title: Prescribing of COX-2 inhibitors in Germany after safety warnings and market withdrawals.
abstract: The emergence of safety concerns associated with the use of selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) led to market withdrawals of rofecoxib in September 2004 and valdecoxib in April 2005. These events were accompanied by safety alerts from drug authorities and recommendations from professional medical associations. This study analysed the temporal influence of these measures on drug use in Germany, with the objective to assess overall appropriateness of prescribing and to evaluate the potential for pharmaceutical interventions. Drug prescriptions for patients within the statutory health insurance system (GKV) were analysed based on the total amount of DDDs of single drug substances dispensed every month in German pharmacies. The market withdrawal of rofecoxib in September 2004 resulted initially in increased prescribing of other coxibs. New safety warnings on coxibs later in 2004 and the withdrawal of valdecoxib in April 2005 led to pronounced reductions in coxib prescribing. Comparing the third quarter of 2005 with 2004, coxib prescriptions dropped from 47.5 to 10.4 million DDDs. Conversely, in the same time frame, NSAID prescriptions increased by 19.0 million DDDs. This is mostly due to increased prescribing of ibuprofen, diclofenac and, to a lesser degree, meloxicam, acemetacin, piroxicam, and naproxen. However, total prescribing of inhibitors of cyclooxygenases decreased by about 8.4%, indicating a relative reluctance to prescribe these drugs after cardiovascular safety warnings have been issued by drug authorities. Unexpectedly, also prescribing of metamizol (dipyrone) increased by 2.8 million DDDs (20%), despite recommendations to limit its use by medical associations. Furthermore, increased prescribing of proton pump inhibitors of 12.6 million DDDs could be observed. NSAIDs and coxibs are to a larger extent prescribed by a broad range of medical specialist groups including orthopaedists and surgeons, whereas drugs used in gastrointestinal or cardiovascular disorders are mainly prescribed by general practitioners and internal specialists, respectively. Therefore, the individual physician may not always be aware of the risk profiles of their patients. Pharmacists can close this gap by providing comprehensive medication records and information on self medication used by the patient to prescribing practitioners, thereby contributing to improved patient safety.
authors.affiliation: German Institute for Drug Use Evaluation, Eschborn, Germany. k.schuessel@dapi.info
authors.forename: K
authors.initials: K
authors.lastname: Schüssel
authors.forename: M
authors.initials: M
authors.lastname: Schulz
mesh_terms: D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D016527:Drug Costs; D011307:Drug Prescriptions; D004363:Drug Utilization; D017850:Economics, Pharmaceutical; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007348:Insurance, Health / Q000706:statistics & numerical data; D010595:Pharmacists
chemical_list: D000897:Anti-Ulcer Agents; D052246:Cyclooxygenase 2 Inhibitors