Dataset Information

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

ABSTRACT:

Introduction

The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies.

Objectives

Our objective was to explore the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; to explore gaps and inconsistencies in the reporting process; and to identify the causes of under-reporting ADEs in these settings.

Methods

The Tufts Center for the Study of Drug Development (Tufts CSDD) interviewed 11 thought leaders and conducted a survey between May and August 2014 among US-based healthcare providers (HCPs) in diverse settings to assess their experiences with, and processes for, reporting ADEs.

Results

A total of 123 individuals completed the survey (42 % were pharmacists; 27 % were nurses; 15 % were physicians; and 16 % were classified as 'other'). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously (66 % of respondents); that HCPs lack sufficient time to report ADEs (63 % of respondents); poor integration of ADE-reporting systems (53 % of respondents); and uncertainty about reporting procedures (52 % of respondents).

Discussion

The results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies.

SUBMITTER: Stergiopoulos S

PROVIDER: S-EPMC5045838 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

Stergiopoulos Stella S Brown Carrie A CA Felix Thomas T Grampp Gustavo G Getz Kenneth A KA

Drug safety 20161101 11

<h4>Introduction</h4>The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies.<h4>Objectives</h4>Our objective was to explore the process for reporting ADEs in US hospitals, ...[more]

PMID: 27638657

Similar Datasets

Project description:BackgroundPharmacovigilance based on spontaneously reported suspected adverse events (AEs) from veterinary professionals is a powerful tool for detecting potential risks of using medicinal products. However, it is heavily dependent on the voluntary participation of veterinary professionals. Estimates suggest that over 90% of suspected AEs remain unreported. This survey was conducted to accumulate information on current practices and attitudes of Swedish veterinary professionals in relation to AE reporting and their perceptions of the accessibility of updated product safety information.MethodsSwedish veterinary professionals were surveyed using a web-based questionnaire prepared by the Swedish Medical Products Agency (SMPA). The survey included three sections with 13 questions and was distributed via several communication channels, including the Swedish Veterinary Association.ResultsThe survey was answered by 412 veterinary professionals, including veterinarians and licensed veterinary nurses. The survey identified that most veterinarians comply with national legislation by reporting directly to the SMPA, but not all observed AEs are reported. Veterinary professionals indicated that it is important to have an easy and efficient reporting system, preferably directly from an electronic medical records system. Feedback is considered important. Veterinary nursing staff could potentially improve the reporting rate of suspected AEs in Sweden. The degree of knowledge relating to the reporting of AEs varies among professionals, thus impacting on reporting frequency. A single source of product safety information is mainly used, and improvements are required to enhance accessibility and distribution of updated product safety information.ConclusionsThe insight gained from this survey will be used to influence attitudes and facilitate adaptations needed to fulfil the requirements of the European Union regulations. To reduce underreporting of AEs and facilitate access to updated product safety information, various approaches are required including educational interventions, new digital reporting tools and adaption of communication strategies.

Project description:Objectives: The objectives of this study were to describe the knowledge, attitudes and practices of Adverse Drug Reactions (ADR) reporting among healthcare professionals at Teaching Hospital Karapitiya (THK), a tertiary care hospital in Sri Lanka. Methodology: A descriptive cross-sectional study was conducted at THK. The healthcare professionals working in THK who were available during the study period were invited to the study. A self-administered pre-tested questionnaire was administered to the participants. Respondents were evaluated for their knowledge, attitudes and practices related to ADR reporting. The data were analyzed using SPSS statistical software. Results: Of the total 444 respondents, 31% were doctors and 69% were nurses. The majority of respondents, 90% (n = 400) were aware of the term ADR, while 64.8% (n = 288) could correctly define it. Among the respondents, 30.8% (n = 137) knew about the types of ADR and only 15.5% (n = 70) were able to mention a drug that is banned due to ADR correctly. Among the respondents, only 38.7% (n = 172) were aware of a formal process of reporting ADR and, only 35.3% (n = 157) stated that they had seen the ADR reporting form. Further, only 33.7% (n = 150) respondents have recognized ADR during their clinical practice and only a small proportion 18.2% (n = 81) have ever reported an ADR during their practice. Regarding attitudes toward ADR reporting, overall 84.1 (n = 373) had positive attitudes toward ADR reporting, while 13.54% (n = 60) of them stayed neutral and 2.25% (n = 10) had negative attitudes toward ADR reporting. Conclusions: Although the majority were aware of ADR , the knowledge and practices regarding spontaneous reporting of ADR are inadequate. However, most respondents have shown a positive attitude toward ADR reporting. A sincere and sustained effort should be made by concerned bodies to enhance the healthcare professionals' knowledge, attitudes, and practices regarding ADR reporting.

