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  • 1. Broms, Gabriella
    et al.
    Kieler, Helle
    Ekbom, Anders
    Gissler, Mika
    Hellgren, Karin
    Leinonen, Maarit K.
    Pedersen, Lars
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Sorensen, Henrik Toft
    Granath, Fredrik
    Infant Infections after Maternal Anti-TNF Treatment in Pregnancy2019In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 28, p. 10-10Article in journal (Other academic)
  • 2. Bröms, Gabriella
    et al.
    Kieler, Helle
    Ekbom, Anders
    Hellgren, Karin
    Gissler, Mika
    Lahesmaa-Korpinen, Anna-Maria
    Pedersen, Lars
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Sorensen, Henrik T.
    Granath, Fredrik
    Tnf inhibitor treatment during pregnancy and risk of preterm birth2018In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, p. 30-31, article id 60Article in journal (Other academic)
  • 3.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Mjörndal, Tom
    Dahlqvist, Rune
    Spontaneous reporting of adverse drug reactions by nurses2002In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 8, p. 647-650Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Spontaneous reporting of adverse drug reactions (ADRs) remains one of the most effective methods to detect new and serious drug reactions. However, it is well known that there is a high degree of under-reporting. OBJECTIVE: This study was carried out as an attempt to improve and increase the reporting of ADRs by investigating the utility of nurses reporting in addition to physicians, as usual. METHODS: During a 12-month study period, nurses working at two departments of geriatric medicine in northern Sweden received special instruction regarding drugs and ADRs, ADR reporting and special aspects of ADRs in elderly people. The reports from the nurses were scrutinized concerning the seriousness of the reaction, reported drugs and type of reaction (type A or B). All nurses working at the two departments (117) were eligible to report but in practice only those attending the teaching sessions did so. A comparison with historical reporting and with reporting from other geriatric departments in Sweden was also carried out. At the end of the study all participating nurses received a questionnaire aimed at investigating their attitudes towards ADR reporting. RESULTS: After the 12-month study period 18 ADR reports involving 22 reactions had been received. Seven of these were assessed as serious reactions. All of the reactions were of type A. In comparison, during the corresponding time period from the study clinics during the preceding year, only two reports were registered. During the study period only 15 reports were registered from the other 50 geriatric departments in Sweden. CONCLUSION: Even though the total number of ADR reports was small, our data indicate a substantial increase in the reporting rate. This indicates that instructed and interested nurses could play an important role in detecting and reporting suspected ADRs.

  • 4.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Mjörndal, Tom
    Dahlqvist, Rune
    Under-reporting of serious adverse drug reaction in Sweden2004In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 13, no 7, p. 483-487Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Adverse drug reactions (ADR) constitute a major problem, both from a medical point of view and as an economical burden. Spontaneous reporting of ADRs is one of the methods for post marketing surveillance of drug safety. Under-reporting can also provide an important obstacle to rapid and relevant signal detection. AIM: To investigate the rate of under-reporting serious ADRs of selected ICD 10 diagnoses. METHOD: In order to investigate the under-reporting rate we investigated at five hospitals within the county of Norrbotten in Sweden the total number of diagnosed cases during a period of 5 years (1996-2000) with the following diagnoses: cerebral haemorrhage (I 61.0-I 61.9), pulmonary embolism (I 26.0 and I 26.9), embolism or thrombosis (I 74.0-I 74.9), phlebititis, thrombophlebitits or venous thrombosis (I 80.0-I 80.3, I 80.8 and I 80.9) and portal vein thrombosis and other thrombosis or emboli (I 82.0-I 82.3, I 82.8 and I 82.9). The identity of these patients was obtained through a database search. The patients' case records were then scrutinized by a specially trained nurse and the drugs used at the time of the event were noted. An assessment of the possibility of an ADR was performed using standard WHO causality criteria. Later, database search in the Swedish ADR registry was performed in order to investigate whether these suspected ADRs had been reported to the national authority in Sweden or not. RESULTS: In total 1349 case records were found and scrutinized. Of these, 107 patients had received drugs that could have been a probable or possible cause to the diagnoses. Of these 92 cases had not been reported and only 15 patients were found in the database, giving an overall under-reporting rate of all ADRs of 86%. The most commonly occurring diagnoses were cerebral haemorrhage followed by venous thrombosis, 545 and 468 respectively. Among those cases that should have been reported according to the existing rules for spontaneous reporting of suspected ADRs the most frequently occurring diagnosis was cerebral haemorrhage (I 61.0) in connection to treatment with anticoagulants. CONCLUSION: The rate of spontaneous ADR reporting is very low, also for serious and fatal reactions.

