Drug Topics back issues from January 2008:
Judge rules against AMP
Jan 14, 2008; ... A temporary injunction has stopped the Centers for Medicare & Medicaid Services from implementing the average manufacturer price (AMP) rule for Medicaid generic drug reimbursement. In a December hearing, Judge Royce Lamberth granted the injunction after concluding that the case filed by NCPA ...
CMS sets accreditation deadlines for Part B DMEPOS suppliers
Jan 14, 2008; ... The Centers for Medicare & Medicaid Services recently announced accreditation deadlines for all Part B durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) providers. In order for any Part B supplier to obtain or retain their Part B enrollment National Supplier ...
Drug Topics launches time capsule for future pharmacists
Jan 14, 2008; ... It doesn't contain Oxycontin or Viagra, but Drug Topics'time capsule, which was sealed at the ASHP midyear meeting in Las Vegas last month, harbors other goodies that capture the ethos of pharmacy circa 2007. Set up to commemorate Drug Topics' 150th anniversary last year, the time capsule is ...
New beta-blocker Bystolic gets FDA nod
Jan 14, 2008; ... Beta-blocker nebivolol (Bystolic), from both Forest Laboratories and Mylan, Inc., has been approved by the FDA for the treatment of hypertension. The new molecular entity is orally available and can be used alone or in combination with ...
First drug approved for treatment of phenylketonuria
Jan 14, 2008; ... The FDA and Biomarin Pharmaceutical Inc. have announced the approval of sapropterin (Kuvan), the first new molecular entity given a regulatory nod for the treatment of phenylketonuria (PKU), a condition that affects about 50,000 patients worldwide. Sapropterin is the synthetic form of 6R-BH4 ...
Drug Topics to expand in the digital world
Jan 14, 2008; ... As that well-known song put it so apdy, there is a time for everything. For Drug Topics, it's time for us to plunge deeper into the digital world. Starting with our February issue, Drug Topics has decided to produce five editions every month-one print version and four digital ones. This means ...
Letters
Jan 14, 2008; ... Drug samples should be replaced by vouchers This letter is in response to the actions of a local (New Jersey) pharmacist who was recently arrested for selling samples. The case was reported in The Record and Drug Topics Daily News (Nov. 16). This is the second such incident to come to ...
OTC asthma inhalers: Worthy of more time on market?
Jan 14, 2008; ... The manufacturer of over-the-counter epinephrine pressurized metered-dose inhalers (MDIs) is asking the Food & Drug Administration to give it an extra year -from the end of 2010 to the end of 2011-to get the chlorofluorocarbons (CFCs) out of its product. Armstrong Pharmaceuticals claims that ...
Novel vaccines in works for three disease states
Jan 14, 2008; ... Novel vaccines in three areas of research were the subject of the Ambulatory Care PRN Focus, held at the American College of Clinical Pharmacy's annual meeting in Denver in October. Mary S. Hayney, Pharm.D., MPH, presented vaccine candidates for the prevention or treatment of malaria, HIV, and ...
DEA ends year with a flurry of activity
Jan 14, 2008; ... The end of 2007 has proven to be busy at the Drug Enforcement Administration. In November and December the agency issued a final rule governing Schedule II prescriptions, proposed a newly designed form for ordering Schedule I and II medications, and suspended the licenses of two Cardinal Health ...
Comparing the effectiveness of drug treatments
Jan 14, 2008; ... Most Medicare providers and beneficiaries are unaware of the provision for comparative effectiveness research that is part of the Medicare Modernization Act (MMA). Politicians, policymakers, and manufacturers view it as a key initiative for the future of Medicare and beyond. Insurance ...
ASHP pushes on with training of technicians and residents
Jan 14, 2008; ... As ASHP conferences are wont to be, the midyear meeting, held in Las Vegas last December, offered an opportunity for its officers and staffers to review their accomplishments over the past year and anticipate the challenges ahead. ASHP's record this time reflected some good, some bad, and some ...
Specialty pharmacy: Don't miss the boat
Jan 14, 2008; ... Some believe if s not too late for community pharmacies to get into this field, which is growing by leaps and bounds By 2010, half of all Food & Drug Administration drug approvals will be specialty drugs. Additionally, the biologies share of the pharmaceutical market is expected to ...
What OTCs do R.Ph.s recommend for coughs, colds, and flu?
Jan 14, 2008; ... It's that time of year again when you're likely to hear a pharmacist doling out advice about over-the-counter items for coughs, colds, and flu. Pharmacists report that patients are asking for more counseling as a result of manufacturers' substitution of phenylephrine (PE) for pseudoephedrine ...
