Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Safety study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

FENTANYL

Medical condition to be studied

Cancer pain
Population studied

Short description of the study population

A survey of physicians prescribed Instanyl® in France, the Netherlands and Poland.
Inclusion Criteria:
- Specialists of any of those medical specialties targeted for the EMs as agreed with each national competent authority. The foreseen specialties include the following (subject to changes after the EM distribution plan is completed and agreed with national competent authorities):
o Oncologists and oncoradiologists;
o Anaesthesiologists;
o Pain management prescribers;
o Palliative care prescribers;
o Internal medicine prescribers;
o General practitioners (GPs);
o Other specialties may be locally included such as hematology. Current and potential prescribers may vary between country; thus, some countries may have modified lists of target specialties.
- Physicians who have prescribed Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs (post-EM survey) and who intend to prescribe Instanyl® in the following months after each survey.

Exclusion criteria
1. Physicians who may have a conflict of interest (i.e., prescribers employed by regulatory bodies, pharmaceutical industries);
2. Inactive or retired prescribers;
3. Physicians who did not prescribe Instanyl® in the past 12 months (pre-EM survey) or since the updated EMs are distributed (post-EM survey) and do not foresee treating a patient with Instanyl® in the following 12 months, regardless of whether they have prescribed Instanyl® before.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

536
Study design details

Main study objective

Primary objective of the study is to assess prescribers’ awareness of the updated EMs, changes in prescribers’ knowledge and understanding of the key information contained in the updated EMs, changes in prescribers’ self-reported behavior in prescribing, the reasons for off-label prescription, and to assess whether prescribers are fully aware of patients at risk of misuse and addiction.

Outcomes

Primary outcomes include changes in prescribers' awareness, knowledge and understanding of key safety information, self-reported behavior and reasons for off-label prescription before and after updated EMs.

Data analysis plan

Descriptive statistics method will be presented. Continuous variables will be described by the number of valid cases, mean, standard deviation, and median first quartile-third quartile (Q1, -Q3,), and minimum and maximum. A 2-sided 95% CI of mean will be presented for success criteria, when relevant. Categorical variables will be described as the total number and relative percentage per category. A 2-sided 95% confidence interval (CI) of percentages will be presented for success criteria. Results will be presented overall per country and specialty, at the specialty level (all countries), and at the country level (all specialties), for each survey.