Clinical News

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.

Compounding pharmacists who would like to put their practices to the test can now apply to earn the seal of approval offered by the Pharmacy Compounding Accreditation Board (PCAB).

The pharmacy associations and pharmacy schools in seven ruralstates have signed up for a two-phase demonstration project toshowcase the ability of pharmacists to deliver medication therapymanagement (MTM) services to Medicare patients.

Where once treatments were lacking for myelodysplastic syndromes,now several drugs have been approved for this bone marrow disorder

The link between tubing and catheter misconnections and serious errors, including patient deaths, has been a well-known but underreported problem for years. Hoping to get device manufacturers and healthcare organizations to take more aggressive action in order to reduce the number of adverse events, the Joint Commission on Accreditation of Healthcare Organizations recently issued a Sentinel Event Alert.

Pandora Data Systems recently released a multi-user, HealthInsurance Portability & Accountability Act (HIPAA)-compliantversion of its medication usage analysis software. Designed in 1989in partnership with a local pharmacist to be used in conjunctionwith his Pyxis 1000 automated dispensing system (ADS), the currentversion of Pandora is compatible with the Pyxis 3000 and theMcKesson AcuDose and Omnicell dispensing systems as well.

For many years, doses and rates of administration for continuousinfusions in pediatric patients have been based upon the "rule ofsix." This weight-based method relies on the following formula: sixtimes body weight is the amount of drug to be added to 100 ml ofcarrier fluid.

Cerner Corp.'s CareAware RxStation characterizes the nextgeneration of automated medication dispensing systems. Itintegrates electronic medical records with dispensing cabinets. "Itis a closed-loop system," said Dawn Iddings, director of resourceplanning for the company's device innovation group. "It's anend-to-end solution, fully integrating ordering, dispensing, andadministration at bedside, through a completely sealed device."

Medication errors involving neuromuscular blocking agents (NMBAs)are potentially serious and life-threatening because these agentsparalyze respiratory muscle and, if misused, can adversely affectrespiratory function. NMBAs should be administered only by staffwith experience in maintaining an adequate airway and respiratorysupport in facilities where intubation can readily be performed,oxygen can be administered, and respiratory support can beprovided.

Despite a new Food & Drug Administration mandate, which wentinto effect April 26 requiring all drugs supplied to hospitals tobe bar-coded, less than 10% of U.S. hospitals have a bedsidebar-coding system in place. Many hospital pharmacy executives saythe main reason they are not on board yet is the high cost ofimplementing it.

The pharmaceutical supply chain works wonders, bringing thousandsof drug products to hospitals just as local inventory is fallingtoward zero. The problem is that every chain, including supplychains, is prone to kinks.

Regarding the Clinical Twister in your Feb. 20 issue, the clinicalrecommendations for treating Clostridium difficile infections arecorrect but incomplete. Addition of probiotics is commonlyoverlooked, yet probably the most important therapeutic agent inrepopulating the gut with healthy flora. Probiotics are inexpensive(cost-effective) and very safe. A normalized flora stabilizes thegut, reduces diarrhea, and may help in reducing risk of C.difficile by competitive displacement.

A 68-year-old man is hospitalized with shortness of breath,fatigue, and 2+ edema-his third hospitalization in 12 months.He has heart failure (HF) (currently New York Heart Associationclass IV, ejection fraction 20%), LVH, and MI history. Heart rhythmis normal; lungs clear; lab tests within normal limits excepthemoglobin510.5 gm/dl, SrCr52.3 mg/dl; BP5160/90, pulse 85,respiratory rate522. Admitting medications: furosemide 80 mg,potassium (K), benazepril 20 mg, aspirin 81 mg, carvedilol (Coreg,GlaxoSmithKline) 6.25 mg twice daily. The resident continues allmedications, increasing furosemide to 80 mg twice daily. He askswhether adding digoxin might reduce future hospitalizations.

The National Comprehensive Cancer Network (NCCN) recently sponsoreda roundtable discussion called Cancer Care in the 21stCentury-Reality and Promise. The panelists discussed a widerange of topics, including the most important advances in cancercare since the war on cancer was declared during the NixonAdministration in 1972 and how pharmacogenomics is revolutionizingcancer treatment. The roundtable meeting, at which the group ofoncology leaders assembled for the first time, took place duringthe NCCN 11th Annual Conference, held recently in Hollywood, Fla.

