Prescription Services by Pharmacists/

Pharmacies for Residents in Long-Term Care Facilities PURPOSE: This rule establishes standards for pharmacists providing prescription services to residents in long-term care facilities. The standards are directed to licensed pharmacists and pharmacies, and not to long-term care facilities. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. Therefore, the material which is so incorporated is on file with the agency who filed this rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the rule is printed here. This note refers only to the incorporated by reference material. (1) Licensure. A pharmacist who or pharmacy which provides prescription services to a long-term care facility must be licensed to practice pharmacy in this state. A long-term care facility means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients. (2) Medication Services. (A) Policies and procedures shall be formulated to cover all packaging and dispensing responsibilities of the pharmacist/ pharmacy to the residents of the long-term care facility and shall include, at a minimum: 1. Methods used to dispense medications in a timely fashion to the facility; 2. Proper notification to the facility when a medication is not readily available; 3. Proper labeling requirements to meet the needs of the facility and which are consistent with state and federal laws; and 4. Appropriate medication destruction, return of unused medication, or both, which is consistent with state and federal laws. (B) Container labeling, at all times, shall conform to Chapter 338, RSMo. If a label change is required to reflect a change in directions, the pharmacist personally shall affix the correct label to the container. However, direction change labels which are defined as indicator labels that notify long-term care facility personnel that a change in directions for medication has taken place, may be used and affixed to the container by nursing home personnel in a way as not to deface the original label. Labeling of unit dose packages may be distinguished from the requirements as set forth in section 338.059, RSMo by insuring that the drug name and strength, control number and expiration date and manufacturer’s name appear on the package itself. A patient’s name and directions may not have to appear directly on the medication container but a mechanism should exist to identify for the personnel administering medications, what medications each patient is to receive and the directions for administration. (C) All prescription containers, including, but not limited to, single unit, unit dose and unit-of-use containers utilized for distribution within a long-term care facility shall meet minimum requirements as referenced by the United States Pharmacopoeia (USP) which is incorporated herein by reference. Where applicable, light-sensitive packaging shall be used. (3) Any drug, repackaged or prepacked that is dispensed into a long-term care facility, as defined in section (1) of this rule, in other than the manufacturer’s original container, shall bear the manufacturer’s expiration date or twelve (12) months, whichever is less. (4) Remote dispensing systems are defined as any system of an automated or manual design that is used to provide doses of medication to patients for the immediate administration by authorized health care personnel and is not licensed under Chapter 338, RSMo as a pharmacy. Any medication obtained in excessive amounts shall constitute the practice of pharmacy and will require adherence to all applicable licensure and drug laws. (A) If personnel other than a pharmacist restocks a remote dispensing system, then any drugs or other items that are to be placed within a remote dispensing system must be checked and approved by a licensed pharmacist. (B) Any products that are repackaged for use in a remote dispensing system must comply with all provisions of 4 CSR 220-2.130. (C) Appropriate security must be maintained over any remote dispensing system and there must be policies and procedures utilized in the delivery and storage of drugs and devices that deter misuse or theft. (5) A prescription drug order is defined for the purpose of this rule as an order originating from a long-term care facility that is initiated by a prescriber and entered into the patient’s medical record by the prescriber or qualified personnel for the purpose of initiating or renewing an order for a medication or device. All prescription drug orders shall comply with 4 CSR 220-2.018. (A) A prescription drug order may be transferred to a licensed pharmacy for the purpose of providing an order to prepare, compound or dispense a medication or for the purpose of providing drug or medical information for use by the pharmacist in providing patient care services. (B) In order for a generic substitution as defined in section 338.056, RSMo to take place, a prescription drug order must either comply with the prescription form as defined in section 338.056.2(1), RSMo or provide an alternate method for documenting whether a generic substitution has been authorized as determined by the long-term care medical staff. When a generic substitution is authorized and is executed by the pharmacist a clear documentation must be completed in accordance with 4 CSR 220-2.018(1)(H) and 4 CSR 220-2.080(2) (M). (C) A pharmacy may elect to maintain a separate file system for prescription drug orders that are dispensed. When a separate file is utilized, it must comply with all applicable laws governing the maintenance and use of a prescription file by a pharmacy and the numbering system used to number prescription drug orders must be distinct from any other prescription file that is maintained. (D) Packaging and labeling of containers shall comply with all applicable state and federal laws for any medications that leave the facility or are provided to the patient by the pharmacy for use outside the facility. Prescription drug orders issued for use within the long-term care facility are not valid for refill outside the facility. (6) Nothing in this rule shall be deemed to constitute a waiver or abrogation of any of the provisions of Chapter 338, RSMo or other applicable provisions of state and federal laws and rules, nor should this rule be construed as authorizing or permitting any person not licensed as a pharmacist to engage in the practice of pharmacy. (7) The provisions of this rule are declared severable. If any portion of this rule is held invalid by a court of competent jurisdiction, the remaining provisions of this rule shall remain in full force and effect unless otherwise determined by the court. AUTHORITY: sections 338.010, 338.210, 338.240 and 338.280, RSMo 1994 and 338.140, RSMo Supp. 1999.* This rule originally filed as 4 CSR 220-2.140. Original rule filed Oct. 16, 1987, effective March 25, 1988. Amended: Filed July 5, 1988, effective March 1, 1989. Amended: Filed July 19, 1991, effective Jan. 13, 1992. Amended: Filed Jan. 27, 1995, effective Sept. 30, 1995. Amended: Filed July 28, 2000, effective Jan. 30, 2001. Moved to 20 CSR 22202.140, effective Aug. 28, 2006. *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990; 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.210, RSMo 1951; 338.240, RSMo 1951; and 338.280, RSMo 1951, amended 1971, 1981.