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Medical students as junior adverse drug event managers facilitating reporting of ADRs

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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Medical students as junior adverse drug event managers facilitating reporting of ADRs

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Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice

Abstract Managing adverse drug reactions (ADRs) is a challenge, especially because most healthcare professionals are insufficiently trained for this task. Since context-based clinical pharmacovigilance training has proven effective, we assessed the feasibility and effect of a creating a team of Junior-Adverse Drug Event Managers (J-ADEMs). The J-ADEM team consisted of medical students (1st–6th year) tasked with managing and reporting ADRs in hospitalized patients. Feasibility was evaluated using questionnaires. Student competence in reporting ADRs was evaluated using a case-control design and questionnaires before and after J-ADEM program participation. From Augustus 2018 to Augustus 2019, 41 students participated in a J-ADEM team and screened 136 patients and submitted 65 ADRs reports to the Netherlands Pharmacovigilance Center Lareb. Almost all patients (n = 61) found it important that “their” ADR was reported, and all (n = 62) patients felt they were taken seriously by the J-ADEM team. Although attending physicians agreed that the ADRs should have been reported, they did not do so themselves mainly because of a “lack of knowledge and attitudes” (50%) and “excuses made by healthcare professionals” (49%). J-ADEM team students were significantly more competent than control students in managing ADRs and correctly applying all steps for diagnosing ADRs (control group 38.5% vs. intervention group 83.3%, p < 0.001). The J-ADEM team is a feasible approach for detecting and managing ADRs in hospital. Patients were satisfied with the care provided, physicians were supported in their ADR reporting obligations, and students acquired relevant basic and clinical pharmacovigilance skills and knowledge, making it a win-win-win intervention.

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Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice

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The potential of training specialist oncology nurses in real‑life reporting of adverse drug reactions

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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The potential of training specialist oncology nurses in real‑life reporting of adverse drug reactions

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An inter-professional student-run medication review programme. Reducing adverse drug reactions in a memory outpatient clinic

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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An inter-professional student-run medication review programme. Reducing adverse drug reactions in a memory outpatient clinic

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Medication Management in Homecare Patients

In Nederland gebruiken 65 plussers drie keer zoveel medicijnen als de gemiddelde Nederlander. Voor 75 plussers geldt dat zij vijf keer zoveel medicijnen gebruiken. In combinatie met leeftijdsgerelateerde natuurlijke veranderingen in het metabolisme, verminderde cognitie, multi-morbiditeit, verminderde nierfunctie, polyfarmacie en verminderde capaciteit tot herstel, zijn ouderen kwetsbaar voor medicatiegerelateerde problemen. Thuiszorg cliënten zijn doorgaans ouder dan 65 jaar, waardoor er vaker sprake is van polyfarmacie en verminderde cognitie. Daarom bevinden zich vooral in deze populatie cliënten, die kwetsbaar zijn voor medicatiegerelateerde problemen. Verschillende studies hebben aangetoond dat huisartsen en apothekers een bijdrage kunnen leveren aan het herkennen van medicatiegerelateerde problemen bij hun patiënten. Er is echter weinig aandacht besteed aan het vroegsignaleren van observaties die kunnen duiden op een medicatie gerelateerd probleem door thuiszorgmedewerkers. In aanvulling op de huisarts en apotheker zouden thuiszorgmedewerkers, die hun patiënten op regelmatige basis thuis bezoeken, een bijdrage kunnen leveren aan het vroegsignaleren van potentiële medicatiegerelateerde problemen. Het doel van dit proefschrift is het: 1. verkennen van de opvattingen van ouderen ten aanzien van hun medicatie en hun medicatie management capaciteit gerelateerd aan zelfmanagement vaardigheden en cognitie; 2. beschrijven van de kennis, houding en medicatie management praktijk van thuiszorgmedewerkers; 3. vaststellen of een gestandaardiseerde observatielijst leidt tot vroegsignalering van potentiële medicatiegerelateerde problemen in de thuiszorg

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Medication Management in Homecare Patients

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Quality indicators for appropriate in-hospital pharmacotherapeutic stewardship

