Leaflet

from Wikipedia, the free encyclopedia

A package insert is enclosed with finished medicinal products and contains important information for the consumer, mainly the purpose and correct use of the medicinal product , as well as the frequency and type of side effects. Designations used synonymously are: instructions for use , package insert , patient information or, colloquially, “ wash slip ”. A package insert is compulsory in most countries. The content is, at least in part, regulated by law.

Requirements for the package insert

European Union

Content

For the countries of the European Union , the obligation to provide an instruction leaflet with certain contents results from the " Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the creation of a Community code for medicinal products for human use", which all member states have in their national Must adopt legislation. The package insert is prepared in accordance with the information in the summary of product characteristics (information for healthcare professionals). You must understandable and easy to read information in the official language included the official language of the Member State.

In detail, according to Art. 59 of the Directive, certain information must be included in the order listed there:

  • to identify the medicinal product, the name, followed by the strength and the dosage form , and, if applicable, an indication of whether it is intended for use in infants, children or adults; in addition, in a manner understandable for the patient, the pharmaceutical-therapeutic class or mode of action ;
  • the areas of application ;
  • a list of information that must be known before taking the drug, such as contraindications , appropriate precautionary measures for use, interactions with other drugs and other interactions (for example with alcohol , tobacco , food) that may affect the effectiveness of the drug, if applicable special warnings ;
  • the usual instructions required for proper use (instructions for use ), in particular dosage , type and, if necessary, route of administration, frequency of administration (if necessary with an indication of the exact time) and the express recommendation, if necessary, the doctor or pharmacist to clarify the use of the medicinal product to consult. If applicable, the duration of treatment (if this should be limited), measures to be taken in the event of an overdose or failure to take one or more doses and an indication of the risk of possible withdrawal symptoms after discontinuation of the drug should also be given;
  • a description of the side effects that may be observed with normal use of the medicine and any countermeasures that should be taken; the patient should be expressly requested to inform his doctor or pharmacist of any undesirable effects not listed in the package insert;
  • a reference to the expiry date stated on the packaging and a warning against using the medicine after this date; If applicable, information on special precautionary measures for storage and warning of visible signs that a medicinal product is no longer to be used, the complete composition ( medicinal substances and excipients ), dosage form and content by weight, volume or dosage units, name and address of the authorization holder and name and address of the manufacturer;
  • the date of the last revision of the package insert.

Medicinal products that are authorized in the Member States concerned via a non-centralized authorization procedure with different brand names must contain a list of the names approved in the individual Member States in the package insert.

In the list of information that must be known before taking the drug, the special situation of certain consumer groups must be taken into account (children, pregnant or breastfeeding women, the elderly, people with special diseases). If necessary, the possible effects on the ability to operate machines and drive vehicles must be indicated. Further information may be included in the package insert if it is important for the patient, but it must not have an advertising character.

The European Medicines Agency has forms for the package leaflet that applicants must fill out and submit with the application for authorization. There are pre-formulated phrases that can be used literally to describe a number of issues. The wording of the officially approved package insert is part of the approval certificate. Any change to the package insert must be reported to the competent authority and, if necessary, approved.

Formal package insert design

A guideline of the EU Commission contains a number of recommendations for the design of the package insert. An easily legible font should be used and the font size should be at least 8 points, measured against the Times New Roman font. The spacing between lines must be at least 3 mm; small caps are to be avoided if possible, as well as italics and underlining. Justification and background images in the text are undesirable. A column format can be beneficial for legibility. The highlighting of headings in bold or in color makes it easier to navigate in the text; only a few structural levels should be used. A sufficient contrast between text and background color must be ensured.

The formal design of the package insert also includes the consideration of special regulations on auxiliary materials and the use of standard terms.

For example, the frequency information on the occurrence of side effects is standardized according to MedDRA :

  • “Very common” means that more than 10% of the treated people experience side effects.
  • Side effects are “ common ” if they occur in 1% to 10% of those treated.
  • "Uncommon" side effects affect 0.1% to 1% of those treated.
  • "Rare" side effects affect one in 1,000 to 10,000 people.
  • "Very rare" side effects only occur in less than 1 in 10,000 people.
  • “Not known” frequency cannot be estimated from the available data

Germany

The implementation of the EU directive into national law is given in Germany by the German Medicines Act (AMG), in which the package insert is dealt with in Section 11 AMG. There, the content and sequence of the information in the package insert are specified in accordance with the European Directive. The forms for package inserts from the Federal Institute for Drugs and Medical Devices (BfArM) must be used for national authorization applications . In addition to the requirements to be taken into account by EU guidelines, German package inserts may also contain regulations resulting from the Drug Warning Information Ordinance (AMWarnV) and the stipulated plan procedures.

Another German specialty is the doping notice. If the drug can lead to positive results in doping controls, this must be mentioned in the package insert. The basis for this is § 6a, Paragraph 2 AMG, as amended by the Anti-Doping Act .

In Auseinzelung be given of drugs package insert has a copy.

Austria

In Austria, Sections 16 and 16a of the National Medicines Act implement the EU requirements for the content of the information for use.

Switzerland

In Switzerland, the Medicines Ordinance (VAM) regulates the content and form of the package insert, also known as patient information. The patient information must be written in the three official languages. In contrast to the regulations in the EU, there is only a limited obligation to declare auxiliary materials.

Comprehensibility

WIdO study 2005

A study by the Scientific Institute of the AOK (WIdO) published in October 2005 showed that around two thirds of the patients in Germany read the package insert, but one third felt unsettled by the information and almost one third of the patients continued to discontinue drugs or not at all took. In particular, the incomprehensible statements on the side effects were further points of criticism. In the study, the WIdO presented the package inserts for the 100 most frequently prescribed drugs to 70 test persons. These should evaluate the legibility and understandability of the package insert.

