Pharmacy Services and Medication Management

PURPOSE: This rule establishes the requirements for pharmacy services and medication management in a hospital to ensure optimal selection, safe use, and security of medications. (1) There shall be evidence of the education, training, experience, and demonstrated competency for all duties assigned in the pharmacy technicians’ personnel records. (2) In addition to other authorized duties, a pharmacy technician may perform the following duties: (A) Authenticate medication selected by another pharmacy technician when a pharmacist is present for purposes of distribution within the hospital for subsequent administration by hospital staff authorized to administer medication, provided the final product is verified by authorized hospital staff prior to administration. A pharmacy technician shall not be authorized to authenticate compounded medications or the repackaging activities of another pharmacy technician. In order to authenticate medication as described in this section, the pharmacy technician must— 1. Hold an active pharmacy technician certification issued by a certification entity accredited by the National Commission for Certifying Agencies; 2. Have an initial and annual documented assessment of competency; and 3. Have assisted in the practice of pharmacy as a registered or licensed pharmacy technician in the state of Missouri or another U.S. state or territory for a minimum of one (1) year; and (B) Perform assigned duties under visual and auditory supervision of a pharmacist at a different site, including, technology assisted medication authentication. Documentation of electronic authentication shall be maintained at the dispensing site. 1. The pharmacy technician shall have a current certificate SENIOR SERVICES issued by a certification entity accredited by the National Commission for Certifying Agencies. 2. The pharmacy technician shall have completed training and documented competency in the assigned responsibilities being performed remotely as attested by the director of pharmacy. 3. The director of pharmacy is responsible for developing and implementing standards to ensure adequate supervision of electronically supervised technicians. (3) An intern pharmacist licensed by the Board of Pharmacy may also perform any activity authorized for pharmacy technicians pursuant to this rule. (4) Persons involved in compounding, repackaging, dispensing, administration, and controlled substance disposal shall be identified and the records shall be retrievable. Retention time for records of bulk compounding, repackaging, administration, and all controlled substance transactions shall be a minimum of two (2) years. Retention time for records of dispensing and extemporaneous compounding, including sterile medications, shall be a minimum of six (6) months. (5) All variances, discrepancies, inconsistencies, or noncompliance involving controlled substances—including inventory, audits, security, record keeping, administration, and disposal—shall be reported to the director of pharmacy services for review and investigation. (6) Patient medications may be received from an authorized provider. The medications shall— (A) Be delivered directly to the pharmacy and not to a patient care area unless the pharmacist is not available; (B) When a pharmacist is present, be identified, determined suitable for use and documented by the pharmacist. When a pharmacist is not present, be identified and documented by an authorized practitioner. Unused doses of medication shall be identified by the pharmacist when the pharmacist is present; and (C) The pharmacy may compound, repackage, or re-label medications received from an outside provider, including prescriptions dispensed by a pharmacy, as necessary for proper distribution and administration. Records of compounding, repackaging, or relabeling of prescriptions dispensed by a pharmacy shall allow identification of the original prescription. (7) Sample medications, if allowed, shall be received and distributed only by the pharmacy. (8) Medications may be provided to patients for use outside the hospital, by persons other than the pharmacist. (A) When the patient is a registered patient of the emergency department or is being discharged from the hospital— 1. Medications shall be provided according to the hospital’s policies and procedures, including: A. Circumstances when medications may be provided; B. Practitioners authorized to order; C. Specific medications; D. Limited quantities; E. Prepackaging and labeling by the pharmacist; F. Final labeling to facilitate correct administration; G. Delivery; H. Counseling; and I. A transaction record; 2. Medications shall be labeled with the date, patient’s name, prescriber’s name, name and address of the hospital, exact medication name and strength, instructions for use, and other pertinent information; 3. Medications may be provided only when prescription services from a pharmacy are not reasonably available. Reasonably available includes a pharmacist on duty in the hospital or a community pharmacy that is reasonably accessible to the patient; 4. The medication provided shall be limited to urgently needed treatment; 5. The quantity of medication provided shall be limited to the amount necessary until pharmacy services are available; 6. The provisions of paragraph (A)3. and paragraph (A)5. of this subsection shall not apply when the patient is being treated for an acute condition and it is believed that the immediate health and welfare of the patient and/or the community are in jeopardy. The quantity limit may be extended to provide single-course therapy; and 7. Final labeling, delivery, and counseling shall be performed by a pharmacist, the prescriber or a registered nurse, except that final labeling and delivery may be performed by an automated dispensing system. (B) Automated dispensing systems may be used in accordance with all requirements of this section— 1.When the automated dispensing system is controlled by the prescriber it may be used only during times when no pharmacy services are reasonably available, except as allowed in paragraph (A)6. of this section; and 2. When the automated dispensing system is controlled by a pharmacy according to regulations of the Missouri Board of Pharmacy, including, but not limited to 20 CSR 2220-2.900. (C) Medications in multidose containers that were administered to or used for the patient during the patient’s hospital stay may be sent with the patient at discharge when so ordered by an authorized practitioner. 1. Examples of multidose medication containers include, but are not limited to, inhalers, ointments, creams, medications requiring the original container for dispensing, insulin pens, eye drops, ear drops, and infusions that are currently connected to the patient’s infusion device. 2. Written instructions for use shall be provided by a pharmacist, prescriber, or registered nurse at the time of discharge. 3. Controlled substances shall not be sent with the patient, except that controlled substance infusions or continuous delivery systems currently connected to the patient may be sent as follows: A. The medication is necessary for administration during transport of the patient; and B. The quantity of controlled substance sent is documented in the patient’s medical record by the person sending the medication. (9) The director of pharmacy services or his/her pharmacist designee shall be an active member of the pharmacy and therapeutics committee or its equivalent, which shall advise the medical staff on all medication matters. (10) Medications shall be ordered only by practitioners who have independent statutory authority to prescribe or who are authorized to order medications by their professional licensing agency as provided by state law. Authority to order medications may be granted to a non-physician licensed practitioner in accordance with state law. (11) Medications in the possession of the patient at time of admission shall be given to the patient’s representative unless there is an identified need to retain them. (A) Medications that are not given to the patient’s representative and that are not to be administered shall be documented, sealed, and stored in a locked area accessible only to individuals authorized to access medications. (B) Controlled substances shall be security sealed and stored in a locked area accessible only to individuals authorized to administer controlled substances or to authorized pharmacy personnel. AUTHORITY: sections 192.006 and 338.165, RSMo 2016, and section 197.080, RSMo Supp. 2021.* This rule previously filed as 19 CSR 30-20.021(3)(G). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded and readopted: Filed March 20, 2019, effective Nov. 30, 2019. Amended: Filed June 25, 2021, effective Dec. 30, 2021. *Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995, 2013, 2017; and 338.165, RSMo 2014.