Iowa Admin. Code r. 653-13.2 - Standards of practice-appropriate pain management
This
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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.