I think pharmaceutical labeling content may be the single most impressive example of content reuse opportunities in any industry.

Labeling without Content Reuse Is Redundancy and Sadness

Often when we think about a drug label – and we do think about this often, right? – we think about the paper label that comes in the package. You know the one. It’s printed on thin paper, folded into the tiniest possible rectangle. Sometimes it sticks to the package with a little bit of adhesive, and it take some work to retrieve, unfold, find a magnifying glass, and read the information.

The information ranges from simple descriptions of dosage, ingredients, and storage conditions all the way through warnings about contraindications, drug-drug interactions, and side effects to panic about.

Most people who receive these labels don’t read the entire thing, start to finish. I daresay some people don’t read it at all. Yet the information is there, by law, to ensure that we know exactly how to take our medicine and what to do in the event something goes awry.

What’s not apparent in that piece of paper is just how much work goes into making it. I’m not even talking about the years of innovation and testing in the laboratory or the years of clinical trials that guide drug development.

I’m talking about the months and years of labor that goes into copying and pasting information from one document to another, one data source to another. Several cycles of authors distilling crucial information from thousands of pages of reports and manually updating the company core data sheet (CCDS). And then more years spent copying, pasting, and tweaking that information in dozens of labeling documents, each one a unique file that needs to be written, formatted, reviewed, updated, and published.

If ever there were a use case to prove the business value of content reuse, pharma labeling is it.

Labeling with Content Reuse Is a Paragon of Best Practices

Content reuse is the practice of using one piece of content everywhere you need to provide the same information. You create the content one time, review it one time, approve it one time, translate it one time.

When the content requires an update, you update that information in the single source of truth and send that update through the review and approval cycle. The updates can then apply automatically in ever labeling document that reuses that content.

Each of the 70-plus global health authorities provides their own requirements for what content to include in a label, in what order, and what that content must look like. To enter all these markets, pharma companies produce many variants of the same basic document. These variants may be the same information in a different order. Some information is required by one market by not for another.

As you can imagine, there is a lot of redundancy in this content. Most markets require the label to provide basics such as dosage, method of administration, drug-drug interactions, serious adverse events, and so on. Some markets require more detailed information about use in special populations than other markets.

If we think of labeling content not as a series of documents, but rather as a set of building blocks of information (called components), we start to see just how much potential there is for content reuse. You have a component for dosage, a component for method of administration, a component for “do not operate heavy machinery while using this product,” and so on. These components are stored in a single repository and attached to the documents that need them.

With content reuse, a significant portion of labeling documents can be created automatically simply by updating the components of the CDS. The labeling documents reuse those components in whatever order they need to. Content unique to a particular labeling document is managed in a separate component and included in the document wherever it belongs.

Because labeling is global and requires localization, pharma companies gain even more benefit from content reuse. The translated versions of these documents automatically receive the updates in the translated versions of the components.

If the same Spanish component applies to a dozen different regional labels, then that component can be reused in a dozen different labels – but it is only translated one time. There is no need to send an entire document for translation each time one or two pieces of information change. Only the changed component has to be sent.

Structured Content Enables Content Reuse

The company CDS is an attempt to manage labeling information in a document. A structured content repository of components provides a true single source of truth for this information. It is the evolution of the company CDS.

Content reuse is a fundamental capability of all component-based structured content management systems (SCMS). A robust SCMS also offers full translation management capabilities to extend that reuse potential into the localized labels.

Content reuse is one of the major business reasons that companies adopt structured content authoring. The results of content reuse include reduced time spent producing content and reduced risk of introducing errors through manual processes.

At Content Rules, we have 27 years of experience helping customers design, build, and execute structured authoring solutions. We have worked with dozens of MedTech companies to help them implement the best solution for their content requirements. Drop us a line today to find out how we can help you solve the XML authoring conundrum, too.

Regina Lynn Preciado