TITLE 16 OCCUPATIONAL
AND PROFESSIONAL LICENSING
CHAPTER 19 PHARMACISTS
PART 11 NURSING
HOME DRUG CONTROL
16.19.11.1 ISSUING
AGENCY: Regulation and Licensing Department - Board
of Pharmacy, Albuquerque, NM, (505) 841-9102.
[16.19.11.1
NMAC - Rp 16 NMAC 19.11.1, 12-15-02]
16.19.11.2 SCOPE:
All nursing homes and custodial care facilities; all health care
professionals who provide pharmaceutical products or services, including the
ordering and administration of drugs, to patients in nursing homes and custodial
care facilities. Hospital based Skilled Nursing Facilities are not subject to
this regulation - See Part 7.
[16.19.11.2
NMAC - Rp 16 NMAC 19.11.2, 12-15-02]
16.19.11.3 STATUTORY
AUTHORITY: Section 61-11-6.A(6)
NMSA 1978 authorizes the Board of Pharmacy to license nursing home drug
facilities and all places where dangerous drugs are dispensed or administered
and to provide for the inspection of their facilities and activities. Section
61-11-14.B(9) NMSA 1978 directs the Board to issue
drug custodial licenses for licensed nursing homes and to adopt regulations
that define and limit those licenses.
[16.19.11.3
NMAC - Rp 16 NMAC 19.11.3, 12-15-02]
16.19.11.4 DURATION:
Permanent
[16.19.11.4
NMAC - Rp 16 NMAC 19.11.4, 12-15-02]
16.19.11.5 EFFECTIVE
DATE: December 15, 2002, unless a later date is
cited at the end of a Section.
[16.19.11.5
NMAC - Rp 16 NMAC 19.11.5, 12-15-02]
16.19.11.6 OBJECTIVE:
The objective of Part 11 of Chapter 19 is to establish standards for the
ordering, administration, maintenance and disposal of drugs for patients in
nursing homes, skilled nursing facilities, and long-term care and custodial
care facilities and to ensure that the facilities' pharmaceutical services are
organized and carried out for the benefit and safety of the patients.
[16.19.11.6
NMAC - Rp 16 NMAC 19.11.6, 12-15-02]
16.19.11.7 DEFINITIONS:
A. Licensed
Facility - Any facility, skilled nursing facility, intermediate care or any
other upper level of care facility as defined by Health and Human Services
Department that is required to maintain custody of patients drugs in a drug room, and such drugs are administered by the facilities'
designated personnel.
B. Licensed
Custodial Care Facility - Any facility or business, including non-profit entity
which provides care and services on a continuing basis, for two or more
in-house residents, not related to the operator, and which maintains custody of
the residents' drugs.
C. Consultant
Pharmacist - means a pharmacist who is responsible to the administrator of the
facility and the Board of Pharmacy for the development of the drug storage and
distribution and record keeping requirements of a licensed nursing home
facility, and as further defined in 16.19.4.11 NMAC.
D. Designated Agent
- A licensed nurse, certified nurse practitioner, physician assistant,
pharmacist or pharmacist clinician authorized by a practitioner and employed in
a facility to whom the practitioner communicates a
prescription drug order.
E. Prescription
Drug Order - An order from a practitioner or a practitioner's designated agent
to a pharmacist for a drug or device to be dispensed.
[16.19.11.7
NMAC - Rp 16 NMAC 19.11.7, 12-15-02]
16.19.11.8 MINIMUM
STANDARDS:
A. MINIMUM
STANDARDS FOR THE DISTRIBUTION, STORAGE, HANDLING AND RECORD KEEPING OF DRUGS:
(1) The
pharmaceutical service shall be organized and maintained primarily for the
benefit and safety of the patient.
(2) All
medications administered to patients shall be by direct order of a physician,
or other licensed practitioner, as defined in the Pharmacy Act, 61-11-2P.
(3) The
pharmaceutical service shall be under the direction of a registered pharmacist,
who may be on a part-time or consultant basis.
