Objectives To establish the nature of medication errors occurring within community pharmacy and analyse common error patterns. To identify factors which influence the occurrence of medication errors and near misses, with the intention of designing systems or strategies to reduce the occurrence of these events. Setting Fifteen community pharmacies situated within Brighton and Hove City Primary Care Trust, East Sussex, between January and March 2004. Method A self-reporting form was designed, piloted and administered to pharmacists, which gathered information on the detection of an error or near miss in the dispensing process. Key findings One-hundred and thirteen near misses and thirty-two medication errors were reported. The majority of near misses were detected by the pharmacist at the final check, and the majority of medication errors were detected by the patient or patient's representative. Selection errors were most common, with similar drug names and packaging cited as the main contributory factors. 'Business' was frequently cited as the circumstance surrounding the error. Conclusion This study demonstrates that pharmacists do have an important part to play and the positive impact of community pharmacists in preventing, detecting and correcting errors and thus preventing harm to patients in the primary care setting. However, medication errors do occur, and therefore a multifactorial approach by manufacturers, marketing and packaging personnel, in addition to input from pharmacists, may be an effective permanent solution in reducing the errors made.Rigorous clinical trials prove medicines to be therapeutically effective treatments. However, with an increasing range of medicines available for each therapeutic area, complicated drug regimens and an ageing population becoming reliant on more than just one drug for a variety of conditions, the risk for interactions and scope for human error is increased. Many medication errors display strong similarities to incidents that have occurred on previous occasions, and in some cases replicate them.
Aims: Radiotherapy clinical trials are integral to the development of new treatments to improve the outcomes of patients with cancer. A collaborative study by the National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group and the National Institute for Health Research was carried out to understand better if and why inefficiencies occur in the setup of radiotherapy trials in the UK. Materials and methods: Two online surveys collected information on the time taken for UK radiotherapy trials to reach key milestones during setup and the research support currently being provided to radiotherapy centres to enable efficient clinical trial setup. Semi-structured interviews with project managers and chief investigators identified better ways of working to improve trial setup in the future. Results: The timelines for the setup of 39 UK radiotherapy trials were captured in an online survey showing that the median time from grant approval to trial opening was 600 days (range 169e1172). There were 38 responses from radiotherapy centres to a survey asking about the current support provided for radiotherapy research. Most of these centres have more than one type of staff member dedicated to supporting radiotherapy research. The most frequent barrier to radiotherapy trial setup identified was lack of physicists' time and lack of time for clinical oncologists to carry out research activities. Four main themes around trial setup were identified from semi-structured interviews: the importance of communication and building relationships, the previous experience of the chief investigator and clinical trials units, a lack of resources and having the time and personnel required to produce trial documentation and to process trial approval requests. Conclusions: This unique, collaborative project has provided up to date information about the current landscape of trial setup and research support in the UK and identified several avenues on which to focus future efforts in order to support the excellent radiotherapy trial work carried out across the UK.
IntroductionThe AXIS trial established axitinib as a standard of care treatment for patients with metastatic renal cell carcinoma (mRCC) after failure of a prior tyrosine kinase inhibitor. Axitinib dosing begins at 5 mg twice daily, with escalation of doses to 7 and 10 mg after consecutive 2-week intervals if tolerated (as per the drug label). Given clinical concerns about drug-related toxicity, we have used a pragmatic strategy where dose escalations were made only after disease progression or where rapid responses were clinically required.MethodsWe performed a retrospective review of electronic health records and radiology of all patients with mRCC treated with axitinib for >2 weeks at Addenbrooke’s Hospital, Cambridge, UK, over a 37 -month period to determine the clinical and radiological effects of dose escalations made according to the above strategy.Results42 patients fitting these criteria were identified, 29 having ≥1 dose escalation event (DEE). 60 DEEs were identified (median of two per patient), and the objective radiological consequences of 53 DEEs could be evaluated. The disease control rate (partial response or stable disease) after the first DEE instituted for disease progression was similar to that after the second DEE (68.8% vs 70%). 56.6 % of all DEEs and 63.6 % of DEEs made as a result of disease progression resulted in disease control. The median OS from the commencement of axitinib for all dose-escalated patients was 19.9 months, and 16.5 months for the entire cohort. The mean dose (for all patients) at 90 days after starting axitinib was 5.92 mg.ConclusionThese data suggest that dose escalation of axitinib after disease progression may be an effective dosing strategy for patients with mRCC, and this may be a preferred option in patients in whom there are particular concerns about drug-related toxicity, quality of life optimisation or healthcare-associated costs.
464 Background: The AXIS trial established axitinib as an effective second line treatment for patients with metastatic renal cell carcinoma (mRCC). The dosing schedule of axitinib in this trial begins at 5mg twice daily, with escalation of individual doses to 7mg and 10mg after consecutive 2 week intervals if tolerated. We observed significant drug-related toxicity using this dosing strategy, particularly after dose escalations, while clinical responses were often observed at the starting dose. We therefore switched to a pragmatic strategy where dose escalations were made only after disease progression or where a rapid response was deemed clinically pertinent. Methods: We performed a retrospective review of electronic health records and radiology of all patients with mRCC treated with axitinib for greater than 2 weeks at Addenbrooke’s Hospital, Cambridge, UK (a tertiary referral center), over a 40 month period to determine the clinical and radiological effects of dose escalations made according to the above strategy. Results: 42 patients fitting these criteria were identified; of these, 29 had at least one dose escalation event (DEE). A total of 58 DEEs were identified, with a median of 2 per patient, and the objective radiological consequences of 50 of these could be determined. The disease control rate (partial response or stable disease) after the first DEE instituted for disease progression was similar to that after the second DEE (68.8% versus 70%). 56% of all DEEs, and 62.5% of DEEs made as a result of disease progression, resulted in disease control. The median overall survival from the commencement of axitinib for all dose-escalated patients was 19.9 months, and 6.7 months for non-dose-escalated patients. The median survival for dose-escalated patients with a higher than median time on a prior tyrosine kinase inhibitor has not been reached at the time of data cut-off. The mean dose (for all patients) at 90 days after starting axitinib was 5.92 mg. Conclusions: These data suggest that dose escalation of axitinib after disease progression may be an effective dosing strategy for patients with mRCC, and may reduce toxicity through lower drug exposure. Our survival data compares favourably to the AXIS trial in a real practice population.
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