The mean age of participating patients was 64.5 years with the majority aged 50 or above; their age ranged from 38 to 79 years. While most participants were of German origin, three had a migrant background (Turkish, Belgian). Most participants were diagnosed with at least two of the diseases that rendered them suitable for inclusion in the study. The mean number of regular daily tablets to be taken was 6.5 (range: 1 to 21). The average duration of the focus group discussion was 123 minutes with a range of 96 to 150 minutes. During the focus groups participants engaged well with the topic. From the wealth of material that our focus group discussions have generated the following results will focus on a specifically selected subset of data pertinent to patients’ emotional reactions and their subsequent behavior caused by PILs. Three categories will be presented: (i) The vast amount of side effects and drug interactions described in PILs provoke various emotional reactions in patients which (ii) lead to specific patient behaviors of which (iii) consulting the GP for assistance is among the most common.
Emotional reactions caused by PILs
Possible side effects and drug interactions were among the most prominent issues discussed across all focus groups. Several discussions revolved around the general question of whether side effects should be included in PILs. The vast majority of participants, however, considered such information important enough to be included. Some participants spoke in favor of including only what they called ‘most severe’, ‘relevant’ or ‘important’ side effects without being able to specify these attributes further. The majority of participants agreed with the terminology for frequency of occurrence of side effects suggested by the European Commission Pharmaceuticals Committee and wanted only ‘very common’ and ‘common’ side effects to be included. ‘Uncommon’, ‘rare’ and ‘very rare’ side effects were deemed expendable as they had the potential of upsetting the reader unnecessarily as the following quote demonstrates.
"Very common" and perhaps even "common"; more than 1 in 10 users is very common, well, this [side effect] is going to occur more frequently. Ok, "common" perhaps as well; this is 1 in 100 users but as far as I’m concerned "uncommon" side effects no longer need to be included. And "rare" and "very rare" is merely upsetting (3/165).
The most frequently reported emotional response triggered by the overall appearance of PILs was "fear". For many participants the appearance of PILs was decisive of whether they were being read. Almost all participants perceived their current PILs as frightening. Patients stressed the importance of designing PILs in a way that they felt encouraged to read them. Especially the side effects described in current PILs frightened participants and caused them a great deal of uncertainty about whether they would be affected by them. Participants used the notion of "being shocked" to describe their feelings triggered by the vast amount of information contained in PILs and the severity of potential side effects. In addition, the use of a much too small and difficult to read font size had a rejecting effect. Some participants felt literally ill when reading the PIL as the following quotes illustrate:
If I see all the side effects of the drug I am already ill (5/346).
Generally, you shouldn’t read the side effects otherwise you might think you are already dead (4/33).
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.
Within this key category the two most frequently mentioned response behaviors were: ‘seeking support’ and ‘stopping the medication’. With regard to the former, participants contacted their GPs, pharmacists, family members or friends. This was particularly true for those with a migration background whose command of the German language was perceived as being insufficient. Participants said they were thankful for a knowledgeable person who could explain the content of the PIL in plain language. Accessing additional information from alternative sources such as consulting a medical dictionary or the internet was a frequently employed strategy for clarification. Some participants reached the decision of whether or how to take the medication based on such sources.
Another frequently reported response behavior was taking a break from the prescribed medication. In five out of six focus groups participants reported on discontinuing their medication after reading PILs. The often lengthy and incomprehensible description of possible side effects was a major reason for this decision. In all but one focus group it was mentioned that the huge amount of potential side effects would outweigh the benefits of the medication and therefore patients did not take their drugs or reduced the dosage without consulting their GPs. The following quotes get to the point of this:
If you read the entire thing [PIL], you would not want to take the tablets anyway (1/147).
My wife says: "I’m getting anxious [when reading the PIL], I don’t take the tablets." And I say to her: "Just throw the patient information leaflet away and take the tablets" (2/317).
Yet another commonly reported response was contacting the GP or less often the pharmacist. Both professional groups were considered to be in a position to provide advice regarding the prescribed drug. Although participants expressed a strong desire to receive customized information from their GP, they did not necessarily consult them at times because they thought that their GP was too busy. Instead pharmacists would be sought out for assistance. However, it was attested that GPs were the ones who had an overview of all the medications a patient was taking. Even if PILs were well written and easy to comprehend they could never substitute for a GP’s individual judgment; PILs were generally seen as less helpful than face-to-face advice.
The patient-physician relationship
Since PILs were not considered as being able to take the place of a GP’s individual judgment, participants had much confidence in their GPs and believed that they were best positioned to know what was good for them. Thus, participants were convinced that tailored information regarding the medication and its undesirable side effects was best provided by their GPs. Some participants wished that GPs would explain in plain language the medical terminology used in PILs as the quote below highlights. Participants also felt it is vital to have a follow-up appointment when a new medication was prescribed to see if it had the desired effect. Consulting the GP became even more important if side effects occurred; a situation in which a leaflet is regarded as not being useful.
All these medical terms which patients don’t understand anyway. Each time [I read the PIL] I need a GP as mediator who explains everything to me (6/298).
Despite the above, participants mentioned that GPs would sometimes prescribe medication without providing any instructions on how to take the medication. Yet GPs were considered as crucial mediators between the information contained in PILs and their patients. Some participants mentioned that after the prescription of a new drug they were more likely to adhere to it but more reluctant to read the PIL. For participants with a migration background insufficient knowledge of the German language prevented them from reading PILs. Instead, they relied heavily on their GPs to make sense of the information irrespective of the quality of the PIL.
Participants were well aware that some medications should not be combined with others or that the efficacy of a drug could be altered when given in combination with others. Participants trusted their GPs in communicating this relevant information to them. Yet they also criticized that their GPs did not have the time for it or forgot to discuss possible drug interactions. Because of this, participants thought that drug interactions should be included in PILs to provide users with the opportunity to look them up for themselves in order to make informed decisions regarding their prescribed medication.