54.1-3434.02 - Automated drug dispensing systems. - Virginia Statutes

§ 54.1-3434.02. Automated drug dispensing systems.

A. Hospitals licensed pursuant to Title 32.1 or Title 37.2 may use automateddrug dispensing systems, as defined in § 54.1-3401, upon meeting thefollowing conditions:

1. Drugs are placed in the automated drug dispensing system in a hospital andare under the control of a pharmacy providing services to the hospital;

2. The pharmacist-in-charge of the pharmacy providing services to thehospital has established procedures for assuring the accurate stocking andproper storage of drugs in the automated drug dispensing system and forensuring accountability for and security of all drugs utilized in theautomated drug dispensing system until the time such drugs are removed fromthe automated drug dispensing system for administration to the patients;

3. Removal of drugs from any automated drug dispensing system foradministration to patients can only be made pursuant to a valid prescriptionor lawful order of a prescriber;

4. Adequate security for automated drug dispensing systems is provided, asevidenced by written policies and procedures, for (i) preventing unauthorizedaccess, (ii) complying with federal and state regulations on prescribing anddispensing controlled substances, (iii) maintaining patient confidentiality,and (iv) assuring compliance with the requirements of this section;

5. Accountability for drugs dispensed from automated drug dispensing systemsis vested in the pharmacist-in-charge of a pharmacy located within thehospital or the pharmacist-in-charge of any outside pharmacy providingpharmacy services to the hospital;

6. Filling and stocking of all drugs in automated drug dispensing systemsshall be performed under the direction of the pharmacist-in-charge. The taskof filling and stocking of drugs into an automated drug dispensing systemshall be performed by a pharmacist or a registered pharmacy technician, whoshall be an employee of the provider pharmacy and shall be properly trainedin accordance with established standards set forth in a policy and proceduremanual maintained by the provider pharmacy. The pharmacist stocking andfilling the automated drug dispensing system or the pharmacist-in-charge, ifthe automated drug dispensing system is stocked and filled by a registeredpharmacy technician, shall be responsible for the proper and accuratestocking and filling of the automated drug dispensing system.

B. Drugs placed into and removed from automated drug dispensing systems foradministration to patients shall be in the manufacturer's or distributor'ssealed original packaging or in unit-dose containers packaged by thepharmacy. Drugs in multi-dose packaging, other than those administeredorally, may be placed in such a device if approved by thepharmacist-in-charge in consultation with a standing hospital committeecomprised of pharmacy, medical, and nursing staff.

C. The pharmacist-in-charge in a pharmacy located within a hospital or thepharmacist-in-charge of any outside pharmacy providing pharmacy services to ahospital shall be responsible for establishing procedures for (i)periodically inspecting and auditing automated drug dispensing systems toassure the proper storage, security, and accountability for all drugs placedin and removed from automated drug dispensing systems, and (ii) reviewing theoperation and maintenance of automated drug dispensing systems. Thismonitoring shall be reviewed by a pharmacist while on the premises of thehospital and in accordance with the pharmacist-in-charge's procedures and theBoard of Pharmacy's regulations.

D. The Board of Pharmacy shall promulgate regulations establishing minimumrequirements for random periodic inspections and monthly audits of automateddrug dispensing systems to assure the proper storage, security, andaccountability of all drugs placed in and removed from automated drugdispensing systems and for reviewing the operation and maintenance ofautomated drug dispensing systems.

(1999, c. 750; 2004, c. 140; 2009, c. 100.)