Satisfaction and usability of the recombinant chorionic gonadotropin prefilled pen: a survey in Italy

Abstract

Background Due to high purity, recombinant human chorionic gonadotropin (hCG) is suitable for subcutaneous injection, and hence for self-administration, in assisted reproduction. To increase usability and reduce the risk of dosing errors, a prefilled pen was produced. We investigated the ease of administration and satisfaction with the product amongst patients and healthcare professionals. Methods A survey was conducted amongst women with infertility who underwent in vitro fertilization treatments with recombinant hCG to trigger ovulation in various clinics in Italy. Results A total of 276 Italian women were interviewed. The median score of preference for the prefilled pen in comparison with hCG powder to be reconstituted in the solvent was rated as 9 (range 8–10), and 125 women answered that the prefilled pen had major advantages. Reasons for preference of the prefilled pen were linked to ease of use and safety: avoidance of dosage mistakes and of concern of such, ease of administration, certainty that the drug is correctly taken, safe administration and no anxiety. The procedure for recombinant hCG administration through the prefilled pen was judged as easy by 80% of respondents, with a median score of 9 (range 8–10) for easiness on a 1–10 scale. Out of 276 respondents, 249 (90%) had no problem with the injection. Conclusion Overall, the respondents reported a favourable perception of the prefilled pen with hCG, which was reported to be easy to use and perceived to prevent dosage mistakes.

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR®)

“… 21 A second study conducted among patients undergoing ART also reported that avoiding dosage mistakes was of great importance. 13 Ease of use was identified in previous studies as the most important attribute by patients undergoing ART, however, in the current study this attribute was perceived as of below average importance. 13 , 21 Similar differences between patient and nurse perceptions were found in a previous study, which examined FSH injection pen perception in the European market.…”

“… 13 Ease of use was identified in previous studies as the most important attribute by patients undergoing ART, however, in the current study this attribute was perceived as of below average importance. 13 , 21 Similar differences between patient and nurse perceptions were found in a previous study, which examined FSH injection pen perception in the European market. 21 This implies a possible trend in perception differences between nurses and patients, where each group tends to place a greater value on attributes that affect their daily lives.…”

“… 21 The widespread acceptance of pre-filled injection devices is, therefore, driven by a range of benefits including convenience, simplicity, suitability for home use, reduction in wasted products and associated environmental benefits, and greater dose precision. 12 , 13 , 19 , 20 …”

“…In the current study, a list of attributes of a pre-filled gonadotropin self-injection pen device was prepared which contained a total of 14 options ( Table 1 ). The options were selected to reflect standard attributes investigated in prior research and similar publications examining pre-filled injection pens 13 , 20 , 21 and were validated by feedback obtained from fertility specialist nurses regarding features of pen devices that were considered to be of greatest importance. Attributes were intended to cover key areas including training, injection preparation, injection experience, how the injection fits into the patient’s daily routine and the overall appearance/look of the injection pen.…”

“… 11 European studies that have investigated the perception of pre-filled pens found that ease of use is the most important attribute for patients undergoing ART. 13 , 21 However, interestingly, differences were found between fertility nurses and patients with regard to key attributes. Patients place greater value on factors that influence their daily life, such as injection site pain and device reusability, while nurses value pens that are easier for patients to learn to use correctly, and which carry minimal risks of incorrect use.…”