|June 14, 2013|
Previously published on June 13, 2013
Pharmacists are under increasing pressure to take extraordinary steps to verify prescriptions for controlled substances, especially in light of the fact that the Drug Enforcement Administration (“DEA”) has asserted that pharmacists are the gatekeepers or the “last line of defense” in the fight against prescription drug abuse. Alan G. Santos, DEA, Combatting Pharmaceutical Diversion: Targeting “Rogue Pain Clinics” & “Pill Mills,” Prescription Drug Awareness Conference, May 4-5, 2013, unnumbered slides. However, if the American Medical Association (“AMA”) adopts either of two committee resolutions at its 2013 meeting, pharmacists who serve that gatekeeper role should not expect cooperation from prescribing physicians. One AMA delegation has introduced a resolution to the Organized Medical Staff Section that would characterize routine pharmacist inquiries “for verification of the rationale behind prescriptions, including diagnosis, treatment plan, ICD-9 codes and/or previous medications/therapies that were tried/failed, and for routine pharmacist calls for such verification of this rationale, to be an inappropriate interference with the practice of medicine and unwarranted.” AMA Organized Medical Staff Section Resolution 12 (A-13), AMA Response to Drug Store Chain Intrusion into Medical Practice, received May 15, 2013. Delegations from New England have put forth an almost identical resolution to the AMA House of Delegates that also, while noting the regulations “only” require pharmacists to ensure the prescription is legitimate, pharmacists are “under no circumstances should be required to confirm the appropriateness of a prescription; the decision is purely a medical one, completely in the purview of the treating physician.” AMA House of Delegates Resolution 218 (A-13), AMA Response to Drug Store Chain Intrusion into Medical Practice, received May 17, 2013. Furthermore, calls from pharmacists to doctors’ offices to verify prescriptions will be deemed an “inappropriate interference with the practice of medicine and unwarranted ....” Id. If pharmacists continue to conduct routine prescription verification, the AMA plans to take its fight to the implicated companies (i.e., drug store chains), DEA, and other involved state and federal regulators to stop what the AMA believes is interference in the physicians’ practice of medicine and their medical treatment decision-making. If those efforts fail, the AMA will turn to Congress for legislation to eliminate any form of pharmacist prescription verification requirement, or to otherwise clarify physician and pharmacist roles in dispensing controlled substances.
The impetus for the AMA resolutions appears to be the policy of a “national drug store chain” that requires its pharmacists to call and speak with the practitioner to “verify” controlled substance prescriptions prior to filling them. While both proposed resolutions recognize a pharmacist’s “responsibility to vet any prescription for legitimacy,” they characterize pharmacist due diligence efforts not as a “last line of defense” against the prescription drug epidemic but instead an invasion of the patient-physician relationship. The resolutions suggest that pharmacists’ questioning prescribers about their controlled substance prescriptions is a perversion “of the “spirit and intent” of DEA’s pharmacist corresponding responsibility regulations. While DEA regulations do not specifically require a pharmacist to contact practitioners to verify controlled substance prescriptions, DEA’s interpretation of its regulations and recent administrative actions against pharmacies demonstrate that closely scrutinizing most if not all controlled substance prescriptions, including verifying prescriptions with prescribing physicians, is at a minimum exactly what DEA expects pharmacists to do.
DEA regulations have long established that a corresponding responsibility rests with dispensing pharmacists to ensure, with the prescribing practitioner, that a prescription for a controlled substance has been issued for a legitimate medical purpose by the individual practitioner acting in the usual course of professional practice. 21 C.F.R. § 1306.04(a). Many pharmacists, even with the current prescription abuse epidemic fueled by rogue practitioners, remain reluctant to question a practitioner about their controlled substance prescriptions. This is not unreasonable, given that it is the physician, armed with a medical degree and clinical training, sees the patient, treats the patient, and determines the appropriate medical treatment. While pharmacists are responsible for guarding against fraudulent prescriptions and potential doctor-shopping patients, questioning the prescribing practices and medical judgment of a physician and evaluating whether a prescription was issued for a legitimate medical purpose is far more difficult.
DEA traditionally viewed medical practitioners as the gatekeepers who determined through examination, administering, dispensing and prescribing which patients legitimately needed controlled medications. However, in recent years, because of the diversion created by rogue Internet pharmacies and pain clinics, DEA has focused more on pharmacists as the controlled substance gatekeepers, holding them accountable for dispensing pursuant to prescriptions not issued for legitimate medical purposes. See East Main Street Pharmacy; Affirmance of Suspension Order; 75 Fed. Reg. 66149 (Oct. 27, 2010). DEA officials have expressed their belief that the pharmacist, with their pharmacological training, rather than practitioners, is the “drug expert” in the healthcare arena and therefore responsible for policing practitioners. Responding to the Prescription Drug Abuse Epidemic: Hearing Before the S. Caucus on Int’l Narcotic Control, 112th Cong. 2 (2012) (Statement of Joseph T. Rannazzisi Deputy Assistant Administrator, DEA). Pharmacists must fulfill their corresponding responsibility through reasonably diligent efforts and judgment to ensure that a prescription has been issued for a legitimate medical purpose. See East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. Reg. 66149 (Oct. 27, 2010).
The AMA’s proposed resolutions are directly at odds with DEA’s legal and regulatory position on a pharmacist’s corresponding responsibility to ensure that prescriptions are issued for a legitimate medical purpose and in the course of a physician’s professional practice. For example, DEA has based an Order to Show Cause, in part, on a pharmacist’s assertion that it was “not [his] job to question a physician.” Id. DEA also requires pharmacists to resolve certain “red flags” signaling invalid prescriptions, including at a minimum verifying controlled substance prescriptions with the physician’s office prior to filling those prescriptions. See id.; Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 67 Fed. Reg. 62315 (Oct. 12, 2012).
Noticeably absent from the resolutions are any indication that the AMA will urge its physician members to assist pharmacists in their corresponding responsibility to ensure that controlled substances are issued for a legitimate medical purpose. If the AMA adopts either of the proposed resolutions, pharmacists will not only encounter continued physician resistance to prescription verification, but also find it even more difficult to comply with their corresponding responsibility to ensure that the prescriptions they fill have been issued for legitimate medical purposes.
The AMA and DEA must come to a consensus concerning the scope of a pharmacist’s corresponding responsibility to ensure that prescriptions are legitimate in light of the prescription drug epidemic so that patients obtain needed medication, pharmacists are not second-guessing medical decisions, and pharmacists who fill controlled substance prescriptions are not legally culpable for a physicians’ illegal or otherwise improper prescribing practices.
The AMA Organized Medical Staff Section and House of Delegates will consider the resolutions during the association’s 30th Annual Assembly this week in Chicago.