| Pain Management & Continuing Medical Education |
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| OMB STATEMENT OF PHILOSOPHY ON PAIN MANAGEMENT |
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The OMB urges the use of effective pain control for all patients, irrespective of the etiology of their pain. This includes, but is not limited to, pain derived from malignancies, acute pain resulting from injuries, acute illnesses or invasive procedures and chronic pain of diverse etiology. Management of pain is considered to be within the scope of practice of most physicians. It is the expectation of the Board that physicians will be knowledgeable or become knowledgeable in treatment of pain for problems that are within their scope of practice.
Physicians choose not to provide pain care to patients for the following reasons: 1) concern about causing addiction; 2) lack of knowledge about pain management techniques and pain medication pharmacology; 3) fear of scrutiny and discipline by regulatory agencies; 4) challenges in determining the appropriate treatment; 5) inadequate compensation. The Board does not consider any of the reasons above to be legitimate excuses for a physician to exclude treatment of pain from their clinical practice. The Board expects that physicians will treat pain within the scope of their practice or refer when appropriate.
The treatment of acute pain caused by injuries, acute illnesses or interventional procedures requires aggressive management and frequent feedback from the patient regarding the adequacy of the pain control prescribed. The potential for addiction is very low when short courses of opioids are used to treat acute, self -limited pain. Skillful pain management techniques, including oral, parenteral and, when available, regional pain management techniques can achieve maximum patient comfort and may reduce the total amount of opioids required. The OMB encourages physicians to become well informed in acute pain management and to hone their skills in the latest techniques for control of these acute, self-limited episodes of pain.
Management of the patient with a chronic pain syndrome requires different techniques but a similar degree of skill. In 1995, the Oregon Legislative Assembly passed ORS 677.470-485, commonly referred to as the Intractable Pain Act. This act allows a physician to prescribe or administer controlled substances to a patient diagnosed with a condition causing intractable pain without fear of sanction from the Oregon Medical Board, so long as that physician complies with the provisions of this statute. Both this statute and its facilitating Oregon Administrative Rule (847-030-0015), as revised in 2004, assure that patients with chronic pain syndromes: (1) receive careful assessment, documentation, and management of the pain; (2) are informed of the risk of taking the controlled substances used in the course of their treatment; and 3) acknowledge receipt of this information by signing the approved material risk form*. Although the 2003 Legislature amended the Act to remove a stipulation that all chronic pain patients receive an “evaluation by one or more physicians specializing in the treatment of the body area, system or organ perceived as the source of the pain”, the OMB notes that the accepted standard of care includes such consultations (evaluations) when the diagnosis or appropriate treatment is uncertain or when the current treatment is not producing expected results.
Physicians should make every effort to relieve the pain and suffering of their terminally ill and dying patients. The OMB believes this effort is the physician’s primary obligation to these patients. Pain control in terminally ill/dying patients may require doses of opioids well above the usual amounts administered intermittently or continually. The natural dying process may involve declining blood pressures, decreasing respirations and altered levels of consciousness. When these patients continue to experience pain, opioids should not be withheld on the basis of physiologic parameters or from fear of hastening death.
Appropriate management of all of these types of pain is the treating physician’s responsibility. Although there is often a significant amount of latitude regarding the amount of medication required for control of the pain, the Board considers under treatment as well as over treatment to be below the standard of care.
-- Revised 7/9/04
* A Board approved example of a Material Risk Notice (MRN) form appears on the Board’s web site. www.oregon.gov/OMB/forms
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| Important Links |
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A Board approved example of a Material Risk Notice (MRN) form appears on the Board’s web site. www.oregon.gov/OMB/forms
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| OMB ADMINISTRATIVE RULES ADDRESSING INTRACTABLE PAIN |
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Written Notice Disclosing the Material Risks
Written Notice Disclosing the Material Risks Associated with Prescribed or Administered Controlled Substances for the Treatment of "Intractable Pain."
847-015-0030
Written Notice Disclosing the Material Risks Associated with Prescribed or Administered Controlled Substances for the Treatment of “Intractable Pain.”
(1) Controlled substances may be prescribed for long term treatment of “intractable pain”, ORS 677.475 (1). The attending physician records must contain the attending physician’s examination, diagnosis and any other supporting diagnostic evaluations and other therapeutic trials, including records from previous providers. If there is a consulting physician, written documentation of his/her corroborating findings, diagnosis and recommendations shall be included in the record.
