A. CONSULTING
PHARMACISTS TO INSTITUTIONAL (LTC) FACILITIES
1. Unless specifically authorized by the
Board to do so, no person shall serve as a consultant pharmacist or act or
purport to act in this capacity to any institutional facility unless he/she
possesses the following qualifications:
A.
Have and maintain a license to practice pharmacy within the State of
Mississippi;
B. Have attended
within the last two years a training course of not less than eight (8) hours in
institutional pharmacy services that has been approved by the Board of
Pharmacy;
C. In order to be
approved by the Board of Pharmacy, the training course for a consultant
pharmacist to an institutional facility shall provide instruction in the areas
of clinical pharmacy services, drug distribution systems and state and federal
pharmacy regulations governing the practice of institutional
pharmacy.
2. For
purposes of this ARTICLE a Consultant Pharmacist shall mean a Mississippi
licensed pharmacist who is responsible for developing, coordinating and
supervising pharmaceutical services on a regularly scheduled basis in an
institutional facility as well as the following responsibilities.
A. Reviewing policies and procedures
regarding the distribution and storage of medications within the facility and
as necessary making recommendations to the facility and provider
pharmacist;
B. Monitoring
utilization and therapeutic response of medications prescribed for and
administered to residents of the facility as well as providing consultation on
matters related to medications;
C.
Serving as a resource for pharmacy related educational services within the
facility;
D. Communication and
discussion with the provider pharmacist regarding areas of concern and
resolution thereof;
E. Serving on
appropriate committees;
F.
Supervising and assisting in the disposal of all discontinued, expired or
otherwise un-needed controlled substance medications;
G. Reviewing records of the destruction of
all medications and verification of the reasons for destruction;
H. Ensuring that complete and accurate
records of the acquisition and disposition of controlled substance medications
which have been dispensed for residents of the institutional facility are
maintained;
I. Attending, within
the last two (2) years, a consultant pharmacist seminar which has been approved
by the Board;
J. Maintain
consultant pharmacist eligibility as described in Section 1.
3. A Long Term Care
Facility which is permitted by the Board and where the services of a consultant
pharmacist are required shall have the following responsibilities:
A. Policy Manual. The institution shall
develop policies and procedures regarding pharmacy services which includes, but
is not limited to proper labeling of patient medications and emergency drugs,
security of patient medications and emergency drugs, administration and
controlled substances record-keeping and accountability. This procedural manual
shall be the responsibility of the institution and is to be promulgated with
the concurrence of the consultant pharmacist, nursing home administrator and
the directors of medical and nursing services.
A. Reference. Reference materials shall be
located in the nursing stations(s) and contain current editions of appropriate
reference materials as may be deemed necessary by the consultant pharmacist and
the medical and nursing directors.
B. Reporting. The institution shall establish
policies and procedures which assures that all medication errors and adverse
drug reactions are reported immediately to the patient's physician and the
consultant pharmacist and an entry made in the patient's record. These
procedures should assure that corrective measures are implemented. The
consultant pharmacist should be notified within twenty-four (24) hours of
discovery of any discrepancy in counts or of a loss of any controlled
substances. The consultant pharmacist should notify the Board immediately upon
his/her notification with a plan to investigate the loss.
D. Emergency Medication Kits. The institution
shall establish policies and procedures which assure that the institution is in
compliance with ARTICLE XXXV INSTITUTIONAL EMERGENCY MEDICATION KIT PERMITS of
these Pharmacy Practice Regulations.
D. Disposal of Patient Medication. The Long
Term Care Facility, with the assistance of the consultant pharmacist shall
establish policies and procedures which assures the proper disposal of any
discontinued, expired, or otherwise unwanted patient medications. Policies and
procedures should ensure that any medication, removed subject to destruction,
does not have a current valid order for the medication on the patient's
medication profile. Policies and Procedures for disposal of these medications
should include as follows:
(1) All unwanted
patient medications should remain in a secured location at the institution
until proper disposal is made; and
(2) Documentation of any disposal of patient
medications should include a paper trail from the time the medication was
logged into the discontinued drug
storage area until destruction is made. This paper trail shall include a log
containing the patient name, medication and strength, and quantity to be
destroyed as well as the initials of the person logging in the medication for
destruction. This documentation should be stored at the institution and be
readily retrievable for inspection by Board Agents for a period of two (2)
years; and
(3) Discontinued and
unwanted patient medications should be destroyed on a timely basis not to
exceed ninety (90) days from the date that the medication was discontinued. Any
such destruction should be performed by two licensed personnel and documented
for their signatures.
4. A consultant pharmacist shall document
communication of the findings of his/her reviews to the attending physician and
director of nursing along with their response and maintain these records for a
period of two (2) years. A copy of these reviews must be maintained at the
facility and available for inspection.
B. UNIT DOSE DISPENSING SYSTEMS FOR (LTCF)
Definitions: For the purpose of this ARTICLE XXX, the
following definitions apply:
A.
