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NM MPJE 2024 > NMBOP: 32, 33, & 34 > Flashcards

NMBOP: 32, 33, & 34 Flashcards

1
Q

PART 32 WAIVER PROVISIONS

A
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2
Q

Q: What does “waive/waivers” mean in the context of New Mexico pharmacy regulations?

A

A: “Waive/waivers” means to refrain from pressing or enforcing compliance with certain regulations for a specified period of time, provided the health, safety, or welfare of patients and staff are not in danger. Waivers are issued at the sole discretion of the New Mexico Board of Pharmacy.

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3
Q

Q: What is the process for an entity seeking to obtain a waiver from the New Mexico Board of Pharmacy?

A

A: The process includes:
1. Submitting a petition to the Board of Pharmacy.
2. The petition must include:
- Name of the party
- Address of the business
- Type of business
- Reason for waiver request, including each affected New Mexico administrative code citation
- Supporting documents
- The expected public benefit as a result of the waiver
- Any other information requested by the board

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4
Q

Q: What must a licensed facility do once granted a waiver?

A

A: Any licensed facility granted a waiver must publicly display the “waiver” in proximity to the facility’s current registration.

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5
Q

Q: What information will be included in a waiver granted by the New Mexico Board of Pharmacy?

A

A: The waiver granted will include:
1. Date granted
2. Name and license number of the person or facility
3. Type of license
4. Specific regulation(s) waived
5. Duration of the waiver
6. Any alternative requirements imposed by the board

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6
Q

Q: Are waivers granted by the New Mexico Board of Pharmacy subject to any review?

A

A: Yes, all waivers will be subject to review and reconsideration.

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7
Q

PART 33 TELE-PHARMACY AND REMOTE DISPENSING

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8
Q

Q: What is meant by “Electronic link”?

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A: “Electronic link” means a real-time, continuous HIPAA-compliant computer video and audio link between the hub pharmacy and the remote tele-pharmacy during all hours of the remote tele-pharmacy’s operation and in compliance with Paragraph (4) of Subsection A of 16.19.33.9 NMAC.

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9
Q

Q: Define “Indirect supervision” in the context of tele-pharmacy.

A

A: “Indirect supervision” means continuous supervision through a constant live video link with not less than four camera views which provide for real-time live monitoring by the hub pharmacy of the remote tele-pharmacy, recorded for a minimum of 90 days. This supervision must comply with Subsection B of 16.19.22.7 NMAC.

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10
Q

Q: What is a “Patient-pharmacist audio visual link”?

A

A: “Patient-pharmacist audio visual link” means a real-time HIPAA-compliant audio-visual link from the private patient counseling area of the remote tele-pharmacy to the pharmacist at the hub pharmacy.

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11
Q

Q: What is a “Hub pharmacy”?

A

A: “Hub pharmacy” means a board-licensed pharmacy located in New Mexico operating under the direct control of a board-registered pharmacist from which computer-aided pharmacist supervision of a remote tele-pharmacy occurs.

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12
Q

Q: Define “Hub pharmacist”.

A

A: “Hub pharmacist” means a board-registered pharmacist who provides the indirect supervision of a remote tele-pharmacy via a HIPAA-compliant electronic link, including provisions for visual observations and inspection of the remote tele-pharmacy and all prescription orders prior to dispensing. This oversight includes visual inspection and patient consultation for any prescription order dispensed from the remote tele-pharmacy and is in compliance with Subsection B of 16.19.22.7 NMAC.

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13
Q

Q: Who is the “Pharmacist-in-charge”?

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A: “Pharmacist-in-charge” means the pharmacist for the hub pharmacy from which the hub pharmacist oversees the day-to-day operation of a remote tele-pharmacy and who shall comply with 16.19.6.9 NMAC.

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14
Q

Q: What are “Pharmacist site visits”?

A

A: “Pharmacist site visits” means the visitation and inspection of the tele-pharmacy by the hub pharmacist, during which the hub pharmacist is physically present to assess the remote tele-pharmacy’s compliance with all laws and regulations.

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15
Q

Q: What is a “Remote dispensing site”?

