Opioids prescription in the Valencia Region: Patterns of Use, Misuse and Trends 2011-2017. A Population-based Real World Data Cohort

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Persons 18 years of age or older (turned between 2011 and 2018) who have at least least one prescription or dispensing of an opioid registered in the Pharmaceutical provision information system (GAIA) of SVS Data Warehouse.
• 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)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  To create a cohort of patients initiating with opioids in the region of Valencia to study:- indicence and prevalence of use of opioids and the impact of the june 2018 informative note of the AEMPS (objectives funded by Grunenthal)- appropiateness of prescription and management of episodes, and the relation between treatment duration and opiod-related events (not funded by Grunenthal)
• Data analysis plan:
  Baseline characteristics will be described, total and stratified by type of pain (oncologic, chronic non-oncologic, other) and duration of treatment. Proportion of inappropiate prescription will be provided using several indicators. Use of healthcare resources in the year following start on opiods will be accounted. Crude and standardized use rates and time series will be constructed to picture evolution of use. Interrupted time serie analysis will be used to assess the impact of 2008 AEMPS note, using Prais-Winsten models with Cochrane-Orcutt transformation and Durbin-Watson test to assess autocorrelation correction. Multilevel regression analysis will be used to assess the association between treatment duration and opiod-related events, with patient factors in first level, basic health zone in second and health department in third level.

Documents

Study, other information

20190211 01_2 OPIOIDS_V0_02 ANEXOS

Informe FIS-FEN-2019-01