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For Immediate Release:
December 13, 2006

 

(Alexandria, Va) – The belief that the administration of opioids (including morphine) hastens death can be a significant barrier to effective pain management for dying patients reports the National Hospice and Palliative Care Organization. A new study appearing in the December issue of the Journal of Pain and Symptom Management suggests that the timing of death among patients with advanced illness involves a complex interplay of variables and that effective opioid use actually poses little risk of hastened death.

Under treatment of pain is a far more pressing concern than is the risk of hastened death in those with advanced disease. Available research indicates that physicians should be encouraged to use opioids effectively to relieve suffering at the end of life.

This study examined outcomes of 725 hospice patients who were receiving opioids and had at least one change in dose prior to death. The study looked at both the total daily amount of opioid given and the changes in dose on the timing of death. Opioid dosing explained little of the variation in survival time among these patients.

In a hospice population, survival is influenced by complex factors, many of which may not be measurable.

The study concluded that concern about hastening death does not justify withholding opioid therapy. 

“Most clinicians understand the value of using opioids to relieve suffering at the end of life but fear of hastening the death of seriously ill persons contributes to unnecessary suffering,” said Stephen Connor, vice president of research and international development for NHPCO and a co-author of the study. “This study reassures clinicians that their effective use of opioids in the seriously ill will not hasten death and will lead to better quality care. We all want to be kept comfortable and pain free at the end of our lives”.

Extensive data pertaining to clinical outcomes during end-of-life were collected as part of the National Hospice Outcomes Project, a prospective longitudinal study of patients admitted to hospice programs, funded by the Robert Wood Johnson Foundation.

Download this article, "Opioid Use and Survival at the End of Life: A Survey of a Hospice Population," from NHPCO's Web site.

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Contact:  Jon Radulovic
NHPCO VP of Communications.
Ph: 703-837-3139
jradulovic@nhpco.org

Editor’s Note: Stephen Connor, PhD, is available for comment. Contact Jon Radulovic at NHPCO. 

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PLEASE NOTE: The information below is a snip from the original PDF document New Study Helps Dispel Myth that Opioids Hasten Death, link provided at end of "Discussion"

 

Discussion

Although pain due to advanced illness usually can be managed with an opioid regimen, undertreatment is common.1 Clinician concern about the potential for serious toxicity in medically frail patients may contribute to undertreatment. Although a robust literature has generally endorsed the application of the ethical principle of double effect as the moral justification for aggressive therapy,3,5,6 this may not allay concerns. This literature typically assumes a substantial risk of hastened death due to the opioid. Opioid use at the end of life also has been discussed in the literature on physician-hastened death.5,8,9,12 These writings also assume that opioid toxicity is substantial during endof- life care and that these drugs may be used intentionally to shorten life.

These assumptions contrast with the common clinical experience of specialists in pain management or palliative medicine, who typically use opioid drugs in whatever doses are needed to achieve analgesia and rarely encounter a scenario consistent with a primary opioid-related death. This sanguine experience is supported by a small number of studies 9,13e15 that together suggest a relatively low risk of serious opioid toxicity.

  To reconcile these opposing views, studies must specifically assess the extent to which opioid use affects survival among those with advanced illness. The NHOP analyses demonstrate that final opioid dose, but not percent change in dose, was one of several factors associated with survival, but the association is very weak, and in multivariate analyses, this and other relevant factors explain only a very small percentage of variation in survival.

The implication that opioid dose poses an extremely small risk of hastened death in this population was supported further by the relatively long intervals between final dose change and death, and the lack of higher opioid risk in subsamples receiving high doses. These findings resonate with clinical experience and findings of other surveys.13,14 Although experienced clinicians are aware that serious toxicity, including risk of hastened death, could be produced by rapid dose escalation, the usual approach to opioid therapy incorporates incremental dose changes that, on balance, appear relatively safe even if patients are near the end of life, require relatively high doses, or need frequent dose increases. These findings have several limitations. The results apply to a hospice population, and although the methodology incorporated systematic prospective data collection, the study was not primarily designed to address the question of opioid risk. Given missing data and data collection by treating nurses, the possibility of observer bias, and referral and selection biases, must be acknowledged. Finally, variation in opioid regimens may have limited the ability to identify the ‘‘signal’’ of opioid toxicity during a complex interplay of many other relevant phenomena. These limitations notwithstanding, this analysis suggests that the timing of death in populations with far advanced illness involves a complex interplay of variables, including important factors that were not assessed in this study, and that opioid therapy should not be the focus of future research of this type. Equally important, these data should help advance the appropriate use of opioids for symptom control. Undertreatment of pain is a far more pressing concern than is the risk of hastened death in those with advanced disease,  and physicians should be encouraged to use opioids effectively to relieve suffering at the end of life.

