By Marie-Claire Wilson Engagement Manager, Matt Aspinall Digital Engagement Manager
The scope of these programmes is to ensure that female patients are not pregnant when starting therapy and that female patients do not become pregnant during the course of and/or soon after stopping the therapy. PPPs could also target male patients when use of a medicinal product by the biological father might have a negative effect on pregnancy outcome.
It has been recognised by Health Authorities and in the literature that PPPs are not always effective. According to Perera et al. (2019) “review..demonstrated prescription of valproate to 20% of 98 women aged 15-45 with little evidence of advice regarding risk and contraception”. Vrignaud et al. (2019) noted that “the high incidence of serious ADR and the non-application of pregnancy prevention program lead the French National Agency for Medicines to limit the first prescription of alitretinoin to dermatologists.”
Given the potential serious impacts of a PPP ineffectiveness, Axian Consulting considers this an area that could benefit from an updated approach. We therefore developed a prototype PPP app aimed at patients and used this as part of a survey of women who had used pharmaceutical products requiring a PPP.
The test approach leveraged a new end user testing platform technology, recently adopted by Axian, allowing the rapid recruitment, feedback and analysis of results from 20 appropriately screened female patients, meeting our criteria for this research.
The survey was conducted using an unmoderated method and utilised both Qualitative and Quantitative data collection techniques, with feedback received in the form of a user narrated screen record video. Questions focussed firstly on the patient’s experiences of a PPP, then stepped through an Axian developed mobile application prototype that covered the key information areas, presented in a user-friendly format.
Users answered multichoice questions (providing a justification for their selection) together with narrated responses to open-ended questions on the design, content sections and perceived usability of the prototype presented. Below is a summary of the feedback obtained:
* (Please note the survey questions below have been shortened for the purposes of this article)
Main response: by Doctor
Main response: by Doctor
Other interesting anecdotal feedback received was around how digital resources were used for additional research or to seek out support. Reddit was mentioned by a number of patients as a means of finding out about and sharing experiences of using a particular pharmaceutical product. TikTok was also referenced as a source of pharmaceutical product information, specifically around product side effects .
The results reinforced to us that despite the ubiquity of digital methods of communication, face to face contact with a Health Care Professional still remains the way that most patients initially receive risk information and is unanimously the preference for receipt of this type of information. Reasons cited by our respondents were the ability to ask questions during the conversation as well as an HCP being a ‘trusted’ source of information, and very importantly, also having the context of a specific patient’s medical history too.
Digital sources were seen as good ways of obtaining additional information and for supporting ongoing management of a condition or its treatment. The mention of platforms such as Reddit and TikTok is a potential area of concern, as patients may be accessing unregulated or misleading content. Pharmaceutical companies are understandably reticent about interacting with patients via social media, but the industry may soon be faced with a choice: provide patients with the information they need in format they want, or accept that drug safety may be compromised by patients using their chosen formats to access potentially harmful information.
Regarding a potential app to support women on PPPs, our prototype was well received and applauded by users for appearing well designed, user friendly and easily navigable. Proposed content areas broadly covered our respondents perceived needs. However, we received useful suggestions on additional tools that would be helpful.