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PAIN MEDICINE Volume 2 Number 4 2001 © Blackwell Science, Inc. 1526-2375/01/$15.00/355 355–358 355 ETHICS FORUM — Edited by Michel Y. Dubois The Case Ethics and Standards of Care A hospice and palliative medicine physician is con- cerned about how a pain specialty group is practic- ing in his hospital and is writing you for advice. Simply, the pain management group in question will place indwelling tunneled epidural catheters at- tached to external CADD pumps for the adminis- tration of medications, typically morphine and bupi- vacaine. While the patient is in the hospital, the pain group makes adjustments in the epidural medica- tions, but once the patient is discharged they no longer feel any responsibility to make further ad- justments of the analgesics in the pump and, in fact, turn the care of the patients back to the referring physician, typically an oncologist. The local oncol- ogists have been asking this physician to assume the care of these patients with pumps attached to the tunneled epidural catheters. It is his feeling that the pain group’s philosophy of practice in this regard is below the standard of care as practiced throughout the United States and also is unethical. Should they not continue to provide consultation and advice re- garding the treatment of these patients? Opinion #1: Maripat Welz, RN Following American Pain Society’s Guidelines Without knowing the types of patients and the de- tails of their clinical problems, it is difficult to know exactly how this situation developed. My first response is that this is inadequate care and truncated care, cer- tainly not meeting the standard of appropriate conti- nuity. It appears to me that this situation involves both communication problems and issues of “performance improvement.” Performance—the way an individual, group, or or- ganization carries out or accomplishes its functions— is measured by established standards or indicators [1]. If these physicians reviewed the American Pain Soci- ety’s quality improvement guidelines for the treat- ment of acute pain and cancer pain [2], they would note the following standard: Once pain has been rec- ognized, assessed, and treated with appropriate anal- gesics, should there be a further need for advanced analgesic technology, the health care system should follow explicit policies and safeguards to implement this technology. At the very least, this pain specialty group should have a documented policy about the long-term management of these patients, particu- larly designating who, if not themselves, will as- sume care on discharge. If at discharge there is no established plan of follow-up care, with documen- tation of who will be caring for the patient, and a scheduled follow-up visit with a physician who is comfortable with the care of these devices, it should be the specialty practice physicians’ ethical respon- sibility to continue care of these patients. Is a sur- geon not responsible for his or her patients after they leave the hospital? Without adequate follow-up care, this practice is placing these patients at risk for infection, inflam- mation, or dermatitis at the insertion site. For them to assume that a physician without training in the management of these devices or that a family mem- ber at home will be comfortable and capable of pro- viding this care is ethically questionable. A second issue is that protocols for making deci- sions about the choice of procedure and the timing of the procedure must be present and followed when clinically appropriate. I coordinated two hos- pice programs in the Philadelphia area for a num- ber of years. A rule of thumb for anyone familiar with palliative care is as follows: If a patient is alert, oriented, and able to tolerate food or liquids, then the desired route for medication is oral or transder- mal. Many factors are to be considered before place- ment of a device, such as cost of drugs, availability of needles and supplies, evaluation and teaching of a support system, and management of pump malfunc- tion (it has been this clinician’s experience that most malfunction at 2 a.m. or over a weekend!). In regard to the latter, adequate oral opioids must be available in the home for backup should there be a pump mal- function at 2 a.m. Other concerns include whether there is insurance coverage for home visits for medi- cation refills of the pump, under what circumstances the patient must travel to the physician’s office, and whether there is an ongoing evaluation of the ade- quacy of pain control via this route. These are but a few of the many considerations in this circumstance. If one or more problems occur, it is the patient who experiences fear and anxiety, which increases their pain and suffering, nullifying the entire reason for the placement of this device in the first place! Reprint requests to: Michel Y. Dubois, MD, Pain Manage- ment Center, New York University Medical Center, 530 First Avenue, Suite 9T, New York, NY 10016. Tel: (212) 263-7316; Fax: (212) 263-7901.

