Health Trends
Health Trends
Pharmacists Lower Costs of Medical Care
Preliminary study results presented this spring by the Philadelphia College of Pharmacy at the American Pharmaceutical Association's annual meeting indicate that patients taking prescription medications are less likely to be hospitalized for an emergency event if they consult with a pharmacist at the time their prescriptions are filled.
Researchers compared two models of pharmacy care with a control model. In one of the study models, pharmacists discussed directions for use and relevant precautions and warnings with all patients presenting new prescriptions; in the other study model, pharmacists provided in-depth ongoing consultation to patients receiving high-risk drugs such as those taken for heart problems or seizures.
Pharmacists in the control model provided patient consultation at their discretion or when the patient requested it.
Both of the experimental models reduced hospital use and improved patient satisfaction.
Topiramate Approved for Epilepsy
The U.S. Food and Drug Administration has approved topiramate (Topamax), a new antiepileptic agent, for adjunctive treatment of adults with partial-onset seizures. The drug blocks voltage-sensitive sodium channels, enhances the activity of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and blocks the action of the excitatory neurotransmitter glutamate.
In clinical trials, topiramate appeared to be a more effective anticonvulsant than gabapentin or lamotrigine. The initial dose is 50 mg a day, gradually increasing during an eight-week titration period to 400 mg a day in two divided doses.
Adverse effects include psychomotor slowing (17% incidence), difficulty concentrating (8%), speech and language problems (6%), fatigue (11%-12%), and somnolence (30%). These reactions were generally dose-related.
During clinical studies, 1.5% of patients taking topiramate developed kidney stones, thought to be due to carbonic anhydrase inhibition. This can be managed by increasing fluid intake.
A Potent Combination
Study results presented in March at a conference of the American Association of Geriatric Psychiatry indicate that post-menopausal women who take estrogen may respond better to antidepressant medications.
The six-week study involving 358 women was part of a randomized, double-blind experiment in which some subjects took 20 mg of fluoxetine (Prozac) a day while some received a placebo. Seventy-two of the women in the study were also on an estrogen replacement regime.
Results of the study showed that among the women taking Prozac, those who also took estrogen showed a significant improvement in their depression, while those who were not taking the hormone did not show significant improvement.
New One-Dose Treatment for UTIs
A newly approved broad-spectrum antibiotic for the treatment of uncomplicated urinary tract infections in women may improve compliance because of its ease of use, according to its manufacturer.
Forest Laboratories' Monurol (fosfomycin trimethamine) is taken as an orange-flavored powder mixed with water; it delivers 3 gm of fosfomycin, which achieves bacteriocidal activity in the urine within two to four hours and continues to be effective for almost four days.
Clinical trials indicate the new drug's efficacy is similar to that of nitrofurantoin.
Goodbye Flu?
Gilead Sciences has announced that it plans to petition the U.S. Food and Drug Administration for permission to begin human trials on an experimental oral compound that interferes with the reproduction of the influenza virus.
The manufacturer claims that the teatment has been shown to block infection by all major flu strains in animal species.
FDA Seeks Pharmacists' Help
The U.S. Food and Drug Administration is interested in hearing from health care professionals about adverse consequences associated with therapeutic switches, according to a recent memo from the U.S. Department of Health and Human Services.
The memo indicates that HHS has received expressions of concern from patients and health care workers about programs that use limited formularies or manage pharmaceutical care by substituting a different member of a pharmacologic class or a drug of a wholly different class for a prescribed drug. FDA has apparently received several reports of apparent adverse effects associated with such therapeutic switches.
FDA asks that health professionals who are aware of any adverse effects of therapeutic switches report them through FDA's MedWatch reporting system as quickly as possible. The agency asks that the names of both the originally prescribed drug and the drug to which the patient was switched be included.
As with all MedWatch reports, the identity of patients is kept confidential; the reporter's identity may be shared with the manufacturer of the drug unless the reporter requests otherwise.
Call 800-FDA-1088 to report by telephone or request a reporting form; reports may be faxed to 800-FDA-0178.
FDA asks that reporters please note that this request for focused reporting does not apply to adverse events associated with generic drug substitution, though reporting of all serious generic-related events continues to be encouraged.
New Indication for Foscavir
Astra USA announced last month that it has received FDA authorization for a new indication for its antiviral drug Foscavir (foscarnet sodium) injection in the treatment of AIDS-related cytomegalovirus (CMV) retinitis.
CMV retinitis is an opportunistic infection that often causes blindness in people with AIDS.
The new indication allows use of Foscavir together with intravenous Ganciclovir (cytovene) in CMV retinitis patients who have relapsed after an initial course of single treatment with either drug. Foscavir may also be prescribed as monotherapy for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus infections in immunocompromised patients.
CMV infections are prevalent in persons with suppressed immune systems and are the leading cause of vision loss in people with AIDS.
Spotlight on Performance
The Joint Commission on Accreditation of Healthcare Organizations has announced the release of the National Library of Healthcare Indicators: Health Plan and Network Edition, a compendium of performance measures for health plans and networks.
The one-volume library is made up of 225 indicators that can be used to assess the performance of health plans, integrated delivery networks, provider-sponsored organizations, and other health delivery systems. The 225 performance measures included in the library were selected from more that 900 suggested measures received in response to the Joint Commission's Request for Indicators, issued in 1995. The suggested measures were screened for validity by a panel of experts, and most have not yet been field-tested.
Each indicator included in the library has a profile that:
The indicators are divided into four broad categories, and include 123 clinical performance measures, 20 health status measures, seven satisfaction measures, and 75 administrative/financial measures.
