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MODEL STANDARDS FOR PHARMACY …

MODEL STANDARDS FOR PHARMACY compounding OFHAZARDOUSSTERILE PREPARATIONS MODEL STANDARDS for PHARMACY compounding of Hazardous Sterile PreparationsApproved by the national Association of PHARMACY Regulatory Authorities (NAPRA) Board of Directors April 2015, published September November 2016 (Sterilization by Filtration in the Glossary corrected to 30 psi from 50 psi previously published).Adapted with permission from Pr paration de produits st riles dangereux en pharmacie Norme , Ordre des pharmaciens du Qu bec, 2014. national Association of PHARMACY Regulatory Authorities, 2016. All rights part of this document may be reproduced in any form by any photographic, electronic, mechanical or other means, or used in any information storage and retrieval system, without the written permission of the national Association of PHARMACY Regulatory Authorities (NAPRA) 130 Albert Street, Suite 1800, Ottawa, ON K1P 5G4 E-mail: | Telephone: (613) 569-9658 | Fax (613) 569-9659 ACKNOWLEDGEM

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1 MODEL STANDARDS FOR PHARMACY compounding OFHAZARDOUSSTERILE PREPARATIONS MODEL STANDARDS for PHARMACY compounding of Hazardous Sterile PreparationsApproved by the national Association of PHARMACY Regulatory Authorities (NAPRA) Board of Directors April 2015, published September November 2016 (Sterilization by Filtration in the Glossary corrected to 30 psi from 50 psi previously published).Adapted with permission from Pr paration de produits st riles dangereux en pharmacie Norme , Ordre des pharmaciens du Qu bec, 2014. national Association of PHARMACY Regulatory Authorities, 2016. All rights part of this document may be reproduced in any form by any photographic, electronic, mechanical or other means, or used in any information storage and retrieval system, without the written permission of the national Association of PHARMACY Regulatory Authorities (NAPRA) 130 Albert Street, Suite 1800, Ottawa, ON K1P 5G4 E-mail: | Telephone.

2 (613) 569-9658 | Fax (613) 569-9659 ACKNOWLEDGEMENTS The national Association of PHARMACY Regulatory Authorities (NAPRA) would like to first thank one of its members, the Ordre des pharmaciens du Qu bec, for having made possible the adaptation of its document entitled Pr paration de produits st riles dangereux en pharmacie Norme to create this national document, MODEL STANDARDS for PHARMACY compounding of Hazardous Sterile Preparations. This adaptation would not have been possible without the work and dedication of the members of the NAPRA ad hoc Committee on PHARMACY compounding . Special thanks are extended to these individuals: - Ronald Guse, formerly Registrar, College of Pharmacists of Manitoba (Chair)- Bob Nakagawa, Registrar, College of Pharmacists of British Columbia- Marshall Moleschi, Registrar, Ontario College of Pharmacists- Susan Wedlake, formerly Registrar, Nova Scotia College of Pharmacists- Carole Bouchard, formerly Executive Director, NAPRA (ex officio) The Committee was supported by a number of individuals with various types of expertise in this area, whose technical contributions were instrumental in completing the MODEL STANDARDS .

3 Special thanks are also extended to these individuals:- Meechen Tchen, consultant, NAPRA- Judy Chong, Ontario College of Pharmacists - Cameron Egli, formerly Director, Hospital PHARMACY Practice and Technology, College of Pharmacists of British Columbia - Danielle Fagnan, Ordre des pharmaciens du Qu bec - Bal Dhillon, PHARMACY technician, British Columbia- Eric S. Kastango, President/CEO of Clinical IQ, LLC and Critical Point, LLCMODEL STANDARDS FOR PHARMACY compounding OF HAZARDOUS STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)1 CONTENTS1. INTRODUCTION 32. OBJECTIVES 43. REGULATORY FRAMEWORK 54. ABBREVIATIONS 75. CORE REQUIREMENTS FOR A STERILE compounding SERVICE Personnel Policies and procedures Facilities and equipment General maintenance log 406.

4 PRODUCT AND PREPARATION REQUIREMENTS Beyond-use date and dating methods Compounded sterile preparation protocols Compounded sterile preparation log Patient file Conduct of personnel in areas reserved for the compounding of hazardous sterile preparations Aseptic compounding of hazardous sterile preparations Packaging Receipt and storage of hazardous products Transport and delivery of hazardous compounded sterile preparations Recall of hazardous sterile products or final hazardous compounded sterile preparations Incident and accident management Hazardous waste management 627. QUALITY ASSURANCE PROGRAM Program content Results and action levels Verification of equipment and facilities Quality assurance of personnel involved in aseptic compounding Quality assurance of hazardous compounded sterile preparations Documentation of quality control activities 718.

