Disclaimer: The information and opinions expressed in this blog are based on the authors best understanding of the updates from HDA’s 2018 Distribution Management Conference and Expo and do not necessarily reflect the official policies or opinions of the industry in whole.
Blue Link was excited to participate for the first time in the 2018 HDA Distribution Management Conference and Expo March 4-7 in Austin, Texas. The annual conference is the largest supply chain education event of it’s kind and aims to engage attendees on topics related to healthcare supply chain and provide a forum for operation and strategic discussions among key players in the pharmaceutical distribution industry.
As an exhibitor at the show, Blue Link spoke with pharmaceutical wholesale and distribution companies about how Blue Link’s pharmaceutical ERP software, complete with CSOS functionality, helps automate processes and maintain compliance across all business departments. Having attended the HDA’s Traceability Seminar in November of 2017, most of the information discussed at the Distribution Show was in line with information shared at the Traceability Seminar and continues to confirm that Blue Link’s pharmaceutical specific functionality and software is aligned with existing regulatory requirements and future compliance updates. As a leader in the pharmaceutical ERP space, Blue Link continues to provide advanced functionality for small-medium sized pharmaceutical distributors at an affordable price.
Key Takeaways from the Show:
Most information discussed at the DMC was similar to that discussed at last year’s Traceability Seminar. Read our full recap of the show last year to learn more.
Suspicious Order Monitoring:
States across the USA are seeking greater clarity for suspicious order monitoring (SOM). Many states are specifically concerned with the ability to manage the data received and deal with irrelevant information. In addition, there is a concern around receiving data in inconsistent formats from multiple sources. To address these concerns, the HDA is advocating for a single DEA Suspicious Order Reports database that will be accessible by state legislators and law enforcement to help make it easier to deal with suspicious order reporting. It will also expand the DEA’s data collection capabilities and allow it to more effectively use advanced analytical tools to help deal with the opioid epidemic. This database is currently in development by the DEA and the HDA is advocating to share the information in the database with the appropriate members of legislative bodies and law enforcement. This database will then allow distributors to submit suspicious order reports electronically instead of through manual processes.
The HDA supports the DEA’s development of an online system for managing suspicious orders which require users follow a specific reporting format. The goal is to standardize reporting to help the DEA identify trends which may indicate that a pharmacy or other dispenser has violated distribution allowances when it comes to controlled substances.
Blue Link functionality for suspicious order monitoring consists of an automated procedure that assesses all open sales orders containing scheduled drug products against past invoiced sales orders for each individual customer. An algorithm then determines if there are any suspicious order quantities on a sales order based on sales history.
If the SOM determines a suspicious order quantity, a number of activities automatically happen simultaneously:
A file is automatically sent via email to the assigned user with the applicable information for easy review
The same file is automatically saved in a pre-determined folder
The sales order in question is automatically placed on “hold” and its order status changed, preventing the order from being processed
To release the “hold” status, an authorized user must change the status. In some situations, the quantity outside the threshold calculated is acceptable and the user has the ability to change the order type to prevent the SOM process from placing that specific order on hold again.
Serial Verification Router Service:
Starting November 2019, distributors accepting saleable returns will be expected to validate returned serial numbers with manufacturers prior to re-introduction into the channel.
Blue Link is adding features to its 2018/2019 application update that will allow distribution companies to scan and validate that the serial numbers accepted were in fact originally sold by the company, by comparing data elements of the product with company data stored in Blue Link. Alternatively, Blue Link intends to add support for any standardized “Router Verification Service” to allow customers to validate with the manufacturer. As of today, no such Router Verification Service exists, and during the DSCSA panel discussions at the conference, no one was able to verify is such a service is in development.
Opioid Tax Issue:
To address concerns about the abuse of opioids, legislation targeting manufacturers was brought forward in 2017. Some states received multiple proposals to add tax to the sale of opioids, but all proposals were successfully defeated by the HDA. Starting in 2018, additional requirements to the 2017 legislation has been brought forward with a focus on shifting from taxing mostly manufacturers to targeting distributors as well. This change of direction puts pressure on distributors to take more ownership of the safe and compliant sale of opioids, requiring stricter systems for tracking product and sales.
Looking ahead to the rest of 2018, Blue Link will be attending the HDA Traceability Seminar again this year in Washington, DC from October 17-19th. Be sure to stop by and say hello if you plan on attending. Other projects ahead for 2018 include further software advancements as the industry pushes towards the November 2023 DSCSA deadline.