Source New Study Helps Dispel Myth that Opioids Hasten Death http://www.nhpco.org/files/public/JPSM/Dec06_Opioid_survival_JPSM.pdf


Use of opioid analgesics for the treatment of chronic noncancer pain – A consensus statement and guidelines from the Journal of the Canadian Pain Society 

 II) The need for a Canadian Pain Society consensus 

1: In the past several years, there has been growing recognition on the part of health care providers, government regulators and the public that the undertreatment of pain is a major societal problem (1). Despite numerous published guidelines, current literature continues to document that acute pain, such as postoperative pain and pain in the emergency department, is often poorly managed. Although there has been significant progress, cancer pain continues to be undertreated (2). Patients with acquired immunodeficiency syndrome (AIDS) also suffer from poorly recognized and undertreated pain. A major contributor to this problem of undertreatment is the reluctance of physicians to prescribe adequate opioid therapy. 

2: A bioethicist writes, "To leave a person in avoidable pain and suffering should be regarded as a serious breach of fundamental human rights"

3: In 1997, the Canadian Pain Society published a position statement on Pain Relief, which included the following statements: "Almost all acute and cancer pain can be relieved, and many patients with chronic non-malignant pain can be helped. Patients have the right to the best pain relief possible…. [H]ealth professionals need to understand pain management strategies, including non-pharmacological techniques and the appropriate use of opioids" ...

Side effects: There is no recorded risk in the medical literature of direct permanent organ damage with the long term clinical use of opioid  therapy. This is in contrast to most other classes of analgesics in use today. Fear of causing respiratory depression has often been invoked as a rationale for not using opioids to treat pain. It is now widely accepted that respiratory depression caused by opioid analgesics tends to occur largely in opioid-naive patients. It is a short-lived phenomenon that tends to be antagonized by pain. In CNCP, the risk of respiratory depression with oral dosing is extremely low and can be further minimized by careful titration of the dosage of opioids to the level of pain. Constipation commonly accompanies opioid therapy and is usually harder to treat than to prevent. It is, therefore, important to manage this side effect prophylactically using a stepped approach involving adequate dietary fibre, stool softeners, osmotic agents and, if necessary, regular stimulant laxative use. Nausea is a common early side effect of regular opioid therapy, and usually resolves with continued use. Antinauseants may be recommended during the initial titration phase. Sedation and cognitive deficits are also early side effects for which tolerance with continued use frequently develops once stable dosing has been achieved. There is little current evidence that the long term use of scheduled, stable dose opioid therapy leads to clinically significant cognitive or psychomotor deficits in patients with chronic pain. Recent evidence suggests that pain itself can have an adverse effect on cognitive performance, which is improved with opioid analgesia ...

The longest clinical noncancer experience with patients on opioids is over 30 years of continuous use in the methadone maintained population of opioid addicts. Studies of this population have shown no organ toxicity and no increase in markers of cognitive dysfunction such as motor vehicle accidents or infractions of driving codes. A recent study comparing cancer patients on stable, long term, opioid therapy with a group on no opioids, demonstrated no significant difference in functions related to driving ability. ... Cognitive deficits in opioid-treated patients are more often due to the concurrent use of sedative medications such as benzodiazepines. Therefore, use of sedatives in patients on long term opioid therapy should be avoided where possible. (Emphasis in bold added by CHN editor)

 For the complete article, go to http://www.pulsus.com/Pain/03_04/opio_ed.htm

The URL for the Canadian Pain Society is http://www.medicine.dal.ca/gorgs/cps/


 

 

Proponents of assisted suicide often argue that when a doctor helps a patient who wants to die, it is no more ethically troubling than when a doctor kills a patient slowly with morphine, often without the patient's knowledge or consent, a medical practice these proponents say is increasingly common.

So why forbid doctors to prescribe lethal pills that could allow patients to control how and when they die? There is no question that doctors use morphine this way. "It happens all the time," said Dr. John M. Luce, a professor of medicine and anesthesiology at the University of California in San Francisco. And there is no question that most doctors think that morphine can hasten a patient's death by depressing respiration. But Luce and others are asking whether morphine and similar drugs really speed death.

Experts in palliative care say the only available evidence indicates that morphine is not having this effect. Dr. Balfour Mount, a cancer specialist who directs the division of palliative care at McGill University in Montreal, firmly states that it is "a common misunderstanding that patients die because of high doses of morphine needed to control pain."

 No one denies that an overdose of morphine can be lethal. It kills by stopping breathing. But, said Dr. Joanne Lynn, director of the Center to Improve Care of the Dying at George Washington University School of Medicine, something peculiar happens when doctors gradually increase a patient's dose of morphine. The patients, she said, become more tolerant of the drug's effect on respiration than they do of its effect on pain. The result, Dr. Lynn said, is that as patients' pain gets worse, they require more and more morphine to control it. But even though they end up taking doses of the drug that would quickly kill a person who has not been taking morphine, the drug has little effect on these patients' breathing.

