiary centers (6.2 ± 1.7; P = .028) had higher knowledge scores. While 228 (76%) respondents had observed incidents of ADR during their professional practice, only 75 (25%) have ever reported it. Only 113 (37.7%) of respondents had seen the adverse drug reaction reporting form with only 53 (17.7%) ever using it. The reporting methods preferred by respondents were through email/internet (102; 34.0%), phone/SMS (78; 26.0%) and using the hard copy of the forms (95; 31.7%). The attitude of respondents towards ADR reporting was mainly positive. Conclusion: There was significant variation in the knowledge of different categories of HCPs and facility levels about ADR reporting. Encouragingly, the overall attitude of respondents towards ADR reporting was positive. Based on the above, strategies are needed to build capacity of HCPs in the area of on adverse drug reaction and its’ reporting.


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.


Author(s):  
Lohit K ◽  
Leena A. ◽  
Jose Maria ◽  
Amruta A. Pandit

Background: Lack of knowledge regarding pharmacovigilance and adverse drug reaction (ADR) reporting among healthcare providers have been identified as major factors for under reporting of ADR in developing countries. Hence this study was planned to assess the knowledge and attitude of nursing faculty and students towards ADR reporting and also to determine the barriers to reporting ADR.Methods: A validated questionnaire based cross sectional study conducted among the nursing faculty and students in a tertiary health care center. Data was assessed by frequency, percentage, mean and standard deviation. Statistical analysis was performed by using SPSS version 22.Results: The composite score on knowledge on ADR reporting was found to be moderate among nursing staff, GNM and BSc nursing students. The knowledge on burden due to ADR was found to be poor among all the three categories. Around 70% of all the respondents were of the opinion that ADR reporting by one person can make a significant difference to the community. More than 80% of nursing staff and GNM students opined one should have a suspicion of possible ADR during treatment. Majority of the nursing staff were in favour of mandatory and voluntary ADR reporting in the hospital.Conclusions: The nurses were only moderately aware of pharmacovigilance and adverse drug reaction reporting. Though the attitude towards ADR reporting was adequate, our study has shown that the actual practice of ADR reporting is unsatisfactory. Hence, it is essential to include pharmacovigilance training in the undergraduate teaching programs of nurses to promote reporting of adverse reactions.


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