Latebreakers

November 21, 2005

R.Ph. appeals punishment for refusal to dispense OCs

R.Ph. appeals punishment for refusal to dispense OCs

Neil Noesen, a Wisconsin pharmacist who refused to dispense or transfer a script for oral contraceptives (OCs), has appealed the disciplinary decision issued last spring by the pharmacy board. He was formally reprimanded, ordered to attend pharmacy ethics classes, and pay for the cost of the investigation. Noesen's filing contends that OCs reduce the likelihood of implantation of a fertilized egg, which constitutes "unlawful, reckless endangerment of the safety of an unborn child" and that the board's standard of care is "not in accordance with the timeless philosophy of our profession to care for the sick and the suffering." The state attorney general has until Dec. 1 to respond to the filing.

Experience with Medicare Rx cards shows need for Part D enrollment help

Compounded bioidentical HRT claims not supported, says ACOG

There is no scientific evidence to support claims that compounded bioidentical hormone replacement therapy is safer or more efficacious, according to the American College of Obstetricians & Gynecologists. The group also cautioned that compounded hormones should be considered to have the same safety issues as FDA-approved HRT products and may have additional risks arising from the compounding process. Prescribing decisions should be made by a physician in consultation with the patient and R.Ph., said L. D. King, head of the International Academy of Compounding Pharmacists. He also urged ACOG to disclose the extent of its financial relationship with Wyeth, which makes commercial HRT products.

ISMP, FDA plan campaign on error-prone medical abbreviations

The Institute for Safe Medication Practices is partnering with the FDA to create an educational campaign to eliminate potentially harmful abbreviations. The initiative, to be launched in the first half of 2006, will recommend that ISMP's list of abbreviations, symbols, and dose designations most often associated with medication errors be referenced whenever and wherever medical data are being communicated. Some of those notations are included in the current JCAHO National Patient Safety Goal 2B, a "do not use" list of error-prone abbreviations and dose designations. ISMP's full listing includes additional abbreviations that have been associated with errors reported to its medication error reporting program. Specific audiences targeted will include physicians, R.Ph.s, nurses, and other healthcare providers.

Maine's PBM law upheld

The constitutionality of a Maine law mandating PBM transparency has been upheld by the U.S. First Circuit Court of Appeals. The three-judge panel affirmed a lower court ruling in favor of the state law requiring PBMs to disclose to their clients more information about their dealings with drug companies, including rebates. The law also requires PBMs to be fiduciaries looking out for the best interests of their clients, not their own. Representing PBMs, the Pharmaceutical Care Management Association voiced strong opposition to such laws, which it contends raise Rx prices for consumers. NCPA countered that the decision is a major defeat for PCMA and its PBM members.

Biogen revises Amevive labeling

Biogen Idec and the FDA have notified healthcare professionals of revisions to the prescribing information for Amevive (alefacept), indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Amevive should not be administered to patients infected with HIV. Amevive reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease. Other sections of the labeling were revised to reflect additional safety information. For more information, visit http://www.fda.gov/medwatch/safety/2005/safety05.htm#Amevive/.