Perception and Barriers of Adverse Drug Reactions Reporting and Monitoring among Doctors in Public Hospitals Quetta, Pakistan (Preprint)

2020 ◽  
Author(s):  
Muhammad Raza ◽  
Nafees Ahmad ◽  
Amjad Khan ◽  
Abdul Wahid ◽  
Asad Khan

BACKGROUND Adverse Drug Reactions will continue to pose threat to public health globally. Prompt ADR reporting is crucial in ensuring drug safety. However, underreporting is a prime problem among Doctors. OBJECTIVE The aim of the current study was to evaluate perception and barriers of adverse drug reactions reporting and monitoring among doctors in public hospitals of Quetta. METHODS This cross sectional study was carried out at Bolan Medical Complex and Sandeman Provincial Hospital Quetta. A self-developed reliable and validated questionnaire was used to collect the data. Statistical Package for Social Sciences (SPSS version 20) was used for analyzing data. RESULTS A total of 150 doctors were included with mean age of the study participants35.78±11.082 years. Majority of the doctors belonged to the age group 24-35 years (53.3%), were males (62%)and were ethically Pakhtoon, with qualification of Post-graduation(52%),practice duration of > 2 years (25.3%)and had graduated from a medical college located in Baluchistan province(74%).A notable proportion of doctors(32.7%)were not aware of the presence of National Pharmacovigilance Centre. A vast majority of doctors (88%)had not reported any ADR ever. Majority of the study participants (76.7%)mentioned that time limitation is not a hindrance in reporting ADR but concern about a wrong report is (30%).Majority of the evaluated participant (62%) did not know where, when and how to report an ADR. A noteworthy proportion of the doctors (28.7%) thought that existing ADR reporting and monitoring system would not benefit the patient or improve the patient care.Majority of the doctors(64%) thought that pharmacist’s management of adverse drug reaction is useful. CONCLUSIONS The present study strongly suggests that awareness regarding ADRs reporting and monitoring is very poor among physicians which will improve pharmacovigilance process in future.

Author(s):  
Kadir Alam ◽  
Badri Karki ◽  
Amit Kumar Gupta ◽  
Deependra Prasad Sarraf ◽  
Subash Wagle

<p class="abstract"><strong>Background:</strong> Community pharmacist’s (CPs) knowledge, attitude and practice (KAP) of pharmacovigilance and adverse drug reactions (ADR) play a vital role in preventing harmful effects of medicine. The objective was to assess the KAP of pharmacovigilance and ADR reporting among CP.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was carried out among 132 CP in Dharan between February-March 2019 by using a self-administered 25-item semi-structured questionnaire. The KAP score was categorized as good (score 13-25) and poor (score 0-12). The descriptive statistics were calculated using Microsoft excel 2010.</p><p class="abstract"><strong>Results:</strong> Out of 132 pharmacies, only 77 responded giving a response rate of 58.3%. There were 45 (58.4%) male. Majority of the participants (45, 58.4%) had completed diploma in pharmacy course. Only 23 (29.9%) respondents gave the correct responses regarding the definition of pharmacovigilance and 23.4% were aware of the national pharmacovigilance centre. 50.9% agreed that reporting of ADRs is a part of pharmacist duty and it was important to report ADRs and was leading cause of hospitalization. Sixty three (81.8%) participants had never ever been trained on how to report ADR. Seventy (90.9%) participants were willing to report ADR, however, 51 (66.2%) had never seen the ADR reporting form. Only 3 (3.9%) participants had good KAP score (23.33±1.54).</p><p class="abstract"><strong>Conclusions:</strong> Despite of relatively better attitude towards pharmacovigilance and ADR reporting, they had a limited knowledge and practice with regard to ADR reporting and pharmacovigilance. The study findings highlights the need to strengthen the community pharmacovigilance program for safer medication use at the community level.</p>


Author(s):  
Ali Awadallah Saeed ◽  
Osman Umballi ◽  
Namareg Ahmed ◽  
Shaza Ali ◽  
Azza Alfaki

Introduction: Adverse drug reactions resulting from the use of a medicinal product and were harmful or unpleasant reaction. Pharmacovigilance is related pharmaceuticals product after marketing and associated with collection, detection, assessment, monitoring and prevention of adverse effects. The aim of study is to recognize the awareness of pharmacists regarding pharmacovigilance and adverse drug reactions reporting. Methodology: Descriptive cross-sectional study conducted to 237 pharmacists working in Khartoum’s locality pharmacies from August 2019 to March 2020 selected by simple randomization. The data were collected by face to face interview using self-administrated Questionnaire and analyzed by SPSS version 23. Results: 57.4% from the total sample size never seen adverse drug reactions reporting form, 76.4% never receive training on how to report it and only 10.5% from the pharmacists in the study report it to pharmacovigilance center. 79% from pharmacists in the study were not aware about existence of pharmacovigilance program in Sudan. 51.5 % from pharmacists have good attitude about adverse drug reactions and pharmacovigilance in Sudan while 48.5% had poor attitude. Difficulty in communicating with pharmacovigilance centre in Sudan and how to write the report were the factors discourage pharmacists from reporting of adverse drug reactions. Conclusion: Community pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting while they had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting, this can be strengthened by educational trainings and workshops.                   Peer Review History: Received: 4 September 2021; Revised: 9 October; Accepted: 29 October, Available online: 15 November 2021 Academic Editor:  Dr. Jennifer Audu-Peter, University of Jos, Nigeria, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.  Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Neelam H. Zaidi, Fiji National University, Fiji, [email protected] Dr. U. S. Mahadeva Rao, Universiti Sultan Zainal Abidin, Terengganu Malaysia, [email protected] Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] Dr. Andrzej Szymański, Poznan University of Technology, Poland, [email protected] Similar Articles: AWARENESS OF PHARMACISTS TOWARDS ASPARTAME SIDE EFFECTS IN KHARTOUM CITY, SUDAN ASSESSMENT OF THE ROLE OF COMMUNITY PHARMACISTS IN MANAGEMENT OF HIV-POSITIVE INDIVIDUALS IN THE SOUTHERN REGION OF NIGERIA


Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.


2015 ◽  
Vol 47 (1) ◽  
pp. 126 ◽  
Author(s):  
S Bhowmick ◽  
VR Chowrasia ◽  
Shipra Bhattacharya ◽  
RN Chatterjee ◽  
Arindam Sen ◽  
...  

Author(s):  
June W. Njiru ◽  
Eunice M. Mwangi ◽  
Musa Oluoch

Background: Reporting of adverse drug reactions remains the mainstay of a vibrant pharmacovigilance system that seeks to safeguard medicines in a health system. This study sought to establish the impact of the national medicines regulatory body, The Pharmacy and Poisons Board (PPB), the operationalization of pharmacovigilance implementation strategies in the retail chemists, the effect of the capacity and that of underlying motivation factors of the retail chemist personnel on reporting of adverse drug reactions.Methods: This was a descriptive cross-sectional study design conducted between May 2018 to June 2018.Results: 149 (60%) of the respondents stated that PPB did not engage retail chemists as stakeholders in pharmacovigilance, 127 (51%) said they had never read any PPB publication on pharmacovigilance, 151 (61%) said they had general knowledge on pharmacovigilance, receiving feedback from PPB was considered a major motivational factor towards ADR reporting by 237 (96%). Multivariate analysis of the determinants of ADR reporting in retail chemists established that the pharmacovigilance implementation strategies (p<0.026), retail chemist personnel (p<0.001) and underlying motivational factors (p<0.05) had significant influence on ADR reporting in retail chemists in Nairobi County.Conclusions: PPB has not engaged retail chemists on pharmacovigilance matters as key stakeholders and this has impacted the quality of the pharmacovigilance implementation strategies in the chemists as well as the capacity and motivation of the retail chemist personnel to report ADRs.


Author(s):  
Mamatha N. ◽  
Reshma Nadaf

Background: The objective of the study was to evaluate the knowledge and attitude towards pharmacovigilance and adverse drug reaction (ADR) reporting among the undergraduates, interns and postgraduate students.Methods: This was a cross sectional study done among the undergraduates, interns and post graduate medical students at Karnataka Institute of Medical Sciences, Hubballi using a pre-validated questionnaire that included 20 questions to evaluate the participants knowledge and perception of ADR and pharmacovigilance. The questionnaire was distributed to the participants (n=606) after taking their informed consent. The data was compiled and evaluated as percentages.Results: About 52% of the participants were aware of pharmacovigilance and 38.7% knew about the purpose of pharmacovigilance programme of India. 51% of the participants have experienced ADRs during their professional practice out of which 23% have reported to the pharmacovigilance centre. The most common barrier for under-reporting was lack of time to report ADR among 34% of the participants. 31% of the participants felt that managing patient was more important than reporting ADRs. 29% of the participants gave the reason as lack of access to ADR reporting forms. 25% of the participants had difficulty to decide whether ADR has occurred or not.Conclusions: Our study strongly suggests a greater need to create an awareness among undergraduate medical students, interns and postgraduate students to improve the reporting of ADRs.


