| 1. |
- Tjäderborn, Micaela, et al.
(författare)
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Tramadol dependence : a survey of spontaneously reported cases in Sweden.
- 2009
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Ingår i: Pharmacoepidemiology and drug safety. - : Wiley. - 1099-1557 .- 1053-8569.
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE: The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug reactions. METHODS: The Swedish database for spontaneously reported adverse drug reactions, Swedish Drug Information System (SweDIS), was searched for reports on tramadol dependence from 1 January 1995 until 31 December 2006. Selection was conducted based on the DSM-IV definition of dependence. Available information was scrutinised and registered and then presented descriptively. RESULTS: A total of 104 reports of tramadol dependence were identified, of which 60 (58%) concerned women. The median age (range) was 45 (15-84) years. Information on a history of substance abuse was present in 31 patients (30%) and 41 patients (39%) had a documented past or current use of a drug of abuse. Prescribed doses of tramadol ranged between 50-800 mg/day, and ingested doses between 50-4000 mg/day. Time of onset ranged from some weeks up to 4 years. In 72 (69%) cases the reaction was classified as serious, mainly due to hospitalisations for detoxification or discontinuation of tramadol. CONCLUSIONS: There is an occurrence of tramadol dependence in association with analgesic treatment within the recommended dose range. In susceptible patients a severe and serious dependence syndrome may develop. A history of abuse or use of a drug of abuse seems to be an important risk factor. Copyright (c) 2009 John Wiley & Sons, Ltd.
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| 2. |
- Dahlén, Elin, et al.
(författare)
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Sibship and dispensing patterns of asthma medication in young children : a population based study
- 2019
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Ingår i: Pharmacoepidemiology & Drug Safety. - Stockholm : Karolinska Institutet, Dept of Medical Epidemiology and Biostatistics. - 1053-8569 .- 1099-1557.
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Our aim was to study the association between sibship and dispensing patterns of asthma medication in young children, focusing on incidence and persistence, and taking sibship status, asthma diagnoses, and siblings’ medication into account. Methods: A register-based cohort study including all children (n=50,546) born in Stockholm, Sweden 2006–2007, followed up during 2006–2014. Exposure was sibling status; outcome was incidence of dispensed asthma medication and persistence over time. A Cox-model was used to study the association between sibship and asthma medication. Persistence was defined using two different time windows (4- and 18-months) in a refill sequence model including siblings’ and unrelated control children’s medication. Results: After one year of age, the adjusted hazard ratio of dispensed asthma medication was 0.85 (95%CI 0.80–0.90) among children with siblings compared to singletons. The estimated proportion of children with persistent controller medication was 7.2% (4-month model) and 64.5% (18-month model). When including the siblings’ controller medication, the estimated proportion was 8.8% (4-months) and 7.8% for control children (relative risk, RR 0.89, 95%CI 0.81-0.98). The persistence was lower for those with siblings compared to singletons (adj. RR 0.72, 95%CI 0.62-0.85 for 4-months) with similar estimates for older, younger, and full siblings and regardless of asthma diagnoses. Conclusions: Siblings have different dispensing patterns of asthma medications compared to singletons regardless of asthma diagnoses. After including the siblings’ asthma medication and compared with control children, the proportion of children with persistent medication increased which may indicate that siblings share asthma medications.
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| 3. |
- Hedman, Anna M, et al.
(författare)
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Agreement between asthma questionnaire and health care register data
- 2018
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Ingår i: Pharmacoepidemiology & Drug Safety. - Stockholm : Karolinska Institutet, Dept of Medical Epidemiology and Biostatistics. - 1053-8569 .- 1099-1557.
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Risk factors and consequences of asthma can be studied using validated questionnaires. The overall objective of this study was to assess the agreement of parental-reported asthma related questions regarding their children against Swedish health care registers. Methods: We linked a population-based twin cohort of 27,055 children aged 9-12 years, to the Swedish Prescribed Drug Register, National Patient Register and the Primary care register. Parent-reported asthma was obtained from questionnaires and diagnoses and medication were retrieved from the registers. For the agreement between the questionnaire and the registers, Cohen’s kappa was estimated. Results The kappa of the ‘reported ever asthma’ against a ‘register-based ever asthma’ was 0.69 and 0.57 between the parental-‘reported doctor’s diagnosis’ and ‘register-based doctor’s diagnosis’ ’. The highest agreement between ‘reported current asthma’ and ‘register- based current asthma’ with at least one dispensed medication or a diagnosis applied to different time-windows was seen for an 18 month window (kappa=0.70). Conclusions We found that parent-reported asthma-related questions showed on average good agreement with the Swedish health care registers. This implies that in depth questionnaires with rich information on phenotypes are suitable proxies for asthma in general and can be used for health care research purposes.
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| 4. |
- Ortqvist, Anne K., et al.
