The Legal Pitfalls in Prescribing Opioids

Carolyn Buppert, NP, JD

Disclosures

November 18, 2009

In This Article

Preventing Drug Abuse or Diversion

Potential Signs That a Patient May be Seeking Drugs for Abuse or Diversion

Here is what the DEA wrote in a Proposed Rule in 2006[10] regarding how clinicians can distinguish patients who have legitimate pain from those who are drug dealers:

"Many physicians have requested a list of the possible indicators that a patient might be seeking controlled substances for the purpose of diversion or abuse. DEA has provided this type of list in various publications over the years. While not an exhaustive list, the following are some of the common behaviors that might indicate that a patient is seeking drugs for the purpose of diversion or abuse:

  • Demanding to be seen immediately or stating that he or she is visiting the area and is in need of a prescription to tide him or her over until returning to a local physician;

  • Appearing to feign symptoms, such as abdominal or back pain, or pain from kidney stones or a migraine, in an effort to obtain narcotics;

  • Indicating that nonnarcotic analgesics do not work for him or her;

  • Requesting a particular narcotic drug;

  • Complaining that a prescription has been lost or stolen and needs replacing;

  • Requesting more refills than originally prescribed;

  • Using pressure tactics or threatening behavior to obtain a prescription;

  • Showing visible signs of drug abuse, such as track marks."

Legal Responsibilities to Prevent Diversion and Abuse When Prescribing Controlled Substances

Here, from that same Proposed Rule, is what the DEA expects clinicians to do to prevent prescription drug abuse:

"In each instance where a physician issues a prescription for a controlled substance, the physician must properly determine that there is a legitimate medical purpose for the patient to be prescribed a controlled substance and the physician must be acting in the usual course of professional practice. Moreover, as a condition of being a DEA registrant, a physician who prescribes controlled substances has an obligation to take reasonable measures to prevent diversion. The overwhelming majority of physicians in the United States who prescribe controlled substances do, in fact, exercise the appropriate degree of medical supervision -- as part of their routine practice during office visits -- to minimize the likelihood of diversion or abuse. Again, each patient's situation is unique and the nature and degree of physician oversight should be tailored accordingly, on the basis of the physician's sound medical judgment and consistent with established medical standards."

Additional Precautions When a Patient Has a History of Drug Abuse

"As a DEA registrant, a physician has a responsibility to exercise a much greater degree of oversight to prevent diversion and abuse in the case of a known or suspected addict than in the case of a patient for whom there are no indicators of drug abuse. Under no circumstances may a physician dispense controlled substances with the knowledge that they will be used for nonmedical purposes or that they will be resold by the patient. Some physicians who treat patients who have a history of drug abuse require each patient to sign a contract agreeing to certain terms, such as periodic urinalysis, designed to prevent diversion and abuse. Although such measures are not mandated by the Controlled Substances Act (CSA) or DEA regulations, they can be very useful."

Can a Clinician Be Investigated Solely on the Basis of the Number of Tablets Prescribed for an Individual?

Here, from the same Proposed Rule, is what the DEA says about prescribing large numbers of pills:

"The Supreme Court has long recognized that an administrative agency responsible for enforcing the law has broad investigative authority, and courts have recognized that prescribing an 'inordinately large quantity of controlled substances' can be evidence of a violation of the CSA. DEA therefore, as the agency responsible for administering the CSA, has the legal authority to investigate a suspicious prescription of any quantity.

Nonetheless, the amount of dosage units per prescription will never be a basis for investigation for the overwhelming majority of physicians. As with every other profession, however, among the hundreds of thousands of physicians who practice medicine in this country in a manner that warrants no government scrutiny are a handful who engage in criminal behavior. In rare cases, it is possible that an aberrant physician could prescribe such an enormous quantity of controlled substances to a given patient that this alone will be a valid basis for investigation. For example, if a physician were to prescribe 1600 (sixteen hundred) tablets per day of a schedule II opioid to a single patient, this would certainly warrant investigation as there is no conceivable medical basis for anyone to ingest that quantity of such a powerful narcotic in a single day. Again, however, such cases are extremely rare. The overwhelming majority of physicians who conclude that use of a particular controlled substance is medically appropriate for a given patient should prescribe the amount of that controlled substance which is consistent with their sound medical judgment and accepted medical standards without concern that doing so will subject them to DEA scrutiny."[7]

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