The amount of ink and pixels dedicated over the past year to the subject of the Drug Supply Chain Security Act, or DSCSA, rivals the coverage received over the same period
by all the Kardashians combined.
Similar to the Seven Stages of Grief, pharmaceutical manufacturers are dealing with the Four Stages of DSCSA Compliance:
Shock and Denial, Anger and Bargaining, Working Through, and
Acceptance and Renewal.
It’s important to note that each player in the pharmaceutical
supply chain is moving through each stage individually at their
own pace and not collectively as an industry. In a 2016 survey,
only 13.5% of respondents stated their companies had their full
serialization program in operation.1 Today, many are walking in
the sunlight of acceptance and renewal while many others still
inhabit the dark recesses of shock and denial.
DSCSA IT AIN’T SO!
First, let’s discuss the initial three stages. The DSCSA, passed as
part of the Drug Quality Security Act, was signed into Law in
2013 with the purpose of strengthening protections for patients
from receiving diverted or counterfeit product. The mandated solution, involving concepts including serialization and track-and-trace, require a re-engineering of hardware, software, procedures
and workflow of every touchpoint along the prescription pharmaceutical supply chain. The FDA, in charge of enforcing the Act,
established four deadlines over a ten-year period from 2015-2023
that created milestones leading to full industry compliance.
Wrong. We now know that, like translating a foreign language,
the requirements were interpreted many different ways. Cue the
shock and denial.
The Psychology of DSCSA:
Four Stages of Serialization
It’s time for manufacturers to adopt post-serialization efficiencies
Marketing Manager, WDPrx – Woodfield Pharmaceutical, LLC