The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses’ reporting

Karlsson, Sofia Axia; Jacobsson, Ingela; Boman, Marit Danell; Hakkarainen, Katja M.; Lövborg, Henrik; Hägg, Staffan; Jönsson, Anna K.

doi:10.1007/s00228-015-1839-6

Cited by 14 publications

(8 citation statements)

References 15 publications

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“…This finding illustrates that HCPs have a very positive attitude towards ADR reporting, regardless of the cause and type of reaction. Nurses believed that reactions of a serious nature require more attention and should thus be reported more often than other types of reactions (Karlsson et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study

Alshammari

Almoslem

2018

Saudi Pharmaceutical Journal

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IntroductionAdverse drug reactions (ADRs) are a major global clinical problem, causing substantial mortality and morbidity especially in hospitals. Healthcare professionals (HCPs) knowledges’, attitude and practices are crucial points to evaluate the hospital safety environment. Objective of the study was to investigate the knowledge, attitudes, and practices of HCPs regarding the ADRs reporting system.MethodsA cross-sectional survey was conducted between January and February of 2013 in nine tertiary care hospitals (governmental and private) that provide highly specialized medical services in Riyadh, Qassim, and the Eastern region of the Kingdom of Saudi Arabia. A validated questionnaire was used to assess the knowledge, attitudes, and practices of HCPs regarding the ADR reporting system. All statistical analyses were performed using SAS version 9.2.ResultsIn total, 480 questionnaires were distributed, and the response rate was 70% (n = 336). Only 33% of the participants were aware of the National Pharmacovigilance Centre (NPC). Of those HCPs who were familiar with the NPC and their responsibility to report ADRs, most (50%) were pharmacists, followed by physicians (24%) and nurses (16%), and these differences were statistically significant (p < 0.01). Twenty-seven percent of the participants were involved in reporting ADRs; among these HCPs, 62% were pharmacists, 26% were nurses, and 6% were physicians. Most participants (95%) favoured reporting ADRs caused by antibiotics and new/old drugs. The prominent factors discouraging ADR reporting included fear that the report might be incorrect (46%) and lack of time (44%).ConclusionsA significant lack of knowledge, positive attitudes, and practices regarding ADRs and reporting was observed in hospital HCPs. This finding represents an international concern, and urgent action is needed to promote drug safety and pharmacovigilance in this region.

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Section: Discussionmentioning

confidence: 99%

Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study

Alshammari

Almoslem

2018

Saudi Pharmaceutical Journal

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“…This could be explained by an increase in awareness through institutional campaigns and educational activities. However, as described in the literature, underreporting is the main challenge in pharmacovigilance activities, and methods such as campaigns, incentives, and even legislative changes have minimal effect on reporting 18‐20 . Our team's goal was, despite the limited number of reports, to focus on measures that could be taken to prevent harm based on those few reports we received.…”

Section: Discussionmentioning

confidence: 99%

Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented

et al. 2020

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What is known Limitations of clinical trials in determining all safety concerns related to a drug are well recognized. Monitoring spontaneous adverse drug reaction (ADR) reports remains an easy and relatively inexpensive method for overseeing that a drug remains a safe and effective option for patients. Objective To characterize and describe ADR reports at one of the largest healthcare institutions in the region and share the measures implemented by the team. Methods We conducted a retrospective analysis of all ADRs submitted by healthcare providers in a tertiary healthcare system in Saudi Arabia between January 2016 and December 2019. The main outcome measures included reporting rate, patient characteristics, suspected drugs involved, seriousness and reporting specialities. Results and discussion Throughout this study, 1156 ADR reports were submitted. The top reported ADR was immune system disorders (87.8%). The most represented class were antimicrobials (56.8%), followed by analgesics (11.4%) and diagnostic agents (5.1%). The ADRs were deemed definitely avoidable in 11.4% (132/1156) of the cases, and 24.2% (280/1156) were deemed possibly avoidable. Reporting ADRs has steadily increased over the years at our institution, but there continues to be a lack of reporting by physicians. Almost one‐third of the reported ADRs were considered to be avoidable or possibly avoidable, which is a driver to continue pharmacovigilance activates on an institutional level and provide specific and tailored preventative measures guided by the specific types of ADRs reported. What is new and conclusion This is the first study to report trends of ADRs spontaneously reported at one of the largest healthcare institutions in the Middle East. It shows similar trends to what has been reported by other institutions, with mainly immediate immunological ADRs being the top reported ADRs, which could be explained by the immediate onset which simplifies the temporal association. Every institution should support and maintain an active ADR team, with responsibilities of evaluating incidents, monitoring trends and most importantly identifying opportunities to improve medication and patient safety. We share here our workflow and hope it serves as a guide for other institutions.

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“…Comprehensive, formalised structured monitoring by administration of the ADRe Profile before scheduled appointments or reviews has potential to bridge this hiatus in communications and care, introduce a nursing voice into the refinement of therapeutic regimens and involve nurses in ADR management. 118 …”

Section: Discussionmentioning

confidence: 99%

Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines

et al. 2018

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IntroductionImproved medicines’ management could lead to real and sustainable improvements to the care of older adults. The overuse of mental health medicines has featured in many reports, and insufficient patient monitoring has been identified as an important cause of medicine-related harms. Nurse-led monitoring using the structured adverse drug reaction (ADRe) profile identifies and addresses the adverse effects of mental health medicines. Our study investigates clinical impact and what is needed to sustain utilisation in routine practice in care homes.Methods and analysisThis process evaluation will use interviews and observations with the participants of all five homes involved in earlier research, and five newly recruited homes caring for people prescribed mental health medicines. The ADRe profile is implemented by nurses, within existing resources, to check for signs and symptoms of ADRs, initiate amelioration and share findings with pharmacists and prescribers for medication review. Outcome measures are the numbers and nature of problems addressed and understanding of changes needed to optimise clinical gain and sustain implementation. Data will be collected by 30 observations and 30 semistructured interviews. Clinical gains will be described and narrated. Interview analysis will be based on the constant comparative method.Ethics and disseminationEthical approval was conferred by the National Health Service Wales Research Ethics Committee. If the ADRe profile can be sustained in routine practice, it has potential to (1) improve the lives of patients, for example, by reducing pain and sedation, and (2) assist in early identification of problems caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we shall communicate our findings to healthcare professionals, policy-makers and sector regulators.Trial registration numberNCT03110471.

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The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses’ reporting

Cited by 14 publications

References 15 publications

Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study

Knowledge, attitudes & practices of healthcare professionals in hospitals towards the reporting of adverse drug reactions in Saudi Arabia: A multi-centre cross sectional study

Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented

Nurse-led medicines’ monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines

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