Readability Testing is Really Readable or Understandable??

All medicinal products placed on the Community market are required by Community law (Article 54, Article 55 and Article 59 of Directive 2001/83/EC) to be accompanied by labelling and package leaflet which provide a set of comprehensible information enabling the use of the medicinal product safely and appropriately.

Article 63(2) of Directive 2001/83/EC also requires that the package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals.

Article 59(3) of Directive 2001/83/EC provides that the package leaflet shall reflect the results of consultations with target patient groups to ensure the requirements of Article 63(2) are met.

Article 61(1) of Directive 2001/83/EC says that the results of assessments carried out in cooperation with target patient groups shall also be provided to the Competent Authority. Report summarising the result of consultation with target patient groups must be included in the CTD dossier, Module 1.3.4.

The Main Purpose of Readability Testing is:

• The leaflet must reflect the product licence, the Summary of Product Characteristics (SmPC) of the product to which it refers. Differences between the SmPC's for the same medicine available from different MA holders lead to inconsistent information in the PIL, resulting in frequent complaints from patients.
• Many leaflets were lenghty due to the complexity of the SmPC, and were poorly laid out. Patients quickly lost interest in the document, failing to read or understand information crucial to the safe use of the medicine.
• Readability testing qualifies that the medical information contained in the leaflet is usable i.e. understood by potential users of the medication. 

The PIL should be compliant to harmonized agreed QRD template.

Generally user testing is required to at the time of initial (first) marketing authorization. However it also required when certain changes happened to PIL. Situation when is also required:

• Change in legal status (Rx to OTC)
• Addition of pack size or new presentation (PVC blister or Alu-alu blister or HDPE container)
• Addition of safety data

In the “Readability Guideline” the following assessment criteria are listed for Competent Au-thorities’ approvals of package leaflets related to the consultations submitted in support of a pack-age leaflet:

• Data gathered from users under defined conditions
• The people who are likely to rely on the package leaflet for a particular medicine will de-pend upon a number of factors and may include carers (e.g. parents, partners, friends, as well as nursing assistants) rather than patients if the medicine is generally intended for ad-ministration by someone other than the patient.
• In order to ensure that those involved can understand and apply the information, the evi-dence presented must demonstrate that they can pick out the relevant information, interpret this and describe the action they would take as a result.
• The key information will need to be defined prior to the consultation by the marketing au-thorisation holder and is likely to include significant side effects, warnings, what the medi-cine is for and how to take/use the product.

Reference:

1. Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human use.
2. Chapter 7 General Information