Qualitative Risk Assessment Of Follicle Stimulating Hormone Injectable Products

Background Gonadotropin injections for fertility treatment regimens are usually self-injected, typically over 8-12 days during the assisted reproductive technology cycle. Parenteral gonadotropins are available in different formulations and administered through various systems. A user experience study and risk assessment were performed to evaluate different product types for risks to the patient when preparing and administering injections. Methods Nine women of child-bearing age each prepared and administered injections of six products representing single- and multidose vials of menotropin for reconstitution (Merional (R) and Menopur (R)), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon (R)), and without cartridges (Gonal-f (R)), and single-use FSH pre-filled pens (Bemfola (R)). Risk assessments based on user feedback were made with reference to EU regulations for implementing practices for safe use of injectable products. Results Products requiring reconstitution with diluent in glass ampoules were associated with medium risk for sharps injury and a lower level of user confidence. Pen injectors were considered easy-to-use, with a low risk of sharps injury. Single-use pens were associated with the lowest risk of dosing errors. Conclusions The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice.