Section 0940-05-42-.15 - MEDICATION MANAGEMENT(1) Opioid Drugs. Facilities shall develop and implement written policies and procedures for prescription, dispensing and administration of opioid drugs and their security. No standardized routines or schedules of increases or decreases of medications may be established or used. These policies and procedures shall include the following:(a) Administration. 1. A program physician shall perform a medical assessment to determine the service recipient's initial dose and schedule. The physician shall communicate the initial dose and schedule to the person supervising medication.2. The proper initial dose shall be based on the clinical judgment of the program physician who has examined the service recipient and who has considered all available relevant information, including, but not limited to, drug screens, quantitative methadone levels, service recipient interview, and specific circumstances pertaining to the individual service recipient.3. A physician may assign such dose and schedule by verbal order only on an emergency basis. If a verbal order is given, the physician shall examine the service recipient within 72 hours. Both the verbal order and the results of the physical examination shall be documented in the service recipient's record. Verbal orders must be taken by a licensed nurse or physician assistant, qualified by training and experience, and categorically approved by the medical staff of the Facility. Upon hearing the order, the receiver shall record the order in the service recipient's record, and then shall read back the written order to the issuing professional to assure that the order is understood clearly. "Oral" and "Telephone" orders must be documented as such and staff recording must sign their name and title. "Oral" and "Telephone" orders must be countersigned by the physician no later than 72 hours.4. The initial dose of methadone may not exceed 30 milligrams. Only in extraordinary circumstances may the total dose for the first day exceed 40 milligrams. A transferring service recipient may receive an initial dosage of no more than the last daily dosage authorized at the former facility unless in the clinical judgment of the medical director, there are extenuating circumstances documented in the records which justify an initial dosage that is greater than the last daily dosage authorized at the former facility.5. Subsequent doses shall be authorized by a prescriber, as defined by Rule 0940-05-42-.01(2)(x). Additional dosage may be dispensed in the first day where the prescriber documents that the initial dose does not suppress withdrawal symptoms. Service recipients are stabilized on methadone when they are receiving a therapeutic dose that is sufficient to stop opioid use and sufficient to keep the service recipient comfortable for at least 24 hours with no need to resort to illicit opioids to satisfy opioid cravings.6. No dosage increases shall occur on the days that the Facility is closed.7. No methadone may be administered unless the prospective service recipient has undergone all of the screening and admission procedures required, unless there is an emergency situation that is fully documented in the records. In that case, intake procedures shall be completed on the next working day. No take-home medication may be given in such an emergency.8. The administration of greater than 100 milligrams of methadone to a service recipient requires written notification to the SOTA within 10 working days, signed by the program physician, which details clinical justification for exceeding 100 milligrams.9. No dose of methadone in excess of 120 milligrams may be ordered or administered without the prior approval of the SOTA.10. Benzodiazepine Use. If a service recipient has a positive benzodiazepine screen:(i) The treatment team shall meet with the service recipient within 14 days of receiving the results of the screen, to develop a benzodiazepine action plan in the service recipient's record. The plan shall be reviewed and signed by the medical director;(ii) If the plan requires the service recipient to become clean from benzodiazepines, a time period for detoxification shall be established. The plan must contain a justification for any time period longer than 90 days;(iii) The Facility shall provide detoxification treatment services either directly or through referral to another provider of detoxification treatment services;(iv) If the plan calls for the continued use of benzodiazepines, the Facility shall coordinate the care with a qualified prescriber and document this coordination in the service recipient's record;(v) The plan shall contain requirements for counseling, frequency of urine drug screens, and the consequences for failing to comply with the action plan on take-home privileges, and continued treatment at the OTP; and(vi) The plan and weekly progress notes about plan implementation shall be documented in the service recipient's record.(b) Any opioid drug prescribed and administered shall be documented on an individual medication administration record that is filed with the IPP. The record shall include:4. Frequency of administration;5. Route of administration;6. Date and time administered; and7. Documentation of staff administering medication or supervising self-administration.