Project description:BackgroundHealthcare professional's knowledge and attitudes to adverse drug reaction (ADR) and ADR reporting play vital role to report any cases of ADR. Positive attitudes may favour ADR reporting by healthcare professionals. This study was aimed to investigate the attitudes towards and ways to improve adverse drug reaction (ADR) reporting among healthcare professionals working at four Regional Pharmacovigilance Centres (RPCs) of Nepal.MethodsA cross sectional study was done by survey using a self-administered structured questionnaire. The questionnaire was distributed to 450 healthcare professionals working at four RPCs.ResultsThe overall response rate was 74.0%. There were 74.8% of healthcare professionals who had seen patient experiencing an ADR; however, only 20.1% had reported. Reporting form not available (48.1%) and other colleagues not reporting ADR cases (46.9%) would significantly discourage the ADR reporting among healthcare professionals working at four RPCs. Healthcare professionals perceived that seriousness of the reaction (75.6%); unusual reaction (64.6%); reaction to new product (71.2%); new reaction to existing product (70.2%); and confidence in diagnosis of ADR (60.8%) were important factors on the decision to report ADR. Awareness among healthcare professionals (85.9%), training (76.0%), collaboration (67.0%), and involve pharmacist for ADR reporting (63.1%) were mostly recognized ways to improve reporting. Regular newsletter on current awareness in drug safety (71.2%), information on new ADR (65.8%), and international drug safety information (64.0%) were the identified feedbacks they would like to receive from the Nepal pharmacovigilance programme.ConclusionHealthcare professionals working at four RPCs of Nepal have positive attitudes towards ADR reporting. Awareness among healthcare professionals, training and collaboration would likely improve reporting provided they would receive appropriate feedback from the national pharamcovigilance programme.

Project description:BackgroundAdverse drug reaction (ADR) reporting has been studied relatively extensively in all the Nordic countries besides Finland, but no definitive solution to decrease under-reporting has been found. Despite many similarities in reporting, the most notable difference compared to other Nordic countries is that ADR reporting is completely voluntary in Finland.PurposeThe purpose was to examine if voluntary reporting influences healthcare professional (HCP) ADR reporting, why HCPs do not report all suspected ADRs, how could reporting be enhanced, and do we need to develop the process for collecting ADR follow-up (F/U) information from HCPs.MethodsAn open and anonymous questionnaire was developed and made available online at the e-form portal of the University of Helsinki. Trade and area unions distributed the questionnaire to their respective member physicians, nurses, and pharmacists. Two independent coders performed the content analysis of answers to open-ended questions.ResultsA total of 149 responses was received. Two fifths (38%) of the HCPs confirmed that they had not always reported suspected ADRs. The main reason for not reporting was that the ADR was already known. HCPs who had no previous ADR reporting experience did not report ADRs mainly because it was not clear how to report them. Seriousness (chosen by 76%) and unexpectedness of the reaction (chosen by 64%) were the most actuating factors in reporting an ADR. Only 52% of the HCPs had received ADR reporting training and only 16% of the HCPs felt that they had enough information about reporting. Most HCPs felt that ADR F/U requests are justified, and these requests did not affect their ADR reporting willingness.ConclusionsAs in other Nordic countries, ADR under-reporting occurs also in Finland despite differences in reporting guidance. ADR reporting rate could be enhanced by organizing recurring training, information campaigns, and including reporting reminders to the patient information systems that HCPs use. Training should primarily aid in recognizing ADRs, educate in how to report, and promote a reporting culture among HCPs.

Dataset Information

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

Introduction

Objectives

Methods

Results

Discussion

Publications

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets