NMBOP: 16.19.29 CONTROLLED SUBSTANCE PRESCRIPTION MONITORING PROGRAM Flashcards

1
Q

“Audit trail information”

A

“Audit trail information” means any query based information resulting from an authorized prescription monitoring program user’s request for a prescription monitoring program report, which could include the user’s name, date and time of the query or other related information.

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2
Q

“Delegate”

A

“Delegate” means an individual authorized as an agent of a practitioner or pharmacist for the purpose of obtaining data from the PMP for review by the practitioner or pharmacist. The delegate must report directly to said practitioner or pharmacist and the practitioner or pharmacist shall be accountable for the delegate’s actions:

(1) a pharmacist’s delegate must be a certified pharmacy technician or a registered intern;
(2) a pharmacy technician or pharmacist intern may access information to the extent the information relates specifically to a current patient to whom the pharmacist is dispensing or considering dispensing any controlled substance or drug(s) of concern, or for the purposes of a pharmacist providing pharmaceutical care as defined in law.

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3
Q

“Dispenser”

A

“Dispenser” means the person who delivers a schedule II - V controlled substance or drug(s) of concern to the ultimate user, but does not include the following:

(1) a licensed hospital pharmacy that distributes such substances for the purpose of inpatient hospital care;
(2) a practitioner, or other authorized person who administers such a substance; or

(3) a practitioner who dispenses to the patient no more than 12 dosage units or 72 hours’ worth (whichever is less) of such a substance or;
(4) a wholesale distributor of a schedule II - V controlled substance or drug(s) of concern;
(5) clinics, urgent care or emergency departments dispensing to the patient no more than 12 dosage units or 72 hours’ worth (whichever is less) of such a substance or;
(6) a veterinarians or veterinary clinics dispensing to non-human patients.

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4
Q

“Drug of concern”

A

“Drug of concern” means a non-controlled dangerous drug that the Board has by rule determined to require dispenser PMP reporting of in the same manner as controlled substance prescription dispensing, when required reporting is expected to protect patients due to interaction of the drug of concern with controlled substances or other compelling issue. Gabapentin is a drug of concern, except when dispensed pursuant to a prescription issued by a veterinarian.

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5
Q

“PMP report”

A

“PMP report” means a compilation of data generated from the PMP concerning a patient, a dispenser, a practitioner, or a schedule II - V controlled substance or drug(s) of concern.

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6
Q

“Prescription monitoring program” (PMP)

A

“Prescription monitoring program” (PMP) means a program as described in 16.19.29.6 NMAC which includes a centralized system to collect, monitor, and analyze electronically, for schedules II - V controlled substances and drug(s) of concern, prescribing and dispensing data submitted by dispensers of which the data is to be used to support efforts in education, research, enforcement and abuse prevention.

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7
Q

Q: What substances are monitored under the mandatory reporting requirements to the PMP?

A

A: The board shall monitor the dispensing of all Schedule II - V controlled substances and drugs of concern by all dispensers licensed to dispense such substances to patients in this state.

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8
Q

Q: What information must each dispenser submit to the board?

A

A: Each dispenser must submit information regarding each prescription dispensed for drugs included under Schedule II - V or drugs of concern. This information includes:
1. Dispenser NPI number
2. Dispenser NCPDP number
3. Dispenser DEA number (unless no controlled substances are dispensed and dispenser has no DEA number)
4. Patient name
5. Patient address
6. Patient date of birth
7. Patient gender
8. Reporting status (new, revised, void)
9. Prescription number
10. Date prescription written
11. Refills authorized
12. Date prescription filled
13. Refill number
14. Product ID (NDC) + product ID qualifier
15. Quantity dispensed
16. Days’ supply
17. Drug dosage units
18. Transmission form of Rx origin
19. Payment type
20. Prescriber NPI number (except veterinarians)
21. Prescriber DEA number (unless prescriber is prescribing a drug of concern and has no DEA number)

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9
Q

Q: How should dispensers submit the required information?

