(Source: Pharmafile 2015-05-18）
Recent legislation assumes that visual information can have direct effects on people’s behaviour. It starts from the assumption that a symbol could improve the reporting of side effects, and that a logo has an influence on the online buying of unreliable medicines.
Legal requirements also suggest that patients could and should verify authentic packaging, recognise tampering, and identify individual packs. However, I think that it is unlikely that a modification in visual presentation has much influence on people’s actions.
The fundamental problem with the legislation is that it prescribes standardised solutions. It does not describe what needs to be achieved, it does not use adequate criteria, it does not indicate an appropriate process, and it does not specify relevant performance levels.
If we really want to ‘enable people to act appropriately’, then it is necessary to pay attention to these four elements of effective communication.
Recent legal requirements influence visual information about medicines
The Falsified Medicines Directive (FMD)and the pharmacovigilance regulation will influence some of the information that pharma provides about medicines. In both the directive and the regulation, several forms of visual communication are mentioned.
The FMD introduces a range of measures to strengthen the legal supply chains and protect them from falsified medicines, and demands three safety features: verification of authenticity, identification of individual packs, and providing evidence of tampering.
The ‘verification of authenticity’ and ‘evidence of tampering’ will be seen by patients. Some identification features might be visible, others are probably not. The directive also asks for a ‘common logo’, an “awareness campaign to warn of the risks of purchasing medicinal products from illegal sources via the internet”, and ‘information campaigns’ about the dangers of falsified medicinal products.
Separately, but also related, the pharmacovigilance regulation asks for a ‘symbol’ and suggests a ‘black triangle’ that will be explained in the package leaflet. There will be ‘standard web-based structured forms’ and a “web-portal for the dissemination of information on medicinal products”.
As a graphic designer, I’m pleasantly surprised that the European Parliament and the Commission take visual communication seriously enough to include it directly into legislation. In the next years, patients are likely to notice changes in packaging, new logos on websites, forms on websites, digital medicine portals, and different campaigns. All of these artefacts need to be designed and developed. Where are we now?
The visual artefacts are in different stages of development at the moment. The three safety features are being developed, discussed, produced, and tested. A ‘common logo’ has been developed so far. There has been a public consultation and the results of this consultation have been published.
This logo will fully be available in the second half of 2015.
The ‘symbol’ has been agreed upon: the black triangle, which pharma companies will already be familiar with. The aim of this triangle is that “patients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring” and “to allow them to share with the competent authorities and the marketing authorisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions”.
The databases and systems for reporting adverse effects are available. There is, for example the European database of suspected adverse drug reaction reports, or the EudraVigilance system.
But I’m not sure how far the pharma industry is with creating the information and awareness campaigns they will need to communicate the changes enforced in the directive.
The timing of these campaigns needs to be considered in relation to the introduction of the safety features on the packaging.
Are the expected outcomes and criteria related to the chosen media?
I’m a bit worried about the sustained – but unsupported – confidence that the European Parliament and Commission have in the effects of visual information. The criteria that are mentioned indicate that there may be a substantial discrepancy between the expectations and the actual results.
Three examples are:
• A common logo must be ‘recognisable across the Union’. However, there are very few logos at the moment that are truly recognisable across the European Union, and it needs to be questioned if this is possible at all.
• An abstract symbol ‘can identify’ or will ‘easily identify’ a medicine that is subject to additional monitoring. It is expected that this “allows people to share any information they have from the use of the medicinal product and in particular to report suspected adverse reactions”. But there is little relation between the shape of the symbol and its meaning. This is likely to make both the identification as well as the sharing of information difficult.
• Raising public awareness in an ‘awareness campaign’ can effectively warn of the risks of purchasing medicines via the internet.
In the legislative texts, there are several descriptions of “people who need to look at visual information”. The directive refers to people as the ‘public’, or ‘general public’. Furthermore, it mentions ‘consumer awareness’, ‘patients’, and ‘healthcare professionals’, yet the differences between these groups are not made clear.
For example, the difference between ‘patient’ and ‘consumer’ is important, because their meanings change according to the situation. A person who uses ‘prescription only medicines’ is a patient, but if this person buys these medicines in a digital store, he or she becomes a consumer.
The combination of criteria that are not directly related to the visual presentation, in combination with the vague descriptors of people who need to undertake actions, reduces the practical value of this legislation.
It is now implied that ‘all patients’ (regardless of their intentions, background knowledge, and practical needs) need to be able to ‘recognise a digital logo’, regardless of its context. All patients must be able to report all side effects, regardless of the type of medicine or the severity of the reaction. And the awareness campaigns are not directed at anyone in particular.
The actual consequences and effects of the legislation are therefore very hard to determine. It is not clear what is expected from whom, because the criteria and specific groups of people are poorly related to each other. This makes it very hard to implement and even harder to control.
Focus group feedback
The only way to find out if pharma’s expectations are relevant to patients is to ask real patients what their opinions are, observe their actions, and ask for reactions. From the feedback from patients, it seems there are two problems with the current legislative approach.
The choice of a standardised symbol (the black triangle) makes it impossible to develop alternatives that could be more effective. A common logo might work for a while, but it requires substantial efforts to enforce it online. The use of a standardised and legally-obligatory symbol blocks the development of schemes that might be more effective.
Also, none of the visual solutions that are mentioned in the legislation could achieve the intended performance, because they ignore the current practical context and the actual problems.
An additional approach: user-centred and performance-based
In order to really ‘enable people to act appropriately’, we need to design situations in which people are able to make suitable decisions. It needs to be clear who does what in the whole process from manufacturing medicines to taking and using them.
The following tasks should be considered:
• Patients must be able to check if a medicine is authentic, and bring it back to a pharmacy if it is not. So the question for pharma is, how likely is it that patients can do this?
• Patients must be able to identify the code on an individual pack, and communicate this number to others. Pharma has to decide if this is really a task for patients.
• Patients must be able to recognise tampered packs, and report this. But how often does this happen in practice, and what would be an acceptable level of returned medicines?
• Patients must know the risks of buying medicines online. Is this achievable for everyone and all medicines? If not, who is most vulnerable, and what are the most risky situations?
• Patients must be protected against the purchase of questionable medicines. What are the factors that influence the highest risks?
• Patients must be motivated to report side effects. What is the real problem the industry wants to address here? Is it that there are not enough reported side effects? Is there a lack of motivation? Are some side effects reported more often than others? So what’s my advice to the industry?
Pharma companies should consider a combination of increasing knowledge, improving design features visually and tangibly, improving their processes, and developing reliable systems based on new relations between stakeholders.
This depends on different situations in different regions (and will affect things like cultural practices, the prevalence of different illnesses, the availability of shops and pharmacies, and access to the internet), problems and risks.
It will also affect the approach used to promote the changes enforced under the directive, such as awareness campaigns, packaging redesigns and promotional websites.
Such an integrated approach – in which all possible means are applied to achieve required performance levels – seems an option that needs to be considered. Unfortunately, the current regulatory framework makes this impossible.
In Europe, in the next years, patients will have to learn what an abstract standardised symbol means, click on a ‘recognisable logo’ to check the reliability of a digital retailer, and relearn how to look at packaging.
All these require additional efforts that are not really essential to patients for their normal activities.
It is therefore very unlikely that these ‘solutions’ will have the intended effects, and if there are, they are likely to be a lot more minor than is potentially possible.
Standardising ‘solutions’ that are not optimally effective should be avoided because they really prevent the progress that pharma wants to make.
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