NMBOP: 16.19.10 LIMITED DRUG CLINICS Flashcards

1
Q

“Clinic”

A

means any facility where one or more licensed practitioners diagnose and treat patients, and where drugs are stored, dispensed, distributed or administered for the diagnosis and treatment of the facility’s patients; provided that this definition shall not include the privately owned practice of any licensed practitioner or group of licensed practitioners exempt under Section 61-11-22 of the Pharmacy Act.

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2
Q

“Dispensing Unit”

A

means a container or containers of a drug entity, either prepackaged (repackaged per Board requirements) or the manufacturer’s original container(s), containing a quantity suitable for the prescribed treatment or condition.

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3
Q

“Distribute”

A

means delivery of a dispensing unit (as defined in this section) by a licensed practitioner to a patient of the clinic by means other than dispensing.

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4
Q

“Drug Storage Area”

A

means an area restricted to the storage, dispensing and distribution of dangerous drugs

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5
Q

“Medical Records”

A

means the medical information gathered and maintained for a clinic’s patient, including but not restricted to the patients weight, height, sex, D.O.B., allergies, diagnosis and treatments.

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6
Q

“Mobile Narcotic Treatment Program”

A

means a narcotic treatment program (NTP) operating from a motor vehicle, as defined in this section, that serves as a mobile component (conveyance) and is operating under the registration of the NTP, and engages in maintenance and/ or detoxification treatment with narcotic drugs in schedules II–V, at a location or locations remote from, but within the same State as, its registered location. Operating a mobile NTP is a coincident activity of an existing NTP.

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7
Q

“Transfer”

A

means the direct delivery, physically or electronically, of dangerous drug stock unopened containers, except samples, from a clinic or the clinic’s supplier to a pharmacy to be dispensed by the pharmacy to patients of the clinic.

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8
Q

MEDICAL STATIONS AND FIRST AID STATIONS

Q: What does the New Mexico Board of Pharmacy acknowledge regarding Medical Stations and First Aid Stations?

A

A: The New Mexico Board of Pharmacy acknowledges their establishment for employees in industrial plants and business organizations, requiring adherence to laws and safeguards pertaining to drugs, and Board supervision for medications.

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9
Q

MEDICAL STATIONS AND FIRST AID STATIONS

Q: What are the requirements for the variety and quantity of medications at an Industrial Health Clinic?

A

A: The variety and quantity of medications must be kept to a minimum and only sufficient to meet the needs of the individual station.

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10
Q

MEDICAL STATIONS AND FIRST AID STATIONS

Q: Who must order the legend drugs for a Medical Station, and what additional registration is required for controlled substances?

A

A: The physician in charge must order the legend drugs. To purchase and stock controlled substances, the physician must obtain a separate controlled substance registration.

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11
Q

MEDICAL STATIONS AND FIRST AID STATIONS

Q: How must legend drugs be stored when the nurse or physician is not in attendance?

A

A: All legend drugs must be kept under lock when the nurse or physician is not in attendance, with extra precautions for the security of controlled substances.

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12
Q

MEDICAL STATIONS AND FIRST AID STATIONS

Q: What information must be recorded in the book for legend drugs at a Medical Station?

A

A: The record book must indicate:
1. Date received
2. Quantity received
3. Date of administration
4. Name of patient
5. Name of medication
6. Dosage administration
7. Name of physician responsible for the order

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13
Q

ANIMAL CONTROL CLINICS

Q: What does the New Mexico Board of Pharmacy acknowledge regarding animal control clinics?

A

A: The New Mexico Board of Pharmacy acknowledges their establishment and requires that laws and safeguards pertaining to drugs be observed, with Board supervision for medications.

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14
Q

ANIMAL CONTROL CLINICS

Q: Who must specify the dangerous drugs used in an animal control clinic, and what additional registration is required?

A

A: The veterinarian in charge must specify the dangerous drugs. The clinic must obtain a separate controlled substance registration issued under the clinic’s name to purchase and stock controlled substances

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15
Q

ANIMAL CONTROL CLINICS

Q: How must dangerous drugs be stored in an animal control clinic?

