When new regulations on how dispensers (including doctor’s offices) document the transfer and purchases of pharmaceuticals kick in on November 1st of this year, will your ophthalmology practice be prepared?
Do you buy from distributors in full compliance with the law, who themselves obtain their products from compliant manufacturers?
If you’re not prepared, or you’re not sure either way, then you’re putting your business and reputation on the line—so let’s discuss what these regulations entail and how to keep on the right side of them.
The Drug Quality and Security Act (DQSA)
H.R. 3204, aka the Drug Quality and Security Act (DQSA), established a uniform national standard for tracing pharmaceuticals from manufacturer to end user. Intended to eliminate redundancies and inconsistencies in the laws between various states and ensure drug safety for patients, the bill requires all parties involved in a pharmaceutical logistics chain to document the receipt and transfer of drugs, then maintain those records for 6 years.
After delays for the manufacturers, wholesale distributors, and dispensers of the bill, manufacturers and wholesale distributors became subject to the standards on May 1st and dispensers are on schedule to start following the law by November 1st.
All doctors and practices will need to adhere to the standard on most pharmaceuticals (with a few key exemptions such as transfers within affiliate companies, IV products, radioactive drugs and biologics, etc.).
The Document at the Core of DQSA Compliance: Your T3s
Essentially, the regulation boils down to a single document that you (and your logistics chain) needs to make sure it receives before or at the time the drug is delivered and kept on record for 6 years:The T3.
The document is named for the three “T”s which it tracks:
In theory, this should represent a net simplification of logistics documentation for many businesses in the pharmaceutical and medical industries, but it does represent a change which businesses may lag to comply on, especially if they operate in states with less stringent standards than the new federal standard.
What This Means for You
It’s important to understand that a business in full DQSA compliance, maintaining T3 documentation as mandated by the law for all necessary materials, may still find itself running afoul of these regulations indirectly.
If part of your logistics chain fails to adequately comply with the law and finds itself on the wrong side of a federal audit after November 2015, then your ophthalmology practice will almost inevitably find itself with logistical issues. In theory, a supplier with faulty T3 documentation could lead to a ‘corruption’ of your own documentation down the line, as well, making you susceptible to unfavorable audit outcomes through no fault of your own.
Make sure that your books are in order first, then make thorough inquiries up the line—all the way to the pharmaceuticals’ manufacturers, if need be.
This isn’t a particularly difficult new regulation to remain in compliance of, but it does carry the risks of exposure inherent to all such regulation.
Make sure your ophthalmology practice documents its drugs thoroughly and works with companies careful about their DQSA compliance to ensure smooth operations after November 1st.