This framework focuses on four guiding principles, as shown in Fig. 2 and expanded in the following four sections.

Fig. 2

Framework of four guiding principles for the digital provision of medical information for healthcare professionals

While the guiding principles are shared for consideration, they are not meant as directives. Rather, they may help provide direction to companies as they develop and deploy their digital solutions and engage with stakeholders.

While MILE has taken every effort to provide informed and professional guidance, individual companies must make their own decisions and MILE is not accountable for the interpretation or implementation of this guidance.

In proposing this framework of principles, MILE maintains the importance for all pharmaceutical companies to continue complying with the legal requirements (e.g., laws and regulations applicable to our industry such as pharmaceutical, competition, intellectual property and data protection laws as well as anti-bribery and anti-corruption legislation), and integrity commitments.

The framework applies a range of standard definitions which have been agreed across the MILE membership (Table 1).

2.1 Optimal User Experience

Modern technology has the ability to vastly improve the user experience of MI services. For MI, it is important to consider the accessibility of the services, the discoverability of the content and also it’s suitability for the digital channel. MILE recommend that the design principles shared in Table 2 should be considered to optimise the HCP experience.

Table 2 Design principles2.2 Healthcare Professional Authentication

MILE recognises that pharmaceutical companies should put guardrails in place to limit access to content to the intended audience. However, there is also a personal responsibility of the user to correctly identify themselves. In the context of providing online MI (non-promotional and unsolicited), MILE considers self-validation an appropriate measure to limit access to HCP resources by the general public or patients. This approach is effectively the same as telephone calls or emails, where the customer simply confirms that they are an HCP, without the need for additional confirmation.

Companies should also provide other MI services and/or relevant resources for the general public and patients, which further reduces the risk of inappropriate access of online HCP resources.

Companies should always clearly indicate the intended audience for the content. For example, pages for HCPs should include wording along the lines of ‘This information is intended for healthcare professionals only’ and indicate the country. Patients, consumers and other non-HCPs should be directed away from the HCP-only pages.

There are many advantages for customers and companies in implementing self-validation on MI websites, including:

avoiding significant access hurdles caused by time-consuming, cumbersome registration processes, thereby offering HCPs straightforward access to MI content. This avoids the need to turn to other online, potentially unauthoritative, but easy to access resources;

aligning with customers’ expectations in terms of easy access to information in a digital environment;

supporting discoverability of MI websites through search engines, which is often limited by registration mechanisms;

facilitating access and improving legitimate transparency for HCPs who require the information for their clinical decision making.

Where central HCP authentication systems already exist and are widely adopted, such as DocCheck in Germany, these could also serve as a straightforward HCP authentication mechanism. However, these should not be a prerequisite for HCPs to access MI content.

2.3 Surfacing Scientific Content

MILE proposes that MI websites should be able to compliantly surface scientific content online and deliver a positive user experience.

Information which is on-label could be retrieved through a free-text search tool, guided searching, site navigation (e.g., using a product list) or internet-wide search engine. However, information which is off-label should only be accessible behind a free-text search tool on the MI website.

Search algorithms and tools should be sophisticated enough to ensure appropriate levels of specificity. Ideally, such search algorithms should deal with word stemming, medical synonyms and abbreviations.

2.3.1 Providing Information Supporting the Label

On-label non-promotional MI content may also be published without the need for specific search logic. It could be retrievable by search engines. MI websites may also offer sections that contain information that supports the Product Label (e.g., through product-related ‘Frequently Asked Questions [FAQs]’ or chatbots which guide HCPs through fixed menu options to obtain the response to their enquiry). The interest in these topics has been demonstrated (e.g., through high enquiry volumes on other channels), making MI responses appropriate for inclusion on these tools. Other topics could also be included based on their importance (with referral to the Product Label or adverse event reporting information).

In these scenarios, the HCP remains in control of the information they click on. When providing scientific content, companies should ensure that upfront displays of information only include relevant details for the purpose of navigating, and there must be a proactive click from the HCP to retrieve the full information. To obtain scientific content relating to a specific product, the HCP must always indicate which product their enquiry relates to.

It is MILE’s position that, if HCPs are required to proactively click to obtain the information, MI websites housing FAQs or chatbots adhere to the MI standards for enquiries to be unsolicited.

2.3.2 Free-Text Search Functionality

Free-text searching typically works by indexing specific attributes of the scientific content (title, keywords) or full-text indexing of the entire document. Specific attributes can then be weighted or mandated to ensure only relevant content is returned. This functionality offers an appropriate method to ensure that results are only surfaced if specifically requested by the appropriate search terms used by an HCP. Therefore, it is MILE’s proposal that both on- and off-label content should be accessible through free-text search to the extent necessary to answer a specific question about a particular medicinal product.

2.3.2.1 Unsolicited Nature

If online MI is surfaced within the below framework, MILE considers online provision of MI unsolicited in nature. HCPs must proactively initiate the search for scientific content, based on their information need.

Companies should demonstrate that they have put strategies in place to ensure specificity (see below). If Scientific/Standard Response Documents (SRDs) or other MI resources are being provided (e.g., mode-of-action videos, administration guidelines, infographics), companies should limit search results to only display the material titles or succinct summaries that support HCPs in identifying content relevant to their need. HCPs should be required to perform another proactive step where they select content that matches their information need, demonstrating the request for information was intrinsically motivated.

2.3.2.2 Ensuring Specificity

Where search functionality is included, companies should put strategies in place to ensure specificity so that the HCP viewer is most efficiently directed to the content they require. Depending on the type of content provided, a range of different tactics may be deployed. For example:

requiring a product name to be provided in order to retrieve scientific content aligned to that product;

requiring a minimum number of words to be entered for a valid search (excluding connecting words);

ordering and limiting the search results based on their relevance to the search terms;

developing search algorithms that are systematic, logical, non-arbitrary, objective and support surfacing content with high relevancy;

enhancing the search methodology over time. For example, through periodic reviews of search terms and search results to ensure relevancy.

2.3.2.3 Adherence to MI Standards

In the digital context, it is important to recognise that search algorithms cannot guarantee 100% specificity. It is MILE’s position that, if companies deploy the above-mentioned strategies coupled with proactive searching by HCPs, this supports adherence to MI standards.

2.4 Content

To ensure compliance to MI standards, content surfaced on digital MI platforms should always be up-to-date, referenced, accurate and balanced, unsolicited, non-promotional, specific and relevant to the question. In line with other MI response channels, the content offered should contain clearly visible and appropriate statements to inform HCPs of potential off-label information.

It would be good practice for the approved Product Label to be referenced and easy to access. Disclaimers may also be used to indicate that data provided is intended to inform HCPs in their clinical decision-making and that it does not constitute medical advice.

Digital resources must also include clear signposting for adverse event reporting and product quality concerns.

MILE recognises the sensitivity of providing access to information relating to off-label use through online MI resources and so, to ensure appropriate provision of off-label information to the extent necessary to answer a specific question, recommends that such information should only be accessible behind a robust search functionality.

MILE also recognises there are topics that are not specifically described within the Product Label which could be important for the safe and effective use of medicines (e.g., safety or allergen information). It is MILE’s position that these do not contradict the Product Label and are non-promotional and therefore should be easier to access than off-label information.