Assigned to HHS FOR
COMMITTEE
Assigned to HHS FOR
COMMITTEE
ARIZONA STATE SENATE
Fifty-Third Legislature, Second Regular Session
Purpose
Expands the definition of pharmacy to include a remote dispensing site pharmacy (RDSP) and establishes rules and procedures for RDSPs.
Background
Established in 1903, the Arizona State Board of Pharmacy (Board) regulates the practice of pharmacy and the distribution, sale and storage of prescription medications, prescriptive devices and nonprescription medications. Current statute defines a pharmacy as a place where drugs, devices and other substances are sold at retail and where a pharmacist dispenses or compounds prescriptions orders (A.R.S. 32-1901).
In order to operate, maintain, open or establish a pharmacy, or any other place in which or from drugs are manufactured, compounded, dispensed, stocked, exposed, sold or offered for sale an applicant must first apply for a permit to the Board. Statute requires that a pharmacist be present and responsible at the time drugs are stocked and secured in the pharmacy. Additionally, a U.S. Drug Enforcement Administration permit must be obtained if controlled substances are stocked (A.R.S. 32-1929). The Board must review each application within 60 days and, if they are filled out correctly, place the application on the next Board meeting agenda. The Board then determines if the applicant is satisfactory and issues a permit (A.R.S. 32-1931).
A pharmacist in Arizona must: 1) be of good moral character; 2) be a graduate of an accredited pharmacy program; 3) have completed an approved practical experience program; 4) pass the pharmacist licensure examination; and 5) pay an application fee to the Board (A.R.S. 32-1922). An applicant for licensure as a pharmacy technician or pharmacy technician trainee must 1) be of good moral character; 2) be at least 18 years of age; and 3) have a high school diploma or equivalent. Additionally, a pharmacy technician must also complete a training program prescribed by Board rules and pass a Board approved pharmacy technician examination (A.R.S. 32-1923.01).
According to statute, if a medical practitioner who dispenses a controlled substance, or if a prescription for a controlled substance is dispensed by a pharmacy, a health care facility for outpatient use or a Board-permitted nonresident pharmacy for delivery to a person residing in Arizona, the medical practitioner, health care facility or pharmacy must report specified information to the Controlled Substances Prescription Program (CSPMP). Authorized dispensers of controlled substances are not required to submit the outlined information more than once each day (A.R.S. § 36-2608).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Expands the definition of pharmacy to include a RDSP where a pharmacy technician or pharmacy intern prepares, compounds or dispenses prescription under the remote supervision of a pharmacist.
2. Requires a pharmacy technician to do the following before preparing, compounding or dispensing prescription medications at a RDSP:
a) complete, in addition to any other Board-approved mandatory continuing education requirements, a two-hour continuing education program on RDSP practices; and
b) have at least 1,000 hours of experience as a pharmacy technician in an outpatient pharmacy setting under the direct supervision of a pharmacist.
3. Requires a pharmacy technician working at a RDSP to maintain an active, nationally recognized pharmacy technician certification.
4. Prohibits a pharmacy technician working at a RDSP from performing extemporaneous sterile or nonsterile compounding.
5. Allows a pharmacy technician working at a RDSP to prepare commercially available medications for dispensing, including the reconstitution of orally administered powder antibiotics.
6. Requires a RDSP to obtain and maintain a pharmacy license.
7. Establishes that RDSPs must meet all of the following requirements:
a) either be jointly owned by a supervising pharmacy in Arizona or be operated under a contract with a pharmacy licensed in Arizona;
b) be supervised by a pharmacist licensed and located in Arizona and who is designated as the pharmacist responsible for the oversight of the RDSP;
c) display a publicly visible sign indicating the facility is a RDSP, is under continuous video surveillance and that the video surveillance is recorded and retained; and
d) use a common electronic recordkeeping system between the supervising pharmacy and the RDSP or allow the supervising pharmacy to access the RDSP's dispensing system records.
8. Allows a pharmacist who supervises and dispenses in a licensed pharmacy to supervise one RDSP.
9. Allows a pharmacist to supervise up to two RDSPs if the pharmacist is not simultaneously supervising and dispensing at another licensed pharmacy, and allows for supervision of additional sites with Board approval.
10. Permits a RDSP to store, hold and dispense all prescription medications.
11. Requires that a RDSP do the following:
a) maintain a perpetual inventory of controlled substances;
b) secure schedule II controlled substances that are opioids separately from other prescription medications in a manner that prohibits access by unauthorized personnel;
c) require that the CSPMP central database tracking system can be queried by a pharmacist designated for the oversight of the RDSP prior to dispensing a prescription for a schedule II controlled substance;
d) comply with any dispensing limits associated with prescribing opioids; and
e) maintain a continuous system of video surveillance and recording of the pharmacy department for at least 60 days after the date of the recording.
12. Directs each RDSP to maintain a policy and procedures manual that must be available to the Board and include the following:
a) a description of how the RDSP will comply with federal and state laws;
b) the procedure for supervising the RDSP and counseling the patient or patient's caregiver using audio and visual technology that complies with HIPAA;
c) a plan for monthly inspection by the supervising pharmacist;
d) a procedure for monthly reconciliation of the perpetual inventory of controlled substances to the on-hand count; and
e) a description of how the RDSP will improve patient access to pharmacists and pharmacy services.
13. States that a RSDP's policy and procedures manual is in addition to any Board-approved community pharmacy requirements.
14. Requires a pharmacy intern or pharmacy technician of a RDSP to obtain a CSPMP patient utilization report for the preceding 12 months before dispensing a schedule II controlled substance.
15. Defines remote dispensing site pharmacy and remote supervision by a pharmacist.
16. Makes technical and conforming changes.
17. Becomes effective on the general effective date.
House Action
HEALTH 1/18/18 DPA 9-0-0-0
3rd Read 2/13/18 DPA 57-2-1
Prepared by Senate Research
March 2, 2018
CRS/NW/lat