Patient safety redefined. Digitised, personalised and optimised.
Patient safety redefined. Digitised, personalised and optimised.

Roles for digital in pregnancy prevention programmes – and beyond

By Marie-Claire Wilson, Engagement Manager at Axian

Pregnancy prevention programs (PPPs) are a form of additional Risk Minimisation Measure (described in GVP Module XVI) intended to prevent pregnancy exposure during treatment with a medicinal product with known or potential teratogenic effects. Traditional paper-driven models for delivering PPPs may not deliver on their objectives, and there are opportunities for digital approaches to improve their effectiveness.

In a world growing increasingly reliant on the convenience and immediacy digital devices provide, today’s PPP interventions often take the form of paper pamphlets and mailed reminder cards — tactics that are not always judged effective. 

Consider isotretinoin, a prescription acne medication known to cause birth defects when taken during pregnancy. In a 15-year study, the Canadian Network for Observational Drug Effect Studies found a surprising consistency in pregnancy rates among isotretinoin users, despite Canada’s well-established PPP. isotretinoin studies conducted in the United States, Europe and Israel have yielded similar results, suggesting widespread international problems with program consistency, delivery and adherence.

In July 2020, Axian life sciences experts explored the future of PPPs in a webinar hosted by Huron. In a survey of attendees, only 25% of respondents deemed traditional PPPs mostly successful in reducing pregnancy exposure to teratogenic products, while 73% felt that digital delivery models could improve PPP effectiveness. Participants also ranked the top factors in PPP failure, lending insight into the areas in which digital tools could improve programme efficacy.

Why do PPPs fail and what are the opportunities for digital?

Inconsistent implementation of PPPs across geographies was mentioned most frequently as a key reason for PPP failure by survey respondents, followed by poor communication from healthcare professionals (HCPs) about PPPs to patients and a lack of regulatory harmonisation.

Many of the shortcomings of traditional, paper-driven PPPs such as inconsistent delivery, miscommunication, misunderstanding and human error are areas where digital tools can make a positive impact on programme efficacy. But these improvements are just the beginning. Digital offers opportunities to achieve standardisation across pregnancy prevention programs worldwide and to build a personalised platform that can evolve with
its users. 


Today’s consumers are seeking healthcare experiences that more closely align to the experiences they have in other industries in terms of ease of access, immediate answers, transparency and personalisation.

In the 2020 Healthcare Consumer Market Report by Huron, the desire for personalisation and convenience outranked all other healthcare consumer motivators. And 79% of consumers want a single point of contact for their health information needs, with more than half in favour of a mobile app.

In response, many personalised health apps have emerged to meet consumer demands. For example, according to data from Bloomberg in 2019, over 100 million people worldwide use period-tracking apps, which provide specific health recommendations and a convenient platform to track and improve reproductive health.

PPP advice apps that align with trends and meet consumers’ demands for personalisation, convenience and immediacy stand to improve patients’ adherence to guidelines and advice —simply by presenting these materials in a more personally relevant and convenient manner.


Regulatory bodies around the world hold disparate views regarding additional risk minimisation measures (aRMMS) like PPPs.

To achieve standardisation across borders, guidelines and methods, regulators need a delivery model that is unified and adaptable. Replacing print materials with centralised apps or websites creates a consistent platform for communicating the core messaging about aRMM. From there, Marketing Authorisation Holders (MAHs) can easily adapt the content to reflect the local cultures and regional guidelines, making PPPs more relevant and accurate.

While the regulatory environment for digital tools is still evolving, many agencies are supportive of new ways of delivering information if they can understand the benefits. Many pharmaceutical companies have successfully obtained regulatory approval to implement digital aRMMS in countries worldwide.


When implemented correctly, apps and websites can transform the efficacy of PPPs in four key areas:

Access Digital materials are available 24/7, providing information that patients and HCPs can trust in a centralised and convenient location. Not only is it easy to keep information up to date when disseminated digitally, it is also easier to tailor information to reflect regional regulations, promoting compliance and consistency across programs and borders.

UnderstandingApps and websites offer a host of methods to make complex information more digestible and personally relevant. Simply breaking up text or using expandable tabs can greatly improve readability, while introducing animations, videos and audio guides can help programs cater to different learning styles. Additionally, by gaining consent to collect small amounts of nonsensitive and locally stored user data, apps hold the key to a more meaningful, personalised patient journey.

Behaviour Providing HCPs and patients with digital checklists, convenient notifications and automated reminders are possibilities for driving behavioural change. Explanatory videos also allow HCPs to communicate consistently and effectively with patients, either in person or during a remote or “contactless” telehealth visit.

Engagement Patient dashboards and knowledge checks not only empower HCPs to administer more effective interventions — they also provide insights that can lead to continuous improvements in digital PPP tools and strategies. By understanding how patients are interacting with the materials, how well they have understood key points, and what their communication preferences are, stakeholders can make data-driven decisions about where to improve or expand program materials to achieve better outcomes.


  • Fits in with users’ digital lifestyles
  • Up-to-date content available 24/7
  • Contactless delivery of information and education
  • Standardised delivery across geographies


  • Content is clear and accessible to all all users
  • Complex information is adapted for different learning styles and preferences
  • Smart content can be tailored to patients


  • Educational material adapted for HCPs and patients to use together
  • “Nudges” and reminders, such as calendar entries and pop-ups keep users on track Continuing Medical
  • Education support with interactive learning and decision-making scenarios


  • Information is presented in a way that is relevant to users to increase uptake and retention
  • Patient usage dashboards for HCPs to provide detail on how patients are interacting with the content, and their understanding of key materials
  • Usage data can help to improve the experience and contribute to continuous improvement of the offering
Vision for the future

The potential for regulatory advice apps to transform outcomes extends beyond PPPs.

According to a 32-year study conducted by the Centers for Disease Control and Prevention (CDC), between 70% and 80% of pregnant women reported taking at least one medication during their first trimester, and about half reported taking a prescription medication. Yet for many people of child-bearing age, prescription drugs and their risks are a grey area. 

HCPs may not feel they have adequate support when making prescribing decisions for patients who are, or who could become pregnant, and patients may be confused and worried about whether to take a medication during pregnancy. This is a topic of interest for the MHRA and EMA, with the MHRA being part of the Safer Medicines in Pregnancy and Breastfeeding Consortium and the EMA running a workshop on safe use of medicines during pregnancy and breastfeeding.

There is therefore an unmet need for unbiased, accurate information and guidance in this area. Digital channels would be well suited to delivery, as information can be kept up to date easily and content can be presented in an accessible and engaging manner. Digital also offers opportunities for collection of data on user interactions, thus enabling continuous improvement.

The way forward

PPPs are an important type of aRMM, and digital certainly offers ways to improve their effectiveness. There are also opportunities to expand the scope of such initiatives to meet the needs of people of childbearing potential, pregnant and breastfeeding patients and the HCPs who care for them.

Any digital initiative should be only part of a broader user-centric approach, though, that encompasses product lifecycle strategy, organisation and process review.

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