Legal News

Abbott is complying with FDA's request to withdraw sibutramine (Meridia) from the U.S. market because the obesity drug may pose unnecessary cardiovascular (CV) risks to patients.

The DEA has changed its policy and now recognizes long-term-care nurses as agents of prescribers of Schedule C-III through C-V medications, according to a Federal Register notice released today.

Underlying a recent FDA-hosted public meeting and workshop was the question of how FDA as a regulatory agency should increase its current oversight of clinical laboratories, specifically those developing genetic tests that may be offered at their own facilities or made available through direct-to-consumer channels.

Thirty-nine states now have a tool to help pharmacists identify at least some questionable prescriptions and suggest when a patient may be doctor-shopping or pharmacy-shopping in order to obtain controlled substances. That tool is the state prescription monitoring program.

FDA advisory committee members voted 25 to 10 to reject a proposed plan to establish a risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.

A Congressional bill aims to boost the capacity for information exchange among state programs that monitor prescription controlled substances and seeks to provide continued grant funding to support such efforts.

Use of bar-code technology is widespread in the general retail environment. Its advantages have not yet been fully exploited in the hospital and community-pharmacy settings.

The 2,400-page healthcare reform bill included language establishing the Patient Centered Outcomes Research Institute, a group grounded in the tenets of comparative effectiveness research. Its mission is significant, but whether it has the power to effect change remains to be seen.

Although the Patient Protection and Affordable Care Act (PPACA) creates an abbreviated approval pathway for biological products that are demonstrated to be ?highly similar? (biosimilar) to or ?interchangeable? with an FDA-approved biological product, only time will tell how long it will take for these biosimilars to reach the marketplace.

Oregon's law requiring prescriptions for pseudoephedrine products practically eliminated its illicit methamphetamine problem. But some pharmacists, consumer groups, and the drug industry say that it will increase healthcare costs and inconvenience consumers. They think electronic sales-tracking systems would be a better approach.

The promise of personalized medicine is approaching realization. As more medications are developed, pharmacists will be on the front line of individualized prescribing based upon genome-based diagnostic tests.

The healthcare reform legislation signed into law March 23 is expected to give healthcare access to 32 million Americans who are currently uninsured. The legislation gives pharmacists a role in helping alleviate the influx of new patients.

Both the FTC?s consumer protection and competition bureaus are spearheading an investigation into CVS Caremark?s alleged monopolistic practices. HHS is investigating possible false Medicare claims. DEA is investigating charges of improper sale of pseudoephedrine in 2007 and 2008. And the SEC has received complaints of insider trading.

An overview of several provisions of "The Patient Protection and Affordable Care Act" affecting pharmacies and pharmacy practice.

While the government deems that marijuana has a "high potential for abuse" and "has no currently accepted medical use," some states have undertaken initiatives to pass legislation permitting its use for pain control and for control of nausea and vomiting by cancer patients.

Pharmacies are experiencing financial, regulatory and reimbursement challenges that have increased pressure on their operations. A regular review of financial circumstances and business options can help pharmacies stay afloat in turbulent times.

As their growing role in healthcare causes pharmacists to focus more on medication management and patient consulting, some are specializing in healthcare issues and needs specific to women.

A webinar examining the pharmacy error that led to the death of a two-year-old girl and the conviction of an Ohio pharmacist criticized the legal system for criminalizing the event as well as the flawed hospital procedures that prevented discovery of the pharmacy tech's fatal error.

After settling a lawsuit with the State of New York over the sale of expired products, CVS is involved in a similar suit initiated by the State of Connecticut.