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The FDA and GlaxoSmithKline are notifying healthcare professionalsof changes in the Warnings section of the prescribing informationfor both Paxil (paroxetine) and Paxil CR, after a company-performedmeta-analysis found an increased risk of suicidal behavior in youngadults (aged 18-24) taking the drug (2.19% versus 0.92% onplacebo). The clinical trials analyzed included almost 9,000patients treated with paroxetine and about 6,000 on placebo.

Since the launch of Medicare Part D, the top three PBMs have postedrecord earnings, according to the Association of CommunityPharmacists Congressional Network. At a time when Part Dreimbursements to pharmacies are slow and low, ACP*CN noted thatMedco alone generated $650 million in new Medicare sales for thefirst quarter and that Part D allows PBMs to keep any drug companyrebates instead of passing the savings on to seniors.

The Office of Inspector General (OIG) has entered into a SettlementAgreement and Corporate Integrity Agreement (CIA) with LincareHoldings and its subsidiary Lincare Inc. Lincare providesrespiratory care, infusion therapy, and medical equipment topatients in the home. The settlement resolves allegations thatLincare paid illegal kickbacks and violated the PhysicianSelf-Referral Law (also known as the Stark Law).

The Center for Substance Abuse Treatment is seeking public commentson the revised draft guidelines for the accreditation of opioidtreatment programs. The draft guideline may be obtained atwww.dpt.samhsa.gov.

DEA will hold a public meeting on electronic prescribing ofcontrolled substances on July 11 and 12 at Washington, D.C.'sReagan National Airport. The deadline to register for theconference or to submit written comments is June 26.

Advancis Pharmaceutical Corp. has been given the go-ahead to marketits antibiotic Keflex (cephalexin) in two newstrengths-333-mg and 750-mg capsules. The company said thiswill give healthcare providers an easier way to prescribe a totaldaily dose of 1,500 mg.

UnitedHealth Pharmaceutical Solutions has expanded its Half-TabletProgram, in which beneficiaries volunteer to split pills to savemoney on co-pays for medications that can be divided. The drugsalso have similar pricing across dosages and are administered oncedaily.

Medicare Part D contributed to a 24% jump in the number of Rx drugclaim rejections during the first three months since the drugbenefit began, according to an analysis of claims data by WoltersKluwer Health. The Part D launch was marred by problems with claimsinvolving dual eligibles, who accounted for 64% of enrollees.

For many years, doses and rates of administration for continuousinfusions in pediatric patients have been based upon the "rule ofsix." This weight-based method relies on the following formula: sixtimes body weight is the amount of drug to be added to 100 ml ofcarrier fluid.

Cerner Corp.'s CareAware RxStation characterizes the nextgeneration of automated medication dispensing systems. Itintegrates electronic medical records with dispensing cabinets. "Itis a closed-loop system," said Dawn Iddings, director of resourceplanning for the company's device innovation group. "It's anend-to-end solution, fully integrating ordering, dispensing, andadministration at bedside, through a completely sealed device."

Medication errors involving neuromuscular blocking agents (NMBAs)are potentially serious and life-threatening because these agentsparalyze respiratory muscle and, if misused, can adversely affectrespiratory function. NMBAs should be administered only by staffwith experience in maintaining an adequate airway and respiratorysupport in facilities where intubation can readily be performed,oxygen can be administered, and respiratory support can beprovided.

Despite a new Food & Drug Administration mandate, which wentinto effect April 26 requiring all drugs supplied to hospitals tobe bar-coded, less than 10% of U.S. hospitals have a bedsidebar-coding system in place. Many hospital pharmacy executives saythe main reason they are not on board yet is the high cost ofimplementing it.

The pharmaceutical supply chain works wonders, bringing thousandsof drug products to hospitals just as local inventory is fallingtoward zero. The problem is that every chain, including supplychains, is prone to kinks.

Regarding the Clinical Twister in your Feb. 20 issue, the clinicalrecommendations for treating Clostridium difficile infections arecorrect but incomplete. Addition of probiotics is commonlyoverlooked, yet probably the most important therapeutic agent inrepopulating the gut with healthy flora. Probiotics are inexpensive(cost-effective) and very safe. A normalized flora stabilizes thegut, reduces diarrhea, and may help in reducing risk of C.difficile by competitive displacement.