Opinion #4: Vitaly Gordin, MD

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Page 1: Opinion #4: Vitaly Gordin, MD

PAIN MEDICINE

Volume 2

Number 4

2001

© Blackwell Science, Inc. 1526-2375/01/$15.00/355 355–358

355

ETHICS FORUM

— Edited by Michel Y. Dubois

The Case

Ethics and Standards of Care

A hospice and palliative medicine physician is con-cerned about how a pain specialty group is practic-ing in his hospital and is writing you for advice.Simply, the pain management group in questionwill place indwelling tunneled epidural catheters at-tached to external CADD pumps for the adminis-tration of medications, typically morphine and bupi-vacaine. While the patient is in the hospital, the paingroup makes adjustments in the epidural medica-tions, but once the patient is discharged they nolonger feel any responsibility to make further ad-justments of the analgesics in the pump and, in fact,turn the care of the patients back to the referringphysician, typically an oncologist. The local oncol-ogists have been asking this physician to assumethe care of these patients with pumps attached to thetunneled epidural catheters. It is his feeling that thepain group’s philosophy of practice in this regard isbelow the standard of care as practiced throughoutthe United States and also is unethical. Should theynot continue to provide consultation and advice re-garding the treatment of these patients?

Opinion #1: Maripat Welz, RN

Following American Pain Society’s Guidelines

Without knowing the types of patients and the de-tails of their clinical problems, it is difficult to knowexactly how this situation developed. My first responseis that this is inadequate care and truncated care, cer-tainly not meeting the standard of appropriate conti-nuity. It appears to me that this situation involves bothcommunication problems and issues of “performanceimprovement.”

Performance—the way an individual, group, or or-ganization carries out or accomplishes its functions—is measured by established standards or indicators [1].If these physicians reviewed the American Pain Soci-ety’s quality improvement guidelines for the treat-ment of acute pain and cancer pain [2], they wouldnote the following standard: Once pain has been rec-ognized, assessed, and treated with appropriate anal-gesics, should there be a further need for advanced

analgesic technology, the health care system shouldfollow explicit policies and safeguards to implementthis technology. At the very least, this pain specialtygroup should have a documented policy about thelong-term management of these patients, particu-larly designating who, if not themselves, will as-sume care on discharge. If at discharge there is noestablished plan of follow-up care, with documen-tation of who will be caring for the patient, and ascheduled follow-up visit with a physician who iscomfortable with the care of these devices, it shouldbe the specialty practice physicians’ ethical respon-sibility to continue care of these patients. Is a sur-geon not responsible for his or her patients afterthey leave the hospital?

Without adequate follow-up care, this practice isplacing these patients at risk for infection, inflam-mation, or dermatitis at the insertion site. For themto assume that a physician without training in themanagement of these devices or that a family mem-ber at home will be comfortable and capable of pro-viding this care is ethically questionable.

A second issue is that protocols for making deci-sions about the choice of procedure and the timingof the procedure must be present and followedwhen clinically appropriate. I coordinated two hos-pice programs in the Philadelphia area for a num-ber of years. A rule of thumb for anyone familiarwith palliative care is as follows: If a patient is alert,oriented, and able to tolerate food or liquids, thenthe desired route for medication is oral or transder-mal. Many factors are to be considered before place-ment of a device, such as cost of drugs, availabilityof needles and supplies, evaluation and teaching of asupport system, and management of pump malfunc-tion (it has been this clinician’s experience that mostmalfunction at 2 a.m. or over a weekend!). In regardto the latter, adequate oral opioids must be availablein the home for backup should there be a pump mal-function at 2 a.m. Other concerns include whetherthere is insurance coverage for home visits for medi-cation refills of the pump, under what circumstancesthe patient must travel to the physician’s office, andwhether there is an ongoing evaluation of the ade-quacy of pain control via this route. These are but afew of the many considerations in this circumstance.If one or more problems occur, it is the patient whoexperiences fear and anxiety, which increases theirpain and suffering, nullifying the entire reason forthe placement of this device in the first place!

