Abstract Specialist oncology nurses (SONs) have the potential to play a major role in monitoring and reporting adverse drug reactions (ADRs); and reduce the level of underreporting by current healthcare professionals. The aim of this study was to investigate the long term clinical and educational efects of real-life pharmacovigilance education intervention for SONs on ADR reporting. This prospective cohort study, with a 2-year follow-up, was carried out in the three postgraduate schools in the Netherlands. In one of the schools, the prescribing qualifcation course was expanded to include a lecture on pharmacovigilance, an ADR reporting assignment, and group discussion of self-reported ADRs (intervention). The clinical value of the intervention was assessed by analyzing the quantity and quality of ADR-reports sent to the Netherlands Pharmacovigilance Center Lareb, up to 2 years after the course and by evaluating the competences regarding pharmacovigilance of SONs annually. Eighty-eight SONs (78% of all SONs with a prescribing qualifcation in the Netherlands) were included. During the study, 82 ADRs were reported by the intervention group and 0 by the control group. This made the intervention group 105 times more likely to report an ADR after the course than an average nurse in the Netherlands. This is the frst study to show a signifcant and relevant increase in the number of well-documented ADR reports after a single educational intervention. The real-life pharmacovigilance educational intervention also resulted in a long-term increase in pharmacovigilance competence. We recommend implementing real-life, context- and problem-based pharmacovigilance learning assignments in all healthcare curricula.
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Aims: Prescribing medication is a complex process that, when done inappropriately, can lead to adverse drug events, resulting in patient harm and hospital admissions. Worldwide cost is estimated at 42 billion USD each year. Despite several efforts in the past years, medication-related harm has not declined. The aim was to determine whether a prescriber-focussed participatory action intervention, initiated by a multidisciplinary pharmacotherapy team, is able to reduce the number of in-hospital prescriptions containing ≥1 prescribing error (PE), by identifying and reducing challenges in appropriate prescribing. Methods: A prospective single-centre before- and after study was conducted in an academic hospital in the Netherlands. Twelve clinical wards (medical, surgical, mixed and paediatric) were recruited. Results: Overall, 321 patients with a total of 2978 prescriptions at baseline were compared with 201 patients with 2438 prescriptions postintervention. Of these, m456 prescriptions contained ≥1 PE (15.3%) at baseline and 357 prescriptions contained ≥1 PEs (14.6%) postintervention. PEs were determined in multidisciplinary consensus. On some study wards, a trend toward a decreasing number of PEs was observed. The intervention was associated with a nonsignificant difference in PEs (incidence rate ratio 0.96, 95% confidence interval 0.83–1.10), which was unaltered after correction. The most important identified challenges were insufficient knowledge beyond own expertise, unawareness of guidelines and a heavy workload. Conclusion: The tailored interventions developed with and implemented by stakeholders led to a statistically nonsignificant reduction in inappropriate in-hospital prescribing after a 6-month intervention period. Our prescriber-focussed participatory action intervention identified challenges in appropriate in-hospital prescribing on prescriber- and organizational level.
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The Junior Adverse Drug Event Manager (J-ADEM) team is a multifaceted intervention focusing on real-life education for medical students that has been shown to assist healthcare professionals in managing and reporting suspected adverse drug reactions (ADRs) to the Netherlands Pharmacovigilance Centre Lareb. The aim of this study was to quantify and describe the ADRs reported by the J-ADEM team and to determine the clinical potential of this approach. The J-ADEM team consisted of medical students tasked with managing and reporting ADRs in hospitalized patients. All ADRs screened and reported by J-ADEM team were recorded anonymously, and categorized and analysed descriptively. From August 2018 through January 2020, 209 patients on two wards in an academic hospital were screened for ADR events. The J-ADEM team reported 101 ADRs. Although most ADRs (67%) were first identified by healthcare professionals and then reported by the J-ADEM team, the team also reported an additional 33 not previously identified serious ADRs. In 10% of all reported ADRs, the J-ADEM team helped optimize ADR treatment. The ADR reports were largely well-documented (78%), and ADRs were classified as type A (66%), had a moderate or severe severity (85%) and were predominantly avoidable reactions (69%). This study shows that medical students are able to screen patients for ADRs, can identify previously undetected ADRs and can help optimize ADR management. They significantly increased (by 300%) the number of ADR reports submitted, showing that the J-ADEM team can make a valuable clinical contribution to hospital care.
