Palliative Care

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How do you balance effective analgesia for terminal patients with regulatory concerns? 

Provision of comfort care can seem like a balancing act if the clinician, trying to relieve pain, feels conflicting obligations. Read the thoughts of three providers who share their experience providing pain relief for dying patients.

Cathy D. Trame RN, MS, CNS:

Cathy D. Trame RN, MS, CNS is Clinical Nurse Specialist for Pain Services, Miami Valley Hospital, Dayton, Ohio 

Effective analgesia while treating the terminal patient may more realistically be inhibited by unwanted side effects from the opiates versus regulatory concerns. The uncomfortableness of prescribers usually stems from unwarranted fears of legal action or licensure restrictions related to patient treatment. Statistically it is more likely that regulatory sanctions would occur as a result of under-treatment of pain versus over-treatment. Falson versus Hillhaven Corp.(1990); Bilder versus Oregon Medical Board (1999); Bergman versus Chin (2001); and Michigan versus Wound Care Specialist (2002); were all cases successfully waged against physicians, based on the under-treatment of pain. Two of these cases involved terminal cancer patients. As with all patients, fluid, frequent communication with the family and patient is the best defense against legal action, but not a substitute for quality care.

Regulatory concerns of healthcare providers while prescribing opiate analgesics for the terminal patient are often unfounded. Over-prescribing, inappropriate prescribing, or diversion of controlled substances, are situations in which the provider may feel threatened. Clearly in a terminal patient, two of these concerns would be secondary. Diversion is somewhat out of the control of the prescriber who is treating legitimate pain issues of a patient. Addiction, one of the biggest concerns for prescribers of opiates, is not typically relevant to the treatment of the terminal patient. Even if the patient had known addiction issues, should opiate analgesics be withheld from a terminal patient?

Ohio House Bill 187, which dictates the necessary documentation and follow-up of patients on opiates long term, exempts patients with terminal conditions from the rules. Specific laws at the state level that are applicable to opiate prescribing should be reviewed. Laws may be devised to protect the practitioner. At the federal level, the Drug Enforcement Agency (DEA) would not typically investigate prescribing practices related to terminal patients without peer, patient, or family complaints. The DEA supported the judicious use of opiates, including oxycontin, for chronic and malignant pain control in the media, amidst reported oxycontin diversion and overdoses.

Concerns regarding side effects may be related to prescribing opiates and/or sedatives that could ultimately inadvertently sedate the patient to the point of respiratory depression. Ohio Sub House Bill 474 states that although, "...assisted suicide is against the public policy of the state"; the bill shall not "...prohibit a person from administering, prescribing, or dispensing medications or treatments to relieve pain or discomfort, even if the medication or treatment may hasten or increase the risk of death..." In other words, effective analgesia should not be withheld based on the risk of unintended adverse or even fatal effects. Policies within individual states may vary related to opiate prescribing and assisted suicide. In a sense, "over prescribing" could be a legally protected fallacy while treating the terminal patient depending upon your state laws.

In summation, lack of information or misinformation about regulatory scrutiny, should not paralyze prescribers from providing needed analgesic therapy in terminal patients. Withholding analgesics while attempting to second guess possibilities of diversion or addiction in the terminal patient will only complicate quality patient care. In contrast to the rare instance that a prescriber is "duped", many, many more patients will receive the needed analgesic that they ethically deserve. As practitioners it is our duty to do everything we can to enhance the quality of our patients' lives during their final days.

How do you balance effective analgesia for terminal patients with regulatory concerns? 

Provision of comfort care can seem like a balancing act if the clinician, trying to relieve pain, feels conflicting obligations. Read the thoughts of three providers who share their experience providing pain relief for dying patients.

Phyllis A. Grauer, RPh, PharmD:

Phyllis A. Grauer, RPh, PharmD is President, Palliative Care Consulting Group; Assistant Clinical Professor, The Ohio State University College of Pharmacy; Pharmacist Section Leader, National Council of Hospice and Palliative Professionals, National Hospice and Palliative Care Organization, Dublin, OH. 

It's not so much an issue of balance as it is just a matter of maintaining good communications and documentation and practicing good standards of care in the treatment of pain. Unfortunately, doing what it takes to provide adequate pain control entails both time and knowledge. From prescribers' perspectives, decreased third party reimbursement leads to decreased time spent with patients. Because of the subjective nature of pain, thorough patient assessment is needed. This is not only physical assessment but also psychosocial and emotional assessment.

