16 Del. Admin. Code § 6001-III-14.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 6001-III-14.0 - Opioid Treatment Services:

In addition to these standards, all programs providing Opioid treatment services shall be in full compliance with Federal Regulations regarding Opioid treatment.

14.1 Admission procedures in addition to the admission procedures described in § 8.1.2:

14.1.1 If an applicant for Opioid treatment services has been discharged within seven (7) years from treatment at another OTP, the admitting program shall document that a good faith effort was made to review whether or not the client is enrolled in any other OTP.

14.1.2 A client enrolled in another program shall not be permitted to enroll in treatment in any other OTP except in exceptional circumstances as determined by the medical director. Exceptions shall be:

14.1.2.1 Noted in the client's record.

14.2 Special admission populations (where the absence of physiological dependence shall not be an exclusion criterion with a clinically justifiable admission) shall include:

14.2.1 Persons recently released from a penal institution; (within six (6) months after release.)

14.2.2 Pregnant clients; (Program physician shall certify pregnancy)

14.2.3 Previously treated clients; (Up to two (2) years after discharge)

14.2.4 Adolescents, provided that:

14.2.4.1 Individuals under the age of 18 have had two documented attempts at short-term medically supervised withdrawal (detoxification) or drug-free treatment to be eligible for maintenance treatment;

14.2.4.2 In addition to the consent of the client, Individuals under 18 years old, unless otherwise permitted by 16Del.C.§ 2210 to consent to treatment, have had a parent or legal guardian complete and sign the agency's consent to OTP Treatment.

14.3 Client Orientation

14.3.1 In addition to the requirements of § 8.1.2.1.4 OTPs shall inform clients of:

14.3.1.1 The facts concerning the use of methadone, buprenorphrine, or other Opioid treatment medications dispensed by the program, including, but not limited to:

14.3.1.1.1 An explanation of the interaction between the Opioid treatment medication(s) dispensed by the program and other medications, medical procedures and food;

14.3.1.1.2 Any potential adverse reactions, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures and food; and

14.3.1.1.3 The importance of notifying the client's primary care physician of their admission to and discharge from the program;

14.3.1.1.4 The facts concerning the withdrawal from the use of methadone, buprenorphrine, or other Opioid treatment medications dispensed by the program, including, but not limited to:

14.3.1.1.5 Policies and procedures regarding voluntary, involuntary, and against medical advice withdrawal from Opioid treatment medications;

14.3.1.1.6 An explanation of the potential interaction between withdrawal from the Opioid treatment medication(s) dispensed by the program and other medications, and medical procedures;

14.3.1.1.7 Any potential adverse reactions as a result of withdrawal from Opioid treatment medications, including those resulting from interactions with other prescribed or over-the-counter pharmacological agents, other medical procedures; and

14.3.1.1.8 The importance of notifying the client's primary care physician of withdrawal from the program.

14.3.1.2 The program's drug-screening procedure;

14.3.1.3 The program's Opioid treatment medication dispensing procedure, including the days and hours of operation;

14.3.1.4 The program's rules including non-compliance, and discharge procedures, to include administrative Opioid treatment medication withdrawal;

14.3.1.5 The signs and symptoms of overdose and when to seek emergency assistance;

14.3.1.6 The emergency procedures maintained by the program as required in § 5.1.4.4.1.21 shall be available twenty-four (24) hours per day.

14.3.1.7 Safe storage practices for take-home Opioid treatment medications;

14.3.1.8 The financial aspects of treatment, including the consequences of nonpayment of required fees.

14.3.2 Upon admission, the program shall obtain from or issue to each client a photo identification card.

14.4 Client Re-admissions

14.4.1 A client re-admitted to the same program within thirty (30) days need not receive a medical examination and laboratory tests if s/he received a medical examination and laboratory tests within the previous year.

14.5 Hours of Operation, Staffing, and Staff Orientation

14.5.1 OTPs shall operate six (6) days per week, with at least two (2) hours of medicating time accessible daily outside the hours of 8 a.m. to 5 p.m. Monday through Friday, and three (3) hours on Saturday or Sunday.

