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1ISG-015 Assessment of preparatory staff’s knowledge of carcinogenic, mutagenic and reprotoxic (CMR) risks
  1. E Simon,
  2. C Jurado
  1. Chu Toulouse, Pharmacie, Toulouse, France


Background and Importance Context: The preparation of pharmaceutical products is governed by Good Preparation Practices (GPP). Guideline 2: ‘Preparation of medicinal products containing substances that may present a risk to health and the environment’ states that personnel must be trained and informed.

Objectives To assess the initial knowledge of the preparation team on carcinogenic, mutagenic and reprotoxic (CMR) risks and to establish appropriate training.

Method A SPHINX® questionnaire was developed based on bibliographical data with methodological support from COMEDIMS, risk preventionists and occupational medicine. The 12-question questionnaire covered not only basic knowledge of the risk, but also the practical application of CMR risk management in the unit. It was submitted to all staff over a 1-month period. The analysis of the results led to the implementation of a training programme adapted to all staff.

Results 28 people completed the questionnaire with a mean score of 12.5/20 [5.8–17.9]. Staff seniority seemed to contribute to a better knowledge of risk (Student, p = 0.06), with a mean of 14.7 for those working in our department for more than 5 years compared to 12.1 for new staff. In terms of knowledge, the basic concepts of CMRs and personal protective equipment were acquired (64% and 79% of workers answered these questions correctly). On the other hand, collective protection equipment, guidelines and what to do in case of exposure were less well understood (39%, 7% and 11% respectively).

Discussion Based on the results of the questionnaire, CMR risk concepts are not fully understood by all staff, although seniority in the department seems to increase their knowledge. The responses have enabled us to identify the gaps in the team’s knowledge and to propose a targeted training course for all, combined with situational exercises. The effectiveness of the training is then evaluated using a questionnaire combined with a satisfaction survey.

Conclusion This assessment enables us to meet the initial training requirements of Guideline 2. The training and assessment materials will form the basis for maintaining skills as part of the unit’s ongoing training.

Conflict of Interest No conflict of interest.

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