News CAPSULES: August 2008

DEA RULE WOULD ALLOW ELECTRONIC RXs FOR CONTROLLED SUBSTANCES

The US Drug Enforcement Administration(DEA) is seeking public commenton proposed regulations thatwould allow physicians and other prescribersto issue electronic prescriptionsfor controlled substances and permitpharmacies to receive, dispense, andarchive them.

Under the proposal, pharmacies, hospitals,and practitioners would have theability to use modern technology forcontrolled substance prescribing whilemaintaining the closed system of controlsfor dispensing these medications.It is hoped the regulations also willreduceprescription forgery and thepaperwork burden on DEA registrantswho prescribe or dispense controlledsubstances.

PHARMACY QUALITY PROJECTS ANNOUNCED

As a board member of the pharmacyquality alliance PQA Inc, the NationalAssociation of Chain Drug Stores announcedrecently the launch of 5 demonstrationprojects that will examine theopportunities for measuring the qualityof pharmacy performance.

The 5 projects are:

• Highmark in collaboration withCECity.com and the Rite Aid Corp
• Outcomes Pharmaceutical HealthCare in collaboration with KerrDrug Inc and the University ofNorth Carolina Eshelman School ofPharmacy
• Pharmacy Society of Wisconsin, representingthe Wisconsin PharmacyQuality Collaborative, including thefollowing payers: State of WisconsinDept of Health and Family Services,United Healthcare of Wisconsin,Unity Health Insurance, and GroupHealth Cooperative of South CentralWisconsin
• Purdue University School of Pharmacyand Pharmaceutical Sciencesin collaboration with the RegenstriefInstitute (an informatics and healthcare research organization), IndianaHealth Information Exchange Inc, andthe Indiana Pharmacists Alliance
• University of Iowa and the IowaFoundation for Medical Care in collaborationwith Wellmark Blue Crossand Blue Shield and Iowa MedicaidEnterprise

PQA Inc is partnering with >20 organizationsin testing new models for dataaggregation, report generation, and qualityimprovement related to pharmacyservices and use of medications.

KIDS SHOULD BE SCREENED FOR CHOLESTEROL

The American Academy of Pediatrics(AAP) has issued new guidelines callingfor widespread cholesterol screening forchildren and adolescents. The AAP reportreplaces its 1998 policy statement onthe issue and appears in the July issue ofPediatrics.

Screening of children is now being recommendedby the AAP for the following:those with a family history of high cholesteroland heart disease; those whosefamily history is unknown; and thosewho 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 elevatedcholesterol readings should focus onweight reduction and increased activitywhile receiving nutritional counseling.For children ≥8 years old and who havehigh low-density lipoprotein concentrations,however, the AAP policy statesthat pharmacologic intervention withcholesterol-reducing medications shouldbe considered.

AAP?fs policy change has raised concernamong some pediatricians, however, whoquestion whether enough information isavailable to recommend putting somechildren 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 andSubstance Abuse at Columbia University (CASA) reports a dropin Web sites advertising or selling controlled prescription drugsduring the first quarter of 2008 (365), compared with 581 sitesduring the same period in 2007. Only 2 of the 365 sites werecertified by the National Association of Boards of Pharmacy as"Verified Internet Pharmacy Practice Sites," however.

The CASA report had some troubling findings. Researchersfound sites selling online "medical consultations" that enableInternet users to get controlled drugs online without a properprescription. Of the few sites that require prescriptions, halfpermit the prescription to be faxed, allowing significant opportunityfor fraud, the report notes.

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

The Senate passed online pharmacy consumer protectionlegislation April 1, and a companion bill is pending in theHouse.

PRACTICE LAB TO IMPROVE PHARMACY TRAINING

CVS/Pharmacy is partnering withHoward University in establishing a stateof-the-art Pharmacy Practice Laboratoryat the university's Washington, DC campusto help attract and train talentedstudents for careers in pharmacy.

The facility opened last month withsupported from a $300,000 grant fromCVS/Pharmacy. It offers 24 workstationsfor pharmacy students to hone their skillsin a practice setting, including ensuringappropriate delivery of medications,patient counseling, and medication therapymanagement. The facility is stockedwith prescription and OTC medications,alternative medications, and home-testingdevices, so that students may practicedispensing and advising on medicationand home tests.

"CVS/Pharmacy is committed to buildingan outstanding workforce throughwin?win partnerships such as withHoward University, and through the hiring,training, development, and retentionof quality colleagues," said GordonHoward, area vice president for the company'sWashington, DC market.

Howard University reports an increaseddemand for its 70 freshman pharmacypositions, growing from 300 applicantsannually 10 years ago to 1300 applicantstoday.

FDA UPDATES AVANDIA LABEL?

