Original Title: Dosage sanguin du pentobarbital par HPLC-MS/MS

Authors' objectives: A request to introduce a new test into the Répertoire québécois et système de mesure des procédures de biologie médicale (hereinafter referred to as the Répertoire) has been submitted to the Ministère de la Santé et des Services sociaux (MSSS) by the grappe Montréal-Centre hospitalier universitaire Sainte-Justine (hereinafter referred to as the "applicant laboratory"). The MSSS mandated the Institut national d'excellence en santé et en services sociaux (INESSS) to reassess the relevance of including the blood determination of pentobarbital by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) into the Répertoire. INESSS’s initial assessment in 2013 resulted in a refusal of introduction due to insufficient evidence supporting the clinical utility of the test.

Authors' results and conclusions: RESULTS (#1 POPULATIONAL DIMENSION): According to the clinicians consulted, pentobarbital blood testing would primarily serve the purpose of shortening the time required to confirm death by neurological criteria (DNC), when the patient's condition is progressing towards a fatal outcome. (#2 CLINICAL DIMENSION): Clinicians consulted agreed that the proposed turnaround time of less than 24 h, suggested by the applicant laboratory to rule out the confounding effect of pentobarbital on DNC assessment, is acceptable. (#3 ORGANIZATIONAL DIMENSION): Clinicians consulted indicated that, if the test is added to the Répertoire, reference values should be included in the report to support interpretation of the results. (#4 SOCIOCULTURAL DIMENSION): Guidelines for the determination of DNC indicate that the confounding effect of pentobarbital on clinical assessment of DNC can be ruled out if its blood concentration is known. (#5 ECONOMIC DIMENSION): Introducing the test to the Répertoire could lead to additional costs of approximately $13,000 over the first three years for 108 analyses. Sensitivity analyses show that the net impact could range from $8,700 to $21,900.

Authors' recommendations: In light of the findings of the assessment of the five dimensions of value of interventions, INESSS recommends that the Minister include the pentobarbital blood determination by HPLC-MS/MS in the Répertoire québécois et système de mesure des procédures de biologie médicale. However, INESSS recommends to:  Seek solutions that ensure compliance with clinical turnaround times, regardless of the origin of the samples;  Ensure the test meets the requirements of ISO 15189 standards.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-du-pentobarbital-par-hplc-ms-ms.html

Year Published: 2025

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dosage-sanguin-du-pentobarbital-par-hplc-ms-ms.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)