14.5.2 Each OTP shall post medication dispensing and counseling hours in a public place within the facility.

14.5.3 Each OTP shall have the services of licensed medical personnel including:

14.5.3.1 A designated medical director, who is a physician, responsible for the administration of all medical services performed by the program and for compliance with all federal, state and local laws, rules and regulations regarding medical treatment of narcotic dependence;

14.5.3.2 At all times when the clinic is open, if a physician is not on site, a physician shall be available for consultations and emergency attendance;

14.5.3.3 Prior to services delivery, in addition to training requirements in § 5.1.7.1, OTPs shall provide new staff orientation, including:

14.5.3.3.1 Clinical and pharmacotherapy issues,

14.5.3.3.2 Overdose, and other emergency procedures,

14.5.3.3.3 Provision of services to special populations such as adolescents, pregnant women, and senior citizens.

14.6 Administration of Opioid treatment medication

14.6.1 No dose of Opioid treatment medication shall be administered until the client has been identified and the dosage compared with the currently ordered and documented dosage level.

14.6.2 Only a licensed professional authorized by law may administer or dispense Opioid treatment medication.

14.6.3 Ingestion shall be observed and verified by the personnel authorized to administer the Opioid treatment medication.

14.6.4 There shall be only one client in the dispensing area at a time.

14.6.5 A physician shall obtain a detailed history of drug use within the last twenty-four (24) hours prior to initial dose, and,

14.6.5.1 Determine the client's initial dosage after a physical examination;

14.6.5.2 The initial dose of Methadone shall not exceed thirty (30) mg.;

14.6.5.3 Additional medication shall not be administered, unless:

14.6.5.3.1 After three (3) hours of observation, the physician documents in the client's record that the initial dose did not suppress opiate abstinence symptoms; and

14.6.5.3.2 The physician writes orders for additional medication.

14.6.5.4 The initial total daily dose of methadone for the first day shall not exceed forty (40) mg., unless the physician documents justification for a higher dosage in the client record that forty (40) mg did not suppress opiate abstinence symptoms.

14.6.5.5 The initial dose of any other Opioid treatment medications shall not exceed federal regulations, guidelines or medical protocol.

14.6.5.6 The program physician shall justify any deviations from dosages, frequencies, and conditions of usage described in the approved product labeling.

14.6.5.7 Qualified medical personnel shall determine all subsequent dosage levels and shall:

14.6.5.7.1 Document each order change on the physician's medication orders;

14.6.5.7.2 Sign each order change; and

14.6.5.7.3 Date the order.

14.6.5.8 Programs shall dispense methadone in an oral form, in accordance with federal and state law and regulations in containers conforming to 42 CFR (Part VIII) Section 12.(i)(5)..

14.6.5.9 Any Opioid treatment medication error or adverse drug reaction shall be reported promptly to the medical director and an entry made in the client's record.

14.6.5.10 The medical director shall ensure that significant adverse drug reactions are reported to the Federal Food and Drug Administration and to the manufacturer in a manner that does not violate the client's confidentiality.

14.6.5.11 Each program shall develop a written emergency procedure to be implemented in the case of an employee strike, fire or other emergency situation that would stop or substantially interfere with normal dispensing operations. The emergency procedure shall comply with 9.3 and also include:

14.6.5.12 Arrangements with a security provider for immediate security of Opioid treatment medications;

14.6.5.13 Written agreements, updated annually, with back-up licensed professionals authorized by law, for the coverage of dispensing and other medical needs if regular personnel are not available;

14.6.5.14 A reliable system for confirming the identities of clients before dispensing; and

14.6.5.15 Written agreements, updated annually, for the use of an alternate program, hospital or other site for dispensing during an emergency period.

