The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets.

BACKGROUND: Inadequate access to useful scientifically accurate patient information is a major cause of the inappropriate use of drugs resulting in serious personal injury and related costs to the health care system. The definition of useful scientifically accurate patient information for prescription drugs was accepted by the US Secretary of the Department of Health and Human Services in 1996 as that derived from or consistent with the US FDA approved professional product label for a drug. Previous quality content studies found that English language patient drug information leaflets distributed by US pharmacies failed to meet minimum criteria defining useful and scientifically accurate information. METHOD AND FINDINGS: Evaluation forms containing the explicit elements that define useful scientifically accurate information for three drugs with known serious adverse drug reactions were created based on the current US FDA approved professional product labels. The Arabic language patient drug information leaflets for celecoxib, paroxetine, and lamotrigine were obtained locally and evaluated using a methodology similar to that used in previous quality content patient drug information studies in the US. The Arabic leaflets failed to meet the definition of useful scientifically accurate information. The celecoxib leaflet contained 30% of the required information and the paroxetine and lamotrigine leaflets contained 24% and 20%, respectively. There are several limitations to this study. The Arabic leaflets from only one commercial North American vendor were evaluated and the evaluation included a limited number of drugs. A larger study is necessary to be able to generalize these results. CONCLUSIONS: 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.

Development and evaluation of a required patient safety course.

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.