Anette Lampert

Ten Years after the International Committee of Medical Journal Editors’ Clinical Trial Registration Initiative, One Quarter of Phase 3 Pediatric Epilepsy Clinical Trials Still Remain Unpublished: A Cross Sectional Analysis

Introduction Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy. Methods We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria. Results Considering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated. Conclusion Ten years after the ICMJE’s clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures.

Safeguarding the process of drug administration with an emphasis on electronic support tools.

The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety.

Thirty Years of Orphan Drug Legislation and the Development of Drugs to Treat Rare Seizure Conditions: A Cross Sectional Analysis.

Background Epilepsy is a serious chronic health condition with a high morbidity impairing the life of patients and afflicted families. Many epileptic conditions, especially those affecting children, are rare disorders generating an urgent medical need for more efficacious therapy options. Therefore, we assessed the output of the US and European orphan drug legislations. Methods Quantitative analysis of the FDA and EMA databases for orphan drug designations according to STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) criteria. Results Within the US Orphan Drug Act 40 designations were granted delivering nine approvals, i.e. clobazam, diazepam viscous solution for rectal administration, felbamate, fosphenytoin, lamotrigine, repository corticotropin, rufinamide, topiramate, and vigabatrin. Since 2000 the EMA granted six orphan drug designations whereof two compounds were approved, i.e. rufinamide and stiripentol. In the US, two orphan drug designations were withdrawn. Orphan drugs were approved for conditions including Lennox-Gastaut syndrome, infantile spasms, Dravet syndrome, and status epilepticus. Comparing time to approval for rufinamide, which was approved in the US and the EU to treat rare seizure conditions, the process seems faster in the EU (2.2 years) than in the US (4.3 years). Conclusion Orphan drug development in the US and in the EU delivered only few molecular entities to treat rare seizure disorders. The development programs focused on already approved antiepileptic drugs or alternative pharmaceutical formulations. Most orphan drugs approved in the US are not approved in the EU to treat rare seizures although some were introduced after 2000 when the EU adopted the Orphan Drug Regulation.

A systematic review of medication administration errors with transdermal patches

Introduction: Transdermal patches provide an attractive route of drug delivery with considerable advantages over other routes of administration, for example maintenance of constant plasma drug levels and convenient usage. However, medication administration errors abound with this dosage form and frequently result in harm or treatment failure. Areas covered: A systematic literature search was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using appropriate keywords to identify articles reporting faulty transdermal patch administration. Common pitfalls and errors that were identified through the systematic literature search were discussed alongside individual steps of the transdermal patch administration process. Expert opinion: The systematic investigation of published errors illustrated that every step in the transdermal patch administration process is prone to errors. Thereby, the lack of knowledge and awareness of the importance of a correct administration practice were a major source of risk. Based on the identified errors and causes of errors prevention strategies were developed as a first step in avoiding transdermal patch administration errors.

Reasons for Drug Administration Problems and Perceived Needs for Assistance of Patients, Family Caregivers, and Nurses: A Qualitative Study.

Objective Investigation of drug administration problems, respective causes, and needs for assistance. Methods Focus group discussions with patients, family caregivers, and nurses were conducted using a semi-structured interview guideline for a focused exploration of the participants’ drug administration experiences and perceived needs for assistance. All discussions were audio-recorded and video-recorded, verbatim transcribed, and analyzed according to Mayring’s qualitative content analysis. Results In total, 6 focus group discussions were conducted. The qualitative content analysis revealed that patients and family caregivers frequently trivialized drug administration, were unaware of errors, and primarily blamed the dosage form of causing administration problems. Nurses also considered health-care system–related conditions and patient factors as potential causes of administration problems. Conclusions The administration problems and perceived causes were multifaceted and often directed toward inappropriate dosage forms or health-care system–related conditions rather than critically questioning the medicine user’s administration skills. To increase medicine users’ motivation to scrutinize wrong administration practices, health-care professionals should consider individual perspectives on administration problems and perceived causes, assist medicine users’ to identify the true cause of a distinct problem, and provide individualized support.

DI-035 Should we make patients and nurses aware of their drug administration problems and training needs?

Background Medicines administration errors are a well-known safety risk for patients and a lack of knowledge is one major cause of errors. Therefore, every effort is made to close knowledge gaps among medicine users to make drug administration safe. However, rarely the medicine users were prospectively asked for specific drug administration problems and training needs. Purpose The first step in preventing errors is to study their aetiology. Therefore, we qualitatively assessed the medicine users’ drug administration problems in order to investigate causes of errors and training needs. Material and methods Focus groups with patients, caring relatives, and nurses were conducted using semi-structured interview guides for a focused exploration of participants’ drug administration experiences and training needs. All discussions were audiotaped and videotaped. After verbatim transcription, data were analysed using Mayring’s qualitative content analysis. Ethical approval was obtained from the local ethics committee and informed consent was signed by all participants prior to the study. Results We conducted three focus groups with eleven patients and caring relatives, two focus groups with ten nurses from a nursing home, and one focus group with four nurses from a university hospital. In accordance with the published literature, patients and nurses reported drug administration problems related to different dosage forms, and potentially at every step in the administration process. The qualitative content analysis revealed that patients frequently trivialised drug administration, were unaware of errors, and primarily blamed the dosage form for administration problems. In contrast, nurses also sought out the patient as potential causes of administration problems e.g. due to dysphagia. Conclusion Patients who are unaware of problems will not ask for help, and hence might not be reached by a traditional educational intervention. For the implementation and evaluation of the success of an educational intervention it is crucial to ask the intended target group, i.e. medicine users, for training needs. References and/or acknowledgements Conflict of interest.