Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Apr 2014
Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies.
The increase in online purchasing of medications raises safety concerns regarding teratogenic drugs. The use of the teratogenic drug 'isotretinoin' for women of childbearing age requires strict adherence to the Pregnancy Prevention Programme (PPP), a risk minimisation measure imposed on prescribers and users. We sought to determine how readily consumers can purchase isotretinoin online and the associated safety procedures and information. ⋯ The Internet provides a loophole for purchasing of medications known to cause congenital abnormalities, which needs to be addressed by medicines regulatory agencies worldwide. The current PPP for isotretinoin may be failing to protect mothers and babies from preventable harm-clinicians need to be aware of this, and the public needs to be educated about the potential risks.
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Pharmacoepidemiol Drug Saf · Apr 2014
Comparative StudyRisk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers - a cohort study using the Clinical Practice Research Datalink.
Results of two randomized trials (ROADMAP and ORIENT) suggest that high-dose (40 mg/day) olmesartan (Olm) is associated with increased cardiovascular mortality compared to placebo in diabetic patients. We evaluated the risks of acute myocardial infarction (AMI) and death in patients initiating Olm compared with an active comparator group, other angiotensin receptor blockers (ARBs), with a focus on high-dose and diabetic subgroups. ⋯ Overall, no differences in risk were observed in the main cohort analyses comparing Olm initiators with patients initiating therapy with other ARBs; however, HRs were marginally increased for all study endpoints which compared high-dose subgroups, suggesting potential increased risk may be associated with high-dose Olm. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.
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Pharmacoepidemiol Drug Saf · Apr 2014
Differences among admitting departments in alerts and alert overrides for drug-drug interaction.
To determine differences in the incidence and risk factors of alerts for drug-drug interaction (DDI) and the rate of alert overrides by an admitting department. ⋯ Admitting department was an independent risk factor for alerts and alert overrides. Strategies to reduce alerts and alert overrides should consider the admitting department.
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Pharmacoepidemiol Drug Saf · Apr 2014
Impact of a drug utilization review program on high-risk use of prescription controlled substances.
Prescription drug abuse has prompted considerable concern. We evaluated a retrospective drug utilization review program to reduce controlled substance use among individuals with high-risk utilization. ⋯ Retrospective drug utilization review programs may reduce controlled substance scores and claims among individuals with patterns suggesting high-risk utilization.
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Pharmacoepidemiol Drug Saf · Apr 2014
Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan.
To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010. ⋯ The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population.