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A: “Remote dispensing site” means a pharmacy location primarily staffed by technicians and remote dispensing technology electronic link and indirect supervision with required pharmacist supervision and pharmacist site visits.

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16
Q

Q: Define “Remote tele-pharmacy”.

A

A: “Remote tele-pharmacy” means a board-licensed pharmacy located in the state of New Mexico staffed by a remote tele-pharmacy technician who practices under the direct, computer-aided supervision of a hub pharmacist working from the hub pharmacy by electronic link during all hours of operation.

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17
Q

Q: What is a “Remote tele-pharmacy technician”?

A

A: “Remote tele-pharmacy technician” means a board-registered pharmacy technician employed by the hub pharmacy, with a minimum of 2,000 hours of experience working as a certified registered pharmacy technician, who handles the day-to-day operation of a remote tele-pharmacy, including the preparation and dispensing of prescription drugs under the computer-aided supervision of an off-site pharmacist.

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18
Q

Q: What does “Practice of tele-pharmacy” involve?

A

A: “Practice of tele-pharmacy” means the provision of pharmacist care by board-licensed pharmacies and board-licensed pharmacists through the use of telecommunications or other technologies to patients or their agents at a remote tele-pharmacy site.

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19
Q

Q: What are the licensing requirements for a remote tele-pharmacy?

A

A:
1. The license holder of the hub pharmacy must apply for a license to operate a remote tele-pharmacy.
2. The remote tele-pharmacy license is issued to a tele-pharmacy connected to a hub pharmacy via an electronic link.
3. The initial licensure fee and subsequent renewal fee are the same as those for retail pharmacies, as required by Subsection E of 16.19.12.13 NMAC.

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20
Q

Q: What is required if a remote tele-pharmacy operates under different ownership from the hub pharmacy?

A

A: A written contractual agreement outlining the responsibilities of each pharmacy must be submitted with the initial licensure application. Any subsequent changes to the agreement must be submitted to the board’s executive director for approval. The addition of a tele-pharmacy must augment or expand the availability of pharmacy services in the proposed area.

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21
Q

Q: What conditions must be met for a remote tele-pharmacy’s electronic link?

A

A:
1. The remote tele-pharmacy must be connected to a hub pharmacy via a HIPAA-compliant electronic link.
2. All links must be fully operational during all hours of operation.
3. If the link malfunctions, the remote tele-pharmacy must be closed to the public unless a pharmacist is physically present.

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22
Q

Q: What are the video equipment requirements for a remote tele-pharmacy?

A

A:
1. Video equipment must provide not less than four simultaneous camera views of the pharmacy operation.
2. The video resolution must allow for identification of medication dosage forms and reading of bottle labels.
3. Video equipment must record and maintain at least 90 days of video surveillance.
4. Only a designated remote tele-pharmacy technician or a physically present pharmacist may access the site.

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23
Q

Q: What are the operational requirements for a remote tele-pharmacy regarding technicians and pharmacists?

A

A:
1. The remote tele-pharmacy may remain open only if the designated pharmacy technician is present and the hub pharmacist is providing indirect supervision or is physically present.
2. The name of each certified pharmacy technician at a remote tele-pharmacy must be recorded with the board.

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24
Q

Q: What technologies must a remote tele-pharmacy use for dispensing?

A

A: The remote tele-pharmacy must utilize bar coding or similar technology to ensure the drug or device selected matches the prescription label.

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25
Q

Q: What must be included in the written policies and procedures for a remote tele-pharmacy?

A

A: The policies and procedures must:
1. Ensure safety, accuracy, security, and patient confidentiality.
2. Comply with laws for drug procurement, handling, storage, and dispensing.
3. Identify authorized personnel for drug access.
4. Ensure records are maintained in compliance with laws.
5. Maintain the integrity of prescriptions.
6. Include criteria for monthly inspections and documentation.
7. Address medication error prevention and training standards.

26
Q

Q: What are the limits on the number of pharmacies a hub pharmacist can oversee?

A

A: A hub pharmacist shall not provide direct or indirect supervision for more than four pharmacies.

