Iowa Administrative Code › Agency 653 - Medicine Board › Chapter 13 - Standards of Practice and Principles of Medical Ethics › Rule 653-13.2 - Standards of Practice-appropriate Pain Management

Current through Register Vol. 47, No. 3, July 24, 2024
This rule establishes standards of practice for the management
				of acute and chronic pain. The board encourages the use of nonopioid
				pharmacologic therapy and nonpharmacologic therapy, including but not limited
				to adjunct therapies such as acupuncture, physical therapy and massage,
				osteopathic manipulative therapy and occupational therapy in the treatment of
				acute and chronic pain.
1. This rule
			 is intended to encourage appropriate pain management, including the use of
			 opioids for the treatment of pain, while stressing the need to establish
			 safeguards to minimize the potential for substance abuse and drug
			 diversion.
2. The goal of pain
			 management is to treat each patient's pain in relation to the patient's overall
			 health, including physical function and psychological, social and work-related
			 factors. At the end of life, the goals may shift to palliative care.
3. The board recognizes that pain management
			 is an important part of medical practice. Unmanaged or inappropriately treated
			 pain impacts patients' quality of life, reduces patients' ability to be
			 productive members of society, and increases patients' use of health care
			 services.
4. Physicians should not
			 fear board action for treating pain with opioids as long as the physicians'
			 prescribing is consistent with appropriate pain management practices. Dosage
			 alone is not the sole measure of determining whether a physician has complied
			 with appropriate pain management practices. The board recognizes the complexity
			 of treating patients with chronic pain or a substance abuse history. Generally,
			 the board is concerned about a pattern of improper pain management or a single
			 occurrence of willful or gross overtreatment or undertreatment of
			 pain.
5. Inappropriate pain
			 management is a departure from the acceptable standard of practice in Iowa and
			 may be grounds for disciplinary action.
(1)
Definitions.
For the purposes of this rule, the following
			 terms are defined as follows:
"Acutepain"
means the normal, predicted
				physiological response to a noxious chemical, thermal or mechanical stimulus
				and typically is associated with invasive procedures, trauma and disease.
				Generally, acute pain is self-limited, lasting no more than a few weeks
				following the initial stimulus.
"Addiction"
means a primary, chronic,
				neurobiologic disease, with genetic, psychosocial, and environmental factors
				influencing its development and manifestations. It is characterized by
				behaviors that include the following: impaired control over drug use, craving,
				compulsive use, and continued use despite harm. Physical dependence and
				tolerance are normal physiological consequences of extended opioid therapy for
				pain and are not the same as addiction.
"Chronic pain"
means pain that typically lasts
				longer than three months or past the time of normal tissue healing. Chronic
				pain can be the result of an underlying medical disease or condition, injury,
				medical treatment, inflammation, or an unknown cause.
"Opioid"
means any U.S. Food and Drug
				Administration (FDA)-approved product or active pharmaceutical ingredient
				classified as a controlled substance that produces an agonist effect on opioid
				receptors and is indicated or used for the treatment of pain.
"Pain"
means an unpleasant sensory and
				emotional experience associated with actual or potential tissue damage or
				described in terms of such damage. Pain is an individual, multifactorial
				experience influenced by culture, previous pain events, beliefs, mood and
				ability to cope.
"Physical dependence"
means a state of
				adaptation that is manifested by drug class-specific signs and symptoms that
				can be produced by abrupt cessation, rapid dose reduction, decreasing blood
				level of the drug, or administration of an antagonist. Physical dependence, by
				itself, does not equate with addiction.
"Pseudoaddiction"
means an iatrogenic syndrome
				resulting from the misinterpretation of relief-seeking behaviors as though they
				are drug-seeking behaviors that are commonly seen with addiction. The
				relief-seeking behaviors resolve upon institution of effective analgesic
				therapy.
"Substance abuse"
means the use of a drug,
				including alcohol, by the patient in an inappropriate manner that may cause
				harm to the patient or others, or the use of a drug for an indication other
				than that intended by the prescribing clinician. An abuser may or may not be
				physically dependent on or addicted to the drug.
"Tolerance"
means a physiological state
				resulting from regular use of a drug in which an increased dosage is needed to
				produce a specific effect, or a reduced effect is observed with a constant dose
				over time. Tolerance may or may not be evident during opioid treatment and does
				not equate with addiction.
"Undertreatment of pain"
means the failure to
				properly assess, treat and manage pain or the failure to appropriately document
				a sound rationale for not treating pain.
(2)
Laws and regulations.
Nothing in this rule relieves a physician from fully complying with applicable
			 federal and state laws and regulations.
(3)
Undertreatment of pain.
