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Susan Winckler, R.Ph., Esq., has resigned as VP for policy and communications and staff counsel at APhA to join the FDA as director of policy communication, a newly created position. Her resignation will be effective Sept. 16.

Large majorities of pharmacists (86%) and physicians (71%) believe that the Medicare Part D prescription drug law is helping people on Medicare save money on medications, but respondents gave the program only a C- grade.

NPPES to get upgrade

CMS' National Plan & Provider Enumeration System (NPPES) will be upgraded on Monday, Sept. 18, and will be down from 5:00 A.M. ET through 2:00 P.M. ET.

"New Outcomes Data for Type 2 Diabetes" is the subject of a breakfast continuing education program that will be held in Chicago on Thursday, Oct. 5. The session, hosted by Drug Topics and Formulary magazines, will examine the implications of new diabetes research and will also look at the need for tighter glucose control to minimize complications as well as the economic impact of early intervention for patients at risk for Type 2 diabetes.

Duane Reade settles probe

Duane Reade will pay $50,000 to state consumer affairs officials to settle an investigation into sales of expired products. The New York-based drugstore chain also agreed not to sell nonprescription drugs, infant formula, baby food, and cosmetics beyond their expiation dates.

Rite Aid pharmacists will lead teams of walkers this fall in the American Diabetes Association?s ?America?s Walk for Diabetes.? Rite Aid teams will participate in markets where the company is located to raise funds and help find a cure for diabetes.

CDC has announced that 100 million doses of influenza vaccine will be manufactured for the upcoming season, more than any previous year. Almost all of the vaccine is expected be shipped in October and November, and new policies are in place this year that are designed to deliver at least some of the vaccine by the end of October to all the providers who placed orders.

Women in Government, a nonprofit organization that represents women state legislators, has recommended that all girls entering middle school be vaccinated against the human papillomavirus (HPV) to prevent cervical cancer.

Barr ups the ante for Pliva

Woodcliff Lake, N.J.-based Barr Pharmaceuticals raised its bid for Pliva to $2.5 billion. Barr's chief rival in the Pliva acquisition is Iceland-based Actavis, which offered $1.85 billion for Pliva, based in Croatia. If Pliva accepts Barr's offer, Barr would become the world's third-largest generic drug manufacturer behind second-place Novartis and No. 1 Teva.

A new report from market research firm Decision Resources, entitled Antibiotics: Reaction of PCPs, Pediatricians, and Managed Care to Major Patent Expiries and New Products, has found that the expected FDA approval of faropenem medoxomil, the first oral penem antibiotic, triggered mixed feelings regarding its usefulness among healthcare providers surveyed.

Dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin (Januvia, Merck), currently under review by the FDA, can cause a 2.1 percentage point drop in A1c levels in patients receiving the drug in conjunction with metformin, according to study results released at the 42nd Annual Meeting of the European Association for the Study of Diabetes this week.

Almost 70% of minor surgeries are now performed in surgical centers, physicians' offices, and hospital outpatient departments. Procedures including cardiac catheterizations and colonoscopies can be done using sedatives such as midazolam and fentanyl instead of general anesthesia.

The American Society of Clinical Oncology (ASCO) recently updated its guidelines for the use of hematopoietic colony-stimulating factors (CSFs). The 2005 update committee unanimously agreed that the reduction in febrile neutropenia (FN) was an important clinical outcome that justified the use of CSFs, regardless of impact on other factors, when the risk of FN was approximately 20% and no other equally effective regimen that did not require CSFs was available. The first guidelines were published in 1994, and they were updated in 1996, 1997, 2000, and, most recently, 2005.

The Joint Commission on Accreditation of Healthcare Organizations is looking for a few good hospitals. A few good psychiatric hospitals, that is. JCAHO is rolling out its first-ever hospital-based performance measures for inpatient psychiatric care for a year-long trial run starting in January 2007. Final measures will be released in October 2008.

Data from a new study funded in part by the Agency for Healthcare Research & Quality (AHRQ) revealed a robust reduction in patients' blood sugar levels when pharmacists or nurses were utilized as case managers who made independent decisions regarding medication use instead of waiting for physician approval.

An incident that tied a compounded drug solution to three deaths and eight acute illnesses has captured the attention of both the media and the many pharmacists who regularly compound critical care drug products for hospital use.

The Food & Drug Administration recently issued letters to three pharmacies warning them to "stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nationwide." The three named companies, RoTech Healthcare, CCS Medical, and Reliant Pharmacy Services, were all warned that if they did not comply, they risked injunctions and the possible seizure of their products in question.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recently created a consensus statement on the management of hyperglycemia in patients with Type 2 diabetes. "This is a consensus document that is supported by evidence from clinical trials. Some of the recommendations are based on expert opinion, but this is true for any guideline. These guidelines will likely be useful to pharmacists and nurses because many times their practice is driven by guidelines," stated Stuart Haines, Pharm.D., FCCP, FASHP, professor and vice chair for education at the University of Maryland school of pharmacy.

Managing patients with valvular heart conditions can be a real challenge. They often require lifelong monitoring, with replacement surgery and subsequent anticoagulation. Recently, in a joint effort, the American College of Cardiology (ACC) and the American Heart Association (AHA) revised their 1998 recommendations to create the ACC/ AHA 2006 Practice Guidelines for the Management of Patients with Valvular Heart Disease. The executive summary and recommendations were published in the Aug. 1, 2006, issues of the Journal of the American College of Cardiology and Circulation.

For a disease that affects an estimated 3.9 million Americans, the treatment of choice works only about 50% of the time for patients with genotype 1, the most common type of hepatitis C virus (HCV) found in the United States, according to the Centers for Disease Control & Prevention. Sustained response rates are slightly higher in genotypes 2 and 3 (up to 80%).

In an effort to improve the care of patients with sexually transmitted diseases (STDs), the Centers for Disease Control & Prevention recently updated its STD guidelines. The update is an evidence-based document, the result of experts' evaluation of the medical literature since the previous publication of Sexually Transmitted Diseases Treatment Guidelines in 2002.

The pharmacy community seems to be solidly behind the Food & Drug Administration's move to switch Duramed Pharmaceuticals' Plan B (levonorgestrel) emergency contraception to over-the-counter status. In giving the green light, the FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for girls 17 and younger.

A majority of pharmacists want an overarching federal approach to drug pedigree laws, according to an Instant Poll on Drug Topics' Web site, posted in August. Fifty-six percent of the 538 voters stated that they preferred a standard law across the country to a patchwork of state laws.

A Pharmacy Quality Alliance work group is drafting a starter set of measures to evaluate pharmacy performance under Medicare Part D. This is a part of CMS' pay-for-performance approach, under which health plans would pay pharmacists who perform according to metrics identified by industry stakeholders.

Mark McClellan, M.D., Ph.D., chief administrator of CMS, will leave the agency in early October. McClellan had run the agency since March 2004 and has been both lauded and criticized for his management during implementation of the Medicare Part D drug plan this year.