Production of unapproved carbinoxamine items to cease
June 19th 2006The FDA has ordered manufacturers of all unapproved carbinoxamine-containing products to stop producing their offerings over the next 30 to 90 days. The agency has received 21 reports of death in children under two years of age associated with these products.
Educational campaign to launch for HFA transition
June 19th 2006The Allergy and Asthma Foundation of America (AAFA) will launch a campaign to educate patients and physicians to help ease the transition to hydrofluoroalkane (HFA) inhalers from the less environmentally friendly chlorofluorocarbon (CFC)-containing versions.
AMA adopts guidelines for in-store clinics
June 19th 2006The American Medical Association house of delegates has adopted a series of key principles to guide the establishment and operation of store-based healthcare clinics. The following principles are included in the guidelines: store-based health clinics must have a well-defined and limited scope of clinical services, consistent with state scope of practice laws; establish arrangements by which their healthcare practitioners have direct access to and supervision by physicians; and establish a referral system with physician practices or other facilities for appropriate treatment if the patients' condition or symptoms are beyond the scope of services provided by the clinic.
On-line college offers techs B.S. degree
June 19th 2006Excelsior College has launched an on-line bachelor's degree in health sciences for pharmacy technicians and other healthcare professionals seeking to advance into related positions in the health science professions. The program offers flexibility so students can continue to work while completing the course work at their own pace, according to the nonprofit distance education college located in Albany, N.Y.
R.Ph.s can help manage the cost of drugs
June 19th 2006Pharmacists are playing a key role in medical groups' efforts to manage prescription drug costs, according to a study prepared for the U S. Department of Health & Human Services by Abt Associates, Cambridge, Mass. Lead author Harmon Jordan, Sc.D., told Drug Topics, "Clinical pharmacists are helping to educate physicians and patients, and they're forming relationships with physicians where they seem to have a very synergistic existence."
Clinical Twisters: Treating depressive episode
June 19th 2006A 28-year-old woman, S.A. (two months' pregnant), is brought to your ER by her husband, who believes she is suicidal. According to your health-system medical records, S.A. was diagnosed with bipolar II disorder several years ago. She was previously treated with lithium and lamotrigine (Lamictal, GlaxoSmithKline) separately but was noncompliant. Her psychiatrist is weighing a mood stabilizer and/or antidepressant therapy during pregnancy. He asks for your recommendation.
Breakthroughs reported in controlling colon cancer
June 19th 2006Of the thousands of drug studies presented at the recent meeting of the American Association for Cancer Research (AACR) in Washington, D.C., two took center stage as "genuine breakthroughs in colon cancer treatment and prevention." First, international scientists cited the biologic panitumumab (Amgen) for extending progression-free survival in advanced cancer patients. Then they hailed new research on celecoxib's (Celebrex, Pfizer) potential to prevent colon cancer-despite concern about heart-related side effects.
USP proposes new 797 standards
June 19th 2006While most people haven't had time to digest the intricate details of the United States Pharmacopeia's proposed changes to General Chapter 797 (Pharmaceutical Compounding-Sterile Preparations), response to the protracted document has been almost universally positive.
New industry alliance fosters patient compliance
June 19th 2006Is it possible to raise public awareness about the value of medications while demonstrating the important role of community pharmacists in maximizing the effectiveness of drug therapy? The Pharmacy Value Alliance (PVA), a coalition of pharmaceutical companies and community pharmacy organizations, thinks so.
R.Ph.s told they can help shape nation's direction
June 19th 2006Pharmacy may be at a moment of unaccustomed visibility just at a time when the nation's direction is in flux, political commentators told the several hundred pharmacists who went to lobby Washington during the National Community Pharmacists Association's legislative conference last month.
Perfect Storm: Pharmacy seeks shelter from Medicaid disaster
June 19th 2006Still reeling from the economic havoc churned up by Medicare Part D's slower and lower reimbursements, pharmacy is bracing for the destruction swirling its way in the form of reimbursement cuts spawned by another monster storm named Medicaid.
Third new treatment option for MDS patients
June 19th 2006Myelodysplastic syndromes (MDS), a collection of disorders in which the bone marrow does not produce enough mature cells, has received a lot of attention in recent years despite the fact that it affects only about five in 100,000 people. This is due in part to the Food & Drug Administration's approval of several new molecular entities used in its treatment, including azacitidine (Vidaza, Pharmion) in 2004 and lenalidomide (Revlimid, Celgene) in 2005. And just last month the agency approved a third drug, decitabine injection (Dacogen, MGI Pharma).
New drug helps patients stub smoking
June 19th 2006The Food & Drug Administration recently approved varenicline (Chantix, Pfizer) as an aid to smoking cessation. Varenicline is the first new prescription treatment for smoking cessation to receive FDA approval in nearly a decade and only the second nicotine-free smoking cessation therapy ever approved by the agency. This new molecular entity received priority review because of its potential benefit to public health. Pfizer plans to make the drug available in U.S. retail pharmacies in the second half of 2006-most likely during the third quarter.
New drug approved in fight against Parkinson's
June 19th 2006The Food & Drug Administration has approved rasagiline (Azilect, Teva) for the treatment of Parkinson's disease (PD). Rasagiline is an irreversible monoamine oxidase type B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that transmits signals between the substantia nigra and other parts of the brain.
Washington board backs refuse-and-refer policy
June 12th 2006Washington pharmacists could refuse to dispense emergency contraception but would have to provide patients a "timely alternative," under a policy endorsed by the state pharmacy board. The "refuse-and-refer" policy is opposed by women's and pro-choice groups, as well as Gov. Christine Gregoire.
Study finds restricting mail-service could up costs
June 12th 2006Pennsylvania bill H.B. 814 could increase the state's consumers' and employers' prescription drug costs by as much as $123 million annually, according to new study from the actuarial firm Milliman and released by PCMA. The bill calls for proposed restrictions on consumers' and employers' ability to choose the mail-service pharmacy option and also eliminates co-pay differentials between retail and mail-service prescriptions.
Mental health patients face higher Part D costs
June 12th 2006Part D enrollees with mental illness will have to pay up to four times more in out-of-pocket expenses than their privately insured counterparts, according to a study from Thomson Medstat. They will also reach the donut hole in coverage two months earlier than the average for all Medicare patients.
Coalition launches anticoagulant educational program
June 12th 2006The results of three surveys performed by Harris Interactive have led the SOS Rx (Senior Outpatient Medication Safety) Coalition, a project of the National Consumers League, to launch an educational program aimed at improving the use of anticoagulants. The group surveyed 426 patients taking the blood thinners, 109 caregivers looking after these patients, and 101 physicians prescribing the drugs.
AMA resolution opposes some compounding
June 12th 2006Declaring some pharmacies are mass-producing non-FDA-approved nebulizer drugs for substitution without the patient's approval, asthma and allergy specialists proposed a resolution urging AMA to ask the FDA to take enforcement action against such pharmacies and to ask CMS to reconsider paying for such drugs. The resolution also urges AMA to educate physicians about the potential liability of approving such drug substitutions.
New fentanyl delivery system for in-hospital use
June 12th 2006Johnson & Johnson's affiliate Alza has received the FDA's nod for Ionsys (fentanyl iontophoretic transdermal system), a needle-free, patient-activated analgesic system. Ionsys will be the first product to utilize Alza's proprietary E-Trans system, which employs iontophoresis, a process in which a low-intensity electric field is used to transport the drug (fentanyl) across the skin and into the circulatory system.