Translating Medical and Pharmaceutical Materials – Focus on Quality, Consistency and Precision

Medicine and pharmacy are the areas that require the highest level of specialist knowledge in order to produce a high-quality translation. This includes using the correct terminology and the linguistic adaptation of every single piece of information in the source material.

This is particularly important because both medical experts and patients need to know precisely how to use certain medicinal products and medical devices, as well as their indications and contraindications. The purpose of medical translation is to facilitate healthcare and treatment in general, avoiding adverse events and consequences and thus enabling the growth of the life sciences sector.

In addition to linguistic skills, medical translators should have specific training and experience in the field, as well as knowledge of the subject matter. This is because medical texts are highly regulated, often extremely technical and contain sensitive information that needs to be managed with utmost caution due to the serious nature of such texts.

Types of commonly translated medical and pharmaceutical materials

  • Documents related to clinical trials – study protocols and protocol amendments, communication with local regulators, informed consent forms (ICFs), patient reported outcomes (PROs), case report forms (CRFs), etc.
  • Summaries of Product Characteristics (SmPCs)
  • Instructions for Use (IFUs) for medical devices and product specifications
  • Package leaflets/inserts (PILs), instructions for patients
  • Results of various laboratory and diagnostic tests and examinations
  • Medical records
  • Questionnaires, protocols, training materials, medical bulletins, etc.
  • Legal medical texts – regulatory texts, approval documents, lawsuits, etc.
  • Patents for medical devices
  • Complete product dossiers (CPDs)
  • Medical labels

 

Sources of information, templates, standards

When translating medical and pharmaceutical texts, it is important to comply with the technical terminology of a certain field or specialization, to search for relevant, approved and official resources, to use available templates approved by certain health authorities, and to comply with the standards of the profession.

Such resources include the websites of national regulatory agencies for medicinal products and medical devices, medical terminology portals, medical dictionaries, glossaries and databases (in both electronic and printed form), templates for translating SmPCs and package leaflets/inserts approved and published by the European Medicines Agency (available in EU languages), and scientific publications (articles published in relevant journals, official websites of government authorities and agencies, healthcare organizations, etc.).

Translators and other language professionals working in the field of life sciences (such as reviewers or medical writers), although not healthcare professionals, are nevertheless a part of the industry and perform an important auxiliary service in bringing medicinal products and drugs to customers around the world. Therefore, their adherence to industry standards and terminology is an essential requirement.

The purpose and context of the materials – is it intended for healthcare professionals or patients?

The wording of medical and pharmaceutical materials intended for medical experts must be professional, unambiguous, clear and precise. These texts feature medical terminology and, more often than not, many acronyms and abbreviations. The wording of patient-facing materials also needs to be unambiguous, clear and precise, but it is usually simpler, featuring more common terminology, and certain terms are sometimes described in more detail for the purpose of facilitating the reader’s understanding.

Depending on their purpose, these materials may cover a wide range of topics, from legal information to instructions for use of medical devices, and all of this must be conveyed in a clear and unambiguous manner to make the information understandable to the non-expert target audiences.

It is therefore necessary to pay attention to aspects such as context, format, general purpose of the text and target audiences, and to adjust the terminology and wording accordingly.

Translating Medical and Pharmaceutical Materials

Lexical semantics in medicine and pharmacy – synonymy, homonymy, polysemy, hypernymy and hyponymy

It is very important to take these concepts into account when translating medical and pharmaceutical texts to avoid ambiguity and mistranslation, and to provide a precise and clear translation intended for a particular target population.

For example, synonymy is relevant when it comes to translating materials intended for healthcare experts as opposed to patient-facing materials. Materials for experts will feature medical terminology, while patient-facing materials will feature their more common synonymous counterparts, which will enable patients/end-users of medicinal products to better understand their condition and the context of the material itself.

Translators also need to pay attention to homonyms that have the same spelling (or pronunciation) but different meanings to avoid mistranslation, to polysemic words that may have more than one meaning, and to hypernyms that have a broader meaning than hyponyms (this is important when describing certain medical conditions that may also include other conditions).

Acronyms present another potential issue; translators need to be careful to convey their proper meaning in the target language, since many acronyms may have the same spelling but completely different meanings, and some of them may even cover completely unrelated concepts from different medical and pharmaceutical fields.

Tips for translators

It is of utmost importance to be consistent in the use of terminology throughout the translation in order to avoid issues with multiple meanings and mistranslated terms because consistent terminology contributes to the meaningfulness and integrity of the translated materials.

Translators must also pay attention to end users – is the translation intended for healthcare professionals, or for patients and laypersons? What is the context of the text? Translators must adjust the translation and terminology accordingly; for example, by providing additional explanations, full forms of abbreviations, by using appropriate words, etc.

They must also adhere to spelling and grammar rules of the target language, be careful with meanings and modifiers within sentences, as well as with syntax and the general structure of sentences. This is particularly important for the fluency and clarity of a translation, as well as how easy it is to understand.

Translators should also regularly refer to all available and relevant resources, search for technical terminology specific to a particular field or specialization, and comply with approved and published templates for translating specific types of documents.

The translation must be clear, unambiguous and precise, and it must contain all the relevant information in the source material, regardless of the intended target audiences.

Every piece of information in a medical or pharmaceutical document is important – the mistranslation, omission or addition of a single piece of information may have a negative impact on human lives or expose them to unwanted risks.

Final considerations

Translations with errors may lead to the following:

    • Wrong diagnosis which may result in wrong treatment
    • Medicinal products having an adverse effect because, for example, the actual composition of a medicinal product differs from the composition provided in the source text or on the product labe
    • Misuse of medical equipment due to incorrect or unclear translation of instructions for use
    • Patients refusing a treatment or declining to participate in a clinical trial because they do not understand the information provided in the informed consent form

High-quality translations lead to the following:

  • Successful communication between doctors and patients, improved adherence to therapy
  • Proper and safe use of medicinal products, medical devices, medical equipment and drugs
  • Better understanding of certain medical conditions and diseases, as well as the adverse effects of medicinal products and drugs (particularly when it comes to patient-facing materials), which in turn contributes to the assessment of the safety and efficiency of medicinal products and drugs placed on the market
  • A lower risk of adverse events and harmful consequences that may compromise the health and lives of patients

 

Since medicine and pharmacy are highly specialized fields, the focus of translation and localization of medical and pharmaceutical materials must be on providing the best possible quality, as well as precision and consistency.

The medical and pharmaceutical industries are highly regulated, so companies and clients who need translations of such documents often choose agencies that have dedicated linguistic experts with broad knowledge and experience in providing language solutions to the life sciences sector.

These experts understand the specificities and challenges of both fields, as well as the importance of avoiding all mistakes.

The skills of medical translators go beyond linguistic expertise and language proficiency, so project managers also need to make sure to assign such projects to the people who are the most appropriate for each project, depending on their experience and specialization, and who can produce a coherent, consistent and high-quality translation.

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