Rules & Regulations of the State of Tennessee
Title 1140 - Pharmacy
Chapter 1140-04 - Institutional and Alternate or Alternative Infusion Pharmacy Practice Sites
Section 1140-04-.09 - EMERGENCY AND HOME CARE KITS
Universal Citation: TN Comp Rules and Regs 1140-04-.09
Current through April 3, 2024
Drugs and devices and related materials may be provided by emergency kits as defined by policies and procedures provided that such kits meet the following requirements:
(1) Emergency Kits.
(a) Drugs and devices and
related materials may be provided by emergency kits as defined by policies and
procedures, provided that such kits meet the following requirements:
1. Emergency kit drugs are those drugs which
may be required to meet the immediate therapeutic needs of patients and which
are not available from any other authorized source in sufficient time to
prevent risk of harm to patients. Drugs in this kit are to be used only for
emergency orders.
2. The policies
and procedures to implement the requirements of this subsection and to approve
the contents of the emergency kit will be determined by a committee composed of
representatives of the medical and nursing staff and the pharmacist in charge
or his/her designee.
3. The
emergency kit shall be provided sealed or electronically secured by authorized
personnel in accordance with established policies. The expiration date of the
kit shall be clearly marked on the exterior of the kit to represent the
earliest expiration date of any drug, device, or related materials contained in
the kits.
4. Emergency kits shall
be stored in a secured area at the institutional facility or patient care site
to prevent unauthorized access. To ensure a proper environment for preservation
of the drugs contained therein, appropriate policies and procedures shall be
written to include storage at the site of patient care.
5. Only authorized individuals may obtain
drugs, devices or related materials from the emergency kit in accordance with
established policies and state and federal laws and regulations.
6. A list of the emergency kit contents shall
be readily accessible and it shall include the drugs, devices, and related
materials contained therein and include the name (trade and/or generic),
strength, and quantity of the products contained therein.
7. A mechanism must be in place to ensure
that the emergency kits are not in use after the expiration date.
8. Drugs contained within the emergency kit
shall be properly labeled according to the United States Food and Drug
Administration (FDA) labeling requirements for the drug or device and with
additional information that may be required by the staff to prevent
misunderstanding or risk of harm to the patients.
9. Removal of any drug, device, or related
material from the emergency kit shall be pursuant to a valid medical or
prescription order and must be documented by established policy which may
include patients identification, name of the drug, strength, amount, date,
time, and identification of the authorized individual removing the
drug.
10. When an emergency kit is
opened for any reason, the pharmacy practice site shall be notified, and the
kit shall be restocked and resealed within a reasonable time so as to prevent
risk of harm to patients.
(2) Home Care Kits.
(a) A home care kit is a kit containing
certain drugs, as determined by the board, to be kept in the home of the
patient for use by a healthcare professional engaged in home healthcare of a
patient as necessary to meet the therapeutic needs of patients and which are
not available from any other source in sufficient time to prevent risk of harm
to patients.
1. A home care kit may contain:
(i) Sodium Chloride for Injection 0.9%
Bacteriostatic
(ii) Sterile Water
for injection Bacteriostatic or Preservative Free
(iii) Epinephrine injection 1mg/ml
(iv) Diphenhydramine
(v) Heparin Flush [LESS THAN EQAUL TO] 100
units/ml
(vi) Naloxone
(vii) Sodium Chloride for
Irrigation
(viii) Sterile Water for
Irrigation
(ix) Dextrose
50%
(x) Urokinase 5000
units
(xi) Any other legend drug as
approved by the board.
(b) Drugs contained in home care kits are to
be used for emergencies only. Maintenance of a central venous catheter is
considered an emergency if confirmed with the patient's physician or his/her
designee.
(c) Policies and
procedures for the dispensing, use, storage at the patient care site, security
and expiration date review, and reconciliation of drug contents shall be
determined as in section (1)(a)2 of this rule. Additional policies or protocols
for treating anaphylactic reaction, maintaining patency of intravenous or
central venous catheters, or flushing of intravenous devices shall be
established, in the same manner.
(d) Removal of any drug from the Home Care
Kit shall be pursuant to a valid medical or prescription order and/or protocol
and must be documented in the patient's medical record.
(e) When a home care kit is opened for any
reason, the pharmacy practice site shall be notified and the kit shall be
restocked and resealed within a reasonable time so as to prevent risk of harm
to patients.
(3) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board's authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.
Authority: T.C.A. §§ 63-10-304, 63-10-504, and 63-10-504(b)(1) and (2).
Disclaimer: These regulations may not be the most recent version. Tennessee 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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