John Libbey Eurotext

Journal de Pharmacie Clinique

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Standards for the preparation of sterile products in pharmacy in Quebec Volume 38, issue 4, Décembre 2019

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Authors
1 Faculté de pharmacie, Université de Montréal, Montréal (Québec), Canada
2 Département de pharmacie, Hôpital Anna-Laberge, Centre intégré de santé et de services sociaux de la Montérégie-Ouest, Châteauguay (Québec), Canada
3 Département de pharmacie, Hôpital Pierre-Boucher, Centre intégré de santé et de services sociaux de la Montérégie-Est, Longueuil (Québec), Canada
4 Membre du Groupe de travail sur les préparations stériles de l’Association des pharmaciens des établissements de santé du Québec, Montréal (Québec), Canada
5 Hôpital général de Montréal, Département de pharmacie, Centre universitaire de santé McGill, Montréal (Québec), Canada
6 Département de pharmacie, Hôpital de la Cité-de-la-Santé, Centre intégré de santé et de services sociaux de Laval, Laval (Québec), Canada
7 Service de soutien - courte durée, Département de pharmacie, Hôpital de la Cité-de-la-Santé, Centre intégré de santé et de services sociaux de Laval, Laval (Québec), Canada
8 Secteur fabrication, Département de pharmacie, Centre hospitalier universitaire Sainte-Justine, Montréal (Québec), Canada
9 Permanence de l’Association des pharmaciens des établissements de santé du Québec, Montréal (Québec), Canada
* Correspondance

The production of sterile preparations requires a strict regulatory framework in order to standardize and optimize aseptic techniques. In spring 2014, the Ordre des pharmaciens du Québec has reviewed its existing guidelines and published two new standards for sterile preparations. Several recommendations and modifications have been added to the existing 1995 standard to provide greater public protection, including the use of the required protective garb, strict aseptic procedures and determination of the Beyond-Use Date of the preparations. Two independent standards are now available for pharmacists who supervise the production of sterile preparations in Quebec. One concerns non-hazardous sterile preparations (standard 2014.01) and the other concern hazardous sterile preparations (standard 2014.02). Pharmacist involved in this type of practice must be familiar with the various aspects of these standards in order to maintain the quality and to minimize microbial and chemical contamination. It is also important to ensure the safety of the assigned personnel to the compounding of hazardous sterile preparations which must fully respect the requirements to avoid significant risks.

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