TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 24 EMERGENCY MEDICAL SERVICES DANGEROUS DRUGS
16.19.24.1 ISSUING AGENCY: Regulation and Licensing Department Board of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505) 841-9102.
[12-15-99; 16.19.24.1 NMAC - Rn, 16 NMAC 19.24.1, 03-30-02]
16.19.24.2 SCOPE: All Emergency Medical Services Providers (EMS) that operate in the State and administer drugs. Other rules applying to EMS drug use are found in 7.27.3 NMAC.
[12-15-99; 16.19.24.2 NMAC - Rn, 16 NMAC 19.24.2, 03-30-02]
16.19.24.3 STATUTORY AUTHORITY: Section 61-11-6(A) NMSA 1978 requires the Board of Pharmacy to provide for the licensing of EMSs and for the inspection of their facilities and activities. Pursuant to 61-11-14(B) 11 the Board is authorized to issue licenses for EMSs. Section 26-1-16(A) NMSA 1978 prohibits the sale, disposal, or possession of any dangerous drug except by individuals and entities identified in the statute.
[12-15-99; 16.19.24.3 NMAC - Rn, 16 NMAC 19.24.3, 03-30-02]
16.19.24.4 DURATION: Permanent.
[12-15-99; 16.19.24.4 NMAC - Rn, 16 NMAC 19.24.4, 03-30-02]
16.19.24.5 EFFECTIVE DATE: December 15, 1999, unless a later date is cited at the end of a Section.
[12-15-99; 16.19.24.5 NMAC - Rn & A, 16 NMAC 19.24.5, 03-30-02]
16.19.24.6 OBJECTIVE: To ensure the safe and competent maintenance, and administration of drugs by EMS.
[12-15-99; 16.19.24.6 NMAC - Rn, 16 NMAC 19.24.6, 03-30-02]
16.19.24.7 DEFINITIONS: All terms defined in the Pharmacy Act or elsewhere in the Board regulations shall have the same meanings in this regulation unless otherwise defined as follows:
A. "Emergency Medical Service" or "EMS" refers to an organization which: transports patients and/or in which patient care is delivered off-site primarily by mobile units in which one or more licensed practitioners assesses or diagnose and treat patients; and in which drugs are stored, distributed, dispensed, or administered for patient treatment.
B. "In Use" means when dangerous drugs and controlled substances are removed from the principle place of business' stored inventory and placed in jump kits or mobile units for emergency use.
C. "Jump Kit" means portable carrying devices that contain emergency medical supplies and drugs.
D. "Location" refers to any sites which are part of the EMS's operations, including its headquarters, stations, vehicle bays, docks, or hangers. This can include the mobile units or the practitioner's jump kits.
E. "Medical Director" means a physician who is responsible for all aspects of patient care of an EMS as defined in NMSA 24 10 B(3).
F. "Mobile Unit" means to a vehicle such as an ambulance, rescue or fire truck; boat or ship; or aircraft.
G. "Practitioner" refers to a licensee under the laws and regulations who is an employee or contractee of an EMS and is authorized to assess or diagnose patients, and to dispense drugs for emergency treatment. They may include physicians, physician's assistants, nurses, and/or emergency medical technicians/paramedics.
H. "Principle Place of Business" refers to any site's which are part of the EMS's operations, including its headquarters, stations, vehicle bays, docks, or hangars where dangerous drugs and/or controlled substances are stored, but does not include dangerous drugs or controlled substances "in use".
[12-15-99; 16.19.24.7 NMAC - Rn, 16 NMAC 19.24.7, 03-30-02; A 11-30-04]
16.19.24.8 MEDICAL
DIRECTOR:
A. The Medical Director shall specify the dangerous drugs to be used in such service.
B. The Medical Director shall develop protocols for use of medical procedures and dangerous drugs.
[12-15-99; 16.19.24.8 NMAC - Rn, 16 NMAC 19.24.8, 03-30-02]
16.19.24.9 ADDITIONAL REGISTRATIONS: In order to purchase and stock any controlled substance, the EMS must obtain separate Drug Enforcement Administration (DEA) and state of New Mexico controlled substance registrations to be issued under the name of the service.
