Package Leaflets, QRD Templates and Forms
Package leaflets enclosed in medication packages are an important source of information for patients or carers about a particular drug, whether prescribed or bought over-the-counter, and should be read before starting treatment and while taking the medication. In addition to providing vital information on indications, contraindications, side effects of the medication, they should also motivate patients to actively participate in their treatment. Improved levels of patient satisfaction have been recorded for patients who received a package leaflet with their medicine. They also improve patients’ knowledge of how to take their medicines correctly, raise awareness of potential side effects and generally improve compliance.
One study showed that patients who had received a patient package leaflet reported the same number of side effects as those who had not, but those who had received information were more likely to attribute the experienced reactions to the drug whether the particular side effect was listed or not. However, it has been reported that the patient information leaflet is read by only about 70 -80% of patients and few request more specific information on their own initiative. It is well known that patients forget or misunderstand much of what is said during consultation with a doctor or pharmacist and it has been found that on average patients had forgotten half of what the doctor told them within 5 minutes of leaving the surgery.
A survey showed that although 90 % received verbal information about the treatment regimen, fewer were told how to take the drug or the duration of treatment. The package leaflet is therefore a vital source of information for when the patient returns home following a doctor’s consultation.
The situation does arise, however, that many patients are subsequently deterred from taking the medicine as the content of the leaflet made them afraid of the treatment. Specialists have reported that patients frequently have less confidence in their medicine after reading the package leaflet. The consequence of ‘less confidence’ in a particular medicine due to the complex and detailed information contained in a package leaflet can lead to non-compliance which can have major negative health and economic implications.
The official body regulating how these documents are written and translated is the European Medicines Agency (EMA). Any pharmaceutical company that wants to market their products in any EU member state must submit a marketing authorisation application through a centralised procedure. As part of this procedure, the company needs to prepare the product’s SPC, PIL and label in compliance with the so-called Quality Review of Documents (QRD) template which contains the approved headings and dictates what needs to be included in these documents in every member state. This template is available in 24 languages (the official EU languages plus Norwegian and Icelandic) and they must be followed individually in each country for a successful approval.
From time to time this template is updated. What this means is that pharmaceutical companies need to make sure that their existing documentation meets the new requirements set out in the latest updated template and that their new applications also follow this latest version. Also, with this update, a new type of document – Annex II – has been added to the list of required documents in every language.
And this is where having a reliable and expert translation partner comes in handy. A linguist like José A. Gomes that has over 25 years of experience with pharmaceutical translations knows exactly what to do and can ensure that every document in Portuguese complies with the specifications. QRD template updates can be a tricky business as each and every language may have country-specific changes, so it’s not just a case of translating the changes in the English template into the target languages.