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Pharmacovigilance: spontaneous reporting in health care
Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry. (eHälsoinstitutet)ORCID iD: 0000-0003-4550-4598
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Pharmacovigilance in healthcare is essential for safe drug treatment. Spontaneous reporting is the most common source of information in the context of implementing label changes and taking a drug off the market. However, underreporting is found to be very prevalent. One way to decrease underreporting is to include different categories of healthcare professionals in such reporting and to investigate attitudes towards and incentives for reporting adverse drug reaction (ADR)s.

As nurses form the largest group of health professionals, a sample of nurses were allowed and encouraged to report ADR during a 12 month period after they had received training in pharmacovigilance. A questionnaire posted to physicians and nurses investigated their knowledge and attitudes towards reporting. Spontaneous reports of torsade de pointes (TdP) and erectile dysfunction (ED) were scrutinized with respect to the reported drugs, risk factors and if the reaction was listed in the summary of product characteristics (SPC).

After training, the nurses produced relevant reports and three years after the introduction of nurses in the reporting scheme, more than half of the responding nurses were aware of their role as reporters. Both nurses and physicians stated that the most important factor for reporting a suspected ADR was the severity of the ADR and an ADR arising in response to a newly approved drug. A web-based reporting system was deemed to facilitate the reporting. In spontaneous reports of TdP, citalopram was reported as a suspected drug. However, neither QT prolongations, nor TdP, were labelled in the SPC. ED was reported for all antihypertensive drugs including angiotensin II type I blockers. A positive information component (IC), assessing the disproportionality between the observed and the expected number of reports, was found indicating that ED was reported more often in association with antihypertensive drug classes, except for angiotensinconverting enzyme inhibitors.

This thesis demonstrates the importance of pharmacoviglilance in healthcare in terms of capturing new signals. By including nurses as reporters, the overall safety of drugs might improve. Information and education are needed to secure safe treatment when applying drugs.

Place, publisher, year, edition, pages
Linnaeus University Press, 2013. , p. 56
Series
Linnaeus University Dissertations ; 132/2013
Keyword [en]
Pharmacovigilance, adverse drug reaction, spontaneous reporting, nurses, physicians, attitudes, torsades de pointes, erectile dysfunction
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-26820ISBN: 978-91-87427-24-4 (print)OAI: oai:DiVA.org:lnu-26820DiVA, id: diva2:630690
Public defence
2013-05-08, N2007, Smålandsgatan 26a, Kalmar, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2013-06-19 Created: 2013-06-19 Last updated: 2017-05-30Bibliographically approved
List of papers
1. Adverse drug reaction reporting by nurses in Sweden
Open this publication in new window or tab >>Adverse drug reaction reporting by nurses in Sweden
2007 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 63, p. 613-618Article in journal (Refereed) Published
Abstract [en]

AIM: To investigate whether nurses could be a useful tool for improving the reporting rate of adverse drug reactions (ADRs). Furthermore, we wanted to study how physicians working at the study departments would respond to nurses as reporters of ADRs and if the reporting from the nurses affected the reporting rate from the physicians.

METHOD: Three departments of internal medicine and one unit for orthopaedics were selected for the study. Nurses with special drug responsibilities were invited to participate. At the start of the study period, the nurses received an introduction with background, objective, method and other practical issues concerning the study. After this, an education programme about ADR reporting, definitions, and ADR classification according to mechanism and organ system was given. To study their knowledge about and attitude towards ADRs, a questionnaire was handed out to the nurses. A questionnaire was also handed out to all physicians at the participating departments in order to investigate their attitude towards nurses as reporters of ADRs.

RESULTS: Fifty-four nurses participated in the study. During the study period, a total number of 23 reports with 39 ADRs were sent to the regional centres by the nurses. Seventeen (74%) of the reports were assessed as serious. Eight of the 39 ADRs were unlabelled and all reports were considered appropriate. The reporting rate from the physicians during the study period was similar to the previous year, indicating that the nurses contributed with additional reports. At the end of the study, the nurses thought that they had enough knowledge to report ADRs. Sixty-eight percent of the physicians did not object to nurses being included as reporters of suspected ADRs.

CONCLUSION: Adverse drug reaction reporting by nurses could improve the overall safety of drugs.

Place, publisher, year, edition, pages
Berlin: Springer, 2007
Keyword
Attitude of Health Personnel, Nurses
National Category
Nursing
Research subject
Health and Caring Sciences
Identifiers
urn:nbn:se:lnu:diva-26498 (URN)10.1007/s00228-007-0274-8 (DOI)
Available from: 2013-06-13 Created: 2013-06-13 Last updated: 2017-12-06Bibliographically approved
2. Awareness among nurses about reporting of adverse drug reactions in Sweden
Open this publication in new window or tab >>Awareness among nurses about reporting of adverse drug reactions in Sweden
2012 (English)In: Drug, Healthcare and Patient Safety, ISSN 1179-1365, E-ISSN 1179-1365, Vol. 4, p. 61-66Article in journal (Refereed) Published
Abstract [en]

Background: The purpose of this study was to investigate awareness among nurses regarding their new role as reporters of adverse drug reactions in Sweden and factors that may influence reporting by nurses.

Methods: In 2007, all nurses were included in the adverse drug reaction reporting scheme in Sweden. A questionnaire was sent to 753 randomly selected nurses in September 2010.