[12-15-99; 16.19.24.9 NMAC - Rn, 16 NMAC 19.24.9, 03-30-02]
16.19.24.10 CONSULTANT PHARMACIST: Any EMS licensed by the Board is required to have a consultant pharmacist as defined in 16 NMAC 19.4.11. In addition, the consultant pharmacist shall:
A. review all instances in which controlled substances were used, and review all or a sample of instances in which other drugs were used, at least every 90 days;
B. report in writing any exceptions to the Medical Director and the chief executive within 24 hours upon learning of same;
C. otherwise make a written report to the Medical Director and chief executive at least annually on the EMS's drug handling practices, including corrective action taken on exception; and
D. such reports shall be available for review by the Board upon request.
E. the consultant pharmacist will develop policies and procedures for EMS regarding the following:
(a) functions of consultant pharmacist;
(b) formulary;
(c) security of drugs;
(d) equipment;
(e) universal precautions;
(f) licensing;
(g) drug storage;
(h) packaging and repackaging;
(i) distribution records;
(j) document use of expired drugs for training;
(k) administration and/or patient care records;
(l) storage of drugs in jump kits;
(m) drug destruction and records;
(n) drug and device procurement;
(o) receipt of drugs and devices;
(p) delivery of drugs and devices;
(q) designate items to be included in jump kits, define par levels of drugs, storage conditions and locations where the jump kits are in use.
[12-15-99; 16.19.24.10 NMAC - Rn, 16 NMAC 19.24.10, 03-30-02]
16.19.24.11 STORAGE
OF DANGEROUS DRUGS BY EMS:
A. All dangerous drugs must be stored with appropriate security to limit access when authorized personnel are not present. Extra precautions shall be provided for security of controlled substances.
B. Jump kits shall be kept in the possession of a licensed emergency practitioner or in a locked compartment of a mobile unit when not in use.
C. Jump kits shall be stored in the facility if the mobile unit is parked outside of a secure vehicle bay.
D. Drugs shall be stored in an area: providing proper ventilation, lighting, and temperature controls as specified by the drug manufacturer.
E. Drugs that are outdated or which have been exposed to adverse conditions shall be segregated from the inventory and held for disposition by the consultant pharmacist.
[12-15-99; 16.19.24.11 NMAC - Rn, 16 NMAC 19.24.11, 03-30-02]
16.19.24.12 Administration of dangerous drugs by EMS:
A. EMS drug administration shall be limited to drugs currently authorized by scopes of practice for EMS personnel. Each licensee shall provide a formulary to the Board on an annual basis or as changes occur.
B. EMS shall keep an up to date record in readily retrievable format for review by the Board, indicating the following information for the administration of all dangerous drugs;
(1) date of administration;
(2) name of patient;
(3) drug name and dosage administered;
(4) name of physician responsible for the order, if by other than the Medical Director’s protocols;
(5) name of EMS personnel administering the drug or drugs.
C. EMS shall keep SCHEDULE II controlled substances administration and receipt records separately from other drug records.
D. EMS may keep SCHEDULE III - V controlled substances receipt and administration records in the same record in which dangerous drugs are recorded, provided a mechanism is employed to identify these records (such as a red “C” marked in the margin of these entries).
E. All drug receipt and administration records must be readily retrievable and retained for a period of at least three years.
[12-15-99; 16.19.24.12 NMAC - Rn 16 NMAC 19.24.12, 03-30-02]
16.19.24.13 EMS licensure fees: Fees for initial and renewal applications are listed in 16.19.12.15.1.4 NMAC.
[12-15-99; 16.19.24.13 NMAC - Rn 16 NMAC 19.24.13, 03-30-02]
16.19.24.14 Training Facilities:
A. EMS Training facilities. Injury Prevention and EMS Bureau of the Department of Health will be licensed by the Board.
B. Pre-licensing inspections and fees for licensure will be waived.
C. EMS Training Facilities will conduct periodic (no less that quarterly) inventories of dangerous drugs.
D. Other than 16.19.24.14.1 NMAC and 16.19.24.14.3 NMAC regarding EMS will not apply to these training facilities.
[16.19.24.14 NMAC - N, 03-30-02]
History of 16.19.24
NMAC:
Pre-NMAC History: None.
History of Repealed Material: [RESERVED]
Other History:
16 NMAC 19.24, Pharmacists - Emergency Medical Services - Dangerous Drugs, filed 12-07-99, reformatted, renumbered and amended to 16.19.24 NMAC, Emergency Medical Services - Dangerous Drugs, effective 03-30-2002.