(2) Before initiating treatment of “intractable pain” with controlled substances, the attending physician shall discuss with the patient the material risks associated with the prescribed or administered controlled substances. Following the discussion the patient may request further explanation prior to signing the material risks notice. Following completion of the discussion, the attending physician shall provide to the person and the person shall sign a written notice of the material risks associated with the prescribed or administered controlled substances to be prescribed, ORS 677.485.
(3) The material risk notice should include but not be limited to:
(a) The diagnosis;
(b) The controlled substance and/or group of controlled substances to be used;
(c) Anticipated therapeutic results;
(d) Alternatives to controlled substance therapy; and
(e) Potential side effects (if applicable):
(A) General;
(B) Central Nervous System;
(C) Gastrointestinal;
(D) Respiratory;
(E) Dermatologic, and
(F) Other.
(f) Allergy Potential;
(g) Interaction/Potentiation of other medications;
(h) Potential for dose escalation/tolerance;
(i) Withdrawal precautions;
(j) Potential for dependence and addiction;
(k) Potential for impairment of judgment and/or motor skills;
(l) Satisfaction with or desire for more explanation; and
(m) Patient signature (dated).
(4) The material risk consent form will be maintained as a permanent component of the patient record as shall documentation of long term follow-up to demonstrate the continued need for this form of therapy, ORS 677.480(1)(3). A dispensing record of the amount and dose of the prescribed or administered controlled substances shall be maintained as part of the patient record.
OMB ADMINISTRATIVE RULES ADDRESSING PAIN MANAGEMENT EDUCATION
847-010-0100
Mandatory Pain Management Education
(1) All licensees of the Oregon Medical Board, except the licensees listed in section (2) of this rule, will complete mandatory continuing medical education (CME) in the subjects of pain management and/or the treatment of terminally ill and dying patients as follows:
(a) A one-hour pain management course specific to Oregon provided by the Pain Management Commission of the Department of Human Services; and
(b) A minimum of 6 (six) continuing medical education credit hours in the subjects of pain management and/or the treatment of terminally ill and dying patients. Any combination of CME coursework focusing on pain management and/or treatment of terminally ill and dying patients may be used to fulfill this requirement.
(2) Licensees holding the following types of licenses shall not be required to meet this requirement:
(a) Lapsed license;
(b) Telemedicine license; or
(c) Teleradiology license.
(3) The required CME must be completed after January 1, 2000 and before January 2, 2009.
(4) Licensees must be prepared to provide documentation of CME if requested by the Board.
(5) All applicants granted a license after January 2, 2009, excepting those with a type of license listed in Section (2), must obtain the required CME coursework within twelve months of the date the Board granted licensure.
FREQUENTLY ASKED QUESTIONS ON CME REQUIREMENTS FOR PAIN MANAGEMENT
1. What continuing medical education (CME) is acceptable to satisfy the requirements of ORS 409.560 pertaining to pain management education?
Answer: Any 6 hours of CME on pain management or end-of-life care obtained after 2000.
2. How do I get credit for the one (1) hour pain management course specific to Oregon provided by the Pain Management Commission?
Answer: You can obtain that (1) one hour by going to www.oregon.gov/DHS/pain and watching the video at that site. At the completion of the video, follow the directions online.
3. When does the CME have to be completed?
Answer: By January 2, 2009.
4. What do I do with the documentation of having completed this pain management CME?
Answer: Keep it in safe place so you can demonstrate your completion of the requirement if you are challenged. Please DO NOT send it to the OMB!
5. Which licensees of the OMB are required to complete these requirements?
Answer: All licensees under the OMB are required to obtain the 6 hours of CME on pain management or end-of-life care, plus the 1 hour of pain management CME specific to Oregon.
6. Where can I read the Board’s administrative rules on pain management education?
Answer: The full text of the rules are available at OMB Administrative Rules Addressing Pain Management.
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| INTRACTABLE PAIN AND PAIN MANAGEMENT |
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FALL 2005 OMB NEWSLETTER ARTICLE
"Prescribing Poses a Plethora of Problems, Pitfalls and Perils"
By Philip Parshley, M.D.
Medical Director,
Oregon Medical Board
Prescribing medication is an essential task within a physician’s practice. But the fast pace of scientific progress, societal problems of drug addiction and abuse, and a multi-level myriad of rules and regulations make it a problematic task as well.
