Controlled Substance Regulations from KY Medical Board
MODEL GUIDELINES FOR THE
USE OF CONTROLLED SUBSTANCES
IN PAIN TREATMENT
The Kentucky Board of Medical Licensure
(KBML) recognizes that principles of quality medical practice dictate
that the people of Kentucky have access to appropriate and effective
pain relief. The appropriate application of state-of-the-art treatment
modalities can serve not only to improve the quality of life for those
patients who suffer from pain but also can reduce the morbidity and
costs associated with inappropriately treated pain. The Board encourages
physicians to view effective pain management as a part of quality medical
practice for all patients with pain, acute or chronic. Pain management
is particularly important for patients who experience pain as a result
of terminal illness and can be difficult for patients with chronic
nonterminal pain. It is imperative that physicians become knowledgeable
about effective methods of pain treatment as well as statutory requirements
for prescribing controlled substances.
Inadequate pain control may result either
from physiciansí lack of knowledge about pain management or their misunderstanding
of addiction. Fears of investigation or sanction by federal, state,
and local regulatory agencies may also result in inappropriate or inadequate
treatment of the pain patient. Accordingly, these guidelines have
been developed to clarify the Boardís position on pain control, especially
as related to the use of controlled substances for nonterminal/nonmalignant
chronic pain, in order to alleviate physician uncertainty and to encourage
better pain management.
The Board recognizes that controlled substances
(including opioid analgesics, benzodiazepines, and stimulants) may
be essential in the treatment of acute pain and chronic pain, whether
due to cancer or noncancer origins. Physicians are referred to the
US Agency for Health Care Policy and Research Clinical Practice Guidelines1 for
a sound approach to the management of acute and chronic, malignant
and non-malignant pain. The medical management of pain should be based
on current knowledge and research and includes the use of both pharmacological
and non-pharmacological modalities. Pain should be assessed and treated
promptly, and the quantity and frequency of doses should be adjusted
according to the intensity and duration of the pain. Physicians should
recognize that tolerance and physical dependence are normal
consequences of sustained use of opioid analgesics and are not synonymous
with addiction. Addiction refers to both dependence on
the use of substances for the drugís psychic effects and compulsive
use of the drug despite consequences.
The KBML is obligated under the laws of
the state of Kentucky to protect the public health and safety. The
Board recognizes that the inappropriate prescribing of controlled substances
may lead to drug diversion and abuse by individuals who seek the drugs
for other than legitimate medical use. Physicians must be diligent
in preventing the diversion of drugs for illegitimate purposes. The
Board believes the adoption of these guidelines will protect legitimate
medical uses of controlled substances, while helping to prevent drug
diversion and eliminating inappropriate prescribing practices.
Physicians should not fear disciplinary
action from the Board for prescribing controlled substances for a legitimate
medical purpose and in the usual course of professional practice. The
Board will consider the prescribing of controlled substances for pain
a legitimate medical purpose if such prescribing is (1) based on accepted
scientific knowledge of pain treatment and (2) if based on sound clinical
grounds. All such prescribing must be grounded in clear documentation
of unrelieved pain and in compliance with applicable state or federal
Each case of prescribing for pain will
be evaluated on an individual basis if and when brought to the Boardís
attention. The Board does not take disciplinary action against
a physician who fails to adhere strictly to the provisions of these
guidelines if good cause is shown for such deviation. The physicianís
conduct will be evaluated to a great extent by the treatment outcome,
taking into account: (1) whether or not the drug used is medically
and/or pharmacologically recognized to be appropriate for the diagnosis;
(2) the patientís individual needsĖincluding improvement in functioning;
and (3) a recognition that some types of pain cannot be completely
The Board will judge the validity of prescribing
based on the physicianís treatment of the patient and on available
documentation, rather than only on the quantity and chronicity of prescribing.
The goal is to control the patientís pain for its duration while effectively
addressing other aspects of the patientís functioning, including physical,
psychological, social and work-related factors. The following guidelines
are not intended to define complete or best practice, but rather to
communicate what the Board considers to be within acceptable boundaries
of professional practice when prescribing for recurrent or persistent
chronic pain. The prescribing guidelines for acute pain would be appropriately
less stringent but, in principle, the same.
The Kentucky Board of Medical Licensure has adopted the following
guidelines when evaluating the use of controlled substances for control
of recurrent or chronic pain.
Evaluation of the Patient
A complete medical history and physical
examination must be conducted and documented in the medical record.
A family history should be documented with particular reference to
any history of first degree relative with chemical dependence problems.
