Abstract
BackgroundIn 2009, the European Medicines Agency recommended withdrawal of dextropropoxyphene (DXP); in March 2011 it was withdrawn from the market in France. Up until that time the combination dextropropoxyphene-paracetamol (DXP/PC) was widely used for analgesia. At withdrawal, French regulators recommended that DXP/PC be replaced by other step 2 analgesics, i.e. tramadol, codeine, or opium-containing drugs, or by PC for a weak level of pain. To investigate prescribing behaviours after DXP/PC withdrawal, dispensations of analgesics before and after withdrawal were analysed.MethodsAggregated dispensation data of analgesics prescribed between January 2009 and December 2012 in the Rhône-Alpes region were obtained from the general health insurance claims data; changes in analgesic dispensation over time were analysed with the ATC/DDD methodology. Pre (Jan-June 2009) and post-withdrawal (Jan-June 2012) changes of DDDs where computed for each analgesic step.ResultsThe dispensations of DXP/PC experienced a two-step decrease until 2011. Over the withdrawal period 2009-2012, there was a 14% decrease in the overall use of analgesic (from 109 to 94 DDDs), while the use of step 2 analgesics declined by 46% (− 22 DDDs, from 47 to 25 DDDs). This latter decline included a cessation of use of DXP/PC (29 DDDs in 2009) that were only in part (+ 7 DDDs, from 18 to 25 DDDs) compensated by increased use of codeine, tramadol and opium, in monotherapy or combined with PC. For step 1 analgesics, use increased with 9%, mostly PC (+ 8 DDDs, from 31 to 39 DDDs). Step 3 analgesics dispensations remained largely unchanged over this period (around 3 DDDs).ConclusionsIn the Rhône-Alpes region, DXP/PC withdrawal was accompanied in part by an increased use of same level analgesics, and in part by an increased use of PC in monotherapy. The extent of DXP/PC use before withdrawal, and the increased use of PC after DXP withdrawal, underline the complexity of pain management.
Highlights
In 2009, the European Medicines Agency recommended withdrawal of dextropropoxyphene (DXP); in March 2011 it was withdrawn from the market in France
To provide a first set of data, an analysis of the RhôneAlpes URCAM (Regional Union of Health Insurance Fund) database with 5 million inhabitants covered by the general health insurance scheme was performed, to describe analgesics dispensation between 2009 and 2012, around the time of DXP/PC withdrawal
A first decrease occurred in June 2009, following an European Medicines Agency (EMA) announcement of DXP/PC withdrawal from the European market
Summary
Analysis of analgesic dispensations To investigate DXP/PC replacement, dispensation data of all prescribed analgesics were requested for the period January 2009 to December 2012 for the Rhône-Alpes region of France. The regional fund that is part of the national health insurance system [16] provided a dataset containing records of all analgesics that had been dispensed during that period to patients covered by the general health insurance scheme (i.e. 80% of the regional population). This extraction was based on CIP code (specific national identification code of medicinal products) of all analgesics (Table 1).
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