Aviso legal y Política de privacidad

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Farmácitas S.L.
CIF.Nº B-85293470
C/ Libertad, 6, 2º dcha.
28004 MADRID
Correo electrónico: farmacitas@farmacitas.org
http://www.farmacitas.org

Readability of leaflets

Versión en español

Farmaiuris, Legibilidad y Prospectos is willing to inform you the main updates and changes that occur in both the legislative and practical field about the medicinal package leaflets. Novelties, which may allow a better understanding of the medicinal package leaflet legislation for the patient’s use.

Actually, we’ve designed a special method to do User Test (or Test de Legibilidad). This test allows us to consider if the chosen package leaflet has been understood by the majority of the population.
In contrast with other test, our Test de Legibilidad is being used currently in hospitals (in the area of Pharmaceutical Services).
By means of interviews, the patient is evaluated about his knowledge of a certain package leaflet. The results are finally evaluated by a psychologist who’s been trained in this particular area.

Our wish is to be able to analyze the possible contradictions occurred when elaborating the leaflets. It is our intention to make them easier for the patient´s understanding and therefore allow a better and safer use of the medicinal treatments.

ALWAYS NEXT TO THE PHARMACEUTICAL INDUSTRY

AS AN INTRODUCTION

FARMAIURIS, traditional legal consulting, well recognized in the pharmaceutical sector, has a new team of professionals who provides to the Pharma industry advisory services in the areas of labelling, packages leaflets (PL) and in general, about packaging material contents. This new service arise to comply with the provisions of RD 1345/2007, and to optimize procedures for the medicines and/or medical devices authorization and to minimize the risk of complaints about responsibility that the industry has, due to a poor writing of the leaflets.

Responsible people:

Gloria Rivero - Lawyer
Cristina Román - Pharmacist, Ph.D
Mariano Avilés - Lawyer
Irene Domingo - Psychologist

A Leaflet never intended to convince with arguments, but to transmit the accurate information accordingly. This information is not always of a pleasant character

AIMS

To give service to the Pharma companies, FARMAIURIS READABILITY OF LEAFLETS has created an innovative model very useful, both for the content of the test as well as the way to do it. This will allow:

To assess the readability of the medicines leaflets, doing the test in the pharmacy services of the selected hospitals.
To improve the language used in the leaflets and the level of understanding of the patients.
To establish some parameters used to verify the strong points and the ones we should improve in each leaflet.
To evaluate the test results by a psychologist.

Words have its history and the sentences that we compose with them may not match easily, acquiring different meanings.

WORKING METHOD

FARMAIURIS readability of leaflets has designed an intervention protocol to analyze the leaflet content and the information that is obtained in the readability test. This is done by the Pharmacy Services of the selected hospitals and the evaluation of results is made by a psychologist.

Parameters for evaluation: definitions

COMPREHENSION OF CONTENTS: Easeness or difficulty by which the patient understands the information that the Package Leflet (PL) transmits, in order to see if it is well interpreted by the reader.

FINDING OF INFORMATION: Easeness or difficulty that the patients have to search the information in the PL, in order to test if they are able to find the information needed to carry out the treatment correctly.

PL GENERAL EVALUATION: Package leaflet suitability from the patient point of view, in reference to how the information is setting out, size and type of the letter used, etc, among other items, to facilitate the texts reading and understanding.

COMPREHENSION OF PICTURES AND SYMBOLS IN THE PL: Easeness or difficulty for the patient in order to understand and put into practice the pictures of the instructions - refered to the manipulation of medicine –opening, administration, use of devices (inhaler…), mixing of compounds, ect-. Interpretation of graphic language –symbols, icons, colours, ect- used to transmit or emphasize important messages about the medicine or its use.

EVALUATION OF RESULTS

Following the parameters given above, we include an example of one of them "Comprehension of content" that we asses in our final report:

This parameter is constructed with the average result obtained of each one of the different sections of the leaflet. We assess how easy is for the reader to understand the information contained in the texts.
In a numeric scale, it is also depicted the average of the results after the evaluation of questionnaire. The readers may evaluate each one of the leaflet sections from 1 to 10.

The information given has to be appropriate to avoid serious harms, not only in what concerns to the right use of medicines for the wanted purpose, but also when assuming responsibility arisen from the lack of information

FARMAIURIS READABILITY OF LEAFLETS

Farmaiuris Readability of Leaflets, will have the support of an INDEPENDENT ADVISORY BOARD (CAI) that will express periodically their opinion in order to contribute with current issues that will improve the quality of the leaflet contents.

More information: farmaiurislegibilidad@farmaiuris.org

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Aviso legal y Política de privacidad

C/ Libertad 6, 2º dcha. 28004 MADRID tel. 913 605 755 | fax. 915 227 797 | farmacitas@farmacitas.org