The medical record should document the nature and intensity of the
pain, current and past treatments for pain, underlying or coexisting
diseases or conditions, the effect of the pain on physical and psychological
function, and history of any substance abuse. The medical record also
should document the presence of one or more recognized medical indication(s)
for the use of a controlled substance. By definition, pain is a subjective statement
of a patientís perception of actual or potential tissue damage. The
distinction between pain and suffering should be established. A patient
may suffer due to pain, but may have other reasons for suffering as
well. The assessment of a patientís overall condition should be made
at the initial evaluation and thereafter. It is the goal of the physician
to assist in the relief of suffering no matter the cause. Financial,
emotional, mental, physical, and spiritual factors may contribute to
the patientís suffering. Relief of the underlying reasons for suffering
as well as the pain will lead to optimal treatment and utilization
of controlled substances.
Before beginning a regimen of controlled
drugs, the physician must determine, through actual clinical trial
or through patient records and history that non-addictive medication
regimens have been inadequate or are unacceptable for solid clinical
reasons. Speaking with the patientís significant other or conducting
a family conference can be helpful if there is any doubt regarding
the patientís integrity. Utilizing the Kentucky All Schedule Prescription
Electronic Reporting [i.e., The KASPER Report2] initially
can also aid in documenting the patientís history of drug utilization.
The written treatment plan should state
objectives that will be used to determine treatment success such as
pain relief and improved physical and psychosocial function, and should
indicate if any further diagnostic evaluations, consultations or other
treatments are planned. After treatment begins, the physician should
adjust drug therapy to the individual medical needs of each patient.
Other treatment modalities or a rehabilitation program may be necessary
depending on the etiology of the pain and the extent to which the pain
is associated with physical and psychosocial impairment.
Informed Consents and Treatment Agreements
The physician should discuss the risks
and benefits of the use of controlled substances with the patient or
his / her surrogate, including the risk of tolerance and drug dependence.
If the patient is determined to be at high risk for medication
abuse or has a history of substance abuse, the physician may employ
the use of a written agreement between physician and patient
outlining patient responsibilities, including:
One prescribing doctor and one designated pharmacy.
Urine / serum drug screening when requested.
No early refills and no medications called in. If medications
are lost or stolen, then a police report could be required before
considering additional prescriptions.
The reasons for which drug therapy may be is continued such as
violation of a documented doctor-patient agreement.
At reasonable intervals based on the
individual circumstances of the patient, the physician should review
the course of treatment and any new information about the etiology
of the pain. Continuation or modification of therapy should depend
on the physicianís evaluation of progress toward stated treatment
objectives such as reduction in patientís pain intensity and improved
physical and / or psychosocial function (i.e., ability to work),
need of health care resources, activities of daily living, and quality
of social life. If treatment goals are not being achieved despite
medication adjustments, the physician should reevaluate the appropriateness
of continued treatment. The physician should monitor patient compliance
in medication usage and related treatment plans. Periodic requests
for a KASPER Report could be utilized.
The physician should be willing to refer
the patient as clinically indicated for additional evaluation and
in order to achieve treatment objectives. Special attention should
be given to those pain patients who are at risk for misusing their
medications and those whose living arrangements pose a risk for medication
misuse or diversion. The management of pain in patients with a history
of substance abuse or with a coexisting psychiatric disorder may
require extra care, monitoring, documentation, and consultation with
or referral to an expert in the management of such patients.
The physician should keep accurate and complete
records, to include:
The medical history and physical examination;
Diagnostic, therapeutic, and laboratory results;
Evaluations and consultations;
Discussion of risk, benefits, and limitation
Medications (including date, type, dosage, and
Instructions and agreements;
Periodic reviews; and
Records should remain current and be maintained
in an accessible manner and readily available for review.
Initial or periodic KASPER Report(s) should not be part of the patientís
records and should not be released to the patient or a third party.
Compliance with Controlled Substances Laws and Regulations
To prescribe, dispense, or administer
controlled substances, the physician must have an active license
in the state and comply with applicable federal and state regulations.
Kentucky physicians can refer to prior Board-published recommendations
for prescribing Scheduled II drugs including opioids, benzodiazepines,
Physicians should studiously avoid prescribing scheduled drugs for
themselves, immediate family, or staff in accordance with the American
Medical Associationís Code of Medical Ethics and the KRS Medical
By publishing these guidelines, the KBML
wishes to encourage Kentucky physicians to utilize adequate medications
to treat their patients with serious pain complaints without undue
fear of legal or licensure repercussions. Concurrently, the Board
strives to prevent as much as possible, drug diversion and inappropriate