NMBOP: 16.19.10 LIMITED DRUG CLINICS Flashcards
(53 cards)
“Clinic”
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.
“Dispensing Unit”
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.
“Distribute”
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.
“Drug Storage Area”
means an area restricted to the storage, dispensing and distribution of dangerous drugs
“Medical Records”
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.
“Mobile Narcotic Treatment Program”
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.
“Transfer”
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.
MEDICAL STATIONS AND FIRST AID STATIONS
Q: What does the New Mexico Board of Pharmacy acknowledge regarding Medical Stations and First Aid Stations?
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.
MEDICAL STATIONS AND FIRST AID STATIONS
Q: What are the requirements for the variety and quantity of medications at an Industrial Health Clinic?
A: The variety and quantity of medications must be kept to a minimum and only sufficient to meet the needs of the individual station.
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: The physician in charge must order the legend drugs. To purchase and stock controlled substances, the physician must obtain a separate controlled substance registration.
MEDICAL STATIONS AND FIRST AID STATIONS
Q: How must legend drugs be stored when the nurse or physician is not in attendance?
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.
MEDICAL STATIONS AND FIRST AID STATIONS
Q: What information must be recorded in the book for legend drugs at a Medical Station?
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
ANIMAL CONTROL CLINICS
Q: What does the New Mexico Board of Pharmacy acknowledge regarding animal control clinics?
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.
ANIMAL CONTROL CLINICS
Q: Who must specify the dangerous drugs used in an animal control clinic, and what additional registration is required?
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
ANIMAL CONTROL CLINICS
Q: How must dangerous drugs be stored in an animal control clinic?
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.
ANIMAL CONTROL CLINICS
Q: What information must be recorded to account for the administration of dangerous drugs in an animal control clinic?
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
ANIMAL CONTROL CLINICS
Q: What are the requirements for keeping records up-to-date and their inspection?
A: Records must be kept up-to-date at all times and are subject to inspection by Board of Pharmacy Drug inspectors.
ANIMAL CONTROL CLINICS
Q: How should records for Schedule II controlled substances be maintained?
A: Schedule II controlled substances must be recorded in a separate record with the same information as required for other dangerous drugs.
ANIMAL CONTROL CLINICS
Q: How should records for Schedules III, IV, and V controlled substances be maintained?
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.
ANIMAL CONTROL CLINIC
Q: What are the requirements regarding a consultant pharmacist for an animal control clinic?
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.
PUBLIC HEALTH CLINICS
Q: What types of clinic drug permits are described in 16.19.10.11 NMAC?
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.
PUBLIC HEALTH CLINICS
Q: What are the requirements for formulary development in clinics?
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.
PUBLIC HEALTH CLINICS
Q: What are the requirements for a consultant pharmacist in a clinic?
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.
PUBLIC HEALTH CLINICS
Q: What are the roles and requirements for pharmacy technicians and support personnel in a clinic?
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.
