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Decrease in Switches to 'Unsafe' Proton Pump Inhibitors After Communications About Interactions with Clopidogrel
Willemien J Kruik-Kollöffel1,2, Job van der Palen3,4, Myrthe P P van Herk-Sukel5
1Department of Clinical Pharmacy, Saxenburgh Group, P.O. Box 1, 7770 AA, Hardenberg, The Netherlands. w.kruik@sxb.nl.
Regulatory safety statements reduced proton pump inhibitor switches to (es)omeprazole when patients started clopidogrel. A temporary shift to histamine 2-receptor antagonists was also observed.
Area of Science:
- Pharmacovigilance
- Drug safety
- Clinical pharmacy
Background:
- Medicines regulatory agencies issued safety statements in 2009-2010 concerning proton pump inhibitors (PPIs) and clopidogrel.
- Investigated changes in gastroprotective drug prescribing behavior among prevalent users from 2008-2011.
Purpose of the Study:
- To assess the impact of regulatory safety statements on prescription behavior.
- To analyze changes in gastroprotective drug use around clopidogrel initiation.
Main Methods:
- Utilized interrupted time series (ITS) analyses.
- Data sourced from the PHARMO Database Network's Out-patient Pharmacy Database.
- Examined drug switches at clopidogrel initiation and during clopidogrel therapy.
Main Results:
- Following the June 2009 safety statement, PPI switches to (es)omeprazole at clopidogrel initiation decreased significantly (-14.9%).
- An adjusted statement in February 2010 led to a further decrease in (es)omeprazole switches (-4.5%).
- A temporary increase in switches from PPIs to histamine 2-receptor antagonists was noted, with a significant decrease in the reverse switch (-23.0%).
Conclusions:
- Interrupted time series analysis confirmed reduced switching from other PPIs to (es)omeprazole.
- Observed a near 100% increase in the reverse switch (from (es)omeprazole to other PPIs).
- Safety statements effectively influenced gastroprotective drug switching patterns around clopidogrel initiation.
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