Qrd template patient leaflet

Make sure that the information is sufficiently detailed for the user to recognise possible adverse effects and make the appropriate measures and actions. Applicant has to choose a font that is easily read. Make sure that i, l, and 1 are easily distinguished from each other. Do not usenarrowed fonts as they are difficult to read. Large font size makes the text easy to read Times New Roman does not qualify as an easily read font, however, a font size of 9 points as measured in font Times New Roman is considered as a minimum.

Bold font may be used for headlines and subheadings. Do not use underlining. Italics shall only be considered when using Latin terms. Avoid excessive use of capital letters. The meaning of the pictogram shall be clear and aid correct use of the medicine. Pictograms must be accompanied by a text. Before the test, applicant has to decide how to recruite participants in addition to describe inclusion- and exclusion criterias. Recruit participants who are relevant users age, gender of the particular medicine.

The participants should neither have too high educatuion level, a profession where they use written material on a daily basis nor have used the medicine in the past.

Be sure to exclude people who are directly involved with medicines such as doctors, nurses and pharmacists. Before the questions are made, review the package leaflet and identify the information considered crucial for safe use. Further, the questions should not have long answers. Assure that the questions covers crucial safety information. The PL should include general information regarding what the patient should do if a dose is missed or a specific adverse event occurs.

A user test should also focus on the instructions on adminitration and dosing. The questions should also consider pictograms if applicable. Generally, questions will be sufficient. In certain instances when comprehensive information is necessary to ensure safe use, additional questions might be needed. It is recommended to perfom a pilot before the user test. The main purpose of a pilot is to review whether the questions can be considered suitable.

The interviewer asks the questions orally. For each question, the participant shall locate the information in the package leaflet and answer in their own words. It is important to have questions to prove that the particant is able to use the information i. There should be clear instructions for the interviewer. An instruction should decribe what the interviewer should do if the participant does not find the answer. For example the interviewer can be allowed to read the question again, but not help the participant to find the answer.

A total of 10 persons in the first round is usual. Describe the recruitment of the target patient group and present demographic data of participants. Present results of each round separately. The number of participants able to find the information and the number of participants who have understood the information, should be presented. The aim of the user test is to ensure that the package leaflet is legible and easy to use.

The applicant should discuss the results, and suggestions from the partcipants shoud be taken into considerations. Any weaknesses inditified, should be addressed in an approriate way to improve the readability for the user. This means to have 16 out of 20 participants should been able to find the information and have answered each question correctly and shown that they can use the information.

Is it required to perform a user consultation for package leaflets that were approved before the requirement on user consultation was implemented in the regulation? Many medicinal products were approved before the requirements on user consultation came into force.

The Norwegian Medicines Agency has not required user consultation of the package leaflet for those products. If a company applies for a line extension, i. The applicant should make a thorough decision on which approved and user tested package leaflet it wishes to use for the comparison. The approval should be quiet recent. Information on safe use and medical terminology in need for explanation should be presented in a similar way.

If there are no available approved package leaflet that are sufficient similar, the applicant may need to present a full user consultation or a focused user consultation. A focused user consultation could be use when the new package leaflet are similar to an approved package leaflet apart from e. Since the design and layout of the information is crucial to how the information is used and understood, the leaflets should be of the same design, layout and font.

As layout and design often have an corporate design it may be necessary to compare the package leaflet with more than one approved package leaflet i.

Often, only a couple of questions may be sufficient for a focus test. Design the questions to make sure that the user can find, understand and use new and important information. Batches of medicinal products that are QP released 6 months or later after the approval date must haveupdated packaging. Delayed implementations in the packaging, later than 6 months, shall be applied for as batch-specific variations.

All QP released batches for a medicinal product shall have updated package leaflet implemented at least 6 months after the date of approval.

Nevertheless, the Norwegian Medicines Agency may accept a 12 months implementation deadline from the approval date, if the conditions below are fulfilled. Delayed implementations in the package leaflet, later than 6 months, which do not fulfil the conditions below, shall be applied for as batch-specific variations.

NoMA may determine a shorter implementation deadline of the updates in the package leaflet. If the updates include any safety issues for the medicinal product, NoMA may demand immediate implementation with the first produced batch or consequent withdrawal. For human medicinal products, the hyperlink to the Felleskatalogen. The following sentence shall be inserted in the English package leaflet, at the first opportunity: «Detailed information on this medicine is available on the website of name of MA Agency hyperlink.

For centrally authorised medicinal products, the reference to the Felleskatalogen. Advice to consumers on buying face masks. New Tech — new technological possibilities and medical devices. Patient safety and safe medical devices. Development of medical devices. CE marking. Incident reporting.

