Boca Medical Products and the FDA have notified consumers andhealthcare professionals of an extension of an earlier recall ofUltilet insulin syringes and the additional recall of Closercareinsulin syringes because of bacterial contamination withPaenibacillus. This presents a risk of local infection due to softtissue injection with a contaminated syringe as well as a risk ofintroduction of contaminating organisms into a previously sterilevial.
Triax Pharmaceuticals has launched a patient assistance program(PAP) for the prescription acne treatment system Tretin-X(tretinoin). The program is administered through RxHope, a PAP Webportal for uninsured patients.
Results of two studies in patients aged six to 12 years have ledNovartis to update the labeling of dexmethylphenidate HCl (FocalinXR) extended-release capsules. Significant improvements in ADHDsymptoms were observed at every hour up to 12 hours afteradministration of 20 mg of the drug compared with placebo.
AstraZeneca has launched a campaign directed at healthcareproviders after receiving reports of confusion between brand-namedrugs Toprol-XL (metoprolol succinate), Topamax (topiramate,Ortho-McNeil), and Tegretol (carbamazepine, Novartis) and TegretolXR that have led to medication errors. The effort will aim toincrease awareness of the problem and reinforce accurateprescribing and dispensing of Toprol-XL.
Sanofi-Pasteur, manufacturer of the meningococcalpolysaccharide-protein conjugate vaccine (MCV4), has announced ashortage of the vaccine that will last at least through the summerof 2006. Due to the limited supply, CDC is now recommending thatproviders immunize only adolescents at high school entry who havenot previously received MCV4 as well as college freshman living indormitories.
Remember the long list of do's and don'ts CMS came up with latelast year related to how the Medicare Part D plans are to bemarketed? CMS has proposed new guidelines for the 2007 contractyear and has given only one week's time for the public to comment.
Children with active Crohn's disease will now have a new treatmentoption as the FDA has given the regulatory nod to infliximab(Remicade, Centocor) for the treatment of the disease. Themonoclonal antibody works to reduce the inflammation of the bowelassociated with Crohn's by blocking the action of tumor necrosisfactor-alpha and inducing remission of the condition.
Where once treatments were lacking for myelodysplastic syndromes,now several drugs have been approved for this bone marrow disorder
The link between tubing and catheter misconnections and serious errors, including patient deaths, has been a well-known but underreported problem for years. Hoping to get device manufacturers and healthcare organizations to take more aggressive action in order to reduce the number of adverse events, the Joint Commission on Accreditation of Healthcare Organizations recently issued a Sentinel Event Alert.
Fifty-eight percent of adults have visited a drugstore in the past30 days to make a prescription purchase, a decrease from 62% in2004 and 64% in 2000, according to the results of a recent Vertisstudy. Vertis is a Baltimore, Md.-based provider of targetedadvertising, media, and marketing services.
Electronic prescribing that includes patient-specific formularyinformation could cut a payer's drug spend by 8% to 15% anddrug-spend inflation could be reduced by as much as 1% per year,according to an analysis commissioned by RxHub. An e-prescribingnetwork, RxHub processed more than 26 million requests forpatient-specific eligibility, benefit, and formulary informationlast year and is on track to top 60 million patient events thisyear.
New Hampshire is set to become the first state to ban drugcompanies from getting physicians' prescription data. The law wouldprevent all types of pharmacies, PBMs, insurers, and data-miningcompanies from selling, transferring, using, or licensing Rxinformation for any commercial purpose.
Medco Health Solutions has reached a tentative agreement with theUnited Steelworkers union over a contract with technicians at thePBM's Las Vegas mail-order pharmacy. Terms of the deal were notannounced.
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.
Pandora Data Systems recently released a multi-user, HealthInsurance Portability & Accountability Act (HIPAA)-compliantversion of its medication usage analysis software. Designed in 1989in partnership with a local pharmacist to be used in conjunctionwith his Pyxis 1000 automated dispensing system (ADS), the currentversion of Pandora is compatible with the Pyxis 3000 and theMcKesson AcuDose and Omnicell dispensing systems as well.
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.