Against this background, it is understandable that the Federal Court of Justice considers doctors to be obliged to explain the risks and side effects of medication regardless of the content of any package inserts. If the prescribing doctor fails to do this, he may be liable.

Readability test

More recent legislation takes into account the problem of package inserts that are difficult to understand. For example, in the countries of the EU since 2005 it has been necessary, when submitting the application for approval for a human medicinal product, to submit the results of evaluations of the package insert to the competent approval authority, which were carried out in cooperation with patient target groups (so-called readability tests ).

Comprehensibility study 2011

In December 2011, a new study by LangCor Service GmbH and the H&H Communication Lab was presented. The study shows that even 6 years after the readability guidelines were introduced, there is still considerable room for improvement. The information in many package inserts is still difficult to very difficult to understand. In addition, the texts can often only be read under difficult conditions and important content can hardly be found. The study examined 20 patient information leaflets of the top-selling drugs in 2010. These were drugs that can be bought in pharmacies without a prescription. What is particularly explosive is that with these drugs, patients are actually dependent on the information in the package inserts, since there are usually no discussions with doctors or pharmacists.

Study to Understand the Risks of Side Effects 2013

A study on the understanding of side effect risks in the package insert among doctors, pharmacists and lawyers found that "only a few respondents were able to assign the correct percentage value to the terms for frequency in the context of side effects, although it is part of their professional tasks, probabilities or risks of Communicate side effects. " The authors conclude that "the definitions do not correspond to the everyday usage of the terms."

Access for the visually impaired and the blind

Marketing authorization holders must ensure that the information leaflet for a medicinal product is available upon request from patient organizations in formats that are suitable for blind and visually impaired people. Usually audio versions are distributed on CD.

Motion for a resolution to the German Bundesrat in 2015

In December 2015, the Saarland presented the Federal Council a resolution to allow the readability will improve package leaflets which had been agreed, the Federal Council in March 2016th At the national level, the federal government is to examine together with the higher federal authorities ( PEI , BfArM ) how the BfArM's “publication of recommendations for the design of package inserts” can be implemented in a patient-friendly manner. In the EU, the Federal Republic should also work to ensure that the readability of package inserts is improved.

Causation of side effects

Package inserts do not differentiate between side effects according to whether they are triggered by the drug or would have occurred without taking the drug. Package inserts are misleading in this regard. A comparison of the frequencies of side effects with and without drug use would improve understanding. Since the package insert forms the basis for questions of liability, the currently used list of side effects serves to provide legal protection instead of informing the patient, according to the Buko Pharmakampagne organization and the Bremen General Practitioner Association .

Technical aspects

Package inserts are often printed on thin printing paper and, if necessary, can be folded up very small using special folding machines so that the often extensive information can also be accommodated in small folding boxes. However, the paper used must be sufficiently opaque so that the text does not show through, and the folds must not impair legibility either.

Individual evidence

  1. ↑ Guideline on the readability of the label and package leaflet of medicinal products for human use . Revised version of January 12, 2009 (English; PDF file; 118 kB).
  2. ↑ Excipients in the label and package leaflet of medicinal products for human use (PDF file; 222 kB) from July 2003.
  3. ↑ Appendix II (DOC file; 51 kB)
  4. ↑ Appendix 5.1 to Art. 14 of the Medicines Ordinance
  5. ↑ WIdO study on patient information leaflets , published on October 27, 2005
  6. ^ BGH, judgment of March 15, 2005, Az. VI ZR 289/03, full text .
  7. ↑ Medical information leaflets are often difficult to understand for laypeople , published on December 8, 2011
  8. ↑ Deutscher Ärzteverlag GmbH, editorial office of the Deutsches Ärzteblatt: Understanding of side effect risks in the package insert. October 4, 2013, accessed May 22, 2019 .
  9. ↑ Federal Institute for Drugs and Medical Devices: Publication of recommendations for the design of package inserts in accordance with Section 11 of the German Medicines Act (AMG) for medicinal products for human use (in accordance with Section 77 (1) AMG) and the requirements of Section 22 (7) sentence 2 AMG (review of the comprehensibility of package inserts ). (PDF) April 14, 2015, accessed June 27, 2019 .
  10. ↑ Helga Blasius: Less would be more - The package insert: Patient protection through education . In: Deutsche Apotheker-Zeitung . No. 19 , May 11, 2017, pp. 24 ( deutsche-apotheker-zeitung.de ).
  11. ↑ Odette Wegwarth, Ingrid Mühlhauser, Roman Prinz, Viktoria Mühlbauer: Alternative package leaflets improve people's understanding of drug side effects — A randomized controlled exploratory survey . In: PLOS ONE . tape 13 , no. 9 , September 13, 2018, ISSN  1932-6203 , p. e0203800 , doi : 10.1371 / journal.pone.0203800 , PMID 30212555 .
  12. ^ Helga Einecke Frankfurt: Doktern on the package insert . In: sueddeutsche.de . 2015, ISSN  0174-4917 ( sueddeutsche.de [accessed on May 22, 2019]).
  13. ↑ Tom Nebe: How the package insert can be understood . March 4, 2015 ( welt.de [accessed on May 22, 2019]).

Web links

Wiktionary: Package insert  - explanations of meanings, word origins, synonyms, translations
  • PharmNet.Bund database, which contains administrative data on all medicinal products approved in Germany as well as their technical and usage information (publicly available, but partly subject to a charge)
  • Medikamio.com AT database containing the instructions for use of all pharmaceuticals approved in Austria