201 KAR 2:074. Pharmacy services in hospitals or other organized health care facilities.
RELATES TO: KRS 315.010, 315.020, 315.030, 315.121
STATUTORY AUTHORITY: KRS 315.191(1)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1) requires the Kentucky Board of Pharmacy to establish requirements to regulate and control pharmacies. KRS 315.002 and 315.005 require standards of practice in all settings where drugs are handled and requires the board to insure the safety of all drug products provided to the citizens of Kentucky. This administrative regulation establishes requirements for pharmacy services in hospitals or other organized health care facilities.
Section 1. (1) "Institutional pharmacy" means that portion of an acute care hospital licensed under 902 KAR 20:016 or a pharmacy serving another organized health care facility which is engaged in the manufacture, production, sale or distribution of drugs, medications, devices or other materials used in the diagnosis or treatment of injury, illness, or disease.
(2) "Investigational drug" means any drug which has not been approved for use in the United States, but for which an investigational drug application has been approved by the FDA.
(3) "Other organized health care facility" means a facility:
(a) Whose primary purpose is to provide medical care and treatment to inpatients; and
1. An intermediate care facility;
2. A skilled nursing facility;
3. A hospital other than an acute care hospital licensed under 902 KAR 20:016;
4. A licensed personal care home;
5. A licensed family care home;
6. A nursing home;
7. A nursing facility;
8. An intermediate care facility for mental retardation; or
9. An Alzheimer's nursing home.
(4) "Unit dose distribution" means a system in which drug therapy profiles are maintained in the pharmacy and doses are scheduled, prepared, and delivered in a ready-to-administer form to the patient care area as they are needed.
Section 2. Pharmacy Administration. (1) General. The pharmacy, organized as a separate department or service, shall be directed by a professionally competent, legally qualified pharmacist. The director of pharmacy services shall be responsible for departmental management and the development and implementation of goals and objectives to meet the needs of the institution.
(2) Director of pharmacy.
(a) The director of pharmacy services shall be thoroughly knowledgeable about institutional pharmacy practice and management.
(b) If the director of pharmacy services is not employed full time, the institution shall establish an ongoing arrangement in writing with an appropriately qualified pharmacist to provide services required by this administrative regulation and KRS 315.020(1). The director of pharmacy services shall be responsible to the chief executive officer of the institution or his designee.
(c) If a hospital pharmacy is decentralized, each decentralized section or separate organizational element shall be under the immediate supervision of a pharmacist responsible to the director.
(3) Pharmacy personnel.
(a) The institutional pharmacy shall maintain additional pharmacists in cooperation with the institution's administration, either full time or part time, as they are required to operate safely and effectively to meet the needs of the patients.
(b) If nonpharmacist personnel are employed, they shall perform all duties under the supervision of a pharmacist and they shall not be assigned, nor shall they perform, duties that are to be performed only by pharmacists.
(a) Lines of authority and areas of responsibility within the pharmacy shall be clearly defined. Written job descriptions for all categories of pharmacy personnel shall be prepared and revised as necessary.
(b) There shall be policies and procedures to provide for selection of drugs as well as a distribution system to serve the needs of the patient. Provision for procurement of drugs in an emergency situation shall be provided for.
(5) Supportive personnel.
(a) Sufficient supportive personnel (technical, clerical, and other) shall be available in order to optimize the participation of pharmacists in activities requiring professional judgment.
(b) The training and supervision of supportive personnel shall be the responsibility of the pharmacist.
(a) The services of a pharmacist shall be available at all times. However, if around-the-clock operation of the pharmacy is not feasible, the pharmacist shall be available on an on-call basis and an adequate night drug cabinet shall be established. The pharmacy itself shall not be designated as the night drug cabinet.
(b) Hospitals not having a full-time pharmacist, but in which drugs are prepackaged or relabeled or transferred from one container to another, shall obtain a pharmacy permit and have at least a part-time pharmacist designated to perform those functions or to provide personal supervision of those functions.
Section 3. Physical Facility. (1) The institutional pharmacy shall have adequate space, equipment, and supplies sufficient to provide for safe and efficient drug storage, preparation and distribution, patient education and consultation, drug information services, and proper management of the department.
(2) Legal requirements. The physical facility shall meet state and federal regulations and shall be accessible by key by authorized pharmacy personnel only.
(3)(a) A currently licensed hospital shall be exempt from the provisions of subsection (2) of this section if it:
1. Is authorized by the Department for Health and Human Services to provide pharmacy services; and
2. Does not currently possess a pharmacy permit.
(b) A currently licensed hospital exempt from the provisions of subsection (2) of this section shall permit access by authorized personnel only.
(4) Location. Locked storage or locked medication carts shall be provided for use in each nursing unit or service area.