Reprint requests to:

Michel Y. Dubois, MD, Pain Manage-ment Center, New York University Medical Center, 530First Avenue, Suite 9T, New York, NY 10016. Tel: (212)263-7316; Fax: (212) 263-7901.

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Dubois et al.

It would be wise for all physicians involved to tryand implement an interdisciplinary committee todiscuss these issues. Hospitals often provide leader-ship in establishing these committees; this tendencywill be reinforced by the new Joint Commission onAccreditation of Healthcare Organizations standardsmandating the quality care of pain. Although the phy-sicians mentioned may be perfectly capable of provid-ing good interventional pain management, there ismore to the quality care of pain than the technicalplacement of a device; one must wonder why this spe-cialty group does not monitor these patients, whendischarged, on an outpatient basis. There may be ap-parently insurmountable administrative-structuralbarriers. Is this a hospital anesthesia-based practicewith no outpatient services? How are referrals madeto this group? Is it their understanding that control-ling a patient’s acute pain, which has not respondedto various other measures, is their responsibilityand that follow-up care is by the referring physi-cian? Why are the oncologists referring these pa-tients to this group if follow-up care is not pro-vided? Are the patients taking such astronomicalamounts of oral opioids that the placement of anindwelling catheter is their only option, or are thephysicians involved afraid to prescribe opioids? Arehospital administrators, who may hire physiciangroups for this function, denying follow-up carebecause of poor reimbursement?

These are just a few of the questions physiciansneed to ask themselves and discuss with each other.The answers to these questions lie at the interfaceof clinical ethics, clinical standards, and health eco-nomics. As long as these physicians continue to workas “independents” in the treatment of pain and notconsider what other disciplines may have to offer, itwill be the patient and their families, our health caredelivery system, and society that ultimately suffer. Pa-tients will not receive the optimal care in pain manage-ment. Insurers will continue to pay out large amountsfor frequent emergency room visits from patients witha pain crisis who do not know who they should becalling and will continue paying for the high cost ofpain care (CADD pump, epidural catheter, medica-tion, supplies, home care), which might be managedextremely effectively with medication. Of course,that insurers would continue to subsidize substan-dard care, while not supporting more cost-effectivemultidisciplinary care, is both a health economics is-sue and an ethical issue that society must consider.

For these physicians not to take the interdiscipli-nary approach that is needed to facilitate the dis-cussion of the many options for “best practice” ofpain management and not to consider the best and

most effective process of care for their patients pre-sents a much larger ethical concern for this caregiver.Physician education and health system standards areneeded to address these matters.

References

1 Haase R, Miller K. Performance improvement in ev-eryday clinical practice. Am J Nurs 1999;99:52–4.

2 American Pain Society. Quality improvement guide-lines for the treatment of acute pain and cancer pain.JAMA 1995;274:1874–80.

Maripat Welz, RN, the clinical coordinator of the PainMedicine and Rehabilitation Center at Graduate Hospi-tal, Tenet, in Philadelphia, has directed two hospices inthe Philadelphia region and presently participates in phar-macological and outcomes research in chronic pain disor-ders and precepts MPH students at the School of PublicHealth, MCP Hahnemann University.

Opinion #2: Jeffrey Livovich, MD

Owning Fiduciary Responsibility

This case demonstrates numerous issues related toethical practice at many levels. It also demonstratesopportunities and necessity for action at a physician–professional group level as well as organizationallevel.

The primary concern is the delivery of the bestpossible care to the patient. All physicians partici-pating in the global care of a patient have a fiduciaryresponsibility to the patient with whom they enterinto a treating relationship. The pain practice grouphas been asked to provide specialty care to cancerpatients. The physicians who have sought the exper-tise of the pain specialists have done so in recogni-tion of the special knowledge and technical expertisethat the trained pain specialist can provide in thecare of the patient. Techniques such as a tunneledepidural catheter and neuraxial agents can providesignificant relief from symptoms and greatly im-prove the quality of life for such patients. However,when physicians refer patients for pain treatment,their expectations are for the pain specialist not onlyto perform technical services but also to manage thataspect of the patient’s care. No one else on the treat-ing team has the expertise to do this as safely and ef-fectively as the pain specialist.

