At 5 p.m. on June 22, I arrived home from work and retrieved my mail. Inside the box was an urgent alert from the Utah Pharmacist's Association about a proposed change to the Utah Pharmacy Practice Act Rules. Current rules in Utah allow no more than a 3:1 ratio for technicians to a licensed pharmacist. The proposed rule would remove that limit.
Notably, the public meeting on this topic occurred at 2 p.m on June 22: it was over. Reading the proposed changes, I became increasingly concerned about their implications.
The proposal would delete the following language:
* R156-17b-601. "The licensed pharmacist on duty can...provide on-site supervision for up to three pharmacy technicians...on duty at any one time, and only one of the three technicians can be unlicensed."
* R156-17b-601. "Pharmacy technicians, including no more than one pharmacy technician-in-training, shall be supervised on-site by a pharmacist in accordance with R156-17b-603 (19)."
* R156-17b-603 (19). "assuring that no pharmacy or pharmacist operates the pharmacy or allows operation of the pharmacy with a ratio of pharmacist to pharmacy technician/pharmacy intern/support personnel which, under the circumstances of the particular practice setting, results in, or reasonably would be expected to result in, an unreasonable risk of harm to public health, safety, and welfare;..."
The wording of the proposed rule is utterly ambiguous from any kind of legal or regulatory standpoint. The "...circumstances of the practice setting.." must not "....result(s) in, or reasonably would be expected to result in, an unreasonable risk of harm...". No objective definition of these terms exists or is even possible.
The proposed "no pharmacy or pharmacist" language places personal responsibility on the pharmacist to ensure that the site is adequately staffed. Yet decisions about staffing ratios and pharmacist supervisory capability clearly lie with the site, not the pharmacist. Sites have an obvious incentive to require pharmacists to supervise a large number of technicians and to hire pharmacists willing to push the limits.
Most importantly, it seems irrefutably true that public safety and quality of care are threatened by this rule change. Quality improvement projects across all industries are based on an ongoing analysis of the relationship between structures, processes, and outcomes. Staff training, education, and adequacy are structural elements that are known to be absolutely vital in the provision of safe, quality care.
With this proposed rule, the State of Utah abdicates its responsibility to set minimum health care standards for the public. The rule allows industry to set its own standard and places the public at risk. Yet liability for outcome is placed on the individual pharmacist.
While this example deals only with pharmacy, it is an easy jump to imagine the same situation occurring in medicine, nursing, physical therapy, etc. Does anyone imagine that this approach will improve medical outcomes? Will we realize cost savings over the long term? The text of the proposed change to the Utah Pharmacy Practice Act is available at: Utah Division of Occupational and Professional Licensing. http://www.dopl.utah.gov/laws/R156-17b-raf.pdf.
Melissa Hofer, PharmD, MS, lives in Layton.