(4) Policies
relating to the control, distribution and administration of medications shall
be developed by the pharmacist. Preparation of a written procedures manual
shall be the responsibility of the pharmacist.
(5) An
automatic stop-order policy shall be adopted to provide guidance in these
instances where medications ordered are not specifically limited as to time or
number of doses.
(6) Adequate
facilities to be provided for storage of medications. Proper labeling is
required on each patient's medication container.
(7) Complete
records - In addition to those records specifically required by federal and
state laws, records shall be maintained of the receipt, use, or disposition of
medications. The receipt and destruction
journal shall show:
(a) date;
(b) patient's name;
(c) pharmacy's name;
(d) name of drug;
(e) strength and dosage form;
(f) prescription number;
(g) quantity;
(h) initials of
person accepting delivery; and
(i) inventory
of drugs to be destroyed.
(8) Appropriate
current drug reference sources shall be provided at the facility.
(9) In
licensed nursing homes an emergency drug supply shall be maintained to be used
in a medical emergency situation, contents and quantity to be determined by a
physician, nursing director and the pharmacist of each institution. In licensed custodial care facilities an
emergency drug supply may be used. This
emergency drug supply shall be accessed only when licensed personnel are on
duty. In licensed custodial care
facilities without a 24-hour/365 day per year on-site nurse, the emergency drug
tray shall not contain any controlled substances. Licensed custodial care facilities, with a
24-hour/365 day per year on-site nurse may use an emergency drug tray
containing controlled substances. A list
of the contents of the emergency drug supply shall be attached to the outside
of the tray.
(10) Medication
errors and drug reactions should be documented and a method of reporting shall
be addressed in the pharmacy procedure manual.
B. POLICY AND
PROCEDURES MANUAL:
(1) The
pharmacist shall be responsible for the preparation of a written procedures
manual, the aim of which shall be:
(a) To
improve communications with the facility;
(b) To
improve patient care;
(c) To
aid in personnel training;
(d) To
increase legal protection;
(e) To
aid in evaluating performance;
(f) To
promote consistency and continuity.
(2) There
shall be a copy of the policy and procedure manual at each facility
location. This copy must be read and
initialed by all personnel responsible for the procurement, administration or control
of the patient's medication.
(3) The
consultant pharmacist shall make an annual review of the procedures
manual. Findings of which shall be
reported to the facility administration.
(4) Guidelines
for developing a pharmaceutical procedures manual;
(a) Drug
Policy: A written policy concerning
methods and procedures for the pharmaceutical services stating the appropriate
methods and procedures for obtaining, dispensing and administering drugs and
biologicals.
(b) Prescription
Drug Orders: The designated agent of the
facility may transcribe prescription drug orders from a licensed practitioner
and transmit those orders via telephone or facsimile to the pharmacy.
(c) Licensed
practitioners will identify the designated agents of a facility by written
authorization according to the facility's policy and procedures manual.
(d) The
facility shall have a medication administration record (MAR) documenting
medications administered to residents, including over-the-counter
medications. This documentation shall
include:
(i) Name of resident;
(ii) Date
given;
(iii) Drug
product name;
(iv) Dosage and form;
(v) Strength
of drug;
(vi) Route of administration;
(vii) How
often medication is to be taken;
(viii) Time
taken and staff initials;
(ix) Dates when the medication is
discontinued or changed;
(x) The
name and initials of all staff administering medications.
(e) Any
medications removed from the pharmacy container or blister pack must be given
immediately and documented by the person assisting.
(f) All
PRN medications shall have complete detail instructions regarding the
administering of the medication. This
shall include:
(i) Symptoms that indicate the use of
the medication;
(ii) Exact
dosage to be used;
(iii) The
exact amount to be used in a 24 hour period.
(g) Describe
medication storage, procedures, and function at the nursing stations.
(h) Describe
the medication administration system used with means of verifying accuracy of
delivered dosage. Describe the procedure for recording missed or refused doses
and the procedure followed for missed or refused doses.
