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.
Genetic testing and custom-tailored drug treatments promise a sea change in pharmacy practice
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.
Latebreakers
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.
DEA is designating six pharmaceutical products as exempt anabolic steroids under the Controlled Substances Act. The reason is that these six products are similar to other preparations that have already been exempted.
DEA has issued a final rule regarding new registration fees. As of Nov. 1, pharmacies applying or renewing their DEA registration must pay an annual fee of $184.
On Sept. 5, U.S. marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advance Arthritis Support capsules distributed by Advantage Nutraceuticals LLC of Fort Walton Beach, Fla., valued at about $55,000. The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
PhRMA is introducing a multimedia national health education campaign to promote cancer awareness. The effort stresses the importance of patients consulting with their healthcare providers.
How will new travel rules affect OTC/HBC sales?; How will new travel rules affect OTC/HBC sales?
As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.
As the saying goes, two are better than one. And that's just what Takeda Pharmaceuticals is saying about its new combination drug recently approved by the Food & Drug Administration. Duetact takes pioglitazone (Actos, Takeda)-a thiazolidinedione-and adds glimepiride-a sulfonylurea-in an effort to offer Type 2 diabetes patients a new, once-daily alternative.
Paul Duncsak, a pharmacist who was employed by Franklin Lakes, N.J.-based Medco Health Solutions, was found shot to death in his Ramsey, N.J., home on Aug. 23. According to newspaper reports, Duncsak was involved in a bitter divorce and child-custody battle with his ex-wife.
There are several important things that all Medicare Part D beneficiaries can do to avoid falling in the Medicare Part D "donut hole," according to the Academy of Managed Care Pharmacy. Recommendations from the organization include make use of generic drugs whenever appropriate; talk to your doctor or pharmacist about alternative drugs; don't stop taking your medications to save money; talk to your doctor or pharmacist about cutting tablets in half; and remember to use your Medicare card each time you purchase drugs, whether or not you have reached the donut hole.
Seventy-nine percent of drugs and medical devices are approved by the FDA's outside advisory panels, according to a study conducted by National Research Center for Women & Families. The Washington-based nonprofit research group termed the committees as little more than "rubber stamps" for drug companies.
After a computer glitch sent out more than $50 million in reimbursements to approximately 230,000 Medicare recipients, CMS plans to ask for the money back. Some Medicare beneficiaries also received letters from the Social Security Administration http://www.ssa.gov/ that erroneously said the agency will no longer deduct their monthly prescription drug benefit premiums from their Social Security checks.