Aims: In-hospital prescribing errors may result in patient harm, such as prolonged hospitalisation and hospital (re)admission, and may be an emotional burden for the prescribers and healthcare professionals involved. Despite efforts, in-hospital prescribing errors and related harm still occur, necessitating an innovative approach. We therefore propose a novel approach, in-hospital pharmacotherapeutic stewardship (IPS). The aim of this study was to reach consensus on a set of quality indicators (QIs) as a basis for IPS. Methods: A three-round modified Delphi procedure was performed. Potential QIs were retrieved from two systematic searches of the literature, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement. In two written questionnaires and a focus meeting (held between the written questionnaire rounds), potential QIs were appraised by an international, multidisciplinary expert panel composed of members of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Results: The expert panel rated 59 QIs and four general statements, of which 35 QIs were accepted with consensus rates ranging between 79% and 97%. These QIs describe the activities of an IPS programme, the team delivering IPS, the patients eligible for the programme and the outcome measures that should be used to evaluate the care delivered. Conclusions: A framework of 35 QIs for an IPS programme was systematically developed. These QIs can guide hospitals in setting up a pharmacotherapeutic stewardship programme to reduce in-hospital prescribing errors and improve in-hospital medication safety.

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Quality indicators for appropriate in-hospital pharmacotherapeutic stewardship

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An Interprofessional Student-Run Medication Review Program

As the population ages, more people will have comorbid disorders and polypharmacy. Medication should be reviewed regularly in order to avoid adverse drug reactions and medication-related hospital visits, but this is often not done. As part of our student-run clinic project, we investigated whether an interprofessional student-run medication review program (ISP) added to standard care at a geriatric outpatient clinic leads to better prescribing. In this controlled clinical trial, patients visiting a memory outpatient clinic were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The medications of all patients were reviewed by a review panel (“gold standard”), resident, and in the intervention arm also by an ISP team consisting of a group of students from the medicine and pharmacy faculties and students from the higher education school of nursing for advanced nursing practice. For both groups, the number of STOPP/START-based medication changes mentioned in general practitioner (GP) correspondence and the implementation of these changes about 6 weeks after the outpatient visit were investigated. The data of 216 patients were analyzed (control group = 100, intervention group = 116). More recommendations for STOPP/STARTbased medication changes were made in the GP correspondence in the intervention group than in the control group (43% vs. 24%, P = < 0.001). After 6 weeks, a significantly higher proportion of these changes were implemented in the intervention group (19% vs. 9%, P = 0.001). The ISP team, in addition to standard care, is an effective intervention for optimizing pharmacotherapy and medication safety in a geriatric outpatient clinic.

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An Interprofessional Student-Run Medication Review Program

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Returning to the Origins of Multilevel Regulation

The article engages with the recent studies on multilevel regulation. The starting point for the argument is that contemporary multilevel regulation—as most other studies of (postnational) rulemaking—is limited in its analysis. The limitation concerns its monocentric approach that, in turn, deepens the social illegitimacy of contemporary multilevel regulation. The monocentric approach means that the study of multilevel regulation originates in the discussions on the foundation of modern States instead of returning to the origins of rules before the nation State was even created, which is where the actual social capital underlying (contemporary) rules can be found, or so I wish to argue. My aim in this article is to reframe the debate. I argue that we have an enormous reservoir of history, practices, and ideas ready to help us think through contemporary (social) legitimacy problems in multilevel regulation: namely all those practices which preceded the capture of law by the modern State system, such as historical alternative dispute resolution (ADR) practices.

