Current through Register Vol. 50, No. 9, September 20, 2024
A. The facility
must arrange for the provision of pharmaceutical services including procedures
that assure the accurate acquiring, receiving, dispensing, and administering of
all drugs and biologicals to meet the needs of each resident. Prescription
drugs not covered by Medicaid or Medicare shall be at the expense of the
resident. However, every attempt should be made to get the attending physician
to order a covered medication before the resident incurs any expense.
1. The facility shall provide routine and
emergency drugs and biologicals to its residents, or obtain them under an
agreement with an outside resource.
2. The arrangement/agreement with an outside
resource shall specify in writing that the facility assumes responsibility for:
a. obtaining services that meet professional
standards and principles that apply to professionals providing services in such
a facility; and
b. the timeliness
of the service.
B. Pharmacist or Pharmaceutical Consultant.
Facilities shall employ or obtain the services of a licensed pharmacist. The
Pharmacist/Consultant shall be expected to:
1. provide consultation (at least 1 hour per
quarter) on all aspects of the provision of pharmacy services in the facility
to insure compliance with all state and federal regulations pertaining to
Pharmacy Practice;
2. establish a
system of recording the receipt and disposition of all controlled drugs in
sufficient detail to enable an accurate reconciliation;
3. determine that drug records are in order
and that an account of all controlled drugs is maintained and monthly
reconciled;
4. perform drug
monitoring;
5. identify drug
errors;
6. alert the facility to
drug recalls; and
7. be aware of
adverse reactions/allergic reactions;
a. every
30 days the staff pharmacist or pharmaceutical consultant in nursing facilities
shall conduct drug regimen reviews. Additionally, (s)he shall ensure compliance
with drug record requirements and compliance with accounting requirements for
controlled drugs;
b. the staff
pharmacist or pharmaceutical consultant shall notify the attending physician if
changes are appropriate;
c. the
pharmacist shall report all irregularities to the attending physician or the
Director of Nursing or both and these reports must be acted upon. The physician
or director of nursing must verify that the irregularity has been noted, even
if no changes are made, by initialing and dating;
d. the facility shall maintain a
pharmaceutical committee which develops written policies and procedures for
safe and effective drug therapy, distribution, control and use;
e. Pharmaceutical Committee:
i. the committee shall be composed of at
least the pharmacist, director of nursing, the administrator and one
physician;
ii. the committee
oversees the pharmaceutical services in the facility, makes recommendations for
improvement and monitors the services to ensure accuracy and
adequacy;
iii. the committee meets
at least quarterly and documents its activities, findings, and the adequacy of
the drug program at the nursing facility;
iv. when medications are recorded or placed
in unidose by pharmacist, expiration dates shall comply with pharmaceutically
accepted practices;
v. the
pharmaceutical committee and the facility assessment and assurance committee
may be the same committee as long as all requirements are met.
C. Drug
Therapy. The facility must ensure that:
1.
for each drug ordered for residents there shall be a diagnosis or condition to
validate the use of the drug;
2.
residents shall not receive antipsychotic drugs unless the drug therapy is
necessary to treat a specific condition;
3. residents who receive antipsychotic drugs
should receive gradual dose reductions or behavioral programming unless
clinically contraindicated in an effort to discontinue these drugs;
4. the facility shall be free of significant
medication error rates; and
5.
residents shall be free of any significant medication errors.
D. Approved Drugs and Biologicals.
Only approved drugs and biologicals are used.
1. Such drugs and biologicals are:
a. included or approved for inclusion in the
United States Pharmacopeia, National Formulary, or United States Homeopathic
Pharmacopeia; or
b. included or
approved for inclusion in AMA Drug Evaluations or Accepted Dental Therapeutics,
except for any drugs and biologicals unfavorably evaluated therein;
or
c. not included nor approved for
inclusion in the compendia listed in the above paragraphs but may be considered
approved if such drugs:
i. were furnished to
the resident during his prior hospitalization, and
ii. Were approved for the use during a prior
hospitalization by the hospital's pharmacy and drug therapeutics committee (or
equivalent), and
iii. Are required
for the continuing treatment of the resident in the facility.
E. Labeling
of Drugs and Biologicals. The labeling of drugs and biologicals is based on
currently accepted professional principles and includes the resident's full
name, physician's name, full name of pharmacist dispensing, prescription
number, name and strength of drug, date of issue, expiration date of all
time-dated drugs, name, address, and telephone number of pharmacy issuing the
drug, appropriate accessory and cautionary instructions. Non-legend or
over-the-counter drugs may be labeled by the facility with resident's full name
and room number not to obscure lot number and expiration date.
1. Medication containers which have soiled,
damaged, incomplete, illegible, or makeshift labels are to be returned to the
issuing pharmacist or pharmacy for relabeling or disposal. Containers which
have no labels are to be destroyed in accordance with State and Federal
laws.
2. An approved emergency
medication kit shall be readily available and have a permit issued by the State
Pharmacy Board. Facility must have definition of bonafide emergency in its
policies and procedures.
3. The
medications of each resident are to be kept and stored in their originally
received containers. Transferring between containers is forbidden except by
registered pharmacists.
4. A
narcotic record shall be maintained which lists on separate sheets for each
type and strength of narcotic the following information:
a. date;
b. time administered;
c. name of resident;
d. dose;
e. physician's name;
f. signature of person administering dose;
and
g. balance (i.e. Barbiturates,
non-narcotic analgesics and hypnotic).
5. Poisons and medications for "external use
only" shall be kept in locked area separate from internal
medications.
6. Medications no
longer in use are to be disposed of or destroyed in accordance with Federal and
State laws and regulations.
7.
Expired medications shall be removed from usage and properly disposed
of.
F. Storage of Drugs
and Biologicals. Drugs and biologicals shall be stored in accordance with State
and Federal laws. Drugs and biologicals must be stored in locked compartments
and under proper temperature controls. Only authorized personnel shall be
permitted access to the keys.
1. Separately
locked, permanently affixed compartments for storage of controlled drugs listed
in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of
1970 shall be provided.
2. Other
drugs subject to abuse must be secure except when a single unit package drug
distribution system is used in which the quantity stored is minimal and a
missing dose can be readily detected.
H. Ordering of Medications. The facility
shall neither expect, accept, nor require any provider to give a discount or
rebate for prescription services rendered by pharmacists.
1. The facility may order at least a
one-month supply of medications from a pharmacy of the resident's choice unless
the attending physician specifies that a smaller quantity is necessary for a
special medical reason. If a one-month supply is less than 100 unit doses, then
100 unit doses may be ordered.
2.
The facility administrator or the authorized representative shall certify
receipt of prescribed medications by signing and dating the pharmacy
bill.
I. Unnecessary
Drugs
1. Each resident's drug regimen is free
of unnecessary drugs. For each drug ordered for residents there must be a
diagnosis or condition to validate the use of the drug.
2. Residents shall not receive antipsychotic
drugs unless the drug therapy is necessary to treat a specific condition. There
shall be documentation in the chart that the resident is being monitored for
side effects.
3. Residents who
receive antipsychotic drugs should receive gradual dose reductions or
behavioral programming unless clinically contraindicated in an effort to
discontinue these drugs.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
46:153.