27
Q

Q: What is required regarding controlled substances at a remote tele-pharmacy?

A

A:
1. Controlled substances must be kept in accordance with 16.19.20 NMAC.
2. The remote tele-pharmacy must be registered with the DEA and have a valid New Mexico controlled substance registration.
3. Controlled substances must be listed on a perpetual inventory log and undergo monthly inventory reconciliation.

28
Q

Q: What are the requirements for prescriptions handled by a remote tele-pharmacy?

A

A: Prescriptions may be received, entered, filled, or re-filled by the hub pharmacy and sent to the remote tele-pharmacy. A hub pharmacist must complete a final check before the prescription leaves the remote tele-pharmacy, with the pharmacist’s and technician’s initials recorded.

29
Q

Q: How should patient counseling be conducted at a remote tele-pharmacy?

A

A: Patient counseling must be done by a hub pharmacist via a patient-pharmacist audio-visual link in accordance with Subsection F of 16.19.4.16 NMAC.

30
Q

Q: What is the maximum number of prescriptions a remote tele-pharmacy may fill per day?

A

A: A remote tele-pharmacy is limited to filling no more than 200 prescriptions per day. If it exceeds this number, it must be converted to a retail pharmacy and comply with all applicable requirements of 16.19.6 NMAC.

31
Q

Q: What is prohibited at a remote tele-pharmacy regarding drug preparation?

A

A: No drug compounding shall occur at any remote tele-pharmacy.

32
Q

Q: How long must records be kept at a remote tele-pharmacy?

A

A: All records required by these regulations must be kept on-site at the tele-pharmacy for at least three years and must be readily retrievable for inspection by the board or its agent.

33
Q

PART 34 PRESCRIPTION DRUG DONATIONS

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34
Q

Q: What is the definition of a “clinic” according to the regulation?

A

A: “Clinic” means a facility licensed pursuant to Section 61-22-14 NMSA 1978 in which one or more licensed practitioners diagnose and treat patients and in which drugs are stored, dispensed, or administered for the diagnosis and treatment of the facility’s patients; provided that “clinic” does not include the privately owned practice of a licensed practitioner or group of licensed practitioners exempt under Section 61-11-11 NMSA 1978.

35
Q

Q: Who is considered a “donor” under these regulations?

A

A: “Donor” means an individual who donates an unused prescription drug to a clinic or participating practitioner, who originally prescribed that prescription drug for their patient, for the purpose of redistribution to established patients of that clinic or practitioner.

36
Q

Q: What qualifies as an “eligible drug”?

A

A: “Eligible drug” means an unused prescription drug stored in a tamper-evident container, or by a tamper-evident process preventing unauthorized access, and has an expiration date of six months or greater listed on the packaging. No drug shall be re-dispensed more than one time.

37
Q

Q: What is an “ineligible drug”?

A

A: “Ineligible drug” means any controlled substances or any prescription drug within the risk evaluation and mitigation strategies (REMS) requirements as set forth by Section 505-1[21 USC355-1] of the Food Drug and Cosmetic Act (FD&C Act), with the exception of a medication guide (MedGuide) as set forth in Title 34, CFR, Subsection 208, patient package insert (PPI) or a communication plan, without prior board approval.

38
Q

Q: Who is a “participating practitioner”?

A

A: “Participating practitioner” means a licensed practitioner who is authorized to prescribe drugs, who registers with the board and is subject to rules promulgated by the board to participate in the collection of donated drugs prescribed for use by established patients of that practitioner, and donated for the purpose of redistribution to established patients of that practitioner.

39
Q

Q: What is meant by “prescription drug” in this context?

A

A: “Prescription drug” for the purposes of this rule means any drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.

40
Q

Q: Who is considered a “recipient”?

A

A: “Recipient” means an individual who voluntarily receives donated prescription drugs.

41
Q

Q: What does “tamper-evident” mean?

A

A: “Tamper-evident” means a device or process that makes unauthorized access to protected pharmaceutical packaging easily detected.

42
Q

Q: What is “REMS”?