(c) Take-home doses of methadone or buprenorphine shall be handled in accordance with applicable rules of the Substance Abuse and Mental Health Administration or other applicable federal agency.1. All requests for take-home exceptions shall be reviewed and approved by the SOTA and any other applicable federal agency.2. The Facility shall check the PMP database prior to requesting any take-home or dosing exceptions and shall submit this report to the SOTA with the exception request.3. The Facility shall provide counseling prior to providing take-home doses to any service recipient. Progress notes in the service recipient's record shall document the counseling provided.4. The Facility shall document in the service recipient's record the basis for approving "take-home" medication for the service recipient. The following criteria shall be considered in determining the service recipient's eligibility for "take-home" medications.(i) Cessation of illicit drug use;(ii) Regularity of program attendance;(iii) Length of time and level of treatment in medication therapy (ability to responsibly self-medicate);(iv) Absence of known recent criminal activity (especially drug dealing);(v) Absence of serious behavioral problems;(vi) Absence of abuse of drugs including excessive use of alcohol;(vii) Other special needs of the service recipient, such as split dosing, physical health needs, pain treatment, etc.;(viii) Capacity to safely store "take-home" medication within the service recipient's home;(ix) Stability of the home environment and social relationships;(x) Service recipient's work, school, or other daily-life activity schedule; and(xi) Hardship experienced by the service recipient in traveling to and from the Facility.(d) Adverse drug reactions and errors shall be reported to a program physician immediately and corrective action initiated. The adverse reaction or error shall be recorded in the drug administration record, the nurse progress notes and the IPP, and all persons who are authorized to administer medication or supervise self-medication shall be alerted.(e) All medications shall be stored in a locked safe when not being administered or self-administered.(f) Medication orders and dosage changes shall be written or printed on a form which clearly displays the physician's signature. The dosage dispensed, prepared or received shall be recorded and accounted for by written or printed notation in a manner which achieves a perpetual and accurate inventory at all times. Every dose shall be recorded in the service recipient's individual medication record at the time the dose is dispensed or administered. If initials were used, the full signature and credentials of the qualified person administering or dispensing shall appear at the end of each page on the medication sheet. The perpetual inventory shall be totaled and recorded in milligrams daily.(g) Computer-based Recording. 1. Any such computerized system shall have the capability of producing a hard-copy printout of any medical or dosing order data which the OTP is responsible for maintaining under the laws and/or regulations of this state and/or the federal government. Any computerized system shall, upon the request of the SOTA, send or provide such a printout within 48 hours excluding weekends.2. In the event that an OTP which utilizes such a computerized system experiences system down-time, the OTP must have a written or readily retrievable auxiliary policy and procedure for documentation of all medical and dosing orders. The auxiliary procedure shall ensure that each medical or dosing order is authorized, and that all appropriate data are retained for on-line data entry as soon as the computer system is available for use again.(h) The Facility shall check the PMP database upon admission of the service recipient, at least every six months to determine if controlled substances other than methadone are being prescribed for the service recipient, and thereafter as clinically indicated. The service recipient's record shall include documentation of the check of the PMP database and the date upon which it occurred.(i) Guest Dosing. 1. Guest dosing shall be provided for a maximum of 14 days. Anything beyond 14 days shall be approved by the SOTA before dosing occurs.2. Service recipients shall have been enrolled at the home clinic for a minimum of 30 days before being eligible for a guest dose. Service recipients enrolled less than 30 days at the home clinic shall be eligible for guest dosing only if approved by the SOTA.3. Service recipients shall have two consecutive clean urine drug screens before being eligible for a guest dose unless the medical director determines that the benefits of guest dosing outweigh the risks and documents the justification for granting guest dosing privileges in the service recipient's record.Tenn. Comp. R. & Regs. 0940-05-42-.15
Original rule filed September 20, 2012; effective December 19, 2012.Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, and 33-2-404.