Structured content is your value-adding resource in the highly regulated pharmaceutical industry. Without it, your product would not even pass the first regulatory hurdle. In the second of a three-part series on structured content and labeling, we take a closer look at the FDA’s Structured Product Labeling (SPL) and Canada’s Structured Product Monograph (SPM). You can read Part I here.
Ultimately, structured content is all about the health of patients and the safety of medicines, and the exchange of information readily and easily within the healthcare ecosystem.
This is facilitated by structuring content in predefined formats, and these formats are mandated by regulatory bodies, including the US Food and Drug Administration (FDA) and by Health Canada.
Structured Product Labeling (SPL) – Setting the structured content standard
There was a time when new drug applications (NDAs), including samples of draft or final printed labeling (FPL), were packed into a sturdy bag in hardcopy duplicates and ferried nervously to the regulating body. As technologies developed, new opportunities for efficiency arose. In 1999, the FDA issued first guidance on electronic submissions. Its stated reasons at the time will be all too familiar to proofreaders who are working on New Drug Applications (NDAs) or other submissions: “Because reviewers currently conduct… comparisons manually using two paper copies of the labeling, the process is slow and subject to error.” [1] Around 2003, the FDA did this each year for 3600 labeling changes for approved NDAs and Biologics License Applications (BLAs), or original and supplemental labeling changes for Abbreviated New Drug Applications (ANDAs).
This and other manual review headaches set the ball rolling for the later introduction of electronic submissions in Structured Product Labeling (SPL) format. In 2005, the Center for Drug Evaluation and Research (CDER) adopted this as a requirement, and from 2009 many other divisions followed suit. [2, 3]
SPL in overview
Structured Product Labeling (SPL) is based on XML (eXtensible Markup Language), with content organized into machine-readable components. Components specify labeling content and include product data elements such as dosage form, ingredients, route of administration, characteristics (size, colour, shape), marketing information, and much more. For the submissions of solid oral dosage form, the data is accompanied by so-called SPLIMAGE – SPL image. [4] Much the same way governments across the world have their own specifications for biometric passport or visa images, SPLIMAGE is subject to guidelines that literally give the FDA a snapshot of the new drug. Information in SPL is indexed using machine-readable tags that don’t appear in the labeling itself. Companies marketing their drugs in the US must also register their manufacturing sites for the product in SPL format, regardless of where in the world the drugs are produced. Today the SPL specification (version 3) has proved to be invaluable for exchanging labeling and other information electronically with the FDA.
Content structured in SPL format improves communication and is crucial to interoperability – the ability of different systems to exchange information with each other. It should be noted, however, that SPL is format-dependent (XML) rather than a solution in a wider technological sense to provide technical interoperability – the ability of different systems to “talk” with each other. Its strength is so-called “semantic” and “syntactic” interoperability and the associated tags. Nevertheless, the days when the FDA must pore over hardcopy have long gone, and Health Level 7 Structured Product Labeling format in XML is an excellent facilitator of data exchange, especially from a consistency standpoint. It is also a faster and better way of communicating any changes to labeling post-approval, and offers efficiencies within an organization itself.
For the uninitiated, the format may appear not particularly user friendly, however support is provided through software tools (including SaaS portals) with user-friendly interfaces, as well as through external providers experienced in providing regulatory services requiring SPL format.
Structured Product Monograph (SPM)
The success of the SPL format has also led to the phased introduction of the Structured Product Monograph (SPM) by Health Canada, which is based on SPL and its controlled vocabularies. Health Canada has adopted the SPL format, but it has also adapted its scope to account for Canadian regulatory requirements, such as bilingual labeling in English and French. [5] As a result, the exchange of information across the border with the US and other countries has become simpler and more efficient, and of course SPM has all the other advantages SPL offers for the exchange of data.
Empowering regulators and companies
Like SPL, SPM provides clear, comprehensive frameworks for the type of information required by regulatory bodies. It empowers regulatory bodies, especially because it streamlines the submission process, or allows data to be aggregated, managed and used better. But it also empowers companies, because structured content in SPM/SPL format offers an effective way to harmonize content, store it in one consistent format, and retrieve it and reuse it. In practice, once created and approved, product content can be used with more confidence across different formats and subsidiaries, such as in electronic and paper-based labeling. This saves time and mitigates risk. Additionally, SPM/SPL is an enabler of automation, right down to the creation and verification of promotional materials to ensure that these accurately reflect approved documents. This way, for instance, companies can avoid making false claims and, as a result, possibly costly legal action.
Benefits of SPL/SPM at a glance
- Compliance, especially through a single source
Structured and tagged content in SPL/SPM format promotes the use of an approved single source for content that can be used confidently across different formats (labeling, marketing, electronic and paper-based formats, etc.)
- Streamlined exchange of information
SPL/SPM provides an excellent basis for streamlining the exchange of information between regulatory bodies, companies, and healthcare organizations through its rigorous structure and vocabulary. Everyone is speaking the same “language,” shares vocabularies, and elements are clearly defined so the meaning is unambiguous. But it does have limits that are prompting regulatory bodies to look into improving technical interoperability.
- Reduces risk of variances in content and data in submissions
Variances can occur for very many reasons, ranging from multiple authors and time lags due to staggered filings, through to poor management of changes in the product lifecycle. [6] Using SPL/SPM minimizes these variances.
- Operational efficiency
Internally within an organization as well as across different organizations, SPL/SPM is cost-effective and time-saving due to the efficiencies of storage, retrieval and reuse. Less content must ultimately be drafted or redrafted.
- Fewer revision cycles, with less content to review, especially manually, saving time
- Better data management, aggregation, and availability (storage, search, processing, and retrieval) through centralized repositories
- Greater accountability and accuracy, promoting single source sign-off in efficient processes with rigorous SOPs
- Ability to implement more efficient workflows, with consistent information available throughout the entire workflow
- Greater employee satisfaction, because it promotes automation, which means less time is spent on mundane manual tasks
Is SPL/SPM in its current form for submissions the last word on structured content in the healthcare environment? The format is evolving, because technologies are opening windows to even greater efficiencies and more patient-centric uses of data. A focus today, for example, is on patient health apps, which depend on data exchange and high technical interoperability. Part III of our series on structured content looks at interoperability and how SPL is being taken to the next level with FHIR – Fast Healthcare Interoperability Resources.
Find out more about Reed Tech Single Source™ for drug products and how you can automate your proofreading to ensure accuracy in proofreading in SPL/SPL and any other format.