Joint Commission President Dennis O'Leary, MD, describes the library as a "building block toward a common language and common framework for cataloging, evaluating, and applying performance measures." He says the scope of measures included in the library will expand to include a full range of measures for all types of provider organizations.
A second volume targeting behavioral health care, long-term care, home care, and ambulatory care services is scheduled for release at the end of 1997. The National Library of Healthcare Indicators: Health Plan and Network Edition is available from the Joint Commission's Customer Service Center for $25. Call 630-792-5800 to order. JCAHO's home page is located at http://www.jcaho.org.
Sentimental Journeys
Assisted living and nursing home residents with Alzheimer's disease and other dementias are responding favorably to a new approach that encourages them to relax and enjoy their mental journeys into the past.
"Validation therapy" replaces the often-futile attempt to force these residents back into the present with environmental cues that recall bygone moments important in their lives: antique telephones, woodworking equipment, baby bassinets, rocking chairs, carpet sweepers, briefcases, gardening tools, even dolls.
Caregivers experienced in the new approach explain that older residents with dementias often mentally return to a time or place in life when they were happy and comfortable, such as their years as young mothers or busy hobbyists, and that joining these patients in their reveries can soothe their frustration and calm their agitation better than continual attempts to jog them back to the present.
Assisted living and nursing facilities adopting this approach are furnished with mini "lifestyle environments" such as nurseries or offices, and staff members join actively in residents' psychological "time travel" back to important moments in their lives.
H. Pylori Breath Test Approved
The U.S. Food and Drug Administration has approved a labeled urea breath test as a diagnostic tool to detect the presence of Helicobacter pylori, a common bacterial pathogen that has been implicated in the development of duodenal and gastric ulcers, chronic superficial gastritis, and gastric adenocarcinoma. The gram-negative spiral-shaped H. pylori is considered to be the most common bacterial pathogen in the world, infecting up to half of the world's population.
The newly approved diagnostic test, developed by the Nashville-based company Meretek, requires the patient to swallow a dose of urea labeled with a carbon isotope; if H. pylori is present in the gastric mucosa, the H. pylori pathogen breaks down the labeled urea to form ammonia and labeled carbon dioxide.
The patient then exhales into a device that measures the carbon dioxide level. Test results detect total gastric urease activity, indicating whether a patient is actively infected.
The test, which takes 30 minutes to complete, is supplied with a kit containing materials necessary to send samples to Meretek's diagnostic facility, where levels of the carbon isotope are detected using an automated gas isotope radio mass spectrometer.
In the future, Meretek anticipates offering licensing opportunities to clinics that wish to perform on-site analyses.
Frail Elderly Patients Need to Bundle Up
Routine care procedures that would not ordinarily bother a healthy older person can place frail elders at risk for thermoregulatory problems, including a dangerous drop in core temperature, writes a professor of nursing in the January/February issue of Geriatric Nursing (Vol. 18, No. 1).
Jean B. Worfolk, RN, EdD, writes that although accidental hypothermia was recognized as many as 50 years ago as a risk factor for people over 65, health professionals working with this population still have little knowledge of the condition and its precipitating factors. This includes the fact that some elderly people can experience serious thermoregulatory problems without being exposed to severe cold.
"When acute illnesses, immobility, and temperature-lowering drugs are imposed on a dysfunctional thermoregulatory system, hypothermia can occur any time, any season, anywhere," says Worfolk in her article. She adds that some frail elderly individuals may routinely maintain core temperatures as low as 95 or 96 degrees, leaving them vulnerable to hypothermia when subjected to physiological or psychological stress.
"By virtue of old age and infirmities, frail elderly patients are five times more likely to die of hypothermia than younger people," writes Worfolk. Her article provides a review of the thermoregulatory system, age-related changes that impair its efficiency, and additional stressors that make it difficult for frail elders to maintain their core temperature at comfortable and safe levels. She also suggests interventions to decrease hypothermia risk and guidelines for assessment and emergency care.
Factors that Increase the Risk of Hypothermia in Elders
Thermoregulatory impairment
Conditions that decrease heat production
Conditions that increase heat loss
Conditions that impair central or peripheral control of thermoregulation
Drugs that interfere with thermoregulation
NCQA's Web Site Posts Health Plan Quality Reports
Speakers at ASCP's Eighth Annual Conference on Legislative and Regulatory Affairs in March predicted that in the next few years, the health care market would be dominated by increasing pressure from consumers and payers to produce reliable ways to measure quality in managed care arrangements.
Among the companies engaged in these efforts is the National Committee for Quality Assurance, an independent organization that assesses and reports on the quality of managed care plans, including health maintenance organizations. Visitors to NCQA's Home Page at http://www.ncqa.org/ have access to accreditation and performance information on a variety of managed health care plans. The NCQA Home Page has links to:
About half of the nation's 630 HMOs are currently involved in NCQA's accreditation process.
No Substitutions, Please
Eighty-five percent of Americans favor remedial legislation to halt mandatory substitution of narrow therapeutic index (NTI) drugs without the knowledge of patients and approval of physicians. This is one of the results of a national survey conducted by Opinion Dynamics Corporation of Cambridge, Massachusetts for the Health Alliance for NTI Patient Safety, a national coalition of medical, consumer, and patient advocacy organizations. The survey of 512 Americans examined patient attitudes toward switching from one formulation to another of NTI drugs.
Among the survey's findings:
Said one researcher, "The significance of survey research data can either whisper to you, or it can scream at you. For this survey, the latter is clearly the case."
"It's rare when we see such unanimity of opinion on any subject,"
added Ernest Paicopolos, a partner in Opinion Dynamics Corporation.
"However, this survey shows that the practice of switching
formulations of NTI drugs without patient knowledge and physician
approval meets with strong opposition. In fact, people want to
put a stop to it."