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Returning to the Origins of Multilevel Regulation

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The application of arbitration in transnational private regulation

This paper investigates the prospective application of arbitration by Transnational Private Regulation (TPR). It builds on the study of TPR developed by Fabrizio Cafaggi et al. TPR addresses the ever-increasing transfer of regulatory power from national to global levels, and from public to private regulators. TPR entails private regulatory co-operation be-yond the jurisdictional boundaries of States through voluntary standards. The regimes of TPR are built by a variety of actors, such as companies, NGOs, independent experts, and epistemic communities. Examples of TPR can be found in food safety, forestry management, trade, and derivatives, among other fields. More specifically, they concern private actors engaging in transnational coordination of standard setting such as the Forest Stewardship Council (FSC) that was developed to foster responsible management of the world’s forests. There are four main characteristics of TPR: legitimacy, quality, effectiveness, and enforcement. I will describe those four characteristics in brief here. First, the legitimacy of TPR is built around consent through voluntary entry, participation, and exit of regulated entities. Important to this contribution is that the legitimacy of TPR goes beyond its legal dimension, measured by purely legal standards. Hence, the legitimacy of TPR is largely determined by standards developed by social and economic institutions relevant to specific TPR regimes. The role of those institutions in standard settings is higher in private TPR regimes than private-public TPR regimes, where some forms of compliance are mandatory. Second, the quality of TPR corresponds to the ex ante and ex post evaluation cycle of regulatory processes. It is also linked with the transparency of TPR. Third, the effectiveness of TPR is measured according to the extent to which the objectives of TPR (or selected TPR regimes) are met. And finally, enforcement of TPRis understood as ‘ensuring compliance with commitments’. Enforcement of TPR can take place through courts, administrative agencies, and private dispute resolution—including the arbitration at the core of this contribution. Cafaggi’s study identified rather selective use of arbitration in TPR, but also recommended changes to make arbitration law more adaptable to TPR. Furthermore, the study recommended that more specialized dispute resolution institutions are created to exclusively serve TPR. Against this background, I shift the main focus of analysis from TPR to arbitration. Whereas Cafaggi argued that arbitration may be suitable for TPR as a means of private enforcement, in this paper I go even further, arguing that arbitration as a means of informal, out-of-court dispute resolution is well suited to strengthen the normativity of TPR. This is so because private arbitration actors (including, inter alia, arbitrators and arbitral institutions) are already equipped with the tools necessary to facilitate cross-border TPR, which is done through informal standards and procedures with origins in the communitarian values and reputational mechanisms used by different communities before the development of modern States. The roots of most private justice regimes—including arbitration—are informed by communitarian values such as collaboration, participation, and personal trust. Those values, together with other core characteristics of arbitration correspond to all core characteristics of TPR, making both systems comparable and complementary. The analytical framework incorporated in this paper follows the four core characteristics of TPR. Hence, the paper is organized into five sections. The first section contains the introduction. In the second section, I analyze the legitimacy of arbitration vis-à-vis the legitimacy of TPR. In the third section, I investigate the accountability of arbitration as a means of quality signaling vis-à-vis TPR. In the fourth section, I focus on the remedies available to arbitrators in a view of TPR’s effectiveness. Finally, in the fifth section, I analyze enforcement through arbitration and its impact on the exclusiveness versus complementarity of TPR regimes. Conclusions follow, including recommendations for future research. Part of topic "The blurring distinction between public and private in international dispute resolution"

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Medical students as junior adverse drug event managers facilitating reporting of ADRs

Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice

The potential of training specialist oncology nurses in real‑life reporting of adverse drug reactions

An inter-professional student-run medication review programme. Reducing adverse drug reactions in a memory outpatient clinic

Medication Management in Homecare Patients

Quality indicators for appropriate in-hospital pharmacotherapeutic stewardship

An Interprofessional Student-Run Medication Review Program

Returning to the Origins of Multilevel Regulation

The application of arbitration in transnational private regulation

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Medical students as junior adverse drug event managers facilitating reporting of ADRs

Medical students as adverse drug event managers, learning about side effects while improving their reporting in clinical practice

The potential of training specialist oncology nurses in real‑life reporting of adverse drug reactions

An inter-professional student-run medication review programme. Reducing adverse drug reactions in a memory outpatient clinic

Medication Management in Homecare Patients

Quality indicators for appropriate in-hospital pharmacotherapeutic stewardship

An Interprofessional Student-Run Medication Review Program

Returning to the Origins of Multilevel Regulation

The application of arbitration in transnational private regulation