Revised SOM guide for surveyors bolstering role of consultant R.Ph.s
Jan 14, 2008; ... The Centers for Medicare & Medicaid Services' (CMS) revised survey guidance to the Nursing Facility State Operations Manual (SOM) has been in effect for one year. The survey tags include tag F329, covering unnecessary medications; tag F425, covering pharmaceutical services; tag F428, ...
R.Ph.s tag pseudoephedrine rules as a burden
Jan 14, 2008; ... Pharmacists in at least one area of the country are feeling that record-keeping for pseudoephedrinecontaining products is unduly burdensome and that the process has not reduced the production of methamphetamine. A survey of 193 pharmacists in Albany and other parts of New York State ...
Pharmacotherapeutic treatments for hypertension complicated with proteinuria
Jan 14, 2008; ... Introduction Hypertension affects over 50 million Americans. It is a risk factor for heart disease, stroke, and kidney disease. The incidence of hypertension increases with age, but the onset most often occurs during the third, fourth, and fifth decades of life. Hypertension can ...
New Products
Jan 14, 2008; ... Rx NEW DRUGS Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has secured FDA approval for Tasigna (nilotinib) Capsules. The drug has been approved for the treatment of chronic-phase and acceleratedphase Philadelphia chromosome-positive chronic myeloid leukemia ...
MTM must be expanded for pharmacy to stay relevant
Jan 14, 2008; ... Much has been written about medication dierapy management (MTM). Everyone talks about it, editorializes about it, but is anyone doing it? You bet they are! Our facility, a major health system, has been performing comprehensive ambulatory MTM services since 2003. Although we have ...
FDA warns compounding pharmacies about bio-identical hormones
Jan 28, 2008; ... The FDA has issued an enforcement action against seven pharmacy operations that compound so-called bio-identical hormone drugs used to treat the symptoms of menopause. According to the agency, the prepared products may contain estriol, a drug that has not been approved by the FDA, and the ...
Fewest NME approved by FDA in 24 years
Jan 28, 2008; ... According to analyst Ira Loss of Washington Analyst, the FDA approved 19 new entities in 2007, including 17 new molecular entities (NMEs) and two new biologies. The numbers have not been confirmed by the agency, but represent the lowest number of approvals in one year since 1983. In 2006, the ...
CMS proposes more plans for low-income patients
Jan 28, 2008; ... Looking to reduce the number of low-income subsidized patients it randomly assigns, the Centers for Medicare & Medicaid Services has proposed a new rule that would allow Medicare Part D prescription drug plans to offer reduced premiums for LIS beneficiaries. The new rule, which would take ...
CMS opens second round of Medicare DMEPOS competitive bidding
Jan 28, 2008; ... The Centers for Medicare & Medicaid Services announced the 70 new areas across the nation that will be part of the second phase of a competitive bidding program designed to help lower Medicare beneficiaries' out-of-pocket costs and improve their access to certain durable medical equipment, ...
Pharmacy supports hotline for reporting adverse events
Jan 28, 2008; ... Pharmacy trade associations expressed support for FDA's new rule that requires pharmacies to provide patients with a toll-free number to report adverse events. FDA said it would start enforcing this rule next January. The American Pharmacists Association said, "APhA strongly ...
Letters
Jan 28, 2008; ... Behind-the-counter drugs: A good idea Should FDA approve a behind-the-counter (BTC) class of drugs? Yes because the measure will not only increase pharmacies' foot traffic, thereby creating profit, but will also have a positive effect on Rx volume and confidence in our knowledge and ...
For the record
Jan 28, 2008; ... For the record: A Dec. 10 Special Report in the Health-System Edition inadvertently mixed up daptomycin (Cubicin, ...
How will revised USP 797 guidelines affect you?
Jan 28, 2008; ... The United States Pharmacopeia released its revision of Chapter <797>, "Pharmaceutical Compounding-Sterile Preparations," in December. The new standards become official June 1, 2008. How will the guidelines affect pharmacists? Eric Kastango, R.Ph., CEO of Clinical IQ, LLC, Florham ...
NCCN issues guideline update for multiple myeloma
Jan 28, 2008; ... In October, the National Comprehensive Cancer Network (NCCN) released an updated version of its practice guidelines for multiple myeloma (MM). As part of the revision, NCCN added a new category 1 recommendation for patients with relapsed/refractory multiple myeloma. Bortezomib (Velcade, ...
Can lactose-intolerant patients use lactose-containing medications?
Jan 28, 2008; ... Submitted on Nov. 19, 2007 Q Over the past several months, the International Drug Information Center of the Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, N. Y, has received a number of inquiries concerning intolerabilities to ...
