The Use of Opioid Analgesics: Legal and Regulatory Issues

DISCIPLINARY ACTIONS BY STATE MEDICAL BOARDS

In several studies, physicians have cited state medical board scrutiny as an obstacle to prescribing opioids for pain treatment. The U.S. government’s “war on drugs” resulted in pressure on state medical boards in the 1980s and 1990s to discipline physicians who were “overprescribing” opioids. In some cases, this included physicians who were treating pain patients. A number of these cases received considerable attention in the media, although several were later overturned on appeal. In Florida, the state medical board disciplined Dr. Katherine Hoover for allegedly “inappropriately and excessively” prescribing various controlled substances to seven chronic pain patients. The sanctions included a $4,000 fine, continuing education in the prescribing of “abusable drugs,” and 2 years of probation. The sanctions were imposed by the board despite the fact that the administrative hearing officer determined that the board had failed to prove its charges. Dr. Hoover appealed the board’s decision to the Florida District Court of Appeal. In Hoover v. Agency for Health Care Administration, the Court reversed the board’s decision and noted that the “physicians testifying in support of the board’s action did not treat chronic pain patients” and that “despite this paucity of evidence, lack of familiarity, and seeming lack of expertise” the state’s experts testified that Dr. Hoover had practiced below the standard of care.⁴ The Court also referred to the board’s policing of pain prescription practices as a “draconian” policy.⁴

Another case that attracted considerable attention was that of Dr. William E. Hurwitz. Dr. Hurwitz was the subject of disciplinary action by both the Washington, DC, and Virginia medical boards. In 1996, the Virginia state medical board revoked Dr. Hurwitz’s license to practice for 3 months based on “indiscriminate or excessive prescribing without therapeutic purpose and contrary to sound medical judgment.” The board’s action was initiated following the deaths of two of Hurwitz’s pain patients. The action was taken despite the fact that “expert testimony had essentially disproved the state’s allegation that Hurwitz was at fault.” Based on the evidence, the board recognized that individuals with chronic pain often require high dosages of narcotics and dropped its initial allegations against Hurwitz, but did pursue action against him based on prescribing without adequate medical records.⁵

Since the mid-1990s, when these cases were brought, efforts to educate state medical boards and provide guidelines about appropriate prescribing of opioids for pain have arguably tempered medical board actions against physicians for prescribing high dosages of opioids. In 1998, the Federation of State Medical Boards (FSMB) promulgated Model Guidelines for the Use of Controlled Substances for the Treatment of Pain.

The guidelines included recommended language for adoption by state medical boards and stated in the preamble that “physicians should not fear disciplinary action” from state medical boards or other state regulatory agencies “for prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the usual course of professional practice” and that in states that adopt the guidelines the board “will consider prescribing, ordering, administering or dispensing controlled substances for pain to be for a legitimate medical purpose if based on scientific knowledge of the treatment of pain or if based on sound clinical grounds.”

The guidelines also made it clear that boards should evaluate each case of prescribing for pain on an individual basis and not take disciplinary action against a physician for failing to adhere strictly to the provisions of the guidelines “if good cause is shown for such deviation.” Boards, the guidelines stated, should also “judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation, rather than on the quantity and frequency of prescribing.”

These guidelines were adopted in whole or in part by 24 states. A study of state medical boards in 2002 found that many had shifted their views about disciplinary action for prescribing of opioids. The study suggested (i) that many boards are attempting to find the appropriate balance between identifying physicians who inappropriately “overprescribe” and those who are appropriately treating patients with chronic pain and (ii) that boards are moving away from volume or quantity as a primary basis for investigating a physician connected with prescribing opioids.⁶

To provide additional encouragement to physicians to adequately treat pain, in 2004, the FSMB updated its 1998 guidelines and issued a Model Policy for the Use of Controlled Substances for the Treatment of Pain (Box 37-1). The new policy goes beyond attempting to reassure physicians that they will not be sanctioned for prescribing large doses of pain medication if appropriate but sends a message that undertreatment of pain can be considered substandard care. In the preamble, the policy states that “the inappropriate treatment of pain includes nontreatment, undertreatment, overtreatment, and the continued use of ineffective treatments.”⁷

BOX 37-1 Key Elements of the Federation of State Medical Boards—A 2004 Model Guidelines for the Use of Controlled Substances for the Treatment of Pain

Criteria for evaluating the treatment of pain, including the use of controlled substances.

Evaluation of the patient: A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

Treatment plan: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain, and the extent to which the pain is associated with physical and psychosocial impairment.

