Expanded label approved for Remodulin
March 27th 2006Already approved as a subcutaneous or intravenous infusion for the treatment of pulmonary arterial hypertension (PAH), treprostinil sodium (Remodulin, United Therapeutics) for injection has received expanded label approval from the FDA and can now also be used to diminish the rate of clinical deterioration in patients requiring transition from epoprostenol sodium (Flolan, GlaxoSmithKline). United Therapeutics said it has also successfully completed a phase IV postmarketing study as part of an FDA Subpart H accelerated approval requirement.
R.Ph. discharge counseling reduces adverse drug events
March 20th 2006By reducing medication discrepancies, pharmacist counseling of and follow-up with hospitalized patients at discharge were associated with lower rates of preventable adverse drug events, according to a randomized study of 178 general medicine patients. The study appeared in the March 13 issue of Archives of Internal Medicine.
FDA asks: Should we go with RFID tags now?
March 20th 2006The Food & Drug Administration has been counting on radio frequency identification (RFID) technology to be ready for widespread adoption next year, allowing drug product packages to be tagged with tiny chips containing an electronic product code or unique electronic serial number. Now the agency thinks that may not happen and is in a bit of a quandary.
FDA eases passage for constipation drug
March 20th 2006The first in a new class of drugs, lubiprostone (Amitiza, Sucampo/Takeda) was approved by the Food & Drug Administration in late January for the treatment of chronic idiopathic constipation in the 33 million adults the condition is estimated to affect. It is responsible for 92,000 hospitalizations annually and is more common in women and in patients over the age of 65.
FDA eases passage for constipation drug
March 20th 2006The first in a new class of drugs, lubiprostone (Amitiza, Sucampo/Takeda) was approved by the Food & Drug Administration in late January for the treatment of chronic idiopathic constipation in the 33 million adults the condition is estimated to affect. It is responsible for 92,000 hospitalizations annually and is more common in women and in patients over the age of 65.
Visicol maker calls kidney failure reports misleading
March 20th 2006Salix Pharmaceuticals is calling a recent report linking its bowel prep drug to kidney failure misleading. Consumer advocacy group Public Citizen had cited a study in the Journal of the American Society of Nephrology calling bowel-cleansing products containing sodium phosphate an ?underrecognized? cause of chronic kidney failure.
Private-label OTCs making a dent in brand-name share
March 20th 2006The market for private-label OTC drugs is expected to reach $3.6 billion by 2010, according to a new study by Kalorama Information, a division of MarketResearch.com. The study found that private-label brands ate up 19.7% of the OTC market share in 2004, with sales topping $3.4 billion in 2005.
ECE to review foreign R.Ph. credentials
March 20th 2006NABP has partnered with Education Credential Evaluators (ECE) to evaluate the credentials of applicants for the Foreign Pharmacy Graduate Examination Committee Certificate Program. Beginning April 14, FPGEC applicants will have to submit their educational credential documents to ECE, a nonprofit public service organization
R.Ph. discharge counseling reduces adverse drug events
March 20th 2006By reducing medication discrepancies, pharmacist counseling of and follow-up with hospitalized patients at discharge were associated with lower rates of preventable adverse drug events, according to a randomized study of 178 general medicine patients. The study appeared in the March 13 issue of Archives of Internal Medicine.
Joint fluid therapy has new directions for use
March 20th 2006The FDA has approved new labeling for Supartz, an injectable form of hyaluronic acid that is used for the treatment of pain from osteoarthritis of the knee. New directions for use now allow physicians to choose as few as three intra-articular injections for a course of therapy, instead of the previously approved five weekly injections.
FDA warns of albuterol-inhaler shortages
March 20th 2006Both chlorofluorocarbon (CFC)- and hydrofluoroalkane (HFA)-containing albuterol metered-dose inhalers have been in short supply, according to an FDA announcement. While some manufacturers have had temporary supply shortages, other companies have maintained normal production.
Supreme Court bolsters state rule, claim compounders
March 20th 2006A recent Supreme Court decision bolsters the argument for state regulation of drug compounding, according to the International Academy of Compounding Pharmacists. The decision reaffirmed state jurisdiction in regulating the medical profession by rejecting DEA's position that federal law prohibits prescribing drugs under Oregon's physician-assisted suicide law.
Parents sue on-line pharmacy over teen suicide
March 20th 2006The parents of a California teenaged debate champion who committed suicide seven weeks after getting fluoxetine on-line have sued the Web site, the prescribing doctor, and the pharmacy for negligence and wrongful death. The parents of John McKay allege that the 19-year-old ordered the anti-depressant from USAnet.com that a Colorado psychiatrist whose prescriptive authority was revoked wrote the Rx without examining him, and that a Mississippi-based community pharmacy dispensed the drug.
SEC looking at CVS for stuffed animal barter transaction
March 20th 2006CVS has reported that the U.S. Securities & Exchange Commission has started an informal inquiry into how it accounted for a barter transaction in 2000 that involved stuffed animals. The company's audit committee has determined that accounting for the 2000 transaction was incorrect, CVS said in a filing with the SEC.
