Class action suit filed against Pfizer
April 3rd 2006A group of seven drug plans has filed a class action lawsuit against Pfizer Inc., claiming the company used off-label promotion of atorvastatin (Lipitor) to boost sales. According to New York-based Grant & Eisenhofer, P.A., the securities litigation firm representing the group, the plaintiffs contend that Pfizer's physician and hospital marketing materials have misrepresented treatment protocols established by the National Cholesterol Education Program's Adult Treatment Panel III (ATP III), and that the drug was approved by the FDA only for use in accordance with ATP III.
Viewpoint: Don't forget to give out MedGuides
April 3rd 2006Since 1998, the Food & Drug Administration has had theregulatory authority to require pharmacies to distribute MedicationGuides to patients getting certain high-risk drugs. MedGuides,which provide written information to patients on their Rxs, areprepared by drug manufacturers and approved by the FDA. To date,the FDA lists more than 75 drugs on its Web site that require thedistribution of a MedGuide from a community pharmacy or uponhospital discharge. They include antidepressants, nonsteroidalanti-inflammatory drugs (NSAIDs), and others. Manufacturers ofthese high-risk drugs are responsible for ensuring that asufficient number of MedGuides are available in pharmacies.
Is this prescription for the treatment of Alzheimer's disease or insomnia?
April 3rd 2006The Food & Drug Administration would like to alert healthcare practitioners to three cases of medication dispensing errors in which the Alzheimer's medication Razadyne (galantamine, Janssen Pharmaceutica) was dispensed instead of the insomnia agent Rozerem (ramelteon, Takeda Pharmaceuticals) to geriatric patients. In two cases the wrong drug was actually administered to the patient but with no reported adverse outcomes, while the third error was caught prior to patient administration. Errors between these products could result in unnecessary adverse events or lack of efficacy.
New antifungal offers another option
April 3rd 2006The third echinocandin to hit the market in five years, anidulafungin (Eraxis, Pfizer) received Food & Drug Administration approval in February and joins both caspofungin (Cancidas, Merck) and micafungin (Mycamine, Astellas Pharma) in the fight against fungal infections in seriously ill patients. Anidulafungin is indicated to treat candidemia, other forms of Candida infections (intra-abdominal infections and peritonitis), and esophageal candidiasis.
CVS reaches agreement on tobacco sales
March 27th 2006CVS Corp. has reached an agreement with 42 states and the District of Columbia by promising to strengthen practices that keep minors from buying tobacco products. Under the voluntary settlement, the pharmacy chain agreed to check the identities of customers who attempt to purchase tobacco products if they look younger than 27.
FMI: Supermarkets offering specialty services
March 27th 2006Food retailers are differentiating their businesses from competition by launching target market-focused stores and expanding specialty services, according to the 2005 edition of the Food Marketing Institute (FMI) study, "Facts About Store Development." In-store pharmacies (55.7% of companies) continue to be a popular feature.
Seniors vulnerable to medication poisonings
March 27th 2006Seniors who take multiple medications are at increased risk for accidental poisonings, according to ASHP. Older patients have complex medication regimens, often involving multiple medications prescribed by several physicians, which make them vulnerable to accidental poisonings.
Longs Drugs announces new supplier contract
March 27th 2006Longs Drug Stores announced a new long-term supply contract with AmerisourceBergen Drug Corp. for the supply of prescription pharmaceutical products. The agreement will become effective July 1, 2006, and will run for a term of at least three and as long as seven years, with the actual duration depending on the time when the company's total purchases of branded prescription pharmaceuticals under the agreement reach a certain amount.
PBMI: Pharmacy reimbursement declining
March 27th 2006Reimbursement for retail and mail-service pharmacy continues to decrease, according to the findings of the Prescription Drug Benefit Cost and Plan Design Survey Report, conducted by the Pharmacy Benefit Management Institute (PBMI). The average retail brand-drug dispensing fee decreased from $2.05 in 2003 to $1.95 in 2004.
H.D. Smith awarded Novation contract
March 27th 2006H.D. Smith, the fourth largest national pharmaceutical wholesaler, was recently awarded a multiyear agreement with Novation, the healthcare contracting service organization, to provide members of VHA Inc. and University HealthSystem Consortium (HC) with H.D. Smith's extensive list of products and services.
Walgreens sued for comment on prescription
March 27th 2006A Palm Beach, Fla., woman is suing Walgreens on grounds that when she picked up a prescription for the sleep aid Ambien (zolpidem, Sanofi-Aventis), she found a message attached in the section reserved for patient information that said "Crazy!" The patient, Janey Karp, said the prescription also said, "She's really a psycho! Do not say her name too loud, never mention her meds by names, and try to talk to her when..." The information continued on to another page, which was not attached. Karp is suing for defamation, negligent supervision, and intentional infliction of emotional distress.
Public health advisory issued for abortion pill
March 27th 2006Following reports of two fatalities in women who took mifepristone (Mifeprex, Danco Laboratories) to terminate their pregnancies, the FDA has issued a public health advisory to providers and patients. The agency said they are investigating the cases, but at this time are not certain of the exact cause of death.
Unique combination OC approved
March 27th 2006A new monophasic oral contraceptive (OC) from Berlex Inc. may offer women less hormonal fluctuation between monthly cycles than traditional OCs. Yaz contains both 3 mg of drospirenone and 20 mcg ethinyl estradiol in a 24-day active pill regimen-a longer period of time than traditional OCs, which typically provide 21 days of hormone-containing tablets.
Grapefruit juice interactions not understood
March 27th 2006At the 2006 annual APhA meeting, information was released showing that pharmacists overestimate the number of interactions between drugs and grapefruit juice. A follow-up survey performed by KRC Research for the Florida Department of Citrus has found that while 50% more pharmacists are well informed regarding grapefruit juice interactions compared with the results of the initial 2002 survey, many pharmacists still need more specific information.
Are more specialized tech exams in the offing?
March 27th 2006Just as pharmacists can get board-certified in certain specialties, technicians could show that they are trained to work in certain settings down the line. At present, there is only one Pharmacy Technician Certification Board exam for technicians.
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