Mississippi Administrative Code
Title 30 - Mississippi State Board of Public Accountancy
Part 3001 - MISSISSIPPI PHARMACY PRACTICE REGULATIONS
Article XXX - LONG-TERM CARE FACILITIES (LTCF)
Universal Citation: MS Code of Rules XXX
Current through December 10, 2024
1. CONSULTING PHARMACISTS TO NURSING HOMES
A. Unless
specifically authorized by the Board, no person shall serve as a consultant
pharmacist or act or purport to act in this capacity to any nursing home unless
he/she possesses the following qualifications:
(1) Have and maintain a license to practice
pharmacy within the State of Mississippi;
(2) Have attended within the last two years a
training course of not less than eight (8) hours in LTC or geriatric related
pharmacy services that has been approved by the Board of Pharmacy;
(3) In order to be approved by the Board of
Pharmacy, the training course for a consultant pharmacist shall provide
instruction in the areas of clinical pharmacy services, drug distribution
systems and state and federal pharmacy regulations governing the practice of
long-term care pharmacy.
B. 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 a LTCF, as well as the following responsibilities.
(1) 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;
(2) 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;
(3)
Serving as a resource for pharmacy related educational services within the
facility;
(4) Communication and
discussion with the provider pharmacist regarding areas of concern and
resolution thereof;
(5) Serving on
appropriate committees;
(6)
Supervising and assisting in the disposal of all discontinued, expired, or
otherwise un-needed controlled substance medications;
(7) Reviewing records of the destruction of
all medications and verification of the reasons for destruction;
(8) Ensuring that complete and accurate
records of the acquisition and disposition of controlled substance medications
which have been dispensed for residents of the LTCF are maintained;
(9) Attending, within the last two (2) years,
a consultant pharmacist seminar which has been approved by the Board;
(10) Maintain consultant pharmacist
eligibility as described in Section 1.
C. A LTCF which is permitted by the Board and
where the services of a consultant pharmacist are required shall have the
following responsibilities:
(1) Policy Manual.
The LTCF shall develop policies and procedures regarding pharmacy services
which include, but are 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 facility and is to be
promulgated with the concurrence of the consultant pharmacist, nursing home
administrator and the directors of medical and nursing services.
(2) Reference. Reference materials shall be
readily available 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.
(3) Reporting. The facility 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.
(4) 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 (FIRST DOSE KITS) FOR LONG TERM CARE FACILITIES AND
OTHER APPROVED INSTITUTIONAL FACILITIES of these Pharmacy Practice
Regulations.
(5) Disposal of
Patient Medication. The LTCF, 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:
(a) All unwanted
patient medications should remain in a secured location at the institution
until proper disposal is made;
(b)
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;
(c) Discontinued and
unwanted patient medications shall be destroyed on a timely basis not to exceed
sixty (60) days from the date that the medication was discontinued. Any such
destruction shall be performed by two licensed personnel and documented by
their signatures. The consultant pharmacist is valid personnel to participate
in this activity.
D. A consultant pharmacist shall document
communication of the findings of his/her reviews to the attending physician and
director of nursing along with their responses 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.
2. UNIT DOSE DISPENSING FOR LTCF
A. Definitions: For the purpose of this
ARTICLE XXX, the following definitions apply:
(1) "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.
(2) "Provider
Pharmacy" means any pharmacy permitted by the Board where medications are
dispensed to residents of a LTCF located in this state.
(3) "Unit dose package" is a package, which
contains one dose of a medication for administration to a patient. A unit dose
package may contain one or more individual units or fractions of units of a
distinct medication.
(4) "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.
(5) "Multi-dose strip packaging" (MDS) is a
medication package issued by a provider pharmacy which provides multiple
distinct medications to be administered at the same time.
B. Packaging for all non-sterile medications
stored and dispensed in single unit dose, unit dose, unit of issue or MDS
packages for use in a LTCF shall:
(1) Preserve
and protect the identity and integrity of the drug medication from the point of
packaging to the point of patient administration;
(2) When packaged by the manufacturer or
distributor, be in compliance with Federal Food and Drug Administration
guidelines;
(3) Shall be in
containers clean and free of extraneous matter when the dosage unit(s) are
placed into the package;
(4)
Utilize containers, which are classified according to USP Standard 671 as being
Class A or Class B for oral solid dosage forms or tight containers for liquid
dosage forms.
C.
Labeling for unit dose packaging or multi-dose strip packaging shall comply
with the following;
(1) When packaged by the
manufacturer or distributor shall be properly labeled according to Federal Food
and Drug Administration requirements;
(2) Unit doses or multi-dose strip packaging
packaged by the provider pharmacy shall be properly labeled according to
ARTICLE XXIX. If needed, the provider pharmacy may utilize an external
container to provide required labeling elements. The name of the patient, drug,
dosage strength and form must be on the primary packaging.
(3) Labeling for unit of issue packages shall
contain the following information: Name and facility specific patient
identifier (e.g., 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 utilized for patients in an LTCF
setting.
D. 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.
E. 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:
(1) Not exceed the manufacturer's original
expiration date;
(2) Have an
expiration date assigned based on the unit dose container manufacturer's
recommendations;
(3) 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;
(4) Drugs or dosage forms
having known stability problems or that are not packaged as defined in Article
XXX are assigned an expiration date of less than ninety (90) days.
(5) The shortest time span of any of the
listed conditions shall be the expiration date assigned to the
medication.
3. RETURN OF MEDICATIONS FROM A LTCF TO THE PROVIDER PHARMACY
A. Medication that has been
dispensed for a patient residing in a LTCF facility may be returned to the
provider pharmacy provided that the medication has an approved reason for
return as follows:
(1) Medication was
discontinued prior to delivery;
(2)
Patient no longer a patient or expired prior to medication being
delivered;
(3) Medication dosage
changed prior to delivery;
(4)
Medication is considered to be dispensed when it leaves the dispensing pharmacy
and is delivered to the LTCF.
B. Any medication subject to return must be
intact with no doses removed from blister package (unit dose) and must not have
had contact with other medications. 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.
C. 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.
Disclaimer: These regulations may not be the most recent version. Mississippi may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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