Clinical News

Pharmacists who see a move toward outpatient parenteral therapy are riding the latest shift in patient care. A new report from the Emerging Infections Network (EIN) found that OPAT, outpatient parenteral antimicrobial therapy, has become the de facto standard of care in most hospitals. EIN is part of the Infectious Diseases Society of America.

The 2007 pipeline promises novel therapeutic classes for some diseases but no new drugs in others

In a move that surprised both compounding proponents and advocates, the American Medical Association Board of Trustees adopted a resolution calling for Food & Drug Administration oversight of pharmacy-compounded bioidentical hormones. The resolution, which, according to sources at the AMA, passed with little opposition, also included an amendment that called on the FDA to regulate the use of the term bio-identical hormones.

A new software version for managing orders and calculations for total parenteral nutrition (TPN) compounding was released by Baxa Corp. in August. The company supplies about 70% of the nation's hospitals with automated TPN compounding products.

So you've decided to provide medication therapy management (MTM) services to your Medicare Part D patients. Which technological product should you use to document and bill for these services? "Technology plays a very significant role," commented Stefan Merlo, Pharm.D., manager of pharmacy practice and operations at the National Association of Chain Drug Stores. "If pharmacies are not able to properly document and bill for their services, the process is not going to work."

Protocolized Care for Early Septic Shock (ProCESS), a new multicenter research consortium, is beginning a large-scale study to determine whether specific interventions can halt the progression to severe sepsis or septic shock. Every year, about 750,000 people in the United States are affected with severe sepsis and about 200,000 people die from it. Sepsis is a syndrome characterized by a systemic response to infection that can rapidly lead to death. It is the leading cause of death in noncoronary intensive care units.

Over the years, long-term use of immunosuppressive medications has shown that they reduce morbidity and mortality in transplant patients. One of physicians' challenges is to balance the risk of organ rejection caused by underimmunosuppression with the risk of drug toxicity, secondary infections, and posttransplant lymphoproliferative disorders caused by overimmunosuppressing the patient.

Several dozen neuropsychiatrists and others, at a recent meeting in Washington, D.C., emphasized the need for a national postmarketing surveillance system for drugs. But how will the country move to such a system?

NeoFax recently released an updated version of software for the preparation of total parenteral nutrition solutions for neonatal infants. Named WebApp, the software's data are based on what company officials say is the most widely used neonatal drug manual in the world- NeoFax: A Manual of Drugs Used in Neonatal Care-first published nearly 20 years ago.

A new software version for managing orders and calculations for total parenteral nutrition (TPN) compounding was released by Baxa Corp. in August. The company supplies about 70% of the nation's hospitals with automated TPN compounding products.

New legislation in California takes hospital reporting of serious medication errors to a new and very public level. Signed by the governor in late September, the law requires all hospital medical errors posing serious harm, including medication errors, to be posted on the state Department of Health Services' Web site. The Web site must include a description of the error, any corrective steps taken by the hospital or the state, and the name of the facility.

Suppose you were able to evaluate a hospital based on how well it has implemented quality and safety initiatives. The Leapfrog Group set out to do just that when it commissioned a survey to establish a national rating system that offers a broad assessment of a hospital's quality and safety. Fifty-nine hospitals have been named to Leapfrog's top hospitals list based on data from its survey.

Fungal infections are on the increase, but not for all the usual reasons. Increasing rates of bacterial and viral infections are due in large part to growing resistance to antimicrobials, but fungi and antifungals are different.

The International Society for Heart & Lung Transplantation (ISHLT) has released the first international guidelines for managing heart failure (HF) patients prior to heart transplantation. HF is a serious condition in which the heart is unable to pump blood at a rate sufficient to meet the needs of the body. "The new guidelines will enhance the effectiveness of patient care, optimize patient outcomes, and improve overall cost by focusing resources on the most effective strategies," said Mariell Jessup, M.D., ISHLT task force chair and professor of medicine at the University of Pennsylvania Medical Center.