Regional coalitions forming to improve preceptor training
Jan 28, 2008; ... Colleges of pharmacy are creating coalitions to improve compliance with the 2007 Accreditation Council for Pharmacy Education preceptor training standards. According to George MacKinnon, R-Ph., Ph.D., VP of academic affairs of the American Association of Colleges of Pharmacy, "Schools across the ...
Drug error that harmed Quaid twins shows need for better safety measures
Jan 28, 2008; ... Shortly after their birth, the newborn twins of actor Dennis Quaid were hospitalized at CedarsSinai Medical Center in Los Angeles with staph infections. While they were being treated for the infections, the twins were among three patients who were given 1,000 times the normal concentration of ...
New guide targets heart patients undergoing noncardiac surgery
Jan 28, 2008; ... Statin therapy should be continued throughout noncardiac surgery. So says a new update from bodi the American College of Cardiology and American Heart Association (ACC/AHA). The ACQ AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Noncardiac Surgery has been issued as ...
Infectious disease experts rethink length of antibiotic treatment
Jan 28, 2008; ... Finish the prescription even if you feel better. That's most often the advice pharmacists and physicians give patients along with antibioticsprescriptions that often dictate taking the medicine for as long as 10 days. But this advice is wrong, said Louis Rice, M.D., of Louis Stokes ...
Scientists at ASH unveil new tools to manage bleeding and clotting
Jan 28, 2008; ... Researchers at the American Society of Hematology (ASH) annual meeting evaluated new approaches to managing major bleeding and clotting diseases. These complications affect millions of people worldwide. Here are highlights from the meeting, held recently in Adanta, that created substantial ...
This new service helps you recover lost supply chain dollars
Jan 28, 2008; ... How often has your pharmacy been overcharged for drug purchases? Case in point: when a manufacturer runs out of a product for whatever reason and you have to switch to another drug at a substantially higher noncontract price. Such invoicing errors happen all the time and could cost ...
Patient safety is focus of technology showcase at ASHP meeting
Jan 28, 2008; ... Tools to help hospital pharmacists improve patient safety, better manage medications, and reduce overall costs dominated the exhibit floor at ASHP's Midyear Clinical Meeting in Las Vegas last month. Many of the more than 380 companies that touted their products and services at the meeting used ...
HYPERTENSION: SO MANY TREATMENTS, YET SO UNDERMANAGED
Jan 28, 2008; ... Rising in prevalence and no longer age-discriminating, hypertension is still the silent killer in our midst In the wake of a century marked by health awareness and preventive medicine, hypertension (HTN) appears to remain the very same silent killer it was dubbed decades ago, when blood ...
Fatal medication errors with heparin
Jan 28, 2008; ... The risk for fatal medication errors is highlighted as an important new warning within a revised product label for Heparin Sodium Injection (Baxter Healthcare Corp.) that was approved by the Food & Drug Administration on December 14, 2007. The new WARNINGS section states that fatal ...
Battling chronic fatigue syndrome
Jan 28, 2008; ... About one million people in the United States have chronic fatigue syndrome. It is a disorder that is difficult to diagnose, but adds huge costs to the healthcare system. Chronic fatigue syndrome has also been referred to as chronic fatigue and immune dysfunction syndrome, debilitating fatigue, ...
New Products
Jan 28, 2008; ... Rx NEW DRUGS The new beta blocker Bystolic (nebivolol) from Forest Laboratories, (800) 678-1605, has been approved by the FDA for the treatment of hypertension alone or in combination with other antihypertensive agents. The medication has already been approved in 50 other ...
Multiple Schedule II Rxs: Road to disaster?
Jan 28, 2008; ... Joe suffers from chronic back pain and requests a prescription for OxyContin because he heard from a friend that "this stuff really works." The physician can clearly see that Joe is in pain, so he writes out three prescriptions for OxyContin. The physician says, "To make things more convenient ...
CLINICAL TWISTERS
Jan 28, 2008; ... Interactions impact therapy A 60-year-old Caucasian man, T.W., spent the night in your hospital's cardiac unit with new-onset atrial fibrillation (AF). His physician prescribed amiodarone 200 mg daily and warfarin 5 mg daily, instructing T.W. to return for follow-up in one month. The ...
How to get more out of the 340B drug discount program
Jan 28, 2008; ... The 340B drug pricing program that resulted from the enactment of the Veterans Health Care Act of 1992 has allowed reduced-cost outpatient drugs to be purchased by health centers caring for indigent patients. Although growing in scope, the program is still not well understood, even by many ...