Clinical News

According to the National Center for Health Statistics, premature births are at a record high. Combine that fact with the reality of the crowded living conditions in the wake of recent hurricanes and we may have a recipe for respiratory syncytial virus (RSV) disaster this coming season.

A 70-year-old man, P.A., is seen in your ER with burning, stabbing, shooting pain on his lower back. He has recently had shingles; the emergency physician diagnoses his current discomfort as postherpetic neuralgia (PHN). The physician is debating what to prescribe and asks your opinion. You note from the patient's history that P.A. also takes donepezil (Aricept, Eisai) 10 mg, digoxin .125 mg, and benazapril 20 mg daily. What do you recommend?

The panel advised against the use of fluticasone with ritonavir because the combination resulted in significantly reduced serum cortisol concentrations.

Most surgeons misuse antibiotics most of the time. That is the blunt warning from Robert Sawyer, M.D., codirector of the surgical trauma intensive care unit at the University of Virginia Health System. The problem is not ignorance of appropriate use, he told the American College of Surgeons Clinical Congress meeting in San Francisco recently.

The treatment of elevated blood pressure reduces the incidence of stroke and leads to a significant reduction in mortality and morbidity among patients with cardiovascular problems. Although the beta-blockers are among the most widely prescribed medications for blood pressure control, not all hypertensive patients show benefit from taking these drugs.

Medication therapy management (MTM) for Medicare patients is a first step that could transform the practice of pharmacy. The kinds of services the federal government requires under Medicare Part D beginning in January will spread into the commercial market. So will payment policies, procedures, and amounts.

Patients with myelodysplastic syndrome (MDS) should be tested frequently for iron overload, a common, toxic side effect of repeated red blood cell transfusions. Patients with serum ferritin levels of 1,000 ng/ml to 2,000 ng/ml should be treated with iron chelation therapy, according to a new consensus statement, developed following a conference in Japan earlier this year. The new guidelines, published in a July 2005 supplement to Hematology-Oncology Clinics of North America, offer the first recommendations on the treatment of iron overload in these patients.

In the mid-1800s, Lady Sarah Winchester spearheaded the building of the bizarre California mansion that bears her name. While she did have a flair for design, her spontaneous plans and the results proved chaotic. Staircases led nowhere. Many doors opened to walls or steep drops, and a few bathroom doors had windows. The Victorian anomaly may be fun to visit, but it would be frustrating to live in.

Of the 3,197 sentinel events JCAHO has reviewed from January 1995 through June 30, 2005, almost 11%, or 326 incidents, involved a medication error, making it the fourth most common type of sentinel event reported.

Baxter Healthcare Corp. has received a second Food & Drug Administration Class 1 recall in less than four months for its Colleague Volumetric Infusion Pumps. The FDA's Sept. 19 recall relates to pump battery excessive discharge and swelling failures, which cause the devices to become incapable of operating on battery power for the expected amount of time. This leads to interruption or prevention of therapy and possible death or injury. Baxter said it has received reports from customers that the problem may have been associated with four deaths and 10 serious injuries.

VHA has resurrected a familiar method for hospitals to save money: Trim pharmacy costs. But instead of urging its 2,400 member hospitals to simply slash pharmacy budgets, the not-for-profit hospital alliance is helping members save by shifting prescribing practices.

Current safe-handling procedures for vials containing chemotherapy products are apparently insufficient. Recent U.S. and European tests have determined that product residues adhering to the outside of chemotherapy vials are a pharmacy hazard.

New study results published in the Lancet in September found that the use of drug-eluting stents (DESs) may be less cost-effective than bare-metal stents when used in all angioplasty patients. The results indicate that use of DESs should be limited to elderly patients in high-risk groups.

Patients with myelodysplastic syndrome (MDS) should be tested frequently for iron overload, a common, toxic side effect of repeated red blood cell transfusions. Patients with serum ferritin levels of 1,000 ng/ml to 2,000 ng/ml should be treated with iron chelation therapy, according to a new consensus statement, developed following a conference in Japan earlier this year. The new guidelines, published in a July 2005 supplement to Hematology-Oncology Clinics of North America, offer the first recommendations on the treatment of iron overload in these patients.

A recent study examining the relationship between diabetes, depression, and death demonstrates a need for diabetes patients and pharmacists to be familiar with the symptoms of depression. "We know that people with diabetes who have depression are at a much greater risk of mortality than similar people without diabetes," said Xuanping Zhang, Ph.D., a researcher with the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control & Prevention in Atlanta. "Pharmacists and physicians have a professional obligation to let patients suffering from diabetes and depression know of this risk. Absence of intervention can be life-threatening."

