Tenn. Comp. R. & Regs. 1140-04-.09 - EMERGENCY AND HOME CARE KITS

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.

Notes

Tenn. Comp. R. & Regs. 1140-04-.09

Original rule filed February 7, 1983; effective March 9, 1983. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed August 19, 2002; effective November 2, 2002. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-304, 63-10-504, and 63-10-504(b)(1) and (2).