With a new year in full swing, HDA President and CEO John M. Gray looked ahead to the organization’s 2019 priorities (along with other industry association executives) as part of the Chain Drug Review “Pharmacy Outlook” feature.
The Verification Router Service (VRS) started off as an idea in 2015. In 2016, it was identified as a preferred option for compliance with the 2019 saleable returns requirement (along with sending data via EPCIS). Since 2017, HDA has been convening industry stakeholders to write business requirements for the VRS, later pulling in solution providers to help with the technical details and then facilitating the group that developed the documentation that exists today.
A new report by Avalere Health, "Trends in Opioid Use: History, Background, and Origins of the Epidemic," comes at a critical point in the broader discussion about opioid abuse and misuse, and provides important context around the clinical, regulatory and policy milestones that contributed to the public health epidemic and impacted the national response to the crisis.
Few people understand exactly what role wholesale distributors play in the pharmaceutical supply chain, often confusing them with manufacturers, pharmacy benefit managers or even pharmacists. Just like the wholesale distributor who helps keep your grocery store shelves stocked with many different food brands, pharmaceutical distributors work with large numbers of suppliers (in this case pharmaceutical manufacturers) to ensure that their products (medicines) are safely, securely and reliably delivered to their ultimate destination — such as a state and federally licensed pharmacy, hospital or long-term care facility.
For the past several months, HDA has been collaborating with our pharmacy partners at Allied Against Opioid Abuse (AAOA), the National Community Pharmacists Association (NCPA) and the National Alliance of State Pharmacy Associations (NASPA), to develop a suite of resources specific to the pharmacy community. We are pleased that last week, those resources were mailed to thousands of pharmacists across the country and released online at www.AgainstOpioidAbuse.org/PharmacyToolkit.
As the summer winds down, HDA is hard at work planning our 2018 Traceability Seminar, which will take place three weeks earlier, on October 17–19 at the Renaissance Washington, DC Downtown Hotel. As the industry passes the halfway mark for DSCSA implementation, our 2018 agenda leverages HDA and our members’ unique expertise to help fellow stakeholders answer critical questions while planning for the multiple milestones ahead.
As mentioned in our February 16 blog post, HDA and industry participants continue to make progress working with solution providers as Verification Router Service (VRS) solutions are developed for the 2019 DSCSA saleable returns requirement. This work has taken three paths: establishing governance processes; creating testing scenarios; and launching the testing phase.
HDA and its member companies are committed to reversing our nation’s opioid abuse epidemic. That is why the Alliance is working with stakeholders in communities nationwide to educate and raise awareness about the dangers associated with opioid abuse and misuse.
Last year, FDA announced a period of “enforcement discretion” related to the deadline for manufacturers to serialize products under the Drug Supply Chain Security Act (DSCSA). As the industry quickly approaches the November 2018 deadline, it is essential for companies to prepare now for the reality of conducting business in a serialized environment. Is your company ready to meet the new requirements?
Disposing of unused prescription opioids safely and as soon as they are no longer needed can help prevent these medicines from falling into the wrong hands. Data show that opioid misuse often starts in the home, with more than 40 percent of those who misused prescription pain relievers obtaining the medication from a friend or relative for free.