A drug utilisation study to assess the effectiveness of risk minimisation measures and describe the prescribing practices of Doreta SR and tramadol/paracetamol combinations in Europe (DUS Doreta SR and tramadol/paracetamol combination)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

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

  TRAMADOL
• Anatomical Therapeutic Chemical (ATC) code:
  (N02AJ13) tramadol and paracetamol

  tramadol and paracetamol

Population studied

• Short description of the study population:
  Any dispensed prescriptions of oral FDCs of tramadol and paracetamol during the study periods
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  100000

Study design details

• Study design:
  This is a cross-sectional pre-post, drug utilisation study conducted using secondary data in outpatient settings. It consists of 2 distinct study periods: pre-RMM period and post-RMM period.
• Main study objective:
  This study aims to describe the prescribing practices before and after the implementation of RMMs for Doreta SR proposed by the MAH (i.e. changes in the product information, changes in the product packaging and dissemination of Direct Healthcare Professional Communication DHPC).
• Setting:
  Electronic dispensed pharmacy data/claims data from three European countries: the Czech Republic, Hungary, and Poland.; Prescribing practices between Pre-RMM period and post RMM period were compared
• Outcomes:
  To describe the use of Doreta SR and immediate-release FDCs of tramadol/paracetamol pre- and post-RMM implementation in terms of: Total dose dispensed Indication of the dispensed prescriptions Total dose dispensed per indications Duration of dispensed prescriptions per treatment Comorbidities Concomitant dispensed prescriptions, To describe the demographic characteristics of patients prescribed with Doreta SR and immediate-release FDCs of tramadol/paracetamol pre- and post-RMM. To describe the characteristics of prescribers of Doreta SR and immediate-release FDCs of tramadol/paracetamol pre- and post-RMM
• Data analysis plan:
  Descriptive analysis
• Summary results:
  This report provides insights into the prescribing patterns of Doreta SR and IR FDCs of tramadol/paracetamol in the pre-RMM and post-RMM periods in the Czech Republic, Poland, and Hungary. Generally, both drugs were dispensed in increased doses and for a more extensive duration in the post-RMM period. It is possible that prescribers intended to provide significant medication refills to patients due to the COVID-19 pandemic. In Hungary, dorsalgia was the most prevalent indication for dispensed prescriptions. For both periods, opioids were predominantly dispensed with Doreta SR and IR FDCs of tramadol and paracetamol. No prescriptions in the Czech Republic and Poland as well as zero to nine prescriptions in Hungary for monoamine oxidase inhibitors, which must not be taken together with FDC of tramadol/paracetamol, were dispensed in both periods. As evidenced by sex- and age-related patterns in the use of analgesics, Doreta SR and IR FDC of tramadol/paracetamol were most commonly prescribed to elderly individuals and women in both periods. Both drugs were primarily prescribed by general practitioners.

Documents

Study report

2673514__Krka_Doreta_SR_DUS_KKLR402019_Final_Report_V2.0_25012024.pdf