Multiple prescriptions and the Law
Recently, there has been some confusion regarding prescriptions of Schedule II controlled substances, particularly with regard to federal regulations. The federal Controlled Substances Act (CSA) specifically prohibits refilling prescriptions for Schedule II drugs, but until recently it has been accepted that multiple Schedule II prescriptions may be written and dated on the same day with the additional written comment, “Do Not Fill Until xx/xx/xx (date)”. By advancing the date by one month in sequence on these several prescriptions a healthcare provider, licensed to prescribe Schedule II medications, may provide a one month supply for several months in a row.
This technique was used for reliable individuals who were on stable doses and who were perhaps restricted by insurance rules that allowed only one month supply of medications at a time. The U.S. Drug Enforcement Administration (DEA) in an August 2004 “Frequently Asked Questions” document stated that this was acceptable.
However, in November 2004 the DEA published in the Federal Register a retraction of the previous acknowledgment of that process, and opened the way for public comment. This made the care of chronic pain patients more difficult and more expensive for both the public and healthcare providers. Because of many protests, public commentary was sought, but, after the DEA received many opinions against its November 2004 ruling, it reconfirmed its November action. This was based on the overall rule that refills of Schedule II drugs are forbidden, and that permitting this alternative is “tantamount to writing a prescription authorizing refills of a Schedule II controlled substance.”
Federal authorities explained that such an action would conflict with a fundamental purpose of the federal statute – preventing diversion of controlled substances for unlawful purposes. Authorities have long felt that physicians who unlawfully dispense controlled substances often do so by writing multiple prescriptions for future use. This issue may not be over yet. Stay tuned for now but don’t use this technique.
It is well to note that in situations where federal laws or regulations conflict with state laws or regulations, the more stringent rule or rules are to be followed – particularly in regard to using, prescribing and administering controlled substances.
Oregon requires CME for pain prescribing
An Oregon state law which takes effect January 2, 2006 requires that certain licensees of the OMB must complete continuing medical education (CME) in pain management. The OMB is writing Oregon Administrative Rules (OAR) to require that all licensees complete mandatory CME in the subject of pain management and/or the treatment of terminally ill and dying patients.
The CME includes a one-hour pain management course specific to Oregon, provided by the Pain Management Commission in the Department of Human Services[1], and six hours of CME in pain management and/or treatment of terminally ill and dying patients. Any combination of these subjects may be used.
Licensees holding the following types of licenses are not required to participate: lapsed licenses; telemedicine licenses; teleradiology licenses.
The 2001 Legislature adopted the new law, and health care professionals subject to these CME requirements have 24 months from the effective date (January 2, 2006) to complete the required coursework. The required CME must be completed after January 1, 2000 and before January 2, 2009. All licensees required to obtain this CME must have available documentation of completion, or face disciplinary action by the OMB.
Other organizations offer pain management courses for Oregon providers seeking to comply with the six-hour CME requirement. The University of California, San Diego (UCSD) offers six-hour and 12-hour programs in pain management, designed to comply with California’s pain management education law. The UCSD courses are available on DVD for $150 (six hours) or $200 (12 hours)[2].
The American Medical Association (AMA) offers two free, three-hour courses as PDF downloadable files to all health care providers. The courses are in management of persistent non-malignant pain, cancer pain and end-of-life care.[3] The AMA has a 12-hour course available on line as well, the last six hours of which is included in the above downloadable programs.
Physician assistants are reminded that they must complete all required CME – including pain management – in order to qualify for Schedule II prescribing privileges.
Chronic pain prescribing: Ongoing Issues
Oregon law also requires attending physicians to provide, and patients to sign, Material Risk Notices (MRN) if controlled substances are prescribed and/or administered for chronic intractable pain. As stated in OAR 847-015-0030, the notices should include but not be limited to the following: diagnosis, controlled substance and/or group of controlled substances to be used, anticipated therapeutic results, and alternatives to controlled substance therapy.
In addition, the MRN should inform patients of potential side effects of medication on various systems of the body, possible allergic reactions, impairment and addiction, interactions with other drugs and withdrawal precautions. The MRN also should contain patient-initiated, achievable goals of treatment other than simply control of pain. Progress in achieving these goals provides valuable measurement of the efficacy of the treatment program. Without positive results, the planned treatment should be re-evaluated.
An “approved” example of a Material Risk Notice is available on the Board’s Website, www.oregon.gov/OMB, under “Forms.”
When tracking prescribing of controlled substances, using more than one tracking method is recommended. Flow sheets, organized copies of prescription pads and some electronic records used in concert will help ensure thorough and accurate records of prescriptions for controlled substances used to treat pain.
