The Health and Human Services Office of Inspector General (OIG) just released its report “Drug Supply Chain Security: Dispensers Received Most Tracing Information”. It was not a comprehensive study but rather an unannounced sampling of healthcare providers/dispensers in an attempt to get a realistic readiness assessment of the industry’s ability to respond to DSCSA requests, provide recommendations to the FDA and communicate to the broader healthcare industry where we stand with DSCSA.
The OIG study included 40 dispensers that varied in size and type including retail pharmacies, retail chain pharmacies, small and large hospitals. The OIG requested product tracing information and inquired about systems and infrastructure supporting the DSCSA in the study. Of the 40 facilities, two were utterly unaware of the DSCSA requirements, 14 were missing some elements required for product tracing, and 25 did not review drug product tracing information before accepting drug product. From a summary perspective, this means that 67% of the survey population does not meet the verification requirements of the DSCSA and 40% of the community do not meet the complete tracking and tracing reporting requirements of the DSCSA. The OIG’s conclusion in the report includes a recommendation for the FDA to do more educational and awareness building of the DSCSA requirements with dispensers and for the industry to continue to work towards fuller and more complete compliance.
The RXTransparent team was in discussion with some of the randomly sampled institutions at the time of the OIG’s inquiry. The feedback from our OIG contacts provided us unique visibility into how the survey was conducted and how the market responded. During this survey, none of the sampled institutions were using the RXTransparent’s Compliance Platform. We utilized both of these perspectives as inputs for enhancements to the RXTransparent Compliance platform. The most significant added functionality coming out of this study resulted in the platform’s multi-pedigree capability, which enables our customers to group pedigree queries by date and/or product and send, print, or export a summary and/or details of the collection of pedigrees in one report.
We will be further summarizing and drilling down into the OIG’s latest report in our April DSCSA Quarterly Update Webinar. For more information, please visitwebinars
To read the original OIG report go to: https://oig.hhs.gov/oei/reports