"Provider pharmacist, means a pharmacist licensed to practice pharmacy by the
Board who is responsible for supervising the accurate dispensing and proper
delivery of medications to a (LTCF) located within this state. These services
shall include, at a minimum, proper medication labeling, storage, transport,
record keeping and prospective drug utilization review in compliance with all
federal, state and local laws and regulations.
B. "Provider Pharmacy" means any pharmacy
permitted by the Board where medications are dispensed to residents of a long
term care facility located in this state.
C. "Single unit dose package" is a package,
which contains one discrete pharmaceutical medication dosage form.
D. "Unit dose dispensing systems" are those
drug medication distribution systems determined by the Board, which involve
single unit, unit dose or unit of issue packaging in a manner which helps
reduce or remove traditional drug stocks from patient care areas and enables
the selection and distribution of medications to be provider pharmacy based and
controlled. A unit dose dispensing system shall preserve the identity and the
integrity of the medication until the time of administration.
E. "Unit dose package" is a package, which
contains that particular dose of a medication ordered for the patient for one
administration time. A unit dose package is not always a single unit dose
package.
F. "Unit of issue package"
is a medication package issued by a provider pharmacy, which provides multiple
units/dosages of medications attached to each other but separated in a card or
a specifically designed container;
1.
Packaging for all non-sterile medications stored and dispensed in single unit
dose, unit dose or unit of issue packages for use in (LTCF) other than
hospitals shall:
A. Preserve and protect the
identity and integrity of the drug medication from the point of packaging to
the point of patient administration;
B. When packaged by the manufacturer or
distributor, be in compliance with Federal Food and Drug Administration
guidelines;
C. Shall be in
containers clean and free of extraneous matter when the dosage unit(s) are
placed into the package;
D. Utilize
containers, which are classified according to USP Standard 671 as being Class A
or Class B for oral solid dosage forms or is a tight container for liquid
dosage forms.
2.
Labeling for single unit dose or unit dose packaging shall comply with the
following;
A. Single unit doses or unit doses
packaged by the manufacturer or distributor shall be properly labeled according
to Federal Food and Drug Administration requirements;
B. Single unit doses or unit doses packaged
by the provider pharmacy shall be properly labeled according to ARTICLE XXIX
paragraph 7.;
3.
Labeling for unit of issue packages shall contain the following information:
A. Name and room or bed number of patient,
name of prescribing practitioner, name and strength of drug, directions for
use, and the name and address of the provider pharmacy when a unit of issue
package is utilized for patients in an (LTCF) setting.
4. If a pharmacist selects a generically
equivalent drug product for a brand name drug product prescribed by a
practitioner, labeling must comply with ARTICLE X of the Pharmacy Practice
Regulations of the Board.
5.
Expiration dating for non-sterile medications dispensed and packaged into
single unit doses, unit doses and unit of issue packages shall meet the
following conditions:
A. Not exceed the
manufacturer's original expiration date;
B. Have an expiration date assigned based on
the unit dose container manufacturer's recommendations;
C. May exceed Ninety (90) days from date of
repackaging provided that the container is classified according to USP Standard
671 as being Class A or Class B for oral solid dose forms or is a tight
container for liquid dosage forms, the container is light resistant when the
manufacturer has labeled the drug product "sensitive to light" and the
expiration date is not greater than twelve (12) months;
D. Drugs or dosage forms having known
stability problems are assigned an expiration date of less than ninety (90)
days or are not repackaged as determined by policies developed by the provider
pharmacy.
The shortest time span of any of the listed conditions shall
be the expiration date assigned to the medication.
C. RETURN OF
MEDICATIONS FROM AN INSTITUTIONAL FACILITY TO THE PROVIDER PHARMACY
1. Medication that has been dispensed for a
patient residing in an institutional facility may be returned to the provider
pharmacy provided that the medication has an approved reason for return as
follows:
A. Medication was discontinued prior
to delivery;
B. Patient expired
prior to medication being delivered;
C. Patient in the hospital (discharge status)
at time of delivery;
D. Medication
dosage changed prior to delivery;
E. Patient has excessive medications
remaining from previous cycle (requires written explanation by the Director of
Nurses).
F. Medication is
considered to be dispensed when it leaves the dispensing pharmacy and is
delivered to the institutional facility.
Any such medication subject to return must be intact with no
doses removed from blister package (unit dose). Medications, which have been
dispensed and placed in bulk packages and accepted by a responsible person at
the LTCF, shall not be returned to the dispensing pharmacy for any reason. All
medication subject to return, must be returned to the provider pharmacy by
pharmacy personnel within five (5) days. No controlled substances may be
returned.
The provider pharmacy must implement approved procedures,
which ensure that any returned medication has been properly stored, has not
been tampered with, and the integrity of the medication remains intact. Paper
trails tracking these procedures must be maintained by the provider pharmacy
for a period of two (2) years and be readily retrievable for inspection by
agents of the Board.