On November 18, 2011, the US Food and Drug Administration (US FDA) announced that breast cancer indication for Avastin (bevacizumab) had been withdrawn after concluding that the drug has not been shown to be safe and effective for the treatment of breast cancer. The specific indication that was withdrawn was for the use of bevacizumab in metastatic breast cancer, with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The US FDAs decision has been met with emotion and confusion among the public and health professionals. The purpose of this article is to review the regulatory history of bevacizumab for breast cancer and to examine the scientific evidence that led to the approval and subsequent withdrawal of this indication. Bevacizumab also provides the opportunity to illustrate the value of free publicly available US FDA reviews that may contain rigorously reviewed unpublished data and analyses and to contrast the decisions made in the US and Europe about bevacizumab and breast cancer.
Although this paper was primarily descriptive, the findings revealed a substantial scope for improvement in terms of pharmaceutical policy standards and regulation in the health insurance companies in KSA. Additionally, the study highlighted such areas to augment the overall quality use of medication, over-prescribing and irrational use of medication. Further research, thus, is definitely needed.
Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.
Objectives. To develop, implement, and assess a required patient safety course for second-year doctor of pharmacy students. Design. A patient safety course was developed that included didactic lectures, case studies, in-class activities, and reading assignments. Written examinations and essays were used to evaluate student learning. In addition, a modified minute paper and a pre-and post-intervention student self-assessment survey were used to assess course outcomes. Assessment. Results examining the utility of the course teaching format and the relevance of the material in meeting the course outcomes are presented and discussed. The self-assessment course survey indicated major improvements in the students' knowledge and skills, readiness for knowledge application, and commitment to improve patient safety. Conclusion. The course provided pharmacy students with an increased level of understanding of the principles and concepts of patient safety.
The study results are consistent with those of previous quality content studies of commercially available English patient drug information leaflets. The results have important implications for patients as access to a reliable source of drug information may prevent harm or limit the suffering from serious adverse drug reactions.
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