A

A: All dangerous drugs must be kept under lock when the veterinarian or their designee is not in attendance, with extra precautions for the security of controlled substances.

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16
Q

ANIMAL CONTROL CLINICS

Q: What information must be recorded to account for the administration of dangerous drugs in an animal control clinic?

A

A: The record must include:
1. Date of administration
2. Type of animal
3. Name of medication
4. Dosage administered
5. Name of veterinarian responsible for the order
6. Name of individual administering the dose

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17
Q

ANIMAL CONTROL CLINICS

Q: What are the requirements for keeping records up-to-date and their inspection?

A

A: Records must be kept up-to-date at all times and are subject to inspection by Board of Pharmacy Drug inspectors.

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18
Q

ANIMAL CONTROL CLINICS

Q: How should records for Schedule II controlled substances be maintained?

A

A: Schedule II controlled substances must be recorded in a separate record with the same information as required for other dangerous drugs.

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19
Q

ANIMAL CONTROL CLINICS

Q: How should records for Schedules III, IV, and V controlled substances be maintained?

A

A: Records for Schedules III, IV, and V controlled substances may be kept in the same record as other dangerous drugs, provided a mechanism (such as a red “C” marked in the margin) is used to identify these entries.

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20
Q

ANIMAL CONTROL CLINIC

Q: What are the requirements regarding a consultant pharmacist for an animal control clinic?

A

A:
1. If the clinic does not use controlled substances, a consultant pharmacist should visit at least annually.
2. If the clinic uses controlled substances, a consultant pharmacist should visit at least quarterly.

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21
Q

PUBLIC HEALTH CLINICS

Q: What types of clinic drug permits are described in 16.19.10.11 NMAC?

A

A: The clinic drug permits are classified as follows:
(1) Class A clinic drug permit for clinics where:
(a) Dangerous drugs are administered to patients of the clinic;
(b) More than 12,500 dispensing units of dangerous drugs are dispensed or distributed annually;
(c) Clinics dispensing only one class of dangerous drug or controlled substance, such as oral contraceptives, may be approved by the board as a Class B3 clinic.
(2) Class B clinic drug permit for clinics where dangerous drugs are:
(a) Administered to patients of the clinic; and
(b) Dispensed or distributed to patients of the clinic. Class B drug permits are issued by categories based on the number of dispensing units of dangerous drugs to be dispensed or distributed annually:
1. CATEGORY 1: up to 2,500 dispensing units;
2. CATEGORY 2: from 2,501 - 7,500 dispensing units;
3. CATEGORY 3: from 7,501 - 12,500 dispensing units.
(3) Class C clinic drug permit for clinics where dangerous drugs are administered to patients of the clinic.
(4) Class D clinic drug permit for school-based emergency medicine (SBEM) clinics - any school-based facility that chooses to possess a stock supply of emergency dangerous drugs; these emergency dangerous drugs are albuterol aerosol canisters with spacers and epinephrine standard-dose and pediatric-dose auto-injectors; these emergency dangerous drugs are for administration to students of the school; these emergency dangerous drugs shall be the property of the facility; these facilities will not stock any other dangerous drug.
(5) Class E Narcotic Treatment Program (NTP) clinic drug permit for clinics where opioid agonist treatment medications that are approved by the FDA under section 505 of the Federal Food, Drug, and Cosmetic Act [(21 U.S.C. 355)] for use in the treatment of opioid use disorder are used. An NTP must be licensed and certified as required by state and federal law, including registration under 21 USC 823(g)(1) and certified as an Opioid Treatment Program by the Substance Abuse and Mental Health Services Administration in accordance with 42 CFR 8.11.

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22
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for formulary development in clinics?

