[32 Pa.B. 5638]
[Continued from previous Web Page] § 715.16. Take-home privileges.
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.
(2) The narcotic treatment physician shall make this determination after consultations with staff involved in the patient's care.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
(4) A narcotic treatment physician may rescind take-home medication privileges.
(5) A narcotic treatment program shall develop written policies and procedures relating to granting and rescinding take-home medication privileges.
(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.
(2) Regular narcotic treatment program attendance.
(3) Absence of serious behavioral problems at the narcotic treatment program.
(4) Absence of known recent criminal activity.
(5) Stability of the patient's home environment and social relationships.
(6) Length of time in comprehensive maintenance treatment.
(7) Assurance that take-home medication can be safely stored within the patient's home.
(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.
(c) A narcotic treatment program shall require a patient to come to the narcotic treatment program for observation daily or at least 6 days a week for comprehensive maintenance treatment, unless a patient is permitted to receive take-home medication as follows:
(1) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to three times weekly and receive no more than a 2-day take-home supply of medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 months.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
(2) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to two times weekly and receive no more that a 3-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 2 years.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
(3) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to one time weekly and receive no more than a 6-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 years.
(ii) A patient demonstrates substantial progress in rehabilitation.
(iii) A patient demonstrates responsibility in handling narcotic drugs.
(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.
(v) A patient demonstrates no major behavioral problems.
(vi) A patient is employed, is actively seeking employment, attends school, is a homemaker or is considered unemployable for mental or physical reasons.
(vii) A patient is not known to have abused alcohol or other drugs within the previous year.
(viii) A patient is not known to have engaged in any criminal activity within the previous year.
(d) A narcotic treatment program may make exceptions to the requirements in subsection (c) relating to the length of time of satisfactory adherence to narcotic treatment program rules and number of days of take-home medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:
(1) A patient has a permanent physical disability.
(2) A patient has a temporary disability.
(3) A patient has an exceptional circumstance such as illness, personal or family crisis, or travel which interferes with the patient's ability to conform to the applicable mandatory attendance schedules. In all cases, the patient shall demonstrate an ability to responsibly handle narcotic drugs.
(e) With an exception granted under subsection (d), a narcotic treatment program may not permit a patient to receive more than a 2-week take-home supply of medication.
(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.
§ 715.17. Medication control.
(a) A narcotic treatment program shall comply with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.
(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
(2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:
(i) The name of the medication.
(ii) The date prescribed.
(iii) The dosage.
(iv) The frequency.
(v) The route of administration.
(vi) The date and time administered.
(vii) The name of the person administering the medication.
(viii) The take-home schedule, if applicable.
(5) Security of all substances. A narcotic treatment program shall develop and implement written policies and procedures to minimize the likelihood of loss, theft or misuse of an agent or another controlled substance as well as a plan of action if a loss, theft or misuse does occur. In the event of loss, theft or misuse, the Federal and State statutes and regulations regarding reporting shall be followed.
(6) Inventories. A narcotic treatment program shall conduct monthly inventories of agents and other controlled substances stored. Each inventory record shall include:
(i) The date the inventory was conducted.
(ii) The time of day it was conducted.
(iii) The name and amount of each product on hand at the time of the inventory.
(iv) The name of the individual conducting the inventory.
(7) Drug reactions and medication errors. A narcotic treatment program shall report any adverse drug reaction or medication error to a narcotic treatment physician immediately and initiate corrective action. The narcotic treatment program shall record the reaction or error in the drug administration record and the clinical chart, and shall inform each person who is authorized to administer medication or supervise self-medication of the reaction or error.
§ 715.18. Rehabilitative services.
(a) A narcotic treatment program shall provide, either onsite or through referral agreements, a full range of rehabilitative services. Rehabilitative services shall include:
(1) HIV education services.
(2) Employment services.
(3) Adult educational services.
(4) Behavioral health services.
(b) A patient shall also have the opportunity to access legal services.
§ 715.19. Psychotherapy services.
