PHARMACY

FDA uses pharmacogenomics guidance in harmony with international definitions

BY Adam Kraemer

WASHINGTON The Food and Drug Administration issued guidance on pharmacogenomic definitions and sample coding in order to bring it in line with that of Japan and the European Union.

The new guideline—“E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories”—provides information and definitions related to aspects covered by the definitions and related disciplines, such as proteomics and metabalomics.

The guidance defines a genomic biomarker as a “measurable DNA or RNA characteristic that is an indicator of normal biologic or pathogenic processes or a response to therapeutic or other interventions,” according to FDA reports. It also defines pharmacogenomics—the study of variations of DNA and RNA characteristics as related to drug response, and pharmacogenetics—the study of variations in DNA sequence as related to drug response.

The guideline also offers harmonized definitions for the four general coding categories of biological samples used to generate data in pharmacogenomic and pharmacogenetic studies.

The guidance is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0199-gdl.pdf.

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Proximity, price outweigh technology in consumers’ choice of pharmacies

BY Jim Frederick

DURHAM, N.C. Fully one in three Americans who take prescription medicines have experienced a prescription error or say they know someone who has, a new consumer survey finds.

 The just-released Parata Prescription Safety 2008 poll appears to bolster the case for pharmacy technology vendors, who assert that robotic dispensing technology and other pharmacy technology can greatly reduce medication errors.

More than half of American adults take at least one prescription daily, according to the Parata survey and other reseaerch. However, researchers argue in a report on the results released Thursday, “increased prescription use has not been accompanied by increased consumer vigilance.”

Instead, consumers “readily admit to choosing their pharmacies for speed and convenience, rather than for safe prescription practices” the company reported. Half of those polled cited “proximity to work or home” as the top reason for choosing one pharmacy over another.

The second most cited reason for choosing a particular pharmacy is price, cited by 23 percent of respondents, Parata reported. “Interestingly, a pharmacy’s use of “automated dispensing equipment,” a proven strategy for reducing prescription errors, ranked last in importance, cited by just 2 percent of respondents,” pollsters noted.

The vast majority of prescription-takers [80 percent] spend less than two minutes speaking to their pharmacists when they pick up their medications, according to Parata, and almost half [45 percent] don’t talk to them at all. And while 91 percent of consumers asked could name the doctors who wrote their last prescriptions, only 36 percent could name the pharmacists who filled them, the survey found.

Nevertheless, far more respondents ranked pharmacists as principally responsible for ensuring their prescriptions are accurate than those who said their doctors mostly filled that role, by a margin of 49 percent to 15 percent for doctors.

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Feds’ new view of multisource drugs draws opposition from NACDS, NCPA

BY Jim Frederick

ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association today asked the Centers for Medicare and Medicaid Services to withdraw a new and potentially damaging definition of “multiple source drug,” a definition both pharmacy groups say could scramble the prescription payment system for Medicaid and cut further into reimbursements to pharmacies.

The revised definition comes in the form of an interim final rule adopted by CMS. In comments submitted to CMS today, NACDS president and chief executive officer Steve Anderson and NCPA executive vice president Bruce Roberts called attention to two critical legal concerns with the new way the Bush administration is defining multisourced medications.

“The first concern is that the rule was not subject to the normal notice and comment rulemaking process in accordance with the Administrative Procedure Act, which requires public notice and a comment period prior to most rule changes,” the two leaders noted.

The second sticking point is more serious. Anderson and Roberts said the definition of multiple source drugs “is critical for pharmacies because CMS uses Federal Upper Limits (FULs) to cap Medicaid reimbursement to pharmacies that dispense them.”

That said, they told CMS, “the Social Security Act provides that a drug is not a multiple source drug unless two or more equivalent drug products are ‘sold or marketed in the State;’ that is, whether particular drug products are generally available to the public through retail pharmacies in each state. CMS did not comply with this standard in revising the rule.

“While we appreciate CMS’ efforts to redefine ‘multiple source drug’, it is critical that the revisions meet all guidelines and compliance requirements,” said Anderson and Roberts. “Pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP [average manufacturer’s price] rule [for multi-sourced drugs] and the revised definition. As a result, those who will suffer the greatest burden will be the patients and the states.”

The full comments are posted here.

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