Tackling DSCSA Compliance in Saleable Items Returns
There is a palpable relief within pharmaceutical industry as the deadline for DSCSA’s requirements for saleable returns has extended by a year. The deadline has been extended till November 2020.
As part of compliance with DSCSA, it is mandatory that all prescription drugs returned to wholesale distributors have product identifiers on packages of saleable returned product verified with the manufacturer before being resold. Specific requirements include quarantine and investigation of a product determined to be a suspect product and quarantine, disposition, and notification of a product determined to be an illegitimate
product (Section 582 of the FD&C Act). VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses in order to support DSCSA verification requirements.
According to industry estimates, based on the nature of drugs and their origin, 2-4% of all sold drugs are saleable returns. This constitutes thousands of transactions per day for some of the large distributors. VRS implementation and streamlining would enable distributors to resell returned items in shorter time while conforming to DSCSA requirements. The onus on providing timely verification on saleable item to the distributor, when requested, lies with the manufacturer. This is where complexity comes in. Reconciling data at large scale is a complex and time-consuming process. Often, product data is stored in diverse and dispersed systems that do not talk to each other. Manual intervention is costly, time consuming and prone to errors.
As David Colombo, Director, Life Sciences Advisory Services at KPMG, LLP, noted at healthcare packaging industry seminar, “To meet DSCSA milestone in 2019/ 2020, we need
something efficient, effective and electronic. This has given rise to an immediate need for manufacturers to work with solution providers. According to an instant poll conducted at the seminar, when asked how they plan to respond to verification requests, 62.4% respondents stated they planned to use VRS provided by solution providers (against 8.3% who believed they could internally meet this requirement).
On the distributor side, the “Big 3” pharmaceutical distributors, who account for more than 90 percent of all revenues from drug distribution in the United States: Amerisource
Bergen Corporation, Cardinal Health, Inc. and McKesson Corporation, have all stated that they will not accept nonserialized returned products, also known as saleable returns,
after November 27, 2020. For the VRS system to work seamlessly, the following steps need to work with precision and predictability:
Wholesaler/Distributor submit verification request in the system.
Router service puts look-up directory in action to match the required product information and direct it to the source.
Manufacturers respond to the verification request as an automated system.
Blockchain as VRS enabler
Enterprise blockchain enables secure and immutable copy of a transaction to be formed by enabling a consensus driven logging and registration of a transaction. To update or change a transaction all parties need to agree to change the record and so no single party can change a record on their own. This eliminates fraud and counterfeiting as there is no single point of failure.
While blockchain provides a possible solution for end to end traceability of product consignments (which is the end objective of DSCSA 2023), VRS requirement could be easily integrated into existing enterprise blockchain solutions to enable compliance with DSCSA 2020 VRS requirements. This would be a 2-step process:
Step 1: A solution provider would write APIs to ‘collect’ data residing in different systems and diverse formats in a uniform interface automating access of data from manufacturer side.
Step 2: A request would launch a look up program to match requested data against manufacturer database. Blockchain enabled access would keep the data secure, immutable
Challenges in VRS implementation
1.Lack of understanding of this key DSCSA requirements by key industry stakeholders
2. Concerns around interoperability of data lying in disparate systems
3. Most of the solutions available in the industry are in their infancy and are still being tested
4.Complexities in use cases
5. Limited time left to implement, test, roll out systems and train staff
Conclusion: Compliances are meant to protect end consumers and patients. Industry stakeholders often look upon compliance as the necessary pain to get their products out in the market in the shortest possible time. This means they often leave this important requirement until very late. November 2020 is sooner than it seems and the clock is ticking for manufacturers. Solutions are available but the intent and decisions will need to come from manufacturers.