14.7 Opioid treatment medication schedules; Unsupervised or "take-home use":

14.7.1 Treatment program decisions on dispensing unsupervised or "take-home" medications shall be determined by the medical director. The medical director shall consider the following criteria to determine whether a patient is responsible in handling drugs for unsupervised use:

14.7.1.1 Regularity of program attendance;

14.7.1.2 Absence of recent abuse of drugs, including alcohol;

14.7.1.3 Regularity of clinic attendance;

14.7.1.4 Absence of serious behavioral problems at the clinic.

14.7.1.5 Absence of known recent criminal activity (e.g. drug and drug related arrests, etc.)

14.7.1.6 Progress in meeting treatment plan goals;

14.7.1.7 Length of time in treatment;

14.7.1.8 Responsibility in the handling, and plan for the safe storage, of take home Opioid treatment medications;

14.7.1.9 Stability of the client's home environment and social relationships.

14.7.1.10 When it is determined that a patient is responsible in handling Opioid drugs, the Federal Regulations for take home privileges shall be applied.

14.7.1.11 OTPs shall maintain current procedures adequate to identify the theft or diversion of take-home medications, including:

14.7.1.11.1 labeling containers with the OTP's name, address, and telephone number; and

14.7.1.11.2 requiring patients to come to the clinic on a randomly scheduled basis for drug testing and checking the amount of take-home medication used to that point.

14.7.1.12 Programs shall also ensure that take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers.

14.8 Revocation of take-home privileges.

14.8.1 The program medical director will determine if a client's conduct warrants revocation or suspension of take-home privileges.

14.8.2 Documentation of the rationale for revoking or suspending take-home privileges will be entered into the client's record by the medical director.

14.9 Exceptions.

14.9.1 If, in the judgment of the program physician:

14.9.1.1 A client has a physical disability that interferes with his or her ability to conform to the applicable mandatory attendance schedule, the program physician may permit a reduced attendance schedule.

14.9.1.2 A client is unable to conform to the applicable mandatory attendance schedule because of exceptional circumstances such as illness, personal or family crises, travel, or other hardship, the program physician may permit a temporarily reduced schedule, provided that the client is responsible in handling Opioid treatment medications. In such cases, the program physician shall record or verify the rationale for the exception in the client's record and date and sign the record. No client may receive more than a two (2) week supply of Opioid treatment medication at any one time.

14.9.1.3 Employed clients may apply for an exception to these requirements if the dispensing hours of the clinic conflict with working hours of the client. In such cases, the client may receive take-home medications after verifying work hours through reliable means, provided that the physician documents reasons for permitting take home medication.

14.9.1.4 Any client who transfers from one (1) OTP to another shall be eligible for placement on the same take-home schedule. Before initiating take-home privileges for a client transferring from other maintenance treatment programs, the program physician shall document reasons for permitting take home medication.

14.10 Voluntary Medical withdrawal from Opioid treatment Medication

14.10.1 Voluntary medical withdraw from Opioid treatment medication shall include:

14.10.1.1 A request signed and dated by the client, for voluntary medication withdrawal.

14.10.1.2 Documentation of the physician's rationale for initiation of withdrawal.

14.10.1.3 Documentation of the physician's rationale for continuing the withdrawal if there is any change in the physician's orders.

14.10.1.4 Documentation signed and dated by the client that the withdrawal will be discontinued and maintenance resumed at the client's request.

14.10.1.5 A biological test for pregnancy for all women of child-bearing age prior to the initiation of withdrawal.

14.10.1.6 Revision of the treatment plan with an increase in counseling and other support services in relation to medication dosage changes.

14.10.1.7 Provisions for continuing care after the last dose of Opioid treatment medication.

14.11 Withdrawal against medical advice

14.11.1 Withdrawal against medical advice shall include:

14.11.1.1 Documentation of all efforts taken by staff members to discourage initiation and continuation of withdrawal against medical advice.

14.11.1.2 Documentation of the reasons the client is seeking withdrawal against medical advice.

14.11.2 Involuntary withdrawal:

14.11.2.1 Involuntary withdrawal from an Opioid treatment medication shall be conducted in accordance with a dosage reduction schedule prescribed by the physician.

14.11.2.2 Clients being involuntarily discharged shall be referred to other treatment, as clinically indicated.

14.11.2.3 OTPs shall document the reasons for initiation of involuntarily withdrawal in the client's record.

14.11.2.4 Prior to the beginning of involuntary withdrawal, efforts should be documented regarding referral or transfer of the client to a suitable, alternative treatment program.

