Pain relief & the DEA

[Guest guest]

This seems like it has bearing on more than " only " end-of-life stages, and

it's just out from the New England Journal of Medicine. Online access is free.

http://content.nejm.org/cgi/content/full/354/1/1?query=TOC

Volume 354:1-3 -- January 5, 2006 -- Number 1

The Big Chill ­ Inserting the DEA into End-of-Life Care

E. Quill, M.D., and Diane E. Meier, M.D.

On October 5, 2005, the U.S. Supreme Court heard oral arguments in

v. Oregon. On the surface, this case is about the legitimacy of physicians'

prescribing of medications under Oregon's Death with Dignity Act and

whether the federal government can overrule the states in defining

" legitimate medical practice. " Just beneath the surface, however, lies the

risk of empowering agents of the Drug Enforcement Agency (DEA) ­ whose

traditional role is to prevent drug abuse and diversion ­ to evaluate the

end-of-life practices of physicians whose patients die while receiving

prescribed opioids or barbiturates. A finding in favor of the Justice

Department would not only nullify the Death with Dignity Act, permitting

the DEA to penalize physicians for providing medications to hasten the

deaths of terminally ill patients, but also have a chilling effect on

physicians' willingness to treat patients' terminal symptoms.

Uncontrolled pain and other distressing symptoms are the primary concerns

and greatest fears of patients facing serious illness.1 More than 90

percent of the pain associated with severe illness can be relieved if

physicians adhere to well-established guidelines and seek help, when

necessary, from experts in pain management or palliative care. For the

infrequent instances in which all palliative care alternatives have been

exhausted without providing adequate relief from the symptoms of advanced

terminal disease, there is a growing consensus that sedation to the point

of comfortable sleep is permissible.2 Despite the efficacy of opioids and a

commitment by the medical profession to treat pain, abundant evidence

suggests that patients' fears of undertreatment of distressing symptoms are

justified.1 Although a lack of proper training and overblown fears of

addiction contribute to such undertreatment, physicians' fears of

regulatory oversight and disciplinary action remain a central stumbling

block.3

Several initiatives have lessened the adverse effects of regulatory

constraints on symptom management.4 Many legislatures and regulatory boards

have adopted model pain statutes that encourage compliance with established

standards for the prescribing of pharmacologic agents for pain and other

symptoms and that protect physicians who observe these guidelines from

regulatory intrusion and possible prosecution. Other states have simplified

or eliminated special prescribing rules (such as those requiring the use of

triplicate prescription pads) that were designed to control and monitor

prescribing but that had the (presumably unintended) effect of discouraging

all prescribing of controlled substances. California now requires training

in pain management and palliative care as a condition of licensure.

Two cases in California highlight the legal consequences of physicians'

undertreatment of pain, providing a counterweight to the fear of legal

vulnerability for the prescribing of controlled substances.5 In 2001, in

Bergman v. Chin, a jury found that a dying patient had received inadequate

pain management and convicted the treating physician under the state's

elder-abuse statute, awarding the patient's family $1.5 million. In 2003,

in Tomlinson v. Bayberry Care Center, charges of inadequate pain management

were brought successfully against both the treating physician and the

patient's nursing home. Both cases demonstrate that, in addition to

representing an unacceptably poor quality of care, the undertreatment of

pain may carry legal risks and consequences.

Nevertheless, physicians continue to believe that regulatory oversight

translates into a high risk of disciplinary action for prescribing opioids

and other controlled substances. Consider the following cases.

Patient 1, a young man, became acutely ill with an aggressive but highly

treatable cancer that caused severe acute chest pain. Since he had to make

quick and extremely difficult decisions about his treatment options, he

sought advice and pain medication from his trusted primary care physician ­

only to learn that his physician, wishing to be spared any possibility of

regulatory suspicion, had never applied for prescribing privileges for

strong opioids. At this critical juncture, the patient, who is himself a

physician, had to find a new doctor in order to receive standard pain

treatment.

Patient 2, a middle-aged woman with progressive cancer that had

metastasized to bone, had accelerating pain requiring increasing doses of

morphine. She ran out of pain medicine earlier than anticipated, but her

physician refused to refill her prescription for fear that she was using it

too much and that he might be reviewed for overprescribing. When she went

to the emergency department with a pain crisis, a palliative care

consultant recognized that her worsening pain and increased morphine

requirements were caused by the progression of cancer. With a moderate

increase in her dose, satisfactory pain control was achieved, and the

patient went home to live out her final months in relative comfort.

