Most orthopaedic surgeons dread this type of request, particularly from patients who are beyond the normal timeframe for significant postoperative pain medications. They are concerned not only about engendering dependency when prescribing pain medication, but also with the medical and legal ramifications of prescribing opioid medications. Orthopaedic surgeons may wonder, “Can I be sued for not giving enough pain meds? Can I be prosecuted for giving too many pain meds? What are the guidelines for prescribing pain meds?”

Underprescribing vs overprescribing
Physicians have been successfully sued for both undertreating as well as overtreating pain in their patients. For example, in 1991, a California jury awarded $1.5 million in damages to the family of an 85-year-old patient with lung cancer who complained of severe back pain during a 6-day hospital stay. The suit claimed that the internal medicine doctor had not prescribed the patient enough opioid pain medication. Nursing notes showed that the patient consistently rated his pain between 7 and 10 on a 10-point scale. When the patient was discharged to home, another physician prescribed him opioid pain medication. The patient died 2 days later in hospice care.

Initially, the State Medical Board did not find any actionable offense. Trial lawyers, however, called the internist’s actions “amazingly reckless,” and sued for elder abuse. The jury found the internist recklessly negligent for not treating the patient’s pain aggressively enough. As a result of this case, California law now requires every doctor in the state to obtain 12 hours of continuing medical education credit in pain management and end-of-life care.

Conversely, physicians can also be sued when they do prescribe pain medication. In a Massachusetts case, a physician was sued because his patient, who was taking prescribed opioid pain medications for cancer, fell asleep while driving and killed a pedestrian. The trial court initially upheld the physician’s motion for summary judgment, agreeing that the physician owed no duty to nonpatient third parties.

The appeals court, however, disagreed, holding that “...a physician owes a duty of reasonable care to everyone foreseeably put at risk by his failure to warn of the side effects of his treatment of a patient.” This ruling is alarming because it expands a physician’s duty to include nonpatient third parties. (See “How far does your obligation go?” AAOS Now, December 2008.)

Physicians can also be criminally prosecuted for overprescribing pain medications. Recently in Florida, an undercover agent posed as a patient with back pain. After listening to his lungs and conducting a 5-minute interview, the physician wrote the agent a prescription for 120 tablets of opioid medication. When federal agents reviewed the physician’s patient logs, they found that the physician had written a large number of oxycodone prescriptions and that a high percentage of his patients had criminal records. Ultimately, the physician was charged with racketeering and drug trafficking.

Background
Although most physicians prescribe controlled substances for legitimate medical purposes, many opioid pain medications end up being abused as recreational drugs or sold as street drugs. This is known as “diversion” and is a high priority action item for the DEA.

Currently, providers rather than users are being targeted to control diversion. According to Douglas Coleman, a special agent with the DEA, the primary target is not the consumer, but the seller. “For us, the possession of these drugs is not the issue,” he said. “It’s the transfer and the distribution of these drugs to other people and other sources.”

The legal ramifications for this are not insignificant. Drug trafficking carries a federal punishment of no less than 5 years in jail and up to $5 million in fines.

Legitimate medical purpose
The relevant law regarding pain medication prescription comes from the Controlled Substances Act (CSA), which states that no controlled substance may be dispensed without a prescription, except when dispensed directly by a practitioner to the ultimate user. The law also includes limits on the number of times (ranging from 0 to 5) that a prescription may be refilled.

The DEA’s interpretation of the CSA is equally important. Under DEA policy, the legal standard for prescribing controlled substances to treat pain is the same as that for prescribing controlled substances generally: The prescription must be issued for a “legitimate medical purpose” by a registered physician acting within the usual course of professional practice.

Unfortunately, “legitimate medical purpose” has been construed vaguely to mean that physicians must act in their usual course of professional practice. Specific guidelines are lacking, leaving the courts to decide on a case-by-case basis what constitutes legitimate medical purposes.

For this reason, case law may be more instructive. In 1978, the U.S. Court of Appeals for the 5th Circuit looked at the case law and found the following recurring patterns indicative of diversion and abuse:

• An inordinately large quantity of controlled substances was prescribed.
• Large numbers of prescriptions were issued.
• No physical examination was performed.
• The physician warned the patient to fill prescriptions at different drug stores.
• The physician issued prescriptions knowing that the patient was delivering the drugs to others.
• The physician prescribed controlled drugs at intervals inconsistent with legitimate medical treatment.
• The physician involved used street slang rather than medical terminology for the drugs prescribed.
• No logical relationship existed between the drugs prescribed and treatment of the condition allegedly existing.
• The physician wrote more than one prescription on occasions to spread them out.

