Service Learning Project Summary

The purpose of this paper is to report a service learning project that took place with a senior certified pharmacy technician (CPhT) about the roles she has in a clinical trial setting. This paper aims to provide an understanding of the daily roles a CPhT has in a clinical trial setting as well as what role a CPhT in a privet pharmacy setting has in the clinical trial. By exploring the roles and responsibilities of the CPhT within the clinical trial pharmacy team we hope to better understand the way clinical trials are conducted.
A clinical trial is used to evaluate the efficacy and safety of a new drug or a new medical procedure (Merrill, 2013, p. 205) and randomized controlled trials are the most common type of trial conducted in clinical
settings (Merrill, 2013, p. 206). Clinical trials test new treatments and these treatments could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy ("Conducting Clinical Trials," 2014). Since the outcomes of these trials are highly important, both to the patients and the sponsors (person or company paying to evaluate a treatment), the strictest of policies and procedures are implemented.
The pharmacy technician that was followed and interviewed for this service learning project is a senior sterile certified pharmacy technician.
The ‘senior’ in the technician’s title indicates that she has been nationally certified and practicing for a minimum of ten years. This particular CPhT has been practicing for roughly twenty years. The ‘sterile’ in her title indicates that she has undergone additional training and certifications in order to practice sterile product production, such as steroid injections, vitamin injections and/or total parenteral nutrition (TPN). This CPhT currently works with local randomized clinical trials as part of the clinical trial pharmacy team in addition to working at a local sterile compounding pharmacy. The local compounding pharmacy that she works for also provides some of the medication used in certain parts of some of the clinical
trials.
Pharmacy has a vital role in relation to clinical research, which is to safeguard participants, healthcare professionals and the Trust by ensuring Investigational Medicinal Products (IMP’s) are appropriate for use and are procured, handled, stored and used safely and correctly ("Clinical Trials," n.d.). According to the CPhT that was interviewed, protocols for each clinical trial are set by the sponsor (the persons or company paying for the trial). The protocols are detailed and extremely specific, down to the color of ink used to sign and fill out forms (black, the ink color must be black). The CPhT expressed that working at the sterile compounding pharmacy, which has an ISO 8 clean room and high strict standard operating procedures, is less strict than working with a clinical trial. She indicated that the policies and procedures for the sterile compounding pharmacy were not lacks by any means simply that the protocols set for the clinical trials are that strict.
Tasks completed by a pharmacy team in a clinical trial may include reviewing study protocols, writing and approving dispensing procedures, staff training, randomization of products, safe and secure ordering, storage, issuing and destruction of IMPs, accurate record keeping and monitoring of clinical trial activity ("Clinical Trials," n.d.). Part of the protocols set by the sponsor includes reviewing the protocols daily. One of the first duties the CPhT completes after arriving to work for the clinical trial is to read and sign the policy stating that she is aware of her duties, the way that must be completed and recorded and what to do if there are any deviations. This is done for every shift, every day that a trial is active. Some days the CPhT could have as many as four shifts in a 24 hour time period.
Accurate record keeping is part of the protocol set by the sponsor and is strictly enforced. After reading and signing the policy the CPhT starts the rest of her duties which include documentation pick up, retrieving dosing trays, checking randomization, cleaning and prepping the subject area and dosing. All of the mentioned tasks are documented and signed off at every stage. In a clinical trial the term ‘dosing’ has its own set of tasks. ‘Dosing’ includes physically giving the subject the treatment, watching and checking that the treatment was completed, making sure that any fluid or food that is required was completely consumed and checking the subjects’ vitals. All of these tasks are completed for each subject while being documented completely at each stage. For a group of 50 participants, ‘dosing’ could take anywhere from 1 to 4 hours depending on the specific protocols for that study.
The role of the independent pharmacy in the clinical trial is a small one but still important.
In a clinical trial all treatment must be equal. All subjects must eat the same food, the same amount of food and at the same time. Well the medication must be the same too, not just the treatment being studied but all subsequent medications. That means that if the subjects are testing a smoker’s sensation treatment but need to take medication for high blood pressure, then it is critical that all of the blood pressure medications are the same. They must all come from the same drug manufacture and from the same batch containing the same lot numbers. This responsibility falls on the independent
pharmacy.
The purpose of this paper was to report the roles of a certified pharmacy technician in a clinical trial setting. This paper aimed to provide an understanding of the roles of CPhT in a clinical trial setting by exploring some of the policies, procedures, protocols and daily duties the pharmacy team must follow. Furthermore, the relationship between the pharmacy team within the physical clinical trial and the independent pharmacy show how the entire pharmacy community works together in a clinical trial.