(i) State that medications prescribed
for one patient shall not be administered to any other patient.
(j) Describe
policy concerning self-administration of medications by patients. A physician's order shall be required before
any resident is allowed to self-administer medications.
(k) State
procedures for documenting medication errors and drug reactions:
(i) Should a staff member of the
facility notice an error, possible overdose, or any discrepancy in any of the
prescriptions filled by the pharmacy, they will immediately contact the
pharmacy. If necessary, the pharmacy
will contact the physician.
(ii) In
the event of an adverse drug reaction the facility will immediately contact the
physician.
(l) List
labeling and storage requirements of medications in conformity with the
official compendium (USP/NF).
(5) OTHER
INFORMATION
(a) Emergency
Drug Tray - use, inventory control, replacement of drugs, security when
licensed staff is not on duty.
(b) Location
of Emergency Drug Tray.
(c) 24-hour emergency pharmaceutical
services.
(d) Part-time
or consultant pharmacist hours on premises.
(e) In-service
training.
(f) Drug
information service.
(g) Automatic
stop orders.
(h) Controlled
substances - inventory, security and control.
(i) Renewal of physician's orders.
(j) A
policy concerning "PASS" medications.
(k) Discontinued
medication.
(l) Records
and standards of storage of over-the-counter drugs.
(m) Drug
receipt and disposition records.
(6) DRUG
DISTRIBUTION
(a) All
dangerous drugs shall be obtained from a properly licensed facility. Stock
dangerous drugs acquired, maintained and administered by or at the nursing home
shall be listed in the nursing home policy and procedure manual. The stock dangerous drugs shall be used when
a licensed nurse (LPN or RN) is on duty.
The following is the approved list of stock dangerous drugs:
(i) Sterile normal saline and water -
injectable;
(ii) Sterile
normal saline and water - irrigation;
(iii) Tuberculin
testing solution;
(iv) Vaccines as recommended by the
centers for disease control (CDC) and prevention’s advisory committee on
immunization practices and appropriate for the facility population served;
(v) Any
additional nursing home stock dangerous drugs must be defined and listed in the
policy and procedure manual and must be approved by the board of pharmacy or
board’s agent prior to obtaining or using.
(b) No
drugs will be compounded by other than a pharmacist unless done in accordance
with that exemption in the State Pharmacy Act - Section 61-11-22.
(c) The
pharmacist shall be responsible for the proper removal and destruction of
unused, discontinued, outdated or recalled drugs.
(d) The
pharmacist shall require the person receiving a patient's drugs from the
pharmacist or his agent to sign a drug receipt record listing those
prescriptions received from the pharmacy.
(e) The
pharmacist shall provide the staff with a receipt listing those prescriptions
removed from the facility.
(f) Medications
will be released to patients on discharge from the facility only upon the
authorization of the physician.
(7) DRUG
CONTROL
(a) All
state and federal laws relating to storage, administration and disposal of
controlled substances and dangerous drugs shall be complied with.
(b) Separate
sheets shall be maintained for controlled substances records indicating the
following information for each type and strength of controlled substances: date, time administered, name of patient,
dose, physician’s name, signature of person administering dose, and balance of
controlled substance in the container.
(c) All
drugs shall be stored in locked cabinets, locked drug rooms, or state of the
art locked medication carts.
(d) Medication
requiring refrigeration shall be kept in a secure locked area of the
refrigerator or in the locked drug room.
(e) All
refrigerated medications will be kept in separate refrigerator or compartment
from food items.
(f) Medications
for each patient shall be kept and stored in their originally received
containers, and stored in separate compartments. Transfer between containers is forbidden,
waiver shall be allowed for oversize containers and controlled substances at
the discretion of the drug inspector.
(g) Prescription
medications for external use shall be kept in a locked cabinet separate from
other medications.
(h) No
drug samples shall be stocked in the licensed facility.
