The DEA Opines on a Pharmacist’s “Corresponding Responsibility”December 1, 2010
The Drug Enforcement Administration (“DEA”) recently published a decision that considers the scope of a pharmacist’s “corresponding responsibility” under 21 C.F.R. § 1306.04(a). East Main Street Pharmacy (Affirmance of Suspension Order) (Docket No. 09-48) (75 Fed. Reg. 66149 (Oct. 27, 2010)) (“EMS”). As background, 21 C.F.R. § 1306.04 provides that while “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 C.F.R. §1306.04. The regulation further states, “the person knowingly filling such a purported prescription, as well as the person issuing it [is] subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Id. Thus, a pharmacist is prohibited from filling a prescription for controlled substances “when he either knows of or has reason to know that the prescription was not written for a legitimate purpose.” 75 Fed. Reg. at 66163. Further, when prescriptions are not issued for a legitimate medical purpose, a “pharmacist may not intentionally close his eyes and thereby avoid [actual] knowledge of the real purpose of the prescription.” Id. (Quotations and citations omitted) (emphasis added).
Pharmacists are well trained and aware of their “corresponding responsibility.” They must only fill valid prescriptions for controlled substances issued by a legitimate practitioner for a legitimate medical purpose. Nevertheless, the standard for what exactly is – and, specifically, what exactly is the extent of — a pharmacist’s “corresponding responsibility” has been a troublesome concept for practitioners and pharmacies alike. Admittedly, the pharmacist in the EMS matter allegedly engaged in egregious dispensing and recordkeeping misconduct, and the case involved one bad doctor (who the Deputy Administrator called a “drug dealer”). And, although this may be a case where over-the-top facts indeed make bad law, both pharmacists and practitioners should be mindful of the EMS opinion because the DEA has taken significant strides to clarify the scope of a pharmacist’s corresponding responsibility.
First, faced with respondent’s assertion that the “corresponding responsibility” standard is vague, “unknown” and “ambiguous,” the DEA stated that the standard is constitutional: Federal courts have had “little problem” applying the DEA regulation, which gives “fair notice that certain conduct is proscribed.” Id. at 66163.
The DEA next addressed certain “red flags” that should have given the respondent pharmacist a “reason to know” that the prescriptions patients presented to him were not legitimate. Importantly, the DEA did not focus on whether the pharmacist had “actual knowledge” that the prescriptions were not issued for a legitimate medical purpose, but instead whether the pharmacist had “reason to know [they] were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.” Id.
In reviewing the pharmacist’s conduct (and citing the government’s unrefuted expert), the DEA stated that the pharmacist ignored several signs that the prescriptions written by the physician were not legitimate. These flags include the following: (1) “ample evidence” showing that the respondent repeatedly dispensed “cocktailed” prescriptions for oxycodone, hydrocodone, alprazolam, and carisoprodol; finding that this combination prescription is “well known in the pharmacy profession as being used by patients abusing prescription drugs;” (2) no individualization of dosing by the prescribing physician; (3) filling multiple prescriptions for the strongest formulations of hydrocodone and alprazolam; (4) requests for early dispensing of refills; (5) refilling prescriptions of patients or doctors located hundreds of miles away from the pharmacy; (6) an overwhelming proportion (95%) of prescriptions filled by the pharmacy were controlled substances prescriptions; (7) the pharmacist did not reach out to or otherwise contact other pharmacists to determine why they were not filling a particular doctor’s prescriptions; (8) filling prescriptions of patients that travelled to the pharmacist in groups; (9) filling a larger percentage of cash prescriptions. (“This too, was a red flag as ‘[a]ny reasonable pharmacist knows that a patient that wants to pay cash for a large quantity of controlled substances is immediately suspect.’”); and (10) “verification” of a prescription as “legitimate” was not satisfied simply because the practitioner performed MRI’s and blood tests on the patients. Id.
Presented with the above evidence, the DEA stated that even if the pharmacist had verified with the physician “each and every” prescription, the evidence showed he still violated his corresponding responsibility because many of the prescriptions “patently served no legitimate medical purpose.” Id.
The DEA also stated that the single fact that the pharmacist dispensed high quantities of commonly abused drug cocktails containing oxycodone, hydrocodone, and alprazolam and carisoprodol should have called into question the legitimacy of the prescriptions. Id. at 66164-65. The DEA added that “the other evidence,” including all of the evidence referenced above, was “simply icing on the cake” that the pharmacist violated his corresponding responsibility to fill only legitimate prescriptions issued for a legitimate medical purpose. Id. at 66165. When respondent presented some evidence concerning his refusal to fill prescriptions from pain clinics after he received notice to stop filling from the Ohio Board of Pharmacy, the DEA responded that a “responsible DEA registrant should be able to make these determinations without the authorities having to provide him the information on a silver platter.”
Pain experts would certainly argue that in many cases DEA's red flags are in fact the basis for legitimate pain treatment, e.g., the “pain cocktail” is often prescribed because of the anxiety and muscle tension experienced by pain patients. However, pharmacists must be attentive to these factors, “red flags,” or signs — as part of their corresponding responsibility to fill only prescriptions that are issued for a legitimate medical purpose.