How to validate radiopharmaceuticals management software?

Abstract

In the context of securing medication management systems (MMS) in healthcare habilities, implementation of an electronic MMS is a priority area of work. The quality requirements for the production of radiopharmaceuticals have increased significantly in the field of radiopharmacy. The deployment of Information Technology (IT) tools is essential to secure the radiopharmaceutical medication use process. The aim of this work is to propose the first consensual tool to validate radiopharmacy software approved by a panel of experts. A literature review was conduced related to the validation of hospital pharmacy software. The Delphi method was chosen for achieving a consensus in this study. Surveys were sent by mail to selected experts involved in the MMS. Twenty-seven replies were recorded (77%) to the first round, and 17 responses were recorded to the second survey. The final tool is a grid with 44 items. We proposed the first consensual tool to validate radiopharmacy software. This tool could be implemented in all French radiopharmacy to improve quality.

Experience with radiopharmacy information system

“…Furthermore, to improve the RPIS it has also been followed some of the specific requirements of the first published consensual tool for validating radiopharmacy software (Léa et al 2020), proposed by a panel of experts of the French Society of Radiopharmacy (SoFRa), following the Delphi method (McPherson et al 2018). According to this, the most outstanding functionalities added to the RPIS are:…”

“…Software validation in hospital pharmacy is generally not formalized. But just recently it has been published a consensual tool for validating radiopharmacy software (Léa et al 2020), proposed by a panel of experts of the French Society of Radiopharmacy (SoFRa) and following the Delphi method (McPherson et al 2018). Therefore, to improve our RPIS it has been followed some of the specific requirements of this publication.…”

“…A European conformity (CE) marking on any prescription support software is imposed. And, in this regard, it has been published that software in radiopharmacy will eventually acquire medical device status (Blondeel-Gomes et al 2020). But for now, a RPIS is not a medical software, because it does not comply with any of the conditions mentioned in the European regulation in this regard.…”

Experience with Radiopharmacy Information System

“…Software validation in hospital pharmacy is generally not formalized. But just recently it has been published a consensual tool for validating radiopharmacy software (Léa et al 2020), proposed by a panel of experts of the French Society of Radiopharmacy (SoFRa) and following the Delphi method (McPherson et al 2018). Therefore, to improve our RPIS it has been followed some of the speci c requirements of this publication.…”

“…Control and traceability of users tra c entering and leaving the RPIS. Furthermore, to improve the RPIS it has also been followed some of the speci c requirements of the rst published consensual tool for validating radiopharmacy software (Léa et al 2020), proposed by a panel of experts of the French Society of Radiopharmacy (SoFRa), following the Delphi method (McPherson et al 2018). According to this, the most outstanding functionalities added to the RPIS are:…”