All healthcare professionals should recognize “red flags” of controlled substance abuse – seeking and/or diverting drugs for unlawful and non-therapeutic purposes. In addition poor or nonexistent prescription tracking, prescribing or administering drugs to family members or self, inadequate security when drugs are kept at practice locations, are grounds for suspending, revoking or refusing to issue licenses, under ORS 677.190 (7), (24) and (25).
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[1] www.oregon.gov/DHS/pain
[2] www.ab487.com/program/misc/splash.htm
[3] www.ama-assn.org/ama/pub/category/13494.html
WINTER/SPRING 2002 OMB NEWSLETTER ARTICLE
Pain Management "Don't prescribe less - chart better"
Susan W. Tolle, M.D. and Susan E. Hickman, Ph.D.
During the coming months, Oregon is expected to be in the media spotlight on the issue of prescribing controlled substances, particularly for dying patients.
In the fall of 2001, U.S. Attorney General John Ashcroft issued an opinion that the federal Controlled Substances Act prohibits physicians from prescribing medication under the state of Oregon's Death With Dignity Act.
Oregon's state Attorney General Hardy Myers filed suit in federal court, challenging this opinion. Hearings are expected to be held in the spring of 2002.
Increased media attention on prescribing privileges may potentially heighten physician concerns about the prescribing of controlled substances. In other states, such as Utah, the number of morphine prescriptions decreased following civil investigations and the conviction of a physician for the alleged morphine overdoses of several patients. Many believe that the specter of investigation can deter some physicians from appropriate prescribing. Nurse practitioners, who recently gained Schedule II prescribing privileges, also may be susceptible to such pressures.
Oregon data highlights this potential. Oregon Health & Science University's (OHSU) Center for Ethics in Health Care has tracked a range of markers in end-of life care in Oregon for more than a decade from a variety of sources. These include:
- Declining in-hospital death rates;
- The rising rates of advanced-care planning;
- The use of Physician Orders for Life Sustaining Treatment (POLST);
- The increasing rates of hospice referral; and
- The overall rates of morphine use.
These markers of quality end-of-life care have shown steady improvement, with one exception. Family reports of moderate or severe pain in dying hospitalized patients increased in late 1997. Family reports of pain did not change for loved ones dying in long-term care facilities or at home.
In 1998, we sent a survey* to physicians and nurses throughout Oregon, asking them to help us better understand the factors that contributed to this finding. Although results suggest that respondents viewed more than one factor as responsible for the increase in family reports of pain, two-thirds thought physician prescribing of inadequate pain medication was a partial explanation. Physicians who thought reduced physician prescribing was a partial factor rated fears of the Oregon Medical Board (OMB) and the U.S. Drug Enforcement Agency (DEA) as the most likely explanations for decreased physician prescribing.
It is important to note that the OMB's position is that physicians should make every effort to relieve the pain and suffering of their dying patients and that narcotics should not be withheld because of a fear of hastening death. In fact, the OMB has disciplined a physician for inadequate use of pain-relieving medications in dying patients.
In light of upcoming events, these data raise grave concerns and call on all of us to take a more active role in public discussions about pain medication. We must work together to ensure that patients, particularly those who are dying, will continue to receive appropriate medication to control their pain and suffering regardless of what is occurring in the political arena.
The message we share with all of our colleagues statewide is simple: Don't prescribe less for dying patients and those with terminal diseases - chart better. We urge you to resist the fear of possible negative consequences to prescribing controlled substances when addressing suffering in the dying. Instead, spend a few extra minutes to clearly document the need for medication in the patient's medical record. For example, in a patient with metastatic prostate cancer, you could document your orders to increase pain medication with the following: "Patient has metastatic cancer to the bone and bone pain has substantially increased. Morphine doubled to control pain." You could use this approach for other symptoms (e.g. dyspnea) that require controlled substances for optimal symptom alleviation. The brief progress note should clearly indicate your intention to control symptoms with the order to administer or adjust the dosage of a controlled substance.
The best defense is a good offense. Careful documentation adds clarity to any questions regarding your motives in prescribing controlled substances. Thorough documentation, rather than a change in prescribing practices, is an appropriate response for all health care professionals in Oregon. This is particularly important in a climate in which the media may soon bring its spotlight back to the issue of controlled substances and seriously ill patients.
* Hickman SE, Tolle SW, Tilden VP. Physicians' and nurses' perspectives on increased
family reports of pain in dying hospitalized patients. J Palliat Med 2000; 3(4):413-18.
FALL 1998 OMB NEWSLETTER ARTICLE
Pain Management in the Dying: Successes and Concerns
By Susan Tolle, MD and Kathleen Haley, JD
Physicians in Oregon have reason to be proud of the tremendous gains we have made in end of life care. We lead the country in advance care planning and in ensuring respect for the rights of the terminally ill to limit life-sustaining treatment.1 We have distributed over 170,000 of the neon pink Physician Orders for Life Sustaining Treatment (POLST) forms which are now used by most Oregon hospice programs and long term care facilities.
Most people want to die at home, and we are respecting people's choices more often. Oregon has the lowest rate of in-hospital deaths of the 50 states. Only 31% of Oregonians now die in an acute care hospital.
We are referring terminally ill patients to hospice more frequently (although often late in the course of illness). Almost a third of all Oregonians now die with the support of home hospice, and the number continues to rise.
While we are doing well in respecting wishes about the level of aggressiveness of care in life's final months, preliminary findings from a study done by the OHSU research team of Susan Tolle, MD, Virginia Tilden, DNSc and Anne Rosenfeld, RN, PhD, reveal a worrisome trend. The study yields data from interviews with 475 family members listed as the informant from a stratified sample of recent Oregon death certificates. Family members were called two to three months after their loved one died and asked about barriers that the patient and family faced in their loved one's final months. The statewide study focused on identifying the differences in barriers to care of the dying by setting (home, nursing home, and acute care hospital).
Family members were asked about such issues as respect for refusal of treatment, pain and suffering, and communication and logistics. They were asked to specifically describe the degree of pain their loved one experienced during the final week of life. The team interviewed families each month throughout 1997. The reported rate of pain during most of 1997 was similar, whether the loved one died at home, in a nursing home, or in an acute care hospital.
Families reported relatively constant levels of moderate to severe pain during their loved one's final week of life, with one exception. During the final months of 1997, families reported higher rates of moderate to severe pain for those dying in acute care hospitals throughout Oregon. There was no increase in reported rates of pain for the final week of life for those dying at home or in a long-term care facility.
These families cannot tell the researchers cause and effect, only that the trend as perceived by families occurred. When a loved one died in an acute care hospital in late 1997, families more often reported moderate to severe pain during the final week of life. The data revealed that this is a statewide trend, not isolated to one county or health system.
While theories abound, the research team cannot learn the cause from the family interview data. Possible explanations range from higher family expectations of our ability to manage pain following the intensive media campaign on physician assisted suicide, to reduced physician prescribing or reduced nurse administration of controlled substances.
Are physicians in hospitals reducing prescriptions for pain and symptom relief? If so, we need to explore the reason why. Some people have suggested that physicians prescribe less morphine and other controlled substances in times of greater scrutiny or under threat of disciplinary action.2 During late 1997, as physician assisted suicide was first legalized, cameras were eagerly looking for the first case and the DEA was talking of possible sanctions.
Regardless of the cause, the authors and the Board invite all physicians and hospitals to reexamine their practices. We need to consider the reports of moderate to severe pain by family members and determine if a different response is called for. We need to examine the increased reports of pain for those dying in acute care hospitals during the last quarter of 1997 and call on physicians to review both their palliative care practices and the timeliness of their hospice referrals.
The Oregon Medical Board views both under-prescribing and over-prescribing of narcotics and other controlled substances with equal seriousness, and is concerned about the trend found by the OHSU research team. The OMB reemphasizes its position on pain and symptom management in the care of the dying. It strongly endorses quality palliative care practices for the care of the dying, and understands that in some cases the amount of controlled substances required to control the patient's suffering may shorten life.
The Board encourages consultation with hospice and palliative care experts when needed, and expects appropriate documentation in the use of controlled substances. The Board investigates physicians for grossly under-treating pain of the dying with the same interest and thoroughness as those who over prescribe controlled substances. At times, individually tailored educational programs are needed and will be required.
The Board encourages you to educate your colleagues who may be grossly under treating the suffering of their dying patients, and to work with your hospitals and health systems to ensure that patients' suffering in the final weeks of life is properly treated. If those efforts are unsuccessful, then the Medical Practice Act requires physicians to report those colleagues who are practicing in an unprofessional or negligent manner.
1 Tolle, S. W. Care of the Dying; Clinical and Financial Lessons From the Oregon Experience. Annals of Internal Medicine 1998; 128:567-8.
2 Field, M. J., Cassel, C. K. Approaching Death: Improving Care at the End of Life. Washington, DC. National Academy Press, 1997.
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