Section 338.486. Medical institution” and “pharmacy services” defined; pharmacy services in medical institutions.

Rule 16. (1) As used in this rule:

(a)     "Medical institution" means a hospital, skilled nursing facility, county medical care facility, nursing home, or other health facility which is licensed or approved by the state and which directly or indirectly provides or includes pharmacy services.

(b)          "Pharmacy services" means the direct and indirect patient care services associated with the practice of pharmacy.

(2)     Pharmacy services shall be directed and provided by a licensed pharmacist.

(3)          Pharmacy personnel who assist the pharmacist by performing delegated functions in the care of inpatients shall be supervised by a pharmacist who is on the premises of the medical institution.

(4)      The pharmacist who directs the pharmacy services shall develop, implement, supervise, and coordinate all of the services provided, including, at a minimum, all of the following:

(a)     Dispensing medications in a form that minimizes additional preparation before administration to the patient, including the admixture of parenterals.

(b)     Obtaining the prescriber's original medication order, a direct carbonized copy, an electromechanical facsimile, or other electronic order transmission. Security measures shall be in place to ensure that system access by unauthorized individuals is not allowed.

(c)               Interpreting and reviewing the prescriber's medication orders and communicating problems with these orders to the physician or nurse before administration of first doses. If the interpretation and review will cause a medically unacceptable delay, then a limited number of medications may be stocked at the patient care areas for the administration of first doses. These medications shall be provided in a manner that ensures security and immediate availability, such as sealed or secured medication kits, carts, or treatment trays. A pharmacist shall routinely inspect the medications and, after use, shall verify the contents and replace the medications as necessary.

(d)       Monitoring medication therapy to promote positive patient outcomes while evaluating clinically significant chemical and therapeutic incompatibilities.

(e)      Establishing the specifications for the procurement of all pharmaceuticals and related biologicals and chemicals approved for use in the medical institution.

(f)            Not less than once every 6 months, inspecting all areas in the medical institution where medications are stored to verify compliance with the standards for the safe use and storage of the medications.

(g)        Maintaining proper security for all medications stored or kept within the medical institution.

(h)     Providing educational programs regarding medications and their safe use.

(i)      Providing a method by which medications can be obtained during the absence of a pharmacist in a medical institution where a pharmacist is not available 24 hours a day. The method shall minimize the potential for medication error. During the absence of a pharmacist, the services of a pharmacist shall be available on an on-call basis.  Only a limited number of medications that are packaged in units of use shall be available. The medications shall be approved and reviewed periodically as deemed necessary, but not less than once a year, by an appropriate interdisciplinary practitioner committee of the medical institution. The medication shall be kept in a securely locked, substantially constructed cabinet or its equivalent in an area of limited access in a centralized area outside the pharmacy. Each medication shall be labeled to include the name of the medication, the strength, the expiration date, if dated, and the lot number. A written order and a proof of removal and use document shall be obtained for each medication united removed. The order and document shall be reviewed by the pharmacist within 48 hours of removing medication from the cabinet or its equivalent. The pharmacist who directs pharmacy services in the medical institution shall designate the practitioners who are permitted to remove the medication. A pharmacist shall audit the storage locations as often as needed to guarantee control, but not less than once every 30 days.

(5)        Upon recommendation of an interdisciplinary practitioners committee, the pharmacist who directs pharmacy services in the medical institution shall adopt written policies and procedures to promote safe medication practices, to conduct medication utilization review, to approve medications for the medical institution's formulary or medication list, and to promote positive patient outcomes. A pharmacist shall meet with the committee at least quarterly to conduct assigned responsibilities.

(6)   A pharmacy shall ensure that every medication dispensed is identified with its name and strength labeled on the container in which it is dispensed or on each single unit package. A pharmacy that is engaged in drug distribution to medical institutions which use unit-of-use packaging shall place identification on the label of its package to allow the package to be readily traced. The name of the patient, or a unique identifier, shall be labeled on the medication container. The container may be the individual patients' assigned medication drawer. The directions for use shall be on the label of the container if the directions are not communicated in another effective manner. If the medication is to be self-administered, then directions for use shall be on the container. The preceding provisions of this subrule are minimum labeling standards only and do not supersede other applicable laws or rules.

(7)      A pharmacist shall personally supervise the destruction of unused portions of prescription medication, other than controlled substances under part 71 of the code, dispensed to patients. However, medications in single-unit packages and intravenous solutions which are designed to be tamper-evident and which show no evidence that tampering has occurred may be returned to stock. Medications that leave the medical institution or its legal affiliates may not be returned to stock for redispensing.

(8)          The licensed pharmacist who directs pharmacy services in the medical institution shall make the policies, procedures, and written reports required by this rule available to the board of pharmacy, upon request.

History:  1979 AC; 1980 AACS; 1998-2000 AACS; 2013 AACS.