Pharmacovigilance in a rare disease: example of the VIGIAPATH program in pulmonary arterial hypertension.
|アブストラクト||Spontaneous reporting is the primary method used in pharmacovigilance (PV) to detect drug safety signal. Specific criteria used in pharmacovigilance to prove accountability of a drug are rarely present in rare disease. The low number of alerts also makes it challenging. The aim of this commentary is to raise awareness among pharmacists on issues and opportunities for pharmacovigilance in rare diseases, taking pulmonary arterial hypertension (PAH) as example, from which a subset of cases are drug-induced. It is demonstrated how a dedicated program named VIGIAPATH created to reinforce pharmacovigilance of drug-induced pulmonary arterial hypertension at a national level, led to increase self-reporting and confirm safety signals. Thanks to a specific program such as VIGIAPATH, pharmacists can play an important role in communication with clinicians, patients and regulatory agencies, facilitating the detection of potential safety signals at an early stage in rare disease.|
|ジャーナル名||International journal of clinical pharmacy|
|投稿者||Chaumais, Marie-Camille; O'Connell, Caroline; Savale, Laurent; Guignabert, Christophe; Perros, Frederic; Jais, Xavier; Sitbon, Olivier; Humbert, Marc; Montani, David|
|組織名||Faculte de Pharmacie, Univ. Paris-Sud, Universite Paris-Saclay, Chatenay Malabry,;France. firstname.lastname@example.org.;AP-HP, Service de pharmacie, DHU Thorax Innovation, Hopital Antoine Beclere,;Clamart, France. email@example.com.;INSERM UMR_S 999, Hopital Marie Lannelongue, Le Plessis Robinson, France.;firstname.lastname@example.org.;Faculte de Medecine, Universite Paris-Saclay, Univ. Paris-Sud, Le Kremlin;Bicetre, France.;AP-HP, Service de Pneumologie, centre de reference de l'hypertension pulmonaire,;DHU Thorax Innovation, Hopital Bicetre, Le Kremlin Bicetre, France.;Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie;de Quebec, Laval University, Quebec City, Canada.|