Individual Prescribers of Controlled Substances Should Know the CSA Requirements

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Shelby Root

Congress devised a regulatory system to help prevent prescription drug abuse and control both the legitimate and illegitimate traffic of controlled substances. The system makes it unlawful to manufacture, distribute, dispense or possess any controlled substance except in the manner authorized by the Controlled Substance Act (CSA). The CSA requires a practitioner to establish and maintain a legitimate doctor-patient relationship with the patient for whom he/she writes a prescription. It also requires the prescriber to issue a prescription only for a legitimate medical purpose within the usual course of professional practice. If a prescription is not issued in the usual course of the professional’s practice then the person issuing it shall be subject to penalties.


Recent Cases Against Individual Prescribers.

In October 2014, the Drug Enforcement Agency (DEA) revoked Dr. Fiaz Afzal’s registration after he had written prescriptions to 15 patients outside of the usual course of his professional practice. The government alleged he did not take sufficient or objective medical histories from the patients and often there was a lack of diagnosis to support continued prescribing of the controlled substances. Also, he failed to develop individual treatment plans and failed to consider remedies other than controlled substances. The DEA concluded that the physician violated the prescription requirement of the CSA, and was inconsistent with public interest.

In 2013, the DEA revoked Dr. Clair L. Pettinger’s registration after he allegedly issued nine prescriptions for controlled substances to undercover DEA agents who lacked legitimate medical needs. Dr. Pettinger’s revocation was upheld despite his introduction of evidence that the agents may have deliberately induced the prescriptions through symptomology deception. Even after the DEA suspended his registration, he apparently continued to prescribe. Evidence showed that he issued a prescription for hydrocodone after he acknowledged his suspended DEA registration. Thus, the DEA concluded his registration was inconsistent with the public interest.

Violations of the Controlled Substance Act.

The following have been found to constitute violations of the CSA in administrative hearings:

1. Performing an inappropriate, incomplete or no physical examination.
2. Not utilizing appropriate diagnostic testing.
3. Failing to devise and document a written treatment plan.
4. Failing to periodically reassess the effectiveness of treatments.
5. Continuing to prescribe controlled substances without attempting alternative therapies such as physical therapy.
6. Repeatedly prescribing without referring the patient to appropriate specialists such as neurologists, physiatrists, orthopaedic surgeons or neurosurgeons.
7. Failing to keep and maintain proper medical records.
8. Lack of diagnosis to support continued prescribing of a controlled substance.
9. Prescribing controlled substances to patients who lack legitimate medical needs.
10. Failing to take an adequate medical history from the patient.
11. Failing to consider remedies other than the prescription of controlled substances.
12. Failing to follow-up on contradictory symptoms relayed by the patient.

Comments?

What are your thoughts on the DEA’s decision and order? Please leave any thoughtful comments.

Contact a Health Care Attorney That is Experienced in the Representation of Health Care Professionals.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in health law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Government Publishing Office. 78 FR 61655 – Clair L. Pettinger, M.D.; Decision and Order. (October 3, 2013) From:
http://www.thefederalregister.com/2013/10/03/2013-24052.html

Government Publishing Office. 79 FR 61651 – Fiaz Afzal, M.D.; Decision and Order. (October 14, 2014). From:
http://www.gpo.gov/fdsys/granule/FR-2014-10-14/2014-24373

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620. Shelby Root is a summer associate at The Health Law Firm. She is a student at Barry University College of Law in Orlando.

KeyWords: Drug Enforcement Administration, DEA, defense attorney, defense counsel, defense lawyer, Controlled Substance Act, CSA, Show Cause Order, DEA registration, health law, health care law, health law attorney, The Health Law Firm, administrative hearing, controlled substances class, controlled substances database

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law firm. All rights reserved.

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