14.11.2.5 Involuntary withdrawal shall be considered a planned discharge and shall comply with § 8.6 regarding the planned discharge of a client.

14.11.2.6 Documentation during withdrawal shall include:

14.11.2.6.1 Documentation by the physician of the schedule for withdrawal and any changes made to the schedule by the physician during the withdrawal.

14.11.2.6.2 Counseling designed to promote the continuation of services following medical withdrawal.

14.11.3 Detoxification treatment

14.11.3.1 An OTP shall maintain procedures that are designed to ensure that qualified medical personnel admit clients to short- or long-term detoxification treatment.

14.11.3.2 Patients with two or more unsuccessful detoxification episodes within a twelve (12) month period shall be assessed by the OTP physician for other forms of treatment.

14.11.3.3 A program shall not admit a client for more than two (2) detoxification treatment episodes in one year.

14.11.4 Pregnant Clients

14.11.4.1 In addition to the other requirements of this section, for pregnant clients the following shall apply:

14.11.4.1.1 OTPs shall provide priority in initiating treatment.

14.11.4.1.2 The physician shall document in the client record all clinical findings supporting the certification of the pregnancy prior to the administration of an initial dose of Opioid treatment medication.

14.11.4.1.3 The initial dose of Methadone shall not exceed 40 mg.

14.11.4.1.4 The program physician shall evaluate dosing of pregnant women weekly during the last trimester of the pregnancy.

14.11.4.1.5 If there is simultaneous use of alcohol and/or other drugs the program shall document:

14.11.4.1.5.1 Education of the client regarding the potential impact of substance use on the fetus.

14.11.4.1.5.2 Attempts to encourage the client to cease use of substances other than those prescribed by a physician.

14.11.4.1.5.3 Referrals made to appropriate levels of care.

14.11.4.1.6 Pregnant clients shall be given the opportunity for prenatal care either by the program or by referral to appropriate health care providers.

14.11.4.1.7 The program shall document all attempts to assist the client with obtaining prenatal care.

14.11.4.1.8 The program shall offer prenatal instruction on:

14.11.4.1.8.1 Education on fetal development;

14.11.4.1.8.2 Care for the newborn;

14.11.4.1.8.3 Breastfeeding;

14.11.4.1.8.4 Effects of maternal drug use on the fetus;

14.11.4.1.8.5 Information on parenting;

14.11.4.1.8.6 Importance of sound maternal nutritional practices.

14.11.4.2 OTP's shall give priority to pregnant women seeking admission to treatment.

14.11.4.3 OTP's shall maintain current policies and procedures that reflect the special needs of patients who are pregnant. Prenatal and other gender specific services shall be provided either by the OTP or by referral to appropriate health care providers.

14.11.4.4 Medical withdrawal of the pregnant, Opioid - addicted woman from Opioid treatment medication is not indicated or recommended. No pregnant client shall be involuntarily medically withdrawn from an Opioid treatment medication.

14.11.4.5 Pregnant individuals who choose to withdraw from treatment against medical advice shall do so under the direct supervision of the program physician in conjunction with an obstetrician who can monitor the effects on the fetus.

14.11.4.6 If a pregnant client refuses direct treatment, referral for treatment, or referral for other services, the program physician shall have the client acknowledge said refusal in writing. Documentation of the refusal shall be recorded in the client's record.

14.11.4.7 The program physician shall request the physician, hospital, or program to which the individual is referred, to provide reports of prenatal care, and a summary of the delivery and treatment outcome for the client and baby. Documentation of the request(s) shall be included in the client's record.

14.11.4.8 Within three (3) months after termination of the pregnancy, the program physician shall evaluate the individual's treatment status and document whether she should remain in the comprehensive maintenance program or be detoxified.

14.12 Accreditation

14.12.1 Programs shall be accredited by an accreditation body approved by The Substance Abuse and Mental Health Services Administration (SAMSHA) and registered with the Drug Enforcement Agency (DEA), as required.

16 Del. Admin. Code § 6001-III-14.0

14 DE Reg. 471 (11/01/10)