Patient Perceptions of IMPs: An International Perspective was featured in the May/June 2016 issue of Pharmaceutical Engineering® magazine.

This three-part paper focuses on the final results from the EU and China Patient Perceptions of Investigational Medicinal Products surveys and compares some of these results with the original “ISPE Project Concerning Patient Experience with Clinical Trial Materials” published in 2013.  Part two focuses on the results from the surveys.

Contributions and opinions are based on the individuals’ knowledge and expertise; this presentation should not be construed as a statement or opinion by Catalent Pharma Solutions, or any other member of the task team.

Results

Overall ease of use

The vast majority of patients in both studies found their medication easy to use: 85% in the EU study, and 88% in the China arm, which is consistent with the 77% reported in the original US study (Figure 1). This is no reason for complacency, however, as some later results will show.

Patient Perceptions of IMP Surveys Table A - Overall Ease of Use - Pharmaceutical Engineering Magazine

Kit design supported taking medicine on schedule

In the EU survey, 32% found kit design important—almost the same number that found it unimportant. The Chinese population also split evenly: 46% said the design was helpful, and 46% said it wasn’t (Figure 2). This unequivocal result in both EU and China was different from the original US study, where 60% said that the kit design helped them take the medication on schedule.

Patient Perception of IMPs Survey - Figure 2 Kit Design - Pharmeceutical Engineering Magazine

What would help the patient take the medicine on schedule?

To delve deeper into this issue, the patients were asked “What would help you take the medication on schedule?” 81% of EU patients stated clear dosing information on the label (58% US) as useful, followed by 66% who chose the provision of individual dosing units in the medicine container, and 64% who said that verbal instructions from site personnel were useful.

In China, 77% cited “instructions from my physician/nurse/pharmacist at every visit” as helpful, followed by 57% who chose medicine kits organized in daily or weekly doses, and 55% who chose dosing information on the label.

Most helpful form of instruction

Despite a stated preference for dosing information on kit labels in the EU study, 73% of patients said that being able to question the medical staff was most helpful in understanding dosage, storage, and other adherence criteria. Results from the China study were even stronger: 78% cited “Someone telling or showing you how to take/use/store the clinical trial medicine” as helpful (Figure 3). In the original US study, 77% of patients said that having someone tell or show how to use, take, and store the clinical trial medicine was very helpful; 76% said that having the opportunity to ask questions on how to take, use, and store the medicine was very helpful.

Patient Perceptions of IMPs Survey - Figure 3 Most Helpful Form of Instructions - Pharmaceutical Engineering Magazine

Medicine form preference

The EU study population showed a strong preference for blister packs (51%). In China, a very small plurality (33%) favored bottles, followed by 27% that preferred blister packs. Overall, these results demonstrated regional differences between the EU, China, and the United States in the preferred presentation for oral medication. This preference for bottles in China was not as strong as in the original US study: 43% bottles vs. 17% for blisters (Figure 4).

Patient Perceptions of IMPs Survey - Figure 4 Medicine Form Preference - Pharmaceutical Engineering Magazine

Size, storage, and transportation

In the EU survey, 83% of patients said their IMP kit was very easy or OK to store; 90% of patients in the China study said their medicine was easy to store. These results are similar to the original US study, where 82% of patients said their medicine kits were easy or somewhat easy to store. At the outset this was a feature that the survey team was certain would be a concern to patients; the overall consistency and level of patient satisfaction is reassuring.

When asked if the medicine kit size was easy to transport, the answers were similar: 72% of EU patients found the kit was just the right size, compared to 73% from patients in China, and 77% from US patients.

Medicine kept in original container

A concern to the industry as a whole is that patients may remove their medication from the clinical trial kit provided, thus risking incorrect dosing. However, patients in all studies reported similarly encouraging responses: 86% of EU patients and 84% of China patients kept their medicines in the original bottles. This corresponds well with the 86% of US patients who did similarly (Figure 5).

Patient Perceptions of IMPs Survey - Figure 5 Medicine Kept in Original Containers - Pharmaceutical Engineering Magazine

Most important IMP characteristics

Patients overwhelmingly rated clear instructions and ease of use as the most important characteristics of their IMP kits: 89% and 85%, respectively, in the original US study, and 67% and 62%, respectively, in the China survey (Figure 6). In the US survey, 69% of patients rated clear instructions as most important; 64% cited ease of use.

Patient Perceptions of IMPs Survey - Figure 6 Most Important IMP Characteristics - Pharmaceutical Engineering Magazine

Return and reuse behaviors

The results from the EU and China were consistent with the results in the original US study, which found that a high percentage of patients did not return unused medication to the clinical sites, with ±20% of patients in all studies at least sometimes keeping the medication for future use, a result that the industry needs to mitigate against globally (Figure 7). The high “on request” results for the China study may reflect the patient’s interpretation of the question and represent those patients that returned supplies as they were “requested” to do so by the clinical site.