When responsibility for continued care is dis-charged to the referring physician or other physicianinvolved without continued oversight, the argumentcan be made that the pain specialist is not owningthe fiduciary responsibility to the patient. Assumingthat physicians with minimal specialty training in

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Ethics Forum

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pain management can appropriately provide thebest care to the patient without the oversight of apain specialist is a logic that fails even a common-sense test.

The issue of inadequate follow-up is one that Iam frequently hearing from primary care providersand specialists such as oncologists. They are dis-turbed by the fact that, when patients are referredfor pain management, many pain specialists provideinterventions and then send the patient back with-out ongoing follow-up. Chronic pain patients ofany kind bring with them myriad problems that arebest handled by those trained to deal with chronicpain. In other words, I doubt that the palliative carephysician who provides us with this case is the onlyspecialist on the treating team who is upset withthis situation. Given that the team at large is frus-trated with this situation, I believe it would be pru-dent for the oncologists and palliative physicians tomeet with the pain specialists involved and outlinetheir concerns. There is power in the group, andphysicians respond well to peer pressure. From thisdialogue, it is likely that greater oversight of painpatients will be developed.

The palliative physician providing this case stateshis belief that this is not standard of care, but what isstandard of care? Here is an opportunity for profes-sional societies. Standard of care is best defined andsupported by creation of evidence-based and con-sensus guidelines. Such guidelines would providetools that could easily remedy situations such as theone presented here. When guidelines exist, there isno question as to what standard of care is and whatthe expectations are of the treating pain specialist.

Finally, a comment from a population and qual-ity-of-care level. Patients who do not receive ap-propriate specialty oversight in their care are morelikely to have complications and relapse. Such pa-tients are frequently readmitted for more costly care.The cost is high for such fragmented care, not onlyin the suffering that that the patient must endure butalso in the basic costs of additional health care re-source that must be consumed. Can we afford suchpractice?

Jeffrey Livovich, MD, is a pain medicine specialist/anes-thesiologist who currently serves as the West Region Med-ical Director for Aetna US Healthcare.

Opinion #3: Linda A. King, MD, and Bob Arnold, MD

Negotiating Explicit Practice Guidelines

Our experience working with interventional painspecialists suggests that practice patterns do vary

with regard to this issue. The best groups partici-pate actively in both pain assessment and manage-ment decisions and continue to monitor patientsclosely after placing a tunneled epidural or intra-thecal catheter, scheduling regular follow-up con-tact with the patient, responding promptly to prob-lems or changes in a patient’s clinical condition,providing emergency coverage 24 hours a day 7 daysa week, and communicating closely and effectivelywith other clinicians involved in the patient’s care.Other groups remain available for consultation by cli-nicians regarding dose adjustments, catheter prob-lems, and side effects during regular working hoursbut do not remain actively involved with direct pa-tient follow-up. Unfortunately, a few groups do seemto view their role in the patient’s pain management asnothing more than “proceduralists,” responsible forplacing (and perhaps maintaining) the catheter itselfbut nothing more. This range of practice representsour own experience; unfortunately, we do not haveactual data regarding practice patterns and, therefore,cannot state what the standard of care is.

Practice guidelines from the American Society ofAnesthesiologists for both chronic and cancer pain[1,2] include recommendations that pain specialistscoordinate care with other health professionals andprovide appropriate logistical support and follow-upwhen recommending neuroaxial delivery of analge-sics. Although these recommendations are not spe-cific (in terms of who should provide follow-up andin what setting), we believe that clinicians insertingthese catheters should either provide ongoing carefor the patient’s pain or ensure that someone withthe necessary expertise has agreed to provide ongo-ing care. Given that most physicians do not haveexpertise in dosing opioids via this technology, webelieve that the physician who places the catheter hasan obligation to ensure that it is used responsibly byremaining actively involved in the patient’s painmanagement. Otherwise, the risks of having the cath-eter placed and used improperly could outweigh thebenefit it might provide in improved analgesia.

