Clinical News

The always high-interest Late Breaking Clinical Trials at the Annual Scientific Session of the American College of Cardiology, held in Orlando, Fla., were particularly notable this year. First, they included an unprecedented three individual sessions on the antiplatelet agent Plavix (clopidogrel, Sanofi-Aventis). Second, justifying the plunge to lower and lower LDL-cholesterol (LDL-C) targets, they included strong results for a trial of 80 mg of atorvastatin (Lipitor, Pfizer), and, finally, they featured a session with conflicting messages on the risks of COX-2 inhibitors.

How do you increase the dispensing rate of generic prescription drugs in a state that's in the backyard of some of the largest name-brand pharmaceutical companies? That was the dilemma facing Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare Services Inc., New Jersey's largest health insurer.

Compounding pharmacies were put on the defensive recently after a group of health organizations asked federal regulators to crack down on how the pharmacies market their products.

Everyone knows market competition isn't pretty, but the battle between Big Pharma and generic manufacturers is often downright nasty. That's especially true as some generic companies fight Big Pharma—and one another—to stop a practice they find particularly abhorrent: authorized generics. The only thing everyone agrees about is that no one knows where the issue goes from here—to Congress or the Supreme Court.

Everyone knows market competition isn't pretty, but the battle between Big Pharma and generic manufacturers is often downright nasty. That's especially true as some generic companies fight Big Pharma—and one another—to stop a practice they find particularly abhorrent: authorized generics. The only thing everyone agrees about is that no one knows where the issue goes from here—to Congress or the Supreme Court.

The Rx Outreach program, from Express Scripts Specialty Distribution Services Inc. (ESSDS), is the first prescription drug assistance program for generic drugs. Through the program, begun in November 2004, more than 108 million lower-income adults and children can purchase more affordable medications.

Employers like pharmacy benefit programs that encourage members to use generic equivalents—or do they? Two industry-sponsored studies show that the generic prescriptions are continuing to grow as a percentage of total prescriptions filled. However, another study of employer trends, by a nonprofit research firm, showed a decrease in the percentage of workers in the United States who belong to managed care plans that require the use of generic products when they are available.

Generic drug use varies widely by state, according to an Express Scripts study that measured per-capita generic drug utilization in 2003 using a random sample of approximately three million pharmacy benefit plan members.

The generic pharmaceutical industry has hit some speed bumps. Sales by individual generic drugmakers such as TEVA continue to soar, but the industry as a whole is growing about 10% annually. That's not bad compared with the 6% annual growth the typical brand-name drugmaker is logging. But it's a far cry from the 20% to 50% annual growth generic firms have been accustomed to seeing in the past.

Generic and name-brand prescriptions bought over the Internet may be cheaper, but the quality may be severely compromised, according to researchers who published their findings in Science (July 2004). "Reports have been in the news about "battle lines" being drawn between those in favor of drug importation and those opposed," said principal investigator Michael A. Veronin, R.Ph., Ph.D., in an interview. Veronin is an assistant professor of pharmacy practice in the school of pharmacy at the Texas Tech University Health Sciences Center in Amarillo.

When patients don't take their prescribed medications, they often get sicker. The high cost of drugs makes them cost prohibitive to many people. Generic drugs cost significantly less than branded drugs. Putting these three well-established facts together leads some researchers to believe that the availability of generics may positively affect patient compliance.

The Generic Pharmaceutical Association (GPhA) kicked off its 2005 annual meeting in Boca Raton, Fla., in February with an impressive array of allies from the Bush Administration, the Food & Drug Administration, and the Centers for Medicare & Medicaid Services, as well as top leaders from the generic pharmaceutical industry.

Management strategies for nosocomial pneumonia are changing. The American Thoracic Society and the Infectious Diseases Society of America just issued the first new guidelines for the treatment of hospital and healthcare-related pneumonia in nine years. They appeared in the February issue of American Journal of Respiratory and Critical Care Medicine.

Most hospitals are not complying with standard guidelines for antibiotic (ABX) prophylaxis before surgery. Barely more than half of patients in a recent study received antibiotics within one hour of the initial incision. Less than half of patients were taken off ABX prophylaxis within 24 hours following surgery. The result is an unknown number of surgical site infections that could have been prevented with more appropriate treatment.

Without prompt intervention, as many as 30% of patients with heparin-induced thrombocytopenia (HIT) will die, and an additional 10% to 20% will require limb amputation. HIT is an antibody-mediated reaction to heparin that produces a procoagulant state, during which patients are at increased risk for thromboses.