A

A:
(1) For all clinic types, drug procurement and storage are limited to the drugs listed in the dispensing formulary for the clinic. The formulary shall be developed by the pharmacy and therapeutics committee of the facility, or if no such committee exists, by the pharmacist and medical director of the clinic. A dangerous drug with the same generic name is considered one drug within the formulary (e.g., all dosage forms and packages of ampicillin are considered one drug).
(2) For all clinic types, drug procurement and storage are limited to the drugs listed in the administration formulary for on-site administration. The formulary shall be developed by the pharmacy and therapeutics committee of the facility, or if no such committee exists, by the pharmacist and medical director of the clinic. A dangerous drug with the same generic name is considered one drug within the formulary (e.g., all dosage forms and packages of ampicillin are considered one drug).
(3) For Class D (SBEM) clinics, only the approved dangerous drugs may be stocked; albuterol aerosol canisters with spacers and epinephrine standard-dose and pediatric-dose auto-injectors.
(4) A clinic may petition the board for an alternative dispensing formulary as set forth in Subsection R of 16.19.10.11 NMAC.

23
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for a consultant pharmacist in a clinic?

A

A:
(1) Any facility licensed as a clinic by the board which does not employ a staff pharmacist must engage the services of a consultant pharmacist, whose duties and responsibilities are described in Subsection C of 16.19.4.11 NMAC.
(2) The consultant pharmacist shall wear an identification badge listing his name and job title while on duty in the clinic.

24
Q

PUBLIC HEALTH CLINICS

Q: What are the roles and requirements for pharmacy technicians and support personnel in a clinic?

A

A:
(1) Pharmacy technicians, working in a clinic under the supervision of the pharmacist, may perform activities associated with the preparation and distribution of medications, including prepackaging medications and the filling of a prescription or medication order. These activities may include counting, pouring, labeling, and reconstituting medications.
(2) The pharmacist shall ensure that the pharmacy technician has completed the initial training required in Subsection A of 16.19.22.9 NMAC.
(3) A written record of the initial training and education will be maintained by the clinic pursuant to requirements of Subsection C of 16.19.22.9 NMAC.
(4) The permissible ratio of pharmacy technicians to pharmacists on duty is to be determined by the pharmacist in charge or consultant pharmacist.
(5) Support personnel may perform clerical duties associated with clinic pharmacy operations, including computer data entry, typing of labels, processing of orders for stock, duties associated with maintenance of inventory and dispensing records.
(6) The pharmacist is responsible for the actions of personnel; allowing actions outside the limits of the regulations shall constitute unprofessional conduct on the part of the pharmacist.
(7) Name tags including job title shall be required of all personnel while on duty in the clinic.

25
Q

PUBLIC HEALTH CLINICS

Q: What are the regulations for procurement or receipt of dangerous drugs in a clinic?

A

A:
(1) The system of procurement for all drugs shall be the responsibility of the pharmacist.
(2) Records of receipt of dangerous drugs and inventories of controlled substances shall be maintained as required by the Drug, Device and Cosmetic Act 26-1-16 and the Controlled Substances Act 30-31-16 and board of pharmacy regulation 16.19.20 NMAC.

26
Q

PUBLIC HEALTH CLINICS

Q: What are the rules for repackaging drugs in a clinic?

A

A:
(1) Repackaging from bulk containers to dispensing units for distribution at locations other than the site of repackaging requires FDA registration, whether or not the repackaged drugs enter interstate commerce (see FDA Regulations Title 21, Sections 207, 210, and 211).
(2) Repackaging of drug from bulk containers into multiple dispensing units for future distribution to clinic patients at the site of repackaging may be done by a physician, dentist, pharmacist, or by a pharmacy technician under the supervision of the pharmacist as defined in Subsection B of 16.19.22.7 NMAC. All drugs repackaged into multiple dispensing units by a pharmacy technician must undergo a final check by the pharmacist.
(3) A record of drugs repackaged must be maintained, including:
(a) Date of repackaging.
(b) Name and strength of drug.
(c) Lot number or control number.
(d) Name of drug manufacturer.
(e) Expiration date (per USP requirements).
(f) Total number of dosage units (tabs, caps) repackaged (for each drug).
(g) Quantity per each repackaged unit container.
(h) Number of dosage units (tabs, caps) wasted.
(i) Initials of repackager.
(j) Initials of person performing final check.
(4) All dispensing units of repackaged medication must be labeled with:
(a) Name, strength, and quantity of the drug.
(b) Lot number or control number.
(c) Name of manufacturer.
(d) Expiration date.
(e) Date drug was repackaged.
(f) Name or initials of repackager.
(g) Federal caution label, if applicable.
(5) Repackaged units must be stored with the manufacturer’s package insert until relabeled for dispensing, as specified under Subsection G of 16.19.10.11 NMAC.