(i) All drugs shall be properly labeled
with the following information:
(i) Patient's full name;
(ii) Physician's
name;
(iii) Name,
address and phone number of pharmacy;
(iv) Prescription number;
(v) Name
of the drug and quantity;
(vi) Strength of drug and quantity;
(vii) Directions
for use, route of administration;
(viii) Date
of prescription (date of refill in case of a prescription renewal);
(ix) Expiration
date where applicable: The dispenser
shall place on the label a suitable beyond-use date to limit the patient's use
of the medication. Such beyond-use date
shall be not later than (a) the expiration date on the manufacturer's
container, or (b) one year from the date the drug is dispensed, whichever is
earlier;
(x) Auxiliary
labels where applicable;
(xi) The
Manufacturer's name;
(xii) State
of the art drug delivery systems using unit of use packaging require items i and ii above, provided that any additional information is
readily available at the nursing station.
(j) Customized
Patient Medication Packages: In lieu of
dispensing one, two, or more prescribed drug products in separate containers or
standard vial containers, a pharmacist may, with the consent of the patient,
the patient's care-giver, the prescriber, or the institution caring for the
patient, provide a customized patient medication package. The pharmacist preparing a patient medication
package must abide by the guidelines as set forth in the current edition of the
U. S. Pharmacopoeia for labeling, packaging and record keeping.
(k) Repackaging
of Patient Medication Packages: In the
event a drug is added to or discontinued from a patient's drug regimen, when a
container within the patient medication package has more than one drug within
it, the pharmacist may repackage the patient's patient medication package and
either add to or remove from the patient medication packaged as ordered by the
physician. The same drugs returned by
the patient for repackaging must be reused by the pharmacist in the design of
the new patient medication package for the new regimen, and any drug removed
must either be destroyed, returned to the DEA or
returned to the patient properly labeled.
Under no circumstances may a drug within a container of a patient
medication package which contains more than one drug be returned to the
pharmacy stock.
(l) Return
of Patient Medication Package Drugs:
Patient medication packages with more than one drug within a container
may not under any circumstances be returned to a pharmacy stock.
(m) Patient
Medication Packages with only one drug within a container:
(i) Non-Institutional: A patient medication package stored in a
non-institutional setting where there is no assurance of storage standards may
not be returned to pharmacy stock;
(ii) Institutional: A patient medication package stored in an
institutional setting where the storage and handling of the drugs are assured
and are consistent with the compendia standards may be returned to the pharmacy
stock provided the following guidelines are followed: (1) the drug is to be
kept within the patient medication package and is to remain sealed and labeled
until dispensed; (2) the expiration date of drug shall become 50% of the time
left of the expiration for the drug; (3) no Schedule II drugs may be returned
to inventory; and (4) proper record keeping for the addition of other scheduled
drugs into inventory must be done.
(8) DRUG
INFORMATION
(a) The
pharmacist shall be accessible for providing drug information.
(b) A
current reference books shall be located in each nursing station.
(c) Each
nursing station shall have poison control information and phone number and a
conversion chart for pharmaceutical weights and measures, and as a part of the
drug procedures manual.
(9) EMERGENCY
DRUG SUPPLY
(a) There
shall be an accountability record indicating the following:
(i) Name of drug, strength, and amount
of medication used;
(ii) Date
used;
(iii) Time;
(iv) Patient's name;
(v) Physician's
name;
(vi) Nurse administering drug;
(vii) Nature
of emergency.
(b) Pharmacist
shall make notation of date and time medication replacement is made on the line
following that line containing withdrawal information and sign his name, unless
the pharmacy chooses to change out the complete emergency box each time it is
used. The pharmacy shall keep a record
of each time the box is changed and a list of all drugs that were replaced in
the box.
