With conflicting statements from the Food & Drug Administration, Centers for Medicare & Medicaid Services, and a Federal District Court judge, the definition and legality of pharmacy compounding once again seems headed to the Supreme Court or Congress for sorting out.
Like it or not, accreditation is expanding from acute care to other healthcare settings, so get ready for it.
A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.
With dramatic demographic shifts under way in this country, pharmacies should tailor their marketing to multiethnic groups.
We know that about 400,000 people in the United States currently suffer from multiple sclerosis (MS), and it's more common in women and Caucasians. We also know that early treatment of the condition makes a difference. Recently, we've read that Biogen Idec and Elan Corp. were given the go-ahead to reintroduce natalizu-mab (Tysabri) for the treatment of relapsing forms of MS. But beyond that, we haven't heard too much lately regarding the treatment of this devastating disease. What, if anything, coming down the pipeline looks promising? Here are a few of the possibilities.
All symptomatic patients with HIV disease should begin antiretroviral therapy right away, according to new guidelines published by the International AIDS Society-USA and presented at the International AIDS Conference held in August in Toronto. Based on several new developments, the revision marks the seventh time since 1996 that the organization has updated its recommendations for HIV treatment.
DEA recently proposed a rule change that would allow doctors to prescribe up to a 90-day supply of Schedule II controlled substances. The rule must go through a two-month comment period, which ends on Nov. 6, before it can take effect. Schedule II drugs include a wide range of medications such as codeine and OxyContin (oxycodone, Purdue Pharma). The Controlled Substances Act does not allow refills for Schedule II drugs, forcing many doctors to give multiple prescriptions or to have patients with chronic conditions return regularly. "We believe that the statement and proposed rule will help the medical professional ensure that only patients who need medication for pain relief get it," explained DEA administrator Karen Tandy in a written statement.
The Cosmetic, Toiletry, & Fragrance Association (CTFA) has filed comprehensive comments with the FDA on the science and regulation of nanoparticles in personal care products.
Touro College is moving forward with plans to open a new pharmacy school campus in Manhattan for the 2008 school year.
The Office of Inspector General (OIG) has issued a final report on the "Review of Durable Medical Equipment Providers? Medicaid Claims for N.Y. Residents of Assisted Living Programs."
The Duke Clinical Research Institute in conjunction with the FDA will create a virtual electronic database of more than 200,000 electrocardiograms (ECGs) in order to identify as early as possible the potential effects that drugs and devices may have on the heart.
Anti-TNF therapy infliximab (Remicade, Centocor) is now approved for the treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy.
Lamotrigine (Lamictal) has been approved for its fifth indication as an antiepileptic—this time as an add-on therapy to treat primary generalized tonic-clonic seizures in children two years of age and older and adults.
Rare cases of a brain-capillary leak syndrome called reversible posterior leukoencephalopathy syndrome have led to a revision in the Warnings and Adverse Reactions sections of the prescribing information for bevacizumab (Avastin, Genentech).
The first buccal tablet form of fentanyl was recently given the green light by the FDA, according to manufacturer Cephalon Inc.
Tibotec Pharmaceuticals has announced the opening of an expanded-access program for TMC125, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1.
President Bush has named Leslie Norwalk acting administrator of CMS, according to a report from the Associated Press.
Lorrie Kline Kaplan has announced her resignation as executive director of the National Home Infusion Association, effective mid-March 2007.
Pharmacists will have the chance to mix fun with education and outreach during American Pharmacists Month in October.
Lindora, which is recognized for its medically supervised weight management programs in Southern California, and Rite Aid have announced an agreement to open the first in-store healthcare clinics that will also offer medically supervised treatment for weight control.
The Cosmetic, Toiletry, & Fragrance Association (CTFA) has filed comprehensive comments with the FDA on the science and regulation of nanoparticles in personal care products.
The American Academy of Pediatrics has issued the following policy statement opposing the use of retail-based clinics located in supermarkets, pharmacies, and large retail stores: ?These clinics do not support AAP?s commitment to the medical home model that provides accessible, family-centered, comprehensive, continuous, coordinated, compassionate, and culturally effective care for which the pediatrician shares responsibility with the family.?
CDC has published new recommendations for healthcare providers that are designed to make voluntary HIV screening a routine part of medical care for all patients aged 13 to 64.
The Institute of Medicine has issued a report to Congress criticizing the FDA?s drug approval system.
In its ongoing effort to bring Clay-Park Labs products under the Perrigo brand, Perrigo recently announced 12 more product conversions. While most product changes will not affect NDC, UPC, and outer case pack dimensions, the company also created new NDCs for two triamcinolone products.
The AIDS Action Committee of Massachusetts Inc. has launched a new bilingual, statewide hotline to answer questions about pharmacy access to needles.
Abbott?s Ross Division has voluntarily issued a nationwide recall for one lot of alilmentum, two lots of Similac Advance Liquid Infant Formula Ready-to-Feed 32-oz. plastic bottles, and one lot of hospital discharge kits.
The AIDS Healthcare Foundation (AHF) is opening two Positive Healthcare Pharmacies.
CVS/pharmacy will offer flu vaccinations in 4,500 stores nationwide.
An initiative that will appear on the November ballot in Oregon would expand a state prescription drug program to cover all residents without drug coverage.