27
Q

PUBLIC HEALTH CLINICS

Q: How shall drugs be dispensed or distributed in a clinic?

A

A: Drugs shall be dispensed or distributed only to clinic patients on the order of a licensed practitioner of the clinic.

28
Q

PUBLIC HEALTH CLINICS

Q: What must a clinic practitioner record for prescribed drug therapy?

A

A: The clinic practitioner shall record the prescribed drug therapy on the patient medical record indicating the name, strength, quantity, and directions for use of the prescribed drug. This information shall be initialed or signed by the practitioner. A separate prescription form in addition to the medical record may be used.

29
Q

PUBLIC HEALTH CLINICS

Q: What information must appear on the dispensing label affixed to each drug unit?

A

A: The dispensing label must include:
(a) Name of patient.
(b) Name of prescriber.
(c) Date of dispensing.
(d) Directions for use.
(e) Name, strength, and quantity of the drug.
(f) Expiration date.
(g) Name, address, and phone number of the clinic.
(h) Prescription number, if applicable.

30
Q

PUBLIC HEALTH CLINICS

Q: What is required for the final check of a dispensing unit?

A

A: The pharmacist or practitioner must provide a final check of the dispensing unit and sign or initial the prescription or dispensing record.

31
Q

PUBLIC HEALTH CLINICS

Q: How should refill prescription orders be recorded?

A

A: Refill prescription orders must be entered on the patient’s medical record and the dispensing record.

32
Q

PUBLIC HEALTH CLINICS

Q: What are the patient counseling requirements for clinics?

A

A:
(1) Each clinic licensed by the board shall develop and provide to the board policies and procedures addressing patient counseling which are at least equivalent to the requirements of Subsection F of 16.19.4.16 NMAC.
(2) If the consultant pharmacist is absent at the time of dispensing or distribution of a prescription from clinic drug stock to a clinic patient, the patient shall be provided written information when appropriate on side effects, interactions, and precautions concerning the drug or device provided. Alternative forms of patient information may be used to supplement patient counseling when appropriate. Examples include, but are not limited to, written information leaflets, pictogram labels, and video programs. The clinic shall make the consultant pharmacist’s phone number available to patients for consultation on drugs provided by the clinic.

33
Q

PUBLIC HEALTH CLINICS

Q: What must be included in dispensing records for dangerous drugs?

A

A: A record shall be kept of the dangerous drugs dispensed indicating the date the drug was dispensed, name and address of the patient, the name of the prescriber, and the quantity and strength of the drug dispensed. The individual recording the information and the pharmacist or clinic practitioner responsible for dispensing the medication shall initial the record.

34
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for sample drugs in a clinic?

A

A: Samples of medications which are legend drugs or which have been restricted to sale on prescription by the New Mexico board of pharmacy are subject to all the record keeping, storage, and labeling requirements for prescription drugs as defined by Section 26-1-16 NMSA 1978 and other applicable state and federal laws.

35
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for drug storage in a clinic?

