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10.34.28.00.htm 10.34.28.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 34 BOARD OF PHARMACY Chapter 28 Automated Medication Systems Authority: Health Occupations Article, §12-205(a) and 12-605, Annotated Code of Maryland
10.34.28.01.htm 10.34.28.01. 01 Scope.. This chapter defines the parameters under which a permit holder may allow the use of automated medication systems to facilitate the dispensing and distribution of medication.
10.34.28.02.htm 10.34.28.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Automated medication system" means a centralized, decentralized, or remote robotic or computerized device and that device's components designed to:a) Distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health m
10.34.28.03.htm 10.34.28.03. 03 Limitation on Privileges to Administer.. In this chapter, "privileges to administer medication" does not include privileges created by delegation from a licensed health care professional to an unlicensed health care professional.
10.34.28.04.htm 10.34.28.04. 04 Usage Requirements for Centralized Automated Medication Systems.. A. An automated medication system may only be used if:. 1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the centralized automated medication system; and3) The permit holder ensures that:. a) Patients have prompt access to pharmacy service
10.34.28.05.htm 10.34.28.05. 05 Usage Requirements for Decentralized Automated Medication Systems.. A. A decentralized automated medication system may only be used if:. 1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the automated medication system;3) Except for starter doses, a licensed pharmacist reviews each order for medication:.
10.34.28.06.htm 10.34.28.06. 06 Usage Requirements for Remote Automated Medication Systems.. A. A remote automated medication system may only be used if:. 1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the remote automated medication system;3) Except for starter doses, a licensed pharmacist reviews each order for medication:.
10.34.28.07.htm 10.34.28.07. 07 Stocking of Automated Medication Systems.. A. Selection of Medication for Stocking. A licensed pharmacist shall verify the accuracy of medications selected for stocking and replenishment of the automated medication system before the medications are stocked in the system.B. Stocking of Automated Medication System. A registered pharmacy technician may stock an automated medication system provide1) The pharmacy technician’s selection of medications is verified by a pharmacist; and.
10.34.28.08.htm 10.34.28.08. 08 Return of Unused Medication.. A. Single-Drug Unit Dose Packaging.. 1) Automated medication systems that distribute medications in single-drug unit dose packaging may allow for return of unused medications to the system provided that:a) The medication is returned to a designated common, secure, one-way returns bin; and. b) A licensed pharmacist determines whether the medication is in an unadulterated form.. 2) Only a licensed pharmacist may return medicatio
10.34.28.09.htm 10.34.28.09. 09 Education and Training.. The permit holder shall ensure that individuals authorized to utilize centralized, decentralized, or remote automated medication systems receive initial and annual training regarding:A. The capabilities and limitations of the system;. B. Procedures for the operation of the system; and. C. Procedures for system downtime..
10.34.28.10.htm 10.34.28.10. 10 Quality Assurance Program.. A. The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the automated medication
10.34.28.11.htm 10.34.28.11. 11 Record Keeping.. A. The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years.B. The records referred to in §A of this regulation shall include:. 1) Maintenance records and service logs;. 2) System failure reports;. 3) Documentation of patient outcomes resulting from system failures;. 4) Accuracy audits and system performance audits;. 5) Copies of reports and
10.34.28.12.htm 10.34.28.12. 12 Security.. A. The responsible pharmacist shall ensure the security of the automated medication system.. B. In order to restrict access to the automated medication system to authorized individuals, the responsible pharmacist shall, at a minimum:1) Establish a clear process of how passwords will be assigned;. 2) Develop procedures that prohibit the sharing of passwords and reuse of passwords;. 3) Require that the system database be updated daily to remove inactive passwords; and.
10.34.28.13.htm 10.34.28.13. 13 Laws and Compendial Standards.. The responsible pharmacist shall ensure compliance with the laws and compendial standards for packaging and labeling.
10.34.28.14.htm 10.34.28.14. 14 Controlled Dangerous Substances.. Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable State and federal statutes and regulations.
10.34.28.9999.htm 10.34.28.9999. Administrative History Effective date: August 5, 2002 (29:15 Md. R. 1142) ―. Chapter revised effective October 1, 2012 (39:7 Md. R. 493).
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