Wholesale distributors shipping drugs into Kansas may have recently received a letter from the Kansas Board of Pharmacy ("Board") requesting monthly shipment lists of prescription drugs sold or distributed into the state. Why? Well, the letter notes that the request is part of the newly launched Kansas Prescription Monitoring Program ("PMP").
The PMP is a state-wide initiative that tracks prescriptions for controlled substances and “drugs of concern” in the state as a means of combating drug diversion and abuse. The implementing regulations, which appear at Kan. Admin. Regs. 68-21-1 to -7 (2011), define “drugs of concern” as products containing a combination of butalbital, acetaminophen, and caffeine; as well as carisoprodol; and tramadol. Controlled substances include schedules II, III, or IV substances as delineated in the Federal Controlled Substances Act. This information, to be provided by dispensing practitioners and pharmacies, will be synthesized and uploaded into the Kansas Tracking and Reporting of Controlled Substances ("K-TRACS") centralized electronic database.
Kansas joins about 35 other states, such as California and Pennsylvania, that currently have PMPs. Thirteen states and the District of Columbia have enacted legislation to establish a PMP, but the programs are not fully operational.
The purpose of the PMP, as proudly displayed on the Board’s website, is to “provide useful feedback to prescribers on their own prescribing trends as well as their patients’ controlled substance histories. PMPs also provide useful information to prescribers when they suspect that a patient may be non-compliant in their controlled substance use.”
While the purpose and reasoning behind the PMP appear beneficial, if not admirable, the question remains: What do wholesalers have to do with it?
According to the Kansas statutes and regulations, nothing. According to the Board, however, a lot.
A little investigative work into this issue has revealed that the monthly shipment information from wholesale distributors is intended to help the Board identify those practitioners in the state who are dispensing to patients. In other words, rather than notifying all the licensed practitioners in Kansas of this new requirement, and therefore placing the onus on the practitioner to self-identify as a dispenser, the Board has taken the liberty of requesting this information from wholesale distributors. Although the board is requesting this information from wholesalers, the Kansas Legislature expressly exempted licensed wholesalers from PMP reporting obligations.
Does this strategy make sense? Only time will tell.
As of now, it appears that the Board is committed to amassing this information from wholesalers. And as a representative from the Board compellingly expressed, while the enforcement policies have yet to be ironed out, the Board expects full compliance from wholesalers (particularly in light of the fact that it is the entity that issues wholesalers’ licenses).
So, while wholesalers have nothing to do, officially, with Kansas’ PMP, unofficially, they are expected to provide information that will serve as the foundation of the PMP. Go figure.