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Exploring patient participation in reducing health-care-related safety risks

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<strong>Explor<strong>in</strong>g</strong> <strong>patient</strong> <strong>participation</strong> <strong>in</strong> reduc<strong>in</strong>g <strong>health</strong>-<strong>care</strong>-<strong>related</strong> <strong>safety</strong> <strong>risks</strong><br />

48<br />

Other questions can also be raised at this stage.<br />

» Does <strong>patient</strong> <strong>in</strong>volvement really have a positive effect on transfusion <strong>safety</strong>? There is<br />

little <strong>in</strong>formation on the effectiveness of <strong>in</strong>itiatives that aim to <strong>in</strong>form <strong>patient</strong>s and<br />

improve their will<strong>in</strong>gness to participate.<br />

» Does provid<strong>in</strong>g <strong>safety</strong>-<strong>related</strong> <strong>in</strong>formation produce any adverse effects?<br />

» What are the implications for cl<strong>in</strong>ical practice?<br />

» What legislative framework is needed to ensure <strong>safety</strong> becomes a shared<br />

responsibility, with the <strong>patient</strong> as a coproducer of <strong>health</strong>?<br />

Content of this chapter<br />

The chapter provides a brief overview of blood transfusion and <strong>patient</strong> <strong>safety</strong> <strong>in</strong> France<br />

and presents a critical analysis of legislative and applied tools support<strong>in</strong>g <strong>patient</strong><br />

empowerment (with a focus on <strong>patient</strong>s’ rights and <strong>patient</strong> <strong>safety</strong>) <strong>in</strong> relation to blood<br />

transfusion. Theoretical and legislative aspects are compared to cl<strong>in</strong>ical practice and<br />

their consequences for <strong>patient</strong> <strong>safety</strong>, draw<strong>in</strong>g from <strong>in</strong>terviews with experts (particularly<br />

haemovigilance experts) and prescribers and complemented by a case study conducted<br />

at the Etablissement Français du Sang (EFS) [French Blood Transfusion Organization]<br />

centre <strong>in</strong> the city of Tours. The conclud<strong>in</strong>g section summarizes the potential benefits of<br />

<strong>patient</strong> <strong>in</strong>volvement <strong>in</strong> the blood transfusion process to improve <strong>patient</strong> <strong>safety</strong> and offers<br />

recommendations for mov<strong>in</strong>g forward, with suggestions for future research. A list of<br />

relevant legislation is presented at the end of the references section.<br />

Blood transfusion and <strong>patient</strong> <strong>safety</strong> <strong>in</strong> France<br />

Blood transfusion: organization and transfusion-<strong>related</strong> data, <strong>in</strong>clud<strong>in</strong>g number of<br />

adverse events<br />

Organization of blood transfusion <strong>in</strong> France<br />

The EFS was set up on 1 January 2000 (follow<strong>in</strong>g Law No. 98-535 of 1 July 1998),<br />

gather<strong>in</strong>g <strong>in</strong> one unique <strong>in</strong>stitution the previous blood transfusion centres and tak<strong>in</strong>g<br />

responsibility for some of the tasks of the former French blood agency. Regulation and<br />

control tasks were given to the Agence Française de Sécurité Sanitaire des Produits de<br />

Santé (AFSSAPS) [French Health Products Safety Agency], 7 which was created by<br />

the same law, and the Institut National de Veille Sanitaire [Institute for Public Health<br />

Surveillance] (3). The ma<strong>in</strong> actors <strong>in</strong> the field of blood transfusion <strong>in</strong> France today are (4):<br />

» the EFS, which is <strong>in</strong> charge of the collection of blood, the biological qualification of<br />

donations, preparation of LBPs and their distribution at national level; its activities<br />

fall under the control of the AFSSAPS;<br />

» the Centre de Transfusion Sangu<strong>in</strong>e des Armées (CTSA) [Armed Forces Blood<br />

Transfusion Centre], which is responsible for supply<strong>in</strong>g armed forces <strong>in</strong> the field<br />

and military hospitals with LBPs;<br />

7 AFSSAPS was replaced on 1 May 2012 by Agence Nationale de Sécurité du Médicament et des Produits de Santé [National<br />

Security Agency of Medic<strong>in</strong>es and Health Products] under the Law of 29 December 2011 on the Strengthen<strong>in</strong>g of the<br />

Safety of Medic<strong>in</strong>es and Health Products.

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