2018 ◽  
Vol 10 (8) ◽  
pp. 107
Author(s):  
Tablib Salim Al Kablani ◽  
Hilal Salim Al Shamsi ◽  
Abdullah Ghthaith Almutairi

OBJECTIVE: The study aims to evaluate postgraduate resident physicians’ knowledge, attitudes and practices related to reporting adverse drug reactions (ADRs). It also aims to investigate the causes of poor ADR reporting and to suggest possible ways to improve the reporting methods.METHODS: A cross-sectional study was conducted using a self-administered questionnaire. The questionnaire sought to obtain the physicians’ demographic characteristics, knowledge and practices in relation to ADRs and to identify the factors that affect and encourage ADR reporting. The questionnaire was distributed to physicians (n=117) working at governmental healthcare institutions in Al-Buraimi governorate in Oman.RESULTS: The response rate was 80%. Median score for the knowledge components of ADR reporting was 5 (total score: 7); it was 5 (total score: 5) for the attitude components. No significant difference for the knowledge and attitude scores was found between gender, age group or physicians’ medical speciality. Eighty-four of the physicians (89.4%) knew about pharmacovigilance and serious ADRs. Eighty-eight of the physicians (93.6%) believed that reporting ADRs should be mandatory. No statistical differences were found between general practitioners and specialists who felt that ADR reporting should be either compulsory or voluntary (p=0.080). Seventy-eight of the physicians (83%) noted that the lack of awareness about the reporting procedures is the main reason for not reporting ADRs. In this regard, there were no statistically significant differences between physicians younger than 45 or older than 45 (p=0.835).CONCLUSION: Deficits in the practice of ADR reporting can be resolved in the future only if all physicians in the healthcare profession are aware of the importance of reporting ADRs, the reporting system and their obligation to report ADRs.


Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.


2019 ◽  
Vol 2019 ◽  
pp. 1-11 ◽  
Author(s):  
Belete Kassa Alemu ◽  
Tessema Tsehay Biru

Background. The role of health care professionals among other stakeholders in early detection, assessment, documentation, and reporting as well as preventing suspected adverse reactions is very crucial to mitigate drug-related problems in health facilities. Previous reports from literatures have indicated that adverse drug reaction reporting is highly linked to the knowledge and attitude of the health care professionals. Objective. To assess knowledge, attitude, and practice of health care professionals about adverse drug reactions and the associated factors at selected public hospitals in Northeast Ethiopia. Methods. A hospital-based quantitative cross-sectional study design was employed. A structured self-administered questionnaire was used to collect data on KAP of selected health care providers by the convenience sampling method. Data were entered into Epi info version 3.5.3 and analyzed using SPSS Version 20. Association between dependent and independent variables was found by using bivariate and multivariate logistic regression analysis where p<0.05 was considered to be statistically significant. Results. Out of 120 questionnaires distributed, 114 respondents filled and returned, giving a 95% response rate. From total, 49 (43%) were nurses, 26 (22.8%) physicians, 17 (14.9%) pharmacy professionals, 12 (10.5%) health officers, and 10 (8.8%) midwives. About 86 (75.44%) study participants had an inadequate knowledge towards ADR reporting, and half of participants failed to report the adverse drug reactions they encountered. But the majority of participants (84, 73.68%) had a favorable attitude towards ADR reporting. Nurses [AOR = 0.069, 95% CI (0.018–0.275)], health officers [AOR = 0.10, 95% CI (0.015–0.647)], and physicians [AOR = 0.14, 95% CI (0.03–0.64)] were found to be less likely to have adequate knowledge on ADR reporting compared to pharmacy professionals. Conclusion. Even though the majority of health care professionals had a positive attitude, they had inadequate knowledge and poor practice towards ADR reporting.


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