Announcing the Prescribed Products Promotional Standards Distribution
by Tom Richardson
Acquia has long relied on the insights and efforts of its many partners in the wide world of Drupal “shops,” digital agencies, and system integrators to create transformational digital experiences for customers around the world across dozens of industries and specializations. When it comes to assembling the designs, content, and branding around today’s most remarkable digital experiences, those partners bring to bear a breadth of experience gained over years of client work to transform Drupal into the centerpiece of their clients’ online strategies.
One agency partner, Sudler & Hennessey, is a leader in healthcare and life sciences communications. A member of the global WPP family of advertising, public relations, media planning and tracking agencies, Sudler’s digital practice has deep expertise in the development of digital experiences for the world’s leading pharmaceutical firms.
Sudler is collaborating with Acquia to create a new distribution for efficient development of US-based pharmaceutical sites. After years of developing hundreds of sites for prescription drugs, Sudler and Hennessey’s Chief Digital Officer David Cherry recognized there was an opportunity for a more repeatable process for staying “within the lines” of the very strict specifications and rules that make each individual drug’s site compliant with the regulations set forth by the US Food and Drug Administration, the federal agency that regulates and approves the development, release, and promotion of new drugs.
Known as the Rx Promotional Standards Distribution, the Sudler project will be an implementation of Drupal that is tailored to the digital communications requirements of the Life Sciences industry with a goal of facilitating regulatory compliance, something Cherry calls an “Open Source Rx Promotional Standards Build Kit.” But in addition to satisfying regulatory compliance, the Rx Promotional Standards Distribution will also deliver significant operational leverage to pharmaceutical firms by providing them a platform to develop and deploy sites that are responsive, semantically-optimized, engaging, and help achieve the end goal of driving awareness of - and revenues for - the prescription products themselves.
Before getting into the details and challenges of the RxPSD project, first a word on “Drupal Distributions”: one of the most powerful concepts driving the adoption of the Drupal open source content management framework by the world’s greatest institutions.
A crucial benefit of the Drupal framework is this concept of distributions -- a preconfigured set of functional modules, themes, and design elements which accelerate the development and deployment of a site tailored to a specific use-case. There are Drupal “distros” for publishers, learning management systems, commerce sites, corporate intranets, even a distribution for churches. Distributions are an excellent way to capture the ingenuity of one custom build and then reuse it for future projects, speeding the deployment of new sites, ensuring compliance, brand alignment, and any rules or common design elements. Some distributions, such as the Australian Government’s govCMS, are designed to speed the development of new (or the migration of legacy) sites -- keeping them all within official guidelines but at the same time giving control over their daily management to the administrators and authors on the front lines.
To quote Drupal.org: “Distributions provide site features and functions for a specific type of site as a single download containing Drupal core, contributed modules, themes, and pre-defined configuration. They make it possible to quickly set up a complex, use-specific site in fewer steps than if installing and configuring elements individually.”
Cherry explains the driver behind the RxPSD project is the need to comply with “Fair Balance,” one taken from the 2009 directive by the FDA that states: “As a general matter, risk and benefit information should be comparable, noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefit information with similar ease.” In the absence of more specific guidance, this paragraph has spawned a wide variety of approaches for how some consistently required elements are presented within website design.
Within the pharmaceutical industry there is general consensus that there are two distinct audiences: consumers/patients and healthcare professionals (the physicians, nurses and pharmacists who prescribe the drug), and to serve each of these audiences there are four critical information elements:
- The disease-state that the product is approved to treat, and any Important Safety Information (including adverse events experienced by patients taking the product) must be prominent on the site; in some cases “locked” into position
- The experience should differentiate between professionals and patients; access to materials intended for a professional audience should be “gated” (in the US this is a self-identification formality, but this aspect will become critical for the next phase of the distribution when it becomes available for countries outside the US where the law is that no information may be distributed to patients, and HCP license verification is required to view a prescription product site)
- There should be detailed instructions for the patient on how to use the drug (a Medication Guide may be mandated for products with serious side effects); and for the healthcare professionals on how to prescribe it (Prescribing Information is mandated for every product by the FDA, and there is a recommended microdata format for semantic optimization)
- The visitor to the site has to be notified when they are leaving the site so they understand when they are leaving an official set of information and potentially clicking to an unofficial source, e.g. a Wikipedia page about that drug.
Sudler found that there were inconsistencies and different approaches from one client’s digital drug information to another, even within the same parent company. Cherry said, “There are hundreds of companies, all doing “fair balance” their own way. The potential for confusion among the site audiences is terrifying, and completely counter to the FDA’s intention with standardizing both the requirements and the product information they require. In addition, the cost of customizing these elements on each site to the judgment of each individual legal team is enormous. It gets really ugly when you consider the sites have to render across multiple devices with different screen resolutions and browser technologies.”
With Rx sites getting 40% of their traffic from mobile users, Cherry says any new site clearly has to be “responsive” but adhering to the best practices of responsive design has led to the independent development of responsive safety information guidelines at every major Pharma company. “All the guidelines I’ve seen are reasonably close, so why not standardize on one template and take out the guesswork?” he wondered.
Hence the inspiration behind the development of the RxPSD: take the work by a specialist agency exposed to a wide variety of client requirements in the development of Rx digital experiences, develop a framework of excellent execution of the common elements, and then share it freely with the pharmaceutical industry and the digital agencies that support it. Cherry said the benefits will be, “a lot of time and money will be saved and we can re-focus on balanced presentation of data and contextual safety information ‘within the lines’.”
Cherry said, “Sudler selected Acquia to collaborate on the development of RxPSD because the Drupal/Acquia content approval process, capabilities such as Lift and ContextDB, and Acquia’s scalable, HIPAA certified, and secure approach to cloud hosting can deliver even more potential benefits to the industry and help insure auditable compliance. In addition, opening the project to the development community allows us to share the best practices learned on every build to benefit the entire industry, as well as the patients and healthcare professionals they serve.”
He compares the project to the type of guidelines which the Internet Advertising Bureau has delivered to the digital advertising marketplace -- RxPSD will deliver promotional templates for responsive sites and assist regulatory approval for any agency serving pharmaceutical clients. The templates will include:
- Persistent “fair balance” messaging that is search friendly, coded to have at least several lines appear on any screen size, folds into the content when the user scrolls down the page, and is independently scrollable or expandable.
- Semantic markup and navigation elements to consistently and accessibly communicate safety, prescription information and medication guides (including patient versions, with an intention to leverage the Consumer Report’s proposed Prescription Drug Label format)
- A Professional Access Gateway window -- an element to differentiate between patient and healthcare professional versions, and “gate” the professional section of the website..
- A site exit window to notify users when they are leaving official sites.
- Additional variants for other use cases.
Cherry said the project will be dynamic and expand over time to include site templates for non-US countries and regions and to conform to the requirements of non-US regulatory agencies. RxPSD will also eventually extend to propose standards for personalization, banner media, online video, tablet details, native apps, and healthcare semantics.
Sudler has already commenced work on the project and Cherry is aiming for a March 2015 release of the distribution.