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  • 1.
    Blomgren, KB.
    et al.
    Mälardalen University, Department of Caring and Public Health Sciences.
    Sundström, A.
    Medical Products Agency, Uppsala, Sweden .
    Steineck, G.
    Karolinska Institutet, Stockholm, Sweden.
    Wiholm, B-E.
    Medical Products Agency, Uppsala, Sweden.
    Interviewer Variability: Quality aspects in a case-control study.2006In: European Journal of Epidemiology, ISSN 0393-2990, Vol. 21, no 4, p. 267-277Article in journal (Refereed)
    Abstract [en]

    Quality assurance and quality control are important for the reliability of case-control studies. Here we describe the procedures used in a previously published study, with emphasis on interviewer variability. To evaluate risk factors for acute pancreatitis, information including previous diagnoses and medication was collected from medical records and by telephone interviews from 462 cases and 1781 controls. Quality assurance procedures included education and training of interviewers and data validity checks. Quality control included a classification test, annual test interviews, expert case validation, and database validation. We found pronounced variations between interviewers. The maximal number of interviews per day varied from 3 to 9. The adjusted average (95% CI) number of diagnoses captured per interview of cases was 4.1 (3.8-4.3) and of controls 3.5 (3.4-3.7) (excluding one deviating interviewer). For drugs, the average (95% CI) number per interview was 3.9 (3.7-4.1) for cases and 3.3 (3.2-3.4) for controls (excluding one deviating interviewer). One of the fourteen interviewers deviated significantly from the others, and more so for controls than for cases. This interviewer's data ;were excluded. Nonetheless, data concerning controls more frequently needed correction and supplementation than for cases. Erroneous coding of diagnoses and medication was also more frequent among controls. Thus, a system for quality control of coding practices is crucial. Variability in interviewers' ability to ascertain information is a possible source of bias in interview-based case-control studies when "blinding" cannot be achieved.

  • 2.
    Holm, L.
    et al.
    Medical Product Agency, Uppsala, Sweden.
    Ekman, E.
    Skåne University Hospital, Lund, Sweden.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, no 3, p. 335-343Article in journal (Refereed)
    Abstract [en]

    Purpose: To investigate how reporting of adverse drug reactions (ADRs) among adults in Sweden is associated to age and sex, in addition to seriousness of the reaction and drug utilisation. Methods: Individual case safety reports (ICSRs) reported by healthcare professionals to the national pharmacovigilance database 2008–2011 were related to defined daily dose (DDD) in the Swedish Prescribed Drug Register (SPDR) for individual’s ≥20 years. Data were stratified into five age groups. Crude and adjusted (by age standardisation of prescribed drugs) reporting rate (RR) and reporting rate ratio was evaluated as well as impact of sex-dependent drugs. Results: Based on 9898 included ICSRs, the crude results show that overall RR was almost similar for both serious and non-serious reports and indicates highest RR in the youngest age group. Women had higher rates than men, with predominance for non-serious reports, contrary to men who had a higher RR of serious ones. Standardisation led partly to the same result, but age-related distribution was adjusted, with highest overall RR in the oldest age groups. Sex-dependent drugs had marginal impact on the results. Conclusion: Age and sex have impact on spontaneous reporting of ADRs. After adjusting for dispensed drugs and by standardisation of age-related differences in prescribed drugs, results indicate that healthcare professionals more frequently reported ADRs for the oldest individuals and for women. Serious reports were more frequently reported for men. 

  • 3.
    Holm, Lennart
    et al.
    Karolinska Univ.
    Ekman, Elisabet
    Skåne Univ Hosp.
    Mejyr, Stefan
    Karolinska Univ Hosp.
    Blomgren-Jorsater, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare.
    Effects of Age and Sex on Adverse Drug Reaction Reporting in Relation to Drug Utilization in Sweden2011In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 20, p. S117-S117Article in journal (Other academic)
  • 4.
    Johansson-Pajala, Rose-Marie
    et al.
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Gustafsson, Lena-Karin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Fastbom, Johan
    Stockholm University, Stockholm.
    Martin, Lene
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Nurses' use of computerised decision support systems affects drug monitoring in nursing homes2017In: Journal of Nursing Management, ISSN 0966-0429, E-ISSN 1365-2834, Vol. 25, no 1, p. 56-64Article in journal (Refereed)
    Abstract [en]

    Aim: To describe variations in nurses' perceptions of using a computerised decision support system (CDSS) in drug monitoring. Background: There is an increasing focus on incorporating informatics into registered nurses' (RNs) clinical practice. Insight into RNs’ perceptions of using a CDSS in drug monitoring can provide a basis for further development of safer practices in drug management. Method: A qualitative interview study of 16 RNs. Data were analysed using a phenomenographic approach. Results: The RNs perceived a variety of aspects of using a CDSS indrug monitoring. Aspects of ‘time’ were evident, as was giving a ‘standardisation’ to the clinical work. There were perceptions of effects of obtained knowledge and ‘evidence’ and the division of ‘responsibilities’ between RNs and physicians of using the CDSS. Conclusion: The RNs perceived a CDSS as supportive in drug monitoring, in terms of promoting standardised routines, team-collaboration and providing possibilities for evidence-based clinical practice. Implications: Implementing a CDSS seems to be one feasible strategy to improve RNs’ preconditions for safe drug management. Nurse managers’ engagement and support in this process are vital for a successful result.

