Fake drugs, real concerns: Counterfeit HIV medications and community trust.

Counterfeit medications infiltrate drug supply chains at various entry points. While scientific advancements continue to deter counterfeit medications, these imitation therapies still manage to circumvent national and international regulations to reach unsuspecting consumers. Certain manufacturers of human immunodeficiency virus (HIV) prevention and treatment medications within the United States recently encountered counterfeit versions of their therapies that in some instances contained antipsychotic and pain reliever products. People on HIV treatment or those taking HIV prevention therapies who consume counterfeit medications are at risk of having their HIV management strategies compromised or seroconverting from an HIV negative to an HIV positive status, respectively. The implicated manufacturers reportedly took legal actions against the discovered counterfeiters, alerted impacted pharmacies, and assisted them with removal of illegitimate drugs. However, communities' gradual awareness or lack thereof in regards to counterfeit HIV prevention and treatment medications is likely to result in speculation about how many consumers took real versus fake medications, contributing to consumer distrust. This commentary provides details of a stakeholder meeting that took place with one of the leading manufacturers of HIV treatment and prevention medications to query its responses to counterfeit medications identified among its available product supplies in pharmacies. This manuscript also recommends to manufacturers ways to augment their communication strategies to communities if similar medicinal breaches occurred in the future.

Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial.

BACKGROUND: African American accrual to prevention trials at rates representative of the disease burden experienced by this population requires additional resources and focused efforts. PURPOSE: To describe the rationale, context, and criteria for selection of sites that received Minority Recruitment Enhancement Grants (MREGs) to increase African American recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). To determine if African American accrual was higher among the 15 MREG sites when compared with similar nonawarded sites. METHODS: Changes in African American accrual at sites that received MREGs are compared with changes in a group of 15, frequency-matched, nonawarded sites using a quasi-experimental, post hoc analysis. Successful and unsuccessful recruitment strategies reported by the MREG sites are described. RESULTS: The increased number of African American participants accrued per month at MREG sites post-funding was higher than the change at comparison sites by a factor of 3.38 (p = 0.004, 95% CI: 1.51-7.57). An estimated 602 additional African American participants were recruited at MREG sites due to MREG funding, contributing to the overall 14.9% African American recruitment. Successful recruitment strategies most reported by MREG sites included increasing staff, transportation resources, recruiting through the media, mailings, and prostate cancer screening clinics during off-hours. LIMITATIONS: Comparison sites were chosen retrospectively, not by randomization. Although comparison sites were selected to be similar to MREG sites with regard to potential confounding factors, it is possible that unknown factors could have biased results. Cost-effective analyses were not conducted. CONCLUSIONS: MREG sites increased African American accrual in the post-funding period more than comparison sites, indicating MREG funding enhanced the sites' abilities to accrue African American participants. Targeted grants early in the accrual period may be a useful multi-site intervention to increase African American accrual for a prevention study where adequate African American representation is essential.