Section 22-B1915. AUTOMATED MEDICATION DISPENSING SYSTEMS

 

1915.1An automated medication dispensing system may be utilized in a licensed pharmacy or health care facility if the requirements of this section are being met.

 

1915.2An automated medication dispensing system shall be used only in settings where there is an established program of pharmaceutical care that ensures prescription orders are reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy practice.

 

1915.3The recordkeeping requirements of this section may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.

 

1915.4A pharmacy shall provide the Director written notice of the installation of an automated medication dispensing system prior to utilizing an automated medication dispensing system. The notice shall include:

 

(a)The name and address of the pharmacy;

 

(b)The location of the automated equipment;

 

(c)The identification of the responsible pharmacist; and

 

(d)The type of system, manufacturer's name, make, and model.

 

1915.5An automated medication dispensing system shall have adequate security and procedures to:

 

(a)Prevent unauthorized access;

 

(b)Comply with federal and District of Columbia laws and regulations; and

 

(c)Maintain patient confidentiality.

 

1915.6An automated medication dispensing system shall electronically record all transactions involving drugs stored in, removed, or dispensed from the system.

 

1915.7The pharmacy, or provider pharmacy providing remote pharmacy services, shall:

 

(a)Maintain records regarding the automated medication dispensing system in a readily retrievable manner for at least five (5) years. The records shall include:

 

(1)Maintenance records and service logs;

 

(2)System failure reports;

 

(3)Accuracy audits and system performance audits;

 

(4)Copies of reports and analyses generated as part of the quality assurance program;

 

(5)Reports or databases related to level of access and changes in the level of access to the system; and

 

(6)Training records including the training content, date, and identity of those attending the training program.

 

(b)Maintain dispensing records for all prescription drugs or devices dispensed or distributed from the automated medication system for a period of five (5) years and shall include:

 

(1)Identity of the system accessed;

 

(2)Identification of the individual accessing the system;

 

(3)Date of transaction;

 

(4)Name, strength, dosage form, and quantity of drug accessed; and

 

(5)Name of the patient for whom the drug was accessed.

 

(c)Maintain stocking and removal records of all drugs stored in and removed from the system for a period of five (5) years, which shall include identification of the person stocking or removing drugs from the system and identification of the pharmacist who verified that the system was accurately filled;

 

(d)Maintain records, including records of drugs discarded through the use of a reverse distributor, of all drugs discarded as waste for a period of five (5) years, which shall include identification of the person discarding the drugs and the identification of the pharmacist who verified that the drugs were properly discarded in accordance with federal and District law and regulations;

 

(e)Ensure that the automated medication dispensing system maintains the integrity of the information in the system and protects patient confidentiality;

 

(f)Ensure that a comprehensive program of quality assurance for the automated medication dispensing system is in place;

 

(g)Ensure that the system complies with this chapter;

 

(h)Maintain policies and procedures related to:

 

(1)The operation of the system;

 

(2)Training of personnel using the system; and

 

(3)Operations during system down time;

 

(i)Establish a process to:

 

(1)Ensure the security of the system;

 

(2)Account for medication added to and removed from the system; and

 

(3)Minimize the potential for misidentification of medications, dosages, and dosage forms by those accessing the automated medication system; and

 

(j)Ensure that authorized individuals working with the automated medication dispensing system receive initial and annual training regarding:

 

(1)The capabilities and limitations of the system;

 

(2)The operation of the system; and

 

(3)Procedures for system downtime.

 

1915.8The records which are required to be maintained pursuant to § 1915.7 shall be stored on site where the automated medication dispensing system is located.

 

1915.9The Director of Pharmacy or pharmacist-in-charge shall:

 

(a)Control access to the automated medication dispensing system;

 

(b)Designate in writing the individuals who are authorized to access the system;

 

(c)Establish criteria and a process for determining which drugs may be stored in the automated medication system;

 

(d)Develop policies and procedures regarding the automated medication system; and

 

(e)Be responsible for all pharmacy operations involving the automated medication dispensing system.

 

1915.10Access to the automated medication dispensing system shall be limited to individuals that have completed documented training concerning the automated pharmacy system and who are one of the following:

 

(a)Licensed pharmacist;

 

(b)Qualified pharmacy personnel under a licensed pharmacist's supervision; or

 

(c)Individuals permitted by law to administer medication.

 

1915.11Where a centralized automated medication dispensing system is being used, a licensed pharmacist shall perform a final check of each medication that is removed from the system prior to distribution or dispensing, unless:

 

(a)A licensed pharmacist utilizing a centralized automated medication dispensing system distributes patient specific medications within the licensed health care facility and the medication is distributed for subsequent administration by a health care professional permitted by law to administer medication; or

 

(b)A licensed pharmacist performs a daily quality assurance check of the integrity of the system that includes random sampling of the output.

 

1915.12Where a decentralized automated medication dispensing system is being used:

 

(a)A licensed pharmacist shall perform a review of each order for medication before the medication is removed from the system, except if the order is for a starter dose; and

 

(b)A licensed pharmacist shall perform a review of each order for a starter dose within twenty-four (24) hours of removal of the starter does from the remote or decentralized automated medication system, if the patient is still under the care of the facility when the review is to be performed.

 

1915.13Only a licensed pharmacist may fill an automated medication dispensing system, unless otherwise specifically permitted by this section.

 

1915.14Automated medication dispensing systems that possess sufficient safeguards to ensure accuracy of the replenishment may be filled by:

 

(a)Authorized personnel pursuant to § 1915.9(b), supervised by a licensed pharmacist with a pharmacist performing the final verification; or

 

(b)Health care professionals licensed under the Act, and authorized to access an automated medication dispensing system due to the health care professionals' privileges to administer medication.

 

1915.15Only a licensed pharmacist may return medication to the automated medication dispensing system, unless otherwise specifically permitted by this section.

 

1915.16Automated medication dispensing systems that possess sufficient safeguards to ensure accuracy of the replenishment may allow for medication to be returned to those systems by:

 

(a)Authorized personnel pursuant to § 1915.9(b), supervised by a licensed pharmacist; or

 

(b)Health care professionals licensed under the Act, and authorized to access an automated medication dispensing system due to the health care professionals' privileges to administer medication.

 

1915.17Medication which is returned to an automated medication dispensing system may be used for subsequent administration provided that:

 

(a)The drugs are in sealed, tamper evident packaging which has not been opened;

 

(b)The medication is in an unadulterated form;

 

(c)If in a unit of use package, the medication is in the intact package that the medication was in when initially removed from the system;

 

(d)The return of medication is documented within the system or in other records maintained by a licensed pharmacist; and

 

(e)The return of medication is conducted in accordance with written procedures.

 

1915.18Drugs for use in an automated medication dispensing system shall be packaged in the original manufacturer's container or be prepackaged and labeled in compliance with the requirements of this chapter, and applicable federal and District laws and regulations.

 

1915.19Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable federal and District of Columbia laws and regulations.

 

source

Final Rulemaking published at 38 DCR 6734, 6748 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).