(författare)
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Validation of asthma and eczema in population-based Swedish drug and patient registers
- 2013
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Ingår i: Pharmacoepidemiology and Drug Safety. - Stockholm : Wiley. - 1053-8569 .- 1099-1557. ; 22:8, s. 850-860
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Validated measures of asthma and eczema at the population level remain a challenge. Our aim was to ascertain if register-based information on asthma/eczema medication can function as a proxy for an asthma/eczema diagnosis and to validate register-based asthma diagnoses. Methods Information was requested on all 0-45-year-old individuals with reported asthma/eczema medication and/or diagnoses in the Swedish Prescribed Drug Register and National Patient Register, between July 2005 and December 2009 (N = 250 691). Medical records for 1952 randomly selected individuals were reviewed to estimate the proportion of individuals with the following: (1) asthma/eczema medication that fulfilled predefined criteria of asthma/eczema (positive predictive value (PPV)) and (2) a register-based asthma diagnosis verified as asthma by predefined criteria. Results Positive predictive value for asthma by predefined criteria ranged between 0.75 (95% CI: 0.70-0.78) to 0.94 (95% CI: 0.91-0.96), depending on age group. In pre-school children, PPV for asthma in combination with obstructive bronchitis was 0.87 (95% CI: 0.83-0.90), and PPV for eczema was estimated to 0.45 (95% CI: 0.38-0.51). Eighty percent of children 0-4.5 years and 99% of children >4.5-17 years with a register-based diagnosis of asthma were verified as asthmatics. Conclusion Asthma medication is a suitable proxy for asthma in older children and adults; the same approach is insufficient for eczema. This validation study of two Swedish registers opens for future large nation-wide register-based studies on asthma. Copyright (C) 2013 John Wiley & Sons, Ltd.
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| 5. |
- Joelson, S, et al.
(författare)
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Geographical variation in adverse event reporting rates in clinical trials
- 1997
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Ingår i: Pharmacoepidemiology and Drug Safety. - 1053-8569 .- 1099-1557. ; 6:Suppl. 3, s. S31-S35
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Tidskriftsartikel (refereegranskat)abstract
- A group of 13,698 patients from 127 gastro-intestinal clinical trials, conducted in 13 countries was included in the analyses. All adverse events reported were included in the evaluation. The general adverse event reporting rate, the mean number of adverse events reported, the serious adverse event reporting rate and the mean number of serious adverse events reported were calculated for each country. In addition, the pattern of adverse events reported in each country was studied. The general adverse event reporting rate varied between 17% and 68% with a mean of 47% and the serious adverse event reporting rate varied between 1% and 20% with a mean of 8%. The mean number of adverse events, reported by patients reporting adverse events, varied between 1.5 and 2.7 with a mean of 2.1 and the mean number of serious adverse events, reported by patients reporting serious adverse events, varied between 1.1 and 1.7 with a mean of 1.4. In addition to these differences, patients/investigators had a tendency to put emphasis on different kinds of adverse events in different countries.
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| 6. |
- Ekedahl, Anders, 1949-, et al.
(författare)
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Discrepancies between the electronic medical record, the prescriptions in the Swedish national prescription repository and the current medication reported by patients.
- 2011
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Ingår i: Pharmacoepidemiology and Drug Safety. - : John Wiley & Sons, Inc.. - 1053-8569 .- 1099-1557. ; 20:11, s. 1177-1183
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Tidskriftsartikel (refereegranskat)abstract
- Purpose To study discrepancies between (i) the prescribed current treatment stated by patients with congestive heart failure (CHF) compared with patients with other chronic diseases, (ii) the data in the medication list (ML) in the electronic medical record and (iii) the data in the prescription list (PL) on the prescriptions stored in the national prescription repository in Sweden, to determine current, noncurrent, duplicate and missing prescriptions.Methods At one healthcare centre, a random sample of patients 18 years and older with a diagnosis of CHF, diabetes mellitus (DM) or osteoarthritis (OA) provided written informed consent to participate. Participants were interviewed by telephone on the prescribed current treatment.Results Of 161 invited patients (61 CHF, 50 DM and 50 OA), 66 patients were included. More than 80% of the patients had at least one discrepancy, a noncurrent, a duplicate or a missing prescription, in the ML and PL. The overall congruence for unique prescriptions on current treatment between the ML and the PL was only 55%. Patients with CHF had overall more discrepancies and patients with DM fewer discrepancies in the ML.Conclusions Prescriptions for noncurrent treatment, duplicates and missing prescriptions are common in both the ML in the electronic medical record and the list on prescriptions stored in the Swedish National Prescription Repository. Patients with CHF had more discrepancies in the ML. The risk for medication errors in primary care due to incorrect information on prescribed treatment may be substantial.
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| 7. |
- Mannino, S, et al.
(författare)
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Ocular disorders in users of H2 antagonists and of Omeprazole
- 1998
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Ingår i: Pharmacoepidemiology and Drug Safety. - 1053-8569 .- 1099-1557. ; 7:4, s. 233-241
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Tidskriftsartikel (refereegranskat)abstract
- We have conducted a cohort study of users of omeprazole and H2 antagonists in Italy to investigate whether the peroral use of these drugs may be associated with an increased incidence of ocular disorders leading to loss of vision. We have used the Sistema Informativo Sanitario Regionale (SISR database) in Friuli-Venezia-Giulia to identify all subjects who received at least one prescription for cimetidine, famotidine, niperotidine, nizatidine, omeprazole, ranitidine or roxatidine between 1 January 1991 and 31 December 1994. We have identified all hospital admissions for serious vascular or inflammatory ocular disorders following any such prescription, reviewed and validated all medical records. There were 71,108 users of any of the study drugs, contributing a total of 101,827 person years of observation. Seven cases of serious eye disorders were identified, giving an annual incidence rate of 7/100,000 persons. By comparison to non-users, the incidence rate ratio for current users of all of the study drugs together was 0, with a 95% confidence interval of 0 to 2·1. By comparison to non-users, the incidence rate ratio for past users was 0·47 (95% CI: 0·06–2·4). Our data are consistent with previous studies and add weight to the general impression of the ocular safety of these drugs.
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