Report: Kansas makes switch to NPLEx system to track pseudoephedrine sales
TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.
“For Kansas methamphetamine cooks, getting a key ingredient for making the illegal drug is about to get much more difficult,” read a Kansas State Board of Pharmacy newsletter published in September. “The NPLEx system is connected to approximately one-third of the nation’s pharmacies. Launched in Kentucky [in 2008], NPLEx tracks the sale of more than 344,000 boxes of over-the-counter cold-and-allergy medicines per month in pharmacies across the country.”
Appriss, the technology driver of the NPLEx system, has been providing training sessions for all pharmacies located throughout the state and will provide follow-up IT support, according to the newsletter.
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Study: Drug-drug interaction warning letters work
ST. PAUL, Minn. — A letter educating healthcare providers regarding a drug-drug interaction between prescription anticlotting drug Plavix (clopidogrel) and a proton-pump inhibitor has resulted in a reduction in the number of patients combining the two therapies, according to a new study by Prime Therapeutics released Monday.
Recent data has shown the use of some PPIs in combination with clopidogrel can increase a person’s risk for clopidogrel failure and a subsequent cardiac event. Current guidelines suggest providers re-evaluate the need for PPI therapy in patients taking clopidogrel and consider recommending another type of heartburn medication as an alternative treatment.
Researchers from Prime and one of its Blue Cross and Blue Shield clients used a retrospective drug utilization review to analyze claims data from a 1.3 million-member commercial insurer. From this, researchers determined 1,316 members actively were combining clopidogrel with a PPI. A letter then was sent to healthcare providers alerting them of the potentially unsafe drug use and requesting the providers re-evaluate the need for PPI therapy in their patients. The study also tracked a control group of 2,740 patients who met intervention criteria but whose providers did not receive a letter.
At 180 days post-letter, actively enrolled members in both groups were assessed for the presence of a PPI, clopidogrel or both. This analysis showed a significant absolute 7.5% point reduction in the number of members who were combining PPIs and clopidogrel when their healthcare providers received the letter, compared with the control group.
“When patients or physicians are unaware of how drugs can react with one another, they are potentially putting themselves at risk for greater harm and health complications,” stated Patrick Gleason, director of clinical outcomes assessment for Prime. “This study shows that insurers, in partnership with pharmacy benefit managers, can increase member safety using simple and cost-effective tactics to significantly reduce the incidence of concurrent clopidogrel and PPI therapy, and ensure patients continue to receive safe, high-quality care.”
Details of the study will be presented April 29 at the Academy of Managed Care Pharmacy’s 23rd Annual Meeting. The published study abstract can be found in the Journal of Managed Care Pharmacy.
In related news, a recent study sponsored by Takeda Pharmaceuticals North America indicated that its PPIs Dexilant (dexlansoprazole) and Prevacid (lansoprazole) may have less of an inhibiting effect on Plavix than AstraZeneca’s Nexium (esomeprazole).
Based on the consensus recommendations from the 3 organizations and endorsed by their boards published this past December, if the patient is defined to be at risk, the risk/benefit ratio should be determined, and if the patient is determined to be at significant GI risk (mod-severe), using a PPI (any PPI) seems most reasonable. The consensus group did not come down on the side that just omeprazole should be avoided, and felt that there was no significant cardiovascular risk identified for any of the PPIs when coprescribed with clopidogrel. Thus, although pharmacokinetic and pharmacodynamic data suggest varying inhibition by different PPIs of the enzyme systems necessary to convert clopidogrel to its active form, there is no good evidence that these differences on surrogate markers translate into meaningful differences in clinical outcomes. No prospective - head to head trials directly compare the clinical events of different PPIs in patients treated with clopidogrel.
Abbott Diagnostics seeks FDA approval for vitamin D assay
ABBOTT PARK, Ill. — Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.
"Increasing interest in vitamin D is fueling a surge in orders for tests as more healthcare professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," stated Sudarshan Hebbar, senior medical director of Abbott Diagnostics.
The Architect 25-OH Vitamin D assay is a fully automated immunoassay intended to help laboratories manage their increasing vitamin D testing volumes through the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency.
"Research shows that vitamin D levels are a concern for patients with osteoporosis, chronic kidney disease, malabsorption and anyone with a condition or taking a medication that may impair bone health," said Brian Blaser, SVP at Abbott Diagnostics. "This new fully automated vitamin D assay may help physicians better diagnose and counsel patients with suspected vitamin D deficiency."
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