October 2019 | Richard Malone, MHA
Pharmaceutical clinical trials have no doubt become more complicated over the last several years. Trial design, clinical supply logistics, handling and preparation of study products, as well as related documentation have become increasingly difficult and highly scrutinized. Escalations in demand for strict adherence to storage conditions and chain of custody requirements have become prevalent as well.
Managing even a few trials can be demanding for a research pharmacy. Managing hundreds of trials as take place at many academic medical centers across the country can seem downright impossible. Yet study participants receive life-changing medications daily as a result of the hard work going on behind the scenes. In a previous blog, I attempted to shine a light on the role of pharmacists in the clinical research environment. While pharmacists certainly play an integral role in any investigational drug service (IDS), there is usually an equally important set of certified pharmacy technicians working with them as well. In fact, I guarantee any large, top-notch research pharmacy has a team of all-star pharmacy technicians shouldering an impressive amount of work and responsibility every day.
Scope of Research Technician Duties
While many core functions differ very little across research pharmacies, the menu of provided services can vary greatly depending on the practice setting. Demographic elements such as academic medical center affiliation, an array of specialty service lines, and study volume play a role in determining both pharmacist and pharmacy technician staffing levels as well as the level of staff expertise needed.
IDS services at sites with few active trials often provide only basic services including inventory management, dispensing, and accountability tracking coupled with the required interactions with sponsor, CRO, and/or IRT organizations for study setup and monitoring. In such settings, many of the aforementioned duties are often delegated to a technician as a secondary responsibility. It is imperative that part-time research technicians are granted adequate time for training, inventory management, and facilitation of monitoring and audits be set aside to avoid errors, incomplete documentation, and frustration.
Larger academic medical centers conducting hundreds of studies simultaneously generally require a dedicated IDS team. Research is central to these organizations and IDS technicians are typically key contributors that help these services roll smoothly. Predictably, technicians in these environments perform the previously mentioned functions associated with inventory management, order entry, dispensing, and monitoring. However, they are often called upon to take on additional tasks and projects that allow them to work at the “top” of their license (or certification). These duties might include billing, scheduling, and other functions associated with managing the service. IDS technicians are usually the key liaisons between study sponsors along with CRO and IRT partners after enrollment begins.
Worthy of its own paragraph is a description of the IDS technician’s role in non-sterile and sterile compounding. Depending on the scope of service, IDS technicians may be called upon to prepare doses of cytotoxic, biohazardous, radioactive, or otherwise dangerous drugs. Manipulating radioisotopes and virus or bacterial vectors, as well as preparation of sterile parenteral products from non-sterile active pharmaceutical ingredients, are everyday occurrences for many IDS services. IDS technicians also play an integral role in the preparation of oral capsules and liquids to assist in maintaining blinding of studies for which blinded dosage forms are not provided by the study sponsor. One small miscue could result in a harmful situation for the IDS technician, coworkers, and/or the study participant. Mistakes can also lead to lost revenue for the facility as the involved participant might have to be removed from the study.
Qualifications and Desirable Traits for Research Pharmacy Technicians
After reading the previous paragraphs, I’m sure you can piece together a mental list of key qualifications and character traits needed for research technicians to successfully take on the challenges of the job. While some apply broadly to most pharmacy technicians, others are particularly useful in the IDS arena.
It’s difficult to choose one trait that is most crucial to an IDS technician’s success. However, I would declare a tie between a sense of ownership and attention to detail if I were forced to do so.
Technicians that take pride in the service they provide and treat each job function the same every time it’s performed regardless of workload and other competing factors are invaluable to a research pharmacy. I consistently hired and retained team members that exhibited these traits throughout my time managing a very busy IDS at a large academic medical center. I found the hospital’s third shift IV technicians to be the most suitable internal candidates for addition to our team. These team members came to our service with a good baseline technical skillset and also had experience working in an environment with lower levels of staffing and supervision than that seen on other shifts. Employing team members accustomed to working in an environment that required autonomy and personal decision-making allowed me to perform my duties outside the department without the concern that Rome might burn. I never took that peace of mind for granted.
The reminder of the desirable qualifications and traits are given in the table below.
In conclusion, a successful IDS department requires recruitment and retention of quality certified pharmacy technicians. IDS technicians must exhibit competencies in a wide array of areas and must be able to adapt to changing tasks and schedules in a hectic environment. Although these team members are considered “technical” staff members and are typically non-exempt (hourly) employees, their success in the role requires much more of a sense of ownership and more responsibility for managing a practice than is generally associated with their job classification. Certified pharmacy technicians are highly skilled, invaluable members of any successful research team.