What are Patient Information Leaflets?
Patient information leaflets regularly referred to as PILs, are documents provided within the packaging of medical products, either inside or the outside package — like many over-the-counter products. PILs are also known as information leaflets, package inserts, instruction leaflets, consumer medicine information, among others.
PILs provide consumers with essential information about medical products; this is why they must be available in the local language of the target market. Translating PILs from one language into another is a complex and highly regulated process, but before getting into detail, let’s analyze some basic concepts about this medical document.
What must be included in PILs?
The information included in PILs usually comes from another source known as Summaries of Product Characteristics (SPC), which is specially created for physicians when products are being developed and approved. However, because PILs are meant for the layman, they need to be shorter and more concise. In addition, everyone should be able to comprehend what’s written on PILs, regardless of their profession or level of education. They are meant to instruct, inform or warn, therefore they must contain the following items:
- The name of the product, both the pharmaceutical term and the commercial name.
- Dosage, frequency, and duration of treatment.
- Precautions and warnings: interactions with other drugs, contra-indications, potential side effects.
The Different Functions of PILs
People take medicines for different reasons. Here we describe three of the most common uses for PILs:
- As an external memory — When a person takes a medicine occasionally, they need to understand the dosage and potential interaction with other drugs (for example, an aspirin). They can check the PIL whenever they need to remember the instructions.
- As information — When a person takes a medicine frequently or permanently, the PIL must serve as grounds for learning. The person needs to understand how the medicine works and learn it by heart since it will be part of their lives.
- As motivation — When a person is weighing the pros and cons of taking a medication they can rely on the PIL to decide whether the product is right for their condition.
Basic Principles for Writing PILs
PILs are intended for every kind of patient, from adults, children, and adolescents, to people with reduced sight or poor literacy skills. This is why PILs should be written in a clear, detailed and concise manner, using simple syntax and optimizing design elements (font size, alignment, bullet points, etc.) for higher readability. Mistakes in this type of documents can lead to misinterpretation of instructions and potential health hazards.
When writing PILs, it is also important to remember that they will most likely be translated to other languages — in some cases more than twenty. It’s best to keep sentences short, avoid idiomatic expressions or cultural references that can be difficult to translate.
Essentials for Translating PILs
- Target audience: Patient information leaflets need to be understood unequivocally. The translator’s challenge is to balance between a faithful translation and allowing certain flexibility to account for regional differences. The core meaning will stand in every version but language professionals will be able to avoid unnatural-sounding phrases.
- Accuracy and precision: Like other medical content, translating PILs requires language professionals with proven experience in the medical field. It’s not only recommended but also needed to procure specialized translators to avoid any language-related problems that can cause delays in the production, recalls of the product or other legal implications.
- Management of translation assets: When translating medical text it is vital to work with translation memories, reference corpora, glossaries, and term bases. These assets are critical when handling large projects that demand consistency and accuracy, and which need to be updated periodically.
- Compliance: Governments and agencies often have strict guidelines and laws to follow regarding PILs, the order of the information and even their translation. Manufacturers need to comply with these terms to sell their products in different markets.
- Quality control: Quality control is mandatory when translating in the life sciences arena. Even a tiny error can result in a patient receiving the wrong treatment. To guarantee translation quality, language service providers rely on standard processes to check punctuation, omissions, ambiguity, spelling, terminology, grammar, syntax and even editorial changes (for example rephrasing a sentence to match the target culture).
- User testing: Whenever possible, it’s important to user-test translations. User testing can be performed in several stages. A first test, when the person is reading the PIL in real time to see if they understand the document. A second test that focuses on comprehension either after having read the PIL or after having read the PIL and used the medication. Often, user testing is done only in the source language.
Learn more about Ocean’s medical translation services here.