Navigating the Regulatory Environment for Doctors Part 2 – Prescription Drugs

In our previous post, we looked at the disciplinary framework for dentists as a whole.  This post will look specifically at one topic that has increasingly resulted in discipline for both dentists and physicians alike over the last few years: narcotic pain medication prescriptions.

The problem of prescription drug abuse has garnered national attention over the last few years.  Overdoses and deaths related to narcotic painkillers have risen dramatically, and as a result, federal and state lawmakers are enhancing the level of regulation and scrutiny applied to individuals and businesses authorized to dispense these powerful drugs.  You should be aware of these regulations and the potential pitfalls they can pose to your practice.

All narcotic painkillers are regulated under the Controlled Substances Act, and remaining in compliance with all applicable laws and regulations therefore requires and understanding of both state and federal statutes and regulatory codes.

In addition to the federal Controlled Substances Act and associated regulations,[1] Arizona also has laws governing the dispensing of prescription drugs, both in the Arizona Revised Statutes (ARS) and the Arizona Administrative Code (AAC).[2]  This post is intended to provide a brief overview of those authorities and how they may affect your practice.  The following are a few of the most common ways doctors can run into trouble under both state and federal law.

  • Prescribing Medication: The Arizona laws and regulations governing the act of prescribing medications can be found in A.R.S. § 32-1298(1) and A.A.C. R4-11-1401, 21 U.S.C.A. § 829 and C.F.R. 21 §1306.04. The most common violation of these sections, and also the one that can carry the stiffest penalties, is prescribing medication outside one’s scope of practice. An example of this would be a dentist who writes a prescription for a patient’s (or family member’s) chronic back pain.  The penalties for violating these provisions can be significant, up to and including the loss of your DEA license and possible disciplinary action by the medical or dental board.
  • Recordkeeping: Federal and state regulations require dentists to keep detailed records of all medication prescribed to patients, as well as records of all medication stored on the premises.[3]  This includes keeping a documented inventory of all medications in your practice.  To manage this critical function, it may be helpful to dedicate a staff member to assist in recordkeeping, with occasional audits to ensure that inventory controls are maintained.  Doctors are also required to maintain these records for three years from the date dispensed and they must be kept on site for immediate review.
  • Storage: Arizona law requires all prescription-only drugs and devices to be stored in a secured area and all controlled substances in a locked cabinet or room, and control access by a written procedure available to the dental board on demand for inspection. SeeA.C. R4-11-1403. Ideally, controlled substances should be stored using a “two lock” system: a locked cabinet/safe inside a locked room or closet.  Federal law mandates that the DEA registrant (the doctor) is responsible for storage of all controlled substances purchased under his or her registration number.  These precautions are necessary to prevent possible disciplinary action if a staff member or patient improperly accesses the controlled substances on site.
  • Disposal: Controlled substances are the only medications for which disposal is regulated by law, and those guidelines can be found in 21 C.F.R. 1317. This section outlines the various methods by which you may dispose of or destroy expired, contaminated, or defective controlled substances.  The procedures that must be followed for on-site destruction of controlled substances are very specific, so the safest method of disposal is through the use of a DEA-registered reverse-distributor.

Consequences of Violations

If you are found in violation of the regulations concerning prescription drugs, there can be serious repercussions.  In addition to the state disciplinary proceedings we discussed in our previous blog post, the DEA can also suspend or revoke your DEA registration for any of the following reasons: (1) falsification of your DEA registration application; (2) suspension, revocation, or denial of your state license; (3) exclusion from participation in Medicare or Medicaid programs (possibly in response to a violation of the Stark or Anti-Kickback laws discussed in a previous post); (4) conviction of a felony related to a controlled substance; or (5) commission of an “act inconsistent with public interest.”[4]  This last category is a “catch-all” that encompasses any of the violations above, as well as issues like repeatedly over-prescribing narcotic pain medication to patients.

If the DEA seeks to suspend or revoke your registration, you will be served with an order to show cause why your license should not be suspended or revoked.[5]  The order will contain the legal basis and reasons for issuing the order together with a summary of the facts the DEA is alleging.  In response, you will be required to show why your registration should not be suspended or revoked.

Similar to a state disciplinary proceeding, you have the right to request a hearing to challenge the facts alleged by the DEA.[6]  If you do not request one within 30 days, you waive your right to a hearing.  As with a state disciplinary hearing, you will be permitted to submit evidence and present witnesses to an administrative law judge.  However, it is the DEA’s burden to prove by a preponderance of the evidence that the alleged violation was committed.

The laws governing the prescribing and dispensing of prescription drugs are a complex mix of state and federal statutes and regulatory codes.  To aid doctors and dentists in their understanding of the federal regulations, the DEA created a Practitioner’s Manual providing all relevant federal laws and codes.  Review your office policies in conjunction with these statutes and regulatory codes to ensure that you remain in compliance with both Arizona and federal law, and consult with a healthcare attorney if you have any questions.

[1] USCA Title 21, Chapter 13 and CFR Title 21, Chapter 2.

[2] A.R.S. § 32-1298 and Arizona Administrative Code Title 4, Chapter 11, Article 14.

[3] See A.A.C. R4-11-1404, 21 U.S.C.A. § 827, and C.F.R. 21 § 1304.

[4] 21 U.S.C.A. § 824

[5] 21 C.F.R. 1301.37

[6] 21 C.F.R. 1316.47