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Abstract Purpose: The pharmacology and clinical pharmacology and therapeutics (CPT) education during the undergraduate medical curriculum of NOVA Medical School, Lisbon, Portugal, was changed from a traditional programme (i.e. discipline-based, lectures) to a problem-based learning (PBL) programme (i.e. integrated, case-based discussions) without an increase in teaching hours. The aim of this study was to investigate whether this change improved the prescribing competencies of final-year medical students. Methods: Final-year students from both programmes (2015 and 2019) were invited to complete a validated prescribing assessment and questionnaire. The assessment comprised 24 multiple-choice questions in three subdomains (working mechanism, side-effects and interactions/contraindications), and five clinical case scenarios of common diseases. The questionnaire focused on self-reported prescribing confidence, preparedness for future prescribing task and education received. Results: In total, 36 (22%) final-year medical students from the traditional programme and 54 (23%) from the PBL programme participated. Overall, students in the PBL programme had significantly higher knowledge scores than students in the traditional programme (76% (SD 9) vs 67% (SD 15); p = 0.002). Additionally, students in the PBL programme made significantly fewer inappropriate therapy choices (p = 0.023) and fewer erroneous prescriptions than did students in the traditional programme (p = 0.27). Students in the PBL programme felt more confident in prescribing, felt better prepared for prescribing as junior doctor and completed more drug prescriptions during their medical training. Conclusion: Changing from a traditional programme to an integrated PBL programme in pharmacology and CPT during the undergraduate medical curriculum may improve the prescribing competencies of final-year students.
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Background: Home care professionals regularly observe drug-related problems during home care provision. Problems related to the process of the medication therapy could involve discrepancies in medication prescriptions between the hospital discharge letter and the medication administration record lists (MARL) or insufficient drug delivery. The objective of this study is to determine the potential clinical consequences of medication process problems observed by home care professionals, since those consequences have not been assessed before. Methods: A retrospective descriptive study design was performed. An expert panel performed an assessment procedure on the clinical consequences of medication process problems. Such problems were reported by home care professionals during routine care (May 2016 until May 2017) using the eHOME system, which is a digital system developed to assist in the reporting and monitoring of drug-related problems. Using a three-point scale, an expert panel assessed the potential clinical consequences of those medication process problems among older home care patients (aged 65 years and over). Results: 309 medication process problems in 120 out of 451 patients were assessed for potential discomfort or clinical deterioration. The problems involved the following: medication discrepancies (new prescription not listed on the MARL [n = 69, 36.7%]; medication stopped by the prescriber but still listed on the MARL [n = 43, 22.9%]; discrepant time of intake [n = 25, 13.3%]; frequency [n = 24, 12.8%]; and dose [n = 21, 11.2%], therapeutic duplication listed on the MARL [n = 5, 2.6%]; and discrepant information on route of administration [n = 1, 0.5%]); an undelivered MARL [n = 103, 33.3%]; undelivered medication [n = 16, 5.2%]; and excessive medication delivery [n = 2, 0.7%]. Furthermore, 180 (58.2%) out of 309 medication process problems were assessed as having the potential for moderate or severe discomfort or clinical deterioration in patients. Conclusions: The majority of medication process problems may result in patient discomfort or clinical deterioration.
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ABSTRACT Background: We investigated if the addition of an inter-professional student-led medication review team (ISP-team) to standard care can increase the number of detected ADRs and reduce the number of ADRs 3 months after an outpatient visit. Research design and methods: In this controlled clinical trial, patients were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The ISP team consisted of medical and pharmacy students and student nurse practitioners. The team performed a structured medication review and adjusted medication to reduce the number of ADRs. Three months after the outpatient visit, a clinical pharmacologist who was blinded for allocation performed a follow-up telephone interview to determine whether patients experienced ADRs. Results: During the outpatient clinic visit, significantly more (p < 0.001) ADRs were detected in the intervention group (n = 48) than in the control group (n = 10). In both groups, 60–63% of all detected ADRs were managed. Three months after the outpatient visit, significantly fewer (predominantly mild and moderately severe) ADRs related to benzodiazepine derivatives and antihypertensive causing dizziness were detected in the patients of the intervention group. Conclusions: An ISP team in addition to standard care increases the detection and management of ADRs in elderly patients resulting in fewer mild and moderately severe ADRs
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from the repository of Utrecht University: "OBJECTIVES: Antipsychotic drugs are frequently prescribed to elderly patients, but they are associated with serious adverse effects. The objective of the current study was to investigate the association between use of antipsychotics by elderly women and the risk of urinary tract infections (UTIs). COHORT STUDY SETTING: Dispensing data were obtained from the PHARMO Database Network for the period 1998-2008. PARTICIPANTS: Ambulatory Dutch women (≥65 years) with current and past use of antipsychotics. MEASUREMENTS: Incidence rates of UTIs, as defined by use of nitrofurantoin, was calculated within and outside the period of exposure to antipsychotic drugs. Cox proportional hazard regression analysis with Andersen-Gill extension for recurrent events was used to calculate crude and adjusted hazard ratios (HRs). RESULTS: During the study period, 18,541 women with a first prescription of an antipsychotic were identified. Current use of antipsychotics was associated with an increased risk of UTI compared to past use: HR, adjusted for age and history of UTIs, 1.33, 95% CI 1.27-1.39. A strong temporal relationship was found: the risk of being treated for a UTI was higher in the first week after the start of the treatment (adjusted HR 3.03, 95% CI 2.63-3.50) and decreased after 3 months (adjusted HR 1.22, 95% CI 1.17-1.28). Cumulative exposure was not associated with an increased risk of UTIs. There was no difference in effect between conventional and atypical antipsychotics. CONCLUSION: Our results show an increased risk of uncomplicated UTIs during antipsychotic use in older female patients, especially in the first week of treatment."