Dr. Kathleen Foley, who is co-chief of the pain and palliative care service at Memorial SloanKettering Cancer Center in New York, said that she routinely saw patients taking breathtakingly high doses of morphine yet breathing well. "They're taking 1,000 milligrams of morphine a day, or 2,000 milligrams a day, and walking around," she said.

The standard daily dose used to quell the pain of cancer patients, she added, is 200 to 400 milligrams. Dr. Lynn said she sometimes gave such high doses of morphine or similar drugs that she frightened herself. She remembers one man who had a tumor on his neck as big as his head. To relieve his pain, she ended up giving him 200 milligrams of a morphinelike drug, hydromorphone, each hour, 200 times the dose that would put a person with no tolerance to the drug into a deep sleep. "Even I was scared," Dr. Lynn said, but she found that if she lowered the dose to even 170 milligrams of the drug per hour, the man was in excruciating pain. So to protect herself in case she was ever questioned by a district attorney, she said, she videotaped the man playing with his grandson while he was on the drug.

On rare occasions, Dr. Lynn said, she became worried when she escalated a morphine dose and noticed that the patient had started to struggle to breathe. Since she did not intend to kill the patient, she said, she administered an antidote. But invariably, she said, she found that the drug was not causing the patient's sudden respiratory problem.

One man, for example, was having trouble breathing because he had bled from a tumor in his brain, and an elderly woman had just had a stroke. "In every single case, there was another etiology," Dr. Lynn said. "Joanne's experience is emblematic," said Dr. Russell K. Portenoy, the other cochief of the pain and palliative care service at Memorial SloanKettering Cancer Center.

 He said he was virtually certain that if doctors ever gave antidotes to morphine on a routine basis when dying patients started laboring to breathe, they would find that Dr. Lynn's experience was the rule. Patients generally die from their diseases, not from morphine, Dr. Portenoy said.

The actual data on how often morphine and other opiates that are used for pain relief cause death are elusive. But Dr. Foley and others cite three studies that indirectly support the notion that if morphine causes death, it does so very infrequently. One study, by Dr. Frank K. Brescia of Calvary Hospital in the Bronx and his colleagues, examined pain, opiate use and survival among 1,103 cancer patients at that hospital, which is for the terminally ill. The patients had cancer that was "very far advanced," said Dr. Portenoy, an author of the paper. But to his surprise, he said, the investigators found no relationship between the dose of opiates a patient received and the time it took to die. Those receiving stunningly high doses died no sooner than those taking much lower doses.

Another study, by Dr. Luce and his colleagues in San Francisco, looked at 44 patients in intensive care units at two hospitals who were so ill that their doctors and families decided to withdraw life support. Threequarters of the patients were taking narcotics, and after the decision was made to let them die, the doctors increased their narcotics dose. Those who were not receiving opiates were in comas or so severely brain damaged that they did not feel pain. The researchers asked the patients' doctors to tell them, anonymously, why they had given narcotics to the patients and why they had increased the doses. Thirtynine (39%) percent of the doctors confided that, in addition to relieving pain, they were hoping to hasten the patients' deaths. But that did not seem to happen.

 The patients who received narcotics survived an average of 3 1/2 hours after the decision had been made to let them die. Those who did not receive narcotics lived an average of 1 1/2 hours. Of course, Dr. Luce said, the study was not definitive because the patients who did not receive drugs may have been sicker and more likely to die very quickly. Nonetheless, he said, the investigators certainly failed to show that narcotics speeded death.

Dr. Declan Walsh, the director of the Center for Palliative Medicine at the Cleveland Clinic, said it had been 15 years since he first questioned the assumption that morphine used for pain control killed patients by depressing their respiration. He was working in England at the time, and many doctors there were afraid to prescribe morphine or similar drugs for cancer patients, Walsh said, because "they were afraid they would kill the patients."

So Walsh looked at carbon dioxide levels in the blood of cancer patients on high doses of morphine to control their pain. If their breathing was suppressed, their carbon dioxide levels should have been high. But they were not. Nonetheless, Walsh said, the idea that morphine used for pain relief depresses respiration is widely believed by doctors and nurses because it is "drummed into them in medical school." So, said Dr. Susan Block, a psychiatrist in the hematology and oncology division at Brigham and Women's Hospital in Boston, it is not surprising that many doctors try to use morphine to speed dying. "There is more and more evidence most of it unpublished, but it's coming, I've seen it that physicians, in addition to wanting to ease patients' discomfort, also want to hasten death," Dr. Block said. "Everyone is feeling guilty."