A

A:
(1) Space for the storage and dispensing of drugs shall have proper ventilation, lighting, temperature controls, refrigeration, and adequate security as defined by the board or its agent. Minimum space requirements for main drug storage areas are as follows:
(a) For Class A clinics - 240 square foot room;
(b) For Class B clinics:
(i) Categories 1 and 2 - 48 square foot room;
(ii) Category 3 - 96 square foot room;
(c) For Class C clinics - an area adequate for the formulary.
(d) For Class D clinics - an area adequate for the formulary:
(i) Medication is stored in its original packaging until the time of administration, and secured in a secondary tamper-evident container;
(ii) The dangerous drug is stored in a restricted area, secure but unlocked, and readily accessible to authorized, trained personnel;
(iii) For Class D clinics only, the pre-licensing inspection may be completed by a New Mexico board of pharmacy state drug inspector’s approval of record keeping procedures; the policy and procedure manual; any other required forms or documents; and photographs of the proposed dangerous drug storage area, secondary tamper-evident container, and drug storage area thermometer; this pre-licensing inspection may not require an onsite inspection.
(e) For Class E clinics - 96 square foot room.
(2) Controlled substances must be stored as defined in 16.19.20.48 NMAC.
(3) All drug containers in the facility shall be clearly and legibly labeled as required under Subsection F of 16.19.10.11 NMAC – (REPACKAGING and Sections 26-1-10 and 26-1-11 of the Drug, Device and Cosmetic Act).
(4) Purchase, storage, and control of drugs shall be designed to prevent having outdated, deteriorated, impure, or improperly standardized drugs in the facility.
(5) Access to the drug storage area shall be limited to clinic practitioners, the pharmacist, and supportive personnel who are performing pharmacy-related functions.
(6) Clinics licensed by the board prior to adoption of this regulation are exempt from the minimum space requirements set forth in Paragraph (1) of Subsection K of 16.19.10.11 NMAC. When these facilities change ownership, remodel the drug storage area, or relocate after May 15, 1996, the requirements of Paragraph (1) of Subsection K of 16.19.10.11 NMAC shall apply.

36
Q

PUBLIC HEALTH CLINICS

Q: What are the procedures for the disposition of unwanted or outdated drugs?

A

A:
(1) The pharmacist shall be responsible for removal of recalled, outdated, unwanted, or otherwise unusable drugs from the clinic inventory.
(2) Options for disposal are destruction under the supervision of the pharmacist or return to the legitimate source of supply. Controlled substance disposition shall occur in accordance with 16.19.20.38 NMAC.

37
Q

PUBLIC HEALTH CLINICS

Q: What reference materials must be maintained in the clinic?

A

A: Adequate reference materials are to be maintained in the clinic. These shall include a current product information reference such as USPDI, Facts and Comparisons, or American Hospital Formulary Service; a copy of the state drug laws and regulations; and a poison treatment chart with the regional poison control center’s telephone number

38
Q

PUBLIC HEALTH CLINICS

Q: What should be included in the clinic’s procedures manual?

A

A:
(1) Written policies and procedures shall be developed by the pharmacy and therapeutics committee, or if none, by the pharmacist-in-charge and clinic’s executive director, and implemented by the pharmacist-in-charge.
(2) The policy and procedure manual shall include but not be limited to:
(a) A current list of the names and addresses of the pharmacist-in-charge, consultant-pharmacist, staff pharmacist(s), supportive personnel designated to provide drugs and devices, and the supportive personnel designated to supervise the day-to-day pharmacy-related operations of the clinic in the absence of the pharmacist;
(b) Functions of the pharmacist-in-charge, consultant pharmacist, staff pharmacist(s), and supportive personnel;
(c) Clinic objectives;
(d) Formularies;
(e) A copy of the written agreement, if any, between the pharmacist and the clinic;
(f) Date of the last review or revision of policy and procedure manual;
(g) Policies and procedures for:
(i) Security;
(ii) Equipment;
(iii) Sanitation;
(iv) Licensing;
(v) Reference materials;
(vi) Drug storage;
(vii) Packaging and repackaging;
(viii) Dispensing and distributing;
(ix) Supervision;
(x) Labeling and relabeling;
(xi) Samples;
(xii) Drug destruction and returns;
(xiii) Drug and device procuring;
(xiv) Receiving of drugs and devices;
(xv) Delivery of drugs and devices;
(xvi) Record keeping; and
(xvii) Scope of practice.
(3) The procedures manual shall be reviewed on at least an annual basis. A copy of the manual shall be kept at the clinic at all times.
(4) A written agreement defining specific procedures for the transfer, storage, dispensing, and record keeping of clinic dangerous drug stock from a licensed New Mexico pharmacy will be included in the procedures manual. The agreement will be signed by a clinic official and pharmacy official and reviewed annually.

