Actual use of and adherence to ibuprofen 400 mg tablet dosing instructions in a simulated OTC environment
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OBJECTIVE: Evaluate adherence of US consumers to proposed label directions for a new 400 mg ibuprofen formulation. METHODS: In this single-arm, open-label, multicenter, 30-day study simulating an over-the-counter (OTC)-like environment, US analgesic consumers reviewed proposed product packaging for a new 400 mg ibuprofen formulation and made a purchase decision. Purchasers used the product as needed and recorded use over 30 days. Outcomes included the percentage of participants who exhibited correct or acceptable product use for the primary endpoint (not exceeding 1,200 mg/day > 2 times during the study) or secondary endpoint (not exceeding 400 mg/dose > 2 times during the study) and adherence to the labeled dosing interval of 6 - 8 hours. Primary endpoint success was met if the lower bound of the 95% confidence interval (CI) was ≥ 85%. RESULTS: Of 685 purchasers providing use data, correct or acceptable use behavior occurred in 95.2% (95% CI: 93.6%, 96.8%) regarding total daily dose and in 84.4% (95% CI: 81.7%, 87.1%) regarding the number of tablets taken per dosing occasion. Most participants (87.3%) never used > 1,200 mg/day or took > 1 tablet/dose (78.1%). Nearly 43% of subjects re-dosed within 6 hours of the previous dose; of these, ~ 82% re-dosed between the 4- and 6-hour time intervals. Adverse events were consistent with prior ibuprofen 200 mg experience. CONCLUSION: This study provides evidence that a majority of US consumers would be able to use OTC ibuprofen 400 mg tablets in a manner consistent with product labeling. Misuse rates were low and unlikely to generate an excess risk of clinically important adverse events.
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Using community pharmacies to conduct an HSV-1 prevalence study.

PURPOSE: To describe the effectiveness of community-based pharmacists in conducting a study to measure the baseline prevalence of Herpes simplex virus, type-1 susceptibility to two antiviral medications in subjects with recurrent Herpes labialis. METHOD: A cross-sectional study conducted in 47 US community pharmacies. The pharmacist obtained a viral sample from the surface of the lesion, placed the virus-laden swab in a vial of holding medium, and stored it in a refrigerator until shipment to a central laboratory. RESULTS: The population that had swabs processed for viral isolation (1795) was predominantly white (90.1%) and female (67.9%) with a mean age of 37.5 years. A total of 1087 (60.3%) swabs were positive for HSV-1. On-site monitoring revealed 219 protocol deviations related to the stage of the lesion (124), not properly dating or signing the consent form (80), and indeterminate age (15). CONCLUSIONS: This study demonstrates the ability of pharmacists to conduct a large surveillance study in busy community pharmacies. A population of RHL sufferers with active lesions was recruited to study pharmacies during a 5-month period. Pharmacists successfully obtained viral samples from cold sore lesions at a rate comparable to physician-conducted studies. Protocol deviations were generally not serious, and did not compromise the study results or endanger the rights or welfare of participants.