GlaxoSmithKline recently announcedthat the FDA has updated its prescribinginformation for rosiglitazone maleate(Avandia) to include clinical findings fromA Diabetes Outcome Progression Trial(ADOPT), which looked at 3 monotherapiesfor glycemic control among recentlydiagnosed type 2 diabetes patients.

The percentage of patients with inadequateglucose control at 5 years was34% for those on glyburide, 21% forthose taking metformin, and 15% withAvandia, according to the study. ADOPTwas a large, international, multicenter,randomized, double-blind, parallel-groupstudy involving 4351 individuals, aged 30to 75 years from >400 sites throughoutNorth America and Europe.

?AND CALS FOR BLACK BOX ON FLUOROQUINOLONES

The FDA is now requiring that manufacturersof fluoroquinolone antibioticsinclude a boxed warning in the productlabeling concerning the increased risk oftendinitis and tendon rupture, along witha medication guide for patients aboutpossible side effects.

"Fluoroquinolones are effective in treatingcertain bacterial infections," notedEdward Cox, MD, director of FDA's Officeof Antimicrobial Products, "but healthcare professionals and patients need tobe aware of the increased risk associatedwith the use of these drugs of developingtendonitis and tendon rupture,particularlyfor certain populations."

These groups include people >60years, those taking corticosteroids, andin kidney, heart, and lung transplantrecipients. The consumer group PublicCitizen had been urging the FDA to takethis action for nearly 2 years, accordingto Sidney Wolfe, director of the PublicCitizen Health Research Group.

HR 6331 LEGISLATION A MAJOR VICTORY FOR PHARMACY

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

"The passage of this bill will guaranteecommunity pharmacies the abilityto help millions of patients and to competeon a level playing field," said BruceRoberts, RPh, executive vice presidentand chief executive officer of the NationalCommunity Pharmacists Association.

Pharmacy associations and its supportersfaced challenges in getting thebill passed. On June 26, the Senate failedto pass the legislation by 1 vote. The fateof the bill changed July 9 with the Senatepassage by a veto-proof margin, 69 to 30.The House passed the measure on June24 by 355 to 59.

HR 6331 would delay implementationof the new Average ManufacturerPrice?based pharmacy payment planuntil October 1, 2009; accelerate fasterpayment of Medicare Part D drug claims;and delay the implementation of thecompetitive billing program for durablemedical equipment, prosthetics, orthotics,and supplies under Medicare Part B.

MEN OVER 40 FACE FERTILITY ISUES

A new study suggests that paternalimpact is stronger than originally thoughtwhen it comes to couples trying to conceivewhen the man is over age 40.

The researchers noted that earlierstudies have indicated that an overalldecline in sperm counts and quality as aman ages is a factor. Until now, however,there has been little evidence that beingolder has such a big effect on fertility,according to findings presented recentlyat the European Society of HumanReproduction and Embryology conferencein France.

For the study, the French researchersanalyzed samples taken from >21,000intrauterine inseminations. The teamexamined the quality of the sperm andfollowed pregnancy, miscarriages, anddelivery rates. Surprisingly, the teamfound that the miscarriage risk was about35% in men older than 40. Although theresearchers do not have an explanation,they said a link between a man's age andDNA decay in sperm that leads it to fragmentcould likely be a reason.

STIEFEL LABORATORIES OTC DIVISION BOOMING

Stiefel Laboratories had a45% growth in its consumerhealthcare division, comparedwith the previous year.With a presence in 100 countries,the dermatology companydates back to 1847.

"It is really exciting to seethe growth of the consumerhealth care division. In thiseconomy, the growth is even moreimpressive," said Shayne Sundholm, vicepresident of the division. "The growthreally speaks to the high-quality of theproducts."

The company recently expanded itsproduct offering in each of its currentproduct lines: PanOxyl (skin care), Sarna(anti-itch), and Zeasorb (antifungal). InMay, the company launched its newadvertising campaign for these 3 productlines. The campaign consists of both nationaltelevision and online advertising.Each commercial directs individuals toa product-focused Web site to obtainmore detailed product information, viewthe commercials, read more about skinconditions, and find a list of retailers thatcarry the products. Furthermore, StiefelLaboratories has expanded itsWeb presence to include a varietyof Internet video and banneradvertisements for all productlines. The company also redesignedpackaging for all its productsto reflect a more consistent,modern look to help enhanceshelf presence and appeal tomore buyers.

The company is continuing its growthwith a new dry skin product line calledImpruv. The product line, which isexpected to be available in December,will be positioned in the high-growth,healing restorative end of the dry skincategory. Impruv will include skin caresolutions to moisturize, repair, and protectdry, sensitive skin.

He said that the company's developmentprocess is "very vigorous andincludes dermatologist,pharmacists, andconsumers."

He also noted that pharmacists playan important role in recommending OTCproducts. Company research indicatesthat individuals follow pharmacists OTCrecommendations and that pharmacistsare a very important resource.