Patient Information Leaflets: Updates and Translation Asset Managements

Patient information leaflets (PIL) or package inserts are abridged, user-oriented versions of Summaries of Product Characteristics (SPC) that provide the consumers with the necessary information on drug purpose, usage, side effects and more. Unlike SPCs, PILs are written by medical professionals for the lay users and for this reason PILs are essential for safe and correct use of pharmaceutical products.

PILs are written in accordance with the set guidelines that help convey the pharmaceutical information accurately and understandably. The same high standards apply to translation and localization of patient information leaflets and other medical and pharmaceutical materials – they should be translated by specialized medical translators, in accordance with the guidelines of the local regulatory agencies, linguistic standards and culture of the target market and they must preserve the same style and purpose of professional material oriented to non-professionals.

These same principles used during writing and translation / localization processes should be applied on updates of PILs as well. PIL updates are not uncommon and may be required due to a change in local regulations, an advancement in research involving a particular pharmaceutical product or for any other reason, but at any rate the PIL and its translation should be thoroughly revised whenever there is an update.

Every type of medical documentation is highly structured as its composition follows the set pattern and terminology, which makes the application of translation asset development and management particularly useful on this type of content. In addition to reduced amounts of time, energy and money, translation asset development secures consistency of translation, which in this particular case also means staying in line with the regulatory requirements and preserving the stylistic features of particular pharmaceutical document.

Translation assets include the previously translated elements – translation memories (TM), glossaries and terminology bases (TB).

Once created, translation assets can be accessed and revised at any time. Maintenance of translation assets includes regular cleaning and updating of translation memories, glossaries and terminology bases and as such saves time and money, serves as an important layer of quality control, provides increased consistency and ensures that the reusable linguistic elements are up-to-date.

In addition to its numerous obvious benefits, professional management of translation assets preserves the integrity of PILs and similar medical and pharmaceutical documents. Their purpose of accurate, understandable and stylistically appropriate communication of drug-related information for the benefit of end users across the different languages and markets is secured, while the time and the resources required for localization are reduced, resulting in a leaner and smoother process at all stages.