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
(2) A narcotic treatment program shall provide each patient at least 1 hour per month of group or individual psychotherapy during the third and fourth year of treatment. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
(3) After 4 years of treatment, a narcotic treatment program shall provide each patient with at least 1 hour of group or individual psychotherapy every 2 months. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
§ 715.20. Patient transfers.
A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.
(1) The transferring narcotic treatment program shall transfer patient files which include admission date, medical and psychosocial summaries, dosage level, urinalysis reports or summary, exception requests, and current status of the patient, and shall contain the written consent of the patient.
(2) A narcotic treatment program shall maintain the confidentiality of patient records remaining in its possession after the transfer under § 715.11 (relating to confidentiality of patient records).
(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.
(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.
§ 715.21. Patient termination.
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
(2) A patient terminated involuntarily, except a patient who commits or threatens to commit acts of physical violence, shall be afforded the opportunity to receive detoxification of at least 7 days. The detoxification may take place at the facility or the patient may be referred to another narcotic treatment program or hospital licensed and approved by the Department for detoxification.
§ 715.22. Patient grievance procedures.
(a) A narcotic treatment program shall develop and utilize a patient grievance procedure.
(b) The procedure shall permit aggrieved patients a full and fair opportunity to be heard, to question and confront persons and evidence used against them and to have a fair review of their grievances by the narcotic treatment program director. If the grievance is filed against the narcotic treatment program director, the review of the case shall be conducted by either a multi-representative group of the narcotic treatment program or a subcommittee of the governing body instituted for the express purposes of grievance adjudication.
(c) Penalties may not be initiated prior to final resolution with the exception that penalties may be initiated against patients who have committed acts of physical violence or who have threatened to commit acts of physical violence in or around the narcotic treatment program premises.
§ 715.23. Patient records.
(a) A narcotic treatment program shall maintain patient records in conformance with 42 CFR 2.16 and 2.22 (relating to security for written records; and notice to patients of Federal confidentiality requirements) and State statutes and regulations. A narcotic treatment program shall maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has completed treatment or treatment has been terminated. Files shall be updated regularly so that the information is current.
(b) Each patient file shall include the following information:
(1) A complete personal history.
(2) A complete drug and alcohol history.
(3) A complete medical history.
(4) The results of an initial intake physical examination.
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
(7) Documentation of a 1-year history of narcotic dependency, if applicable.
(8) The patient's current and past narcotic dosage level.
(9) Other drugs prescribed by the narcotic treatment physician and the reasons therefore.
(10) Urine testing results.
(11) Counselor notes regarding patient progress and status.
(12) Applicable consent forms.
(13) Patient record of services.
(14) Case consultation notes regarding the patient.
(15) Psychosocial evaluations of the patient.
(16) Any psychiatric, psychological or other evaluations, if available.
(17) Treatment plans and applicable periodic treatment plan updates.
(18) Federal and State exceptions to the regulations granted to the project on behalf of the patient.
(19) Referrals to other projects or services.
(20) Take-home privileges granted to the patient.
(21) Annual evaluation by the counselor.
(22) Aftercare plan, if applicable.
(23) Discharge summary.
(24) Follow-up information regarding the patient.
(25) Documentation of patient grievances.
(c) An annual evaluation of each patient's status shall be completed by the patient's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.
(2) The narcotic treatment physician or the patient's counselor shall review, reevaluate, modify and update each patient's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.
(f) If a narcotic treatment program keeps patient information in more than one file or location, it is the responsibility of the narcotic treatment program to provide the entire patient record to authorized persons conducting narcotic treatment program approval activities at the narcotic treatment program, upon request.
§ 715.24. Narcotic detoxification.
If a narcotic treatment program provides narcotic detoxification services, the narcotic treatment program shall develop and implement narcotic detoxification policies and procedures which include the following:
(1) For narcotic detoxification from methadone or any other narcotic, the detoxification service may not exceed 180 days.
(2) For calculating the 1-year narcotic dependency history required for admission to maintenance treatment, the narcotic detoxification period may not be included.