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Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. More precisely, during the production process specific emphasis should be placed on testing the degree of emotional arousal provoked in patients when reading certain risk information. Future generations of PILs should aim at providing information about possible side effects and drug interactions in a language of risk that is causing less anxiety in order to diminish or — if at all possible — avoid typical "knee-jerk reactions" such as altering the dosage or discontinuing the prescribed medication.

In order to improve the outcome of a benefit-risk-assessment of a medication the European Commission should consider including emotional arousal testing as an additional aspect in the guideline on how to produce package leaflets. We thank all the people who took part in the focus groups and the general practitioners who recruited patients in their practices for us. The support of Professor Monika A. Rieger in design and conception of the study is gratefully acknowledged.

Finally, special thanks are due to Professor Emeritus Ruth Schroeck for proof-reading the amended final version of the manuscript. This study — as part of a larger project was supported by the Federal Ministry of Education and Research [grant number: 01 GX ].

The funding source had no involvement in the study design, the collection, analysis and interpretation of the data, in the writing of the report, and in the decision to submit the paper for publication. Competing interests. Authors' contributions. All authors read and approved the final manuscript. Oliver Rudolf Herber, Email: ed. Verena Gies, Email: ed. David Schwappach, Email: hc.

Stefan Wilm, Email: ed. National Center for Biotechnology Information , U. BMC Fam Pract. Published online Oct 2. Author information Article notes Copyright and License information Disclaimer.

Corresponding author. Received Jun 25; Accepted Sep This article is published under license to BioMed Central Ltd.

This article has been cited by other articles in PMC. Abstract Background The purpose of patient information leaflets PILs is to inform patients about the administration, precautions and potential side effects of their prescribed medication. Methods We conducted six focus groups comprising 35 patients which were recruited in GP practices. Results Three interrelated categories are presented: i The vast amount of side effects and drug interactions commonly described in PILs provoke various emotional reactions in patients which ii lead to specific patient behavior of which iii consulting the GP for assistance is among the most common.

Conclusions Future PILs need to convey potential risk information in a language that is less frightening while retaining the information content required to make informed decisions about the prescribed medication.

Keywords: Patient information leaflets, Medication adherence, Qualitative research, Focus groups, Anxiety, General practitioner, Family practice, Type 2 diabetes, Hypertension, Hypercholesterolemia. Background A patient information leaflet is a technical document included in every medicine package to offer written information about the medication. Methods Focus groups were chosen because they are the most appropriate method for different groups of people to interact in order to gain new knowledge and generate meaningful suggestions, opinions and feedback [ 17 ].

Focus groups and generating data The six focus groups were composed of five to seven patients [ 20 ]. Table 1 Focus group discussion guide. Stimuli Prompts 1 st Stimulus "You are currently taking tablets and in each medicine box there is a patient information leaflet. Can you tell me about that? Finally: Coming to a close "Is there anything that you would like to add or mention? Open in a separate window. Data analysis Data analysis was carried out parallel to conducting the focus group discussions.

Results The mean age of participating patients was Emotional reactions caused by PILs Possible side effects and drug interactions were among the most prominent issues discussed across all focus groups. Response behaviors triggered by current PILs During the focus group discussions participants described numerous behaviors which were provoked when reading PILs: 1 they stopped reading the leaflet; 2 they glanced through the leaflet; 3 they discarded the leaflet; 4 they accessed additional information from alternative sources; 5 they sought support from other professional and lay sources; 6 they stopped taking the medication or 7 altered the prescribed dosage without consulting the GP.

Discussion The findings of our focus groups showed that PILs — despite European Commission guidelines and those of other legislative bodies — still have considerable need for linguistic improvements. Conclusions The findings of our qualitative study have shown that current PILs convey risk information in a way that provoked feelings of fear and anxiety in the reader.

Acknowledgments We thank all the people who took part in the focus groups and the general practitioners who recruited patients in their practices for us. Funding This study — as part of a larger project was supported by the Federal Ministry of Education and Research [grant number: 01 GX ].

Footnotes Competing interests The authors declare that they have no competing interests. References 1. European Parliament and the Council of the European Union. European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1. Quality Review of Documents Group. London: European Medicines Agency; Quality Review of Documents. Maat HP, Lentz L. Improving the usability of patient information leaflets.

Patient Educ Couns. Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK. Drug Saf. Gigerenzer G, Edwards A. Simple tools for understanding risks: from innumeracy to insight. Brit Med J. Res Social Adm Pharm.

Pharmacist, general practitioner and consumer use of written medicine information in Australia: are they on the same page? Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother.

Medication nonadherence: part II — a pilot study in patients with congestive heart failure. Manag Care Interface. Fuchs J, Hippius M. Inappropriate dosage instructions in package inserts.