Category: Pharmaceuticals

Every member of the medical profession should first and foremost prioritize patient safety. One such way to be successful at protecting patient safety is to dedicate resources to the proper translation of “instructions for use” (IFU). Essentially, the term IFU refers to the patient labeling found on many prescription medicines and medical devices. The manufacturer of the drug develops the patient label. But the FDA (a United States government agency) is in charge of approving it. IFUs are especially important when a medication has complicated dosing instructions and the patient may need help using the product properly.

As we live in an increasingly global world, medical device manufacturers and pharmaceutical companies will require assistance translating IFUs into other languages. Quality translation improves patient safety and helps get medical devices and medications approved for distribution throughout various regions. 

Why IFUs Matter

From a consumer standpoint, IFUs are of the utmost importance. The information included in an IFU helps provide the proper use of a medication or device, as well as any necessary precautions. The FDA requires that medication guides, such as IFUs, come with certain medical products. Usually, they do so when they’ve determined that: 

• The consumer requires specific information to prevent serious adverse effects.
• A patient has the right to be aware of serious side effects before deciding to use this product.
• Proper usage of the product is essential to its effectiveness.

Medication guides, including IFUs, must be given to consumers each time the medication is dispensed. It is worth noting that not all medications will provide an IFU. If a consumer ever has questions about a medication, it is best that they consult a healthcare provider or pharmacist. 

Where Translation Helps

Now, looking from a business standpoint, European regulations can provide an example of the importance of translating IFUs. The translation of an IFU is necessary for sale in Europe. Medical products in Europe must have a CE Mark. This mark guarantees that the safety and authenticity of a product are verified and translated properly. 

A CE Mark allows a manufacturer to sell a product throughout the EU. In order to obtain that mark, all materials (such as an IFU) are translated into each of the 24 official languages of the European Union. In Europe in particular, all products must have a CE Mark, which enables manufacturers and traders to commercialize them in the European Economic Area (EEA). 

The Future of IFUs

The standards for medical professionals and products evolve and adapt over time. The digital age is, of course, affecting patient safety regulations. Those who wish to market their products in the European Union should prepare for the emergence of the eIFU (electronic information for use) in 2020. The new eIFU requirements aim to increase medical device safety and effectiveness by providing users with the most current information. An eIFU can include video and audio files, which will make it easier to demonstrate how to operate and handle medical devices. eIFUs will allow companies to bring revisions or changes to the market faster. This extra content will require translation services to ensure all consumers can understand a video or audio file. 

New regulations will be in place in 2020 that medical device manufacturers in the European Union need to prepare for. Manufacturers should be prepping for the change now, including getting ahead on any translation needs.

A spoonful of sugar makes the medicine go down. But what makes the medicine work? That’s a process that pharmacovigilance aims to improve. Pharmacovigilance is a facet of patient care. One that aims to utilize medicine and data in the best way possible. To treat and prevent diseases. It is also a field that requires high-quality translation services in order to ensure the proper translation of pharmacovigilance documentation.

What Is Pharmacovigilance?

Pharmacovigilance deals with the detection, understanding, assessment, and prevention of adverse effects. As well as other medicine-related problems. The World Health Organization outlined three main goals of pharmacovigilance:

1. The rational and safe use of medical drugs.
2. The assessment and communication of the risks and benefits of drugs, on the market.
3. Educating and informing patients.

Pharmacovigilance is a critical part of the pharmaceutical and healthcare industries. It aids continuance, drug approval, and the ability to safely promote the use of their products. And it allows medical practitioners to better communicate their knowledge while practicing. It is also the source of all drug safety information and education for patients and the public.

This undeniably important discipline has a tough job to do. The nature of the issues they are dealing with is undesirable, particularly when it comes to pharmaceuticals and medical devices. Adverse events inevitably arise and reporting these events is necessary to create good pharmacovigilance programs. Ideally, these programs identify undesired events before they affect public health.

Public health spreads wide. Across many regions and languages. This is why there can be no language barriers in the reporting process of these events. The adverse events are reported in the local language, but proper translation allows these reports to do more good across more groups of people.

