Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice

Esterly, John S.; Steadman, E. J.; Scheetz, Marc H.

doi:10.1007/s11096-011-9503-4

Cited by 5 publications

(2 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite concerns surrounding the possible risk of bladder cancer with long term use of pioglitazone, this study showed weaker effects of safety warnings on bladder cancer and pioglitazone utilisation. A number of publications have studied the effect of authorities’ warnings in the US and Europe to improve their warning systems [27,54,55]. This is one of the first studies to date that has investigated utilisation patterns in relation to drug safety warnings in Australia and suggests that TGA warnings may not affect prescribing in cases such as this where prescribers may be attuned to particular medicine safety issues described in earlier international warnings or literature.…”

Section: Discussionmentioning

confidence: 99%

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Niyomnaitham

Page

Caze

et al. 2014

BMC Health Serv Res

View full text Add to dashboard Cite

BackgroundA see on cardiovascular diseases and bladder cancer. The changes to the patterns of rosiglitazone and pioglitazone utilisation in Australia following the timing of these various health authority warnings such as the Australian Therapeutic Good Administration (TGA), European Medicines Agency (EMA) press releases or U.S. Food and Drug Administration (FDA) is unknown. This study investigated the utilisation patterns of rosiglitazone and pioglitazone in Australia before and after warnings of major drug authorities.MethodsWe evaluated rosiglitazone and pioglitazone dispensing using the Pharmaceutical Benefit Scheme (PBS) subsidised drug dispensing data for the Australian population from February 2004 to July 2012. The World Health Organisation Anatomic Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) system was used to compare the drug utilisation patterns following the announcements of EMA, FDA, and TGA safety warnings, which first occurred in May 2007. The DDD/1000population/day were examined in a series of time-series regression analysis with the drug safety warnings specified as interventions.ResultsRosiglitazone utilisation increased steadily from 2004 until reaching a peak at 1.96/1000population/day in January 2007. Then rosiglitazone use decreased significantly after the initial EMA press release and FDA warning on cardiovascular risk in May 2007 (with a 15.04% average monthly decline, p-value <0.001), however use did not significantly decrease after the TGA warning or subsequent EMA and FDA warnings. Pioglitazone utilisation proceeded rosiglitazone in September 2008 and remained above 1.5/1000/day during 2009–2010. However, pioglitazone utilisation has slightly declined after the FDA, EMA, and TGA warnings related to bladder cancer.ConclusionsDrug safety warnings were associated with a decrease in rosiglitazone and pioglitazone utilisation in Australia. Rosiglitazone began to decline prior to TGA warnings in December 2007, which suggests that Australian prescribers may have acted in response to scientific evidence or international safety warnings (EMA, FDA), prior to the response of the TGA. Minor effects were observed after bladder cancer warnings on pioglitazone utilisation.

show abstract

Section: Discussionmentioning

confidence: 99%

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Niyomnaitham

Page

Caze

et al. 2014

BMC Health Serv Res

View full text Add to dashboard Cite

show abstract

“…Despite concerns surrounding the possible risk of bladder cancer with long term use of pioglitazone, this study showed weaker effects of safety warnings on bladder cancer and pioglitazone utilisation. A number of publications have studied the effect of authorities' warnings in the US and Europe to improve their warning systems [27,54,55]. This is one of the first studies to date that has investigated utilisation patterns in relation to drug safety warnings in Australia and suggests that TGA warnings may not affect prescribing in cases such as this where prescribers may be attuned to particular medicine safety issues described in earlier international warnings or literature.…”

Section: Discussionmentioning

confidence: 99%

Impact of drug warning system on prescriptions

Niyomnaitham¹

View full text Add to dashboard Cite

The emergence of a serious adverse effect from a recently marketed drug is a great concern. The earlier we can detect and evaluate those unwanted effects, the better we can prevent them. Regulatory authorities play an important role in detecting, assessing and informing healthcare professionals and consumers on drug safety issues. Regulatory authorities use drug safety warnings as a communication tool for notifying prescribers about the risk and providing the recommendation for their practices. Expected outcomes of drug safety warnings are prescribers' awareness of these risks and a change in their prescribing according to the safety information. However, effectiveness of these safety warnings on clinical practice had been reviewed and led to recommendation for reform in These results suggest that changes in patterns of concerned drugs were associated with international warnings, which may get through to Australian prescribers via NPS MedicineWise or other medical associations. In summary, the impact on drug use depends on the intensity and clarity of warnings as well as the certainty, severity and prevalence of adverse effects. This thesis expands the current understanding of the impact of regulatory iii safety warnings on prescriptions and also provides the scope for possible improvement to the warning system in Australia.iv

show abstract

Factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: A systematic review

Alharbi

Berrou²,

Umaru³

et al. 2023

Research in Social and Administrative Pharmacy

View full text Add to dashboard Cite

Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice

Abstract: Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

Cited by 5 publications

References 11 publications

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Impact of drug warning system on prescriptions

Factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: A systematic review

Contact Info

Product

Resources

About