User Testing of Medicinal Leaflets: Europe leads the way

Karolina Chawrylak’s current role is as project assistant in Voisin Consulting’s Melbourne office.

As a well-integrated project team member, she works closely with the User Testing leader, Dr Carolyn Tucek-Szabo, and also Dr Clare Wright in the design, conduct and reporting of patient information leaflet user testing for European and Australian clients; a recent, mandatory requirement for Marketing Authorisation Applications in Europe.

Why is it necessary to test medicinal leaflets?

Medicinal leaflets (known as Consumer Medicine Information (CMI) in Australia, Patient Package Insert (PPI) in the US and Patient Information Leaflets (PIL) in Europe) have not always been clearly understood by patients and their care-takers as more often than not leaflets are written using complex medical language.

The primary objective of conducting user testing is to determine whether important information can be easily located in the medicinal leaflet by the consumer, and whether this information is able to be interpreted by them correctly.

The history of Consumer Medicine Information (CMI)

In the early 1990s in Australia, it was proposed that medicinal leaflets should undergo a process called ‘user testing’ in order to identify possible problems within the leaflet and overcome these to produce a satisfactory finished product. To this end, David Sless and Rob Weisman authored ‘Writing about Medicines for People’ for the Communication Research Institute of Australia (CRIA) in the late 1990s and this publication became the basis of the European Medicines Agency’s (EMEA) guidelines on user testing. As a result of active lobbying by patient advocate groups, all marketing authorisation applications (MAAs) in Europe have, as of 30 October 2005, been required to include a section on “consultation with patient target groups” within their dossiers in Module 1.3.4 (Module 1.3.2 within the Australian dossier). This consultation (i.e. user testing) had until late 2005, been a voluntary undertaking and was not a mandatory aspect of the MAA submission.

Why CMI is important for Australian biotech companies

Although not a compulsory requirement in Australia, there have been several instances where the Therapeutic Goods Administration (TGA) has asked for user testing of CMIs to be performed. There is also some indication that the U.S. Food and Drug Administration (FDA) will follow Europe’s lead at some time in the near future as regulatory guidelines are in the process of being harmonised across the globe.

According to the Australian Government’s Department of Health and Ageing, the CMI is a key component of the Quality Use of Medicines (QUM) and as such CMI user tests should be strongly taken into account when preparing a dossier submission to the TGA. Along the same lines, following recommendations made by the Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information, the FDA has started considering the implementation of user tests in order to provide the most important information to the public within the PPI.

What signifies a successful medicinal leaflet user test?

Based on well defined criteria, analysis of the information provided by the subjects during the leaflet testing, provides evidence as to whether the medicinal leaflet will be successful amongst the targeted patient population as it is, or whether it will need rewriting/reformatting to address identified, problem areas. A successful end result is compliance with the above mentioned guidelines and a medicinal leaflet which is well understood by the patient population for proper medicine use.

Dos and Don’ts for successful medicinal leaflet testing

The most important point to note with respect to conducting medicinal leaflet testing is that the information for the prescriber should be almost finalised before the corresponding PIL is written. If this is not the case, the PIL being tested will almost certainly need to be amended and retested at a later date as the prescriber’s information is amended. The EMEA’s Quality Review of Documents (QRD) describes the full requirements; Schedule 12 of the Therapeutic Goods Regulations 1990 describes what should be included within the Australian version of the medicinal leaflet and how it should be set out to comply with TGA standards, and the FDA’s Guidance on Useful Written Consumer Medication Information provides guidelines on the formulation of package inserts in the USA.

Other points for consideration include:

When developing the questions to be used for the interviews (usually 12 to 15 questions, in a random order), it is important to keep in mind the key messages that the leaflet is trying to convey, such as the indication of the medicinal product, warnings and precautions, instructions for use and possible side effects. Questions should not be written with an expectation of a yes/no answer as these will not reveal any significant issues contained within the leaflet.

• Perform a Pilot Study to test the questions on 3-6 subjects to ensure they are clearly understood.
• Perform a First Round Study in 10 subjects to test the leaflet to discern where the problem areas exist (if any).
• Keep in mind that subjects recruited for the user tests should ideally represent the intended patient population with an even mix of men and women, as well as ages.
• Explain the pass/fail criteria clearly in the report, as according to regulatory guidelines, an overall leaflet pass constitutes that 90% of subjects tested should be able to locate the requested information in the leaflet, of which 90% should be able to understand the information. Therefore, in order for the leaflet to obtain a satisfactory outcome, the overall pass mark must be 81% or more.

Voisin Consulting’s experience in medicinal leaflet user testing

Voisin Consulting has been involved in user testing since the mandatory implementation date and as a result, has acquired a great deal of experience. Direct Agency feedback following dossier submissions has enabled Voisin Consulting to stay current with Agency requirements and to ensure that we develop our methodology to receive positive results.

To date, Voisin Consulting has performed at least a dozen user tests for various products for European as well as Australian submission dossiers and as a result, our methodology has evolved according to the Agency feedback received.

Voisin Consulting Services

Voisin Consulting is a global company which assists biotechnology, pharmaceutical and medical technology companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development.

Products include drugs, biologics, medical devices, combination products, advanced therapy products, as well as borderline products (food supplements and cosmeceuticals).

Voisin Consulting collaborates with start-ups and medium-size companies to bring products to the market in the most efficient and cost-effective manner, within an evolving regulatory framework.

About Karolina Chawrylak

Karolina joined Voisin Consulting Australia in October 2006 and brought with her a strong background in media and research.

She has gained experience in regulatory affairs such as Marketing Authorisation Applications, Variation Submissions, Orphan Drug Designations, Scientific Advice briefing packages and e-submissions through e-CTD software. She assists in all regulatory matters, including communication with national and international agencies, researching regulatory guidelines, translation of basic documents into several European languages and compilation of these for submissions.

Karolina has a Bachelor of Arts (Multimedia) degree, majoring in multimedia and communication studies from Victoria University, Australia.

For more information please contact:

Ms Karolina Chawrylak

Voisin Consulting Australia Pty Ltd

Milton House

Level 1, 25 Flinders Lane

Melbourne, VIC 3000

Australia

Phone: +613 9663 9008

Fax: +613 9663 9009

Email: chawrylak@voisinconsulting.com

www.voisinconsulting.com