Current through Register Vol. 46, No. 39, September 25, 2024
(a)
The facility shall provide pharmaceutical services and develop and implement
policies and procedures that assure the accurate acquisition, receipt,
dispensing and administering of all drugs and biologicals required to meet the
needs of each resident. The facility shall provide routine and emergency drugs
and biologicals directly to its residents, or obtain them under a contract as
described in section
400.4 of this Title. The facility
shall be licensed under article 33 of the Public Health Law and Part 80 of this
Title.
(b) Service consultation.
The facility shall employ or obtain the services of a registered pharmacist
who:
(1) provides consultation on all aspects
of the provision of pharmacy services in the facility;
(2) establishes a system of records of
receipt and disposition of all controlled drugs; and
(3) determines that drug records are in order
and that an account of all controlled drugs is maintained and periodically
reconciled consistent with the requirements of article 33 of the Public Health
Law and Part 80 of this Title.
(c) Drug regimen review.
(1) The drug regimen of each resident shall
be reviewed at least once a month by a registered pharmacist.
(2) The pharmacist shall report any
irregularities to the attending physician and the director of nursing, and
these reports shall be acted upon promptly. The findings and corrective actions
shall be regularly reviewed by the quality assessment and assurance committee
established pursuant to section
415.27 of this Part.
(3) Psychotropic drugs may be administered
only on the orders of a physician and only as part of a plan of care, developed
in accordance with sections
415.4, 415.11 and
415.12 of this Part, designed to
eliminate or modify the symptoms for which the drugs are prescribed.
(d) Labeling of drugs and
biologicals. The facility shall label drugs and biologicals in accordance with
currently accepted standards of practice and include the appropriate accessory
and cautionary instructions and the expiration date. Labeling of all
medications shall be in accordance with article 137 of the State Education Law
and 8 NYCRR Part 29. Facilities which use a unit dose drug distribution system
shall develop and implement an appropriate method of providing accessory and
cautionary instructions.
(e)
Storage of drugs and biologicals.
(1) The
facility shall store all drugs and biologicals in locked compartments under
proper temperature controls, and permit access only to authorized
personnel.
(2) The facility shall
provide separately locked, permanently affixed, compartments for storage of
controlled drugs and other drugs subject to abuse, except when the facility
uses single unit package drug distribution systems in which the quantity stored
is minimal and a missing dose can be readily detected. Storage of controlled
substances shall be in accordance with article 33 of the Public Health Law and
Part 80 of this Title.
(3) Poisons
and medications for "external use only" shall be kept in a locked cabinet and
separate from other medications.
(4) Medications whose shelf life has expired
or which are otherwise no longer in use shall be disposed of or destroyed in
accordance with State and Federal laws and regulations.
(f) Return of unused medications.
(1) When services are provided by a
cooperating vendor pharmacy, the facility shall establish policies and
procedures which permit either the staff registered pharmacist or consultant
registered pharmacist to return to the vendor pharmacy from which it was
purchased any unused medications or drug products, provided such medication is
sealed in unopened, individually packaged, units and within the recommended
period of shelf life for the purpose of redispensing and which are in accord
with the following provisions:
(i) Drug
products which may be returned are limited to:
(a) oral and parenteral medication in
single-dose hermetically sealed containers; and
(b) parenteral medication in multiple-dose
hermetically sealed containers from which no doses have been
withdrawn.
(ii) The drug
products returned show no obvious sign of deterioration.
(iii) Drug products packaged in
manufacturer's unit-dose packages may be returned for redispensing provided
that they are redispensed in time for use before the expiration date, if any,
indicated on the package.
(iv) Drug
products repackaged by the pharmacy into unit-dose or multiple-dose "blister
packs" may be returned for redispensing provided that:
(a) the date on which the drug product was
repackaged, its lot number and expiration date are indicated clearly on the
package;
(b) not more than 90 days
have elapsed from the date of the repackaging;
(c) a repackaging log is maintained by the
pharmacy in the case of drug products repackaged in advance of immediate
needs.
(v) "Blister
packs."
(a) Partially used "blister packs"
may be redispensed only as returned.
(b) Partially used "blister packs" may not be
emptied and repackaged.
(c)
Additional units of medication may not be added to partially used "blister
packs."
(vi) No drug
product dispensed in bulk in a dispensing container may be returned.
(vii) No medication or drug product defined
as a controlled substance in section
3306 of the
Public Health Law may be returned.
(2) The vendor pharmacy to which such drug
products are returned shall reimburse or credit the nursing home or purchaser
of such drug products for the unused medication that is restocked and
redispensed and shall not otherwise charge any individual resident or the
State, if a resident is a recipient or beneficiary of a State-funded program,
for unused medication or drug products returned for reimbursement or
credit.
(g) Emergency
medications. The facility shall ensure the provision of (an) emergency
medication kit(s) as follows:
(1) The
contents of each kit shall be approved by the medical director, pharmacist and
director of nursing.
(2) Limited
supplies of controlled substances for use in emergency situations may be
stocked in sealed emergency medication kits.
(i) Each such kit may contain up to a 24-hour
supply of a maximum of 10 different controlled substances in unit dose
packaging, three of which may be injectable drugs.
(ii) Controlled substances contained in
emergency medication kits may be administered by authorized personnel pursuant
to an order of an authorized practitioner to meet the immediate need of a
resident. Personnel authorized to administer controlled substances shall
include registered professional nurses, licensed practical nurses or other
practitioners, licensed/registered under title VIII of the Education Law and
authorized to administer controlled substances.
(iii) The facility shall maintain all records
of controlled substances furnished or transferred from the pharmacy and the
disposition of all controlled substances in emergency kits, as required by
article 33 of the Public Health Law and corresponding regulations.
(3) For medications other than
controlled substances the medication contents of each kit shall be limited to
injectables except that the kit may also include:
(i) sublingual nitroglycerine; and
(ii) noninjectable prepackaged medications
not to exceed a 24-hour supply. The total number of noninjectables may not
exceed 25 medications for the entire facility.
(4) Each kit shall be kept and secured within
or near the nurses' station.
(h) Medications for leaves. Medication shall
be released to discharged residents or to a resident going on temporary leave.
The medication supply in the facility may be used to supply the medications
needed for a temporary leave of absence.
(i) Verbal orders. All medications
administered to residents shall be ordered in writing by a legally authorized
practitioner unless unusual circumstances justify a verbal order, in which case
the verbal order shall be given to a licensed nurse, or to a licensed
pharmacist, immediately reduced to writing, authenticated by the nurse or
registered pharmacist and countersigned by the prescriber within 48 hours. In
the event a verbal order is not signed by the prescriber or a legally
designated alternate practitioner within 48 hours, the order shall be
terminated and the facility shall ensure that the resident's medication needs
are promptly evaluated by the medical director or another legally authorized
prescribing practitioner.