On-line Part D poll seeks R.Ph. input
March 20th 2006Pharmacists are urged to complete an on-line poll about Medicare Part D being conducted by the National Council of State Pharmacy Association Executives and state pharmacy associations. The survey is being conducted to gauge the experience and concerns of pharmacists about Part D since its implementation.
PAD treatment should cover pharmaceutical care
March 20th 2006People with lower-extremity peripheral arterial disease (PAD) should get treatment, including pharmaceutical treatment, comparable to that for people with established coronary artery disease. That's according to new, comprehensive guidelines on PAD from the American Heart Association (AHA) and other medical groups.
Clinical twisters: Updating antipsychotic choice
March 20th 2006A 58-year-old man, G.C., is hospitalized with an acute myocardialinfarction (MI). His physician has prescribed metoprolol, ramipril,warfarin, and atorvastatin (Lipitor, Pfizer), but is debatingwhether to continue G.C.'s bedtime chlorpromazine 400 mg, whichhe's taken for 20 years for schizophrenia, or switch to a newermedication. G.C. is showing signs of tardive dyskinesia (TD). Hisrecent records show normal fasting blood glucose levels. His BMI is22. He is a smoker. His physician asks your opinion aboutantipsychotic therapy. What do you recommend?
Imatinib-like agents on way to treat CML
March 20th 2006Small signs of resistance to imatinib (Gleevec, Novartis) emerged soon after the drug's approval in 2001 as the first oral tyrosine kinase inhibitor for chronic myeloid leukemia (CML). But second-generation drugs with similar mechanisms of action were already in the pipeline, according to studies presented at the recent 2005 ASH annual meeting, held in Atlanta. Generally about 20% of CML chronic-phase patients relapse after three years of imatinib therapy, researchers pointed out.
ROI model confirms value of pharmacy services
March 20th 2006Pharmacists can and should prove that their treatments provide a significant return on investment (ROI), said Fred Pane, R.Ph., senior director of pharmacy affairs at Premier Inc., the San Diego group purchasing organization. "Pharmacists can move from a compartmentalized budget and expense analysis model to an overall cost-of-care model," he said. "The data exist to establish that the work they do generates the best patient outcomes, with a positive effect on overall costs and reimbursements."
Eliminating insulin errors: R.Ph.s share tricks
March 20th 2006Not only do 11% of serious medication errors involve insulin misadministration, but the same errors seen today have been documented at least as far back as 1975. These were but two of the points Matthew Grissinger, R.Ph., used to emphasize the importance of health-system insulin safety during February's ISMP teleconference, "Preventing Errors with Insulin: A Multidisciplinary Approach."
Medicare cuts threaten access to oncology care
March 20th 2006Oncology care faces two cliffs, said Lee Schwartzberg, M.D., board member of the Community Oncology Alliance (COA): a planned $400 million to $500 million in Medicare cuts and severe payment cuts announced by private insurers. An access-to-treatment crisis was averted primarily by the addition of $400 million in funding through the implementation of a Centers for Medicare & Medicaid Services oncology demonstration project at the end of 2004. Schwartzberg, also a medical oncologist in private practice at The West Clinic in Memphis, addressed a plenary session on the Medicare Modernization Act (MMA) at the First Annual Oncology World Congress, held recently in New York City.
Active education helps prevent antibiotic misuse
March 20th 2006Reducing excessive or inappropriate antibiotic use is the best way to slow down the spread of antimicrobial resistance in bacterial infections. A report examining dozens of studies of quality-improvement (QI) interventions found that actively engaging the clinician in workshops or educational outreach on antibiotic treatment appears to be more effective than simply posting signs about correct/incorrect antibiotic use. However, most QI interventions are generally effective at reducing both inappropriate antibiotic selection and treatment.
JCAHO tightens leash on medication reconciliation
March 20th 2006Dissatisfied with the attention hospitals have been giving to medication reconciliation, the Joint Commission on Accreditation of Healthcare Organizations has issued a sentinel event alert, signaling the high priority it's placing on this issue.
Caring for wounded solders: R.Ph.s' role
March 20th 2006Over the past few years, more than 2,200 U.S. soldiers have died in the wars in Iraq and Afghanistan. In addition, more than 16,000 soldiers and Marines have been wounded but have survived. Ironically, this is due largely to new, high-tech ceramic body armor and new field medical and evacuation systems.
FDA asks: Should we go with RFID tags now?
March 20th 2006The Food & Drug Administration has been counting on radio frequency identification (RFID) technology to be ready for widespread adoption next year, allowing drug product packages to be tagged with tiny chips containing an electronic product code or unique electronic serial number. Now the agency thinks that may not happen and is in a bit of a quandary.
Diabetes control: Closing the gap
March 20th 2006Believe it or not, one in four hospitalized patients has diabetes and the annual cost of treating inpatient diabetes in the United States has reached $40 billion. These stunning statistics represent only two of the reasons why the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA) joined forces in late January to develop a position statement outlining strategies for improving inpatient glycemic control.