39
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for drug transfer from a clinic to a pharmacy?

A

A:
(1) Dangerous drug stock unopened containers, except samples, may be transferred physically or electronically to a pharmacy licensed in New Mexico for dispensing to clinic patients.
(a) Record of transfer shall be maintained at the clinic and the pharmacy. It will include:
(i) Date of transfer or shipment;
(ii) Name and strength of drug;
(iii) Package size;
(iv) Number of packages

40
Q

PUBLIC HEALTH CLINICS

Q: How can a clinic petition the board for an alternative plan?

A

A: A clinic may petition the board for an alternative visitation schedule, dispensing formulary, or drug transfer system (each an “alternative plan”) as follows:
- Prior to implementation, the clinic must provide a written petition to the board describing the proposed alternative plan and justifying the request. The petition must include an affidavit stating that the clinic has a current policy and procedures manual, adequate security to prevent diversion of dangerous drugs, and compliance with all applicable rules. The affidavit must be signed by the medical director, consultant pharmacist, and the owner or chief executive officer of the clinic.
- For an alternative drug transfer system, the petition must include a detailed, written description in the policy and procedures manual of the following:
1. Drug ownership
2. Drug ordering
3. Drug shipping
4. Drug receiving
5. Drug accountability system
6. Formulary for transfer
7. Records of transfer

41
Q

PUBLIC HEALTH CLINICS

Q: What factors will the board consider when approving or denying a petition for an alternative plan?

A

A: The board may consider:
- Degree of compliance by the clinic on past compliance inspections
- Size and type of the patient population
- Number and types of drugs contained in the clinic’s formulary
- The clinic’s objectives
- Impact on the health and welfare of the clinic’s patients

42
Q

PUBLIC HEALTH CLINICS

Q: Who can administer epinephrine in a Class D (SBEM) clinic?

A

A: Only trained personnel may administer epinephrine. Trained personnel can be a school employee, agent, or volunteer who has completed epinephrine administration training documented by the school nurse, principal, or leader, approved by the New Mexico Department of Health, and designated by the school principal or leader to administer epinephrine on a voluntary basis outside of employment scope.

43
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for administering albuterol in a Class D (SBEM) clinic?

A

A: Only a school nurse may administer albuterol to a student in respiratory distress. Written policies and procedures must be maintained at the licensed location, and documentation of required training by the New Mexico Department of Health must be maintained on-site for each nurse.

44
Q

PUBLIC HEALTH CLINICS

Q: What records must be kept on-site in a Class D (SBEM) clinic?

A

A: The following records must be kept on-site and available for inspection for three years:
- Receipt records
- Destruction or other disposition records
- Storage records, including daily temperature, medication sealing, and security measures
- Usage records, including notification to the consultant pharmacist within 72 hours
- Annual self-assessment form
- Consultant pharmacist record of activities and comments
- A current copy of the facility’s New Mexico Board of Pharmacy registration and the consultant pharmacist’s current license
- Policy and procedure manual

45
Q

PUBLIC HEALTH CLINICS

Q: How should albuterol and epinephrine be stored in a Class D (SBEM) clinic?

A

A: Albuterol and epinephrine must be stored in a secure but unlocked, tamper-evident container in a restricted area, readily accessible to trained personnel. A list of the contents, including expiration dates, must be posted on the outside of the container.

46
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for administering, dispensing, distributing, or supplying drugs in an NTP clinic?

A

A: Drugs shall be administered, dispensed, distributed, or supplied only to clinic patients on the order of a licensed practitioner. This does not prohibit guest dosing pursuant to policies and procedures or supplying an opioid antagonist for rescue use. The clinic practitioner must record the prescribed drug therapy, and the order may be prepared by the practitioner, pharmacist, or technician under supervision. The pharmacist or practitioner must provide a final check and sign or initial the prescription or dispensing record.

