Expert Discusses Changes to Drug Supply Chain Security Act

In an interview with Pharmacy Times® at the National Community Pharmacists Association (NCPA) Annual Convention, Lisa Schwartz, PharmD, RPh, senior director of Professional Affairs at NCPA, discusses the Drug Supply Chain Security Act and why it was updated for the distribution of naloxone.

Q: What is the Drug Supply Chain Security Act?

Lisa Schwarts: The drug supply chain insecurity act, and I'll probably say DSCSA, but I’ll try touse the full thing and not the acronym all the time, was passed back in 2013 to address some supply chain security issues, but also to make sure that there was a federal standard way to do this and that states weren't doing things individually. You can imagine the state-by-state supply chain security process would be kind of a nightmare, probably even for pharmacies as well as wholesale distributors. It's really intended to introduce an additional level of security into how drugs move through the supply chain, so between manufacturer to a distributor possibly to a secondary distributor, and then ultimately, they use the phrase dispenser, but of course dispenser most of them are pharmacies.

Q: At the end of September, the DSCSA was updated for the distribution of Naloxone. What is this change and why is it important?

Lisa Schwarts: The FDA issued some guidance really to clarify and make it really plain for the industry that the opioid emergency, the opioid public health emergency, has really created a situation where we need to make it as easy as possible for people to get naloxone. They've clarified that because this is a public health emergency, that the emergency exemption or exclusion to the DSCSA is in effect, and that some of the requirements for exchanging transaction data doesn't apply when a supplier is providing naloxone to either a harm reduction program or harm reduction supplier, which of course, the suppliers supply harm reduction programs.

Q: What other changes does this act make to pharmacies, and when do they go into effect?

Lisa Schwarts: The Act has required pharmacies to put some standard processes in place in their workflow to really address and make sure that when they're ordering from a new supplier that that new supplier is properly licensed, that it's a trading partner that they should be doing business with, that they're inspecting their order when they get the order to make sure it's actually what they ordered, and it's not something that was ever left the supply chain or was brought back in. Just to make sure that ultimately, the drugs that they're receiving and putting on their shelves are safe for patients.

The other aspect of this, there were some changes on the labeling. We've all seen 2D barcodes, or data matrixes. I think that phrase can be used interchangeably, but those 2D barcodes appear on labels, and that barcode contains more information than just the linear barcode. The linear barcode just had an NDC number in it, this data matrix has the serial number for that individual package. A lot more precision in the supply chain now, and we can trace figure out if that package was ever reported lost or stolen or, like in the case that it's a forged label, if it shouldn't exist at all.

Q: How has the DSCSA improved patient safety?

Lisa Schwarts: I think by making sure that the drugs that end up in a pharmacy are coming safely securely through the supply chain and are safe to give to patients.

Q: Any closing thoughts?

Lisa Schwarts: I do want to make sure pharmacies understand, that right now today, they have several obligations, several requirements to comply with the Drug Supply Chain Security Act. Those include making sure that you're only doing business with authorized trading partners. That's sort of the industry jargon for your wholesaler, I guess. So make sure that you buy from authorized trading partners, make sure that when your get your order that all of the pieces of the order have that 2D barcode on it, a compliant product identifier, making sure that the tracing data or the transaction data that you get from your wholesaler that you keep that or you have access to it for at least 6 years in case there's an investigation that needs to happen.

We anticipate at some point a regulator, such as FDA or your board of pharmacy, might ask you to demonstrate your compliance by being able to access your transaction data. If today you don't know how to do that, you really should get in touch with your wholesaler and make sure that you know how to find that transaction data.

Finally, you do need to make sure that you have a written procedure that is you know, tells you tells your employees what to do if you end up with a package, a bottle, a box, whatever it is that comes in a tote from somebody or in a box that you if it looks suspicious that you treat that as suspect product, do an investigation, quarantine it while you're doing your investigation just to really make sure that that product is safe to dispense to the patient. So of course if there are any questions about what those procedures should look like NCPA is very happy to help our members with that.