Qualitative risk assessment of follicle stimulating hormone injectable products.
Expert Opin Drug Deliv
; 17(11): 1647-1654, 2020 11.
Article
em En
| MEDLINE
| ID: mdl-33048624
ABSTRACT
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® and Menopur®), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon®), and without cartridges (Gonal-f®), and single-use FSH pre-filled pens (Bemfola®). 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Técnicas de Reprodução Assistida
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Hormônio Foliculoestimulante Humano
/
Menotropinas
Tipo de estudo:
Etiology_studies
/
Qualitative_research
/
Risk_factors_studies
Limite:
Adult
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Female
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Humans
Idioma:
En
Revista:
Expert Opin Drug Deliv
Ano de publicação:
2020
Tipo de documento:
Article