(3) A 1-year physiologic dependence is not required for narcotic detoxification although documentation of current dependency is required.
(4) Minimum requirements for short-term narcotic detoxification treatment are as follows:
(i) Take-home medication is not allowed during a 30-day narcotic detoxification treatment. A narcotic treatment program shall observe the patient ingesting the medication 7 days per week.
(ii) The narcotic treatment program shall perform an initial drug screening test or analysis.
(iii) The narcotic treatment program shall develop a treatment plan. The patient's counselor shall monitor the patient's progress toward the goal of short-term narcotic detoxification and possible drug-free treatment referral.
(iv) No narcotic treatment program may provide short-term narcotic detoxification treatment to an individual until at least 7 days after the conclusion of any previous short-term narcotic detoxification treatment.
(5) Minimum requirements for long-term detoxification treatment are as follows:
(i) A narcotic treatment program shall administer medication to allow a patient to attain drug-free status and to make progress in rehabilitation within 180 days or less.
(ii) A narcotic treatment program shall perform an initial drug screening test or analysis. A narcotic treatment program shall perform at least one additional random test or analysis monthly on each patient during long-term narcotic detoxification.
(iii) The narcotic treatment program shall develop an initial treatment plan, and update the plan monthly.
(iv) A narcotic treatment program shall observe the patient while ingesting the medication at least 6 days a week.
(v) No narcotic treatment program may provide long-term narcotic detoxification treatment to an individual until at least 7 days after the conclusion of any previous narcotic detoxification treatment.
§ 715.25. Prohibition of medication units.
Narcotic treatment medication units are prohibited.
§ 715.26. Security.
(a) A narcotic treatment program shall meet the security standards for the distribution and storage of controlled substances as required by Federal regulations, including 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls) and State statutes and regulations.
(b) Each narcotic treatment program shall provide the Department with a specific plan describing the efforts it will make to avoid disruption of the community by its patients and the actions it will take to assure responsiveness to the community. This plan shall designate a staff member to act as community liaison.
§ 715.27. Readmission.
If a patient requests readmission to a narcotic treatment program after voluntary termination from that narcotic treatment program, that narcotic treatment program shall provide that patient with an evaluation interview and shall give that patient priority consideration for readmission.
§ 715.28. Unusual incidents.
(a) A narcotic treatment program shall develop and implement policies and procedures to respond to the following unusual incidents:
(1) Physical assault by a patient.
(2) Inappropriate behavior by a patient causing disruption to the narcotic treatment program.
(3) Selling of drugs on the premises.
(4) Complaints of patient abuse (physical, verbal, sexual and emotional).
(5) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(6) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(7) Incident with potential for negative community reaction or which the facility director believes may lead to community concern.
(8) Theft, burglary, break-in or similar incident at the facility.
(9) Drug related hospitalization of a patient.
(10) Other unusual incidents the narcotic treatment program believes should be documented.
(b) These policies and procedures shall include the following:
(1) Documentation of the unusual incident.
(2) Prompt review and investigation.
(3) Implementation of a timely and appropriate corrective action plan, when indicated.
(4) Ongoing monitoring of the corrective action plan.
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
§ 715.29. Exceptions.
A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.
(1) The request for an exception from a specific regulation shall be in writing, with governing body approval, and shall state how the narcotic treatment program will meet the intent of the regulation.
(2) The Department may withhold the granting of an exception and may require a narcotic treatment program to be in actual operation to assess if the exception is appropriate.
(3) The Department will reserve the right to revoke any exception previously granted.
(4) The narcotic treatment program shall maintain documentation of the Department's approval of an exception.
(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient's record.
§ 715.30. Applicability.
This chapter applies to the use of any agent which may be approved by the Department for use in narcotic or opioid dependency medication therapy. This chapter applies to the administration of any agent which may be approved by the Department for use in the treatment of opioid dependency.
[Pa.B. Doc. No. 02-2052. Filed for public inspection November 15, 2002, 9:00 a.m.]
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