In Ohio, there are state laws that support the use of opioids for the treatment of both malignant (terminal) and chronic nonmalignant pain. Most physicians are comfortable prescribing opioids to the dying patient as long as they are satisfied that there is no concern of abuse, diversion or addiction. As stated previously, physicians who do not generally prescribe opioids to their patient population have some level of discomfort of triggering an investigation. I have found that offering suggestions for documentation on both the prescription and in the patient record can alleviate these concerns. Even in those terminally ill patients who have legitimate pain and where there is concern about abuse, addiction or diversion, offering strategies for treating terminal pain can be employed. Although the use of pain management agreements are generally not necessary for the treatment of pain with opioids in the terminally ill patient, in those situations where abuse or diversion is suspected, these agreements will offer boundaries to protect both the patient and the health care team. Along with mandating the use of only one prescriber and one pharmacy, Iimiting the quantity and choosing opioids that provide the least likelihood of abuse are prudent strategies.

Communication among the healthcare team also improves the likelihood that all members of the patient's healthcare team are on the same page with respect to appropriate use of opioids. This is particularly important with respect to the dispensing pharmacist. A pharmacist is liable for insuring that all prescriptions dispensed are for a legitimate medical purpose. A physician should be willing to share information that will legitimize a prescription for opioids when a pharmacist calls the physician.

One strategy we have employed in Ohio is an educational effort directed at pharmacists and physicians to raise the awareness of laws that pertain to the use of opioids in terminally ill patients. This project was a joint effort between the Ohio State Board of Pharmacy and the Ohio Hospice and Palliative Care Organization. The information was disseminated through regional live presentations and audio conferences to pharmacists, physicians and hospice organizations. Additionally, a brochure was developed to equip hospices with written documentation to provide to local healthcare practitioners. This project was also presented at the National Hospice and Palliative Care Organization Conference. Occasionally I find pharmacists and even regulatory inspectors who are still misinterpreting the regulations regarding partial filling, emergency telephone orders and faxing of schedule II prescriptions for terminally ill patients in spite of all the information I provide to them. In those situations, I get them in contact the Ohio State Board of Pharmacy to assist in clarifying the rules. All in all, I find that if I can talk with a pharmacist or prescriber and provide them with the facts, I can eliminate any concerns they have over regulatory scrutiny.

Joshua Cox Pharm.D., R.Ph.:

Joshua Cox Pharm.D., R.Ph. is Pain Management Consultant, Good Samaritan Hospital, Dayton, Ohio

Regulatory concerns regarding the prescribing and distribution of controlled substances are generally unfounded. And in the case of using these agents for symptom management in terminally ill patients, this is even truer since laws governing the use of controlled substances frequently contain certain exemptions for terminal patients. However, one of the most significant concerns that continues to be a barrier to effective pain management in dying patients is the concern that the use of opioid analgesics in this population may hasten death. For some, this situation results in not only a legal dilemma, but an ethical one as well.

The effect of opioid analgesics and other central nervous system depressants on survival has been studied in patient populations in the last stages of life. Thorns and Sykes evaluated 238 consecutive patients in a palliative care unit. A comparison of patients who received marked increases in opioid doses during the last week of life, and those who received no increase during the same period showed no significant difference in survival from time of admission, frequency of unexpected death, or description of death. Morita, et al assessed the relationship between opioid doses and survival of terminally ill patients in the last 48 hours of life. Among the 209 patients evaluated, no difference in survival was found among patients receiving <240mg, 240-599mg, and >600mg of oral morphine equivalent. A similar study evaluating survival times in over 600 home-bound patients found a significant increase in survival time for those patients receiving higher doses of morphine compared to those receiving low doses of morphine. While the increase in survival time is likely due to confounding variables, the results suggest that high doses of morphine are not associated with a hastening of death.

The tools required to manage pain and other symptoms at the end of life have been available for decades. The World Health Organization estimates that correct application of basic pain management principles may lead to an 80-90% improvement in pain relief in dying patients. Yet, the epidemic of undertreatment remains. Lack of experience and inadequate training coupled with the fear of various regulatory and ethical concerns, including the fear of shortening survival, are likely the most important contributors to undertreatment. The utilization of available resources to palliate symptoms in any patient is an ethical obligation shared by all health care professionals. Perhaps when clinicians and regulatory bodies shift focus away from the multitude of existing barriers and focus more on providing for those we serve, practice decisions will begin to be based on principles of beneficence than nonmaleficence.