  • 5.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Mjörndal, Tom
    Dahlqvist, Rune
    Utilization pattern of metamizole in northern Sweden and risk estimate of agranulocytosis2002In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 3, p. 239-245Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: This study was carried out in order to investigate the utilization pattern of metamizole to better estimate the quantitative risk of agranulocytosis since a cluster of such cases have been observed in Sweden. METHODS: Cases of agranulocytosis submitted to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) between 1996 and 1999 were identified. Based on the utilization pattern of metamizole in inpatients at three hospitals and in outpatients in two counties in northern Sweden risk estimates of agranulocytosis during metamizole treatment were estimated. The utilization of metamizole was investigated by scanning 3567 case records at 10 hospital departments as well as stored prescriptions at six pharmacies during a 3-month study period. RESULTS: Ten cases of agranulocytosis during treatment with metamizole have been reported to SADRAC over the period 1996 to 1999. During the 3-month study period metamizole was prescribed to 666 (19%) inpatients. Of these, approximately 96% received the drug for less than 1 week, 7.2% had used the drug previously. At the participating pharmacies 112 metamizole prescriptions for outpatients were found. The drug was prescribed in 34% for less than 1 week, in 28% for 7-15 days, and in 38% for more than 15 days. The mean prescribed daily dose was 2.7 g. Given certain assumptions including the actual amounts prescribed the calculated risks of agranulocytosis would be approximately one out of every 31,000 metamizole-treated inpatients and one of every 1400 metamizole-treated outpatients. CONCLUSION: This study indicates that in most inpatients the use of metamizole in northern Sweden was within the approved indications for the drug. However, a considerable number of outpatients received the drug for a longer time than recommended and this may carry an increased risk for developing agranulocytosis.

  • 6. Gutierrez, Lia
    et al.
    Booth, Helen
    Dedman, Daniel
    Crellin, Elizabeth
    Kaye, James A.
    Franzoni, Carla
    Arana, Alejandro
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Sundström, Anders
    Byström, Camilla
    Case validation of cutaneous lymphoma to minimize protopathic bias2019In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 28, no S2, p. 315-315Article in journal (Other academic)
  • 7. Henriksson, Karin M.
    et al.
    Eriksson, Marie
    Umeå University, Faculty of Social Sciences, Umeå School of Business and Economics (USBE), Statistics.
    Asberg, Signild
    Statin Therapy is Associated with Decreased Risk of First Intracerebral Hemorrhage and Reduced 30-Day Fatality: Results of a Nationwide Observational Study Including 7,696 Cases and 14,670 Controls2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, p. 399-400Article in journal (Other academic)
  • 8.
    Hägg, David
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology. Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
    Eriksson, Marie
    Umeå University, Faculty of Social Sciences, Umeå School of Business and Economics (USBE), Statistics.
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Sundström, Anders
    Psoriasis Patients New to Specialist Care in Sweden 2007-2009: A Two-Year Follow-Up of Treatment Allocation2016In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 25, p. 4-5Article in journal (Other academic)
  • 9.
    Lövheim, Hugo
    et al.
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Geriatric Medicine.
    Karlsson, Stig
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Geriatric Medicine.
    Gustafson, Yngve
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Geriatric Medicine.
    The use of central nervous system drugs and analgesics among very old people with and without dementia2008In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 17, no 9, p. 912-918Article in journal (Refereed)
    Abstract [en]

    PURPOSE: Old people in general, and particularly those with dementia, are more sensitive to adverse drug effects than younger people. Despite this, the use of central nervous system (CNS) drugs among old people is common. The aim of the present study was to compare the use of central nervous system drugs and analgesics among people aged 85 years or older, with and without dementia. METHODS: One half of all people aged 85 years old and all those aged 90, 95 and above in Umeå, Sweden and Vaasa and Mustasaari, Finland, were asked to participate in this part of the GERDA/Umeå 85+ study. Both those living in their own homes and those in institutions were included. Trained investigators performed structured interviews and assessments. Medication data were obtained from the participants and medical records. Dementia disorders were diagnosed according to DSM-IV. RESULTS: Dementia was diagnosed in 247/546 participants (45.2%). A higher proportion of the participants with dementia used paracetamol (50.6% compared to 21.4%, p < 0.001), antipsychotics (22.3% and 2.7%, p < 0.001), antidepressants (33.6% and 11.4%, p < 0.001) and anxiolytics (19.0% and 8.0%, p < 0.001). There were no differences in the use of opioid analgesics, anticonvulsants and hypnotics. CONCLUSIONS: The use of CNS drugs and analgesics was common among this population of very old people. Furthermore, the prescription of CNS drugs was more common among people with dementia. The use of antipsychotics in people with dementia should arouse particular concern, because of the high risk of severe adverse events and the limited evidence of positive effects.

