Good Literacy to Enhance Response in Diabetes Mellitus (GLITTER-DM).

OBJECTIVE: The purpose of this study is to determine the effectiveness of individualized communication strategies and self-management action plans to improve A1c control at 3 months in patients with low health literacy. METHODS: A prospective, open-labeled, pilot study was conducted on 23 patients with diabetes mellitus in a pharmacist-led ambulatory care clinic. Patients who had a Rapid Estimate of Adult Literacy in Medicine- Revised (REALM-R) score of 6 or less and an A1c greater than 7% upon study entry were included. The first group received the teach-back method, personalized actions, and follow-up phone calls to assess comprehension (N = 12). The second group was assigned to usual care (N = 11). RESULTS: Patients receiving literacy-appropriate interventions had greater A1c percent reduction (A1c difference of -2.0 ± 1.3 vs -1.0 ± 2.2; P = 0.02) and less hyperglycemic events per week (0.1 vs. 2.1; P = 0.04). There were no differences in the number of hypoglycemic events, testing frequency, medication-adherence rates, or hospitalizations and emergency room visits related to diabetes. CONCLUSION: Literacy-appropriate methods such as the teach-back method, personalized action plans, and telephone follow-ups may improve glycemic control in low health literate patients with diabetes. PRACTICE IMPLICATIONS AND INNOVATIONS: The findings from this study suggest that pharmacists may improve diabetes outcomes when managing patients who possess low health literacy using simplified teaching methods.

Physician-pharmacist collaborative management of asthma in primary care.

OBJECTIVE: To determine if asthma control improves in patients who receive physician-pharmacist collaborative management (PPCM) during visits to primary care medical offices. DESIGN: Prospective pre-post study of patients who received the intervention in primary care offices for 9 months. The primary outcome was the sum of asthma-related emergency department (ED) visits and hospitalizations at 9 months before, 9 months during, and 9 months after the intervention. Events were analyzed using linear mixed-effects regression. Secondary analysis was conducted for patients with uncontrolled asthma (Asthma Control Test [ACT] less than 20). Additional secondary outcomes included the ACT, the Asthma Quality of Life Questionnaire by Marks (AQLQ-M) scores, and medication changes. INTERVENTION: Pharmacists provided patients with an asthma self-management plan and education and made pharmacotherapy recommendations to physicians when appropriate. RESULTS: Of 126 patients, the number of emergency department (ED) visits and/or hospitalizations decreased 30% during the intervention (p=0.052) and then returned to preenrollment levels after the intervention was discontinued (p=0.83). Secondary analysis of patients with uncontrolled asthma at baseline (ACT less than 20), showed 37 ED visits and hospitalizations before the intervention, 21 during the intervention, and 33 after the intervention was discontinued (p=0.019). ACT and AQLQ-M scores improved during the intervention (ACT mean absolute increase of 2.11, AQLQ-M mean absolute decrease of 4.86, p<0.0001) and sustained a stable effect after discontinuation of the intervention. Inhaled corticosteroid use increased during the intervention (p=0.024). CONCLUSIONS: The PPCM care model reduced asthma-related ED visits and hospitalizations and improved asthma control and quality of life. However, the primary outcome was not statistically significant for all patients. There was a significant reduction in ED visits and hospitalizations during the intervention for patients with uncontrolled asthma at baseline. Our findings support the need for further studies to investigate asthma outcomes achievable with the PPCM model.

Recent changes in pregnancy and lactation labeling: retirement of risk categories.

The rapid development and increased availability of novel pharmacologic therapies and pharmaceutical products has amplified the potential for drug exposure during pregnancy. Many drugs are beneficial for disease state management during pregnancy and provide significant fetal and maternal health benefits. However, a paucity of safety data combined with the imprecision of the current risk category system renders risk versus benefit assessment difficult. In response to decades of criticism, the U.S. Food and Drug Administration (FDA) is implementing a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers. These recommendations will provide clear and detailed information for both patients and health care providers, and they will include three main categories: risk summary, clinical considerations, and data. The new labeling rules remove the previous letter risk categorization system (A, B, C, D, X). In this review, we summarize the upcoming FDA labeling changes and discuss their potential consequences on clinical practice.

Over-the-counter access to emergency contraception without age restriction: an opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence-based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.