Patient Perceptions of IMPs Survey - Figure 7 Return and Reuse Behaviors - Pharmaceutical Engineering Magazine

Home delivery

As patients often have to travel long distances to participate in studies, in order to optimize patient recruitment and retention, there is a growing interest by some sponsors to undertake clinical trials where the IMP is sent to patients’ homes. The survey team wanted to gauge patients’ future preferences for this. Over 70% of patients in both the EU and China reported that having IMPs delivered directly to their homes would be helpful; these results were very similar to those reported in the original US study (Figure 8).

Patient Perceptions of IMPs Survey - Figure 8 Home Delivery of IMPs - Pharmaceutical Engineering Magazine

One interesting finding was that in the EU and China this preference was not significant in any single age group, whilst in the original US survey this preference was much stronger in the younger demographic. This may be a result of increased industry focus in implementing this method of delivery in the two years between the studies.4

Booklet labels

In the EU survey, patients were asked if their IMP kit had a booklet label. Less than a third—23 patients out of 80 who responded to this question (29%)—said yes, there was a label; 45% said no. Of those who saw the label, 20 (45 %) opened and read the booklet label on at least one container. Most EU patients (54%) who read the booklet label found it easy or somewhat easy to view their language, and 71% said that the text was large enough to read.

In the China study, 50% of respondents did not see a booklet label on their IMP kit; 41% did. Of those who saw the booklet label, 83% opened and read it on at least one container. Of the Chinese patients who read the booklet label, 75% found it easy or somewhat easy to view their language, a larger proportion than in the EU study (Figure 9).

Patient Perceptions of IMPs Survey - Figure 9 Easy to Find Language - Pharmaceutical Engineering Magazine

Other sources of information

EU patients may have received dosing information on their medicine kit from a source other than the booklet label; the largest alternative source was the receipt of verbal instructions (21%; N= 109).

When patients in the China study were asked if they received instructions from a source other than the booklet label, 45% said they had, 55% said they hadn’t. Of those patients who received information from a source other than the booklet label, 59% received instructions on a patient card or leaflet (Figure 10).

Patient Perceptions of IMPs Survey - Figure 10 Other Sources of Information - Pharmaceutical Engineering Magazine

In the original 2013 US study, 34% of respondents reported seeing a booklet label on their IMP kit; 42% did not see a booklet label.

Pictograms

Since pictograms can be used in place of text that would otherwise have to be translated, the survey team wanted to gauge patients’ understanding of certain pictograms. Patients were asked to identify each picture in the pictograms below (Figure 11) from a range of provided options.

Patient Perceptions of IMPs Survey - Figure 11 PIctograms - Pharamceutical Engineering Magazine

The correct answers were:

  1. Store between 2°C and 8°C
  2. Do not freeze
  3. Protect from moisture
  4. Protect from light

In the EU study, although 75% had not seen pictograms on their kits; for the examples provided, however, 96% (N = 62) identified them correctly.

Patients commented that pictograms to depict storage would be the most useful; 51% of EU patients found text alone helpful, 41% found text and pictogram together helpful, with only 8% preferring pictograms alone. This unequivocal response may reflect current unfamiliarity with pictograms, and could change as the symbols are standardized and adopted more widely. In the China study, > 82% of respondents found the pictograms at least somewhat helpful.

Future information preferences

The survey team wanted to gauge patients’ preferences for the way they would like to receive information in the future. The results demonstrated that there are geographical preferences in the way that patients wish to receive information on their medication, clinical trial, or future visits. Patients in all regions indicated a strong preference for text (Table B). It is interesting to note, however, that email was the most preferred method in the EU and US, but least preferred in China, potentially because email is not significantly used as a daily or instant electronic communication tool in China.

Patient Perceptions of IMPs Survey - Table 8 Future Information Preferences - Pharmaceutical Engineering Magazine

By: Esther Sadler-Williams, Lynn Wang, Samantha Carmichael, and Paula McSkimming

Catch up on part one of the series Patient Perceptions of IMPs: An International Perspective Part 1.

Receive part three of this three-part series delivered straight to your inbox by subscribing to ISPEAK.  Part three of the Patient Perceptions of IMPs: An International Perspective will be published on  11 July 2016 and focus on the conclusions and next steps.

References
4. Eli, Massimo, Catherine Hall, Marianne Oth, Adrian Peskett, and Esther Sadler-Williams. “Establishing and Managing Processes Enabling Delivery and Returns of Investigational Medicinal Products (IMPs) to Patients’ Homes.” Pharmaceutical Engineering 34, no. 6 (November/December 2014).

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