Not Just Dispensing: The Unique Role of Pharmacists in an Outpatient Research Pharmacy
Denise Swiatek, BS, PharmD and Christopher Daly, PharmD, MBA, BCACP
Pharmacists can serve as essential members of a research team in a role that involves much more than traditional dispensing functions. Cognitive input from pharmacists based on their medication expertise can be a valuable asset for principal study investigators. The vast array of services and work that pharmacists can accomplish on a study protocol can be implemented through a research pharmacy.
For example, the University of Buffalo (UB) research pharmacy, founded in 1995 and located at the UB School of Pharmacy and Pharmaceutical Sciences (UB SPPS), is an outpatient pharmacy registered and licensed in New York State. This secure, closed-door pharmacy features compounding equipment, a safe, refrigerator/freezer, lab benches, scales, and a laboratory fume hood. It also has an extensive history of care with involvement in more than 40 local and nationwide clinical studies.
How a research pharmacy differs from a community pharmacy
The research pharmacy has the same capabilities and functions as a standard community pharmacy. The primary difference is that the patient population in the research pharmacy includes only those enrolled in clinical trials and research protocols. Another difference is that the research pharmacy is considered a nonprofit service center within the university. This means there is no interaction with third-party payers or insurance companies.
Further, in contrast to a community pharmacy, the primary customers of a research pharmacy are the principal study investigators. These investigators are interested in designing and implementing an Institutional Review Board (IRB)–approved clinical research protocol with the assistance of the pharmacists and resources of the research pharmacy. The study medications can be in either the pre-IRB approval or post-IRB approval phase of development.
Who is on the pharmacy team?
Four pharmacists work in the UB SPPS research pharmacy: a supervising pharmacist, a principal investigator, and 2 project pharmacists.
Similar to the supervisor in a community pharmacy, the supervising pharmacist in the UB SPPS research pharmacy oversees all the activities within the pharmacy and ensures that they comply with state and federal laws.
The principal investigator acts as the business manager of the research pharmacy. This role involves strategic planning, marketing, business models, and financial accountability.
The project pharmacists are the hands-on pharmacists involved directly with the research. They work closely with study investigators in all stages of the clinical research, from prestudy to study to poststudy.
What research pharmacists can offer
The research pharmacist can assist investigators in basic, clinical, and translational research. To use the research pharmacy, study investigators complete a research medication services request form, which has a checkbox menu describing the services requested.
The purpose of this à la carte menu is so the project pharmacist can customize and specify his or her role, via the research pharmacy’s services, for a particular study based on the investigator’s needs.
Project pharmacists can perform a number of prestudy activities for the investigator, such as assisting in medication research, including literature searches on any pertinent background information regarding the study drug. He or she can also write the pharmacy section of the study protocol. This may involve describing study drug inventory, dispensing, compounding, and record-keeping procedures.
The pharmacist may also write other parts of the study protocol involving pharmacology, pharmacokinetics, drug exclusion criteria, adverse effects, and adherence monitoring. Determining the study drug cost and procurement procedures for drug and supplies is essential so that an accurate pharmacy budget can be presented to the investigator.
Finally, the pharmacist can generate simple randomization treatment schedules.
Some of the study services offered by project pharmacists include compounding, study drug packaging, storage/inventory control, dispensing, delivery, patient counseling, adverse-reaction monitoring, and record-keeping.
The project pharmacist must perform many tasks upon receipt of the study drug order (ie, “prescription”) from the prescriber. First, the pharmacist can compound individual doses of the study drug and placebo per protocol. Common dosage formulations compounded are capsules, oral solutions, and encapsulation of tablets. Unit dose and specialized packaging may be recommended by the pharmacist depending on the study design.
The pharmacist is responsible for creating a study drug label that meets state and federal regulations. Medications are stored under the proper conditions in the research pharmacy. The pharmacist documents all processes regarding the distribution of study drugs. Transportation of medications to the study location (hospital, clinic, or doctor’s office) is offered, as is delivery to the patient’s residence. Lastly, clinical activities in which the pharmacist can participate are patient counseling, drug-interaction analysis, and adverse-reaction monitoring. Often, clinical activities take place at the study site, where the pharmacist will travel to and meet face-to-face with study participants.
Some poststudy services include destroying unused drug supply, analyzing study data, and providing for transition-of-care services.
Study medication must be disposed of in accordance with state law and per study protocol under the authority of the supervising pharmacist. The project pharmacist will coordinate with UB Environmental Health and Safety for destruction of unused drugs.
The project pharmacist can also assist the investigator with the organization and analysis of study data pertaining to the study medication.
An important role for the pharmacist is to provide transition-of-care services for the study participants. This involves assisting patients moving from study treatment to poststudy therapy. It is important that participants be counseled on health management after they discontinue study medications.
Looking to the future
As project pharmacists expand their role from dispensing study medication to providing cognitive input throughout the life cycle of a clinical research project, opportunities are created for the pharmacist to be a co-investigator for the research protocol.
The pharmacist is in turn regarded by the principal study investigator as an essential member of a multidisciplinary research team. The pharmacist serves as the study medication expert. In terms of grant applications, having a pharmacist as a co-investigator provides a more robust submission to the various funding agencies.
This expanded role of pharmacists will increase opportunities for pharmacy students interested in a clinical research career.