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A 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.

Of 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.

While 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.

Is 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.

Pharmacy 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.

Still 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.

She talked with a slur, slowly. I looked at her eyes. They were hooded with droopy lids. There were food stains on her T-shirt. She wore no makeup and this essentially attractive 35-year-old was showing her worst. I had seen her like this before. But she had been doing so well.

Compounding pharmacists who would like to put their practices to the test can now apply to earn the seal of approval offered by the Pharmacy Compounding Accreditation Board (PCAB).

Myelodysplastic 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).

The 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.

The 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.

Four national pharmacy groups have responded to a commentary on emergency contraception in the journal Obstetrics & Gynecology that argued that R.Ph.s should not be allowed to refuse to dispense medications based on their personal values because they lack the fundamental prerequisites to make clinically sound ethical decisions. APhA, ASHP, AMCP, and ACCP stated their support for a policy that ensures patients get their medications when an R.Ph. steps away from a script based on personal beliefs.

Prescription drug costs will rise 12.2% over the next 12 months, according to a survey of 70 healthcare insurers by Aon Consulting. The projected increase is lower than the 13.1% a year ago.

Washington 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.

Out of a total of 19,420 HIPAA complaints lodged since the medical privacy rule went into effect three years ago, the Bush Administration has imposed no fines and has prosecuted just two criminal cases, according to the Washington Post. The most common allegations included that personal medical information was wrongly revealed, information was poorly protected, and proper authorizations were not obtained.

Pennsylvania 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.

Part 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.

The 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.

Declaring 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.

A federal judge dismissed a lawsuit filed by a Wisconsin pharmacist, who alleged that Wal-Mart fired him last summer for refusing to fill birth control scripts and violated his religious freedom. The judge found that Neil Noesen was dismissed because he was disruptive and that Wal-Mart accommodated his views by having other R.Ph.s fill BC scripts.

Johnson & 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.

The Supreme Court has declined to review a circuit court decision upholding Maine's first-in-the-nation law regulating PBMs. The Pharmaceutical Care Management Association had sued Maine on behalf of its PBM members.

More than 70 Medicine Shoppe franchise owners, representing 82 stores, have filed legal action against Medicine Shoppe International (MSI) and its parent company Cardinal Health. The action was filed on June 2 in Missouri through the American Arbitration Association.

Following this year's mumps outbreak, which resulted in 2,597 cases of the illness in the U.S., CDC has revamped the immunization recommendations in an attempt to better control mumps immunity. The Advisory Committee of Immunization Practices (ACIP) now defines acceptable presumptive evidence of immunity as: documentation of adequate vaccination, laboratory evidence of immunity, birth before 1957, or adequate vaccination-which is now defined as one dose of a live mumps vaccine for preschool-aged children and adults not at high risk, and two doses for school-aged children (grades K-12) and for adults at high risk (e.g., healthcare workers, international travelers, college students).

Genentech is working with five wholesalers in an initiative designed to streamline distribution of the firm's top revenue-producing pharmaceuticals. Novation, the contracting services company of VHA Inc. and the University HealthSystem Consortium, told its customers that Genentech is in the process of modifying its new distribution policy.

The FDA has issued a final guidance outlining the steps the agency will take to address medicines that are marketed without FDA approval. The activity will begin with prescription products containing the antihistamine carbinoxamine because of safety concerns regarding their use in children less than two years of age.

Despite findings from a new study of ACE-inhibitor use during the first trimester of pregnancy, the FDA will not change the drugs' warning labels right now, the agency said in a recent conference call. The study, "Major Congenital Malformations after First-Trimester Exposure to ACE Inhibitors," published recently in the New England Journal of Medicine, found a 2.7 times higher risk for birth defects when the mother was taking an ACE inhibitor during the first trimester of pregnancy.

The Governor of Massachusetts is planning to veto a bill the state senate just passed that does away with the requirement of a prescription before syringes can be sold in pharmacies. The house had already passed the measure in November 2005.

The Generic Pharmaceutical Association (GPhA) called the approvalof Sandoz Pharmaceutical's Omnitrope human growth hormone (HGH) asignificant first step in bringing more affordablebiopharmaceuticals to the U.S. marketplace. GPhA president/CEOKathleen Jaeger said that FDA's Omnitrope decision demonstratesthat sound science exists to support the approval of genericbiopharmaceuticals.

Let's say several prescription drug plans (PDPs) are asking you toprovide medication therapy management (MTM) services, but each planhas its own requirements. How can you best meet their welter ofneeds?