(5) Reference materials. The pharmacy shall have current pharmaceutical reference materials in accordance with 201 KAR 2:090. References related to the following subjects shall also be available:
(a) Drug identification;
(c) Drug interactions;
(d) Parenteral drug compatibility; and
Section 4. Drug Distribution and Control. (1) General. The institutional pharmacy shall be responsible for the procurement, distribution and control of all drugs and parenteral solutions used within the institution. Policies and procedures governing these functions shall be developed by the pharmacist with input from other involved hospital or other organized health care facility staff (e.g., nurses) and committees (e.g., pharmacy and therapeutics committee and patient care committee).
(2) Dispensing. The pharmacist shall dispense medications only on the order of a licensed practitioner.
(3) Prescriber's order. The pharmacist shall review the medication order within a reasonable amount of time.
(4) Recordkeeping. The pharmacist shall maintain appropriate records of each medication order. The records shall be retained for the time and in the manner prescribed by state and federal law.
(5) Patient medication profile. A medication profile shall be maintained for all inpatients and for those ambulatory patients routinely receiving care at the institution. The pharmacist shall utilize this profile to properly review, schedule, prepare, and distribute medications except in emergency situations.
(6) Labeling and packaging.
(a) All licensees shall comply with U.S.P. Standards established pursuant to federal law and all state and federal laws and regulations regarding labeling and packaging.
(b) Labeling and packaging of medications used for outpatients shall meet the requirements of state and federal law.
(7) Dispensing. The pharmacist shall dispense medications by the unit dose distribution system if feasible. If the unit dose distribution system is not utilized, adequate safeguards shall be in place to protect patients.
(8) Stop orders. There shall be established written stop order policies or other methods of assuring that drug orders are not continued inappropriately in accordance with the status of the patient.
(9) Administration. Drugs shall be administered only upon order of a licensed practitioner. The institutional pharmacy shall participate in the establishment of policies and procedures regarding the administration of medications. Specific procedures shall be developed in cooperation with appropriate hospital or other health care facility personnel regarding and shall include personnel authorized to schedule, prepare and administer medications.
(10) Unused medication. The institutional pharmacy shall establish policies and procedures for the disposition of patients' unused medications. Medication in unit dose form may be reissued if package integrity has been maintained and the product is still in date.
(11) Hospital floor stocks.
(a) Floor stocks of drugs shall be kept as small as possible. The pharmacist in charge shall be responsible for authenticating the need for floor stock.
(b) A pharmacist shall review all orders distributed through floor stock within a reasonable amount of time.
(c) The pharmacist in charge shall be responsible for defining those areas of the hospital requiring floor stock (e.g., emergency room, surgery, critical care, or medical or surgical wards).
(d) All drug storage areas within the hospital shall be routinely inspected by pharmacy personnel at least monthly and documentation maintained to insure that no unusable items are present and that all stock items are properly labeled and stored.
(e) This subsection shall not apply to other organized health care facilities.
(12) Drug recall. There shall be a system for removing from use any drugs subjected to a recall.
(13) Sample medications. The institutional pharmacy shall establish policies and procedures regarding medical representatives and the obtaining, storage, and dispensing of complimentary packages of medications.
(14) Emergency drugs.
(a) The institutional pharmacy shall establish policies and procedures for supplying emergency drugs.
(b) For expediency and efficiency, emergency drugs shall be limited in number to include only those whose prompt use and immediate availability are generally regarded by physicians as essential in the proper treatment of sudden and unforeseen patient emergencies.
(c) Emergency stocks shall be routinely inspected by pharmacy personnel on a monthly basis and documentation maintained to determine if contents have become outdated and if the stocks are being maintained at adequate levels.
(15) Investigational drugs.
(a) Policies and procedures controlling the use of investigational drugs (if used in the institution) shall be developed and followed.
(b) The pharmacy shall be responsible for storing, packaging, labeling, distributing, maintaining inventory records (including lot numbers and expiration date) and providing information about investigational drugs (including proper disposal).
(16) Controlled substances. All permit holders shall comply with state and federal laws regarding controlled substances.
Section 5. Assuring Rational Drug Therapy. (1) Appropriate clinical information about patients shall be available and accessible to the pharmacist for use in his daily practice activities.
(2) The pharmacist shall be a member of the pharmacy and therapeutics committee and any other committees where input concerning the use of drugs is required.
(3) The pharmacist shall provide a means to insure that patients receive adequate information about the drugs they receive. Patient education activities shall be in coordination with the nursing and medical staffs and patient education department, if any. (16 Ky.R. 1713; Am. 2150; 17 Ky.R. 2175; eff. 12-13-90; 30 Ky.R. 75; 577; eff. 8-20-2003.)