Clinical News

A 28-year-old African-American man with sickle cell disease, B.B., will be admitted to your hospital to undergo a hip replacement. B.B. has a significant chronic pain problem and uses a regular schedule of controlled-release oxycodone 60 mg every 12 hours plus oral transmucosal fentanyl 400 mcg (Actiq, Cephalon) for breakthrough pain crises (less than two doses per day). He is controlled at a pain level of 2; he also takes hydroxyurea 2,000 mg/day. The surgeon asks you about dealing with B.B.'s pain medications in preparation for surgery. Should drugs be held, decreased, or continued as usual?

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.

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.

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.

As in years past, this year's American Diabetes Association annual meeting offered attendees the latest scoop on the treatment of this growing disease. Marking this year's presentations were those dealing with investigational oral agents and a simplified algorithm for dosing mealtime insulin. Other sessions highlighted unexpected findings: glucose-lowering properties of a lipid-lowering agent and protection from nephropathy with oral contraceptives.

A subdermal implantation of a single etonogestrel-containing rod can prevent pregnancy for up to three years. Does this sound too simple to be true? The manufacturer of Implanon, Organon Inc., is hoping women will be intrigued. The Food & Drug Administration approved the new 68-mg implant just last month. It contains the same component that's in the company's vaginal contraceptive, NuvaRing.

As antimicrobial resistance continues to increase inexorably, the good news is that so far there are very few clinical situations for which there are no therapeutic options, said Robert Moellering Jr., M.D., researcher at Harvard Medical School. "But we are getting very, very close," he warned.

The exhibit floor at the ASHP summer meeting in Orlando was sizzling with the latest wares on display for hospital pharmacy in categories ranging from automation solutions to dispensing equipment, computer hardware and software, drug administration devices, packaging equipment, and pharmacy management services.

Pharmacists are still divided over whether the mandate to drop the B.S. degree was a bad call

In August 2005, Woodland Heights Medical Center (Lufkin, Texas) pharmacy technician Fred Poage, CPhT, was taking a computer programming course while pursuing a mathematics degree at nearby Stephen F. Austin State University. Staff pharmacist Eddie Purifoy, R.Ph., challenged Poage to put the course to good use. "Why don't you do something really useful-tackle this Xigris problem?"

The Centers for Medicare & Medicaid Services has joined a growing list of payers that are giving hospital patients and other medical consumers detailed price and quality information. In June, CMS posted its negotiated rates for 30 common hospital procedures at www.cms.hhs.gov/healthcareconinit/01_overview.asp. Other hospital data are at www.HospitalCompare.hhs.gov.

The formula being used by Medicare to determine the reimbursement rates for intravenous immune globulin (IVIG) is creating serious problems for patients, physicians, hospitals, and pharmacists. The formulas used were changed for physicians' offices and homecare settings in 2005 and for hospital-based settings at the beginning of 2006. Reimbursement rates for almost all approved IVIG products are now below the costs of the products and this, combined with periodic supply shortages, has had patients and hospitals scrambling.

Hospitals with large indigent patient populations have a new financial ally: the Medicare Part D outpatient pharmacy benefit.

A 55-year-old male, P.N., is being followed in your cardiovascular risk reduction clinic. He has been titrated up on Avalide (irbesartan/hydrochloro-thiazide, Bristol-Myers Squibb/Sanofi-Aventis) and today his blood pressure is 130/80. He also takes Vytorin 10/80 (ezetimibe/simvastatin, Merck/Schering- Plough) daily. His current lipid panel is HDL 42, LDL 79, TC 145, triglycerides 120, but he is complaining of severe muscle pain of recent onset. Four days ago, his physician prescribed Ketek (telithromycin, Sanofi-Aventis) 800 mg daily for acute sinusitis. His sinusitis is now asymptomatic. What do you recommend?

The American Society of Clinical Oncology (ASCO) recently issued updated evidence-based practice guidelines for the use of antiemetics in patients who are receiving chemotherapy or radiation. Chemotherapy-induced emesis can negatively affect a patient's quality of life and may have an impact on compliance with future treatments. Approximately 70% to 80% of all cancer patients receiving chemotherapy experience emesis.