  • 5.
    Johansson-Pajala, Rose-Marie
    et al.
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Bastholm-Rahmner, P.
    Karolinska Institutet, Stockholm.
    Fastbom, J.
    Karolinska Institutet, Stockholm.
    Martin, Lene
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare. City University London, United Kingdom.
    Nurses in municipal care of the elderly act as pharmacovigilant intermediaries: A qualitative study of medication management2016In: Scandinavian Journal of Primary Health Care, ISSN 0281-3432, E-ISSN 1502-7724, Vol. 34, no 1, p. 37-45Article in journal (Refereed)
    Abstract [en]

    Objective: To explore registered nurses experience of medication management in municipal care of the elderly in Sweden, with a focus on their pharmacovigilant activities. Design: A qualitative approach using focus-group discussions was chosen in order to provide in-depth information. Data were analysed by qualitative content analysis. Setting: Five focus groups in five different long-term care settings in two regions in Sweden. Subject: A total of 21 registered nurses (RNs), four men and 17 women, aged 27-65 years, with 4-34 years of nursing experience. Results: The findings reveal that RNs in municipal long-term care settings can be regarded as "vigilant intermediaries" in the patients drug treatments. They continuously control the work of staff and physicians and mediate between them, and also compensate for existing shortcomings, both organizational and in the work of health care professionals. RNs depend on other health care professionals to be able to monitor drug treatments and ensure medication safety. They assume expanded responsibilities, sometimes exceeding their formal competence, and try to cover for deficiencies in competence, experience, accessibility, and responsibility-taking. Conclusion: The RNs play a central but also complex role as "vigilant intermediaries" in the medication monitoring process, including the issue of responsibility. Improving RNs possibility to monitor their patients drug treatments would enable them to prevent adverse drug events in their daily practice. New strategies are justified to facilitate RNs pharmacovigilant activities. Key points This study contributes to the understanding of registered nurses (RNs) role in medication management in municipal care of the elderly (i.e. detecting, assessing, and preventing adverse drug events or any drug-related problems).RNs can be considered to be "vigilant intermediaries" in elderly patients drug treatments, working at a distance from staff, physicians, and patients. RNs occasionally take on responsibilities that exceed their formal competence, with the patients best interests in mind. In order to prevent adverse drug events in municipal care of the elderly, new strategies are justified to facilitate RNs pharmacovigilant activities. 

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  • 6.
    Johansson-Pajala, Rose-Marie
    et al.
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Martin, Lene
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Registered nurses’ use of computerised decision support in medication reviews: Implications in Swedish nursing homes2018In: International Journal of Health Care Quality Assurance, ISSN 0952-6862, E-ISSN 1758-6542, Vol. 31, no 6, p. 531-544Article in journal (Refereed)
    Abstract [en]

    Purpose: The purpose of this paper is to explore the implications of registered nurses’ (RNs) use of a computerized decision support system (CDSS) in medication reviews. Design/methodology/approach: The paper employs a quasi-experimental, one-group pre-test/post-test design with three- and six-month follow-ups subsequent to the introduction of a CDSS. In total, 11 RNs initiated and prepared a total of 54 medication reviews. The outcome measures were the number of drug-related problems (DRPs) as reported by the CDSS and the RNs, respectively, the RNs’ views on the CDSS, and changes in the quality of drug treatment. Findings: The CDSS significantly indicated more DRPs than the RNs did, such as potential adverse drug reactions (ADRs). The RNs detected additional problems, outside the scope of the CDSS, such as lack of adherence. They considered the CDSS beneficial and wanted to continue using it. Only minor changes were found in the quality of drug treatments, with no significant changes in the drug-specific quality indicators (e.g. inappropriate drugs). However, the use of renally excreted drugs in reduced renal function decreased. Practical implications: The RNs’ use of a CDSS in medication reviews is of value in detecting potential ADRs and interactions. Yet, in order to have an impact on outcomes in the quality of drug treatment, further measures are needed. These may involve development of inter-professional collaboration, such as established procedures for the implementation of medication reviews, including the use of CDSS. Originality/value: This is, to the best of the authors’ knowledge, the first study to explore the implications of medication reviews, initiated and prepared by RNs who use a CDSS. The paper adds further insight into the RNs’ role in relation to quality of drug treatments.

