Virginia Regulatory Town Hall

Proposed Text


Rules for prescribing opioids for chronic pain
Stage: Proposed
6/30/08  3:34 PM

18VAC85-50-171. Treatment of pain with controlled substances.

A. Definitions. For purposes of this section, the following words and terms shall have the following meanings:

"Acute pain" means pain that occurs within the normal course of a disease or condition or as the result of surgery for which controlled substances may be prescribed for no more than six months.

"Chronic pain" means non-malignant pain that goes beyond the normal course of a disease or condition for which controlled substances may be prescribed for a period greater than six months.

"Controlled substance" means drugs listed in the Drug Control Act (§54.1-3400et seq. of the Code of Virginia) in Schedules II through IV.

"Prescription Monitoring Program" means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

B. Treatment of acute pain.

1. Evaluation of the patient. Prior to initiating treatment with a controlled substance for a complaint of acute pain, the prescriber shall perform a history and physical examination appropriate to the complaint.

2. Medical records. The medical record shall include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan and the medication prescribed (including date, type, dosage and quantity prescribed).

C. Management of chronic pain.

1. Evaluation of the patient. Prior to initiating management of chronic pain with a controlled substance, a medical history and physical examination shall be performed and documented in the medical record, including: a) the nature and intensity of the pain; b) current and past treatments for pain; c) underlying or coexisting diseases or conditions; d) the effect of the pain on physical and psychological and social function; and e) psychiatric, addiction and substance abuse history of the patient and his family. The medical record also shall document the presence of one or more recognized medical indications for the use of a controlled substance.

2. Treatment plan. The medical record shall include a treatment plan that states measures to be used to determine progress in treatment, including but not limited to pain relief and improved physical and psychosocial function. The treatment plan shall include further diagnostic evaluations and other treatment modalities or rehabilitation that may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. The prescriber shall record in the patient records the presence or absence of any indicators for medication misuse, abuse or diversion.

3. Informed consent and agreement for treatment. The prescriber shall document in the medical record informed consent, to include risks, benefits and alternative approaches, prior to the initiation of opioids for chronic pain. There shall be a written treatment agreement in the medical record that addresses the parameters of treatment, including those behaviors which will result in a cessation of treatment or dismissal from care. The treatment agreement shall include, but not be limited to,  permission for the practitioner to query and receive reports from the Prescription Monitoring Program and consult with other prescribers or dispensing pharmacists for the patient.  If the patient is at high risk for medication abuse or has a history of substance abuse, the prescriber should consider the inclusion of a written agreement between the prescriber and the patient outlining patient responsibilities, including:  1) urine/serum medication levels screening, when requested; 2) number and frequency of all prescription refills; and 3) reasons for which drug therapy may be discontinued (e.g., violation of agreement).

4. Periodic review. The prescriber shall review the course of pain treatment and any new information about the etiology of the pain or the patient's state of health at least every 90 days. Continuation of treatment with controlled substances shall be supported by documentation of continued benefit by the prescriber. If the patient's progress is unsatisfactory, the prescriber shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

5. Consultation. When necessary to achieve treatment goals, the prescriber shall refer the patient for additional evaluation and treatment.

6. Medical records. The prescriber shall keep current, accurate and complete records in an accessible manner and readily available for review to include:

a. The medical history and physical examination;

b. Past medical history;

c. Records from prior treatment providers;

d. Diagnostic, therapeutic and laboratory results;

e. Evaluations and consultations;

f. Treatment plan/goals;

g. Discussion of risks and benefits;

h. Informed consent and agreement for treatment;

i. Treatments;

j. Medications (including date, type, dosage and quantity prescribed). During the course of treatment, the physician shall adjust drug therapy to the individual medical needs of the patient and record the rationale for adjustments. Records shall document the medical necessity for any prescriptions in excess of recommended dosage in accordance with §§54.1-2971.01and 54.1-3408.1of the Code of Virginia;

k. Instructions and agreements; and

l. Periodic reviews.


Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume , Issue , eff. Month dd, yyyy.