A

A: Dispensers shall submit the information electronically by the methods and frequency established by the board, but must report within one business day of the prescription being filled.

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10
Q

Q: What should a dispenser do if no Schedule II - V controlled substances or drugs of concern were dispensed during an operating business day?

A

A: The dispenser must submit a “zero report” within one business day. The zero report must include:
1. Dispenser DEA number
2. Reporting start date
3. Reporting end date

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11
Q

Q: What authority does the PMP director have regarding submission schedules?

A

A: The PMP director has the authority to approve submission schedules that exceed one business day.

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12
Q

Q: How should corrections to information submitted to the PMP be addressed?

A

A: Corrections must be addressed as follows:
1. File upload or “outstanding uncorrected errors” must be managed as defined in the PMP data reporting manual.
2. Prescriptions that were not dispensed to the patient must be voided from the PMP.
3. Incorrect information in prescription records must be corrected in the PMP database within five business days once the dispenser is notified or becomes aware of the incorrect information.

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13
Q

Q: Is prescription information submitted to the board subject to the Inspection of the Public Records Act?

A

A: No, prescription information submitted to the board is not subject to the Inspection of the Public Records Act and shall be confidential except as provided in Subsections C through G of 16.19.29.9 NMAC.

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14
Q

Q: What measures does the board take to ensure the privacy and confidentiality of patients and their information in the PMP?

A

A: The board maintains procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained in the PMP is not disclosed except as provided in Subsections C through G of 16.19.29.9 NMAC.

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15
Q

Q: Who can board inspectors disclose prescription information to?

A

A: Board inspectors may review prescription information after receiving complaints and in the course of enforcing board-administered statutes and regulations.

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16
Q

Q: To whom can the board provide PMP information?

A

A: The board can provide PMP information to:
1. Persons authorized to prescribe or dispense controlled substances for providing medical or pharmaceutical care.
2. Consultant pharmacists for providing pharmaceutical care and ensuring proper accounting of controlled substances in facilities.
3. Delegates designated by a practitioner or pharmacist, who must maintain an active account and be authorized to request and receive PMP reports.
4. State practitioner licensing boards (e.g., medical board, board of nursing) related to their licensees.
5. Practitioner licensing authorities of other states if their licensees practice in this state or their prescriptions are dispensed in this state.
6. Local, state, and federal law enforcement or prosecutorial officials engaged in ongoing investigations of licit drug laws.
7. The state human services department regarding Medicaid program recipients.
8. State or federal courts as required by a grand jury subpoena or criminal court order.
9. State drug court personnel as authorized by the PMP director.
10. Board personnel for administration and enforcement of this rule or 16.19.20 NMAC.
11. Prescription monitoring programs of other states with which the state has an interoperability agreement.
12. Living individuals requesting their own PMP report or their authorized agents with a valid HIPAA release form or court-issued subpoena.
13. Parents accessing prescription records for their minor children as personal representatives when consistent with laws.
14. Licensed healthcare professionals (e.g., nurses, pharmacists) from Medicare, health insurers, workers’ compensation programs, and pharmacy benefit managers for patient care.

17
Q

Q: How does the board use de-identified data from the PMP database?

A

A: The board uses de-identified data to identify and report geographic areas with anomalous prescribing, dispensing, or use of controlled substances to state and local public health authorities.

18
Q

Q: How does the board share PMP database data with the department of health?

A

A: The board shares data with the department of health for tracking inappropriate prescribing and misuse of controlled substances or drugs of concern, including drug overdoses.

19
Q

Q: Can PMP data be used for statistical, research, or educational purposes?

A

A: Yes, the board can provide data to public or private entities for statistical, research, or educational purposes after removing identifying information.

20
Q

Q: Are PMP information gained from other states’ prescription monitoring programs subject to civil subpoena or admissible in civil proceedings?

