*Institute of Clinical Pharmacology at Charité Humboldt University Berlin
**Institute of Clinical Pharmacology
Friedrich Schiller University Jena
There is an international trend to improve information for patients about drugs and therapy.(1,2) In 1993, at a meeting jointly organised by the WHO and the Council for International Organizations of Medical Sciences (CIOMS), the right of people to be informed about their healthcare was clearly defined.(3) Furthermore, patients are very interested to get more information and a greater say in questions regarding their own health. In 2002, a survey of over 8,000 people in eight European countries showed that 74% of the participants wanted to be more actively involved in treatment decisions.(4)
Both pharmacists and medical doctors can give verbal or written information to patients within or outside the hospital. The problem is that, by direct communication, only those who provide the information can estimate what each patient has understood. Health professionals, however, have limited time to convey comprehensive information. Therefore, there is a need for a combination of verbal and written information to increase knowledge and compliance. (5–7) This is in agreement with regulations issued by the European Parliament and the Council of the European Union Directive 2001/83/EC,(8) which requires that every drug has to have a package insert.(8,9)
So far, assessments of the package inserts of drugs by patients are rare, as are evaluations about their effects on patients’ health. The survey described below attempted to assess the importance of different issues of package inserts from the patient’s perspective.
A questionnaire focusing on expectations and preferences of patients regarding package inserts was distributed in November 2001 among 1,500 patients in a community pharmacy in Jena (Germany). Of these, 855 people answered the questionnaire (return rate: 57.0%; age: 13–89 years; average: 50 years; female: 66.2%). The educational training of the participants was as follows:
- Eight years: 18.9% (n=162); 10 years: 24.8% (n=212).
- A-levels: 8.1% (n=69); diploma from university for applied science: 17.8% (n=152); university: 23.5% (n=201); no statement: 6.9% (n=59).
The majority (79.6% of all volunteers) said that they “always” read the package inserts of newly prescribed drugs; 19.3% said that they did so “sometimes”; and only 1.1% said they “never” read them.
On request, participants classified the various subject matters of the package inserts into three out of five categories with regard to the importance for the patients. Information about “therapeutic indications”, “dosage instruction”, “contraindications” and “side-effects” were seen as “very important”, whereas details about the “manufacturer” were considered as “less important” (see Table 1). This ranking is also reflected in the structure that participants suggested for future package inserts (see Table 2). This result was independent from the demographic variables of the survey participants.
The participants were also asked about their wishes regarding the amount of information given and the content for a future package insert. Out of 821 participants, 73.4% said they would prefer “less comprehensive” package inserts, 24.5% agreed with leaving the package insert as it was, and only 2.1% wanted more information. According to 76.3% of 822 participants, a package insert should include “only the most important information”; 8% would have liked additional information; and 15.7% were satisfied with the content of the current package inserts. The size of package inserts was also criticised by 18.8%.
More than 50% of the 197 volunteers who gave comments about package inserts found it difficult to understand the information, and 11.2% felt insecure after reading the inserts (see Figure 1).
The results of the survey show many problems associated with package inserts. As package inserts are one of the most frequently used sources of written drug information,(10,11) approaches to optimise them should be explored as soon as possible. This especially refers to difficulties in understanding the extensive information provided, and suggests a more suitable structure for package inserts.(12,13) Other studies confirm the results of this survey on the importance of the content and presentation of package inserts.(11,14,15)
Package inserts should contain only the information that is of importance for the patient, although this is debatable from a legal point of view. Another study, the PAINT survey,(16) showed that patients needed significantly more time to find the information they needed in the original versions of package inserts, compared with shorter versions. The address of the manufacturer for each Member State of the European Union is currently mentioned on package inserts, which can take up to 25% of the space available, and this might have to be reconsidered.(16)
According to the results of different surveys, the structure of package insert should be as follows, in order of importance:
- Name of the medicinal product.
- Therapeutic indication and therapeutic group.
- Appropriate precautions for use and special warnings.
- Dosage instruction.
- Hints for application errors.
- Possible adverse drug reactions.
- Application form and quantity of the drug.
- Date of the last update of the package insert.
The European Parliament and the Council of the European Union changed the structure of package insert with the Directive 2004/27/EC. The new rank order is similar to our recommendation, and all Member States of the EU shall have to bring their national regulations into compliance with this Directive by no later than 30 October 2005.(18)
- AESGP: The association of the European self-medication industry – 40th annual meeting – Self-care in an enlarged Europe – more benefits for more people; Conference report, Madrid, 2–4 June 2004. Available from: http://www.aesgp.be/Madrid2004/Madrid2004ConferenceReport.pdf
- High Level Group on innovation and provision of medicines: recommendations for action – G10 medicines – report, Brussels 2002. Available from: http://pharmacos.eudra.org/F3/g10/g10home.htm
- General policy topics – Ethics and drug promotion – the CIOMS consensus. WHO Drug Information 1994;8:123-4.
- Coulter A, Magee H. The European patient of the future. Philadelphia (PA): Open University Press, 2003.
- Gotsch AR, Liguori S. Med Care 1982;6:581-95.
- Vander Stichele RH, Vandierendonck A, et al. Drug Inf J 2002;36:201-8.
- Little P, et al. BMJ 1998;316:1948-52.
- European Parliament and Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 2001;311:67-128.
- Council of the European Communities: Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. OJ L 1992;113:107-14.
- Weitbrecht WU, Voßkämper C. Fortschr Neurol Psychiatr 2002;4:178-84.
- Vander Stichele RH, et al. Ann Pharmacother 1991;25:1002-6.
- Bernardini C, et al. Pharmacol Res 2000;41:679-88.
- Fuchs J, Hippius M, Schaefer M. Package inserts and their comprehensibility for patients. Proceedings Workshop Programme and Abstracts – 13th International Social Pharmacy Workshop. 2004:42.
- Ridout S, et al. Br J Clin Pharmacol 1986:21:701-2.
- GfK-Marktforschung GmbH. Repräsentativbefragung zum Thema “Beipackzettel von Medikamenten und Beratung”; 2003.
- Fuchs J. Die Packungsbeilagen als ein Mittel zur gezielten Information und Handlungsanleitung für Patienten – Entwicklung und Testung eines Instrumentes zur Beurteilung und Optimierung der Packungsbeilagen von Arzneimitteln [dissertation]. Humboldt University Berlin; 2004.
- Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz) in der Fassung der Neubekanntmachung vom 11. Dezember 1998. BGBl. 1998:3586.
- European Parliament and Council of the European Union. Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJ L 2004;136:34-57.