(10) Destruction
of dispensed drugs for patients in health care facilities or institutions:
(a) The
drugs are inventoried and such inventory is verified by the consultant
pharmacist. The following information
shall be included on this inventory:
(i) name and address
of the facility or institution;
(ii) name and pharmacist license number of the consultant
pharmacist;
(iii) date of drug destruction;
(iv) date the prescription was dispensed;
(v) unique identification number assigned to the prescription by
the pharmacy;
(vi) name of dispensing pharmacy;
(vii) name, strength, and quantity of drug;
(viii) signature of consultant pharmacist destroying drugs;
(ix) signature of witness(es); and
(x) method of destruction.
(b) The
drugs are destroyed in a manner to render the drugs unfit for human consumption
and disposed of in compliance with all applicable state and federal
requirements.
(c) The
actual destruction of the drug is witnessed by the consultant pharmacist and
one of the following:
(i) An agent of the New Mexico board of
pharmacy;
(ii) Facility
administrator;
(iii) The
director of nursing.
(11) A
consultant pharmacist may utilize a waste disposal service or reverse
distributor to destroy dangerous drugs and controlled substances in health care
facilities, boarding homes or institutions provided the following conditions
are met:
(a) The
inventory of drugs is verified by the consultant pharmacist. The following information must be included on
this inventory:
(i) Name and address of the facility or
institution;
(ii) Name
and pharmacist license number of the consultant pharmacist;
(iii) Date
of packaging and sealing of the container;
(iv) Date the prescription was
dispensed;
(v) Unique
identification number assigned to the prescription by the pharmacy;
(vi) Name of dispensing pharmacy;
(vii) Name,
strength and quantity of drug;
(viii) Signature
of consultant pharmacist packaging and sealing container; and
(ix) Signature
of the witness.
(b) The
consultant pharmacist seals the container or drugs in the presence of the
facility administrator, the director of nurses or an agent of the board of
pharmacy.
(c) The
sealed container is maintained in a secure area at the facility or pharmacy
until transferred to the waste disposal service or the reverse distributor by
the consultant pharmacist, facility administrator, director of nursing or agent
of the board of pharmacy.
(d) A
record of the transfer to the waste disposal service or reverse distributor is
maintained and attached to the inventory of drugs. Such records shall contain the following
information:
(i) Date of the transfer;
(ii) Signature
of the person who transferred the drugs to the waste disposal service or
reverse distributor;
(iii) Name
and address of the waste disposal service or reverse distributor;
(iv) Signature of the employee of
the waste disposal service or the reverse distributor who receives the
container; and
(v) The
waste disposal service or reverse distributor shall provide the facility with
proof of destruction of the sealed container.
(12) Record
Retention: All records required above
shall be maintained by the consultant pharmacist and the health care facility
or institution for three years from the date of destruction.
[16.19.11.8
NMAC - Rp 16.19.11.8, 12-15-02; A, 10-24-14; A,
12-13-15]
HISTORY OF 16.19.11 NMAC:
Pre-NMAC History: The
material in this part was derived from that previously filed with the State
Records Center and Archives:
Regulation
No. 11, Nursing Home Drug Control Regulation, 2-7-80.
Regulation
No. 11, Nursing Home Drug Control Regulations, 10-24-85.
Regulation
No. 11, Nursing Home Drug Control Regulations, 12-17-85.
Regulation
No. 11, Nursing Home Drug Control Regulations, 2-2-87.
Regulation
No. 11, Nursing Home Drug Control Regulations, 7-27-90.
History of Repealed Material:
16 NMAC
19.11, Nursing Home Drug Control, filed 3-9-98 was repealed effective 12-15-02.
Other History:
Regulation
No. 11, Nursing Home Drug Control Regulations, filed 7-27-90 was renumbered and
reformatted into first version of the New Mexico Administrative Code as 16 NMAC
19.11, Nursing Home Drug Control, filed 2-2-96.
16 NMAC
19.11, Nursing Home Drug Control, filed 2-2-96 was replaced by 16 NMAC 19.11,
Nursing Home Drug Control, filed 3-9-98.
16 NMAC
19.11, Nursing Home Drug Control, filed 3-9-98 was replaced by 16.19.11 NMAC,
Nursing Home Drug Control, effective 12-15-02.