Tenn. Comp. R. & Regs. 1140-04-.14 - ABSENCE OF PHARMACIST

(1) Institutional pharmacy practice site.

(a) General. During such times as an institutional pharmacy practice site is closed, facility policy as approved by the pharmacist in charge shall provide a process for authorized personnel to obtain drugs necessary for the provision of patient care. This function may also be accomplished as outlined in the After Hours Drug Provision of this section. A pharmacist must be "on call" twenty four (24) hours per day, seven (7) days per week.

(b) After Hours Drug Provision. When an institutional pharmacy practice site is closed, access to prescription drugs shall be by locked cabinet(s), automated dispensing machines or other enclosure(s) constructed and located outside of the pharmacy practice site, to which only personnel authorized by the pharmacist in charge may obtain access. Access should be sufficiently secured to deny entry to unauthorized persons by force or otherwise. Those practice sites utilizing automated dispensing devices for after hours drug provision shall meet the requirements of rule 1140-04-.15. The pharmacist in charge shall develop an inventory listing of those drugs to be included in such after hours storage, and shall ensure that:

1. Such prescription drugs are available therein, properly labeled;

2. Such prescription drugs are prepackaged in amounts not to exceed a seventy-two (72) hour medication period; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products);

3. All prescription drugs therein are inventoried at least once a month;

4. A record shall be made at the after hours storage location including the following elements:

(i) The date and time of removal of a drug;

(ii) The patient's name and location;

(iii) The name, strength, dosage form, and quantity of the prescription drug; and

(iv) The identification of the authorized personnel removing the drug.

5. The prescription order shall be verified by a pharmacist or designee in a timely manner.

6. The above record shall be used by authorized pharmacy personnel to replenish the after hours storage location, and this record shall be kept at the institutional pharmacy practice site so as to be readily retrievable for at least two (2) years;

7. Policies and procedures shall be established to implement the requirements of this section.

(c) Access to the Pharmacy Practice Site within an Institutional Facility. Whenever any prescription drug is not available from floor supplies, emergency kits, or other approved distribution system for the facility, and such prescription drug or device or related material is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such prescription drug, device or related material may be obtained from the pharmacy practice site in accordance with the requirements of this paragraph. Only authorized personnel, accompanied by a security guard or other authorized employee of the institution may have access to the pharmacy practice site and may remove the required drug, device or related material. Such person(s) shall be designated through policies of the facility and shall receive appropriate education and training in the proper methods of access and removal of prescription drugs, records and procedures required prior to such person(s) being permitted to obtain access to the pharmacy practice site. Such education and training shall be conducted by the pharmacist in charge or designee, who shall require, at a minimum, the following records and procedures;

1. Removal of any prescription drug, device or related material from the pharmacy practice site by an authorized person(s) must be recorded in a suitable form at the pharmacy practice site showing:

(i) The date and time of removal of the drug;

(ii) Patient identification and location;

(iii) The name, strength, dosage form, and quantity of the drug, device or related material removed; and

(iv) The signatures of the authorized personnel and the accompanying witness;

2. The above record shall be maintained at least two (2) years at the pharmacy practice site electronically, or in a separate file or log book;

3. The medication or prescription order shall be verified by a pharmacist or authorized personnel; and

4. The quantity of drug removed shall not exceed the amount needed plus one (1) dose until the pharmacy practice site reopens; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products).

(2) Alternate or Alternative Infusion pharmacy practice site.

(a) During such times as an alternate or alternative infusion pharmacy practice site is closed, policies and procedures shall be established by the pharmacist in charge for the provision of prescription drugs, devices and related materials to patients on a twenty four (24) hours per day seven (7) days per week basis.

(b) A pharmacist must be "on call" during all absences.

Notes

Tenn. Comp. R. & Regs. 1140-04-.14

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

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(11), (14), (15), (19), (26), (27), (28), and (34) and 63-10-504(b)(1) and (2).