Should States License Automated Pharmaceutical Dispensing Machines?
The Army has recently been testing automated drug dispensing systems. The Army believes the following scenario will be possible in the not-too-distant future.
At issue was an automated dispensing system machine designed to mechanically sort and then individually label and package oral medications for administration to patients in nursing homes. A licensed pharmacist would load the machine with bulk medications. A nurse would input a prescription order into a nursing home computer. An off-site pharmacist would review the prescription order together with the patientís medication record, and send an order to the automated dispensing system at the nursing home instructing the machine to prepare and dispense the prescription. Access to the bulk medications contained in the automated dispensing system (other than those dispensed) would be limited to a licensed pharmacist. Such a system could potentially reduce medical error, save time and money, and allow physicians to easily vary dosage and duration of prescriptions based on a patientís response. Automated dispensing systems are already used in some hospitals that hold a valid pharmacy license. However, nursing homes typically do not hold pharmacy licenses, nor do they have a licensed pharmacist on staff.
The Texas Pharmacy Act (Tex. Occ. Code Ann. § 551.003) defines a "pharmacy" as "a facility at which a prescription drug or medication order is received, processed, or dispensedÖ" Under the Act, "dispense" means "to prepare, package, compound, or label, in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the userís agent under a practitionerís lawful order." "Deliver" or "delivery" means "the actual, constructive, or attempted transfer of a prescription drug or device or controlled substance from one person to anotherÖ" "Labeling" is defined as "the process of affixing a label . . . to a drug or device container . . ." The Act defines "pharmacist" as "a person licensed by the Board to practice pharmacy." Finally, the "practice of pharmacy" includes, among other things, "being responsible for: (i) dispensing a prescription drug order or distributing a medication order; [and] (ii) compounding or labeling a drug or device."
Since the machine would label, package, and dispense prescription medications, the Attorney General concluded that the machine is legally a "pharmacy" and thus requires a pharmacy license. Further, a pharmacy license entails having a pharmacist on the premises when the pharmacy is open.
The White Paper on Automation in Pharmacy is an effort by the Automation in Pharmacy Initiative, a coalition of pharmacy associations, members of state boards of pharmacy, and representatives from the pharmacy automation industry. The White Paper addresses technical and regulatory issues associated with automation. The paper concludes that regulatory barriers in many states limit use of automated dispensing machines, and proposes adoption by states of amendments to the National Association of Boards of Pharmacy Model State Pharmacy Act and Model Rules to allow broader use of automatic dispensing machines. See http://www.ascp.com/public/pubs/tcp/1998/mar/appendix1.shtml.