5 SOURCES FOR ADDITIONAL INFORMATION 739. GLOSSARY 7410. LIST OF TABLES 79 MODEL STANDARDS FOR PHARMACY compounding OF HAZARDOUS STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)211. APPENDICES 80 Appendix 1 Policies and procedures for the compounding of hazardous sterile preparations 80 Appendix 2 Mandatory and supplemental references 82 Appendix 3 Training of compounding personnel and cleaning and disinfecting personnel 84 Appendix 4 Procedure template 86 Appendix 5 Minimum indicators for certification of controlled areas and containment primary engineering controls 88 Appendix 6 Certification of controlled areas and biological safety cabinets 90 Appendix 7 Template for the drafting of compounding protocols to be completed for each drug 92 Appendix 8 Examples of sterile preparations that must be verified at each stage of

6 compounding 95 Appendix 9 Procedure example: Receiving, unpacking and storing hazardous products 96 Appendix 10 Temperatures for different types of storage 97 Appendix 11 Incident/accident reporting and follow-up form 98 Appendix 12 Components of a quality assurance program 9912. BIBLIOGRAPHY 101 MODEL STANDARDS FOR PHARMACY compounding OF HAZARDOUS STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)31. INTRODUCTIONThe compounding of sterile preparations requires high-quality STANDARDS to ensure preparation quality and safety. Parenteral therapies are becoming more complex, and patients may now receive continuous antibiotic therapy or chemotherapy, among other therapies, for several days at home.

7 Consequently, greater attention must be paid to the environment in which these preparations are prepared, the training of personnel and quality assurance procedures to prevent complications and protect the public more practice and increased awareness of the inherent dangers of compounding sterile preparations for the health of both patients and compounding personnel1, 2, 3, 4 led to the need to review the Guidelines to PHARMACY compounding published by the national Association of PHARMACY Regulatory Authorities (NAPRA) in October new NAPRA MODEL STANDARDS for PHARMACY compounding of Hazardous Sterile Preparations have been adapted from STANDARDS originally developed by the Ordre des pharmaciens du Qu bec, which are in turn based on General Chapter <797> of the United States Pharmacopeia- national Formulary (USP-NF) in effect in the United States since 2004.

8 Requirements of the Chapter <800> of the United States Pharmacopeia- national Formularly (USP-NF) were also taken into consideration in the preparation of the new NAPRA MODEL STANDARDS . Their preparation was led by the NAPRA ad hoc Committee on PHARMACY compounding and involved extensive consultation with experts and Bussi res JF, Prot S. Perspectives sur les pr parations magistrales en pharmacie au Qu bec. Pharmactuel. 2004;37(3):File Selenic D, Dodson DR, Jensen B, Arduino MJ, Panlilio A, Archibald LK. Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital PHARMACY . Am J Health Syst Pharm. 2003:60(14) Patel PR, Larson AK, Castel AD, Ganova-Raeva LM, Myers RA, Roup BJ, et al.

9 Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studies. JAMA. 2006;296(16) Kastango ES. The cost of quality in PHARMACY . Int J Pham Compound. 2002;6(6):404-7. MODEL STANDARDS FOR PHARMACY compounding OF HAZARDOUS STERILE PREPARATIONSNATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITIES (NAPRA)42. OBJECTIVESThe aim of these MODEL STANDARDS is to provide pharmacists and PHARMACY technicians who compound hazardous sterile preparations with the STANDARDS necessary to evaluate their practice, develop service-related procedures and implement appropriate quality controls for both patients and compounding personnel, with a view to guaranteeing the overall quality and safety of sterile preparations.

10 The MODEL STANDARDS will come into effect in each province/territory once they have been adopted by the respective provincial/territorial PHARMACY regulatory authorities. These MODEL STANDARDS represent the minimum requirements to be applied in compounding sterile preparations; however, it is always possible to exceed these STANDARDS . The use of other technologies, techniques, materials and procedures may be acceptable, so long as they are proven to be equivalent or superior to those described MODEL STANDARDS support NAPRA s MODEL STANDARDS of Practice for Canadian Pharmacists and PHARMACY Technicians5, 6, as well as other policies and guidelines that may be in place in provincial/territorial jurisdictions.


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