Pharmacovigilance in a rare disease: example of the VIGIAPATH program in pulmonary arterial hypertension
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COMMENTARY
Pharmacovigilance in a rare disease: example of the VIGIAPATH program in pulmonary arterial hypertension Marie‑Camille Chaumais1,2,3 · Caroline O’Connell3,5,6 · Laurent Savale3,5,6 · Christophe Guignabert3 · Frédéric Perros3,4 · Xavier Jaïs3,5,6 · Olivier Sitbon3,4,5 · Marc Humbert3,5,6 · David Montani3,5,6 Received: 30 January 2018 / Accepted: 1 August 2018 © Springer Nature Switzerland AG 2018
Abstract 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. Keywords Rare diseases · Pulmonary arterial hypertension · Adverse drug reaction · Pharmacovigilance
Impacts on practice • Development of a dedicated program on PV in rare
disease promotes detection and confirmation on druginduced cases and is complementary with the standard pharmacovigilance process.
* Marie‑Camille Chaumais marie‑camille.chaumais@u‑psud.fr 1
Faculté de Pharmacie, Univ. Paris-Sud, Université ParisSaclay, Chatenay Malabry, France
2
AP‑HP, Service de pharmacie, DHU Thorax Innovation, Hôpital Antoine Béclère, Clamart, France
3
INSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France
4
Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec, LavalUniversity, Quebec City, Canada
5
Faculté de Médecine, Université Paris-Saclay, Univ. Paris– Sud, Le Kremlin Bicêtre, France
6
AP‑HP, Service de Pneumologie, centre de référence de l’hypertension pulmonaire, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin Bicêtre, France
• The role of pharmacists in detecting and reporting drug-
induced cases in rare disease is central mostly through medication reconciliation activity and close interaction with clinicians. • An additional system dedicated to a specific rare disease facilitates the detection of new safety signals, prevents new drug side effects and improves the benefit-to-risk ratio of a drug. Spontaneous reporting, where pharmacists and doctors are in the first line, is the primary method for collecting postmarketing information on the risk–benefit ratio of a drug, especially the detection of a new drug safety signal. Once a safety signal
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