Direct patient information: Status quo 2008

In the modern imagination, the patient is an active contributor to his or her health. Politicians and health insurance companies therefore hope that the critical, co-determining patient will influence the system that has so far been controlled by the service providers.

>> Health is a growing economic market worldwide - and especially in western industrialized societies. The competitiveness of companies in the healthcare industry is primarily secured through market-driven innovations. Product innovations not only contribute to improving medical care, but also to creating value and thus securing the existence of our social systems. Innovation is anticipated competition. Patient orientation and interaction are becoming important success factors that run through the entire innovation process - from research through the clinical phases to market launch. In order to make the innovation process successful, it is not enough to develop new product ideas that could constitute medical, pharmacological or technical progress. Comprehensive interactions between business and science, industry and medicine, drug manufacturers and patients, cooperation and communication and the resulting development of networks become success factors for the future orientation of our healthcare system (Harms/Gänshirt/Mayer 2004, Harms/Gäns-hirt/Rumler 2008) .
According to a population-representative EMNID survey, 83 % respondents would like more knowledge about medicines, 76 % about diseases and 71 % would like more information about doctors and medical specialties. A study published in 2005 in collaboration with the Health Care Competence Center (HC3) came to similar results. Within 6 months, more than 5,000 respondents were included in a survey panel. It was examined which questions move people on the subject of health. All fields from self-medication to the purchase of drugs not approved in Germany were examined. It is interesting to note that almost 25 % respondents said they were their own best doctor. 50 % of the participants said that they try to self-medicate before visiting a doctor or pharmacist. 80 % stated that unless it is a serious illness such as a heart attack or stroke, they see themselves as directly responsible. To the question: “Which topic areas in the area of drug supply are of particular interest?”, 56 %: Findings from pharmaceutical research, 57 %: Use of common drugs, 72 %: Effects of drugs, 73 %: Side effects of drugs, 75 answered %: Dangers of drug combination and 75 %: Alternative treatment options (Harms/Gänshirt/Mahl 2007).

Experience with pharmaceutical information campaigns
in Europe

It is known that up to 50 % of Europeans would welcome targeted medical information on selected indications from the pharmaceutical industry. On the other hand, however, there are also clear reservations about industry-based information campaigns, because 76 % of the population fear that the industry will focus primarily on the effects of its preparations and hide the side effects.
This attitude is also reflected in European legislation. In March 1992, the “Council of the European Communities” clearly banned the advertising of prescription drugs (product awareness) with its Directive 92/28/EEC. The industry is only allowed to distribute selected information when it comes to indication-based information concepts (disease awareness), in which the focus is not on the problem-solving competence of the product, but rather on the effect and side effect profile of the disease (WHO 1985, European Commission 2008).
Chronically ill people in particular express their disapproval when information about clinically relevant diagnostic and therapeutic innovations is withheld from them. It turns out that as the severity of the disease increases, both the need for patient information and the willingness to cooperate with the pharmaceutical industry increase (Goldmann-Posch 2005, Harms/Gänshirt/Rumler 2008).
Even if the national and international restrictions only provide limited empirical values about the attitude of the European population to these campaigns, the available data clearly shows that an appropriate implementation of these concepts is desired if the following five points are observed:
1. The information message addressed to the patient must present both the effect and the side effect of a medicinal product in a balanced manner.
2. Corresponding risks should be specifically mentioned and possible contraindications should be pointed out in a way that is adapted to the patient.
3. Regardless of the provision of information, companies are obliged to provide their contacts with the opportunity to generate further information (website, free information hotline, etc.).
4. Cooperation with opinion-forming medical institutions is recommended.
5. A control body should assess the quality of the concepts and intervene if the points mentioned are not observed.

It is important that these five points are mentioned regularly, regardless of whether the respondent generally expresses a positive or negative attitude towards pharmaceutical information campaigns (Harms/Gänshirt/Rumler 2008).
Of particular interest is that apparently more Europeans would respond to the doctor about a particular drug than Americans currently do. Almost 60 % of the population would like to discuss a corresponding message. However, European patients do not only seem to be more active when addressing doctors directly. They are also more 'empowered' when it comes to demanding a specific drug. While in the USA not even 30 % of patients respond to the doctor about a specific prescription, in Europe more than 40 % of patients with a corresponding illness seek a conversation with their doctor or pharmacist with precise ideas (CRS 2005, Lonsert/Schäfer/Harms 2005, Harms/Gänshirt 2006).

