Current through Register Vol. XLI, No. 50, December 13, 2024
Section 69-7-36 - Medication Storage, Administration and Documentation36.1. 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; and36.4.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; and36.7.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; and36.7.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.