(1)
Standards. 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.
a. 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.
b. The goal of pain management is to treat
each patient's pain in relation to the patient's overall health. At the end of
life, the goals may shift to palliative care.
c. 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.
d. Physicians treating pain with opioids in a
manner consistent with appropriate pain management practices should not fear
board action. Dosage 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.
e.
Inappropriate pain management is a departure from the acceptable standard of
practice in Iowa and may be grounds for disciplinary action.
(2)
Definitions.
For the purposes of this rule, the following terms are defined as follows:
"Acute pain" 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 lasts longer
than three months or past the time of normal tissue healing.
"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
reliefseeking 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.
(3)
Laws and regulations.
Nothing in this rule relieves a physician from fully complying with applicable
federal and state laws and regulations.
(4)
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.
(5)
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 only be accomplished within an established
physician-patient relationship and 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. A physician who
prescribes, dispenses or administers opioids to patients for the treatment of
chronic pain should become familiar with the U.S. Centers for Disease Control
and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain
published on March 15, 2016.
(6)
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. Prior
to the patient starting treatment, a patient evaluation must be conducted that
includes a physical examination, a comprehensive medical history, pain
assessment, and examination of physical and psychological function. This
evaluation should also cover diagnostic studies, past interventions, medication
and substance abuse history, and any underlying conditions. Depending on the
complexity of the case and the physician's expertise, consultation or referral
to specialists in pain medicine, addiction medicine, or areas associated with
the patient's pain may be necessary. Interdisciplinary evaluation is
recommended.
b.
Treatment
plan. The physician must create a tailored treatment plan addressing
the patient's individual needs, outlining treatment objectives such as pain
relief or improved functioning, and indicating any planned diagnostic
evaluations or treatments. The plan should include other treatment modalities
and rehabilitation programs used. Short- and long-term pain relief needs should
be considered, along with the patient's ability to request pain relief and the
patient's setting. Whenever possible, opioids should be prescribed by one
physician and filled at one pharmacy.
c.
Informed consent. A
discussion of the risks and benefits of opioids with the patient or person
representing the patient must be documented.
d.
Periodic review. The
physician must regularly review the patient's drug treatment course and pain
source. Drug therapy should be adjusted to meet individual patient needs, based
on progress toward treatment plan objectives. If reviews show treatment plan
objectives are not being met or indicate diversion or substance abuse patterns,
the physician should reconsider drug therapy and explore other treatment
options. Long-term opioid use may lead to tolerance and abnormal pain
sensitivity, meaning increasing doses may not improve pain control or
function.
e.
Consultation/referral. A specialty consultation, including
with a physician with expertise in addiction medicine or substance abuse
counseling, may be considered if there is evidence of significant adverse
effects, lack of response to the medication, diversion, or a pattern of
substance abuse. The board encourages a multidisciplinary approach to chronic
pain management.
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. Physicians treating chronic pain with opioids should
consider implementing a pain management agreement with each patient outlining
medication use rules and consequences for misuse. The decision to use such an
agreement should be based on individual patient evaluation, weighing risks and
benefits of long-term opioid treatment. If opioid treatment exceeds 90 days for
chronic pain, and there is a concern for drug abuse or diversion, a pain
management agreement should be used. If a physician opts not to use a pain
management agreement, reasons should be documented in the patient's medical
records. Pain management agreements are not required for hospice or nursing
home patients.
h.
Substance
abuse history or comorbid psychiatric 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 should 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 should 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.
(7)
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.
(8)
Prescription
monitoring program. The board of pharmacy established a prescription
monitoring program pursuant to Iowa Code sections
124.551 through
124.558 to help prescribers and
pharmacists track controlled substance prescriptions. Physicians must register
for this program when applying for or renewing their controlled substance
prescribing registration. Before prescribing opioids, physicians or their
agents must use the program to guide treatment decisions and enhance patient
care quality. However, utilization is not required for patients in inpatient
hospice care or long-term residential facilities. Orders in hospital settings
are not considered prescriptions under these rules, as patient safety is
managed within these settings.
(9)
Electronic prescriptions. Beginning January 1, 2020, all
prescriptions (controlled and noncontrolled substances) are to 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.
(10)
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's) 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 as referenced in paragraph 13.2(4)"b."
(11)
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.
(12)
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.