Direct from Patient Information Study (DfPI) 2006

Just like in the USA, we in Europe know little about the information needs of chronically ill people. Therefore, the Health Care Competence Center (HC3) in Zurich, in collaboration with the European Health Care Foundation (EUHCF), decided to launch the world's largest direct-from-patient information study (DfPI) to date. Within this study concept, 3,000 chronically ill patients were included in a corresponding survey, divided into 6 indications (diabetes type I, diabetes type II, cardiovascular, gastrointestinal, osteoporosis, rheumatism).
In addition to a large number of health and socio-politically relevant issues, the focus of attention was, among other things, on the attitude of chronically ill people with regard to industry-based information campaigns. This independent scientific study was about how the healthcare industry's concepts should be designed from the patient's perspective. To optimize the study, 150 insulin-dependent type II diabetes patients were interviewed in detail beforehand. These results already provided fundamental insights into the needs structures of these patients. Of those surveyed, 83 told % that they would like to be regularly informed about new forms of diabetes treatment. What is interesting is that the patients not only read this information and file it away, but 80 of the respondents would also speak to their doctor about this information. This approach goes so far that 79 % of patients would ask for a prescription if they had the feeling that the corresponding medication was a relevant option (Harms/Gänshirt/Mahl 2007).
These results were confirmed by further indications within the study. Of the 525 patients with cardiovascular problems, 83 told % that they were very interested in information about the effects and side effects of the medications they should consume daily. When asked how this information would affect dealing with the relevant illness, 70 % of those surveyed said that medical information means active life support for them. Patients said that the more data they had about their illness, the better they could manage their suffering. When asked: “Would you say that what you know about your illness has an impact on the conversation you have with your doctor?”, 84 % patients answered: “The more information I have about my illness, the more I benefit me from my doctor-patient conversation.” Information about innovative medicines is of particular interest. How important these data are for the patients is clearly demonstrated by the following question. To the question: “Assuming you learn that a new drug exists to treat your disease, would you talk to your doctor about it?”, 95 % answered “Yes” (Harms/Gänshirt/Mahl 2007).

Cope 1+2: Communication between
Patients and the Health Care Industry

European policymakers are increasingly aware that existing restrictions may hinder patients' growing need for information about current and new treatment methods. As early as the end of 2004, initiatives were therefore launched that made it necessary to amend the existing legislation. The Pharmaceutical Forum, founded in 2003 (the respective Commissioners for Industry and Health are chairmen, members are the 25 health ministers of the member states, 3 members of the European Parliament and 10 representatives of industry interest groups) is therefore striving to create a corresponding European framework legislation in the course of this legislative period (European Commission 2008, Harms/Gänshirt/Rumler 2008).
Given the impending changes, the European Health Care Foundation (EUHCF) initiated a series of European studies to evaluate patients' attitudes and needs towards health information. The studies form a scientific basis for the development and implementation of new communication concepts - tailored to the needs of chronically ill people in Europe.
The first two phases of the studies - carried out in Germany and Switzerland - have been completed and evaluated. The first phase, the COPE-1 study, determined the information needs of chronically ill people and their attitudes to information from various interest groups such as doctors, pharmacists, insurance companies, politics and - especially the pharmaceutical industry. In addition, it was examined whether patients in Germany would like to have the same access to information about prescription drugs as doctors and pharmacists and what requirements patients would like to see met for the implementation of Direct to Patient Information (DfPI) in Europe.
In a second approach, the COPE-2 study, patients' experiences with health information from the media were collected. Ringier Verlag, the largest Swiss media company, served as a model for this. A few years ago, Ringier founded a specialized health unit that was one of the first topic-related platforms in which various media are directly linked to one another. Ringier's strategy is to publish targeted information on a chronic indication within a certain time interval using various media (television, health weeks, the Internet, special medical issues, patient conferences and even health cruises).
Within this system it was tested whether the patients accept such an information network and whether the information they receive there can lead to sustainable improvements in health behavior.
The primary goal of both studies was the evaluation of the following parameters:
– the wishes and needs of chronically ill patients in relation to health information,
– patient attitudes towards health information,
– the influence of health information on health behavior.
The secondary objective of both studies was the evaluation of the following parameter:
– the development of a basis for the development and implementation of a communication concept for chronically ill patients.

