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The "Corresponding Liability" of the Pharmacist
Transcript of The "Corresponding Liability" of the Pharmacist
1) Prescription Monitoring Programs (PMPs);
2) Federal Law ("Corresponding Liability"); and
3) DEA Enforcement Cases Highlighting Wholesaler Transactions.
Tip of the Iceberg
The "Corresponding Liability" of the Pharmacist
AZ's Prescription Monitoring Program
1939: First known Prescription Monitoring Programs (California's Triplicate Prescription Program ("TPP").
1992: 10 states had functional programs.
Today: Vast majority of states have implemented.
Public Policy Strategy/Challenge: Sharing data between states, harmonizing the reporting burden on practitioners.
Relatively low percentage of practitioners have access.
A valuable and
Corresponding Liability in Plain Terms
In layman’s terms the regulation states that the pharmacist is in the same position as the practitioner who issued the prescription
(but, not an identical position and without having actually conducted an examination of the patient's record)
and must exercise professional judgment to determine whether a prescription for a controlled substance was issued for a legitimate reason.
No longer focused on Patients, Prescribers, and Pharmacists. Wholesalers become an effective enforcement target . . . for the DEA.
Cardinal Health v. Holder, 846 F.Supp. 2d 203 (D.D.C. 2012)
Mark D. Boesen, Pharm.D., J.D.
Director: Dean Wright, Arizona State Board of Pharmacy
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.
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.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and
the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
21 C.F.R. § 1306.04(a).
The Concept of Red Flags
Pattern Prescribing -- The Same Drugs and Same Quantity for Everyone;
Mulitiple and Duplicative Therapies -- e.g., Oxycontin and MS Contin;
Shared Addresses by Same Patients on the Same Day;
Quantity, Quantity, Quantity;
Same Diagnosis Code from Same Doctor; and
Prescriptions Written that are Not Consistent with Specialty.
I Found a Flag...Now What?
Does identifying red flags really mean you are exercising your corresponding responsibility as required by the regulations?
In the DEA’s eyes, are pharmacists only appropriately exercising their corresponding responsibility when they decide not to dispense controlled substances to a patient whose prescription sets off one or more red flags?
How many and/or what combination of red flags must be present for a pharmacist to decline dispensing a particular prescription?
Is it time for the DEA to update its regulations to provide clearer guidance to pharmacists?
Cardinal v. Holder
FACTS: The DEA issued an immediate suspension order against a wholesale distribution facility in Florida, which prohibited the facility from shipping controlled substances without the benefit of an administrative hearing.
BACKGROUND: Cardinal reduced supply and terminated relationships with certain pharmacies ordering suspiciously large quantities of oxycodone. DEA alleged that the wholesaler did not detect and report suspicious orders of oxycodone by its pharmacy customers, which DEA required. D
The wholesaler was required to demonstrate non-speculative, certain harms. Economic injuries were deemed to vague because descriptions of re-routing and shipping from other facilities and lost sales were not sufficient.
The court also rejected harm to the patients who could not obtain their medications as insufficient because that did not constitute harm to the wholesaler.
Krueger Inv. LLC v. Cardinal Health, 2012 WL 3028349 (D. Ariz.)
ISSUE: Whether a pharmacy can obtain an order against a wholesale drug distributor for performance under a distribution agreement when the pharmacy is suspected of controlled substance diversion?
BACKGROUND: Cardinal terminates deliveries of controlled substances to Pharmacy. Cardinal Health argued that the pharmacy was a diversion risk because an audit of the pharmacy showed some inventory shortages and overages, and the pharmacy sold large quantities of controlled substances.
Arizona Board of Pharmacy investigations found no diversion and the DEA did not investigate.
It's All About the Red Flags
The court explained that the wholesale distributor demonstrated that the pharmacy’s business met several factors identified by the DEA as possible indicators of diversion, such as high volume sales of controlled substances and inventory management issues.
Public interest in preventing diversion is significant and the pharmacy did not demonstrate that ordering the wholesaler to provide controlled substance stock is in the public interest.
My Practice is
Not a Target
Regulatory Investigations are Not Limited to the Criminal Enterprise.
Investigations Largely Start Out as Administrative Investigations.
ARCOS Data is Very Powerful to the DEA.
Professional Drug Seekers and Sophisticated Scam Artists can Victimize Almost Anyone.
Best Tool at Times: PDMP.
DEA Prosecutors Talk About the "Should Have Known" Standard.
Defending the "Should Have Known" Standard Can Be Difficult.