Tenfold drug administration errors are common and pernicious in healthcare systems, but they could be almost entirely eliminated. They occur when a decimal placement is written incorrectly or misread. Decimal errors can result in a 10-fold, 100-fold, or even 1,000-fold overdose or underdose. But experts say providers rarely need to use decimals, and, when they are necessary, many steps can be taken to limit errors.

The Institute of Medicine (IOM) recently released Preventing Medication Errors, a 544-page report that is the fourth in its Quality Chasm series. The authors concluded that medication errors harm at least 1.5 million people per year in the United States. In addition, the cost of treating drug-related injuries that occur in hospitals alone conservatively amounts to $3.5 billion per year, according to the Committee on Identifying and Preventing Medication Errors, which wrote the report. The report was funded by the Department of Health & Human Services and the Centers for Medicare & Medicaid Services.

A 76-year-old woman, L.R., is seen in your hospital for a hot, painful, red, swollen leg injury. Deep vein thrombosis is ruled out by ultrasound. L.R. is diagnosed with superficial venous thrombosis and compression stockings are prescribed. L.R. maintains her varicose vein problem worsened significantly when she started nisoldipine (Sular, First Horizon Pharmaceutical) for blood pressure control. L.R.'s physician asks you about this possibility. He also asks you to recommend an alternative drug (to nisoldipine) for L.R.'s hard-to-control hypertension. She currently takes valsartan (Diovan, Novartis) 320 mg, hydrochlorothiazide (HCTZ) 50 mg, plus nisoldipine 20 mg/d. Her BP averages 145/90. Her only other medicine is prednisone 2 mg. What do you recommend?

Since cancer is the No. 1 area for drug research, it's no coincidence that more than 400 targeted compounds are in development and scores were touted at the recent annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Below is a sampling of promising new or improved cancer fighters:

The Food & Drug Administration recently approved the fentanyl iontophoretic transdermal system (IONSYS, Alza Corp.), the first needle-free, patient-activated transdermal analgesic (PATS) system. IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Alza said that it expects to start distributing IONSYS in 2007.

USP wants input from healthcare practitioners and other interested parties regarding the proposed revisions.

Most of the affected individuals are older females with hypertension who are being treated with agents known to affect renal perfusion.

The Food & Drug Administration recently approved three generic versions of simvastatin (Zocor, Merck), the largest-selling drug yet to be opened to generic competition. For the next 180 days, Teva will have exclusive rights to sell the 5-, 10-, 20-, and 40-mg dosages of simvastatin and Ranbaxy will have the rights to sell the 80-mg dosage. In addition, Dr. Reddy's Laboratories will sell all five dosages under an agreement with Merck to be the authorized generic manufacturer of the drug.

Making sense of Medicare Part D prescription drug plans has been a major challenge for seniors. But for Medicare Part D recipients who have received organ transplants, choosing a plan is the least of their problems.

A 28-year-old woman, S.A. (two months' pregnant), is brought to your ER by her husband, who believes she is suicidal. According to your health-system medical records, S.A. was diagnosed with bipolar II disorder several years ago. She was previously treated with lithium and lamotrigine (Lamictal, GlaxoSmithKline) separately but was noncompliant. Her psychiatrist is weighing a mood stabilizer and/or antidepressant therapy during pregnancy. He asks for your recommendation.

Of the thousands of drug studies presented at the recent meeting of the American Association for Cancer Research (AACR) in Washington, D.C., two took center stage as "genuine breakthroughs in colon cancer treatment and prevention." First, international scientists cited the biologic panitumumab (Amgen) for extending progression-free survival in advanced cancer patients. Then they hailed new research on celecoxib's (Celebrex, Pfizer) potential to prevent colon cancer-despite concern about heart-related side effects.

While most people haven't had time to digest the intricate details of the United States Pharmacopeia's proposed changes to General Chapter 797 (Pharmaceutical Compounding-Sterile Preparations), response to the protracted document has been almost universally positive.