A 60-year-old woman, A.R., with rheumatoid arthritis for two years, is being discharged from your hospital after acute myocardial infarction (MI). She uses methotrexate (MTX) 30 mg weekly subcutaneously but still experiences joint pain and swelling; she takes naproxen regularly. Dismissal orders are nitroglycerin 0.4 mg sublingual p.r.n., metoprolol 25 mg, atorvastatin 40 mg, aspirin 162 mg, warfarin 2.5 mg (all q.d.); INR level twice weekly; lipid levels in six weeks. Her physician is pondering whether to add etanercept (Enbrel, Immunex) or another disease-modifying antirheumatic drug (DMARD) to MTX to better control RA. What do you recommend?

Supposedly technicians are not allowed to screen for drug therapy problems, but isn't that exactly what they're doing when they routinely zip past a blizzard of DUR alerts?

A North Carolina coed's death from an overdose of compounded lidocaine gel applied prior to laser hair removal is under investigation by the state pharmacy and medical boards and the Food & Drug Administration.

Hospice Pharmacia (HP), a division of excelleRx, Philadelphia, recently released its Pediatric Medication Use Guidelines (P-MUGs) to the company's 400 partnering hospices around the country. The new tool will provide medication protocols that will aid healthcare workers in the management of end-of-life symptoms for terminally ill children. Up to now, the firm used guidelines designed to manage pain and palliate symptoms in adults.

The good news in the area of pediatric cancer is that many such conditions have become curable. The bad news is that chemotherapies, radiation, and surgical treatments used to attain the cures have toxicities that can surface years later. And these toxicities are becoming a problem as more pediatric cancer survivors age into adulthood.

With a boost from actress Suzanne Somers' new book extolling hormones as the fountain of youth, many compounders are cashing in on bioidentical hormone replacement therapy. But critics contend that such untested products put profits before patients.

When the Centers for Medicare & Medicaid Services was trying to figure out how to implement the Congressional mandate for medication therapy management programs (MTMPs) in the new Medicare prescription drug benefit, the bureaucrats scratched their heads and asked for guidance. Now, the message out of Washington, D.C., is "Never mind."

Of overall computer entry errors, 56% are caused by distractions, according to a U.S. Pharmacopoeia 2003 MEDMARX study. In addition, distractions were cited in 78% of computerized physician order entry (CPOE) errors in reports "that documented a contributing factor other than 'none,'" said John Santell, director of educational program initiatives for the U.S. Pharmacopoeia in Rockville, Md.

When clinical pharmacists teamed up with hospitalists, patient stays were shorter and drug costs lower, according to a study conducted at Brookhaven Memorial Hospital Medical Center in East Patchogue, N.Y., and presented at the 2004 annual meeting of the Society of Hospital Medicine in New Orleans.

If you have a leaky pipe, you call a plumber, not an electrician. Similarly, if you are in a hospital and receiving prescription drugs, having a pharmacist—the drug expert—review your medication orders is the right thing to do. Certainly, the Joint Commission on Accreditation of HealthCare Organizations thinks so.

At the recent annual meeting of the American Society of Hematology held in San Diego, researchers reported improved results with certain types of leukemia. These outcomes were achieved by using higher drug dosages to treat early chronic myelogenous leukemia (CML), and equivalent results occurred with a more convenient subcutaneous, rather than intravenous, route for delivering a biologic for chronic lymphocytic leukemia (CLL).

Relief is finally at hand for patients with leukemia or lymphoma who must undergo extremely high dose chemotherapy and radiation to prep for bone marrow transplant. A new agent will reduce their chances of developing mucositis-severe ulceration of the oral mucosa caused by the cancer treatments themselves.

Relief is finally at hand for patients with leukemia or lymphoma who must undergo extremely high dose chemotherapy and radiation to prep for bone marrow transplant. A new agent will reduce their chances of developing mucositis-severe ulceration of the oral mucosa caused by the cancer treatments themselves.

True to form, ASHP took the high road on several issues during a press conference at its midyear meeting in Orlando last month.

Disruptions in influenza vaccine supplies are creating headaches. Faced with one of the lowest stocks of flu vaccine on record, the Centers for Disease Control & Prevention has issued interim guidelines on flu vaccination, prophylaxis, and treatment. CDC recommends that HIV/AIDS patients and seven other high-risk groups be vaccinated against influenza. Patients at highest risk should receive chemoprophylaxis and antiviral treatment under certain circumstances.