Special Considerations for Proprietary Name Review: Focus on Products That May Be Prescribed "As Directed".

BACKGROUND: Look-alike and sound-alike (LASA) drug name similarity is often cited as a major factor contributing to wrong drug errors. When present on a prescription, differing product characteristics or directions for use may help health care professionals differentiate between 2 LASA drug names. However, evidence suggests that 1% to 5% of prescriptions include only the signa "use as directed" rather than explicit directions for use. METHODS: Using nationally projected US outpatient physician survey data, we analyzed drug classes and their associated signa to identify products commonly prescribed with the signa "as directed." RESULTS: The following categories of products are commonly associated with the signa "as directed": (1) inhalers; (2) oral contraceptives; (3) one-time treatments, such as those for lice or scabies; (4) prepackaged items with specific directions for use on the package; (5) migraine medications; (6) erectile dysfunction medications; (7) bowel evacuation/colonoscopy preparations; (8) topical medications; (9) medications with regimens that may change frequently (eg, warfarin, insulin); (10) otic products; (11) transdermal products; (12) products administered vaginally; (13) products administered rectally; and (14) products that may be titrated upon initiation. CONCLUSIONS: Prescriptions for these products with the signa "as directed" may not include product characteristics or other directions for use. The potential for products to be prescribed with the signa "as directed" should be taken into consideration when evaluating the safety of proposed proprietary names. Sponsors and the FDA can use the results of our research to aid in the selection and review of proposed proprietary names, respectively.

Interactive Web-Based Learning: Translating Health Policy Into Improved Diabetes Care.

In August 2014, the U.S. DHHS's Office of Disease Prevention and Health Promotion released the National Action Plan for Adverse Drug Event Prevention, highlighting prevention of diabetes agent-related hypoglycemia as a key area for improvement. In support of the Action Plan, the Office of Disease Prevention and Health Promotion then developed a web-based interactive module, or eLearning lesson, based on formative research and stakeholder feedback to educate healthcare professionals on strategies to prevent adverse drug events from diabetes agents. The training incorporates health literacy principles by demonstrating, through video scenarios, how to apply shared decision making when setting individualized glycemic targets, and how to use the teach-back method to confirm patients' understanding. Prior to release in September 2014, the training went through intensive usability testing and was pilot tested using a 36-item evaluation. Six months after its release (September 2014 to March 2015), the training landing page on health.gov had 24,334 unique page views. More than 90% of the 234 participants who earned continuing education credit agreed that they will be able to apply the knowledge gained from the lesson to their practice. Online trainings that model key prevention strategies are well received by health professional users and may play an important role in translating policy into improved outcomes.

Racial and ethnic disparities in health care-associated Clostridium difficile infections in the United States: State of the science.

BACKGROUND: Among health care-associated infections (HAIs), Clostridium difficile infections (CDIs) are a major cause of morbidity and mortality in the United States. As national progress toward CDI prevention continues, it will be critical to ensure that the benefits from CDI prevention are realized across different patient demographic groups, including any targeted interventions. METHODS: Through a comprehensive review of existing evidence for racial/ethnic and other disparities in CDIs, we identified a few general trends, but the results were heterogeneous and highlight significant gaps in the literature. RESULTS: The majority of analyzed studies identified white patients as at increased risk of CDIs, although there is a very limited literature base, and many studies had significant methodological limitations. CONCLUSION: Key recommendations for future research are provided to address antimicrobial stewardship programs and populations that may be at increased risk for CDIs.

Adverse Drug Event Prevention: 2014 Action Plan Conference.

Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.