News Briefs
New FDA Web site
Buying drugs and medical products on-line
The FDA has launched a new Web site to educate consumers about the risks of buying prescription drugs and medical products on-line. Risks present themselves to consumers when Web sites masquerading as legitimate pharmacies turn out to be fraudulent.
While consumers enjoy the convenience of the Internet, they also need to know the risks associated with obtaining prescriptions and drugs there and the actions they can take to protect themselves.
By going to the FDA Web site at www.fda.gov and clicking on "Buying Medical Products Online?" consumers can learn:
• how to protect themselves from dangers of buying medications on-line;
• about FDA’s enforcement efforts;
• how to discern a health fraud;
• answers to commonly asked questions about Internet drug sales;
• how to report suspicion or knowledge of illegal on-line sales of drug and drug-related products directly to the FDA.
Surgeon General reveals new health strategy
Surgeon General David Satcher, MD, has announced a 10-year health plan for Americans. The plan focuses on:
• getting kids into better shape;
• getting people to stop smoking;
• cutting drug use;
• encouraging teens to either abstain from sex or use condoms.
As part of the Healthy People 2010 plan, the Surgeon General hopes to see 30% of Americans exercise for 30 minutes each day. Currently, only 15% of us do so. Healthy People 2010 is the first plan of its kind to establish measurements. Data will be collected from state and local health agencies as well as federal agencies that compile health statistics. Eliminating racial disparities is also among the Surgeon General’s goals. While Americans of all backgrounds are, in general, healthier now than they were 10 years ago, disparities still exist between races, Satcher says.
Propulsid warning emphasized
Prescribing information for Propulsid, which is marketed by Janssen Pharmaceutica, has been updated to include a requirement for physicians to conduct certain tests to identify patients who are not appropriate candidates for the drug. An initial electrocardiogram must be conducted to exclude patients with cardiac abnormalities, Janssen reports, along with an assessment of electrolytes and creatinine, which is excreted by the kidneys. Caution also is advised, Janssen notes, regarding Propulsid’s use in the elderly because many elderly patients use contraindicated medications or have contraindicated conditions. Propulsid is for symptoms of nighttime heartburn in adults with gastroesophageal reflux disease.
More diabetes trouble for older women
Older women with diabetes tend to demonstrate lower levels of cognitive function and more rapid rates of decline than do nondiabetic older women, according to a study by Edward W. Gregg and colleagues reported in the Archives of Internal Medicine.
In addition, "The odds of cognitive impairment and major cognitive decline increased with the duration of diabetes," the authors write. Older diabetic women in the study had as much as a twofold increased risk of cognitive impairment and a 74% increased risk of cognitive decline than did older nondiabetic women.
(For more information, read Gregg EW, Yaffe K, Cauley JA, et al. Is diabetes associated with cognitive impairment and cognitive decline among older women? Arch Intern Med 2000; 160:174-180.)
HHS’ year 2000 report: No stockpiling of drugs
Health and Human Services Secretary Donna E. Shalala recently announced that monitoring efforts indicate no significant Y2K-related problem with the supply of pharmaceuticals in the United States. Fears that many consumers would stockpile drugs in preparation for Y2K proved unfounded.
In addition to monitoring by the FDA, the Pharmaceutical Alliance for Y2K Readiness, a group comprising leading drug manufacturers, pharmacies, and health care practitioners, met regularly during 1999 to monitor pharmaceutical production and distribution patterns.
Analysis of those reports showed no notable problems with the nation’s drug supply, nor any production or distribution problems associated with Y2K.
The audit reports are: "Report on the Evalua tion of Manufacturers’ Activities to Assess the Year 2000 Compliance Status of Their Medical Devices," "Report on the Y2K Readiness Survey of Manufacturers of Essential Medical Supplies," "Assessment of Biologics Industries’ Readiness for Year 2000: Interim Report," and "Assessment of Pharmaceutical Industries’ Readiness for Year 2000: Interim Report." You may view the findings at www.fda.gov/oc/y2k/.
FDA issues call for wise prescribing of antivirals
This year’s flu season has seen a high level of prescribing of new antiviral drugs targeting influenza. Indeed, consumers have been reminded over and again of the availability of these new agents through advertising by the manufacturers.