Source: NY TIMES July 23, 1997


By Marc Kaufman
Washington Post Staff Writer
Thursday, October 21, 2004; Page A03

The Drug Enforcement Administration has reversed its support for a set of negotiated guidelines designed to end a controversy over the arrests of hundreds of pain specialists who prescribed powerful narcotics for their patients. The agency took the document off its Web site earlier this month, less than two months after announcing it with great fanfare.

In rescinding its endorsement, the DEA wrote on its Web site that the 31-page document "contained misstatements" and "was not approved as an official statement of the agency." The agency declined to give any more specifics, saying that it hoped to issue a statement "in one or two weeks."

Worried doctors who had worked on crafting the "consensus" document -- written over the past year by DEA officials and prominent pain management specialists -- criticized the agency's unannounced decision to disavow it. They said they were given no explanation or told whether the agency had changed its position on the contentious question of when and how doctors can prescribe the popular painkillers without risking prosecution.

Advocates for aggressive pain management said the DEA's decision appears to have been triggered when defense lawyers tried to introduce the guidelines in the upcoming drug-trafficking trial of William Hurwitz, a McLean physician.

In late September, Hurwitz's defense team sought to introduce them as evidence. Several weeks later, the DEA took the document off its Web site and said it was not official policy.

Twelve days after that, U.S. Attorney Paul J. McNulty, who is prosecuting Hurwitz, filed a motion in the case asking that the guidelines be excluded as evidence, again saying that they do "not have the force and effect of law."

"It seems pretty clear that they felt they had to try to get rid of the guidelines because they supported so many parts of our case," said Hurwitz's defense attorney, Patrick Hallinan. "If the Justice Department followed the guidelines, there would be no reason to arrest and charge Dr. Hurwitz." The case is scheduled for trial Nov. 3.

DEA spokesman Ed Childress said the agency intends to rework the guidelines and publish them again. He said he could not comment on whether the decision to remove them had anything to do with any legal case.

The guidelines, which were published in August in the form of a "Frequently Asked Questions" feature prominently displayed on the DEA Web site, were described at the time as an effort to codify the "balance" that both the DEA and the pain management community have long said they are seeking.

The DEA has complained in the past that irresponsible, and possibly criminal, doctors prescribed narcotic painkillers too frequently and without enough care -- letting the valuable drugs get into the hands of people who sell them, abuse them and sometimes are harmed by them.

But many pain specialists have watched with dismay as scores of colleagues were arrested on criminal charges based on what many believe was sometimes good, aggressive treatment or, at worst, negligent prescribing practices. Many of the cases triggered mandatory sentencing guidelines that can send convicted drug dealers to prison for decades.

The introduction of long-lasting prescription opioids such as OxyContin revolutionized the treatment of pain, which doctors say is greatly under-treated in the United States.

Researchers say a small percentage of patients become addicted, but most people in pain do not. However, OxyContin and other powerful drugs became popular with drug abusers in the late 1990s, especially in rural and southern areas, and it has been linked to numerous hospitalizations and some deaths.

The consensus document was the product of more than a year of work by Russell K. Portenoy, a leading pain expert with New York's Beth Israel Medical Center, University of Wisconsin pain specialist David E. Joranson, professionals involved in the care of dying patients, and two top officials of the DEA.

When the guidelines were made public, DEA Administrator Karen P. Tandy embraced them and said in a statement: "The medical and law enforcement communities continue to work together to carefully balance the needs of legitimate patients for pain medications against the equally compelling need to protect the public from the risk of addiction and even possible death from these medications. . . . The DEA is committed to assisting the overwhelming majority of health care providers who successfully strike that balance every day, as well as the law enforcement officers investigating diversion and abuse of pain medications."

Portenoy said the group worked closely with the DEA, responding to many of its concerns and revising drafts many times to accommodate the agency. Portenoy said agency officials were active in the entire process, and he said he strongly believed that there had been "complete buy-in from the upper echelon" of the DEA regarding the guidelines.

Since word went out the guidelines had been withdrawn, he has received many calls and e-mails from worried and upset doctors, Portenoy said.

"There was a real feeling that we had made significant progress, but now we have to wonder whether that progress is all gone," Portenoy said. "If they don't fix whatever problems they might have and put the document back up, that would speak very clearly that the goal of the DEA is not to collaborate with the medical community or to reassure doctors about the proper role and use of prescription opioids in pain management."

The guidelines were also on many Web sites for pain clinics and programs. The DEA called at least one of them, the Pain & Policy Studies Group of the University of Wisconsin, and asked it to remove the document.

original source http://www.washingtonpost.com/wp-dyn/articles/A49719-2004Oct20.html


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