A

A: No, PMP information from other states’ prescription monitoring programs is not subject to civil subpoena, nor is it discoverable or admissible as evidence in civil proceedings.

21
Q

Q: Is audit trail information maintained by the board subject to the Inspection of Public Records Act?

A

A: No, audit trail information maintained by the board is not subject to the Inspection of Public Records Act and shall be confidential except as provided in Subsections C and D of 16.19.29.10 NMAC.

22
Q

Q: What procedures does the board follow to ensure the confidentiality of audit trail information?

A

A: The board maintains procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained in the PMP is not disclosed except as provided in Subsections C and D of 16.19.29.10 NMAC.

23
Q

Q: Who can board inspectors disclose audit trail information to?

A

A: Board inspectors may review audit trail information after receiving complaints and in the course of enforcing board-administered statutes and regulations.

24
Q

Q: To whom can the board provide audit trail information?

A

A: The board may provide audit trail information to:
1. State practitioner licensing boards (e.g., medical board, board of nursing) for reviewing compliance with PMP utilization.
2. Practitioner licensing authorities of other states if their licensees practice or have prescriptions dispensed in this state, for reviewing compliance with PMP utilization.
3. Personnel of the board for administration and enforcement of this rule or 16.19.20 NMAC.
4. The department of health for tracking inappropriate prescribing and misuse of controlled substances, including drug overdose.

25
Q

Q: Is audit trail information subject to civil subpoena or admissible in civil proceedings?

A

A: No, audit trail information shall not be subject to civil subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil proceeding, nor shall it be deemed admissible as evidence in any civil proceeding.

26
Q

Q: Can the board contract with other agencies or private vendors for the PMP?

A

A: Yes, the board may contract with another agency of this state or with a private vendor as necessary to ensure the effective operation of the PMP. Contractors must comply with confidentiality provisions in 16.19.29.9 NMAC and are subject to penalties in 16.19.29.14 NMAC.

27
Q

Q: How can individuals apply for access to PMP information?

A

A: Persons authorized for access to PMP information must apply as described on the PMP website at http://nmpmp.org or as otherwise indicated. Those granted access must maintain individual accounts and not share access information.

28
Q

Q: What training is required for those applying for access to PMP information?

A

A: All persons authorized for access to PMP information must successfully complete a web-based training program as determined by the PMP director.

29
Q

Q: What must persons reporting prescription information to the PMP do regarding access?

A

A: Persons reporting prescription information to the PMP, but not authorized for access, must also apply for access as described on the PMP website at http://nmpmp.org or as otherwise indicated.

30
Q

Q: What authority does the PMP director have regarding account access?

A

A: The PMP director has the authority to set account access and registration renewal requirements and to cancel inactive accounts.

31
Q

Q: What information exchange is allowed with other states’ prescription monitoring programs?

A

A: The board may:
1. Provide PMP information to other states’ prescription monitoring programs.
2. Request and receive PMP information from other states’ prescription monitoring programs.
3. Develop the capability to transmit and receive information with other prescription monitoring programs using interoperability standards.
4. Enter into written agreements with other states or entities for sharing PMP information.

32
Q

Q: What are the penalties for failing to submit or incorrectly submitting prescription monitoring information?

A

A: Dispensers who knowingly fail to submit prescription monitoring information or submit incorrect information are subject to disciplinary proceedings as defined in Section 61-11-20 of the Pharmacy Act NMSA 1978.

33
Q

Q: What actions may be taken against someone found in violation of PMP confidentiality provisions?

A

A: A person found in violation may face:
1. Termination of access to PMP information.
2. Filing of a complaint with their appropriate professional licensing entities.

34
Q

Q: What happens if any provision of this rule is held invalid or unenforceable?

A

A: If any provision of this rule or its application to any person or circumstance is held invalid or unenforceable, the remainder of the rule remains valid and enforceable.