Central among sessions at this year's European Society of Cardiology 2005 Annual Meeting, held in Stockholm, Sweden, were those focused on the pharmacological treatment of myocardial infarction (MI). Noteworthy among those were two meetings looking specifically at the risks of such therapy, one at timing, and a fourth at an attempt to combine therapies already proven to be successful separately.

The latest science on the diagnosis and treatment of osteoporosis was the focus of many reports from the annual meeting of the American Society for Bone & Mineral Research (ASBMR), held in Nashville late last month. Here are some of the highlights.

Stroke, which results from decreased blood flow to a portion of the brain, remains a leading cause of disability and mortality in America. According to the American Stroke Association, many patients do not recognize acute stroke symptoms and most institutions lack the necessary structure to promptly and efficiently manage stroke patients.

There are a lot of lessons to be learned in the aftermath of Hurricane Katrina. Pharmacists who weathered the experience shared with Drug Topics their take on what went right and what went wrong, so that in the future, risks to patient safety could hopefully be kept to a minimum.

The Food & Drug Administration has the legal power to inspect a compounding pharmacy's facilities, drug products, and labeling, according to a federal appeals court ruling that upheld a lower court decision.

Have you always assumed a drug product marketed without a proprietary (brand) name to be a generic drug? If your answer is Yes, you may have inadvertently substituted and dispensed products that are not therapeutically equivalent. For example, the drug product albuterol sulfate HFA, manufactured by IVAX, was approved without a proprietary name on Oct. 29, 2004, under NDA 21-457. Since the IVAX albuterol sulfate HFA product is labeled with only the established (generic) name, one could easily assume this is a generic version of one of the other two currently marketed albuterol sulfate HFA products: Proventil HFA and Ventolin HFA.

Where there is crisis, there is also opportunity, and one Wichita, Kan., pharmacist sees plenty of that. Only a handful of Kansas hospitals can afford 24-hour pharmacy service. "Once the day-shift pharmacist goes home, many hospitals have a tech or a nurse taking over," Mark Gagnon said. "They don't want to do the pharmacist's job, but what do you do when there's no pharmacist until tomorrow or even next Monday?"

Mercy Hospital, Miami, Fla., is using discounted Rxs to lure patients into a preventive healthcare program. The hospital estimates that 4,000 patients saved an average of $140 for the 10,000 program prescriptions filled during the first quarter of 2005.

Significant deviations from good manufacturing processes in repackaging and relabeling active pharmaceutical ingredients are what the Food & Drug Administration cited in a letter sent to Pragmatic Materials Inc. in June. During site visits in February, the agency found that the company, which repackages ingredients for use by pharmacies for compounding drug products, had not performed the appropriate tests to support the expiration dates assigned to at least six ingredients. Violations such as these can ignite fear and concern in hospital pharmacists and administrators who are outsourcing their sterile or nonsterile products to compounders to save staff time, cut hospital costs, and comply with new regulations.

CMS. HQA. ASHP. Leapfrog Group. NQF. JCAHO. AHQA. VA. AHRQ. The list of regulators, professional associations, government agencies, payers, consumer groups, and others that claim to set standards for health care seems to grow daily. Every new standard, every new information request, every new effort to assess or improve quality adds to the hospital administrative burden.

Hospitals and pharmacies will be adding radio frequency identification (RFID) tags in the years ahead to curb drug counterfeiting. What is RFID? According to the Association for Automatic Identification and Mobility (AIM), a basic radio frequency identification, or RFID, system consists of three components: an antenna or coil, a transceiver (with decoder), and a transponder, which is also called an RF tag and is electronically programmed with unique information.

Many wonder whether the focus of genetically directed pharmacotherapy should be tied to race at all. According to the Nuffield Council on Bioethics, race and ethnicity cannot be given precise biological or genetic definitions because of the considerable genetic variation within population groups depending on the patient's place of birth and other variables.

The Centers for Medicare & Medicaid Services wants to change the way it pays for drugs administered by hospital outpatient services. Starting in 2006, CMS proposes to pay hospitals the average sales price (ASP) plus 8% under the Outpatient Prospective Payment System (OPPS).

Beta-blockers are the top choice for prevention of postoperative atrial fibrillation (AF) and control of ventricular rate, according to the first evidence-based clinical guidelines for the prevention and management of postoperative AF after cardiac surgery, published recently by the American College of Chest Physicians (ACCP).

A 35-year-old patient, C.A., with a mechanical heart valve, has had an INR of 2.5 to 3.5 for several years while on warfarin therapy. Today, at her visit to your anticoagulation clinic, she confides that she is six weeks' pregnant.