Informed consent and agreement for treatment: The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is without medical decision-making capacity. The patient should receive prescriptions from one physician and one pharmacy whenever possible. If the patient is at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including the following.

images Urine/serum medication levels screening when requested

images Number and frequency of all prescription refills

images Reasons for which drug therapy may be discontinued (e.g., violation of agreement)

Periodic review: The physician should periodically review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician’s evaluation of progress toward treatment objectives. Satisfactory response to treatment may be indicated by the patient’s decreased pain, increased level of function, or improved quality of life. Objective evidence of improved or diminished function should be monitored, and information from family members or other caregivers should be considered in determining the patient’s response to treatment. If the patient’s progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

Consultation: The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for medication misuse, abuse, or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.

Medical records: The physician should keep accurate and complete records, including the following:

images Medical history and physical examination

images Diagnostic, therapeutic, and laboratory results

images Evaluations and consultations

images Treatment objectives

images Discussion of risks and benefits

images Informed consent

images Treatments

images Medications (including date, type, dosage, and quantity prescribed)

images Instructions and agreements

images Periodic reviews

Records should remain current and be maintained in an accessible manner and readily available for review.

Compliance with controlled substances laws and regulations: To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration (and any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

In line with concerns about undertreatment of pain, at least two medical boards have disciplined physicians for inadequate pain treatment. In 1999, the Oregon medical board disciplined a physician for prescribing insufficient pain medication for a terminally ill cancer patient (i.e., only acetaminophen); prescribing only a fraction of the dose of morphine typically prescribed for a patient suffering from congestive heart failure, despite recommendations for additional amounts from a hospice nurse; and failing to resume pain medication for a patient on a mechanical ventilator. The physician was ordered by the medical board to complete an educational program on physician-patient communication and to undergo mental-health treatment.⁸

In January 2004, the California medical board disciplined a physician for failure to provide adequate pain treatment to an 85-year-old patient with mesothelioma.⁹ The patient understood that the condition could become extremely painful and had his attorney execute an advance directive stating that he wished to receive all medications necessary to relieve his pain as his life neared its end. Despite this fact, his last days of life were marked by unrelenting pain and allegedly indifferent treatment. Less than a year after his original diagnosis, he was having difficulty breathing and was taken to a nearby medical center. Prior to being admitted, he was taking hydrocodone/acetaminophen around the clock at home to control his pain, but at the medical center his doctor prescribed hydrocodone/acetaminophen only “as needed.” After 4 days, he was transferred to a nursing facility. His medical center physician filled out papers that listed a number of medications but nothing for pain. At the nursing facility, he was seen by a second physician, who saw him on only one occasion, 16 days after his admission. The patient received nothing for his pain until the 4th day after his arrival and then only sporadic medication despite his yelling throughout the night. The board required the nursing facility physician to complete a 40-hour course in pain management, undergo a 2-day assessment of his physical and mental health (he was 80 years old), as well as enroll in a physician-patient communication course.⁹ The case may have been motivated by a 2001 law passed by the California legislature requiring physicians in the state who treat patients to take courses in pain management and end-of-life care and mandating the state medical board to monitor complaints of undertreatment of pain.¹⁰

MALPRACTICE SUITS

In addition to actions by state medical boards, physicians are also at risk of medical malpractice suits for inappropriate pain treatment. Although the risk of a suit is quite low, several cases have been brought in which physicians allegedly prescribed overly high dosages of pain medication. A number of these cases involved wrongful death claims in which the patient became addicted to the medication. Plaintiffs in these suits have won on theories that the physician failed to adequately monitor the patient while the patient was taking pain medications or failed to warn the patient of risks associated with driving while taking the medication. In Weaver v. Lentz, William Weaver died from an overdose of the combination analgesic propoxyphene/acetaminophen, which had been prescribed by Dr. Lentz.¹¹ The South Carolina Court of Appeals affirmed the finding by the trial court that Lentz negligently overprescribed pain medications under circumstances in which he should have known that Weaver was addicted to the medications and was abusing them. A jury found both Dr. Lentz and Mr. Weaver equally at fault for Weaver’s death and awarded Weaver’s estate actual damages of $792,577 and punitive damages of $10,000. Based on Weaver’s contributory negligence, the actual damages were reduced to $396,288.50. In Burroughs v. Magee, Judy Burroughs sued Dr. Magee on behalf of her late husband, who had died in a car accident.¹² The driver of the other car was a patient of Magee’s. Burroughs alleged that Magee “negligently prescribed drugs to a known drug addict, negligently prescribed two contraindicated drugs (i.e., carisprodol and butalbital/acetaminophen), and negligently failed to warn his patient of the risks of driving while under the influence of these drugs.” The court found no evidence that the two drugs were contraindicated. Nor did the court find that Magee had a duty to refrain from prescribing drugs to his patient because the patient was a suspected drug abuser and might pose a risk to others. However, the court did determine that Magee failed to adequately warn his patient of the risks of driving while using the two drugs in combination.

