When Prescribing Controlled Medications, What Type of Conduct Leads to Legal Trouble?

Typical investigation tactics include inspection warrants, search warrants, and medical record review. Others may involve undercover work or “follow the money.” Bolen provided one example of what she called a “bad idea”: “two diversion investigators go out to talk to a physician. Physician opens the door and denies his identity.”

“Expert witnesses” is another investigation tactic, with different types of medical experts having specific roles—and an impact in the courtroom (Table 1).

Table 1. Medical Experts

Type	Their Job	Courtroom Impact
Medical Pharmacy Toxicology Medical Examiner DEA Agent Financial	Review records Give opinions Assist with case development (consulting expert vs. testifying expert issue)	May have history of prior testimony May or may not understand legal standards applicable to cases. May not understand objective/subjective aspects of prescribing standard May or may not be good at describing prescribing in the usual course of professional practice and legitimate medical purpose

Also outlined were topics medical experts frequently address in the courtroom (Table 2). 

Table 2. Frequently the Topic of Courtroom Testimony by Medical Experts

Dose and chronicity of prescribing; combination prescribing; morphine equivalent daily dose (MEDD)

Lack of individualized patient care

Paper over process

Drug testing Failure to do it Failure to confirm RX drugs and unexpected results Financially motivated Kickbacks, Rebates Failure to test for marijuana and failure to address + THC results Failure to address “out of range, above range, below range, quantitative results”

Medication counts (lack of, failure to discuss with patients)

LAO + SAO – same amounts every visit both drugs

Lack of physical examination

Lack of specialty referrals

Failure to address behavioral issues; failure to evaluate abuse/addiction risks and history

Failure to follow the treatment agreement

Failure to engage in informed consent process

Failure to consider non-drug therapies

Failure to consider non-opioid medication

MANY MORE

Copyright 2014, The J. Bolen Group, LLC. All rights reserved.

Early factors of inappropriate prescribing were described in the 1978 case, US v. Rosen:

1. Inordinately large quantity of controlled substances was prescribed.
2. Large numbers of prescriptions were issued.
3. No physical examination was given.
4. Prescriber warned the patient to fill the prescriptions at different drug stores.
5. Prescriber gave prescriptions to patient despite knowing (or having reason to know) that patient was diverting the medication.
6. Medication prescribed at intervals inconsistent with legitimate medical treatment.
7. Prescriber uses street slang to refer to commonly prescribed controlled medications.
8. No logical relationship between the drugs prescribed and the condition treated.
9. Prescriber wrote more than one prescription in order to spread them out.

In the case of Iyer, a 2009 DEA Administrative Case, the three points of which physicians should be aware were 1) responsibility to issue prescriptions for a legitimate medical purpose while acting in the usual course of professional practice; 2) responsibility to monitor patients (as a part of routine clinical practice) for warning signs that they are personally abusing or diverting their medications; and 3) failure to fulfill these responsibilities constitutes acts inconsistent with the public health and safety.

Attendees were encouraged to use the cases Bolen presented to evaluate their own practices and create checklists of areas for improvement. “Harm reduction strategies” that providers can embrace to head off potential lawsuits include patient and staff education; addressing CNS issues and related medical conditions (sleep apnea, multiple CNS depressants in medication therapy, sleep hygiene); weight loss and smoking cessation; alcohol education and compliance measures; safe use, storage, and disposal education, and coordination of care issues.