The “corresponding responsibility” imposed on Oregon pharmacists
It is a crime is to “knowingly or intentionally” distribute or dispense a controlled substance unless “authorized” by the Controlled Substances Act (CSA). See, 21 U.S.C. § 841(a). Authorization is obtained by “registering” with the Attorney General. See, 21 U.S.C. § 822(a)(2). Persons registered with the Attorney General are authorized to possess, manufacture, distribute, or dispense controlled substances to the extent authorized by their registration. See, 21 U.S.C. § 822 (b). Physicians licensed by a state and registered with the Attorney General are “practitioners” and, as such, they are authorized to prescribe and dispense controlled substances (see, 21 U.S.C. § 829(a)&(b)) in “the course of [their] professional practice.” See, 21 U.S.C. § 802(21); see also, United States v. Moore, 423 U.S. 122, 140 (1975). Similarly, pharmacists licensed by a state and practicing in a pharmacy registered with the Attorney General, are authorized to dispense controlled substances. Giving effect to this federal statutory scheme, the Drug Enforcement Administration (DEA) promulgated a regulation that broadly requires all prescriptions to be issued for a “legitimate medical purpose” and imposes “a corresponding responsibility [on] the pharmacist who fills the prescription.” See 21 CFR § 1306.04(a). A pharmacist’s failure to observe whether a prescription is issued for a legitimate medical purpose can lead to administrative and criminal sanctions.
The difficult task faced by Oregon pharmacists
Compared to the prescribing physician or nurse, a pharmacist’s exposure to a patient is but a brief encounter. For most patients, a visit to a pharmacy is more akin to a sales transaction that a health care event and, should something seem amiss to the dispensing pharmacist, neither the patient nor the patient’s prescribing physician will have much tolerance for questions. Nonetheless, it is in this environment that the Oregon pharmacist is expected to ensure that all prescriptions are issued for a legitimate medical purpose.
The current practice standard: screening for “red flags”
I can assure you from my work defending physicians and pharmacists that screening for red flags is expected of all practitioners. For the pharmacist, however, screening for red flags may be one of the better tools available to detect prescription drug diversion, to ensure that all prescriptions are issued for a legitimate medical purpose. Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be a consideration for the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is a suspicion of drug diversion and one or more red flags were present. The Oregon Board of Pharmacy addresses screening for red flags on its website at: http://www.oregon.gov/Pharmacy/pages/index.aspx), and further links to an YouTube educational video: https://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be:
While screening for red flags to prevent drug diversion has its limits (and its critics, which include patients, prescribing and dispensing practitioners, and pain control advocates who may feel pitted against one another), it is nonetheless the current practice standard against which a pharmacist’s conduct will be measured, and it is therefore important to incorporate this type of scrutiny into the Oregon pharmacist’s day-to-day practice.