IntroductionAutomated dose dispensing (ADD) is being introduced in several countries and the use of this technology is expected to increase as a growing number of elderly people need to manage their medication at home. ADD aims to improve medication safety and treatment adherence, but it may introduce new safety issues. This descriptive study provides insight into the nature and consequences of medication incidents related to ADD, as reported by healthcare professionals in community pharmacies and hospitals.MethodsThe medication incidents that were submitted to the Dutch Central Medication incidents Registration (CMR) reporting system were selected and characterized independently by two researchers.Main Outcome MeasuresPerson discovering the incident, phase of the medication process in which the incident occurred, immediate cause of the incident, nature of incident from the healthcare provider's perspective, nature of incident from the patient's perspective, and consequent harm to the patient caused by the incident.ResultsFrom January 2012 to February 2013 the CMR received 15,113 incidents: 3,685 (24.4%) incidents from community pharmacies and 11,428 (75.6%) incidents from hospitals. Eventually 1 of 50 reported incidents (268/15,113 = 1.8%) were related to ADD; in community pharmacies more incidents (227/3,685 = 6.2%) were related to ADD than in hospitals (41/11,428 = 0.4%). The immediate cause of an incident was often a change in the patient's medicine regimen or relocation. Most reported incidents occurred in two phases: entering the prescription into the pharmacy information system and filling the ADD bag.ConclusionA proportion of incidents was related to ADD and is reported regularly, especially by community pharmacies. In two phases, entering the prescription into the pharmacy information system and filling the ADD bag, most incidents occurred. A change in the patient's medicine regimen or relocation was the immediate causes of an incident.
Objectives Pharmacogenetic panel-based testing represents a new model for precision medicine. A sufficiently powered prospective study assessing the (cost-)effectiveness of a panel-based pharmacogenomics approach to guide pharmacotherapy is lacking. Therefore, the Ubiquitous Pharmacogenomics Consortium initiated the PREemptive Pharmacogenomic testing for prevention of Adverse drug Reactions (PREPARE) study. Here, we provide an overview of considerations made to mitigate multiple methodological challenges that emerged during the design. Methods An evaluation of considerations made when designing the PREPARE study across six domains: study aims and design, primary endpoint definition and collection of adverse drug events, inclusion and exclusion criteria, target population, pharmacogenomics intervention strategy, and statistical analyses. Results Challenges and respective solutions included: (1) defining and operationalizing a composite primary endpoint enabling measurement of the anticipated effect, by including only severe, causal, and drug genotype-associated adverse drug reactions; (2) avoiding overrepresentation of frequently prescribed drugs within the patient sample while maintaining external validity, by capping drugs of enrolment; (3) designing the pharmacogenomics intervention strategy to be applicable across ethnicities and healthcare settings; and (4) designing a statistical analysis plan to avoid dilution of effect by initially excluding patients without a gene–drug interaction in a gatekeeping analysis. Conclusion Our design considerations will enable quantification of the collective clinical utility of a panel of pharmacogenomics-markers within one trial as a proof-of-concept for pharmacogenomics-guided pharmacotherapy across multiple actionable gene–drug interactions. These considerations may prove useful to other investigators aiming to generate evidence for precision medicine.
This study showed for a broad range of errors that the Dutch national reporting programme could learn from the three reporting programmes in Canada, the US and the UK. National reporting programmes can benefit from sharing alerts and newsletters that enhance the learning between countries.
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