Clinical News

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.

Heart failure (HF) is a major health problem and a leading cause of hospitalizations among the elderly. Keeping pace with the new treatment approaches, the American College of Cardiology (ACC) and the American Heart Association (AHA) task force recently released updated Guidelines for the Diagnosis and the Management of Chronic Heart Failure in the Adult.

Several articles, published over the past several years, have demonstrated the benefit of clinical pharmacy rounding in intensive care units. Benefits documented include improved quality of care as well as cost savings to the institutions. Our health system recently added clinical pharmacists to patient rounding and found that it has improved our patients' outcomes.

When an Ohio pharmacist recently called Medco Health Solutions to sign up to provide medication therapy management (MTM) services to Medicare beneficiaries, the giant pharmacy benefit manager basically told him to get lost.

Hospitals are seeing the advent of a new generation of systems in the context of computerized physician order entry (CPOE) that are more user-friendly and yield a quicker return on investment (ROI). Several products have evolved in the marketplace. These products are called Paperless Pharmacy Order Systems (PPOSs). They provide a paperless environment in pharmacy and a work-flow engine between pharmacists and clinicians.

Automation governs medication-dispensing systems in many health systems, enhancing safety and efficiency-as long as the computers that operate the systems don&t crash. A growing trend in automation aggressively addresses this problem by allowing vendors to remotely monitor automation computer servers in real time, preventing crashes before pharmacists even know there&s a problem.

Given that errors involving intravenous medications may carry the greatest risk of morbidity and mortality, health professionals are welcoming the advent of smart pumps with programmable safety features that alert hospital staff to potential errors in IV infusions. Implementing such systems involves getting technology vendors, along with pharmacy, nursing, and medical staffs, to communicate with each other so that infusion systems and medical records systems work together.

At Saint Francis Hospital and Medical Center in Hartford, Conn., the pharmacy department has been ahead of the technology curve for quite some time compared with most other hospitals. That's evident from a visit Drug Topics editors paid recently to the hospital.

Patients taking the blood-thinning medication warfarin have fewer complications when managed by a specialized anticoagulation service than do those who receive usual care from their physicians. That was a finding of a study conducted by Kaiser Permanente's Clinical Pharmacy Anticoagulation Service.