Clinical News

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.

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.

Some help for battling the obesity epidemic may be arriving, according to continuing encouraging results for rimonabant (Acomplia, Sanofi-Aventis), not just in helping weight loss but also in improving metabolic risk factors. Other research at this year's American Heart Association 2004 Scientific Sessions, held recently in New Orleans, focused, as well, on metabolic effects of pharmacological agents.

Of the hundreds of posters at this year's Interscience Conference on Antimicrobial Agents and Chemotherapy, only seven featur-ing preclinical antibiotics research worldwide were selected as worthy of mention by the ICAAC program committee in its annual poster summary. Of these, only two were called "outstanding" by expert Steven J. Projan, Ph.D., Wyeth research, who warned in a press briefing, "Fewer and fewer important antibiotics are being developed." Here are the two he recommended for special attention by ICAAC attendees:

Community Care Rx (CCRx), the discount card created by the National Community Pharmacists Association, will pay pharmacists for medication therapy management services (MTMS) to help position the profession as a player when the Medicare prescription drug benefit comes on line in 2006.

Anesthesia awareness-the unexpected cognizance that occurs when anesthesia lightens during surgery-is the subject of a recent Sentinel Event Alert issued by the Joint Commission on Accreditation of Healthcare Organizations. Forty-eight percent of patients who experience awareness report auditory recollections, 48% report being unable to breathe, and 28% report pain-without being able to communicate this to the surgical team.

A 60-year-old Hispanic man, L.C., is being discharged from your hospital after an episode of gastrointestinal bleeding. Prior to admission he was switched to naproxen 500 mg b.i.d. for his osteoarthritis when rofecoxib (Vioxx, Merck) was taken off the market. Dismissal orders include ongoing medications: metformin 850 mg b.i.d., pravastatin 40 mg q.d., ramipril (Altace, Aventis) 10 mg q.d., now with the addition of lansoprazole (Prevacid, TAP) 30 mg q.d. L.C.'s physician is in a quandary about whether to prescribe a different COX-2 inhibitor or an NSAID. Previously, L.C. failed to obtain pain relief from acetaminophen or salsalate therapy. What do you recommend?

Nationwide drug shortages, many of which are caused by manufacturing problems, often leave hospital-based healthcare professionals in a bind. A few years ago, when Wyeth-Ayerst announced the imminent unavailability of hyaluronidase (Wydase), it sent shock waves throughout the hospital community.

Chest pain is exceeded only by abdominal pain as the reason people visit their local emergency department. The American Heart Association (AHA) estimates that 6.8 million Americans have chronic stable angina (CSA). In 1999, the American College of Physicians (ACP) and the American College of Cardiology (ACC) and AHA developed joint guidelines on the management of patients with CSA. ACC/AHA updated these guidelines in 2002, and ACP recognized the document as a scientifically valid, high-quality review of the evidence and background paper.