A program of continuing education as a requirement for re-licensure should be flexible in design, equitable in application, reasonable to administrate, and yet structured enough to serve its purpose.

Because Pyxis is exploring the expanded use of A.D.D. in non-pharmaceutical applications,thus it is important to establish when regulation should apply. All use of Automated Dispensing Devices (ADD) with pharmaceuticals shall be under the management of the Pharmacist in Charge (P.I.C.)

Position 2

Regulations should address ADD's with pharmaceuticals regardless of the configuration of the device and in all environments that they exist

• Use for storage and dispensing of floor stock* medications in Institutional settings
• Used for storage and dispensing of all (or most) doses scheduled for administration:
  • at a patient care unit whether the final destination is a secured, electronically controlled metal device or a unit dose cart with cassettes.
  • in the central pharmacy dispensing doses (in bags) to the patient care unit (utilizing technology -[bar codes]) for accuracy in selection, but delivering to a unit dose cassette.
• Used for storage and dispensing in retail stores to provide labeled prescriptions
• Used for storage and dispensing in remote clinics & physicians offices to provide labeled prescriptions by a practitioner not necessarily on premise.
• ADD's with pharmaceuticals should be under regulations whether located in hospitals, Ambulatory Centers, Long Term Care Centers or Physician's Office

Position 3

VSHP agree with current regulations except for audits; suggested details:

• Doses placed in ADD shall be in the manufacturer's original sealed packaging, or re-package in accordance with the requirements of regulation 5.3
• Authorization to withdraw drugs from ADD shall be limited to persons licensed to prescribe or administer drugs, and to pharmacy personnel; designated by the P.I.C. A register of all authorized users shall be maintained by the P.I.C.
• Placing of drugs in the ADD may be done by Certified Pharmacy Technicians (CPT) designated by the P.I.C. and to persons authorized to withdraw drugs from the ADD, when so designated by the P.I.C.
• There shall be documentation of all drugs withdrawn form the ADD providing date, identification of the drug, quantity withdrawn, identity of person withdrawing the drug, identity of the patient for whom the dose is intended. Documentation shall be maintained for two years.
• Documentation for transactions involving DEA scheduled controlled substances shall meet all requirements for the appropriate regulations involved..
• All drugs in ADD shall be inspected not less then monthly to assure absence of outdated drugs, proper storage, and security
• Random audits of operations of the device against inventory & practice shall be performed monthly. Random checks shall be made to ensure that valid orders exist for each dose administered where a pharmacist does not review prior to first dose given. Audits shall be signed by the performing pharmacist and maintained for two years.

Position 4

Supports Pharmacist review of patient meds prior to drug withdrawal. If used for storage and dispensing for all (or most) doses scheduled for administration, regulations should also require a means by which orders for a drug are reviewed and approved by a pharmacist prior to the drug withdrawal from the ADD for administration.

Position 5

Supports the delineation of one lot # of a drug from another in devices. Currently some automation used in dispensing do not facilitate the differentiation of one lot number from another so long as it is the same size & brand of product. This is poor pharmaceutical care for patient outcomes.

Position 6

Supports the concept of internal management of A.D.D.s by the PIC in institutional setting where more then 1-2 machine exists. Lost of control becomes an issue when devices are managed by outside (non-employed) personnel.

Position 7

Supports the continued search for Quality assurance standards for ADD's. There is criticism for the absence of good Quality Assurance data that can prove these devices provide, not only economical, but quality values also.

Position 8

Supports the integration of ADD with the patient record documentation of doses administered. The circle is not complete until doses withdrawn can dovetail into doses administered. Without it there is duplication of effort and paper shuffling.

Approved by Board of Directors: 9/24/99

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