Introduction: Individual-level data on all prescription drugs sold in Danish community pharmacies has since 1994 been recorded in the Register of Medicinal Products Statistics of the Danish Medicines Agency. Content: The register subset, termed the Danish National Prescription Registry (DNPR), contains information on dispensed prescriptions, including variables at the level of the drug user, the prescriber, and the pharmacy. Validity and coverage: Reimbursement-driven record keeping, with automated bar-code-based data entry provides data of high quality, including detailed information on the dispensed drug. Conclusion: The possibility of linkage with many other nationwide individual-level data sources renders the DNPR a very powerful pharmacoepidemiological tool.
The Nordic prescription databases, with their possibility of record-linkage, represent an outstanding resource for assessing the beneficial and adverse effects of drug use in large populations, under routine care conditions, and with the potential for long-term follow-up.
In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and motherchild linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Several studies indicate that switch to more expensive drugs and increasing treatment intensity, rather than population ageing have been responsible for rising drug expenditures during the 1990s.• Little is known about the driving forces behind the increasing treatment intensity with cardiovascular drugs.
WHAT THIS STUDY ADDS• This study provides a new pharmacoepidemiological method to analyse drug utilization trends, applying dispensing data at the individual level.• The suggested semi-Markov model allows for quantification of the influence of changing incidence, discontinuation and user mortality on rising treatment prevalence.• Increasing treatment incidence was the main driver behind rising treatment prevalence for most cardiovascular drug categories.• Whereas declining discontinuation drove some of the growth, declining mortality among drug users had little influence.
AIMSTo investigate the driving forces behind increasing utilization of cardiovascular drugs.
METHODSUsing register data, all Danish residents as of 1 January 1996 were followed until 2006. Cohort members were censored at death or emigration. Cardiovascular drug utilization on the individual level was traced, applying registered out-of-hospital dispensing. The impact of population ageing on cardiovascular drug utilization was investigated using standardized intensities and prevalences. Based on a three-state (untreated, treated and dead) semi-Markov model, we explored to what extent increasing treatment prevalence was driven by changing incidence, discontinuation and mortality. Expected treatment prevalences were modelled, applying stratum-specific cohort prevalence in 1996 along with incidence, discontinuation and drug user mortality either throughout 1996-2004 or at fixed 1996 levels.
RESULTSTreatment prevalence (ages Ն20 years) with cardiovascular drugs increased by 39% during 1996-2005 from 192.4 to 256.9 per 1000 inhabitants (95% confidence interval 256.5, 257.3). Treatment intensity grew by 109% from 272 to 569 defined daily doses 1000 -1 day -1 . Population 'middle-ageing' accounted for 11.5 and 20.3%, respectively. Increasing treatment incidence was the main driver of the rising treatment prevalence in most drug categories. Declining discontinuation drove some of the growth, declining drug user mortality less. Even with fixed incidence in the model, treatment prevalence continued to increase.
CONCLUSIONSAge-related increases in treatment intensity and prevalence, rather than population ageing, drove the increasing treatment intensity with cardiovascular drugs. Increasing treatment prevalence in subgroups was primarily caused by increasing incidence. Due to pharmacoepidemiological disequilibrium, treatment prevalence will continue to grow even with unchanged incidence.
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