The out-of-focus bias in drug surveillance

Gnädinger, Markus; Mellinghoff, Hans-Ulrich

doi:10.1007/s00228-012-1371-x

Cited by 5 publications

(4 citation statements)

References 14 publications

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“…Non-reporting may be as frequent as 94%. 21 22 O'Beirne et al concluded from a very low report rate (<1 report per person per year) that incident reporting may be “a costly but not very effective way to study safety problems in primary care”. 23 A recent Swiss study analysed safety issues in primary care.…”

Section: Introductionmentioning

confidence: 99%

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System

Gnädinger

Ceschi

Conen³

et al. 2015

BMJ Open

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Background/rationalePatient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events are a threat to patients in the primary care setting as well. Since information about the frequency and outcomes of safety incidents in primary care is required, the goals of this study are to describe the type, frequency, seasonal and regional distribution of medication incidents in primary care in Switzerland and to elucidate possible risk factors for medication incidents.Methods and analysisStudy design and setting: We will conduct a prospective surveillance study to identify cases of medication incidents among primary care patients in Switzerland over the course of the year 2015. Participants: Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System. Inclusion criteria: Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course. Exclusion criteria: Lack of treatment effect, adverse drug reactions or drug–drug or drug–disease interactions without detectable treatment error. Primary outcome: Medication incidents. Risk factors: Age, gender, polymedication, morbidity, care dependency, hospitalisation. Statistical Analysis: Descriptive statistics to assess type, frequency, seasonal and regional distribution of medication incidents and logistic regression to assess their association with potential risk factors. Estimated sample size: 500 medication incidents. Limitations: We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results.Ethics and disseminationNo formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal.Trial registration numberNCT0229537.

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Section: Introductionmentioning

confidence: 99%

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System

Gnädinger

Ceschi

Conen³

et al. 2015

BMJ Open

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“…One further objective of observational studies is to provide Health Authorities with information on the tol-erability of medicinal products when they are used in everyday practice [32][33][34] . Investigators are encouraged to seek cooperation with Health Authorities, as information from a wide spectrum of patients is needed.…”

Section: Discussionmentioning

confidence: 99%

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

Jacqmin

Jichlinski²,

Molinier³

et al. 2017

Urol Int

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Objective: The Hexvix® Observational Patients Evaluation (HOPE) study was designed to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non-muscle invasive bladder cancer (NMIBC) and assess patient and treatment characteristics associated with different endoscopic modalities and to address the French authorities' request for information on routine practices for NMIBC diagnosis and surveillance. Patients and Methods: A prospective, observational study in 30 centres in France with fluorescence endoscopy equipment available. All candidates for endoscopy with transurethral resection who gave their consent were eligible. The primary endpoint was the proportion of patients with an NMIBC diagnosis performed with hexaminolevulinate. Results: 506 patients were included: 252 (49.8%) diagnosed with hexaminolevulinate and 254 (50.2%) with white-light endoscopy alone. There were more patients with tumour recurrence, multiple lesions, lesions with a diameter <3 cm, stage Ta disease, and grade 1 lesions in the hexaminolevulinate group. The first quartile median recurrence-free survival time was 310 days in the hexaminolevulinate group and 144 days in the standard-endoscopy group (p = 0.0015). Conclusion: Hexaminolevulinate was in frequent use in France with specific patient and disease characteristics associated with its use. HOPE illustrates the type of data that can be gained in post-authorisation studies to address requests from European health authorities.

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“…A recent report suggested that small changes in the body condition caused by medication cannot be detected from the PMS data. 13) In the present study, we calculated Q pre and Q other using AERS data. Since the AERS database is based on a spontaneous reporting system, it has a tendency of underreporting to a greater extent than the abovementioned PMS data.…”

Section: Data Sources and Study Limitationsmentioning

confidence: 99%

Quantitative Evaluation of Initial Symptoms as Predictors to Detect Adverse Drug Reactions Using Bayes’ Theory: Expansion and Evaluation of Drug-Adverse Drug Reaction–Initial Symptom Combinations Using Adverse Event Reporting System Database

Kobayashi

Hosaka

Inoue

et al. 2013

Biological & Pharmaceutical Bulletin

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In prescription dispensing in Japan, to avoid adverse drug reactions (ADR) pharmacists provide patients with information concerning the initial symptoms (IS) of any ADR that might be caused by the drugs they have been prescribed. However, the usefulness of such information for preventing ADR has not been quantitatively evaluated. We previously performed a trial calculation of the usefulness of rash as a predictor of drug-induced liver disorders by applying Bayes' theorem and showed that the predictive utility of IS can be quantitatively evaluated using likelihood ratios. However, for other drug-ADR-IS combinations it was difficult to obtain the information required for the calculations from Japanese data alone. In this study, using the Adverse Event Reporting System (AERS) database of the U.S. Food and Drug Administration (FDA), we evaluated 132 drug-ADR-IS combinations that were considered to be potentially clinical significant. Regarding bezafibrate-associated rhabdomyolysis and cibenzoline-associated hypoglycemia, these ADR were not detected in cases involving monotherapy. For 58 combinations, no events that were considered to be IS of the target ADR developed. Fever, nausea, and decreased appetite were the IS of many ADR, making them very useful predictors. In contrast, pruritus and rash were not very useful. Fever might be a predictor of thiamazole-induced agranulocytosis or levofloxacin-or terbinafine-induced liver disorder, tremors might be useful for predicting paroxetine-induced serotonin syndrome, and decreased appetite might be a useful indicator of terbinafine-induced liver dysfunction.

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The out-of-focus bias in drug surveillance

Cited by 5 publications

References 14 publications

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

Quantitative Evaluation of Initial Symptoms as Predictors to Detect Adverse Drug Reactions Using Bayes’ Theory: Expansion and Evaluation of Drug-Adverse Drug Reaction–Initial Symptom Combinations Using Adverse Event Reporting System Database

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