ePedigree and its Requirements

[kishore_sirigiri]

ePedigree provides information of drug movement in entire supply chain – From manufacturing to Pharmacy. This has been initiated by California board of pharmacy as a part of anti-counterfeit drugs program. This will provide genuine medicine to patients and also secure product authenticity and reduce loss due to stolen identity.

Analyzing ePedigree in print form may be tedious because it may run in pages providing details of manufactures and various transactions done till it reaches Pharmacy. It would be better to get the details in a report where a product authenticator can perform due diligence on product to confirm its identity.

Let us understand what kind of information is required on pedigree report and how it can be analyzed to confirm product identity.

Product information

Product information should include

Brand name

Generic name

Pack size and unit size

Shelf life information

Date of manufacture, Date of expiry, batch number

Manufacturer’s information

Manufacturer name

Place of manufacture

Manufacturer’s license

Transaction Details

Details of Transactions executed between two parties while moving drugs from one place to other. For eg: sales order, stock transfer order etc

Name of the seller

Seller’s license

Seller’s address

Key person in seller’s team to contact in case of product discrepancy

Name of the customer

Customer’s license

Customer’s address

Key person in customer’s team to contact in case of product discrepancy

Below are mock SAP screen shots helping to design ePedigree report.

[oliver_nuernberg]

...California ePedigree will be superseded by the federal regulations (Drug Quality and Security Act (DQSA), H.R. 3204) that has passed the senate earlier this week. So once this bill has been signed by president Obama California ePedigree will be history (see this Blog).

Anyhow, you are absolutely right that such a report would be beneficial in any case regardless of the exact way the legislation is written. Customers will have to plow through meriads of data and inc ase of an inquiry for a certain package suich a report would be very valuable.

[kishore_sirigiri]

But DQSA still mostly inline with California board of pharmacy rules, except timelines.

[oliver_nuernberg]

Hi,

in my view DQSA is different from Calidornia ePedigree not only from the timelines but also from the requirements.

The new federal bill (DQSA) in my view governs 2 processes. Starting Jan 1, 2015 Manufacturers are obliged to provide transaction information on a batch level only, so no serialization anymore. The requirement for an electronic signature is also no longer part of DQSA.

DQSA is pushing the serialization requirements to end of 2017 for pure serialization and end of 2023 for serialization & aggregation. The key however is that the new legislation doesn't mandate an ePedigree or DPMS anymore and also doesn't include requirements for a digital signature.

But again, this is only my view. As a reference, the original text of the act can be found here. Original Bill .

[kishore_sirigiri]

You are right Oliver!

There's a change in requirements as well. I need to understand what happens to Florida and California drug requirement rule.

[oliver_nuernberg]

...they are both pre-empted as well, and so are any other state-laws that exist. Everybody is waiting for guidance right now how this will work out exactly.