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DEA RULE WOULD ALLOW ELECTRONIC RXs FOR CONTROLLED SUBSTANCES


The US Drug Enforcement Administration (DEA) is seeking public comment on proposed regulations that would allow physicians and other prescribers to issue electronic prescriptions for controlled substances and permit pharmacies to receive, dispense, and archive them.

Under the proposal, pharmacies, hospitals, and practitioners would have the ability to use modern technology for controlled substance prescribing while maintaining the closed system of controls for dispensing these medications. It is hoped the regulations also will reduce prescription forgery and the paperwork burden on DEA registrants who prescribe or dispense controlled substances.

For a related article, see the Editor's Note.


PHARMACY QUALITY PROJECTS ANNOUNCED


As a board member of the pharmacy quality alliance PQA Inc, the National Association of Chain Drug Stores announced recently the launch of 5 demonstration projects that will examine the opportunities for measuring the quality of pharmacy performance.

The 5 projects are:

PQA Inc is partnering with >20 organizations in testing new models for data aggregation, report generation, and quality improvement related to pharmacy services and use of medications.


KIDS SHOULD BE SCREENED FOR CHOLESTEROL


The American Academy of Pediatrics (AAP) has issued new guidelines calling for widespread cholesterol screening for children and adolescents. The AAP report replaces its 1998 policy statement on the issue and appears in the July issue of Pediatrics.

Screening of children is now being recommended by the AAP for the following: those with a family history of high cholesterol and heart disease; those whose family history is unknown; and those who have other factors for heart disease. Children should be screened after age 2, but no later than age 10.

Patients <8 years old who have elevated cholesterol readings should focus on weight reduction and increased activity while receiving nutritional counseling. For children ≥8 years old and who have high low-density lipoprotein concentrations, however, the AAP policy states that pharmacologic intervention with cholesterol-reducing medications should be considered.

AAP?fs policy change has raised concern among some pediatricians, however, who question whether enough information is available to recommend putting some children on cholesterol-lowering medications. For a related article, visit www.PharmacyTimes.com/CholesterolKids.


FEWER ROGUE INTERNET SITES, BUT STILL TOO MANY

A new white paper from the National Center on Addiction and Substance Abuse at Columbia University (CASA) reports a drop in Web sites advertising or selling controlled prescription drugs during the first quarter of 2008 (365), compared with 581 sites during the same period in 2007. Only 2 of the 365 sites were certified by the National Association of Boards of Pharmacy as "Verified Internet Pharmacy Practice Sites," however.

The CASA report had some troubling findings. Researchers found sites selling online "medical consultations" that enable Internet users to get controlled drugs online without a proper prescription. Of the few sites that require prescriptions, half permit the prescription to be faxed, allowing significant opportunity for fraud, the report notes.

Joseph Califano, CASA's chairman and president, said the drop in the number of Web sites may reflect federal, state, and financial institution crackdown efforts, but he cautioned that in spite of these efforts, "anyone of any age can obtain dangerous and addictive prescription drugs with the click of a mouse. The problem is not going away."

The Senate passed online pharmacy consumer protection legislation April 1, and a companion bill is pending in the House.


PRACTICE LAB TO IMPROVE PHARMACY TRAINING


CVS/Pharmacy is partnering with Howard University in establishing a stateof- the-art Pharmacy Practice Laboratory at the university's Washington, DC campus to help attract and train talented students for careers in pharmacy.

The facility opened last month with supported from a $300,000 grant from CVS/Pharmacy. It offers 24 workstations for pharmacy students to hone their skills in a practice setting, including ensuring appropriate delivery of medications, patient counseling, and medication therapy management. The facility is stocked with prescription and OTC medications, alternative medications, and home-testing devices, so that students may practice dispensing and advising on medication and home tests.

"CVS/Pharmacy is committed to building an outstanding workforce through win?win partnerships such as with Howard University, and through the hiring, training, development, and retention of quality colleagues," said Gordon Howard, area vice president for the company's Washington, DC market.

Howard University reports an increased demand for its 70 freshman pharmacy positions, growing from 300 applicants annually 10 years ago to 1300 applicants today.


FDA UPDATES AVANDIA LABEL?


GlaxoSmithKline recently announced that the FDA has updated its prescribing information for rosiglitazone maleate (Avandia) to include clinical findings from A Diabetes Outcome Progression Trial (ADOPT), which looked at 3 monotherapies for glycemic control among recently diagnosed type 2 diabetes patients.

