The handling of cytotoxic drugs began in the 1940s and, for many years, was carried out by professionals without specific training and using non-standardized techniques. However, since the 1970s, potential highly harmful effects for professionals handling cytotoxic drugs have been recognized, such as the development of tumors, spontaneous abortions, and infertility. These adverse effects resulting from occupational exposure justified the adoption of specific handling techniques to prevent direct contact with cytotoxic drugs, for example, due to spillages. In addition, specific training and assessment have been recommended for pharmacy students and professionals in the handling of cytotoxic drugs. In various areas of health, simulation has been adopted as a way of developing and assessing knowledge and technical skills. It consists of a technique that makes it possible to recreate a situation or environment that allows professionals or students to experience a representation of a real event and also to practice, learn, evaluate, test, and understand systems and human actions. The main aim of this study was to design and evaluate a training protocol to simulate the safe handling of cytotoxic drugs using tonic water. In this descriptive cross-sectional observational study, a simulation protocol was drawn up consisting of:
(i) framework,
(ii) briefing,
(iii) scenario, and
(iv) debriefing.

After being authorized by the ethics committee, the simulation was applied as a pilot test. Participants consisted of Pharmacy undergraduate students approved for an internship in a hospital setting who voluntarily expressed their willingness to participate. Exclusion criteria were: having any physical limitation that would prevent the correct handling of drugs in an aseptic environment and having an allergy to tonic water or quinine. Concerning the framework, the learning objectives of the simulation, the details of the clinical case, and the roles of the members of the team of participants were described. In terms of briefing data, an orientation session was held before the start of the simulated activity, where instructions and preparatory information for the scenario were given. As to the scenario, a purpose-built cleanroom was prepared, equipped with a laminar flow cabinet, and all the necessary materials to simulate the preparation of the cytotoxic drugs of a FOLFOX therapeutic regimen (including personal protective equipment, simulated drugs containing innocuous tonic water instead of cytotoxic drugs, and other materials). Finally, the debriefing data consisted of the identification of the trainers as responsible for its conduction, and the depiction of its different phases (description, analysis, and application). All four participants totally or partially agreed on the suitability of the simulation in its different moments and all the participants totally or partially agreed on the improvement of the various technical or theoretical competencies provided by the simulation (aseptic technique, selection of suitable material and solvents and prevention of the spread of spillages). The development of this training protocol represented the development of an innovative and safe simulation-based alternative for assessing the handling of cytotoxic drugs by pharmacy students. Since all the components of the simulation have been described in detail, it is envisaged that the simulation protocol could be adopted by other higher education institutions.

Keywords: Simulation based-learning, Health education, Pharmacy, Cytotoxic drugs, Chemotherapy.