The Controlled Substances Act and applicable regulations impose the responsibility for the proper dispensing of controlled substances on the pharmacist.[i] Pharmacists have a role in preventing prescription drug abuse, dubbed their “corresponding responsibility” in the Code of Federal Regulations. “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 C.F.R. § 1306.04(a).
This role of the pharmacist is particularly important in the midst of the opioid epidemic. Over 200,000 people have died in the United States from prescription opioid overdoses in the last two decades, and the problem continues to spiral, per the Centers for Disease Control and Prevention (CDC). Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999. In October 2017, President Trump declared the opioid crisis a public health emergency.
Pharmacists must be alert for “red flags”
The pharmacist’s corresponding responsibility frequently involves identifying and resolving “red flags.” A red flag is “a circumstance arising during the presentation of a prescription which creates a reasonable suspicion that the prescription is not, on its face, legitimate.”[ii]
- The prescriber writes significantly more prescriptions (or larger quantities) compared to other practitioners in the area
- The patient is returning too frequently for refills.
- The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. Drug abusers often request prescriptions for “uppers and downers.”
- The patient presents prescriptions written for other people.
- Multiple patients appear simultaneously, or within a short time, all presenting similar prescriptions from the same physician.
- People who are not regular patrons or residents of the community present prescriptions from the same physician.
Pharmacists serve as last line of defense against illegitimate prescriptions
The Department of Justice (DOJ) advocates that pharmacists are the last line of defense before a controlled substance prescribed without any legitimate medical purpose is dispensed.
In a recent case against two Tennessee pharmacies, their owner and pharmacists, the DOJ successfully secured a temporary restraining order, prohibiting the defendants from dispensing controlled substances. United States v. Oakley Pharmacy, Inc. This case is highlighted herein because the DOJ sought equitable relief in addition to the traditional sanctions, but there is nothing new about the grounds for relief.
The DOJ alleged that defendants filled hundreds of illegitimate prescriptions. According to DOJ’s expert, unresolved red flags included combinations of dangerous opioids with known potential for abuse, high-dose opioids, long distances travelled by patients presenting prescriptions, insufficient diagnoses to support prescriptions, cash payments, requests for brand rather than generic medications, family groups receiving similar prescriptions, doctor shopping, and polypharmacy (the use of multiple pharmacies).
In support of its motion, the DOJ cited a litany of corresponding responsibility case law, including:
- If a pharmacist “knows or has reason to know that the prescription was not written for a legitimate medical purpose,” then she must not fill the prescription. Med. Shoppe-Jonesborough v. DEA, 300 F. App’x 409, 412 (6th Cir. 2008) (quoting Medic-Aid Pharmacy, 55 Fed. Reg. 30043, 30,044 (DEA July 24, 1990)).
- A pharmacist who “filled a prescription notwithstanding her actual knowledge that the prescription lacked a legitimate medical purpose” or who “was willfully blind or deliberately ignorant to the fact that the prescription lacked a legitimate medical purpose” violates the corresponding responsibility requirement. Pharmacy Doctors Enterprises, 83 Fed. Reg. 10,876, 10,896 (DEA Mar. 13, 2018).
- A pharmacist illegally distributed controlled substances when the pharmacist “deliberately closed his eyes to the true nature of the prescription.” United States v. Lawson, 682 F.2d at 482.
- Pharmacists must “use common sense and professional judgment” in carrying out their corresponding responsibility. Med. Shoppe-Jonesborough, 300 F. App’x at 412 (quoting Ralph J. Bertolino, 55 Fed. Reg. 4,729, 4,730 (DEA Feb. 9, 1990)).
- A pharmacist who tries to verify a prescription but is “not satisfied by the answer . . . must ‘refuse to dispense.’” Med. Shoppe-Jonesborough, 300 F. App’x at 412 (quoting Ralph J. Bertolino, 55 Fed. Reg. at 4,730).
- A pharmacy violated 21 C.F.R. § 1306.04(a) by filling prescriptions with “at least one red flag that [it] did not attempt to resolve and that could not have been resolved.” Jones Total Health Care Pharmacy, LLC v. DEA, 881 F.3d 823, 830 (11th Cir. 2018).
Pharmacists must either resolve the “red flags” or refuse to fill
The DEA’s position is that pharmacists should refuse to fill when in doubt. “The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances. Such action is a felony offense, which may result in the loss of one’s business or professional license.”[iv] Refusing to dispense based on any doubt would arguably leave patients with legitimate pain without the prescribed relief. Pharmacists must exercise “sound professional judgment” in evaluating any prescription for the presence of red flags. Id.
Notably, red flags are not always specific to the prescription being presented. Pharmacists should also take into consideration the totality of the circumstances, including the practitioner’s prescribing patterns across different patients, e.g., large quantities, high-risk combinations and similar diagnosis codes. And it is important to monitor the overall controlled substance volume and percentage dispensed by a pharmacy. See e.g., United States v. Lawson, 682 F.2d at 483 (“Lawson willingly ignored every signal that he should question the volume of controlled drugs being dispensed from his pharmacies.”).
The pharmacist’s resolution of red flag signals should be documented, either on paper or electronically, in part because this becomes important evidence of meeting corresponding responsibility and refuting willful blindness. However, mere documentation does not always resolve the red flag. Verification by the prescriber may not protect the pharmacist. A pharmacist may be found to have knowledge that the prescription was illegitimate “despite a purported but false verification.” United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979). A refusal to fill may be appropriate, especially in light of the DEA’s stance that there is no duty to fill when in doubt of the prescription legitimacy.
This alert does not purport to be a substitute for advice of counsel on specific matters.
Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Melville, New York City, Rochester, Saratoga Springs, Syracuse, Uniondale and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.
[i] See, e.g., United States v. City Pharmacy, LLC, No. 3:16-CV-24, 2017 WL 1405164, at *3 (N.D.W.Va. Apr. 19, 2017).
[ii] City Pharmacy, 2017 WL 1405164, at *4; see also United States v. Lawson, 682 F.2d 480, 483 n.6 (4th Cir. 1982) (referring to “flags of illegitimacy”).
[iii] Drug Enforcement Administration, Pharmacists Manual: An Informational Outline of the Controlled Substances Act, 2010 Ed. (“DEA Pharmacists Manual”), Appendix D, available at https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_d.htm
[iv] DEA Pharmacists Manual, at p. 30, available at https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html.