జర్నల్ ఆఫ్ ఫార్మకోవిజిలెన్స్

నైరూప్య

Implementation of a Robust Pharmacovigilance Method for Filgrastim Non-Innovator Products in Cancer Patients in Routine Clinical Practice Complying With Mexican Regulations for Biocomparables

Huerta-Sanchez Olivid Marisol, Aguilar-Ponce José Luis, Meneses-García Abelardo, Herrera-Gómez Ángel, Herrera-Hernández Ricardo, Monroy-Cruz María Teresa, Burgeño-Ferreira Juan Andrés, Castañeda-Hernández Gilberto and López-Gamboa Mireya

Background and aim: Mexico, as other countries, has recently changed regulatory requirements for noninnovator biopharmaceuticals (biocomparables); a suitable pharmacovigilance program being now mandatory. Hence, our aim was to implement a robust pharmacovigilance method for filgrastim products of different brands used in routine clinical practice in Mexico.

Method: Prospective, phase IV, non-interventional study performed at the Instituto Nacional de Cancerología (National Institute of Cancerology) of Mexico. All pharmacy dispensations of filgrastim products were reviewed and recorded during four months. Patients received a diary for voluntary notation of adverse drug reactions (ADR) every time they were dispensed filgrastim. Additionally, medical records were consulted and contrasted with patientgenerated information. ADR analysis was performed according to the Mexican official norm on pharmacovigilance NOM-220-SSA1-2012.

Results: The procedure allowed to trace which filgrastim brand was administered to every patient. 373 patients received diaries. 214 patients returned diaries with information suitable for further analysis. Very common ADRs were musculoskeletal pain and headache. Common ADR were pain in extremities, asthenia, general body pain, nausea, pain in site of injection, vomit, paresthesia, abdominal discomfort, decreased appetite and diarrhoea. All ADRs were probably or possibly related to filgrastim and corresponded to previously reported ADRs. No new ADRs were detected.

Conclusion: The used methodology was robust enough to identify and characterize ADRs for each filgrastim brand product directly from patient information. It thus allows performing pharmacovigilance studies for biopharmaceuticals, both innovator and non-innovator, guaranteeing traceability and complying with current Mexican regulations for biocomparables.