A

A: “REMS” means risk evaluation and mitigation strategy as required by the Food and Drug Administration Amendments Act of 2007.

43
Q

Q: What procedures must clinics and participating practitioners follow for accepting and redistributing donated prescription drugs?

A

A: All clinics and participating practitioners shall follow procedures consistent with public health and safety standards for accepting and redistributing certain donated prescription drugs, including refrigerated drugs.

44
Q

Q: What must a clinic or participating practitioner do before accepting donated prescription drugs?

A

A: Before accepting donated prescription drugs, the clinic or participating practitioner shall:

  1. Register with the New Mexico board of pharmacy as a practitioner who will facilitate prescription drug donation.
  2. Provide the donor with the appropriate form for documentation and verification upon acceptance of an eligible donated drug.
  3. Identify the drug as eligible or ineligible prior to accepting the donated drug:
    • (a) Ineligible drugs may not be accepted for donation.
    • (b) Only drugs originally prescribed by a licensed clinic or practitioner may be accepted.
45
Q

Q: What are the standards and procedures for storing donated prescription drugs?

A

A: Donated prescription drugs must be stored in compliance with:
1. The manufacturer’s storage requirements per the drug monograph.
2. All donated drugs must be stored in compliance with the manufacturer’s storage requirements per the drug monograph.

46
Q

Q: What are the standards and procedures for labeling donated prescription drugs?

A

A: For labeling donated prescription drugs:
1. All personal information from the donor must be removed from the packaging.
2. Labeling must comply with FDA and New Mexico state requirements for labeling prescription drugs.

47
Q

Q: What must a clinic or participating practitioner do before redistributing donated prescription drugs?

A

A: Before redistributing donated prescription drugs, the clinic or participating practitioner shall:
1. Comply with all applicable federal laws and state laws regarding the inspection, storage, labeling, and redistribution of donated prescription drugs.
2. Confirm that the donor of a prescription drug is or was a patient of that practitioner or clinic.
3. Examine the donated prescription drug to ensure it has not been adulterated or misbranded and certify that it has been stored in compliance with product requirements.
4. Have the donor read and sign the board-approved donor form, which serves as documentation and verification upon acceptance of eligible donated drugs.
5. Have all recipients of donated prescription drugs read and sign the board-approved recipient form.
6. Confirm the patient receiving the donated prescription drug has a valid prescription/order for the drug.
7. Provide the recipient with a REMS-required patient-directed instructional document, such as a MedGuide or a PPI.
8. Confirm receipt and review of the formal communication plan from the drug manufacturer as part of the REMS requirement for the prescription drug, if applicable.

48
Q

Q: What are the standards and procedures for inspecting donated prescription drugs?

A

A: Standards and procedures for inspecting donated prescription drugs include:

  1. Packaging Inspection:
    • (a) Ensure tamper-resistant packaging is intact.
    • (b) Check for breaks, cracks, or holes in packaging.
    • (c) Confirm the appropriate quantity as indicated on the package.
    • (d) Ensure consistency of information on packaging, expiration date, lot number, and outer packaging.
  2. Inspection of Liquids:
    • (a) Observe color.
    • (b) Check thickness.
    • (c) Look for unusual particles.
    • (d) Confirm transparency.
    • (e) Detect odor.
  3. Inspection of Tablets or Capsules:
    • (a) Confirm uniformity of color.
    • (b) Check shape.
    • (c) Look for unusual spots.
    • (d) Check texture.
    • (e) Detect odor.
    • (f) Check imprint or markings.
    • (g) Look for physical damage, cracks, breaks, erosion, or abrasion.
49
Q

Q: Can a handling fee be charged to the recipient of a donated prescription drug?

A

A: Yes, a handling fee not to exceed twenty dollars ($20.00) may be charged to the recipient by the clinic or participating practitioner to cover the costs of inspecting, storing, labeling, and redistributing the donated prescription drug.

50
Q

Q: What records or forms must clinics and participating practitioners maintain for unused prescription drugs?

A

A: Clinics and participating practitioners must provide separate records or forms documenting the receipt and redistribution of all unused prescription drugs and maintain these records for three years.

