NON-INTERVENTIONAL POST-AUTHORIZATION STUDY WITH THE ACTIVE SUBSTANCE FENTANYL IN THE FORM OF TRANSDERMAL PATCH

Background:

Non- Interventional Post-authorization study with the active substance fentanyl in the form of transdermal patch took place in the Czech Republic from November 26, 2012 to April 30, 2014, as the second phase of the non-interventional monitoring of patients to whom fentanyl in the form of transdermal patches has been prescribed according the common medical practice. Specialized oncology departments and offices aimed for treating pain participated in this study. The aim of Non- Interventional Post-authorization study with the active substance fentanyl in the form of transdermal patch was the evaluation of the indication spectrum, the dosage of medication and compliance of patients treated with transdermal fentanyl for pain, which can be adequately handled only by opioid analgesics. At the same time to verify the efficacy and tolerability of transdermal fentanyl.

Patients and Methods:

In total, 2,691 patients were enrolled into the non-interventional study. Inclusion criteria: 1) Adult patients treated by fentanyl in the form of transdermal patches for at least two weeks. 2) Patients who tolerated opioids in the past. Selection of patients was not allowed to be influenced in advance and had to be solely on the decision of the doctor within the treatment of pain in common medical practice. In context with this non-interventional study patients did not undergo any diagnostic or therapeutic procedures beyond the normal clinical practice. The patient was subsequently monitored during three controls as part of routine clinical practice. Data recorded were: the effectiveness of the treatment, how often the patient changed patch, need of additional attachment of patch, removing of patch residua, undesirable effects, how the patient continues in the treatment and the number of the packages of the medicinal product, where appropriate, the reason for termination of treatment.

Conclusion:

The fentanyl transdermal patch was the most often indicated for the treatment of back pain and cancer pain. After the evaluation of outputs from each follow-up visit the improving analgesic effect between visits is remarkable. During this non-interventional no serious or unexpected undesirable reaction has been reported. The total average number of reported undesirable effect after the fi rst visit increased slightly, from 11% to 14%, which may be given, for example, by titration to a higher therapeutic dose.

Supported by the project CZ 1.05/ 2.1.00/ 03.0076 from European Regional Development Fund.