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Pharmacoepidemiol Drug Saf. 2012 Mar;21(3):281-4. doi: 10.1002/pds.2275. Epub 2012 Jan 10.

Impact of a health safety warning and prior authorisation on the use of piroxicam: a time-series study.

Author information

1
Santiago de Compostela Health Area, Galician Health Service, Spanish National Health System, Spain. eduardo.carracedo.martinez@sergas.es

Abstract

BACKGROUND:

The aim of this study was to assess the quantitative changes in systemic use of piroxicam after the issue of a health safety warning about its risks and the subsequent implementation of prior authorisation.

METHODS:

We determined the number of monthly daily defined doses/1000 inhabitants/day (DHDs) of piroxicam in the period 2005-2008 in a health area in Spain. The data were analysed graphically, and the impact of the safety warning and introduction of prior authorisation were estimated by using segmented regression analysis.

RESULTS:

The graph showed that the number of DHDs of piroxicam was stable both before and after the health safety warning but registered a very marked decrease after implementation of prior authorisation, after which DHDs of piroxicam remained stable at a 98% inferior level compared with previous to prior authorisation. Segmented regression analysis showed no statistically significant immediate jump in piroxicam utilisation after the safety warning nor a change in the slope afterwards, but it did show a significant immediate jump after prior authorisation.

CONCLUSION:

Population exposure to systemic piroxicam remained unaffected by a previous health safety warning but declined sharply after the introduction of prior authorisation.

PMID:
22234915
DOI:
10.1002/pds.2275
[Indexed for MEDLINE]

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