Fred Gebhart, Contributing Editor

Medications are often prescribed for off-label purposes without evidence of effectiveness or safety. Unsupported use is especially high for antidepressants, antipsychotics, and sedatives.

A patient suit against Wyeth Pharmaceuticals may open brand name drug makers to liability for mishaps when patients take a generic product.

Walgreens and Phillip Morris both recently requested injunctions to stop enforcement of San Francisco?s ban on selling tobacco products in pharmacies.

Disposal of unused medications and other controlled substances is an expensive logistical challenge. Pouring controlled substances into sewer systems is harmful. Incineration costs are prohibitive.

Generics were the big winners in the prescription drug world of 2006. While generic prescription volume was surging 11.4% last year compared with 2005, brand-name Rx volume was falling by 5.1%. Generics now account for 56.9% of all scripts and 63.8% of new scripts.

Brand-name drugmakers must have seen January as the 100 Hours from Hell. Generic drugmakers, on the other hand, probably heard angelic choirs. "It's safe to say that you can expect different outcomes in Congress under the Democrats," said Anna Schwamlein Howard, senior legislative representative for AARP. "You will see a lot of things being taken up and moving during this Congress that were never addressed under the last Congress."

Can pharmacist involvement boost the level of inpatient stroke care?

A new specialty certification may be on the horizon. The Board of Pharmaceutical Specialties (BPS) could offer ambulatory care certification as early as 2008. "BPS got the ball rolling, but we have not committed to the development of this specialty," said BPS executive director Richard Bertin. "It is up to the profession to present arguments, pro and con, before that decision can be made."

State legislators have emerged as key players in pharmacy. Faced with shrinking margins from Medicare Part D and the specter of bankruptcy from proposed Medicaid reimbursement rates, many pharmacists are pushing their state legislatures to shift the balance.

NIOSH, the National Institute for Occupational Safety and Health, is updating its list of hazardous pharmaceutical products. The new list will become part of the organization's 2004 alert, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

Final rules on hospital participation in Medicare and Medicaid may help pharmacists crack down on patients who try to provide their own drugs for hospital use. The practice is called "brown bagging," from the brown paper bags patients get from retail pharmacies.

Pharmacists who want to opt out of the traditional career path should keep an eye on Thomas Menighan in Gaithersburg, Md. The former pharmacy owner and onetime American Pharmacists Association president created a new specialty. His current company, SynTegra, audits drug manufacturers, wholesalers, and other links in the pharmaceutical supply chain.

Pharmacists who see a move toward outpatient parenteral therapy are riding the latest shift in patient care. A new report from the Emerging Infections Network (EIN) found that OPAT, outpatient parenteral antimicrobial therapy, has become the de facto standard of care in most hospitals. EIN is part of the Infectious Diseases Society of America.

The long-delayed drug pedigree regulations announced by the Food & Drug Administration in mid-November have evoked a storm of criticism and lawsuits. No one is objecting to the FDA's stated goal of reducing drug diversion and counterfeits, but the cure may be worse than the disease.

Fungal infections are on the increase, but not for all the usual reasons. Increasing rates of bacterial and viral infections are due in large part to growing resistance to antimicrobials, but fungi and antifungals are different.

Patients infected with gram-negative organisms are in trouble. "Drugs that used to be very effective against gram-negative infections no longer work," Johnson & Johnson research fellow Karen Bush, Ph.D., warned the 46th Interscience Conference on Antimicrobial Agents & Chemotherapeutics, held recently in San Francisco.

Two steps forward, one and a half steps back. That's how Jim Schlicht, executive VP for government affairs and advocacy at the American Diabetes Association, described the impact of legislation and regulation on diabetes treatment.

The Joint Commission on Accreditation of Healthcare Organizations is looking for a few good hospitals. A few good psychiatric hospitals, that is. JCAHO is rolling out its first-ever hospital-based performance measures for inpatient psychiatric care for a year-long trial run starting in January 2007. Final measures will be released in October 2008.

Tom Kellenberger wants to do for pharmacy what Expedia, Orbitz, and Travelocity have done for travel: Blow the market wide-open. In late May, the Wisconsin pharmacist flipped the switch on BidRx (www.bidrx.com), an on-line marketplace for prescription drugs, over-the-counter products, and pharmacy services.

The Food & Drug Administration has created a conundrum for short children, their parents, pharmacists, and pediatricians. The agency approved the use of human growth hormone (somatropin recombinant, Humatrope, Eli Lilly) in June 2003 to treat idiopathic shortness. But instead of clarifying which children should be treated for short stature, the FDA may have opened the door to abuse.

Pharmacists don't get enough respect. That's an aspect of modern life that the California Pharmacists Association wants to change. CPhA and the nonprofit Pharmacy Foundation of California (PFC) launched what may be the nation's first radio campaign designed solely to elevate the image of pharmacists.