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- 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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| 2. |
- 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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| 3. |
- 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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