Healthy Skepticism Library item: 6380

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Publication type: Journal Article

Schussel K, Schulz M.
Prescribing of COX-2 inhibitors in Germany after safety warnings and market withdrawals
Pharmazie 2006 Oct 1; 61:(10):878-86

Abstract:

Prescribing of COX-2 inhibitors in Germany after safety warnings and market
withdrawals.

Schussel K, Schulz M.

German Institute for Drug Use Evaluation, Eschborn, Germany.
k.schuessel@dapi.info

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.