What Does All This "DSCSA Stuff" Mean to a Pharmacy?
What Does All This "DSCSA Stuff" Mean to a Pharmacy?
The environment our pharmacy sector has to work in includes a growing number of challenges:
· Pharmacies continue to face unprecedented demand on resources due to the pandemic impact.
· Recent news continues to show counterfeiters are evolving their methods that risk patient safety.
· DSCSA 2023 requirements are just 19 months away.
· DSCSA requires each organization to understand and manage their own compliance.
In our interactions with pharmacies, we have found that more than 50% of the dispensers have not started understanding or addressing DSCSA 2023 requirements. Many have indicated they feel that their suppliers or service providers “have them covered”. While we agree your partners should help you ensure compliance, each organization should remember that they will be held responsible in the event of any federal or state inspections. We have worked on DSCSA since it was passed in 2013 and you should know that the law requires an active approach to ensure compliance and expect that knowledgeable resources will be harder to engage as the date approaches and enforcement takes shape.
In an effort to help share insights, we are starting this blog series to help provide a summary of areas that your organization should be working on and understand why it is important to the pharmacist community(dispensers). We will share thoughts in future blog posts in these areas:
2. Know Your Product and Barcoding
In additon to these areas, your pharmacies should also have processes and procedures in place to cover these as well has handling and communicating suspect and illigetimate product. You should ensure that these related SOPs include documented training events as well as effectiveness checks to keep up on updating FDA and state guidance and policies.
As independent supply chain consultants working with clients in manufacturing to dispensing, one of the most important responsibilities we have to our clients and our profession is to help improve communication and awareness. In the early years of our company, we came across this quote from one of the founding brothers of the Mayo Clinic and feel it represents well the spirit that is required from the broader pharmaceutical industry to help support our frontline healthcare in the complex requirements of DSCSA:
"The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary." William J Mayo, M.D. 1910
It is in this spirit that we share this series of blog post and are open to any comments or feedback as we all learn the pathways forward for the industry.
Feel free to reach out to us through TenCountConsulting.com/contact if you have any questions or just want to chat!
