Federal & State
At minimum how many times does a patient have to submit a UDS per PA State and Federal Regulations?
PA State Regulations: At least once a month.
Federal Regulations: 8/year
(Fed Guide pg. 44); (Ref. 715.14 pg. 715-9)
Who is permitted in the dispensing area during administration of medication?
Only authorized staff and the patient who is reeving medication.
(PA State Reg. 715.17)
What is the average number of hours of psychotherapy that need to be provided each month (for patients not on phase) and how do they need to be distributed?
2.5 hours per month, 1 hour which must be individual.
(PA State Reg. 715.19)
How long will a client be given detoxification if they commit or threaten to commit physical violence?
At least 7 days.
(PA State Regs. 715.21)
The decision as to whether an individual patient should receive take home medication is a decision made by whom?
The Medical Director.
(Fed. Regs Pg. 59)
For what reason can the medical director waive the one year requirement for admission to methadone maintenance?
Previously treated patients (up to 2 years post discharge), recently released from a penal institution with a documented history of opioid use disorder, pregnancy (physician must certify the pregnancy).
(Fed. Reg. Pg. 21)
In what situations should involuntary withdrawal from treatment be utilized?
Nonpayment of fees, Disruptive conduct or behavior, violent conduct or threatening behavior, incarceration and when all therapeutic options have been exhausted.
(Fed. Regs. Pg. 26-27)
How often should treatment plans be updated for clients NOT under a specific treatment protocol per Federal and State Regulations?
Federal Regulations: Regular Intervals (ex. quarterly)
State Regulations: 60 days
(PA State 715.23) (Federal Regs. Pg. 34)
Under what circumstances may a client need an exception from the Federal and State Regulations?
Federal - Transportation hardships, employment, vacation and medical disabilities
State - permanent physical disability, temporary disability, or a patient has an exceptional circumstance such as illness, personal or family crisis, or travel which interferes with mandatory attendance schedules.
(Fed. Regs pg. 58) (PA State Regs. 715.16)
PA State regulations stipulate take-home medication labels have these 4 pieces of information on them, in addition to being packaged per federal regulatory standards.
1. Patient's Name.
2. The Narcotic Treatment Program's Name.
3. The Narcotic Treatment Program's Address.
4. The Narcotic Treatment Program's Phone #.
(PA State Reg. 715.15)
The purpose of ______ is to determine treatment eligibility, develop a treatment plan, and establish a measure for the response to treatment.
(Fed. Regs Pg. 33)
Methadone doses in pregnant women should be carefully monitored, especially during __________, when there are changes such as the rate at which methadone is metabolized or eliminated from the system, potentially necessitating either an increased or a split dose.
Third trimester.
(Fed. Regs. Pg. 31)
How many days can a client miss dosing consecutively to be considered for discharge?
3.
(PA State Reg. 715.21)
When a patient is unable to report to clinic for medication due to illness, pregnancy, incarceration, participation in residential treatment or transportation issues, but they DO NOT meet criteria for unsupervised take homes, what needs to be done to ensure they are medicating safely and the appropriate handling and delivery of medication to the patient is occurring?
A chain of custody needs to be completed.
(Federal Reg. Page 56)
What are the 8 standard criteria a client has to meet in order to be eligible for a take-home dose (aside from time in treatment)?
1. Absence of recent drug abuse 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 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.
(PA State Reg 715.16) (Fed. Regs Pg. 53)
As per PA Reg. 715.14 each UDS must test for these 6 types of drugs?
Opiates
Cocaine
Methadone
Barbiturates
Amphetamines
Benzodiazepines
(Ref. 715.14)
What should medically supervised withdrawal services be accompanied with?
Relapse prevention counseling, overdose prevention education, and a naloxone prescription.
(Fed. Regs. Pg. 26)
On the individual medication record, what are the 8 pieces of information that need to be documented to ensure accurate accounting of medication at all times?
1. Name of Medication
2. Date Prescribed
3. Dosage
4. Frequency
5. Route of Administration
6. Date and time administered
7. Name of person administering medication
8. Take home schedule, if applicable
(PA State Regs. 715.18)
Dispensing time shall be prorated for patient census. There shall be sufficient dispensing staff to ensure that all patients are medicated within this time frame upon arrival at the dispensing area.
15 minutes.
(PA State Regs. 715.7)
What is the ratio of dispensing staff to clients for automated system and non-automated system?
Automated = 1/200 patients
Non = 1/150 patients
How often does the PDMP need to be run for each client?
1. Prior to admission
2. At least quarterly
3. Upon ordering take-home medications
4. During other important clinical decision points.
(Fed. Regs. Pg. 50)
At what point after termination of pregnancy should the narcotic treatment physician enter an evaluation of the patient’s treatment status into her record and state regarding whether she should remain in comprehensive maintenance treatment or receive detoxification treatment?
3 months after termination of the pregnancy.
(PA State Regs. 715.10)
What is the admission and exclusionary criteria for methadone long term detoxification?
Admission (Fed) - Current opioid use; 1 year dependency is waived.
Exclusionary (Fed) - 2 unsuccessful detoxification episodes within a 12 month period (reassessed for other forms of tx); no more than 2 episodes in 1 year
(Fed. Regs. Pg. 24) (PA State Regs. 715.9)
An OTP may readmit a patient who abruptly left the program within ____days of his/her departure without repeating the initial assessment procedure required by 42 CFR § 8.12(f)(4).
30 days.
42 CFR § 8.12(f)(4).
What two regulatory challenges does a lock box present for patients receiving take homes?
1. If the locked container is publicly visible, it may offer a means to identify someone in treatment and violate patient confidentiality
2. The container’s visibility may identify the patient possessing take home medication and place the patient at risk for robbery or assault
(Fed. Regs. Pg. 56)