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 three will focus on the conclusions and next steps.

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.

Discussion

All of the studies—the original US study as well as the EU and China surveys—suggests an overall high level of satisfaction with IMP presentation. While current IMP kit packaging and labeling conveys a significant amount of information, however, there is no clear message that current designs improve compliance.

In the EU and China studies, as many patients said that the design of the kit did not help with taking their medicine on schedule as those that said it did. This was a stronger message than in the original US study, where < 60% of patients said the design was helpful. It also suggests there is room to improve the design of the kits to improve compliance and adherence. Patient feedback to questions about what would help indicate that more attention needs to be paid to providing individual dosing units within kits where possible, as well as clear and unambiguous label information.

The EU and China studies also confirmed a key finding from the original US study: Personal explanations from clinical research staff are instrumental in ensuring that patients have a positive experience, understand the study protocols, and grasp both the importance of compliance and how to achieve it. This was particularly true for patients in the China study. In view of the importance to the patient, as an industry we may need to consider controlling the way verbal information is provided to patients by the clinical site to ensure that it is provided in a consistent manner across sites and geographies.

The IP team initially expected that patients would complain most about the size, weight, and ease of transporting the kits, but they did not. Transportation and storage of the medicine to their home was not reported as an issue; in both the EU and China surveys over 70% of patients reported that their kit was the right size and over 80% found it easy or fairly easy to store at home, results that were consistent with the US findings. Kit size and weight, in fact, were deemed less important than clear label dosing information and instruction from clinical site personnel.

This general satisfaction with kit size and weight may explain why patients generally did not remove drug from the medicine container. In addition, the fact that size and weight did not feature as one of the most important criteria in “kit characteristics” could be because this is a “given” to the patients that were surveyed in that they believe that the size and weight will be the smallest possible.

These studies indicated that US and Chinese patients favor bottles, whilst patients in the EU prefer a blister format if possible—although in the EU and China there were still a similar number of patients who did not have a preference for either.

These studies were also intended to help evaluate booklet labels, an area of intense focus in clinical trial design. Researchers in the studies wanted to see if the booklet label is an effective way to communicate medical information to patients. This is an important issue for regulators, who are concerned that patients do not read booklet labels; a perception expressed by some is that medicine kits are often returned with unopened booklets.

Although the cohort of respondents who remembered receiving booklet labels was small, 55% of patients in the EU and 17% of patients in China never opened their booklet labels. Although this showed a geographic difference, results from both regions indicated that patients frequently prefer and rely on verbal information from the clinical site rather than booklet labels. On a positive note, however, patients who did read their booklet labels found it easy to find their language and read the information; most EU patients found that the text size was large enough to read.

Pictograms may be another emerging vehicle for communication, especially about storage information. In these studies, nearly all the EU patients were able to identify them correctly, and a majority of China respondents found them at least somewhat helpful. This corresponds to the original US 2013 survey, in which most patients found the same pictograms helpful.

Finally, as in the original US study, these studies confirmed that nearly 20% of patients retain medicines for future use. This remains a concerning statistic in terms of potential patient safety issues; it will be important for the clinical supply community to consider strategies to mitigate against this by defining robust processes to ensure that all unused medications are returned to the clinical site.

In summary, whilst many survey responses were consistent in all of the studies, some regional characteristics were apparent: e.g., medicine form preferences, packaging and reminder methodology preferences.

Conclusions

  • Overall patient experience with medicine kits is very positive; patients report strong compliance and a high level of satisfaction with packaging and instructions.
    • Most (> 85%) of patients found IMPs easy to use; > 76% took their medicines on schedule as planned; > 72% said that kit size and weight made the medicine easy to store and transport.
    • EU and China studies show less convincing data than the US study that kit design helped patients take medication on schedule.
    • In all studies, IMP kit size and weight were considered less important than clear instructions.
  • Site personnel play a key role in conveying dosage information, explaining medication regimens, and ensuring that patients have positive experience and that they comply
  • In the China study, 75% of patients who opened their booklet labels found it easy to find their language; in the EU study, the figure was 54%.
    • Patients rely more on verbal information from clinical site personnel than on information contained in the booklet label, however.
  • Technology is not frequently used to support visit and medicine reminders at present, but patients would welcome it. While regional differences among responses were apparent, text reminders were universally liked.
  • EU, China, and US studies all found that ±18% of patients keep IMPs for future use; the industry should mitigate against this globally by improving clinical trial medicine return process.
  • Medicine kit design and labeling could play an even stronger role in assisting compliance through the provision of clear:
    • Dosing information
    • Product handling information (e.g., pictograms for storage)
  • As in the original US study, most patients in both the EU and China studies said that a home-delivery option for IMPs would be helpful, although unlike the original US study, there was no significant difference between age groups.

Next steps

The EU task team has concluded that it is unlikely that further valuable differentiating information will be obtained from more EU countries by translating the survey. The team are exploring a consolidated analysis of US/EU/China data, however.

The teams are also supporting Japan to increase the level of patient feedback from this important region; assuming it is successful, it is hoped that the Japanese data could be included in the final consolidated analysis.

Within ISPE, a task team is exploring the usefulness of pictograms for IMPs. This task team is due to provide its initial recommendations and suggestions for future study in the near future; suggestions that may include initiating dialogue with regulatory agencies on this important topic.

Finally, the IP CoP is now considering how to create a form of global guidance for sponsors and clinical sites, guidance that will be critical to supporting a patient-centric supply chain of the future.

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

Catch up on part one and two of this series:

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