Introduction:
Organ transplantation is a life-saving procedure, but it also marks the beginning of a
lifelong journey for patients. In 2023 alone, over 3,600 organ transplants were performed
in Germany, with kidney, liver, heart, and lung transplants being the most common.
Following a transplant, patients must take a combination of immunosuppressive medications
to prevent their body from rejecting the new organ. These drugs, while essential, come
with significant risks. Many of which have a very narrow therapeutic range and a high
risk of drug interactions. Additionally, these medications have unique side effects that
can affect mortality and health-related quality of life (HRQOL). As a result, organ
transplant patients require constant medical monitoring and comprehensive education about
their medications to ensure long-term graft survival and a better quality of life.
Community pharmacies in Germany have recognized the need to support these patients. Since
2022, community pharmacies have been offering pharmaceutical care services specifically
tailored to organ transplant recipients, focusing on safe medication use and personalized
counseling, including brown-bag reviews. This service is covered by health insurance and
aims to reduce administration errors, improve therapy adherence, and enhance overall
patient safety. However, despite nearly 4,000 new organ transplants each year, only a
small fraction of these patients-less than 3%-benefit from these services annually. The
reality is that public pharmacies rarely interact with transplant patients, as they make
up a small group. Furthermore, there is currently a lack of adequate materials to support
the provision of this service for transplant patients.
This research project addresses this gap by developing and validating specific materials
that will help pharmacies deliver high-quality pharmaceutical care to organ transplant
recipients. A key element of this project is the medication information leaflets designed
by the investigators, which aim to enhance patients' understanding of their
immunosuppressive therapy, reduce medication use errors, and ultimately improve
medication safety.
The aim of this study is to collect feedback from organ transplant patients or their
caregivers/relatives on these medication leaflets, using a questionnaire instrument
called "Adapted Consumer Information Rating Form (CIRF)", developed by Krass et al. The
results will help the investigators evaluate the quality of the medication information
leaflets in terms of their content and design. This will also assist the investigators in
adjusting the content to better meet the specific needs of this unique patient group in
the future.
Study design:
This pilot study is designed as a descriptive survey. It involves a one-time survey,
either online or in paper form, that collects data on participants' evaluations and
opinions regarding the medication information sheets. The instrument that is used, the
original Adapted CIRF, was initially translated by the investigators through a peer
review process, including cultural adaptation from English to German. After two rounds of
peer review, the final version was produced. Permission for the use and translation of
the original Adapted CIRF was obtained from Krass et al. Additionally, demographic data
will be collected in the study. This study was approved by the Ethics Committee:
Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen
Wilhelms-Universität Münster.
The recruitment of the participants will be conducted through cooperating pharmacies and
patient self-help groups, and participation in the questionnaire is voluntary. Data
protection measures will be taken into account to ensure the confidentiality and security
of participants' information.
Procedure for participation in the study:
The study begins as soon as the participants have agreed to the consent form.
The study consists of two parts. In Part 1, participants are asked to select a
medication information sheet and thoroughly read it.
In Part 2, participants will ask to complete the questionnaire.
After completing the questionnaire, the participation is considered finished. The
process will take approximately 10 to 20 minutes.