Medication therapy management (MTM) was the recurring theme at thisyear's Academy of Managed Care Pharmacy (AMCP) meeting, heldrecently in Seattle. The American Pharmacists Association led aworking group of 11 pharmacy organizations to define MTM servicesin 2004. This year, a similar working group led by AMCP defined MTMprograms. The resulting consensus document was presented at theAMCP meeting.

The low molecular weight heparin enoxaparin (Lovenox, Sanofi-Aventis) is superior to unfractionated heparin as an adjunct to thrombolytic therapy in patients with ST elevation myocardial infarction (MI), researchers reported at the 55th Annual Scientific Session of the American College of Cardiology (ACC). The meeting was held in Atlanta last month.

One problem hospitals that have installed a computerized physician order entry (CPOE) system have been grappling with is the torrent of medical alerts generated by this technology.

When a new drug hits the market, it's no surprise to anyone that the price can be pretty steep. High research and development costs, along with huge promotional expenses, are part and parcel of bringing a new drug to consumers.

Virtually none of the more than 1,000 rural critical access hospitals (CAHs) in rural America can afford a round-the-clock R.Ph. on staff. And this lack of coverage can adversely affect quality by slowing the prescription review process, said Tim Stratton, R.Ph., Ph.D., an associate professor at the University of Minnesota College of Pharmacy in Duluth.

The Institute for Safe Medication Practices and ECRI, a medical device safety research company, are investigating a potentially dangerous problem with smart infusion pumps programming pads.

In the aftermath of the Sept. 11 attacks, disaster preparedness became a priority for the nation's hospitals. Then interest in the topic trailed off somewhat. But in the late summer of 2005, Hurricanes Katrina and Rita slammed the Gulf Coast, and disaster preparedness was suddenly back with a vengeance.

An ambulatory 70-year-old man, F.H., has been admitted to yourhospital with a hip fracture that will require surgery. AlthoughF.H. has a history of atrial fibrillation (AF) episodes andtransient ischemic attacks (TIA), his heart is currently in normalsinus rhythm. Medications on admission included verapamil 120 mgand warfarin 5 mg daily; fracture pain is being treated withmorphine intramuscular (IM) injections at present. F.H.'s INR(International Normalized Ratio) on admission is 2.8; bloodpressure is 135/75; lab tests were within normal limits. F.H.'sphysician requests an anticoagulation consult to aid him indetermining the timing of surgery and venothromboembolism (VTE)prophylaxis. What do you suggest?

The Food & Drug Administration has been counting on radio frequency identification (RFID) technology to be ready for widespread adoption next year, allowing drug product packages to be tagged with tiny chips containing an electronic product code or unique electronic serial number. Now the agency thinks that may not happen and is in a bit of a quandary.

People with lower-extremity peripheral arterial disease (PAD) should get treatment, including pharmaceutical treatment, comparable to that for people with established coronary artery disease. That's according to new, comprehensive guidelines on PAD from the American Heart Association (AHA) and other medical groups.

A 58-year-old man, G.C., is hospitalized with an acute myocardialinfarction (MI). His physician has prescribed metoprolol, ramipril,warfarin, and atorvastatin (Lipitor, Pfizer), but is debatingwhether to continue G.C.'s bedtime chlorpromazine 400 mg, whichhe's taken for 20 years for schizophrenia, or switch to a newermedication. G.C. is showing signs of tardive dyskinesia (TD). Hisrecent records show normal fasting blood glucose levels. His BMI is22. He is a smoker. His physician asks your opinion aboutantipsychotic therapy. What do you recommend?

Small signs of resistance to imatinib (Gleevec, Novartis) emerged soon after the drug's approval in 2001 as the first oral tyrosine kinase inhibitor for chronic myeloid leukemia (CML). But second-generation drugs with similar mechanisms of action were already in the pipeline, according to studies presented at the recent 2005 ASH annual meeting, held in Atlanta. Generally about 20% of CML chronic-phase patients relapse after three years of imatinib therapy, researchers pointed out.

New software and hardware