A 68-year-old man is hospitalized with shortness of breath,fatigue, and 2+ edema-his third hospitalization in 12 months.He has heart failure (HF) (currently New York Heart Associationclass IV, ejection fraction 20%), LVH, and MI history. Heart rhythmis normal; lungs clear; lab tests within normal limits excepthemoglobin510.5 gm/dl, SrCr52.3 mg/dl; BP5160/90, pulse 85,respiratory rate522. Admitting medications: furosemide 80 mg,potassium (K), benazepril 20 mg, aspirin 81 mg, carvedilol (Coreg,GlaxoSmithKline) 6.25 mg twice daily. The resident continues allmedications, increasing furosemide to 80 mg twice daily. He askswhether adding digoxin might reduce future hospitalizations.

The National Comprehensive Cancer Network (NCCN) recently sponsoreda roundtable discussion called Cancer Care in the 21stCentury-Reality and Promise. The panelists discussed a widerange of topics, including the most important advances in cancercare since the war on cancer was declared during the NixonAdministration in 1972 and how pharmacogenomics is revolutionizingcancer treatment. The roundtable meeting, at which the group ofoncology leaders assembled for the first time, took place duringthe NCCN 11th Annual Conference, held recently in Hollywood, Fla.

Medication therapy management (MTM) was the recurring theme at thisyear's Academy of Managed Care Pharmacy (AMCP) meeting, heldrecently in Seattle. The American Pharmacists Association led aworking group of 11 pharmacy organizations to define MTM servicesin 2004. This year, a similar working group led by AMCP defined MTMprograms. The resulting consensus document was presented at theAMCP meeting.

Increased customer satisfaction and Rx drug sales ... New pharmacy and supermarket customers ... Another way to differentiate yourself from the competition. These are some of the potential benefits of opening an in-store clinic. You may want to be the first on the block to provide that point of difference. If you don't do it, you may be at a competitive loss.

For the seventh consecutive year, pharmacists requested a recordnumber of licensure transfers last year, according to the NationalAssociation of Boards of Pharmacy.

When I think of the best job I ever had, I have vivid, pleasantmemories. There was pharmacist overlap-and that is the singlemost important criterion for a job to even get in the running forbest job. One of us came in at 9:00 a.m., and the other started hisshift at noon. We worked together for four hours. There was aconstant back-and-forth banter in the pharmacy. The techs jumpedinto the fun with both feet. We joked and laughed and kidded eachother. There were times when the topic of the day was not so funny.We stuck together when a tech needed to clear her head about animpending divorce. Once there was the stress of a child being hitby a car. For me, it was a second family.

Pharmacists who want to get involved at the grassroots level can contact the resources listed below.

The CDC now estimates that more than 70% of bacteria that causehospital-acquired infections are resistant to at least one of thedrugs most commonly used to treat them. With an antibiotic pipelinethat has been quite dry for some time, clinicians continue to worryabout how they'll treat patients who develop resistant infections.Given the unrelenting nature of bacteria to mutate in an effort tooutsmart even the most powerful antibiotics, creating newanti-infectives will always be required. Here are several drugs,currently under review by the FDA, that may soon offer us a fewmuch-needed options:

Daytrana should be applied once-daily and removed after a period ofnine hours from time of application.

The new Pharmacy Quality Alliance (PQA), pushed by the Centers forMedicare & Medicaid Services to develop measures of pharmacyquality, should be working toward some early proposals by late May,according its originators.

CMS has ruled that when Medicare Part D plans impose newrestrictions or eliminate a drug from their formularies, they mustcontinue coverage for the remainder of the year on anybeneficiaries who were already taking the medication.

With the government more an adversary than an ally these days andalso the biggest payer of drugs in the country, NACDS chairman TonyCivello vowed that the association would "get confrontational" ifnecessary to push its agenda. Calling 2005 a year with fewpositives, Civello acknowledged that the association is in part toblame for the bind community pharmacy is in now. Also at fault:pharmacy's fragmented voice, which makes it a weak link vis-?-visdrugmakers and PBMs. To remedy this situation, he said, NACDS andNCPA have formed a coalition to present a unified front forcommunity pharmacy. He made these remarks at the association'sannual meeting in West Palm Beach, Fla., this month.

Due to high demand for a replay, CMS has made available a recordingto its recent pharmacy open door forum on the Pharmacy QualityAlliance. The on-line audio of the telephone conference call can beaccessed at www.cms.gov/pharmacy.