umu.sePublications
Change search
Refine search result
1 - 9 of 9
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Rows per page
  • 5
  • 10
  • 20
  • 50
  • 100
  • 250
Sort
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
Select
The maximal number of hits you can export is 250. When you want to export more records please use the Create feeds function.
  • 1.
    Bäckström, Martin
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Spontaneous reporting of adverse drug reactions: Possibilities and limitations2005Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Adverse drug reactions (ADRs) constitute a major problem in society and in drug therapy. They are a common cause of short-term hospitalization, prolonged hospitalization and death. Spontaneous reporting of ADRs remains one the most effective methods for detecting new and serious drug reactions. In Sweden physicians are legally required to report fatal and serious ADRs. We know from previous studies that there is a substantial degree of under-reporting of ADRs also in Sweden.

    Attitudes towards reporting of ADRs among physicians in the northern region of Sweden were investigated using a questionnaire. The most important factor for not reporting ADRs among physicians and general practioners in our region was that the reaction was considered to be well known. However, their attitudes could also allow for a considerable rate of under-reporting.

    The effect on the reporting rate when nurses received instruction and were encouraged to report ADRs was studied. During a 12-month study period, 18 ADR reports with a total number of 22 ADRs were sent in by the nurses participating in the study to test nurses as reporters of ADRs.

    Using the Swedish ADR database, we calculated the risk of agranulocytosis associated with the use of metamizole by using consumption data from the case records of scrutinized patients’ and stored prescriptions. Over the period from 1996 to 1999, ten cases of agranulocytosis during treatment with metamizole were reported to SADRAC. Metamizole was prescribed to 666 (19%) inpatients during the 3-month study period and 112 prescriptions were identified at the participating pharmacies. Thirty-eight percent of them indicated treatment for more than 15 days. Making certain assumptions, the calculated risk of agranulocytosis was one out of every 31 000 inpatients and one out of every 1400 outpatients. The degree of under-reporting of serious ADRs was studied in five hospitals. More than 1300 case records were scrutinized and among these we found 107 cases that according to current rules for ADR reporting, should have been reported. Only fifteen of these were found in the SADRAC database, indicating a under-reporting rate of 86%.The effect on the reporting rate of ADRs was studied in an intervention study in which a small economical inducement was given to those who reported ADRs.

    The effect of a small economical stimulation to increase the reporting rate was studied. From the intervention area we received 62 suspected ADRs compared with 50 from the control area. The increase in the number of reports was 59% compared with an unchanged reporting rate from the control area.

    The physicians in northern Sweden have a relatively good knowledge of the existing rules for ADR reporting. Nurses could play an important role in detecting and reporting suspected ADRs.

    The risk of developing an metamizole induced agranulocytosis is considerably increased if metamizole is given to patients for a longer time than recommended. The rate of reported ADRs is very low, also for serious and fatal reactions. An increase in the reporting rate of suspected ADRs was observed during study period.

  • 2.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Clinical Pharmacology.
    Ekman, Elizabet
    Regional Pharmacovigilance Unit, Skanes University hospital, CKFL, Lund, Sweden.
    Attitudes among nurses in Sweden and factors for their reporting of adverse drug reactions2011In: Abstracts 27th International Conference on Pharmacoepidemiology & Therapeutic Risk Management Hyatt Regency Chicago: Chicago, Illinois, USA August 14–17, 2011, Wiley , 2011, Vol. 20, p. S202-S203Conference paper (Refereed)
    Abstract [en]

    Background: Adverse drug reactions (ADRs) is a common cause for hospitalization and death. Spontaneous reporting of ADRs remains as one of the cornerstones in post marketing drug safety surveillance. In March 2007 the Medical Product Agency (MPA) in Sweden decided to also accept reports of suspected ADRs from all nurses.

    Objectives: This study was designed to investigate attitudes and factors for reporting adverse drug reactions (ADRs) from nurses within the health care system in Sweden.

    Methods: A questionnaire was distributed to 753 randomly selected nurses in Sweden.

    Results: The most important factors in their decision to report as suspected ADRs were the severity, if the drug was newly approved and if the reaction were unusual. The nurses with a shorter professional experience responded to a higher degree than their colleagues that they made other priorities, did not have the time or where unaware/uncertain what and how to report. Almost two - thirds of the responders assessed that they had insufficient pharmacological knowledge. A vast majority (84%) of the responders would prefer a possibility to report a suspected ADR using a web - based formula.

    Conclusions: Nurses in Sweden have a fairly good knowledge about the existing rules for reporting. However, there is room for improvement in some areas. Further education and information is needed.

  • 3.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Mjörndal, Tom
    A small economic inducement to stimulate increased reporting of adverse drug reactions - a way of dealing with an old problem?2006In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 62, no 5, p. 381-385Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To assess the effect of a small economic inducement on the rate of spontaneous reporting of adverse drug reactions (ADRs) and the attitudes of general practitioners and physicians towards reporting of ADRs. METHOD: One intervention and one control county were selected for the study. Written information about the main purpose of spontaneous reporting of ADRs was personally addressed to all physicians in the two counties. The information was identical, except for the addition that during a period of 6 months two lottery tickets would be given to the receivers in the intervention area with the standard personal feedback to the reporter of the ADR. After the 6-month study period, the actual number of reported ADRs and the seriousness of the reported ADRs were assessed. To investigate the attitude towards this stimulation of reporting, a questionnaire was addressed to all physicians within the intervention area (IA). RESULTS: From the IA a total number of 57 ADR reports were received containing 62 suspected ADRs, 40% of which were assessed as serious reactions. From the control area (CA), 49 reports containing 50 suspected ADRs were received, 32% of which were assessed as serious reactions. The increase of ADR reports from the IA compared to the same time period the previous year was 59% as compared to an unchanged reporting from the CA. Of those responding to the questionnaire, 80% did not believe that a small economic bonus would be a useful tool to improve the reporting rate. CONCLUSION: A small economic inducement is associated with an increase in the reporting of suspected ADRs.

  • 4.
    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.

  • 5.
    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.

  • 6.
    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.

  • 7.
    Bäckström, Martin
    et al.
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Pharmacology.
    Mjörndal, Tom
    Dahlqvist, Rune
    Nordkvist Olsson, Torborg
    Attitudes to reporting adverse drug reaction in northern Sweden2000In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 56, no 9-10, p. 729-732Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: This study was designed to investigate attitudes of general practitioners (GPs) and hospital physicians in Sweden towards spontaneous reporting of adverse drug reactions (ADRs). METHOD: Two areas in the northern region of Sweden were selected for the study. A knowledge and attitude questionnaire followed by a reminder letter 2 weeks later was addressed to all GPs and hospital physicians in the study areas. RESULT: The total response rate from the study areas was 748 of the 1274 questionnaires sent out (58.7%). Of those who responded, 236 were GPs, 433 were hospital physicians and 79 had other positions. Of the responders, 252 stated that they had never reported any ADR and 488 that they had reported at least once in their career. Issues that came out as important in the decision to report or not to report were whether the reaction was considered well-known or not, the severity of the reaction, hesitance to report only on suspicion, lack of knowledge of existing rules, giving priority to other matters and lack of time to report ADRs. Only minor differences in these regards were observed between male and female physicians. CONCLUSION: Our investigation shows that the physicians in northern Sweden have a fairly good knowledge about the existing rules for reporting ADRs in Sweden. However, the attitudes leave room for considerable under-reporting due to matters related mainly to the medical impact of the reaction and of reporting it, but also to the scientific "paradox" of reporting only on suspicion and of course due to lack of time in the health care setting.

  • 8. Ekman, Elisabet
    et al.
    Bäckström, Martin
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Clinical Pharmacology.
    Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden2009In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 65, no 1, p. 43-46Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: This study was designed to investigate attitudes to and incentive for reporting adverse drug reactions (ADRs) in general and towards nurses as reporters of ADRs in particular in a sample of hospital physicians. METHOD: A questionnaire was sent to 1,201 randomly selected hospital physicians. RESULTS: The main factors for the decision to report an ADR were the severity of the reaction, a reaction to a new drug, and an unusual reaction. The most important factor for refraining from reporting was that the reaction was well known. There were no significant differences between males and females or between age groups in these aspects. A majority were positive or neutral to nurses as reporters. Only 6% stated that their willingness to report ADRs would be affected in a negative way if nurses were involved in the program for reporting. CONCLUSIONS: The results of this survey showed that inclusion of hospital nurses as reporters will not decrease the reporting rate from the physicians.

  • 9.
    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.

1 - 9 of 9
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf