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.
�32-1401(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.
.