Who Needs Pharmacovigilance Information

Primarily, medical device manufacturers, pharmaceutical companies, clinical research organizations, and other outsourcing partners such as language translation organizations like Terra are interested in pharmacovigilance.

When is the translation of pharmacovigilance documentation needed?

Pharmacovigilance databases often require translation from various languages into English and vice-versa. Adverse effect reporting, adverse drug reaction databases, and documents related to these subjects generally require a translation.

Why Access Matters

Health and wellness are the primary reasons why it is important for pharmacovigilance information are readily available to anyone who desires it. Pharmacovigilance can only work successfully if the information is shared in a timely fashion. Which is where the World Wide Web comes to the rescue.

The internet has made this information more accessible than ever before. Any concerned party can obtain information about an adverse event online. The ease of access is good. The risk of misunderstandings due to translation errors is not. If the reader does not have access to a properly translated document, then misinformation can spread. Which is highly dangerous. Medical organizations, regulatory agencies, pharmaceutical firms, medical device firms, and the public all need access to properly translated pharmacovigilance information. Translation errors can have dangerous results. Which can cause harm to the public and unnecessary expenses on behalf of stakeholders. Working with a qualified language services provider can help mitigate the risk of mistranslation.

Language touches every area of our lives. Words can gift hope and faith. Or they can start wars. There is no denying that language can mean life or death. Especially when it comes to the medical industry. Mistranslation of medical terminology, treatments, or a patient’s history is extremely dangerous. The pharmaceutical packaging market in particular has rapidly growing translation needs. By 2025, it’s estimated that the pharmaceutical packaging market will be worth $128 billion. For comparison’s sake, as of 2015, the market’s worth was almost $69 billion.

Where is Growth Coming From?

Why such a large increase in growth? To start, there is an increased global demand for medication in emerging economies. Combine that fact with an aging population, increase in chronic diseases, antimicrobial resistance, and strict medical regulations. The Latin American market alone is anticipated to experience a Compounded Annual Growth Rate (CAGR) of 6.51% by 2022.

Where Translation Comes Into Play

Pharmaceutical packaging translation may not be an immediately apparent need. But when broken down, the amount of translation required is substantial. Not only do pharmaceutical labels require translation, but so do those hefty leaflets that come in the packing. All packages must include information on a pharmaceutical’s name, strength, and form. Each will also contain a statement of active substances per dosage. As well as the method and route of administration. And of course, a warning to keep the product out of the reach of children.

All applicable warnings must be included, alongside the:

• Expiration date
• Special storage requirements
• Batch number
• Authorization number
• Disposal guidance
• Contact information for the marketing authorization holder
• Product’s name in braille

All of the above information must be written in the official languages of the country where the product is sold. Similar to medical devices, pharmaceutical products are regulated in most countries. Each has its own set of specific rules.

Canada is a prime example of what to expect when distributing pharmaceuticals in a country that has more than one national language. Because they have two official languages, English and French, pharmaceutical packaging translation is required to ensure both languages are present on the required materials. Even if the drug is available for sale without a prescription, such as over-the-counter allergy medication. The EU requires Member States to make official languages clearly legible on packaging leaflets. In the EU, companies must comply with any guidelines enforced by the European Medicines Agency (EMA) and its Committee for Human Medicinal Products (CHMP), as well as abide by any local regulations.

Pharmaceutical Packaging Translation Solutions

Pharmaceutical packaging translation requires a professional native-speaking translator with medical translation experience and knowledge. Word-for-word translations aren’t sufficient for medical translations. They require complete comprehension of the subject matter. As well as the ability to communicate the true meaning of the text. Which is why it’s important to utilize specialist native translators who have the cultural and linguistic experience required to properly translate pharmaceutical packaging. 

These types of translators are more in demand than ever due to the large number of pharmaceuticals shipped across countries and continents. Not only does proper translation enhance a patient’s safety, but it helps maintain compliance with any country-specific regulatory requirements.

In order to accommodate multiple languages on packages, you can consider utilizing modern labeling techniques that allow more space for multiple translations of vital information. There are tools available that allow you to print multiple languages on one label. Because the label wraps around the prescription bottle multiple times, it can replace a standard adhesive label without negatively affecting legibility, packaging size, or appearance.