In January, the FDA issued a public health advisory to health care workers to remind prescribers that judicious prescribing is necessary in patients with apparent influenza. It is important to identify patients appropriate to receive one of the antivirals available for influenza, the FDA noted, advising that the following items be considered:
1. "Vaccination remains the primary method of preventing and controlling influenza."
2. "Always consider the possibility of primary or concomitant bacterial infection when making treatment decisions for patients with suspected influenza."
3. "Use special caution if prescribing Relenza to patients with underlying asthma or chronic obstructive pulmonary disease."
Health care workers are encouraged to report serious adverse events to the FDA MedWatch program at (800) FDA-1088 [fax: (800) FDA-0178] or to the appropriate manufacturer:
• Flumadine (rimantadine), Forest Pharmaceu ticals, (800) 678-1605;
• Relenza (zanamivir), Glaxo Wellcome, (800) 825-5249;
• Symmetrel (amantadine; also generic), Endo Pharmaceuticals, (800) 462-3636;
• Tamiflu (oseltamivir), Roche Laboratories, (800) 526-6367.
(For more details, see www.fda.gov/cder/drug/ advisory/influenza.htm.)
Help prevent diabetes: Reach for those tennies
The prevalence of diabetes type 2 has continued to increase over past years. Recent evaluation of data shows that its incidence is reduced by being physically active. In a recent paper, Aaron Folsom et al. examined whether the "incidence of type 2 diabetes was lower over 12 years in physically active women compared with inactive women."
The 41,836 older women (ages 55 to 69 years upon first contact) who participated in the Iowa Women’s Health Study responded to an initial questionnaire from Folsom and his colleagues that assessed tobacco and alcohol use, estrogen replacement, height, weight, and family history of diabetes.
An analysis of the data shows that postmenopausal women who partake of any type of regular exercise are approximately half as likely, in a 12-year period, to develop type 2 diabetes as are inactive women. Those findings were strengthened when results were adjusted for body mass index and waist-to-hip ratio.
(The findings can be seen in Am J Public Health 2000; 90:134-138.)
Time to bone up on alendronate treatment
Results published in the Annals of Internal Medicine show that four years of "alendronate treatment prevented postmenopausal bone loss at the spine, hip, and total body and was more effective than two years of alendronate treatment followed by 2 years of placebo."
The 1,609 postmenopausal women who participated in the Early Postmenopausal Intervention Cohort Study were assigned to either alendronate, placebo, or open-label estrogen-progestin combination. Subjects receiving alendronate were given either 2.5 mg/day or 5 mg/day orally for two years, followed by two years of placebo or continued alendronate. Bone mineral density was more greatly affected by four years of the 5 mg dose of alendronate than by the 2.5 mg dose over the same time frame (P < 0.01).
(See Ravn P, Bidstrup M, Wasnich RD, et al. Alendronate and estrogen-progestin in the long-term prevention of bone loss: Four-year results from the early postmenopausal intervention cohort study. Ann Intern Med 1999; 131:935-942.)
CDC stresses guidelines for S. aureus testing
Upon receiving a fourth report of an S. aureus infection with reduced susceptibility to vancomycin, the Centers for Disease Control and Prevention (CDC) in Atlanta is stressing the importance of CDC guidelines for testing for those resistant bacteria. The CDC has expressed concern that many U.S. labs may not be testing properly for antibiotic-resistant bacterial strains.
This recent report of recent bacteria and the death associated with it points again to the important role of the pharmacist in making recommendations for appropriate antibiotic use. Swift and accurate culture and sensitivity determination is important in antibiotic selection. Close work between pharmacists and their labs can expedite the application of lab results in making decisions concerning antibiotic selection and dosing.
(See MMWR 2000; 48:1,165-1,171.)
Change is good, right?
Greg Fulton, editor of Drug Utilization Review for the past two years, has left his editorial post to pursue other career opportunities. We thank Greg for his excellent work during his tenure as DUR editor.
His departure also means the opening of an opportunity for me, your new editor. As a pharmacist myself, I hope to enrich DUR by applying my pharmacy degree and the contacts I’ve made with the many wonderful people I’ve met thus far in my pharmacy career. Knowing how small the world of pharmacy is, I may well contact you as a source of information or ideas.
Motivational speakers and bosses like to tell us that "change is good." I anticipate that it will be good for all involved. You can let me know as we grow and learn together by contacting me at [email protected]. I value your input and ideas.
Sincerely,
Ruth Noland, PharmD
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