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Aim: In-hospital prescribing errors (PEs) may result in patient harm, prolonged hospitalization and hospital (re)admission. These events are associated with pressure on healthcare services and significant healthcare costs. To develop targeted interventions to prevent or reduce in-hospital PEs, identification and understanding of facilitating and protective factors influencing in-hospital PEs in current daily practice is necessary, adopting a Safety-II perspective. The aim of this systematic review was to create an overview of all factors reported in the literature, both protective and facilitating, as influencing in-hospital PEs. Methods: PubMed, EMBASE.com and the Cochrane Library (via Wiley) were searched, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, for studies that identified factors influencing in-hospital PEs. Both qualitative and quantitative study designs were included. Results: Overall, 19 articles (6 qualitative and 13 quantitative studies) were included and 40 unique factors influencing in-hospital PEs were identified. These factors were categorized into five domains according to the Eindhoven classification (‘organization-related’, ‘prescriber-related’, ‘prescription-related’, ‘technologyrelated’ and ‘unclassified’) and visualized in an Ishikawa (Fishbone) diagram. Most of the identified factors (87.5%; n = 40) facilitated in-hospital PEs. The most frequently identified facilitating factor (39.6%; n = 19) was ‘insufficient (drug) knowledge, prescribing skills and/or experience of prescribers’. Conclusion: The findings of this review could be used to identify points of engagement for future intervention studies and help hospitals determine how to optimize prescribing. A multifaceted intervention, targeting multiple factors might help to circumvent the complex challenge of in-hospital PEs.
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from the repository of Utrecht University: "PURPOSE: Previously, a high prevalence of certain psychiatric disorders was shown among non-Western immigrants. This study explores whether this results in more prescriptions for psychotropic medication. METHODS: Data on dispensing of medication among adults living in the four largest Dutch cities in 2013 were linked to demographic data from Statistics Netherlands. Incident (i.e., following no dispensing in 2010-2012) and prevalent dispensing among immigrants was compared to that among native Dutch (N = 1,043,732) and analyzed using multivariable Poisson and logistic regression. RESULTS: High adjusted Odds Ratios (ORadj) of prevalent and high Incidence Rate Ratios (IRRadj) of incident dispensing of antipsychotics were found among Moroccan (N = 115,455) and Turkish individuals (N = 105,460), especially among young Moroccan males (ORadj = 3.22 [2.99-3.47]). Among Surinamese (N = 147,123) and Antillean individuals (N = 41,430), slightly higher rates of dispensed antipsychotics were found and the estimates decreased after adjustment. The estimates for antipsychotic dispensing among the Moroccan and Turkish increased, following adjustment for household composition. Rates for antidepressant dispensing among Turkish and Moroccan subjects were high (Moroccans: ORadj = 1.74 [1.70-1.78]). Among Surinamese and Antillean subjects, the rates for antidepressant dispensing were low and the ORadjlagged behind the IRRadj(Surinamese: 0.69 [0.67-0.71] vs. 1.06 [1.00-1.13]). Similar results were found for anxiolytics. For ADHD medication, lower dispensing rates were found among all migrant groups. CONCLUSIONS: The findings agree with earlier reports of more mental health problems among Moroccan and Turkish individuals. Surinamese/Antillean individuals did not use psychotropic drugs at excess and discontinued antidepressants and anxiolytics earlier. The data strongly suggest under-treatment for ADHD in all ethnic minority groups."
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Uit diverse onderzoeken is naar voren gekomen dat de oudere patiënt extra kwetsbaar is voor medicatiegerelateerde problemen en sneller last van bijwerkingen heeft dan jongeren.Naar de manier waarop ouderen omgaan met hun medicatie is echter nog weinig onderzoek gedaan. Het doel van deze studie was inzicht te krijgen in de manier waarop oudere patiënten hun geneesmiddelengebruik en de begeleiding en voorlichting daarbij organiseren. Tevens is onderzocht in hoeverre deze patiënten therapietrouw waren en of er een relatie was tussen de woonvorm en de wijze waarop patiënten hun medicatiegebruik organiseerden.
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