986 patients in Germany and Switzerland who suffered from diabetes, cardiovascular diseases, cancer, chronic pain and rheumatism were surveyed. When it comes to both aspects of trust and experienced support, patients have the strongest ties to their doctors. The trust placed in them and the support they receive is extremely high. The specialized doctors who received almost 100 percent approval from their patients performed particularly well here. The other service providers were rated significantly worse by patients. Only half of the participants expressed their confidence in the pharmacists. Pharmaceutical companies and politics bring up the rear when it comes to trust and support: only 11 % of patients rated the drug manufacturers and 2 % rated politics as trustworthy.
What is it that creates patient trust in a drug manufacturer? Obviously it's not the advertising. Patients in Europe are familiar with advertising for OTC preparations. Although they welcome the opportunity to learn about new medications, this advertising undoubtedly does not lead to greater trust in the manufacturer. Rather, patients are more likely to be unsure about the benefits of advertised medications and tend to leave these decisions to their doctor or pharmacist. So, what plays the crucial role when it comes to trust in a drug manufacturer? The answer ist quite easy. It is the medication itself (Harms/Gänshirt/Rumler 2008).
Almost 80 % patients said that a good experience with a medication increases their trust in the manufacturer. More than 80 % of German and 50 % of Swiss patients said that they needed additional support to manage their illness. Helping patients self-manage their illness means providing them with information that is empathetic and addresses their real everyday problems. We know from our previous research that patients' treatment compliance and lifestyle are directly influenced by the information they receive and understand. These findings were confirmed in the present study. In Switzerland, 167 patients with rheumatism or chronic pain stated that they had changed their health behavior because of information. For 75 % of these patients, this was a long-term change in their habits that they had maintained up to the day of the survey. This shows that patients - at least for indications with a high level of suffering - can permanently change their health behavior based on information alone if they are informed in the right way.
Besides the doctor, the chronically ill patient is the person who has the greatest influence on the success of the treatment. Some of the patients have already recognized this and as a result around 90 % patients want to have as much influence on therapeutic decisions as their doctor.
Patient empowerment is theoretically accepted and desired by most patients - although it is often not yet really implemented in practice in the doctor-patient relationship. Physicians are therefore called upon to meet their patients on an equal footing. You must recognize that a hierarchical doctor-patient relationship stands in the way of successful therapy because such a relationship in no way supports the self-management behavior of the chronically ill patient. For 91 % of the chronic patients it is important (31 %) or even very important (60 %) to have just as much information e.g. B. about your prescription preparations like your doctor or pharmacist. Almost 100 % of patients say that the information they receive about this should be accurate, balanced, understandable and helpful; this information should also be checked by an independent organization. The patients' point of view is therefore a clear mandate for politicians to carefully implement communication about prescription drugs between patients and drug manufacturers (Fig. 2/3).

Patient information: improvement of
Personal responsibility and compliance

How information provision about prescription drugs could also be implemented in Europe was discussed at the European Life Science Circle on September 12, 2006 in Brussels in collaboration with representatives of the European Parliament, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Cancer Patient Coalition and the European Health Care Foundation (EUHCF).
In particular, representatives of various European patient organizations demanded that patients have a right to know what happens to the 45 to 50 billion US dollars that industry invests in the development of new medicines every year. It was pointed out that there is both a scientific and an economic imperative to involve the chronically ill in the development of innovative medicines. Thus, their empirical values could make a medically and economically meaningful contribution to therapy optimization (Harms/Gänshirt 2007).
What is interesting is that a not insignificant proportion of patients were of the opinion that - regardless of the high need for relevant information on innovative aspects of drug therapy - improved information transfer increases patients' personal responsibility and thus improves compliance, which in the long term conserves the limited resources of the European healthcare systems.
In the discussions that followed, the view was expressed several times that patients can only do what doctors, pharmacists and, increasingly, health policy require of them if they know what to do. Thus, the improved information transfer on innovative medicines could have a positive impact on the development of the healthcare system, because the most expensive medicine is the medicine that is not taken or not taken correctly. After all, the estimated follow-up costs of drug non-compliance in EU countries amount to around 70 billion euros per year (Harms/Gänshirt/Mahl 2007, Harms/Gänshirt/Rumler 2008).
Regardless of the positive or negative attitude towards pharmaceutical information campaigns, pure pharmaceutical advertising (DtC), which only serves to sell medicines, has been categorically rejected. So there will be no American conditions in Europe. It was demanded that pharmaceutical information concepts should not only serve to generate returns for the industry. Political representatives in particular expressed that innovative medicines will only establish themselves as the standard if they not only increase expenditure, but also help to solve medical and socio-political problems by having comprehensible advantages for the patient or for the social system. According to various experts, it would be possible that relevant information - or the avoidance of banal advertising - would improve the general level of information among chronically ill people, increase compliance with taking medication and lead to savings in all areas of medical care.
In other words, direct information about prescription drugs could likely promote transparency in drug therapy. This strengthens the patient's maturity and at the same time reduces over- or under-care, which in turn would improve the efficiency of our health system on the basis of competitive health care (Harms/Gänshirt/Mahl 2007, Harms/Gänshirt/Rumler 2008). <<