From:
Theo Antoniou, CTO at MDScripts theo@mdscripts.com
Travis St.John, Chief Compliance Officer at Logicoy travis.stjohn@logicoy.com
We would like to recommend the following additions/changes to the ASAP format being used for controlled substance reporting. Please provide any comments or feedback.
1- Add “Product Description Field” to the end of DSP segment.
Reason: Too often data collection companies get an NDC (DSP 08) that is not in their database. This leads to a lot of work and communication with the submitter to determine what the Product ID Qualifier (DSP 07) and Product Id (DSP 08) represent. Having a product description with max 64 characters would allow data collection companies to easily add the missing products to their databases.
2- Add “Serial Number” to the end of the DSP segment.
Reason: As of Nov 2017, all pharmaceutical companies have been required to print the DSCSA GS1 barcode ( dot-matrix barcode) on their packaging. The barcode has a unique serial number for each product for upcoming DSCSA track and trace requirements that take effect Nov 2023. Having the serial number will enable the detection of diversion and counterfeits. While not many pharmacy software vendors are capable of storing and reporting the serial number, this will become a requirement in Nov 2023.
3- Add “State License” to the end of PRE segment
Reason: Many states are requiring the reporting of “Drugs of Concern” which are not DEA scheduled medications. Prescribers with no NPI or DEA number can prescribe Drugs of Concern since they are not a scheduled medication from the DEA. Having the state license field would allow the prescriber to be indicated in the prescriber (PRE) segment. The pharmacy (PHA) segment already has a state license field (PHA 13). The standard should indicate that in cases where the either pharmacy or the presciber do not have an NPI or DEA license, the state license fields are required to identify the entity dispensing or prescribing.
Thank you for your consideration.
-Theo/Travis