Qualitative risk assessment of follicle stimulating hormone injectable products.
| Autor: | Steinke DT; School of Health Sciences, Division of Pharmacy and Optometry, University of Manchester , Manchester, UK., Zarroug OH; School of Health Sciences, Division of Pharmacy and Optometry, University of Manchester , Manchester, UK., Mathur R; Department of Reproductive Medicine, Saint Mary's Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre , Manchester, UK., Kendrew H; CARE Fertility Bath , Bath, UK., Jenkins J; Medical Affairs, Gedeon Richter Plc/Preglem SA , Geneva, Switzerland. |
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| Jazyk: | angličtina |
| Zdroj: | Expert opinion on drug delivery [Expert Opin Drug Deliv] 2020 Nov; Vol. 17 (11), pp. 1647-1654. Date of Electronic Publication: 2020 Oct 13. |
| DOI: | 10.1080/17425247.2020.1813106 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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