Results: Of the 453 (60%) responding nurses, 265 (58%) were aware that nurses were included in the reporting of adverse drug reactions. Sixty-one nurses (14%) stated that they had reported an adverse drug reaction. Fifteen percent (n = 70) of the respondents had received training about reporting of adverse drug reactions. Almost one third of these (n = 21, 30%) had reported an adverse drug reaction on at least one occasion. Among nurses without training, a smaller proportion (n = 40, 11%, P < 0.05) had reported an adverse drug reaction on at least one occasion. The two factors considered most important by nurses for reporting were the severity of the adverse drug reaction and if the reaction was to a newly approved drug. A majority of the nurses (n = 397, 88%) were interested in a training course in pharmacology as part of their ongoing professional development. One third (32%) of all nurses stated that one reason for not reporting a suspected adverse drug reaction was that the physician responsible did not regard the reaction necessary to report.

Conclusion: We found that more than half of the study population of nurses in Sweden were aware of their new role as reporters of adverse drug reactions, but few of the responding nurses had reported an adverse drug reaction. Given that training seems to be associated with high reporting frequency, we suggest more training in pharmacovigilance for nurses.

National Category
Nursing Pharmaceutical Sciences
Research subject
Health and Caring Sciences; Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-21312 (URN)10.2147/DHPS.S31103 (DOI)
Available from: 2012-08-27 Created: 2012-08-27 Last updated: 2018-01-12Bibliographically approved
3. Drug-induced torsades de pointes: a review of the Swedish pharmacovigilance database
Open this publication in new window or tab >>Drug-induced torsades de pointes: a review of the Swedish pharmacovigilance database
2008 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 17, p. 587-592Article in journal (Refereed) Published
Abstract [en]

AIM: To describe spontaneously reported cases of torsades de pointes (TdP) in Sweden and to investigate if this adverse drug reaction (ADR) was labelled in the summary of product characteristics (SPC) for the drugs implicated. METHODS: Reported cases of TdP 1991-2006 were identified and evaluated with regard to drug use and other possible risk factor. RESULTS: Among a total of 61 788 ADRs, 88 cases of TdP were identified. In these cases, 27 different suspected drugs were implicated. Cardiac drugs were involved in most reports (74%; 65/88), with sotalol being the most frequently suspected drug (57%, 58/88). In addition to drug treatment two or more established risk factors were present in 85% of the cases (75/88). Heart disease (90%; 79/88) was the most common risk factor followed by age over 65 years (72%; 63/88) and female gender (70%; 62/88). TdP or QT prolongation were labelled in the SPC for 33% (9/27) of the drugs implicated in the 88 cases. However, supporting evidence for an association was found elsewhere in 56% (15/27) for the different drugs implicated in the reports. Although citalopram was the third most common suspected drug in the reports (10%; 9/88), TdP was not listed in the SPC. CONCLUSION: TdP is a rarely reported ADR. Several risk factors are often present. In two thirds of the drugs implicated in the reports neither TdP nor QT prolongation was labelled in the SPC. Further investigations are needed regarding the association between citalopram and TdP.

Place, publisher, year, edition, pages
John Wiley & Sons, 2008
Keyword
torsades de pointes, adverse drug reaction, spontaneous reporting, pharmacovigilance, risk factors
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-26675 (URN)10.1002/pds.1607 (DOI)
Available from: 2013-06-17 Created: 2013-06-17 Last updated: 2017-12-06Bibliographically approved
4. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden
Open this publication in new window or tab >>Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden
2009 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 65, p. 613-618Article in journal (Refereed) Published
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.

Place, publisher, year, edition, pages
Berlin Heidelberg: Springer, 2009
Keyword
Adverse Drug Reaction, Reporting Systems, Spontaneous reporting, Hospital physicians, Attitudes, Nurses
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-26673 (URN)10.1007/s00228-008-0564-9 (DOI)
Available from: 2013-06-17 Created: 2013-06-17 Last updated: 2017-12-06Bibliographically approved
5. Antihypertensive drugs and erectile dysfunction as seen in spontaneous reports, with focus on angiotensin II type 1 receptor blockers
Open this publication in new window or tab >>Antihypertensive drugs and erectile dysfunction as seen in spontaneous reports, with focus on angiotensin II type 1 receptor blockers
2010 (English)In: Drug, Healthcare and Patient Safety, ISSN 1179-1365, E-ISSN 1179-1365, Vol. 2, p. 21-25Article in journal (Refereed) Published
Abstract [en]

AIM: To describe spontaneously reported cases of erectile dysfunction (ED) in association with angiotensin II type I blockers (ARB) and other antihypertensive drugs.

SUBJECTS AND METHODS: All spontaneously reported cases of ED submitted to the Swedish Medical Products Agency (MPA) between 1990 and 2006, where at least one antihypertensive drug was the suspected agent, were scrutinized. Patient demographics, drug treatment and adverse reactions were recorded. Using the Bayesian Confidence Propagation Neural Network (BCPNN) method, the information component (IC) was calculated.

RESULTS: Among a total of 225 reports of ED, 59 involved antihypertensive drugs including ARB (9 cases) as suspected agents. A positive IC value was found indicating that ED was reported more often in association with antihypertensive drugs classes, except for angiotensin-converting enzyme inhibitors, compared with all other drugs in the database. Positive dechallenge was reported in 43 cases (72%).

DISCUSSION: All classes of major antihypertensive drugs including ARB were implicated as suspected agents in cases of ED. Few risk factors were identified. The relatively high reporting of ED in association with ARB is in contrast with previous studies, suggesting that ARB have neither a positive nor any effect on ED. This discrepancy suggests that further studies are warrnted on this potential adverse reaction to ARB.

Place, publisher, year, edition, pages
Dove Medical Press Ltd, 2010
Keyword
erectile dysfunction, adverse drug reaction, spontaneous reporting, antihypertensive drugs, angiotensin II type 1 receptor blockers
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-26677 (URN)
Available from: 2013-06-17 Created: 2013-06-17 Last updated: 2017-12-06Bibliographically approved

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Elisabet Ekman, Doctoral Thesis (Kappa)(902 kB)663 downloads
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