The undertreatment of pain is a departure from the acceptable standard of
			 practice in Iowa. Undertreatment may include a failure to recognize symptoms
			 and signs of pain, a failure to treat pain within a reasonable amount of time,
			 a failure to allow interventions, e.g., analgesia, to become effective before
			 invasive steps are taken, a failure to address pain needs in patients with
			 reduced cognitive status, a failure to use opioids for terminal pain due to the
			 physician's concern with addicting the patient, or a failure to use an adequate
			 level of pain management.
(4)
Assessment and treatment of acute and chronic pain.
Appropriate assessment of the etiology of the pain is essential to the
			 appropriate treatment of acute and chronic pain.
a. Prescribing opioids for the treatment of
			 acute and chronic pain should be based on clearly diagnosed and documented
			 pain. Appropriate management of acute and chronic pain should include an
			 assessment of the mechanism, type and intensity of pain. The patient's medical
			 record should clearly document a medical history, a pain history, a clinical
			 examination, a medical diagnosis and a treatment plan.
b. Prescribing opioids for the treatment of
			 acute and chronic pain should only be accomplished within an established
			 physician-patient relationship and should be based on clearly diagnosed and
			 documented unrelieved pain.
c. On
			 March 15,2016, the U. S. Centers for Disease Control and Prevention (CDC)
			 issued the CDC Guideline for Prescribing Opioids for Chronic Pain to provide
			 recommendations for the prescribing of opioid pain medication for patients 18
			 years of age and older in primary care settings. Recommendations focus on the
			 use of opioids in treating chronic pain (pain lasting longer than three months
			 or past the time of normal tissue healing) outside of active cancer treatment,
			 palliative care, and end-of-life care. A physician who prescribes, dispenses or
			 administers opioids to patients for the treatment of chronic pain should become
			 familiar with the CDC Guideline for Prescribing Opioids for Chronic
			 Pain.
(5)
Effective management of chronic pain.
To ensure that chronic
			 pain is properly assessed and treated, a physician who prescribes, dispenses or
			 administers opioids to a patient for the treatment of chronic pain shall
			 exercise sound clinical judgment and establish an effective pain management
			 plan in accordance with the following:
a.
Patient evaluation.
A patient evaluation that includes a
			 physical examination and a comprehensive medical history shall be conducted
			 prior to the initiation of treatment. The evaluation shall also include an
			 assessment of the pain, physical and psychological function, diagnostic
			 studies, previous interventions, including medication history, substance abuse
			 history and any underlying or coexisting conditions. Consultation/referral to a
			 physician with expertise in pain medicine, addiction medicine or substance
			 abuse counseling or a physician who specializes in the treatment of the area,
			 system, or organ perceived to be the source of the pain may be warranted
			 depending upon the expertise of the physician and the complexity of the
			 presenting patient. Interdisciplinary evaluation is strongly
			 encouraged.
b.
Treatment
			 plan.
The physician shall establish a comprehensive treatment plan
			 that tailors drug therapy to the individual needs of the patient. To ensure
			 proper evaluation of the success of the treatment, the plan shall clearly state
			 the objectives of the treatment, for example, pain relief or improved physical
			 or psychosocial functioning. The treatment plan shall also indicate if any
			 further diagnostic evaluations or treatments are planned and their purposes.
			 The treatment plan shall also identify any other treatment modalities and
			 rehabilitation programs utilized. The patient's short- and long-term needs for
			 pain relief shall be considered when drug therapy is prescribed. The patient's
			 ability to request pain relief as well as the patient setting shall be
			 considered. For example, nursing home patients are unlikely to have their pain
			 control needs assessed on a regular basis, making prn (on an as-needed basis)
			 drugs less effective than drug therapy prescribed for routine administration
			 that can be supplemented if pain is found to be worse. The patient should
			 receive prescriptions for opioids from a single physician and a single pharmacy
			 whenever possible.
c.
Informed consent.
The physician shall document discussion of
			 the risks and benefits of opioids with the patient or person representing the
			 patient.
d.
Periodic
			 review.
The physician shall periodically review the course of drug
			 treatment of the patient and the etiology of the pain. The physician should
			 adjust drug therapy to the individual needs of each patient. Modification or
			 continuation of drug therapy by the physician shall be dependent upon
			 evaluation of the patient's progress toward the objectives established in the
			 treatment plan. The physician shall consider the appropriateness of continuing
			 drug therapy and the use of other treatment modalities if periodic reviews
			 indicate that the objectives of the treatment plan are not being met or that
			 there is evidence of diversion or a pattern of substance abuse. Long-term
			 opioid treatment is associated with the development of tolerance to its
			 analgesic effects. There is also evidence that opioid treatment may
			 paradoxically induce abnormal pain sensitivity, including hyperalgesia and
			 allodynia. Thus, increasing opioid doses may not improve pain control and
			 function.
e.
Consultation/referral.
A specialty consultation may be
			 considered at any time if there is evidence of significant adverse effects or
			 lack of response to the medication. Pain, physical medicine, rehabilitation,
			 general surgery, orthopedics, anesthesiology, psychiatry, neurology,
			 rheumatology, oncology, addiction medicine, and other consultation may be
			 appropriate. The physician should also consider consultation with, or referral
			 to, a physician with expertise in addiction medicine or substance abuse
			 counseling, if there is evidence of diversion or a pattern of substance abuse.
			 The board encourages a multidisciplinary approach to chronic pain management,
			 including the use of adjunct therapies such as acupuncture, physical therapy
			 and massage.
f.
Documentation.
The physician shall keep accurate, timely, and
			 complete records that detail compliance with this subrule, including patient
			 evaluation, diagnostic studies, treatment modalities, treatment plan, informed
			 consent, periodic review, consultation, and any other relevant information
			 about the patient's condition and treatment.
g.
Pain management
			 agreements.
A physician who treats patients for chronic pain with
			 opioids shall consider using a pain management agreement with each patient
			 being treated that specifies the rules for medication use and the consequences
			 for misuse. In determining whether to use a pain management agreement, a
			 physician shall evaluate each patient, taking into account the risks to the
			 patient and the potential benefits of long-term treatment with opioids. A
			 physician who prescribes opioids to a patient for more than 90 days for the
			 treatment of chronic pain shall utilize a pain management agreement if the
			 physician has reason to believe a patient is at risk of drug abuse or
			 diversion. If a physician prescribes opioids to a patient for more than 90 days
			 for the treatment of chronic pain and chooses not to use a pain management
			 agreement, then the physician shall document in the patient's medical records
			 the reason(s) why a pain management agreement was not used. Use of pain
			 management agreements is not necessary for hospice or nursing home patients.
			 Sample pain management agreement and prescription drug risk assessment tools
			 may be found on the board's website at
www.medicalboard.iowa.gov
.
h.
Substance abuse history or
			 comorbidpsychiatric disorder.
A patient's prior history of substance
			 abuse does not necessarily contraindicate appropriate pain management. However,
			 treatment of patients with a history of substance abuse or with a comorbid
			 psychiatric disorder may require extra care and communication with the patient,
			 monitoring, documentation, and consultation with or referral to an expert in
			 the management of such patients. The board strongly encourages a
			 multidisciplinary approach for pain management of such patients that
			 incorporates the expertise of other health care professionals.
i.
Drug testing.
A physician
			 who prescribes opioids to a patient for more than 90 days for the treatment of
			 chronic pain shall consider utilizing drug testing to ensure that the patient
			 is receiving appropriate therapeutic levels of prescribed medications or if the
			 physician has reason to believe that the patient is at risk of drug abuse or
			 diversion.
j.
Termination
			 of care.
The physician shall consider termination of patient care if
			 there is evidence of noncompliance with the rules for medication use, drug
			 diversion, or a repeated pattern of substance abuse.
(6)
Pain management for terminal
			 illness.
The provisions of this subrule apply to patients who are at
			 the stage in the progression of cancer or other terminal illness when the goal
			 of pain management is comfort care. When the goal of treatment shifts to
			 comfort care rather than cure of the underlying condition, the board recognizes
			 that the dosage level of opioids to control pain may exceed dosages recommended
			 for chronic pain and may come at the expense of patient function. The
			 determination of such pain management should involve the patient, if possible,
			 and others the patient has designated for assisting in end-of-life
			 care.
(7)
Prescription
			 monitoring program.
The Iowa board of pharmacy has established a
			 prescription monitoring program pursuant to Iowa Code sections
			 124.551
			 to
			 124.558
			 to assist prescribers and pharmacists in monitoring the prescription of
			 controlled substances to patients. A physician shall register for the
			 prescription monitoring program at the same time the physician applies for
			 registration or renews registration to prescribe controlled substances as
			 required by the Iowa board of pharmacy. A physician or the physician's
			 designated agent shall utilize the prescription monitoring program prior to
			 issuing an opioid prescription to assist the physician in determining
			 appropriate treatment options and to improve the quality of patient care. A
			 physician is not required to utilize the prescription monitoring program to
			 assist in the treatment of a patient receiving inpatient hospice care or
			 long-term residential facility patient care. An order issued in an inpatient
			 hospital setting is not considered a prescription for the purposes of these
			 rules. Patient safety is adequately protected in an inpatient hospital setting,
			 and physicians caring for patients in an inpatient hospital setting do not
			 prescribe. A link to the prescription monitoring program may be found at the
			 board's website at
www.medicalboard.iowa.gov
.
(8)
Electronic
			 prescriptions.
Beginning January 1, 2020, all prescriptions
			 (controlled and noncontrolled substances) shall be transmitted electronically
			 as electronic prescriptions pursuant to Iowa Code section
			 124.308. A
			 prescription shall be transmitted to a pharmacy by the physician or the
			 physician's authorized agent in compliance with federal law and regulation for
			 electronic prescriptions of controlled substances.
(9)
Pain management
			 resources.
The board strongly recommends that physicians consult the
			 following resources regarding the proper treatment of chronic pain. This list
			 is provided for the convenience of licensees, and the publications included are
			 not intended to be incorporated in the rule by reference.
a. American Academy of Hospice and Palliative
			 Medicine or AAHPM is the American Medical Association-recognized specialty
			 society of physicians who practice in hospice and palliative medicine in the
			 United States. The mission of the AAHPM is to enhance the treatment of pain at
			 the end of life.
b. American
			 Academy of Pain Medicine or AAPM is the American Medical Association-recognized
			 specialty society of physicians who practice pain medicine in the United
			 States. The mission of the AAPM is to enhance pain medicine practice by
			 promoting a climate conducive to the effective and efficient practice of pain
			 medicine.
c. American Pain Society
			 or APS is the national chapter of the International Association for the Study
			 of Pain, an organization composed of physicians, nurses, psychologists,
			 scientists and other professionals who have an interest in the study and
			 treatment of pain. The mission of the APS is to serve people in pain by
			 advancing research, education, treatment and professional practice.
d. DEA Policy Statement: Dispensing
			 Controlled Substances for the Treatment of Pain. On August 28, 2006, the Drug
			 Enforcement Agency (DEA) issued a policy statement establishing guidelines for
			 practitioners who dispense controlled substances for the treatment of pain.
			 This policy statement may be helpful to practitioners who treat pain with
			 controlled substances.
e.
			 Interagency Guideline on Prescribing Opioids for Pain. Developed by the
			 Washington State Agency Medical Directors' Group in collaboration with an
			 expert advisory panel, actively practicing providers and public stakeholders,
			 the guideline focuses on evidence-based treatment for chronic-pain patients.
			 The guideline was published in 2007 and updated in 2015.
f. Responsible Opioid Prescribing: A
			 Physician's Guide. In 2007, in collaboration with author Scott Fishman, M.D.,
			 the Federation of State Medical Boards' (FSMB) Research and Education
			 Foundation published a book on responsible opioid prescribing based on the FSMB
			 Model Policy for the Use of Controlled Substances for the Treatment of
			 Pain.
g. World Health Organization:
			 Pain Relief Ladder. Cancer pain relief and palliative care. Technical report
			 series 804. Geneva: World Health Organization.
h. CDC Guideline for Prescribing Opioids for
			 Chronic Pain. On March 15, 2016, the U.S. Centers for Disease Control and
			 Prevention (CDC) issued a guideline to provide recommendations for the
			 prescribing of opioid pain medication for patients 18 years of age and older in
			 primary care settings. Recommendations focus on the use of opioids in treating
			 chronic pain (pain lasting longer than three months or past the time of normal
			 tissue healing) outside of active cancer treatment, palliative care, and
			 end-of-life care.
(10)
Grounds for discipline.
A physician may be subject to
			 disciplinary action for violation of these rules, the rules found in
			 653-Chapter 23, or any of the following:
a. A
			 physician who prescribes opioids in dosage amounts exceeding what would be
			 prescribed by a reasonably prudent physician in the state of Iowa acting in the
			 same or similar circumstances.
b. A
			 physician who knowingly fails to comply with the confidentiality requirements
			 of Iowa Code section
			 124.553 or who
			 delegates program information access to another individual except as provided
			 in Iowa Code section
			 124.553.
c. A physician who knowingly fails to comply
			 with other requirements of Iowa Code chapter 124.
(11)
Unlawful access, disclosure, or
			 use of information.
A person who intentionally or knowingly accesses,
			 uses, or discloses information from the prescription monitoring program in
			 violation of Iowa Code section
			 124.553,
			 unless otherwise authorized by law, is guilty of a class "D" felony. This
			 subrule shall not preclude a physician who requests and receives information
			 from the prescription monitoring program consistent with the requirements of
			 Iowa Code section
			 124.553 from
			 otherwise lawfully providing that information to any other person for medical
			 care purposes. This rule is intended to implement Iowa Code chapters 124, 148
			 and 272C.