In January 2006, the FDA released a major revision to the patient package insert guidelines, the first in 25 years. So, what was the impetus? According to the FDA, "Each year, approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians. By making these changes, FDA is seeking to reduce the complexity of information on prescription drug labels, making them more useful for physicians and their patients."
In the United States, the FDA is clearly taking a firmer stance on the issue of prescription drug labeling and information, including patient package inserts (PPIs). Likewise, in the EU, the European Medicines Agency (EMEA) has issued stricter guidelines for what it calls patient information leaflets (PILs). Other countries, such as Japan, which has its Japanese Ministry of Health, Labor and Welfare (MHLW), also have rules in place today to proscribe insufficient or misleading package labeling.
Alarmed by the rate of preventable patient complications and, even worse, deaths, the industry is now moving in the right direction. Yes, the regulatory cudgel is most often the impetus for change, but at least change is under way. The consequences of inaction actual loss of human life are too costly.
Pharmaceutical manufacturers generate content on an unprecedented scale. Through a combination of mandated communications requirements (e.g., drug complications) and their own branding language, many large manufacturers generate content that rivals the worlds largest publishing houses. From a communications standpoint, the launch of just one popular drug is more costly and complex than distributing a new novel. Add the further complexity of localized regulations and diverse languages and its easy to see why the industry is now so focused on the issue.
The focus on improving patient safety through better communications is also manifested in the FDAs adoption of a standard for electronic submission of label content. Structured Product Labeling (SPL), based on the non-proprietary extensible mark-up language (XML), is the standard manufacturers must now follow for product labeling information the submitted to the FDA.
But many manufacturers dont realize that following SPL can be its own reward. When properly implemented within a manufacturer, the changes SPL forces also help streamline the process of document creation and re-use and automate other time-consuming aspects of content creation and dissemination. For manufacturers, benefits of standardizing under SPL, with XML at its core, include error reduction (as documents do not need to be re-created), dramatic time and cost savings and faster new product rollouts.
Turning Requirement into Opportunity
Clearly, its possible for a manufacturer to turn a process that seems onerous into a business opportunity. Regardless of whether you see SPL and package insert guidelines as a good thing, its impossible to ignore the ways these requirements can spur more efficient and thorough manufacturer-to-doctor and manufacturer-to-patient communication especially at the individual prescription level. Some manufacturers have actually parlayed compliance-related changes into competitive differentiators that allow them to accelerate the introduction of new drugs into profitable global markets ahead of schedule and, most important, well ahead of competition from other branded drugs and, in the long run, generics.
These forward-thinking manufacturers are increasing their global market shares by going beyond the impetus of SPL or PPL requirements to proactively embed new processes, including translation and localization, into their product information management workflow. Yes, it does take considerable front-end work to re-engineer the process, but the long-term rewards far outweigh the costs, especially in a competitive market where a few months of lost sales can have a tremendous impact on the revenue opportunity for a new drug.
So why doesnt every company treat SPL and PPL mandates as strategic opportunities? As with most new processes and enabling technologies, the key question is whether a company has the knowledge and expertise necessary to recognize and capitalize on the inherent advantages. If the answer is no, the processes will be changed only enough to meet minimum requirements, such as the FDA product submissions requirements. In this case there will be no larger strategic benefits, only incremental costs.
If the answer is "yes, we do recognize the advantages of re-engineering an inefficient process," then the rewards are there for the taking: faster, more efficient product rollouts to lucrative new markets; safer drug dispensing and usage; and a more positive overall brand experience for patients and their physicians.
So how does an enlightened pharmaceutical manufacturer reengineer its documentation approach? The first step is embracing the single-source-of-truth approach, which dictates that all content (labels, PPIs, PILs, marketing and promotional materials, Web sites, knowledge bases, etc.) should originate from a single source, thereby maximizing the opportunity to reuse the best and correct content in multiple delivery channels. Separate from the regulatory requirements, this is a proven method for manufacturers to ensure content consistency across the enterprise, including international operations.
While consistency of content seems obvious, one of the greatest challenges companies in all industries face is the translation and localization of content for non-English-speaking markets. The FDA, for example, does not review or approve patient inserts in languages other than English.