Recommendations
The following recommendations may help orthopaedic surgeons curb pain medication diversion and abuse among their patients.

First, do not allow nonphysicians to prescribe pain medications. This may seem obvious, but physicians have encountered problems when physician assistants or athletic trainers write prescriptions for pain medications under the physician’s DEA number.

Second, look for warning signs of abuse. Characteristics of patients who are abusing pain medications include the following:

• Demanding to be seen immediately
• Stating that they are visiting the area and in need of a prescription to tide them over until they can return to their local physician
• Appearing to feign symptoms, such as abdominal or back pain, or pain from kidney stones or a migraine, to obtain narcotics
• Indicating that nonnarcotic analgesics are ineffective
• 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

Orthopaedic surgeons should document any of these behaviors as protection against complaints and suits for undertreatment of pain.

Third, be extra careful with known drug abusers. To prevent diversion, the DEA expects physicians to take extra measures with patients who have a history of drug addiction. If a patient’s history and physical examination note a prior drug abuse problem, take efforts—such as entering into a pain contract with the patient—to prevent diversion. Although not mandated by the CSA or DEA, pain contracts that include specific terms designed to prevent drug diversion or abuse can be very useful in defending a lawsuit.

Lastly, use common sense. According to a study by the National Association of Attorney Generals, approximately one third of all prosecutions by the DEA against physicians are triggered because the physician prescribed pain medications for family members, shared pain medications with their patients, or were charged with, and found guilty of, sexual misconduct with their patients. These improprieties are red flags and will draw scrutiny from regulatory agencies.

Summary
Abuse of prescription pain medications is a real and growing problem in the United States. Physicians are under scrutiny so that they neither overprescribe nor underprescribe opioid pain medication. Although no firm regulatory guidelines exist as to how such medication can be prescribed, orthopaedic surgeons can minimize their risk by avoiding improper behavior, documenting pain medication–seeking behavior by patients, and taking reasonable measures to avoid diversion in patients with histories of past abuse.

References for the studies cited in this article may be found in the online version available at www.aaosnow.org

David H. Sohn, JD, MD, is a member of the AAOS Medical Liability Committee. He can be reached at feedback-orm@aaos.org

Did you know…?

• In 2010, more than 12 million Americans admitted to using prescription pain medications for nonmedical use.
• More people died from overdoses of prescription pain medication than from heroin and cocaine combined.
• Enough pain medications were prescribed to keep every American adult medicated around the clock for a month.

Editor’s Note: Articles labeled Orthopaedic Risk Manager are presented by the Medical Liability Committee under the direction of contributing editor David H. Sohn, JD, MD.

Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.

Email your comments to feedback-orm@aaos.org or contact this issue’s contributors directly.

References:

1. Coombes v. Florio, 450 Mass. 182
2. Pavuk A. Doctors in Orlando pill-mill probe arrested on racketeering charges. Orlando Sentinel, Feb. 3, 2012
3. Centers for Disease Control & Prevention. Prescription Painkiller Overdoses in the United States. CDC Vital Signs, November 2011. Accessed July 19,2012.
4. Browne D. DEA: Prescription Drug Abuse Is Top Drug Problem. Fronteras, October 20, 2011. http://www.fronterasdesk.org/news/2011/oct/20/medication-painkillers-oxycodone-pills-teenagers/ Accessed July 19, 2012
5. U.S. Department of Justice, Drug Enforcement Administration Office of Diversion Control http://www.deadiversion.usdoj.gov/ Accessed July 19,2012
6. Title 21 United States Code (USC) Controlled Substances Act. From the U.S. Code Online via GPO Access [www.gpoaccess.gov] [Laws in effect as of January 3, 2007] [CITE: 21USC829] Accessed July 17,2012
7. DEA policy statement 2006 on Dispensing Controlled Substances.FR Doc E6-14517 [Federal Register: September 6, 2006 (Volume 71, Number 172)] [Notices] [Page 52715-52723] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06se06-137 http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm Accessed July 17, 2012
8. Moore, 423 U.S. at 139 (quoting jury instruction)
9. United States v. August, 984 F.2d 705, 713 (6th Cir. 1992).
10. United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978).
11. DEA Notice 2006. FR Doc E6-14517 [Federal Register: September 6, 2006 (Volume 71, Number 172)] [Notices] [Page 52715-52723] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06se06-137] http://www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm Accessed July 19, 2012.
12. McKee J. Perception Versus Reality: The Facts Regarding Prosecutions and Disciplining of Doctors For Abuses Involving Controlled Substances NAAG Gazette, July 2008 http://naag.org/perception-versus-reality-the-facts-regarding-prosecutions-and-disciplining-of-doctors-for-abuses-in.php Accessed July 18,2012-07-18