Developing an assessment system for pharmacotechnical personnel
13 November 2010K. Balsam1, E. Ledru2 1 Centre Hospitalier de Saint-Denis, Service de Pharmacie, Saint Denis, France
2 E. Ledru - Centre Hospitalier d’Orsay, Service de Pharmacie Orsay, France
In the field of pharmacy personnel are not routinely assessed, but the good phytosanitary practice guidelines stipulate that staff should be evaluated and judged to be competent. Evaluation procedures are in place in the pharmaceutical industry and for personnel working in other high-risk areas such as the preparation of radiopharmaceutical medicines or reconstitution of anti-cancer drugs. The aim of our work is to develop and test a theoretical and practical assessment system for personnel involved in the preparation of capsules.
Thirteen trained operators in this field agreed to participate in the test. The observation grid and simulation tests returned satisfactory results from seven of the thirteen. The test criteria included several challenges at critical points, including homogeneity operations for powder mixes and their distribution. The European Pharmacopeia tests to assess the uniformity of mass and consistency were conducted according to the dosage of the tracer under preparation.
The assessment tools described in the existing literature always include theoretical and practical elements. The challenges posed by the system which we have developed allow you to guarantee the competence of operators for the preparation of capsules over a given period of time. The six operators in our test who did not achieve fully satisfactory results lost points for losing powder, insufficient pulverization and failure to follow official procedures. Staff evaluation is a sensitive operation to be conducted periodically as a complement to staff training. It should be fully explained, and understood in the context of continuous improvement of professional practices. This model could be used to evaluate personnel involved in other pharmaceutical processes.