scholarly journals Strengthening adverse drug reaction reporting in Nepal

2015 ◽  
Vol 6 (4) ◽  
pp. 9-13 ◽  
Author(s):  
Nisha Jha ◽  
Devendra Singh Rathore ◽  
Pathiyil Ravi Shankar ◽  
Sudesh Gyawali ◽  
Mohamed Azmi Hassali ◽  
...  

Pharmacovigilance in Nepal is still in infancy. Till date only healthcare professionals are involved and the problem of underreporting is seen. The national pharmacovigilance centre is located in the national regulatory authority of Nepal, i.e. Department of Drug Administration (DDA). Lack of adequate human resources for managing the pharmacovigilance program in Nepal has been a limitation for the growth of pharmacovigilance activities. Currently, there is neither any involvement of community pharmacists in Adverse Drug Reaction (ADR) reporting process nor any involvement of consumers for the same. This paper reviews the current status of pharmacovigilance and mentions possible benefits of involving consumers or patients in the existing pharmacovigilance program. A systematic review were conducted by searching different databases like PubMed, Google scholar, EMBASE, NepJOL, and Scopus. This study also describes the role of healthcare professionals in ADR reporting, possible reasons for underreporting of ADRs, regulatory perspectives and benefits of involving consumers in pharmacovigilance. DOI: http://dx.doi.org/10.3126/ajms.v6i4.11659Asian Journal of Medical Sciences Vol.6(4) 2015 9-13

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):  
Nirav N. Patel ◽  
Devanshu J. Patel ◽  
Haresh A. Desai

Background: The objective of the present study was to assess knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals of Parul Sevashram Hospital, Parul University, Vadodara.Methods: The study was prospective, observational and questionnaire-based involving medical doctors, nurses and pharmacists of Parul Sevashram Hospital. A total number of 210 structured questionnaires were distributed among health care professionals (100 clinicians from various specialities, 100 nurses and 10 pharmacists). Written informed consent forms were obtained from participants as their consent to participate in the study.Results: All questionnaires were filled and returned producing overall response rate of 100%. 80% of the respondents were aware of the existence of Pharmacovigilance Program of India (PvPI). 90.95% and 91.90% of respondents felt ADR reporting is necessary and it would be beneficial to the patients respectively. Only 11.43% of respondents had reported ADRs. 90.95% and 85.24% of respondents suggested training is required in reporting ADR and regular information should be provided regarding ADR by PvPI respectively.Conclusions: The health care professionals had positive knowledge and attitude towards pharmacovigilance and there is a need to create awareness for better practice of ADR reporting. It would help to improve patient care.


2018 ◽  
Vol 9 (10) ◽  
pp. 585-590 ◽  
Author(s):  
Sheraz Ali ◽  
Oluwaseun Egunsola ◽  
Dalal Salem Al-Dossari ◽  
Ibrahim Abdulaziz Al-Zaagi

Background: Underreporting is a common problem with spontaneous adverse drug reaction (ADR) reporting. In this study, we aim to describe the reporting of ADRs in a tertiary hospital and determine the effect of incentives to healthcare professionals on ADR reporting. Methods: In this interventional study, a time series analysis was used to determine the effect of incentives on ADR reporting in a tertiary hospital between 2015 and 2016. The incentive strategy included public commendation of health care providers and nomination for a monthly award. Results: A total of 967 ADRs were reported over a 2-year period. After the introduction of incentives in January 2016, the number of ADR reports per month increased by 40.6 (95% confidence interval: 26.1–55.1). The proportion of serious ADRs reported was significantly higher in 2016 (39/800) than 2015 (0/167) ( p < 0.001). In 2016, there was a significant association between profession and serious ADR reporting ( p < 0.001). A total of 14/21 ADRs (66.7%) reported by physicians in 2016 were serious compared with 20/700 (2.9%) reported by clinical pharmacists and 5/72 (6.9%) by nurses. Conclusions: ADR reporting was improved by providing incentives, including commendation and reward, to healthcare professionals.


2021 ◽  
Author(s):  
Libsuye Yalgaw Zimamu ◽  
Muluken Chanie Agimas ◽  
Gashaw Mehiret Wubet

Abstract Background: Drugs can treat diseases, reduce symptoms, and enhance patients’ health and quality of life. However, taking a drug is not always as easy as just swallowing a pill. This is because drugs have some unwanted effects. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Objectives: To assess knowledge, attitude, and practice of health care providers on adverse drug reporting among community pharmacists, Gondar, Ethiopia Methods: Community-based cross-sectional study designs were used from July - August 2021. The sampling method was a survey from community pharmacists. Self-administered questioner was used, and the collected data was entered into Epi-info Version 7.0 and exported to SPSS version 20 software for analysis. Result: The study included 215 community pharmacy professionals to assess the knowledge, attitudes, and practices of adverse drug reaction reporting. From a total of 215 community pharmacy professionals, 34 (15.8%) of the respondents were able to differentiate ADR from side effects and only 56(26%) respondents felt that they are adequately trained in ADR reporting. Out of 215 respondents, 78(36.3%) and 146(67.9%) knew the availability of the national reporting system and ADR reporting form in Ethiopia respectively. The study revealed that 21.4% [95% CI: 18.6-35.9] and 42.3% [95% CI: 38.2-65.9] of community pharmacists have poor knowledge and negative attitude towards ADR reporting respectively. Conclusion: Underreporting of ADR by community pharmacists was identified in this study. Training sessions to clarify the role of various community pharmacists in ADR reporting will hopefully fill the observed gap in knowledge and practices. The community pharmacy should formulate strategies to enhance the detection and reporting of ADRs.


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.


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