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Spontaneous reporting of adverse drug reactions: Possibilities and limitations
Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience.
2005 (English)Doctoral 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.

Place, publisher, year, edition, pages
Umeå: Farmakologi och klinisk neurovetenskap , 2005. , 74 p.
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 961
Keyword [en]
Pharmacology, adverse drug reactions, spontaneous reporting, metamizole, general practitioners, hospital physicians, under-reporting, economical inducement, nurses.
Keyword [sv]
Farmakologi
National Category
Pharmacology and Toxicology
Research subject
Clinical Pharmacology
Identifiers
URN: urn:nbn:se:umu:diva-525ISBN: 91-7305-868-8 (print)OAI: oai:DiVA.org:umu-525DiVA: diva2:143706
Public defence
2005-06-03, Föreläsningssal E04, 6A, Norrlands Universitetssjukhus, Umeå, 13:00 (English)
Opponent
Supervisors
Available from: 2005-04-29 Created: 2005-04-29 Last updated: 2012-01-31Bibliographically approved
List of papers
1. Attitudes to reporting adverse drug reaction in northern Sweden
Open this publication in new window or tab >>Attitudes to reporting adverse drug reaction in northern Sweden
2000 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 56, no 9-10, 729-732 p.Article in journal (Refereed) Published
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.

Identifiers
urn:nbn:se:umu:diva-4553 (URN)10.1007/s002280000202 (DOI)11214784 (PubMedID)
Available from: 2005-04-29 Created: 2005-04-29 Last updated: 2012-01-31Bibliographically approved
2. Spontaneous reporting of adverse drug reactions by nurses
Open this publication in new window or tab >>Spontaneous reporting of adverse drug reactions by nurses
2002 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 8, 647-650 p.Article in journal (Refereed) Published
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.

Keyword
adverse drug reaction, spontaneous reporting, nurses
Identifiers
urn:nbn:se:umu:diva-4554 (URN)10.1002/pds.753 (DOI)12512239 (PubMedID)
Available from: 2005-04-29 Created: 2005-04-29 Last updated: 2012-01-31Bibliographically approved
3. Utilization pattern of metamizole in northern Sweden and risk estimate of agranulocytosis
Open this publication in new window or tab >>Utilization pattern of metamizole in northern Sweden and risk estimate of agranulocytosis
2002 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 3, 239-245 p.Article in journal (Refereed) Published
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.

Keyword
metamizole, agranulocytosis, drug utilization, pharmacoepidemiology
Identifiers
urn:nbn:se:umu:diva-4555 (URN)10.1002/pds.697 (DOI)12051124 (PubMedID)
Available from: 2005-04-29 Created: 2005-04-29 Last updated: 2012-01-31Bibliographically approved
4. Under-reporting of serious adverse drug reaction in Sweden
Open this publication in new window or tab >>Under-reporting of serious adverse drug reaction in Sweden
2004 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 13, no 7, 483-487 p.Article in journal (Refereed) Published
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.

Keyword
adverse drug reaction, spontaneous reporting, under-reporting
Identifiers
urn:nbn:se:umu:diva-4556 (URN)10.1002/pds.962 (DOI)15269932 (PubMedID)
Available from: 2005-04-29 Created: 2005-04-29 Last updated: 2012-01-31Bibliographically approved
5. A small economic inducement to stimulate increased reporting of adverse drug reactions - a way of dealing with an old problem?
Open this publication in new window or tab >>A small economic inducement to stimulate increased reporting of adverse drug reactions - a way of dealing with an old problem?
2006 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 62, no 5, 381-385 p.Article in journal (Refereed) Published
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.

Keyword
Adverse drug reaction, Spontaneous reporting, Under-reporting, Economic inducement
Identifiers
urn:nbn:se:umu:diva-27062 (URN)10.1007/s00228-005-0072-0 (DOI)16572320 (PubMedID)
Available from: 2009-11-09 Created: 2009-11-09 Last updated: 2012-01-31

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