Given that practice variation exists and no clearethical standards apply, the most effective strategywould likely be for the involved parties (yourself,the interventional pain specialists, and the local on-cologists) to meet and negotiate explicit practiceguidelines that effectively meet patients’ needs andare acceptable to all clinicians involved. If such ef-forts still did not result in acceptable practices, di-recting patient referrals to different pain specialists(if available) might prove more effective. Sadly, ap-plying financial pressure (loss of referrals) maywork when appeals to do the right thing have not.

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References

1 American Society of Anesthesiologists. Practice guide-lines for chronic pain management. Anesthesiology1997;86:995–1004.

2 American Society of Anesthesiologists. Practice guide-lines for cancer pain management. Anesthesiology1996;84:1243–57.

Linda A. King, MD, is assistant professor of medicine,Section of Palliative Care and Medical Ethics Universityof Pittsburgh. Bob Arnold, MD, is professor of medicine,Chief, Section of Palliative Care and Medical Ethics, Uni-versity of Pittsburgh.

Opinion #4: Vitaly Gordin, MD

Ethical Issues of Appropriateness of High-Tech Devices and Continuity of Care

This case raises several important issues such as theethical issue of appropriateness of high-tech devicesin terminally ill patients and continuity of care. Italso stresses the importance of communication be-tween the caregivers.

Comfort care for terminally ill cancer patients ismost commonly low-tech and high-touch. There-fore, a pain management physician must carefullyconsider the appropriateness of invasive procedureson a case-by-case basis.

“High-tech” delivery systems are expensive andcan sometimes distract the focus of attention fromthe personal care provided to a terminal cancer pa-tient. Their use requires competent personnel whohave training in maintenance and troubleshootingof the equipment involved.

Although the technique itself can be effective,especially for the management of a mixed nocicep-tive and neuropathic pain secondary to cancer, it re-quires very close supervision and frequent adjustmentof the infusion rate and concentration of the medi-cine. It is also not free of side effects and complica-tions in patients who are frequently debilitated by theterminal disease, can have mental status changes, andare susceptible to infectious complications.

According to the Clinical Practice Guidelines onthe Management of Cancer Pain, intraspinal route“requires experience, meticulous technique, signifi-cant family and professional support systems,

andsophisticated follow-up, which are not available in all set-tings

” [1]. In other words, if an adequate follow-up isnot available, an argument can be made against place-ment of these drug delivery systems.

Once the drug delivery system has been placed,the pain management physicians should be in closecontact with both the patients and their family mem-bers and the hospice staff to provide consultationon how to manage the epidural infusion and otherpain management-related issues.

It is in the patients’ best interest when the painmanagement physician is a member of a multidisci-plinary team and, as such, continues to provide com-prehensive pain management to these patients afterdischarge from the hospital.

One of the most constructive ways in dealingwith the described situation would be directly ad-dressing the members of the pain management groupin question. In my opinion, they should obtain staffprivileges at the hospice and participate in regularcase conferences with the rest of the hospice interdis-ciplinary team. They can also provide education tothe health professionals at the hospice and, when ap-propriate, to the family members on the maintenanceand troubleshooting of the drug delivery system.

References

1 U.S. Department of Health and Human Services.Management of Cancer Pain: Clinical Practice Guide-lines. Washington, DC: U.S. Department of Healthand Human Service; 1994: 57.

Vitaly Gordin, MD, is an assistant professor of anesthesi-ology, acting director of the Pain Medicine Division, di-rector of Interventional Pain Management, and directorof the Pain Medicine Fellowship Program at the Pennsyl-vania State University College of Medicine, Milton S.Hershey Medical Center.