The doctrine of double effect—that a harmful effect of treatment is permissible if it occurs unintentionally as a side effect of a beneficial action—is “almost completely irrelevant” in the case of sedatives given in palliative end-of-life care, according to a case study from St. Christopher’s Hospice in London.

After reviewing information about 237 patients who died in the 62-bed hospice, the researchers concluded that most episodes of sedative use were brief, with no evidence that they had precipitated death. Instead, the episodes were a response to features of a dying process that had already begun. The sedatives were intended not to produce unconsciousness but to relieve symptoms such as agitation and restlessness that were associated with the final stages of terminal illness.

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which include aggression, delusions, hallucinations, apathy, anxiety, and depression, can be difficult to treat and are usually managed with various psychotropic drugs.

In this study, a physician assistant ruled out and treated any reversible causes of BPSD, such as pain and infection. The nurses then tried nonpharma-cological approaches. If the patient did not respond and the staff judged it appropriate to try drug therapy, they consulted the clinical pharmacists. The pharmacists worked with the staff to design a pharmacotherapy plan, wrote the orders, monitored progress and any side effects, and adjusted doses.

The drugs were selected on the basis of the patients’ most troublesome symptoms. The most commonly targeted symptoms were physical and verbal aggression, delusions, sleep disturbances, anxiety, and depression. Only two of the 11 patients had received psychotropic drugs before the study. During the study, the most commonly administered drug was medication trazadone (Desyrel drug, Bristol-Myers Squibb), to which all but two patients responded. Quetiapine drug fumarate (Seroquel medication, Astra-Zeneca) and generic  sertraline (Zoloft tablet, Pfizer) were prescribed for these two patients, and they responded favorably.

Overall, the pharmacist-managed consultation service was well received, and treatment was efficient and successful. However, the researchers noted a few kinks in the process. One problem was the use of different terminology to describe the same symptoms. “Agitated,” they point out, can mean anything from restlessness to physical aggression, and treatment can vary correspondingly.

The worldwide market for prescription drugs for women’s health is projected to almost double through the year 2007, according to new data released by Kalo-rama Information in New York City. Manufacturers’ revenues for the year 2002 approached $36 billion and are expected to be almost $64 billion by the year 2008.

The report reveals that the market has been growing at nearly 17% over the past five years, and it is predicted that growth will continue to be in the double digits for the foreseeable future. Growth will be supported by the aging of women around the world, particularly in the U.S., and an increase in product demand, spurred by a still growing women’s health-awareness movement, should expand the total market significantly.
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The study covers the products and markets for prescription drugs in all sectors of women’s health, such as autoimmune diseases, cancer, gynecological infections and sexually transmitted diseases, hormone-related indications (including menopause, contraception, and sexual dysfunction), osteoporosis, and urinary bladder disorders. The comprehensive report provides market size and growth projections, competitive market share, and epidemiological and clinical trends for a wide range of conditions, from breast cancer to yeast infections.

The FDA has issued a Public Health Advisory for physicians, their patients, and families and caregivers of patients about the need to monitor adults and children with depression, especially at the beginning of treatment with selective serotonin reuptake inhibitors (SSRIs) or when doses are increased or decreased.

The FDA has been reviewing the results of studies in children since June 2003, after an initial report on studies of paroxetine (Generic Paxil®, GlaxoSmithKline) and subsequent reports on studies of other drugs appeared to suggest an increased risk of suicidal thoughts and actions in children taking antidepres-sants. There were no suicides in any of the trials. It was unknown whether certain behaviors reported in these studies represented actual suicide attempts or other self-injurious behavior that was not suicide-related.

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Lowering cholesterol far below the level now considered adequate appears to substantially reduce patients’ risk of death from heart attacks. These findings from the “Prove It” Study (Pravastatin generic or Atorvastatin Evaluation and Infection Therapy) may change the way heart disease is treated. The study compared high doses of a powerful statin, or cholesterol-lowering drug, medication atorvastatin calcium (Lipitor®, Pfizer), with a less potent statin, pravastatin sodium (Pravachol®, Bristol-Myers Squibb). The patients taking Lipitor® were much less likely to have heart attacks or to need bypass surgery or angioplasty.

National guidelines currently call for levels of low-density lipoprotein (LDL) cholesterol, which carries cholesterol to arteries, to be below 100 mg/dl in high-risk patients.

In an earlier study, Drug Lipitor halted plaque growth and Pravachol® slowed but did not stop it. The current study suggests that for patients with recent acute coronary syndrome, an intensive lipid-lowering statin regimen might provide greater protection against death or major cardiovascular events than a standard regimen and that patients would benefit from early reduction of LDL cholesterol to below present target levels.

The U.S. Food and Drug Administration (FDA) has approved bevacizumab (Avastin™, Genentech) as a first-line treatment for patients with metastatic colorectal cancer. A monoclonal antibody, it is the first FDA-approved product that prevents the formation of new blood vessels, a process known as angiogene-sis. Avastin™ extended patients’ lives by about five months when it was given intravenously as a combination treatment with standard chemotherapy drugs for colon cancer in a regimen consisting of ironotecan, 5-fluorouracil (5-FU), and leucovorin (IFL).

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Cephalon, Inc., has received approval to market modafinil (Provigil®) tablets to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and “shift work sleep disorder.”

In 1998, modafinil became the first in a new class of wake-promoting agents for patients with narcolepsy.
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In preclinical studies, the drug promoted wakefulness without causing generalized stimulation in the brain. It seems to work selectively through the sleep-wake centers to activate the brain cortex. Activation of the cortex is essential for wakefulness.

The safety of modafinil was shown in clinical trials that enrolled more than 3,500 patients. The drug does not affect the ability to sleep when sleep is desired.