Patient 3 had advanced metastatic lung cancer and had been receiving

opioids at home when he was admitted to the hospital with new metastases to

his thoracic spine. He was confused, could not move his legs, had

difficulty breathing, and was in excruciating pain ­ screaming whenever he

moved and grimacing with each breath. He was near death, and the primary

goal of medical care was to control pain, agitation, and dyspnea. He was

given a subcutaneous infusion of opioids at an equianalgesic dose 30

percent higher than his usual dose, and the nurses were instructed to give

him another dose, equal to 10 percent of the total daily dose, " as needed "

every half hour if he appeared to be in pain (the proper approach,

according to standard guidelines). But several nurses and physicians

refused to give the " as needed " doses, despite evidence of continuing

distress, because they feared hastening his death. Ethics and palliative

care consultants were called in, and they refocused the team on the

professional obligation to relieve pain and suffering. The patient died

hours after receiving the additional doses, and some staff members remained

unsettled about whether they might have been legally liable for " causing "

his death.

For better or for worse, the DEA sets the tone and drives physicians'

perceptions about the legal risk associated with prescribing Schedule 2

drugs (potentially addictive drugs with critical medical uses) for

seriously ill and dying patients. Concerns about regulatory oversight have

led some physicians, such as Patient 1's provider, to avoid prescribing

opioids entirely and have rendered others, such as the physicians of

Patients 2 and 3, fearful or hesitant. It is likely that such physicians

will be further intimidated if the role of the DEA is expanded as the

federal government proposes ­ and the risk of the inadequate management of

symptoms during serious illness will increase.

Two other attempts by the federal government to invalidate Oregon's Death

with Dignity Act preceded v. Oregon. The first was the Lethal Drug

Abuse Prevention Act, which a year later was repackaged as the Pain Relief

Promotion Act (PRPA) of 1999. The PRPA contained some valuable provisions

that would have encouraged education and research in pain management and

palliative care, but the primary purpose of both acts was to make

prescribing controlled substances under the Oregon law a violation of the

Controlled Substances Act.

Although the regulation of medical practice is the legal province of the

states, the PRPA would have allowed the federal government to undermine

state law by making it a crime for physicians to provide medications that

humanely hasten death. Furthermore, the PRPA would have empowered the DEA

to investigate whether or not such a violation had occurred, raising the

specter of DEA oversight of every death of a patient who had received

barbiturates or opioids. After an outcry from both advocates and opponents

of assisted suicide, all of whom recognized the danger such legislation

posed to the practice of pain management and palliative care, the PRPA died

in committee.

Then, in November 2001, U.S. Attorney General Ashcroft issued a

directive suggesting that the prescription of Schedule 2 medications under

the Oregon law violates the Controlled Substances Act, since " assisting in

a suicide is not a `legitimate medical purpose.' " The State of Oregon and

several interested parties challenged this directive, arguing that the

definition of legitimate medical practice is a responsibility of the

states, not a function of the Controlled Substances Act. If passed, this

directive would allow the federal government to overrule established state

law, empower the DEA to investigate whether a violation had occurred, and

potentially open to investigation every instance of prescribing of a

controlled substance for a dying patient. The U.S. Court of Appeals for the

Ninth Circuit supported the arguments made by the State of Oregon, and the

case was recently heard by the Supreme Court. The Court has not yet

announced its decision.

This type of DEA involvement in medical practice would adversely affect far

more patients than those few who seek assistance with a hastened death in

Oregon. If the government thus oversteps its legitimate role and expertise,

allowing DEA agents, trained only to combat criminal substance abuse and

diversion, to dictate to physicians what constitutes acceptable medical

practice for seriously ill and dying persons, it will undermine palliative

care and pain management for the much larger number of seriously ill

patients in all states. Physicians may become hesitant to prescribe the

best available medications to manage the pain, agitation, and shortness of

breath that sometimes accompany the end stages of illness. As a result,

they may, in essence, abandon patients and their families in their moment

of greatest need.

Source Information

Dr. Quill is a professor of medicine, psychiatry, and medical humanities

and the director of the Center for Palliative Care and Clinical Ethics at

the University of Rochester School of Medicine, Rochester, N.Y.; Dr. Meier

is a professor of geriatrics, medicine, and medical ethics and the director

of the Lilian and Hertzberg Palliative Care Institute and the

Center to Advance Palliative Care at the Mount Sinai School of Medicine,

New York.

An interview with Dr. Quill and Dr. Meier can be heard at www.nejm.org.

References

1. Field MJ, Cassel CK, eds. Approaching death: improving care at the end

of life. Washington, D.C.: National Academy Press, 1997.

2. Lo B, feld GD. Palliative sedation in dying patients: " we turn to

it when everything else hasn't worked. " JAMA 2005;294:1810-1816.

[Abstract/Full Text]

3. Drayer RA, J, Reidenberg M. Barriers for better pain control

in hospitalized patients. J Pain Symptom Manage 1999;17:440-440.

4. Gilson AM, Mauer MA, Joranson DE. State policy affecting pain

management: recent improvements and the positive impact of regulatory

health policies. Health Policy 2005;74:192-204. [CrossRef][iSI][Medline]

5. Tucker KL. The debate on elder abuse for undertreated pain. Pain Med

2004;5:214-217. [CrossRef][iSI][Medline]