Ga. Comp. R. & Regs. R. 480-37-.03 - Minimum Requirements
Minimum Requirements. A pharmacy may use a RAMS provided that:
(a) The pharmacy has a policy
and procedure manual at the skilled nursing facility or hospice that includes:
1. The type or name of each RAMS including a
serial number or other identifying nomenclature.
2. A method to ensure security of a RAMS to
prevent unauthorized access. Such method may include the use of electronic
passwords, biometric identification (optic scanning or fingerprint) or other
coded identification.
3. A process
of filling and stocking a RAMS with drugs; an electronic or hard copy record of
medication filled into the system including the product identification, lot
number, and expiration date.
4.
Documentation of inventory procedures including removal of any
discontinued/outdated medications.
5. Compliance with a Continuous Quality
Improvement Program.
6. A method to
ensure that patient confidentiality is maintained.
(b) No more than a 30-day supply of each
individual medication may be stocked in a RAMS at one time.
(c) All drugs in a RAMS must inventoried no
less than once every 30 days and documentation must be maintained of the
inventories including the removal of any discontinued/out of date
medications.
(d) All the registered
pharmacists, licensed pharmacy interns or registered pharmacy technicians
involved in the process of stocking, entering information into RAMS, or
inventorying the RAMS must be identified. No person shall be permitted to
perform a function related to the machine that they are not authorized to do in
the pharmacy. Specifically, where direct supervision is required in the
pharmacy, such supervision must occur in duties related to the RAMS.
(e) Patient confidentiality must be
maintained.
(f) The PIC, or a
pharmacist designated by the PIC, must be able to revoke, add, or change access
to RAMS at any time.
(g) Only a
Georgia registered nurse or a Georgia licensed practical nurse may be assigned
to access and remove dangerous drugs from a RAMS.
(h) Only a Georgia registered nurse may
access and remove controlled substances from a RAMS.
(i) The system ensures that each prescription
is dispensed in compliance with the definition of dispense and the practice of
the profession of pharmacy.
(j) The
system shall maintain a readily retrievable electronic record to identify all
pharmacists, pharmacy interns, or registered pharmacy technicians involved in
the processing of the prescription order.
(k) A RAMS shall provide the ability to
comply with product recalls generated by the manufacturer, distributor, or
pharmacy. The system shall have a process in place to isolate affected lot
numbers including an intermix of drug product lot numbers.
(l) The stocking or restocking of a dangerous
drug or controlled substances shall be completed by:
1. A Georgia licensed pharmacist,
2. A Georgia licensed pharmacy intern/extern
under the direct on-site supervision of a Georgia licensed pharmacist,
or
3. A Georgia registered pharmacy
technician only under the following circumstances:
a. If the remote automated medication system
utilizes radio frequency identification or bar coding in the filling process,
the pharmacy shall retain an electronic record of the filling activities of the
pharmacy technician; or
b. If the
remote automated medication system does not utilize radio frequency
identification or bar coding in the filling process, a pharmacist shall
supervise continuously the filling activities of the pharmacy technician
through a two-way audiovisual system.
(m) A RAMS must use at least two separate
verifications, such as bar code verification, electronic verification, weight
verification, radio frequency identification (RFID) or similar process to
ensure that the proper medication is being dispensed from a RAMS.
(o) All medication shall be packaged and
labeled in compliance with Board rules and laws for patient specific labeled
medication and/or unit of use medication.
(p) The licensed pharmacist responsible for
filling, verifying, or loading the RAMS shall be responsible for their
individual action.
(q) A
prescription drug dispensed by the RAMS pursuant to the requirements of this
rule shall be deemed to have been certified by the pharmacist.
(r) A licensed pharmacist may remove
discontinued and/or outdated medications from the RAMS and return such
medications to the licensed pharmacy for proper disposition. A registered or
licensed practical nurse may remove discontinued and/or outdated medications
and place them in the designated secured return bin in a RAMS.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.