Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Dec 2008
National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.
The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. ⋯ The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs.
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Pharmacoepidemiol Drug Saf · Dec 2008
Databases for pediatric medicine research in Europe--assessment and critical appraisal.
To identify and describe European health care databases that can be used for pediatric pharmacoepidemiological research. ⋯ There are many European healthcare databases providing an enormous potential for pediatric pharmacoepidemiological research. Future research should focus on methods to bring data from different databases together to use the full capacity effectively.
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Pharmacoepidemiol Drug Saf · Nov 2008
Comparative StudyThe impact of co-payment increases on dispensings of government-subsidised medicines in Australia.
Patient co-payments for medicines subsidised under the Australian Pharmaceutical Benefits Scheme (PBS) increased by 24% in January 2005. We investigated whether this increase and two related co-payment changes were associated with changes in dispensings of selected subsidised medicines in Australia. ⋯ The study findings suggest that recent increase in Australian PBS co-payments have had a significant effect on dispensings of prescription medicines. The results suggest large increase in co-payments impact on patients' ability to afford essential medicines. Of major concern is that, despite special subsidies for social security beneficiaries in the Australian system, the recent co-payment increase has particularly impacted on utilisation for this group.
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Pharmacoepidemiol Drug Saf · Nov 2008
An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system.
We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration's (FDA) spontaneous adverse event (AE) reporting system (AERS). ⋯ Although we observed a data mining signal for ALS with statins in FDA's AERS, retrospective analyses of 41 statin clinical trials did not reveal an increased incidence of ALS in subjects treated with a statin compared with placebo.
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Pharmacoepidemiol Drug Saf · Oct 2008
Comparative StudyThe safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care.
To compare mortality and the incidence of hospitalization for myopathy, rhabdomyolysis, acute renal failure and acute liver injury in patients receiving rosuvastatin and those taking other statins. ⋯ We found no evidence that patients prescribed rosuvastatin were at greater risk of these outcomes than patients prescribed other statins. There was no evidence of increased mortality among patients taking rosuvastatin, even after allowing for age, sex and prior statin use.