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  • 7.
    Johansson-Pajala, Rose-Marie
    et al.
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Martin, Lene
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Jorsäter-Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Implications of computer-supported medication reviews in Swedish nursing homes, led by nursesManuscript (preprint) (Other academic)
  • 8.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Computer support and collaboration in the older Person's medication use2019In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 28, no Suppl 2 SI, p. 291-291Article in journal (Other academic)
  • 9.
    Martin, Lene
    et al.
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Johansson-Pajala, Rose-Marie
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Jorsäter Blomgren, Kerstin
    Mälardalen University, School of Health, Care and Social Welfare, Health and Welfare.
    Fastbom, Johan
    Karolinska Institutet, Sweden.
    Nurses' self-reported medication competence in relation to their pharmacovigilant activities in clinical practice2015In: Journal of Evaluation In Clinical Practice, ISSN 1356-1294, E-ISSN 1365-2753, Vol. 21, no 1, p. 145-152Article in journal (Refereed)
    Abstract [en]

    Rationale, aims and objectives

    Adverse drug reactions (ADRs) represent a major health problem and previous studies show that nurses can have an active role in promoting medication safety. The aim of this study was to describe and evaluate nurses' self-reported competence and pharmacovigilant activities in clinical practice and also to explore the impact of age, education, workplace and nursing experience on these matters.

    Methods

    This cross-sectional study was based on a questionnaire covering areas related to nurses' medication competence, including knowledge, assessment and information retrieval, and pharmacovigilant activities within these areas, for example, the detection and assessment of ADRs. A 45-item questionnaire was 2013 sent out to 296 nurses in different settings and counties in Sweden. They were selected on the basis of having applied to a university course including pharmacovigilance during 2008–2011. One hundred twenty-four had participated in the courses (exposed) and 172 had applied to the courses but not participated (unexposed).

    Results

    Completed questionnaires were obtained from 75 exposed (60%) and 93 unexposed (54%) nurses. Overall nurses rated themselves high in medication competence but low in pharmacovigilant activities. Significant (P ≤ 0.001) differences between groups were observed regarding medication competence. The exposure of completed dedicated courses in pharmacovigilance was the strongest factor for self-reported medication competence when adjusted for age, other education, workplace and experience. No significant differences between the groups were found regarding the number of pharmacovigilant activities during the 6 months prior to answering the questionnaire.

    Conclusion

    Dedicated university courses improved nurses' self-reported competence in pharmacovigilance but did not increase the number of related activities. Education per se seems to be not sufficient to generate pharmacovigilant activities among nurses.

  • 10.
    Sundström, A.
    et al.
    University Hospital, Stockholm, Sweden .
    Blomgren, KB.
    Mälardalen University, Department of Caring and Public Health Sciences. University Hospital, Stockholm, Sweden .
    Alfredsson, L.
    Karolinska Institutet, Stockholm, Sweden.
    Wiholm, B-E.
    University Hospital, Stockholm, Sweden .
    Acid – suppressing drugs and gastro-esophageal reflux disease as risk factors for acute pancreatitis – results from a Swedish Case-Control Study.2006In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 15, no 3, p. 141-9Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To study risk factors for acute pancreatitis, here with emphasis on gastro-intestinal diseases and their treatments. METHODS: Population based case-control study covering four areas in Sweden encompassing 2.2 million inhabitants. Included were 462 incident cases of acute pancreatitis aged 20-85 years, hospitalized from 1 January 1995-31 May 1998, and 1,781 unmatched controls randomly selected from the study base using a population register. Information was captured from medical records and structured telephone interviews. RESULTS: Current use of H(2) antagonists starting within 6 months of index-date was associated with acute pancreatitis with an adjusted OR of 4.9 (95% confidence interval (CI) 1.6-15), and current use of proton pump inhibitors (PPIs) with an adjusted OR of 3.2 (95%CI 1.4-7.4). For both drug classes, the ORs tended to be higher at higher doses. Gastritis/gastro-esophageal reflux disease (GERD) within the last 12 months not treated with PPIs or H(2)-antagonists and inflammatory bowel disease (IBD) not treated with anti-inflammatory or immunosuppressive drugs were associated with development of acute pancreatitis with adjusted odds ratios (OR) of 1.9 (95%CI 1.2-3.0) and 5.1 (95%CI 2.0-13) respectively. CONCLUSIONS: Current IBD without treatment and gastritis/GERD without treatment were found to be associated with increased risks to develop acute pancreatitis but the nature of the latter association needs to be further evaluated. On balance, we judge that the observed associations between current use of H(2)-antagonists and PPIs and increased risk of acute pancreatitis are unlikely to be explained by bias.

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