Beginning on January 1, 2013, all pharmacies and health care practitioners, including dentists, who dispense “monitored prescription drugs” to patients in Wisconsin must comply with the data collection and reporting requirements of Wisconsin’s new Prescription Drug Monitoring Program (“PDMP”). “Monitored prescription drugs” include Tramadol and all drugs that require a prescription and are identified as controlled substances in Schedules II, III, IV or V of the Controlled Substances Act (21 USC 812 (b)(2) to (b) (5) and (c)) and/or in Schedule IV or V of the Uniform Controlled Substances Act (Wis. Stat. ch. 961), each as updated and amended by law and applicable regulations.
The data collection and reporting requirements of the new Wisconsin rules apply to all “dispensers” of monitored prescription drugs. Fortunately for dentists, the definition of a “dispenser,” as set forth in the new rules, is a narrow one that will place most of the burden of data collection and reporting on pharmacies. Under the new rules, the “dispenser” of a drug is the person (or pharmacy) who actually delivers that drug to the patient, not the person who writes the prescription for that drug. If, for example, a dentist writes a prescription for a monitored drug that is then filled by a pharmacy, it would be the pharmacy, not the dentist, who would be the dispenser of that drug and who would need to collect and report data to the PDMP. Since dentists more often prescribe, than dispense, drugs, most dentists will not need to report any data to the PDMP to comply with the new rules.
Dentists should be aware, however, that anytime a dentist gives a monitored prescription drug to anyone for use outside of the dentist’s office, the dentist has “dispensed” that drug to the patient and must collect and report all of the required data. If, for example, a dentist gives a patient a sample of a monitored prescription drug, the dentist has “dispensed” that sample and must collect and report all of the required data about the patient and the drug sample. Moreover, dentists should be aware that there is no “de minimis” exception to the data collection and reporting requirements of the PDMP. Even the delivery of a single dose sample of a monitored prescription drug must be reported.
There is, however, an exception to the data collection and reporting requirements that applies whenever a monitored prescription drug is administered directly to a patient by a health care provider. If, for example, a dentist administers a monitored prescription drug to a patient during a dental procedure, the dentist would have no obligation to report the administration of that drug to the PDMP.
The new rules require the dispenser of a monitored prescription drug to record all of the data listed in Phar 18.04(3) of the Wisconsin Administrative Code and then to submit that data to the PDMP within seven days of dispensing the drug. In addition, if a dispenser does not dispense any monitored prescription drugs in a seven day period, the dispenser must submit a report (called a “zero report”) to the PDMP stating that no monitored prescription drugs were dispensed in that seven day period. To make it easier for dispensers to collect all of the information required by the new rules, the Wisconsin Department of Safety and Professional Services has created a form that dentists and other practitioners may (but are not required to) use to collect the information that must be submitted to the PDMP.
The data collection requirements of the new rules are effective on January 1, 2013, but dispensers will not yet be able, or required, to file weekly reports on that date, because the Wisconsin PDMP system will not yet be ready to receive that information. Consequently, dispensers should begin recording the required information immediately on January 1st, and should then submit all accumulated recorded information as soon as the PDMP system is up and running. Once this system is operational, the reporting requirements will become effective, and all dispensers will need to begin submitting weekly reports. The new rules require dispensing data to be submitted electronically, but dispensers may apply for a waiver of the electronic submission requirement, if submitting the information electronically would be burdensome, and the dispenser would like to use paper forms, instead.
This article was written by Janice L. Gauthier, Esq. Ms. Gauthier has an A.B. from Harvard University and a J.D. from Harvard Law School. She is the owner of The Gauthier Law Group, LLC, a boutique law firm that represents dentists, physicians, health care providers, professional service practices and other businesses and business owners in Wisconsin and Illinois. You can contact Ms. Gauthier at 414-270-3857 or by email. To learn more about Ms. Gauthier’s background and experience, visit her Google or LinkedIn profiles.
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