West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-07 - Regulations of Opioid Treatment Programs
Section 69-7-36 - Medication Storage, Administration and Documentation
Universal Citation: 69 WV Code of State Rules 69-7-36
Current through Register Vol. XLI, No. 38, September 20, 2024
36.1. Each opioid treatment program shall have policies and procedures consistent with the United States Drug Enforcement Administration's statutes and regulations regarding the storage, administration and documentation of medications.
36.2. Administration of Medications.
36.2.a. The policies and procedures of an
opioid treatment program shall require all personnel dispensing opioid agonists
to adhere to federal and state laws, rules, and regulations and to protocols
and guidelines from approved authorities.
36.2.b. Each opioid treatment program shall
calibrate medication dispensing instruments consistent with the manufacturer's
recommendations to ensure accurate patient dosing and substance
tracking.
36.2.c. Each opioid
treatment program shall ensure that opioid treatment medications are
administered or dispensed only by a practitioner who is qualified to do so by
his or her scope of practice; is licensed under the appropriate state law; and
is registered under the appropriate state and federal laws to administer or
dispense opioid drugs.
36.2.d. Only
the program physician may order medication and dosages; only the program
physician may approve changes in dosage or take-home privileges.
36.2.e. The patient shall be advised of any
change in medication dosage or administration.
36.3. Each opioid treatment program shall maintain current procedures adequate to ensure that all opioid treatment medication is administered or dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. The procedures must ensure that any significant deviations from the approved labeling, including deviations with regard to dose frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record.
36.4. Documentation.
36.4.a. Each opioid treatment
program is responsible for proper documentation of medications stored,
administered or dispensed.
36.4.b.
Documentation of medication administered or dispensed requires, at a minimum,
the following:
36.4.b.1. The signature or
initials of the qualified person administering or dispensing
medication;
36.4.b.2. The exact
number of milligrams of the substance administered or dispensed; and
36.4.b.3. The daily totals of the substance
administered or dispensed.
36.4.c. Each dosage administered or
dispensed, prepared or received shall be recorded and accounted for by written
signed notation in a manner that creates a perpetual and accurate inventory of
all methadone in stock at all times.
36.4.d. The medication shall be totaled in
milligrams daily.
36.4.e. Each
medication order and dosage change shall be written on an acceptable order
sheet and signed and dated by only the program physician. If initials are used,
the full signature of the qualified person administering or dispensing shall
appear at the end of each page of the medication sheet.
36.4.f. At the time any medication is
administered or dispensed, each dose shall be recorded on an administration
sheet; in the patient's individual medication dose history included in the
patient's individualized treatment plan of care and patient chart; and in the
inventory control program used by the facility to monitor and ensure an
accurate inventory of all medication on the premises.
36.5. Patient Meetings and Screening.
36.5.a. Each opioid treatment program shall
have the capability of obtaining medication blood levels when clinically
indicated, through random drug testing of all patients and on a required
monthly basis.
36.5.b. The program
physician or physician extender shall meet with each patient prior to
prescribing the initial dose of medication and perform an initial medical and
drug screening. All patients must undergo comprehensive monthly drug
screenings, which shall include testing for eight to twelve substances,
including the substance prescribed by the program.
36.5.c. During the first month of treatment,
the program physician or physician extender shall meet individually with the
patient at least once per week to discuss dosage and symptoms. The weekly
meetings shall occur until the dosage is considered stable by the patient and
the physician. Thereafter, the program physician or approved physician extender
shall meet with the patient at least annually for follow-up medical and drug
screenings, if required, and to discuss the possibility of consideration of
titration of medications.
36.5.d.
In addition to the meetings and screenings required by §36.5.c., the
program physician, approved physician extender or a registered nurse shall meet
with the patient at least every six months for further follow-up medical and
drug screenings, if required, and to discuss the patient's current status or
condition, treatment and any related issues.
36.5.e. All meetings, test results and
discussions shall be documented in the patient's chart and individualized
treatment plan of care, along with the individual's decision whether to
continue medications at current levels or to begin a slow titration
process.
36.6. Approved Medications.
36.6.a. An opioid treatment
program shall use only those opioid treatment medications that are approved by
the Food and Drug Administration under section 505 of the Federal Food, Drug
and Cosmetic Act,
21
U.S.C. 355, for use in the treatment of
opioid addiction.
36.6.b. The state
authority is responsible for development of practice guidelines for alternative
treatments as they become available. The guidelines shall be in conformance
with any nationally recognized guidelines approved by the secretary. The opioid
treatment program is responsible for remaining in conformity with practice
guidelines as issued or approved by the state authority.
36.7. Dosage.
36.7.a. Each opioid treatment program shall
have a procedure through which the patient can discuss dosages of medication he
or she receives with appropriate staff members regularly and upon request. This
procedure shall be clearly described to the patient during orientation, upon
admission and at least annually thereafter. A written explanation of the dosing
procedures shall be initialed and dated by the patient and maintained in the
patient chart and individualized treatment plan of care.
36.7.b. The maintenance dose of medication
prescribed for a patient shall be individually determined in accordance with
federal law and with guidelines and protocols from approved authorities.
Adjustments upward or downward in dosage shall not be made either as punishment
or reward, but shall be justified by the clinical documentation of the
patient's condition, subjectively and objectively, in accordance with the
approved guidelines and protocols.
36.7.c. The initial full-day dose of
medication shall be based on the physician's evaluation of the history and
condition of the patient and made in accordance to established guidelines.
Doses shall be sufficient to produce the desired response in the patient for
the desired duration of time, with allowance for a margin of effectiveness and
safety.
36.7.d. Dosage
administration and adjustment shall be guided by outcomes criteria, which shall
be documented and include:
36.7.d.1. Cessation
of withdrawal symptoms;
36.7.d.2.
Cessation of illicit opioid use as documented by negative drug tests and
reduction of drug-seeking behavior;
36.7.d.3. Establishment of a blockade dose of
an agonist;
36.7.d.4. Absence of
problematic craving as documented by a subjective report and clinical
observations; and
36.7.d.5. Absence
of signs and symptoms of too large a dose of an opioid treatment medication
after an interval adequate for the patient to develop complete tolerance to the
blocking dose.
36.7.e.
Dosages of medication should be adjusted so that they shall ultimately:
36.7.e.1. Prevent the onset of subjective
and/or objective signs of opioid abstinence syndrome for twenty-four hours or
more;
36.7.e.2. Reduce or eliminate
drug cravings; and
36.7.e.3. Block
the effects of illicitly acquired opioids without inducing persistent euphoric
or other undesirable effects.
36.7.f. The ordering physician shall ensure
that the justification for daily doses above 100 milligrams is documented in
the patient's record.
36.8. Methadone.
36.8.a. Methadone shall be administered only
in oral form and shall be formulated in such a way as to reduce its potential
for parenteral abuse.
36.8.b. For
each new patient enrolled in an opioid treatment program, the initial dose of
methadone shall not exceed 30 milligrams. The total dose for the first day
shall not exceed 40 milligrams, unless the program physician documents in the
patient's record that 40 milligrams did not suppress opiate abstinence symptoms
after a three-hour period of observation.
36.8.c. The total dose of methadone and the
interval between doses may be adjusted for patients documented to have atypical
metabolic patterns or those prescribed other concurrent medications which alter
rates of methadone metabolism.
Disclaimer: These regulations may not be the most recent version. West Virginia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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