Article | REF: TR330 V2

Traceability of pharmaceutical products in hospitals

Author: Luc ROZENBAUM

Publication date: November 10, 2013

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ABSTRACT

Traceability of pharmaceuticals in hospitals has been a regulatory and normative requirement since 1985. It concerns both drugs and medical devices. It has become essential within the context of health scandals and budget constraints. Examples of the traceability applications of these products in hospitals show the importance of having interoperable computer tools. The objective of such traceability is to ensure the therapeutic management of patients.

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AUTHOR

  • Luc ROZENBAUM: Head Pharmacist - Nanterre Hospital Care Center - Chairman of the AFNOR Standardization Commission on the sterilization of surgical instruments

 INTRODUCTION

The traceability of pharmaceutical products in the hospital environment was imposed by regulations and standards following the numerous health scandals that marked the years 1985-2013. Hospital pharmacists manage pharmaceutical products, which include drugs such as medical gases, sterile medical devices such as prostheses and implants, and the central sterilization of re-sterilizable multi-use surgical instruments. They are also responsible for pharmacovigilance and materialovigilance. In addition to these various responsibilities, hospital pharmacists are developing a culture of recording, which puts them at the forefront of implementing traceability with the establishment's quality department.

The prospect of major risks, whether linked to potential health disasters (chinkungunya, Severe Acute Respiratory Syndrome [SARS] and its coronarovirus variants, H7N9 avian flu pandemic, H1N1 influenza, etc.), or bioterrorism, requires the introduction of a health policy designed to reduce mortality and disorganization in our societies. This health policy calls for the pooling of resources between the various players in the health sphere (hospitals, medical social centers, hospital and out-patient medical staff), which requires us to think about the tools and traceability systems that need to be interoperable.

The traceability of pharmaceutical products is necessary in a context of health safety, economic necessity, and regulatory and normative constraints. Means and examples of implementation of this traceability in a hospital establishment will complete this table.

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KEYWORDS

Traceability   |   Pharmaceutical products


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Traceability of pharmaceutical products in hospitals