Why did the Arizona Medical Board repeal the only guidance for physicians on the treatment of chronic pain with opioids?
Substantive Policy Statement or SPS #7 was published in November 1997 as guidelines for
physicians on how to treat chronic pain with opioids without getting in
trouble.
SPS #7 was revised in May 1999, and then revised again in June 2003.
Then in December 2014 for some reason it was repealed. All guidance for physicians on how not to get in trouble with the Arizona Medical Board or DEA for treating patients with opioid's was gone....
ARIZONA MEDICAL BOARD
9545 East Doubletree
Ranch Road, Scottsdale, Arizona 85258
GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES FOR THE
TREATMENT OF CHRONIC PAIN (SPS 7)
The
Arizona Medical Board (“Board”) strongly urges physicians to view effective
pain management as a high priority in all patients, including children and the
elderly. Pain should be assessed and treated promptly, effectively and for as
long as pain persists. The medical management of pain should be based on
up-to-date knowledge about pain, pain assessment and pain treatment. Pain
treatment may involve the use of several drug and nondrug treatment modalities,
often in combination. For some types of pain the use of drugs is emphasized and
should be pursued vigorously; for other types, the use of drugs is better
de-emphasized in favor of other therapeutic modalities. Physicians should have
sufficient knowledge or consultation to make such judgments for their patients.
Drugs, in particular the
opioid analgesics, are considered the cornerstone of treatment for pain
associated with trauma, surgery, medical procedure and cancer. Physicians are
referred to the U.S. Agency for Health Care Policy and Research Clinical
Practice Guidelines as a sound yet flexible approach to the management of these
types of pain.
The prescribing of
opioid analgesics for other patients with intractable non-cancer pain also may
be beneficial, especially when efforts to remove the cause of pain or to treat
it with other modalities have been unsuccessful. For the purposes of these
guidelines, intractable pain is defined as:
A pain state in which
the cause of the pain cannot be removed or otherwise treated and which in the
generally accepted course of medical practice no relief or cure of the cause of
the pain is possible or none has been found after reasonable efforts including,
but not limited to, evaluation by the attending physician and surgeon and one
or more physicians and surgeons specializing in the treatment of the area,
system or organs of the body perceived as the source of the pain.
Therefore, these
guidelines are an attempt to communicate to physicians who prescribe opioids
for intractable pain not to fear disciplinary action from this Board for
prescribing or administering controlled substances in the course of treatment
of a person for intractable pain. Also, physicians should use sound clinical
judgment, and care for their patients according to the following principles of responsible
professional practice.
I. STATUTORY ABILITY TO
DEVELOP GUIDELINES
Pursuant to Arizona
Revised Statutes § 32-1403(A)(3), the Board may develop and recommend standards
governing the profession in Arizona.
II. GUIDELINES FOR
PATIENT CARE WHEN PRESCRIBING CONTROLLED SUBSTANCES FOR CHRONIC PAIN
A) Pain Assessment
Pain assessment should
occur during initial evaluation, after each new report of pain, at appropriate
intervals after each pharmacological intervention, and at regular intervals
during treatment. Unless a patient is terminally ill and death is imminent (in
which case the diagnosis is usually evident and diagnostic evaluations may be
of little value and discomforting to the patient), the evaluation should
include:
1. Medical history,
including the presence of a recognized medical indication for the use of a controlled
substance, the intensity and character of pain, and questions regarding
substance abuse;
2. Corroboration of
medical history by reviewing patient’s medical records and/or speaking with
patient’s former physicians. Patients frequently seek out a new prescribing
physician after their previous prescribing physician has terminated them for
non-compliance, substance abuse, and/or drug diversion;
3. Psycho-social
assessment, which may include but is not limited to:
a. The patient's understanding of the medical diagnosis, expectations about
pain relief and pain management methods, concerns regarding the use of
controlled substances, and coping mechanisms for pain;
b. Changes in mood which have occurred secondary to pain (i.e., anxiety,
depression); and
c. The meaning of pain to the patient and his/her family.
4. Physical examination,
including a neurologic evaluation and examination of the site of pain.
5. Urine drug screen,
testing for commonly abused street drugs as well as prescription pain drugs that
are known abused or diverted drugs. Such screening will help identify drug
abusers and drug diverters.