More recently, several malpractice and wrongful death suits have been filed against physicians for prescribing the pain medication controlled-release oxycodone (OxyContin, Purdue Pharma L.P., Stamford, Connecticut). Claims in these suits include failure to obtain adequate informed consent by virtue of not disclosing the addictive potential of the drug and failing to warn of addiction and other risks associated with the drug.¹³ In Walsh v. Tabby, Joann Walsh and her husband sued Dr. David Tabby.¹⁴ Tabby had prescribed controlled-release oxycodone for Walsh from 1997 until 2001 to treat her reflex sympathetic dystrophy. He increased her dose in 1999 despite Walsh having expressed concerns to him about the drug’s addictive potential and effects. Tabby “allegedly assured Walsh that her dosage was not abnormally high.” In a decision in response to a motion by the plaintiffs to remand the case from federal court back to a Pennsylvania court, the U.S. District Court in the Eastern District of Pennsylvania further described the facts of the case as follows:

In October 2001, two agents from the Attorney General’s Office approached Walsh and informed her that there was an investigation into her OxyContin use because her prescriptions were said to be abnormally high. The agents informed Walsh that they believed that she and Dr. Tabby were illegally distributing the prescription drug OxyContin. Walsh informed Dr. Tabby about the Attorney General’s investigation at which time Dr. Tabby refused to further treat her or to recommend another physician for her treatment. At that point, Walsh began to wean herself off of OxyContin and eventually she admitted herself into a drug rehabilitation center in February of 2002 for her addiction to the pain reliever. Walsh alleges that she continues to suffer from injuries related to her addiction to OxyContin.

A final disposition in this case, and many similar cases, is not available either because the case was settled and the terms of the settlement remain confidential or because the suits have not yet been finally adjudicated.

In contrast to suits for inappropriate or “over” prescribing, few judicial opinions have discussed undertreatment of pain. In 2001, a California case received considerable attention when a physician was successfully sued for inadequate treatment of a patient’s pain.¹⁵ While Mr. Bergman (85 years old), an inpatient at Eden Medical Center of Costro Valley, California, in 1997, complained of intolerable pain. His preliminary diagnosis was lung cancer that had metastasized to his bones. Nurses recorded his pain levels as between 7 and 10, with 10 being the maximum. His physician, Dr. Chin, only prescribed 25-mg injections of meperidine during this time. On the day of his discharge, Mr. Bergman described his pain rating as a 10. Dr. Chin wrote a prescription for an oral analgesic (hydrocodone/acetaminophen), which did not fall under the “triplicate” prescribing requirement the state imposed at that time. Mr. Bergman’s daughter, convinced that this would not be adequate to relieve her father’s pain, requested something stronger. In response, Mr. Bergman was given another shot of meperidine and a skin patch containing fentanyl. Because he continued to be in pain when he arrived home, Mr. Bergman’s children contacted his regular physician, who prescribed a different pain medication. At the trial, the plaintiffs argued that Chin did not comply with clinical guidelines on the management of cancer pain published in 1992 by the Agency for Health Care Policy and Research (AHCPR, now the Agency for Health Care Research and Quality). The AHCPR guidelines state that pain medication should be prescribed on an “around-the-clock” basis rather than in response to a patient’s request in order to prevent recurrence of pain.

Under California’s medical malpractice law, plaintiffs cannot receive damages for pain and suffering. As a result, Chin was sued under the state’s elder abuse law, which required that plaintiffs prove that the defendant’s actions were not simply negligent but reckless.¹⁶ A California jury awarded $1,500,000 to Bergman’s children. Although the award was subsequently reduced by the court, it was a dramatic message to the medical community.

STATE REGULATION: MEDICAID RESTRICTIONS

State Medicaid policies intended to prevent drug diversion and inappropriate use of Medicaid dollars may also hamper adequate pain treatment. These policies include limitations on the number of medication dosages that may be prescribed at one time and limits on the number of refills of a prescription. States may also use Medicaid fraud and abuse laws to target physicians who inappropriately prescribe opioids to Medicaid patients (Box 37-2).

BOX 37-2 Medicaid Restrictions Affecting Prescribing Practices for Treating Patients with Pain

images Limitations on the number of medication dosages that may be prescribed at one time