  • 10. Miranda, Jamilette
    et al.
    Lilja, Birgitta
    Wettermark, Bjoern
    Ljunggren, Gunnar
    Henriksson, Roger
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    A Study on Treatment and Characteristics of Prostate Cancer Patients Using Real-World Data2015In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 24, p. 533-533Article in journal (Other academic)
  • 11.
    Mjörndal, Tom
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Boman, Marit Danell
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Hägg, Staffan
    Bäckström, Martin
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Wiholm, Bengt-Erik
    Wahlin, Anders
    Dahlqvist, Rune
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Adverse drug reactions as a cause for admissions to a department of internal medicine.2002In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 1, p. 65-72Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To assess the occurrence and pattern of adverse drug reactions as a cause for acute hospital admission.

    METHODS: In 681 randomly selected patients, acutely admitted to a clinic of internal medicine at a Swedish university hospital, information was collected from their medical records about current symptoms and use of drugs, previous diseases and the results of medical investigations and tests. In addition, a standardized interview according to a questionnaire was carried out. A group of experts in clinical pharmacology assessed the data obtained from the patients' case records and the results of the interviews, and then, according to WHO criteria, judged the probability that an adverse drug reaction could have caused or contributed to the actual admission to hospital.

    RESULTS: Out of the 681 cases included, 94 (13.8%) had symptoms and signs that were judged as drug-related and that had caused or contributed to the admission. Eighty-two patients (12.0%) had altogether 99 symptoms that were classified as adverse drug reactions. Of these, 91% were type A reactions. The relationship between the medication and the reaction was judged certain in eight, probable in 17, and possible in 74 cases. The most common adverse drug reactions were cardiovascular (36.3%). Twelve patients (1.8%) had symptoms indicating intoxications.

    CONCLUSIONS: The prevalence of drug-related problems causing or contributing to admission to a clinic of internal medicine is high and is dominated by type A reactions, i.e. reactions in principle predictable and preventable. This implies a possibility to increase drug safety by preventive measures.

  • 12.
    Sjölander, Maria
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Clinical Pharmacology.
    Eriksson, Marie
    Umeå University, Faculty of Social Sciences, Umeå School of Business and Economics (USBE), Statistics.
    Glader, Eva-Lotta
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Few sex differences in the use of drugs for secondary prevention after stroke: a nationwide observational study2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no 9, p. 911-919Article in journal (Refereed)
    Abstract [en]

    PURPOSE: This observational study describes the sex differences in the use of secondary preventive drugs after ischemic stroke in terms of prescribing and persistence. Also, sex differences in patient- and treatment-related factors associated with drug use were investigated.

    METHODS: In this nationwide register-based study, the Swedish Stroke Register was linked to the Swedish Prescribed Drug Register for information on drugs prescribed for, and bought by, stroke patients. Background factors were included from the Swedish Stroke Register.

    RESULTS: Included in the database were 9331 men and 9018 women. Men were more often prescribed statins, 48.8% versus 38.1% [age-adjusted prevalence ratio (PR) = 0.86, 95%CI = 0.82-0.91], and warfarin, 38.4% versus 26.4% after stroke (age-adjusted PR = 0.88, 95%CI = 0.79-0.97). There were no differences in prescribing of antihypertensive or antiplatelet drugs. No sex differences were seen regarding not continuing drug treatment after discharge (primary non-adherence). Women had slightly higher persistence to antihypertensive treatment 2 years after discharge, 76.3% versus 71.9% for men (age-adjusted PR = 1.05, 95%CI = 1.00-1.09), but there were no differences in persistence to antiplatelet, warfarin or statin treatments. Similar factors were related to statin and warfarin prescribing for both men and women. Only antihypertensive treatment before stroke was associated to persistence to antihypertensive treatment, and this increased persistence for both men and women.

    CONCLUSIONS: This study showed few differences between men and women after stroke. Patients' use of secondary preventive drugs needs to be improved, and from a public health perspective, poor persistence is probably a greater problem than differences between the sexes. Copyright © 2011 John Wiley & Sons, Ltd.

  • 13. Tan, Edwin C. K.
    et al.
    Johnell, Kristina
    Bell, J. Simon
    Garcia-Ptacek, Sara
    Fastbom, Johan
    Nordström, Peter
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation.
    Eriksdotter, Maria
    Does use of acetylcholinesterase inhibitors prevent or delay the prescribing of psychotropic medications in people with dementia?: Analyses of the Swedish dementia registry (SveDem)2019In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 28, p. 424-425Article in journal (Other academic)
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