Legal News

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.

The continuing debate over healthcare reform keeps the subject of medication adherence in the public eye. For pharmacy, says NACDS, the issue is a top priority.

Pharmacies can enhance their continuous quality improvement program results by working on three critical elements: implementation, training, and monitoring.

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.

A pharmacist's most important job is to see that the right drug in the right strength with the right label reaches the right patients.

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.

Many independent and small chain pharmacies nationwide are seeing flexible spending account transactions declined, pushing patients out of independent pharmacies and into chains.

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.

When pharmacies are planning their quality assurance or continuous quality improvement plans, they need to determine whether their goals are strictly conformity with state and federal requirements, or something more.

The House Small Business Committee has passed the Small Business Health Information Technology Financing Act, which could provide up to $10 million in loans to help pharmacies implement HIT. The act is now slated for vote by the full House of Representatives.

The American Recovery and Reinvestment Act, signed into law on February 17, included the Health Information Technology for Economic and Clinical Health Act (HITECH), which expands covered-entity and business-associate requirements established by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

RxPatrol, an information clearinghouse operated by Purdue Pharma, has teamed up with the National Community Pharmacists Association to offer a 10-minute training video on crime-prevention measures for pharmacy staff.

Respondents to this year's business outlook survey are generally upbeat about the business their pharmacies are doing and their prospects for the coming year.

The Centers for Medicare & Medicaid Services and the Office of the Inspector General of the federal Department of Health and Human Services are going after perpetrators of medical identity theft as part of a broader effort to reform healthcare.

Retail pharmacy managers are discovering that many third-party administrators do not agree that their inventory information approval systems meet compliance requirements set by the Internal Revenue Service for customers' use of flexible spending accounts.

Working with healthcare professionals and the public, the FDA is developing new guidelines for prevention of medication misuse and abuse and other medication errors linked to preventable harm.

The National Institute for Occupational Safety and Health (NIOSH) may recommend that healthcare workers, including pharmacists and pharmacy technicians, be transferred from positions where they handle hazardous drugs if the workers are trying to conceive, are pregnant, and/or breastfeeding.

In the prescription drug market, discriminatory pricing is common for independent community pharmacies and their patients. This fall, a Federal District Court in New York will consider a critical case: Drug Mart Pharmacy Corp. et a. v. American Home Products Corp. et al. The outcome of the case may determine whether discriminatory pricing techniques are illegal.

With the subject of healthcare reform on the front burner in Washington and across the country, Drug Topics invited members of its Frontline editorial advisory board to share their thoughts. A selection of their responses is presented here.

Hospitals and health systems have taken the lead in expanding the role of pharmacy technicians. "The better educated techs are, the more they can support pharmacists," says Mary Mohr, RPh, MS, of Clarian Health.

The FDA can require risk evaluation and mitigation strategies for certain prescription drugs and biological products, to ensure that the benefits of such products outweigh the risks. The effect of REMS ripples down through the supply chain to affect how pharmacies dispense medication.

When manufacture of biogenerics is a legal reality, brand manufacturers will still retain a strong market share for several years.

The FDA has announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies.

Pharmacy groups have filed three lawsuits that argue that California, New York, and Washington have not met their legal requirements to assure Medicaid patients receive access and quality care at least equal to patients in the general public.

Controversy is in the mix after two mail-order prescription surveys with conflicting results were released within two days of each other.