The percentage of patients with inadequate glucose control at 5 years was 34% for those on glyburide, 21% for those taking metformin, and 15% with Avandia, according to the study. ADOPT was a large, international, multicenter, randomized, double-blind, parallel-group study involving 4351 individuals, aged 30 to 75 years from >400 sites throughout North America and Europe.


?AND CALS FOR BLACK BOX ON FLUOROQUINOLONES

The FDA is now requiring that manufacturers of fluoroquinolone antibiotics include a boxed warning in the product labeling concerning the increased risk of tendinitis and tendon rupture, along with a medication guide for patients about possible side effects.

"Fluoroquinolones are effective in treating certain bacterial infections," noted Edward Cox, MD, director of FDA's Office of Antimicrobial Products, "but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendonitis and tendon rupture, particularly for certain populations."

These groups include people >60 years, those taking corticosteroids, and in kidney, heart, and lung transplant recipients. The consumer group Public Citizen had been urging the FDA to take this action for nearly 2 years, according to Sidney Wolfe, director of the Public Citizen Health Research Group.


HR 6331 LEGISLATION A MAJOR VICTORY FOR PHARMACY


Congress' bipartisan support to override President George Bush's veto of the Medicare Improvements for Patients and Providers Act of 2008 (HR 6331) ensures 3 provisions that will protect patient access to community pharmacies. The House voted 383 to 41 and the Senate voted 70 to 26 to override the veto July 16.

"The passage of this bill will guarantee community pharmacies the ability to help millions of patients and to compete on a level playing field," said Bruce Roberts, RPh, executive vice president and chief executive officer of the National Community Pharmacists Association.

Pharmacy associations and its supporters faced challenges in getting the bill passed. On June 26, the Senate failed to pass the legislation by 1 vote. The fate of the bill changed July 9 with the Senate passage by a veto-proof margin, 69 to 30. The House passed the measure on June 24 by 355 to 59.

HR 6331 would delay implementation of the new Average Manufacturer Price?based pharmacy payment plan until October 1, 2009; accelerate faster payment of Medicare Part D drug claims; and delay the implementation of the competitive billing program for durable medical equipment, prosthetics, orthotics, and supplies under Medicare Part B.


MEN OVER 40 FACE FERTILITY ISUES

A new study suggests that paternal impact is stronger than originally thought when it comes to couples trying to conceive when the man is over age 40.

The researchers noted that earlier studies have indicated that an overall decline in sperm counts and quality as a man ages is a factor. Until now, however, there has been little evidence that being older has such a big effect on fertility, according to findings presented recently at the European Society of Human Reproduction and Embryology conference in France.

For the study, the French researchers analyzed samples taken from >21,000 intrauterine inseminations. The team examined the quality of the sperm and followed pregnancy, miscarriages, and delivery rates. Surprisingly, the team found that the miscarriage risk was about 35% in men older than 40. Although the researchers do not have an explanation, they said a link between a man's age and DNA decay in sperm that leads it to fragment could likely be a reason.


STIEFEL LABORATORIES OTC DIVISION BOOMING


Stiefel Laboratories had a 45% growth in its consumer healthcare division, compared with the previous year. With a presence in 100 countries, the dermatology company dates back to 1847.

"It is really exciting to see the growth of the consumer health care division. In this economy, the growth is even more impressive," said Shayne Sundholm, vice president of the division. "The growth really speaks to the high-quality of the products."

The company recently expanded its product offering in each of its current product lines: PanOxyl (skin care), Sarna (anti-itch), and Zeasorb (antifungal). In May, the company launched its new advertising campaign for these 3 product lines. The campaign consists of both national television and online advertising. Each commercial directs individuals to a product-focused Web site to obtain more detailed product information, view the commercials, read more about skin conditions, and find a list of retailers that carry the products. Furthermore, Stiefel Laboratories has expanded its Web presence to include a variety of Internet video and banner advertisements for all product lines. The company also redesigned packaging for all its products to reflect a more consistent, modern look to help enhance shelf presence and appeal to more buyers.

The company is continuing its growth with a new dry skin product line called Impruv. The product line, which is expected to be available in December, will be positioned in the high-growth, healing restorative end of the dry skin category. Impruv will include skin care solutions to moisturize, repair, and protect dry, sensitive skin.

He said that the company's development process is "very vigorous and includes dermatologist, pharmacists, and consumers."

He also noted that pharmacists play an important role in recommending OTC products. Company research indicates that individuals follow pharmacists OTC recommendations and that pharmacists are a very important resource.