{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T10:20:16Z","timestamp":1773310816980,"version":"3.50.1"},"reference-count":0,"publisher":"Canadian Society of Healthcare-Systems Pharmacy","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Can J Hosp Pharm"],"abstract":"<jats:p>R\u00c9SUM\u00c9 \nContexte : La pr\u00e9paration des chimioth\u00e9rapies injectables est un processus critique vu leurs toxicit\u00e9s ainsi que le nombre \u00e9lev\u00e9 d\u2019intervenants, ce qui n\u00e9cessite une \u00e9valuation syst\u00e9matique et proactive des risques.\nObjectif : Analyser les risques li\u00e9s au processus de pr\u00e9paration des m\u00e9dicaments cytotoxiques, par la m\u00e9thode d\u2019analyse des modes de d\u00e9faillance, de leurs effets et de leur criticit\u00e9 (AMDEC) au sein d\u2019une unit\u00e9 de pr\u00e9paration centralis\u00e9e des cytotoxiques (UPCC).\nM\u00e9thodologie : Une \u00e9tude analytique a \u00e9t\u00e9 men\u00e9e dans une UPCC sur une p\u00e9riode de six mois. L\u2019analyse des risques a \u00e9t\u00e9 r\u00e9alis\u00e9e par la m\u00e9thode AMDEC. Un plan d\u2019action a \u00e9t\u00e9 \u00e9labor\u00e9 pour traiter les sc\u00e9narios critiques. Un deuxi\u00e8me cycle d\u2019AMDEC a \u00e9t\u00e9 r\u00e9alis\u00e9 pour \u00e9valuer l\u2019efficacit\u00e9 des mesures mises en \u0153uvre.\nR\u00e9sultats : Au total, 189 modes de d\u00e9faillance ont \u00e9t\u00e9 identifi\u00e9s dont 2 % jug\u00e9s inacceptables et 30 % tol\u00e9rables sous contr\u00f4le. Un plan d\u2019action a \u00e9t\u00e9 \u00e9labor\u00e9 reposant sur la formation, le double contr\u00f4le visuel et la mise en place d\u2019un contr\u00f4le analytique. Lors de l\u2019AMDEC de suivi, une r\u00e9duction de 23 % de l\u2019indice de criticit\u00e9 global a \u00e9t\u00e9 observ\u00e9e, avec une am\u00e9lioration significative des niveaux de criticit\u00e9. Sur 60 actions, 73 % ont \u00e9t\u00e9 finalis\u00e9es et une mise \u00e0 jour du plan d\u2019action a \u00e9t\u00e9 propos\u00e9e.\nConclusion : Ces r\u00e9sultats t\u00e9moignent de l\u2019implication r\u00e9elle de l\u2019\u00e9quipe de l\u2019UPCC dans la gestion des risques et de l\u2019utilit\u00e9 de la m\u00e9thode AMDEC dans une d\u00e9marche d\u2019am\u00e9lioration continue du circuit de pr\u00e9parationdes cytotoxiques.\nMots cl\u00e9s : chimioth\u00e9rapie; analyse des modes de d\u00e9faillance, de leurs effets et de leur criticit\u00e9; AMDEC; analyse des risques; plan d\u2019action\nABSTRACT\nBackground: The preparation of injectable chemotherapy drugs is a critical process, given their toxicity and the large number of stakeholders involved. As such, systematic and proactive risk assessment is required.\nObjective: To analyze the risks associated with the cytotoxic drug preparation process using the failure mode, effects, and criticality analysis (FMECA) method within a centralized cytotoxic drug preparation unit (CCDPU).\nMethods: An analytical study was conducted in a CCDPU over a 6-month period. The risk analysis was performed using the FMECA method. An action plan was developed to address critical scenarios. A second FMECA cycle was conducted to evaluate the effectiveness of the implemented actions.\nResults: A total of 189 failure modes were identified, of which 2% were deemed unacceptable and 30% were tolerable when controlled. An action plan was developed based on training, double visual inspection, and the implementation of analytical control. During the follow-up FMECA, a reduction of 23% in the overall criticality index was observed, with a significant improvement in criticality levels. Of the 60 actions, 73% were completed, and an updated action plan was proposed.\nConclusion: These results demonstrate the CCDPU team\u2019s genuine commitment to risk management and the usefulness of the FMECA method in a continuous improvement approach to the cytotoxic preparation circuit.\nKeywords: chemotherapy; failure mode, effects, and criticality analysis; FMECA; risk analysis; action plan<\/jats:p>","DOI":"10.4212\/cjhp.3851","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T17:07:36Z","timestamp":1770829656000},"source":"Crossref","is-referenced-by-count":0,"title":["Processus de pr\u00e9paration des cytotoxiques injectables : gestion des risques par l\u2019application de la m\u00e9thode d\u2019analyse des modes de d\u00e9faillance, de leurs effets et de leur criticit\u00e9"],"prefix":"10.4212","volume":"79","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2101-7288","authenticated-orcid":false,"given":"Wiem","family":"Ben Ayed","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Azza","family":"Ben Haddada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Azza","family":"Ben Said","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imen","family":"Toukabri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imen","family":"Limayem","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2732","published-online":{"date-parts":[[2026,2,11]]},"container-title":["Canadian Journal of Hospital Pharmacy"],"original-title":[],"link":[{"URL":"https:\/\/www.cjhp-online.ca\/index.php\/cjhp\/article\/download\/3851\/5827","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cjhp-online.ca\/index.php\/cjhp\/article\/download\/3851\/5828","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cjhp-online.ca\/index.php\/cjhp\/article\/download\/3851\/5827","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T16:00:44Z","timestamp":1773244844000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cjhp-online.ca\/index.php\/cjhp\/article\/view\/3851"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,11]]},"references-count":0,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,3,11]]}},"URL":"https:\/\/doi.org\/10.4212\/cjhp.3851","relation":{},"ISSN":["1920-2903","0008-4123"],"issn-type":[{"value":"1920-2903","type":"electronic"},{"value":"0008-4123","type":"print"}],"subject":[],"published":{"date-parts":[[2026,2,11]]},"article-number":"e3851"}}