47
Q

PUBLIC HEALTH CLINICS

Q: What are the labeling requirements for take-home methadone in an NTP clinic?

A

A: The following information must appear on the label affixed to the take-home medication unit:
- Name of patient
- Name of prescriber
- Date of dispensing
- Directions for use
- Name, strength, and quantity of the drug
- Expiration date
- Name, address, and phone number of the clinic
- Prescription number, if applicable
- Additional required information, such as federal statement(s)

48
Q

PUBLIC HEALTH CLINICS

Q: What records must an NTP clinic maintain for dangerous drugs?

A

A: Records must include:
- Name of substance
- Strength of substance
- Dosage form
- Date dispensed
- Adequate identification of the patient
- Name of the prescriber
- Amount consumed
- Amount, units, and dosage form taken home by the patient
- Initials of personnel who administered, dispensed, distributed, or supplied

49
Q

PUBLIC HEALTH CLINICS

Q: Can an NTP clinic use an automated/computerized data processing system for dispensing records?

A

A: Yes, if the system:
- Maintains required information
- Produces hard copy printouts
- Prints a hard copy of each day’s records
- Is approved by DEA
- Maintains an off-site backup
- Produces accurate summary reports

50
Q

PUBLIC HEALTH CLINICS

Q: What are the requirements for mobile NTP operations?

A

A:
- An NTP must notify the Board in writing and receive approval before operating a mobile NTP.
- A mobile NTP must operate only within New Mexico and cannot reverse distribute, share, or transfer controlled substances between mobile components.
- Vehicles must have valid county/city and State information and conform to security requirements, including the use of a safe and alarm system for controlled substances.
- Mobile NTPs must establish procedures to account for and secure controlled substances if the vehicle becomes inoperable.
- Patients must wait in a separate area from narcotic storage and preparation areas.
- Controlled substances transported for disposal must comply with regulations.
- Conveyances must be supplied with narcotic drugs only by the registered NTP that operates the conveyance.

51
Q

INPATIENT HOSPICE FACILITIES

Q: What licenses and permits are required for an inpatient hospice facility that maintains and administers drugs to patients?

A

A:
1. Custodial Care Facility License: Required for facilities maintaining custody of patients’ drugs administered by designated personnel, as described in 16.19.11.7.A or 7.B NMAC.
2. Limited Drug Permit: Required for facilities acquiring and maintaining dangerous drugs for administration to patients, as described in 16.19.10.11(A).
3. Controlled Substance Registration: Required if the facility maintains controlled substances for administration from stock, as described in 16.19.20.8 NMAC through 16.19.20.10 NMAC.

52
Q

INPATIENT HOSPICE FACILITIES

Q: What drug control and procedure manual regulations must be followed by inpatient hospice facilities?

A

A:
1. Drug Control Regulations:
- Facilities holding a license as described in 16.19.11 NMAC must comply with 16.19.11 NMAC.
- Facilities holding a license as described in 16.19.10.11.A NMAC must comply with 16.19.10.11.A.(1), 11.C through 11.K.

  1. Procedure Manual Regulations:
    • Facilities with a license as described in 16.19.11 NMAC must comply with 16.19.11.H.(1) NMAC.
    • Facilities with a license as described in 16.19.10.11.A NMAC must comply with 16.19.10.11(12).
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Q

INPATIENT HOSPICE FACILITIES

Q: What are the fee requirements for inpatient hospice facilities based on their licensing?

A

A:
1. License as described in 16.19.11 NMAC: Submit an application with license fees as described in 16.19.12.14 NMAC.
2. License as described in 16.19.10.11.A NMAC:
- Submit an application with fees as described in 16.19.12.15 NMAC.
- Submit fees as described in 16.19.12.18 NMAC for the initial inspection of the facility prior to the issuance of the license.
3. Reinstatement of Expired License: Submit an application with fees as described in 16.19.12.20 NMAC.