Section 211.9. Pharmacy services

(a) Facility policies shall ensure that:

(1) Facility staff involved in the administration of resident care shall be knowledgeable of the policies and procedures regarding pharmacy services including medication administration.

(2) Only licensed pharmacists shall dispense medications for residents. Licensed physicians may dispense medications to the residents who are in their care.

(b) Medications shall be administered by authorized persons as indicated in § 201.3 (relating to definitions).

(c) Medications and biologicals shall be administered by the same licensed person who prepared the dose for administration and shall be given as soon as possible after the dose is prepared.

(d) Medications shall be administered under the written orders of the attending physician.

(e) Each resident shall have a written physician’s order for each medication received. This includes both proprietary and nonproprietary medications.

(f) Residents shall be permitted to purchase prescribed medications from the pharmacy of their choice. If the resident does not use the pharmacy that usually services the facility, the resident is responsible for securing the medications and for assuring that applicable pharmacy regulations and facility policies are met. The facility:

(1) Shall notify the resident or the resident’s responsible person, at admission and as necessary throughout the resident’s stay in the facility, of the right to purchase medications from a pharmacy of the resident’s choice as well as the resident’s and pharmacy’s responsibility to comply with the facility’s policies and State and Federal laws regarding packaging and labeling requirements.

(2) Shall have procedures for receipt of medications from outside pharmacies including requirements for ensuring accuracy and accountability. Procedures shall include the review of medications for labeling requirements, dosage and instructions for use by licensed individuals who are authorized to administer medications.

(3) Shall ensure that the pharmacist or pharmacy consultant will receive a monthly resident medication profile from the selected pharmacy provider.

(4) Shall have a policy regarding the procurement of medications in urgent situations. Facilities may order a 7-day supply from a contract pharmacy if the resident’s selected pharmacy is not able to comply with these provisions.

(g) If over-the-counter drugs are maintained in the facility, they shall bear the original label and shall have the name of the resident on the label of the container. The charge nurse may record the resident’s name on the nonprescription label. The use of nonprescription drugs shall be limited by quantity and category according to the needs of the resident. Facility policies shall indicate the procedure for handling and billing of nonprescription drugs.

(h) If a unit of use or multiuse systems are used, applicable statutes shall be met. Unit of use dispensing containers or multiuse cards shall be properly labeled. Individually wrapped doses shall be stored in the original container from which they were dispensed.

(i) At least quarterly, outdated, deteriorated or recalled medications shall be identified and returned to the dispensing pharmacy for disposal in accordance with acceptable professional practices. Written documentation shall be made regarding the disposition of these medications.

(j) Disposition of discontinued and unused medications and medications of discharged or deceased residents shall be handled by facility policy which shall be developed in cooperation with the consultant pharmacist. The method of disposition and quantity of the drugs shall be documented on the respective resident’s chart. The disposition procedures shall be done at least quarterly under Commonwealth and Federal statutes.

(k) The oversight of pharmaceutical services shall be the responsibility of the quality assurance committee. Arrangements shall be made for the pharmacist responsible for the adequacy and accuracy of the services to have committee input. The quality assurance committee, with input from the pharmacist, shall develop written policies and procedures for drug therapy, distribution, administration, control, accountability and use.

(l) A facility shall have at least one emergency medication kit. The kit used in the facility shall be governed by the following:

(1) The facility shall have written policies and procedures pertaining to the use, content, storage and refill of the kits.

(2) The quantity and categories of medications and equipment in the kits shall be kept to a minimum and shall be based on the immediate needs of the facility.

(3) The emergency medication kits shall be under the control of a practitioner authorized to dispense or pre-scribe medications under the Pharmacy Act (63 P. S. § § 390.1—390.13).

(4) The kits shall be kept readily available to staff and shall have a breakaway lock which shall be replaced after each use.

The provisions of this § 211.9 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (240331) to (240335).

Notation

Authority

The provisions of this § 211.9 amended under section 803 of the Health Care Facilities Act (35 P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).