PHARMACY

Staying seated could up diabetes risk for women, study finds

BY Allison Cerra

NEW YORK — Women that are seated for longer periods of time are more likely to develop diabetes when compared with men, according to a new study.

Researchers from the departments of health sciences and cardiovascular sciences at University of Leicester in England assessed more than 500 men and women that were 40 years old and the amount of time the subjects spent sitting over the course of one week. They found that women who spent the longest time sitting had higher levels of insulin, as well as higher amounts of C-reactive protein and chemicals released by fatty tissue in the abdomen, leptin and interleukin6, which indicate problematic inflammation, the researchers said. The association between sitting and diabetes was not found, however, among the male subjects in the study.

"This study provides important new evidence that higher levels of sitting time have a deleterious impact on insulin resistance and chronic low-grade inflammation in women but not men and that this effect is seen regardless of how much exercise is undertaken," lead study author Thomas Yates said. "This suggests that women who meet the national recommendations of 30 minutes of exercise a day may still be compromising their health if they are seated for the rest of the day. It therefore suggests that enabling women to spend less time sitting may be an important factor in preventing chronic disease."

The study, "Self-Reported Sitting Time and Markers of Inflammation, Insulin Resistance and Adiposity," appeared in the American Journal of Preventive Medicine.


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PHARMACY

Utah passes Pharmacy Audit Integrity and Recovery Act

BY Allison Cerra

ALEXANDRIA, Va. — Legislation designed to reform the pharmacy audit process has been approved in Utah and will be sent to the state governor to sign.

In a 73-1 vote, H.B. 76, known as the Pharmacy Audit Integrity and Recovery Act, "requires health benefit plans, the Public Employees’ Benefits and Insurance Program and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims," according to the legislation document. Key provisions included:

  • Clerical or recordkeeping error, such as a typo, should not be considered fraud or subject to recoupment or criminal penalties;

  • Findings of overpayment or underpayment must be based on actual overpayment or underpayment and not a projection;

  • Audits cannot recoup dispensing fees from the pharmacy;

  • An auditing entity may not be paid based on a percentage of the amount recovered;

  • All pharmacies are to be audited under the same standards or parameters as other pharmacies;

  • The period covered by the audit may not exceed 18 months, unless superseded by federal law; and

  • Audits have a 200 script maximum limit.

The bill’s chief sponsor was Rep. Evan Vickers (R-Utah), who is a pharmacist and a member of the National Community Pharmacists Association.

"This legislation is an important step forward for patients and pharmacists across Utah," NCPA CEO Douglas Hoey said. "Fair auditing of pharmacies is a legitimate way to protect public and private health plans from waste, fraud and abuse. However, recently pharmacy auditing practices are sapping pharmacists’ time to counsel patients and appear to be more about generating revenue for the middleman than rooting out fraud. There’s no reason for community pharmacists to routinely lose time and thousands of dollars in audits when the right medication is dispensed to the right patient at the right time. We commend state representative, pharmacist and NCPA member Evan Vickers, the Independent Pharmacy Cooperative and the Utah Pharmacists Association for making it happen. NCPA was proud to support their grassroots efforts."

The passage of the Pharmacy Audit Integrity and Recovery Act also was praised by the National Association of Chain Drug Stores.

"The passage of this legislation is an important step in curbing questionable tactics used by PBMs that only seek to hurt patients and increase already-skyrocketing healthcare costs," NACDS president and CEO Steve Anderson said. "The lack of transparency by PBMs in the audit process has penalized community pharmacy and more importantly, posed challenges to patients including increased drug costs. We thank Rep. Vickers for his leadership in passing this bill, as well as the efforts of the Utah Retail Merchants Association and the Utah Food Industry Association in achieving this legislative victory."


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Endo seeks tougher standards for generic versions of Lidoderm

BY Alaric DeArment

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

The drug maker added an amendment to a citizen petition it filed with the FDA in 2006 concerning the drug Lidoderm (lidocaine), a patch used to treat post-herpetic neuralgia, a painful condition associated with shingles. The drug maker said the amended petition "highlights the growing scientific and regulatory support" for requiring clinical studies from generic drug makers looking to gain FDA approval for generic versions of such locally acting topical drugs as Lidoderm.

"Since we filed the original citizen petition in 2006, new studies and opinions from research scientists, as well as public statements from FDA officials, have further validated the need for comparative clinical endpoint studies to ensure a locally acting topical medication is bioequivalent to the branded product," Endo chief scientific officer and EVP research and development Ivan Gergel said. "FDA must publicly address the many unanswered questions from the original petition, as well as the additional concerns raised in this amendment, before taking any formal steps toward the approval of a generic version of Lidoderm."

Specifically, Endo said pharmacokinetic studies, which measure the level of a drug in the bloodstream, are not enough to demonstrate that a generic version of Lidoderm would be equivalent to the branded drug. The company also said that scientists had not identified any method other than clinical endpoint studies to show that drugs like Lidoderm and generic versions are equivalent and asked the agency to address allegations by another drug maker that the FDA had answered Endo’s 2006 petition in private correspondence, which Endo said would be illegal if it’s true.


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