A Review of the Evidence on Its Safety and Benefits

Alex J. Adams; Steven J. Martin; Samuel F. Stolpe


Am J Health Syst Pharm. 2011;68(19):1824-1833. 

In This Article

Core Elements of Existing Programs

Further insight into TCT may be found by examining existing TCT programs, as defined by the governing state laws and regulations. In the previously mentioned 2009 NABP survey, 12 states (California, Colorado, Idaho, Iowa, Kansas, Kentucky, Michigan, Minnesota, Montana, North Dakota, South Carolina, and Washington) indicated that they allow pharmacy technicians to check the work of other technicians in hospital and institutional or community pharmacy settings, or that they had a pilot program in place to evaluate potential implementation.[17] In addition to the NABP data, published reports indicated the existence of TCT in 3 more states: Maryland, North Carolina, and Oregon.[12,18,31,32] Also, Illinois officials indicated in the NABP survey that rules currently being developed may alter their decision and allow for TCT in that state.[17] Therefore, those 4 states were included in this review.

The laws, rules, and regulations posted on board of pharmacy web-sites in each of these 16 states were searched for references to TCT.[33–48] Nine (56%) of the 16 states had clear language about TCT programs; a discussion of these core elements follows (Table 3). It is important to note that the 9 states reviewed in depth in the following sections are not the only states that permit TCT initiatives. Some states allow TCT through waivers or "requests of variance" from board of pharmacy rules. Similarly, institutions in some states may be practicing TCT because the applicable state laws do not specifically prohibit its use. The purpose of the following sections of this article is not to offer a comprehensive overview of states that allow or do not allow TCT but to highlight the key operational elements of TCT programs in states that explicitly reference the practice in their laws and regulations.

Clinical Settings and Allowed Activities

Of the nine states with well-defined TCT programs and pilot programs, all but North Dakota restrict TCT to hospital and institutional settings (Table 3). This restriction is generally accomplished through a direct statement of allowable clinical settings. Kentucky does not list allowable settings but permits certified pharmacy technicians to "certify for delivery unit dose mobile transport systems that have been refilled by another technician," effectively limiting TCT to hospital and institutional settings.[39] Several states indicate that an allowable setting must have a licensed health professional to provide additional, independent verification before medication administration; that safeguard is unique to hospitals and other institutional settings and may be one reason that all states (with the exception of North Dakota) specifically restrict the use of TCT to those settings.

Most states articulate the permissible activities for technicians practicing in a TCT program. Generally, technicians are allowed to check the work of other technicians when refilling automated medication dispensing machines located on hospital floors and when filling unit dose batches of prescription refills previously approved by a pharmacist. Several states require that pharmacists check products that have been compounded or repackaged, perhaps because those tasks may require a greater degree of skill or expertise or entail a higher potential for harm, thus necessitating the clinical expertise of pharmacists.

Technician Training

All nine states with active or pilot TCT programs stipulate education or training requirements for technicians before they are permitted to check the work of other technicians. Requirements vary from state to state, with some referring to "specialized and advanced training"; other states require technician registration or certification, and some have more structured and comprehensive programs than others. Minnesota and Montana provide the most detailed overview of their TCT training program requirements, and the two states have adopted a similar approach.[42,43] Technicians who meet a minimum threshold of required experience (generally six months to one year in a unit dose distribution system) can become "tech-checkers" by completing didactic and practical training components, followed by a validation period. Didactic training involves the successful completion of a self-study module, whereas practical training requires the direct observation of pharmacists performing final verification in a unit dose distribution system. Validation requires pharmacy technicians to be audited and achieve a minimum accuracy rate before they are permitted to independently perform final verification. In Minnesota, for example, technicians must check 1500 consecutive doses over five audit periods. Errors are randomly introduced into the sample to ensure the error-detection capability of technicians is accurately assessed. Technicians must demonstrate a 99.8% accuracy rate in order to pass the validation.[42]

Quality Assurance

Six states directly call for TCT quality-assurance programs (Table 3). Most states simply state that ongoing evaluations and monitoring should take place and that practice sites should have detailed procedures for monitoring quality. Minnesota recommends the number of doses to be audited, what constitutes passing and failing grades, and what process occurs if a technician fails an audit.[42] Both Minnesota and Montana mandate time frames for TCT audits and specify that technicians who lose validation as a result of random audits must be retrained, revalidated, or both before resuming verification duties.[42,43] Minnesota also requires revalidation for pharmacy technicians who have not performed TCT in the previous six months.[42] North Dakota specifies that every error occurring in a TCT program must trigger a pharmacist review to identify potential corrective actions.[45] Ongoing quality assurance and monitoring of TCT help ensure the continued safety and accuracy of medication dispensing. It has been noted that TCT may have more over-sight than is currently built into traditional practices using pharmacists for final verification.[12]

Pharmacist Redeployment

Three states address issues related to the expanded role of the pharmacist in TCT programs (Table 3). Minnesota directly states that TCT may not be used as a means of reducing pharmacy staff.[42] Minnesota also notes that pharmacists operating in a TCT program must perform a daily appropriateness review of each patient's profile, examining it for allergies and contraindications, among other activities. Both California and Montana mention that TCT should be used as a means to redirect pharmacists to clinical services and patient-centered activities.[33,43] California defines permitted pharmacist services in licensed health care facilities to include ordering drug therapy-related patient assessments and laboratory tests, administering drugs, and initiating or adjusting drug regimens pursuant to prescriber authorization.[33]


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