Prescribing Physicians
After reading the article in the required reading: “The medicine shoppe v. Loretta lynch, et al.: Pharmacists and prescribing physicians are equally liable.” Discuss the following:
- Identify and discuss the duties and responsibilities of a pharmacist toward a patient.
- Based upon your research and assessment of the case, did the pharmacist perform the required duties and uphold patient rights?
- Is the pharmacy at fault? Why or why not?
- What is the impact of the pharmacist’s actions on the patient and community?
- What precautions can be taken to ensure these types of incidents by allied professionals don’t happen to others? Should there be more regulations in place?
Grass, Jeffrey C, JD, MS, ACLM . The Health Lawyer ; Chicago Vol. 28, Iss. 3, (Feb 2016): 28-37.
ProQuest document link
ABSTRACT
[…]Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled Substances
Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R. § 1306.04(a) (2014) on
the grounds that these standards exceed the United States Attorney General’s and the DEA’s statutory authority
under the CSA.7 On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without
comment, thereby leaving open the question of whether or not the United States Attorney General may expand the
professional duty of pharmacists to require they either endorse or overrule the medical judgment of the prescribing
physician. FULL TEXT
On November 3, 2011, the Dmg Enforcement Administration (“DEA”) conducted an inspection of The Medicine
Shoppe, a small family-owned pharmacy in San Antonio, Texas. DEA Diversion Investigators (“Dis”) seized
prescriptions filled by patients of a local physician who was under investigation for possible dmg diversion. On
October 7, 2013, the DEA Deputy Administrator issued an Order to Show Cause (“OTSC”) to revoke The Medicine
Shoppe’s controlled substances Certificate of Registration (“COR”) on the grounds that the pharmacy had filled
prescriptions written by the target physician that were not for a “legitimate medical purpose.”1 The DEA alleged
that The Medicine Shoppe’s pharmacists failed to exercise their “corresponding responsibility,” along with the
physician, “to assure that its prescription for controlled substances was issued for a legitimate medical purpose”
and “in the practitioner’s usual course of professional practice” under DEA regulation.
The Medicine Shoppe responded that the pharmacists had known the patients and the prescribing physician for
many years and had contacted the prescribing physician’s office to verify the prescriptions before filling them.2
The Medicine Shoppe argued that therefore it had complied with the requirements of their pharmacists’
professional licenses and absent clear evidence of diversion, the pharmacists were obliged to fill the
prescriptions.3
On October 2nd, 2014 the DEA revoked The Medicine Shoppe’s COR.4 The Medicine Shoppe then filed a Petition for
Review with the United States Court of Appeals for the District of Columbia Circuit, which has original jurisdiction
for appeals of DEA Orders under the Administrative Procedure Act (“APA”).5 The Medicine Shoppe appealed on the
grounds that imposing a “corresponding responsibility” on pharmacists to ensure that controlled substances are
prescribed for a “legitimate medical purpose'” requires them to make medical judgments beyond their education
and training.6 Moreover, should the DEA disagree with a physician’s medical judgment and the medical necessity
of a prescribed medication, pharmacists who now share a “corresponding responsibility,” along with the physician,
“to assure that its prescription for controlled substances was issued for a legitimate medical purpose” will be
subject to the same civil and criminal liability for the physician, despite authenticating the order with the
prescribing doctor, as required by state law.
Accordingly, Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled
Substances Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R.
§1306.04(a) (2014) on the grounds that these standards exceed the United States Attorney General’s and the
DEA’s statutory authority under the CSA.7
On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without comment, thereby
leaving open the question of whether or not the United States Attorney General may expand the professional duty
of pharmacists to require they either endorse or overrule the medical judgment of the prescribing physician.
The Backdrop of Expanding DEA Enforcement
The DEA has declared prescription drug abuse to be the Nation’s fastest-growing dmg problem.8 It is of particular
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