Comparison of knowledge and perception about adverse drug reaction reporting and pharmacovigilance between pharmacy and medical students

Background: Adverse drug responses are serious public health issues worldwide. Pharmacovigilance (PV) is an important part of the healthcare system since it assesses, monitors, and discovers medication interactions and their consequences in humans. Objective were to assess knowledge and perception about adverse drug reactions (ADR) and PV among pharmacy and medical students. Methods: A cross-sectional study was conducted for pre-final year and final-year of pharmacy and medical students. Study conducted through semi structured questionnaires and a total 607 participants were recruited in this study. Results: A total 607 participants of pharmacy (52.5%) and medical (47.4%) from pre final (50.2%), final year (49.9%) students participated in this study. Pharmacy students had a significantly better overall knowledge of ADRs than medical students (p<0.05). The perception of pharmacy students regarding ADRs reporting and PV were significantly more than those medical student’s (p<0.05). In comparison to pharmacy students, a lack of knowledge of where and how to report ADRs was the main barrier that medical students perceived to ADR reporting (0.02). Conclusions: This study shows that compared to medical students, pharmacy students had better awareness of ADR reporting and shown good perceptions of PV. To enhance the knowledge of PV among healthcare students, an instructional intervention ought to be implemented.

A retrospective and observational study of the adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

Pattern of adverse drug reactions reported at a tertiary care teaching hospital in Punjab

Background: This study was undertaken to characterize the pattern of adverse drug reactions (ADRs) reported through spontaneous reporting system at ADR reporting unit in a tertiary care teaching hospital (Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar).Methods: A prospective, observational study was conducted over one year between 1st July, 2013 and 30th June, 2014. The ADRs reported were from patients attending outpatient department (OPD) and in-patient department (IPD) of this hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and ADR characteristics and outcome of the ADRs. Causality and severity assessment was done by WHO-UMC system and modified Hartwig and Siegel criteria.Results: A total of 202 ADRs which were reported over one year were evaluated. Overall ADRs were more common in females than in males (60.2% vs. 39.8%). Majority of the ADRs were reported from psychiatry department (50%). Most ADRs occurred due to antidepressant drugs (55.1%). Majority of the ADRs involved the central nervous system (25.24%). Upon causality and severity assessment, majority of the reports were rated as probable (57.42%) and mild (57.92%). None of the ADRs were severe or fatal.Conclusions: In conclusion, majority of the ADRs were reported by psychiatry department and occurred due to antidepressant drugs. Most of the ADRs were mild. This data reveals the need for regular spontaneous reporting by healthcare professionals of all specialties. This data also reveals the opportunities for interventions and policy initiatives to ensure safer use of drugs in future.

Knowledge, attitude and perception of suspected adverse drug reactions in consumers: a prospective observational study in a tertiary care hospital

Background: Adverse drug reactions (ADRs) are the main leading causes of hospitalization which leads to morbidity and mortality worldwide. Reporting of ADRs to national databases is necessary. To strengthen this system, consumers apart from health-care professionals have also been empowered to report any ADRs directly to the regulatory agencies. Direct and spontaneous patient or consumer reporting offers various benefits beyond pharmacovigilance (PV). Consumer reporting of ADRs has existed in several countries for decades, but in India, with the inclusion of consumer reporting of ADR, the data on the same is valuable and limited. Hence the present study is taken up. The aim of this study was to explore the knowledge, perceptions and practice of ADR reporting among consumers in KIMS hospital and research center, Bangalore.Methods: The data was collected from Patients attending OPD’s, admitted in wards and at pharmacy in KIMS Hospital and Research Center, Bangalore. It is a cross sectional descriptive study. Study period is for six months from 1st April to 31st September 2018 and sample size is 200. A structured questionnaire in English and Kannada was used as a tool.Results: Of the 200 patients from the surveyed, in males the knowledge scores were better when compared to females and attitude, perception scores were same (statistically not significant). Most of the patients opined for the establishment of consumer pharmacovigilance system at hospitals and local pharmacies.Conclusions: Knowledge about ADR reporting and pharmacovigilance is less in consumers. So that there is a need to increase awareness in consumers.

Practice of Informatization of Adverse Drug Event Management in Outpatient Pharmacy of Our Hospital / 中国药房

OBJECTIVE:To promote the informatization of adverse drug event(ADE)management in outpatient pharmacy so as to reduce the risk of drug use. METHODS:From the aspect of the construction of two information platforms as problematic prescription management and ADR monitoring record and report,the practice of the informatization of ADE management in outpatient pharmacy of our hospital was introduced;the effects of information management were evaluated by real-time online record for the number of dispensing error and ADE and the number of ADR reported by outpatient pharmacists. RESULTS:The application of ADE management module for outpatient pharmacy developed by our hospital realized the following functions as real-time online record of"suspected prescription",problematic prescription inquiry and summary,ADE report without delay, electronic ADR monitoring and reporting. 148 times of dispensing internal errors during Apr.-Jun. 2017(accounting for 0.035% of total prescription)and 15 ADEs during Jun. 2016-Jun. 2017(accounting for 0.008‰ of total prescription)were recorded in outpatient pharmacy of our hospital. There were 82 ADR cases reported by outpatient physicians using user-friendly electronic ADR monitoring and reporting(accounting for 36.94% of total ADR). CONCLUSIONS:The construction of informatization promotes timely record of related error and adverse events,targeted management and ADR reporting and reduces the risk of drug use.

Investigation and Analysis of ADR Reported and Causes of Missing Reports by Medical Staff in A Third Grade Class A Hospital / 中国药房

OBJECTIVE:To provide reference for improving the reporting of adverse drug reactions (ADRs) in the hospital.METHODS:A questionnaire survey was conducted to investigate the reporting of ADRs and causes of missing reports by medical staff in all departments of a third grade class A hospital.The related data were statistically analyzed.RESULTS:A total of 967 questionnaires were distributed,and 900 questionnaires were collected,with a recovery rate of 93.07％.Among them,875 were valid questionnaires,and the effective rate was 97.22％.Among the medical staff,who can correctly answer the main causes of ADRs (drugs were toxic,individual difference),accounted for 42.51％ and 49.26％;35.89％ of staff did not receive any ADRs training in one year;33.83％ did not know the ADRs reporting system and ways;30.06％ would fill in the ADRs statement voluntarily;61.49％ considered that the absence of full-time personnel was the main difficulty in reporting ADRs;41.60％ indicated that they had previously reported ADRs.The causes of missing ADR reports by medical staff were ranked as high to low:uncertainty about ADRs,and there was no relevant information in the hospital (accounting for 45.94％);the filling process of ADR reports was complicated (accounting for 34.97％);do not have the phone number of ADR supervision department in hospital (accounting for 33.60％);do not know the reporting process (accounting for 33.49％),and so on.CONCLUSIONS:The situation of ADR reporting by medical staff in the hospital is not satisfactory,most of them have varying degrees of missing ADRs.The inadequate management and publicity of ADR monitoring,poorly trained by the hospital is an important reason for missing reporting.

Investigation on the Perception of Surgeon to ADR Reporting System / 中国药房

OBJECTIVE: To investigate the perception of surgeon to ADR reporting system. METHODS: Postal questionnaire was used for survey among 300 surgeons in November 2009. RESULTS & CONCLUSIONS: Surgeons mastered a little knowledge about ADR reporting system. More than 50% of surgeons took one-side view on national ADR monitoring with ADR reporting rate of 42.8%. 57.2% of surgeons hadn’t received relevant training. It is suggested that surgeons receive training and education about the knowledge of ADR reporting.