A 20-year-old patient, T.C., managed in your hospital's asthma clinic has recently been diagnosed with paroxysmal supraventricular tachycardia (SVT). To control his asthma, T.C. uses a fluticasone 250 mcg/salmeterol 50 mcg inhaler (Advair Diskus, GlaxoSmithKline) regularly plus an albuterol inhaler as needed. T.C.'s physician suspects the beta agonists used to control asthma could be a factor in T.C.'s episodes of SVT. He requests a pharmacist consult about how best to deal with the asthma to prevent episodes of heart arrhythmia. What do you suggest?

Diabetes is undertreated among inpatients, especially acute care patients, sometimes with devastating results. "Blood glucose levels are too often not treated as intensively as other medical conditions among floor patients," said Almut G. Winterstein, Ph.D., assistant professor of pharmacy health care administration at the University of Florida College of Pharmacy. "If hospitals made a more aggressive effort, it could save quite a significant number of lives."

Dasatinib (Sprycel, Bristol-Myers Squibb) is a new tyrosine kinase inhibitor for chronic myelogenous leukemia (CML). The Food & Drug Administration approved the drug in June, and now the National Comprehensive Cancer Network (NCCN) has added dasatinib to its CML guidelines.

Drug-eluting stents (DESs) greatly reduce the chances of restenosis, a gradual growth of abnormal cells within the stent. However, the results of a new study reveal that DESs may also put patients at a higher risk for a sudden and potentially fatal thrombosis.

The Food & Drug Administration recently approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioids for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the first tablet formulation of the opioid fentanyl. It is also the first new medication approved for the treatment of breakthrough pain in opioid-tolerant patients with cancer since 1998.

At most large tertiary care hospitals and academic medical centers, around-the-clock pharmacy service is relatively common. But in some small and rural hospitals, 24-hour, seven-day-a-week pharmacy coverage is not economically feasible or practical. How are pharmacy services provided in those facilities? And how do health-system pharmacists feel about a Joint Commission on Accreditation of Healthcare Organizations proposal that would require all hospital pharmacies to provide 24/7 service?

So you've decided to provide medication therapy management (MTM) services to your Medicare Part D patients. Which technological product should you use to document and bill for these services? "Technology plays a very significant role," commented Stefan Merlo, Pharm.D., manager of pharmacy practice and operations at the National Association of Chain Drug Stores. "If pharmacies are not able to properly document and bill for their services, the process is not going to work."

Notwithstanding its concerns about the safety of Alaris SE infusion pumps, the Food & Drug Administration is not requiring manufacturer Cardinal Health to recall the 140,000 pumps in use in thousands of hospitals around the country.

Tracking and locating lost medications is a chronic problem for many hospitals. When a medication gets lost, there are so many different places it can be, including the several different drop-off points along the way before a drug reaches a patient.

Tracking medication errors in an inpatient hospital setting is fairly common. But what about errors that occur when patients self-administer, or when parents administer drugs to their children at home? Who checks to see if patients are being compliant, or if prescribing errors have been made? Did the family members who are charged with dispensing to children understand the instructions? Or are they doing things doctors and pharmacists are not expecting them to?

While the Food & Drug Administration has always been deeply concerned with drug safety, the organization is taking new and improved measures to pay closer attention to this issue, said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs at FDA.

As a physician at Eli Lilly & Co., the manufacturer of Xigris (drotrecogin alfa [activated]), I am responding to an article that appeared in your Aug. 21 issue, referencing a pharmacy technician who created a "Xigris calculator."

Drug delivery systems are hot. As they expand into more and more therapeutic categories, they are altering the status quo of drug administration for an increasing number of patients. They are also fueling a need for patient education, a need that is perhaps unobtrusively shaping the face of pharmacy.

In some patients with acute myocardial infarction (MI), the use of sirolimus (Rapamune, Wyeth)-eluting stents drastically reduced the rate of in-stent restenosis at one year, compared with uncoated, bare-metal stents, according to the results of a new study.

The 2006 World Congress of Cardiology (WCC) was host to more than 25,000 cardiologists this year. Noteworthy among the thousands of presentations were several large-scale drug trials, most of which evaluated agents affecting the renin-angiotensin system (RAS).