B) Treatment Plan
A treatment plan should
be developed for the management of chronic pain and state objectives by which
therapeutic success can be evaluated, including:
1. Pain relief;
2. Improved physical functioning;
3. Proposed diagnostic evaluations (i.e., blood tests, radiologic,
psychological and social studies such as CAT and bone scans, MRI and
neurophysiologic examinations such as electromyography); and
4. Analysis of inclusion and exclusion criteria for opioid management:
Inclusion criteria includes a clear diagnosis consistent with symptoms, all
reasonable alternative therapies have been explored; the patient is reliable
and communicates well, there has been informed consent or a treatment agreement
signed; Potential exclusion criteria include a history of chemical dependency,
major psychiatric disorder, chaotic social situation, or a planned pregnancy.
C) Informed Consent
The physician should
advise the patient, guardian, or designated surrogate of the risks and benefits
of the use of controlled substances. The patient should be counseled on the
importance of regular visits, the impact of recreational drug use, the number
of physicians and pharmacies used for prescriptions, taking medications as
prescribed, etc.
The physician and the
patient should enter into a pain treatment contract that specifically states
the patient’s required compliance with the treatment plan and what the
consequences of non-compliance, misuse and abuse will be. It is particularly
important that patients understand that they will be discontinued from the
prescribed controlled substances, in a safe manner, should it be revealed that
they are abusing or diverting drugs.
D) Ongoing Assessment
The assessment and
treatment of chronic pain mandates continuing evaluation, and if necessary,
modification and/or discontinuation of opioid therapy. If clinical improvement
does not occur, the physician should consider the appropriateness of continued
opioid therapy, and consider a trial of alternative pharmacologic and
nonpharmacologic modalities.
E) Consultation
The physician should
refer the patient as necessary for additional evaluation to achieve treatment
objectives. Physicians should recognize patients requiring individual
attention, in particular, patients whose living situations pose a risk for
misuse or diversion of controlled substances. In addition, the prescription of
controlled substances to patients with a history of substance abuse requires
extra care, monitoring, and documentation, and may also require consultation
with an addiction medicine specialist.
F) Documentation
The physician must
maintain adequate, accurate and timely records regarding items A-E from above. "Adequate
Records," pursuant to A.R.S. º32-1401(2), "means legible records
containing, at a minimum, sufficient information to identify the patient,
support the diagnosis, justify the treatment, adequately document the results,
indicate advice and cautionary warnings provided to the patient, and provide
sufficient information for another practitioner to assume continuity of the
patient's care at any point in the treatment." Specific to chronic pain
patients, the documentation should include:
1. The medical history
and physical examination;
2. Related evaluations and consultations, treatment plan and objectives;
3. Evidence of discussion regarding informed consent;
4. Prescribed medications and treatments;
5. Periodic reviews of treatments and patient response; and
6. Any physician-patient agreements or contracts.
G. Counting and Destroying Medication
The physician may desire
to see and count a patient’s medication to determine if the patient is taking
the medication as prescribed. The patient should display and count the
medication in front of the physician. Under no circumstance should the
physician touch a patient’s controlled substances. If the medication must be
destroyed, the patient should flush the medication down the toilet in the
physician’s presence. The physician should document this fact in the patient’s
chart.
H. Post-Dated Prescriptions
Post-dated prescriptions
are illegal in the State of Arizona. Therefore, physicians may not issue
post-dated prescriptions.
I. Referral of Patients with Active Substance Abuse Problems
Patients discovered to
have an active substance abuse problem should be referred to either a
detoxification and rehabilitation program or to an appropriate maintenance
program for addicts.
III. COMPLIANCE WITH
LAWS AND REGULATIONS
A. Prescribing Controlled Substances
To prescribe controlled
substances, physicians must comply with all applicable laws, including the
following:
1. Possess a valid
current license to practice medicine in the State of Arizona; and
2. Possess a valid and current controlled substances Drug Enforcement
Administration registration for the schedules being prescribed.
B. Dispensing Controlled Substances
To dispense controlled
substances, physicians must comply with all applicable laws, including the following:
1. Possess a valid
current license to practice medicine in the State of Arizona;
2. Possess a valid and current controlled substances Drug Enforcement
Administration registration for the schedules being prescribed;
3. Comply with Arizona Revised Statutes § 32-1491, et seq. and A.A.C. R4-16-201
through R4-16-205; and
4. Comply with 22 CFR 1306.07(a) if controlled substances are dispensed for
detoxification.
