adverse drug reaction reporting
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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.


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


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hen-Hong Chang ◽  
Su-Yin Chiang ◽  
Pei-Chun Chen ◽  
Chia-Han Tsai ◽  
Rong-Chi Yang ◽  
...  

AbstractThe Taiwan Adverse Drug Reaction Reporting System for Herbal Medicine (TADRRS-HM) has systematically documented suspected adverse events from adverse drug reaction (ADR) reports from 1998 (prior to its formal establishment in 2001) and evaluates safety profiles of herbal medicines. This article describes findings from 2079 ADR reports filed between 1998 and 2016: 941 reports involved single herbs and 87 involved folk herbals; 842 were generated from clinical trials, while 209 ADR reports involving foods, health foods, dietary supplement foods and herbal cuisine were grouped as Other. Severity assessments using the Modified Hartwig and Siegel scale classified 72.4% of ADRs as mild, 17.4% as moderate and 6.5% as severe. System Organ Class classification of the ADRs identified gastrointestinal system disorders as the most common (33.4%), followed by skin and subcutaneous tissue disorders (21.2%). The TADRRS-HM records indicate that herbal medicines may cause a wide range of ADRs. Aconiti Radix, Xiao-Qing-Long-Tang, and Datura suaveolens were the most commonly reported single herb, herbal formula, and folk herbal, respectively. The data indicate that herbal medicines may cause a wide range of ADRs. This system will confer long-term benefits for the development of Taiwan’s herbal medicines adverse reaction database and facilitate epidemiological analysis.


2021 ◽  
Vol 9 (3) ◽  
pp. 10-23
Author(s):  
Ayuba Daniel

Medicines have the potential to cause Adverse Drug Reactions (ADRs) and therefore the need for health professionals to detect and spontaneously report to the National Agency for Food and Drug Administration and Control (NAFDAC) for further actions to ensure patients and public safety. The study was conducted to ascertain the proportion and reporting procedures of ADRs reported by health professionals in the Government Hospitals in Katsina State, Nigeria. This was a cross-sectional survey of 392 health professionals randomly selected from the 19 secondary hospitals in Katsina state. Data were collected through a self-administered structured questionnaire from 18th January to 19th February 2021 with a 98.7% and 1.3% response rate. Data were analyzed using STATA software Version 15.0. Descriptive statistics were used to describe the background characteristics of respondents, and the outcome, such as the proportion of ADR reported summarized in percentages, frequencies, and charts. There was only a 28.3% ADRs reporting rate, and 25.1% of health professionals who saw an ADRs case reported it by completing the ADRs form. The level of knowledge on ADRs reporting procedures was 58.3% among respondents. The main systemic challenge with ADRs reporting was the lack of access to the reporting form for ADRs. Therefore, there is a need to improve access to the reporting form in all the hospitals. Keywords: Adverse Drug Reaction Reporting, Government Hospitals, Health Professionals, Katsina state, Nigeria, Reporting Rate.


2021 ◽  
pp. 001857872110468
Author(s):  
Hai-Yen Nguyen-Thi ◽  
Minh-Thu Do-Tran ◽  
Thuyen Lu Ngoc ◽  
Thuy-Tram Nguyen-Ngoc ◽  
Nguyen Dang Tu Le

Background: Under-reporting is a major issue of ADR spontaneous reporting system. This study assesses the knowledge, attitude, and practice of healthcare professionals in Children’s Hospital in Vietnam and suggests solutions to enhance ADR reporting rate based on findings. Methods: A cross-sectional study was conducted and 397 self-administered structured questionnaires were distributed to all potential HCPs working in surveyed hospital within 2 weeks from June 03 to June 20, 2020. Results: Overall response rate was 97% with 384 responses. A majority answered correctly ADRs’ knowledge apart from form supplier (1.6%) and possible causes (2.6%). The need to focus on patient care (33.3%) and the trivia of reaction (31.5%) reduced HCPs’ attention. About 61.7% reported once in their career, 49.7% had training. Having trained group had numbers of practice significantly higher than their counterparts. Major reason for not reporting was lack of information and instruction. Preferred solutions were regularly training, updating, and collaboration of HCPs in reporting ADR. Conclusion: Healthcare professionals had adequate knowledge, positive attitude, and moderate practice. Training significantly raised the number of practices in reporting ADR. Preferred solutions were regular training, updating, and collaboration of healthcare professionals in ADR reporting.


2021 ◽  
Author(s):  
Ziqi Yan ◽  
Zhanchun Feng ◽  
Zhiming Jiao ◽  
Chaoyi Chen ◽  
Ganyi Wang ◽  
...  

Abstract Introduction: Adverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. Objective: This study has analyzed the factors leading to the occurrence of SADRs, determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. Methods: We used descriptive analysis and chi-square test analysis the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. Result: A total of 387 642 people’s 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. Conclusions: The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories , and use imported drugs and biological agents with caution to ensured the safety and health of patients.


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