51
Q

Q: What information must be included on the form signed by the donor when donating prescription drugs?

A

A: The form signed by the donor must include at least the following:

  1. Date the drug was donated.
  2. Name, address, and telephone number of the donor.
  3. Name, strength, and quantity of the drug.
  4. Manufacturer and lot number (if applicable) of the drug.
  5. Expiration date of the drug.
  6. Name, date, and signature of the practitioner or pharmacist who is accepting and inspecting the donated drugs.

The form serves as a receipt verifying the donor voluntarily donated the drug, the donated prescription drug has been properly stored—not stored at temperature extremes nor hazardous conditions and protected from light and humidity, the container has not been tampered with, and the drug has not been adulterated or misbranded.

52
Q

Q: What information must be included on the form signed by the recipient of a donated prescription drug?

A

A: The form signed by the recipient must specify:

  1. Knowledge that the donor is not a pharmacist and took reasonable care of the donated prescription drug.
  2. That the donor is known to the clinic or the participating practitioner.
  3. That there is no reason to believe that the donated prescription drug was improperly handled or stored.
  4. Any person who exercises reasonable care in donating, accepting, or redistributing pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death, or loss.
  5. That the immunity provided by this section shall not decrease or increase the civil or criminal liability of a drug manufacturer, distributor, or dispenser that would have existed but for the donation.

The form shall include at least the following:

  1. Date the recipient received the drug.
  2. Name, address, and phone number of the recipient.
  3. Name, strength, and quantity of the drug.
  4. Manufacturer and lot number (if applicable) of the drug.
  5. Expiration date of the drug.
  6. Documentation that the donated drug was dispensed with applicable forms as deemed by the REMS requirement.
  7. No product where integrity cannot be assured shall be accepted for redistribution.
53
Q

Q: What liability protections are provided for individuals involved in donating, accepting, or redistributing prescription drugs?

A

A: Any person who exercises reasonable care in donating, accepting, or redistributing prescription drugs pursuant to this section shall be immune from civil or criminal liability or professional disciplinary action of any kind for any related injury, death, or loss.

54
Q

Q: Does the immunity provided by this section affect the liability of drug manufacturers, distributors, or dispensers?

A

A: The immunity provided by this section does not decrease or increase the civil or criminal liability of a drug manufacturer, distributor, or dispenser that would have existed but for the donation.

55
Q

Q: Are manufacturers liable for failure to transfer or communicate product consumer information or expiration dates for donated prescription drugs?

A

A: No, a manufacturer shall not be liable for failure to transfer or communicate product consumer information or the expiration date of the donated prescription drug pursuant to this section.

56
Q

Q: Does this section restrict the authority of government agencies to regulate or ban the use of any prescription drugs?

A

A: No, this section does not restrict the authority of an appropriate government agency to regulate or ban the use of any prescription drugs.

57
Q

Q: What must practitioners and licensed clinics do to participate in the reuse of prescription drug donations?

A

A: Practitioners and licensed clinics must submit the required application form provided by the board to obtain eligibility for participation.

58
Q

Q: Can the board remove practitioners or licensed clinics from participating in the reuse of prescription drug donations?

A

A: Yes, the board may remove at any time practitioners or any licensed clinics from participating in the reuse of prescription drug donations should they fail to comply with regulations stated therein.

59
Q

Q: What information will the board maintain and publish regarding participating practitioners and licensed clinics?

A

A: The board shall maintain and publish a current listing of participating practitioners and licensed clinics including names(s) and address.

60
Q

Q: How should unused donated prescription drugs that were collected but not redistributed be disposed of?

A

A: Participating practitioners and licensed clinics may dispose of unused donated prescription drugs, that were collected but not redistributed, in accordance with state and federal requirements for disposal of prescription drugs.

61
Q

Q: What is required of participating practitioners regarding FDA recalls, market withdrawals, and safety alerts?

A

A: Participating practitioners shall monitor FDA recalls, market withdrawals, and safety alerts and will communicate with recipients if medications they received may be impacted by this FDA action.

NM MPJE 2024 (37 decks)

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