
Provisions under House and Senate versions of prescription drug benefits legislation and their impact on FDA final rules regarding generic drug approvals under the Waxman-Hatch Act.

Provisions under House and Senate versions of prescription drug benefits legislation and their impact on FDA final rules regarding generic drug approvals under the Waxman-Hatch Act.

Generic drug use playing larger role in contract negotiations for health benefits with unions.

Generic biologics

2003 is turning out to be a positive year for generic drug approvals.

CMS proposes to eliminate Medicare funding for pharmacy residencies, drawing opposition from pharmacy.

JCAHO offers an alternative way for hospitals to protect patient safety.

FDA advisory committee reevaluates OTC status of ipecac syrup, an OTC since 1965.

A protease inhibitor (PI) that circumvents the problems of earlier PIs such as certain adverse events, a complex dosing regimen, and toxicities such as lipid disturbances and glucose metabolism will soon be available to those infected with HIV. The FDA recently approved atazanavir (Reyataz, Bristol-Myers Squibb) for use in combination with other antiretroviral agents for the treatment of HIV infection. Atazanavir will be available in pharmacies sometime this month.

Just in time for the 2003/2004 flu season, clinicians will be able to offer their "needle phobic" patients the first cold-adaptive, live-attenuated influenza vaccine (CAIV) that is administered as a nasal spray. The FDA recently approved influenza virus vaccine live, intranasal (FluMist, MedImmune Vaccines/Wyeth Vaccines) for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years old, and healthy adults, 18 to 49 years old. The vaccine will be available in pharmacies beginning in the late summer to early fall.

Philadelphia-based U.S. Attorney Jim Sheehan intervened in two whistleblower lawsuits alleging that Medco Health Solutions violated terms of an Rx benefits contract covering federal employees.

If you are subpoenaed, can you release protected health information under the HIPAA act?

Clinicians who treat persons with Parkinson&s disease will soon be able to offer them the first drug to be approved for the treatment of Parkinson&s in 3 years. The FDA recently approved carbidopa, levodopa, and entacapone (Stalevo, Novartis/Orion Pharma) for the treatment of persons with idiopathic Parkinson&s disease. This new product is indicated as a substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual drugs, and as a replacement for immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience end-of-dose "wearing-off." Stalevo will be available during the third quarter of 2003.

Rite Aid ordered to pay $250,000 to woman who said information pamphlet on Lyme disease medication told her to take milk and having done so compromised the antibiotic's effectiveness.

Maine passes law regulating pharmacy benefit managers.

FDA will require new labeling for Opium Tincture and Paregoric, which have been associated with several drug errors.

Velcade for injection to treat multiple myeloma.

Patients with a hereditary form of emphysema caused by alpha-1 proteinase inhibitor (A1PI) deficiency now have another therapeutic option. The FDA recently approved alpha1-proteinase inhibitor (human) [Aralast, Baxter] for chronic augmentation therapy in patients having congenital deficiency of A1PI with clinically evident emphysema. Aralast is currently available exclusively through the specialty pharmacy providers Accredo Health, Caremark, and Coram Healthcare. To obtain more information about Aralast, contact Baxter at (800) 423-2090.

Even though they're professionals, pharmacists should get paid for overtime work.

Public Citizen finds fault with the patient leaflets pharmacists distribute to consumers at the time of dispensing.

Clinicians who treat persons with Parkinson&s disease will soon be able to offer them the first drug to be approved for the treatment of Parkinson&s in 3 years. The FDA recently approved carbidopa, levodopa, and entacapone (Stalevo, Novartis/Orion Pharma) for the treatment of persons with idiopathic Parkinson&s disease. This new product is indicated as a substitute for immediate-release carbidopa/levodopa and entacapone previously administered as individual drugs, and as a replacement for immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience end-of-dose "wearing-off." Stalevo will be available during the third quarter of 2003.

What marketing practices are allowed under HIPAA?

A guest commentary on why average manufacturer prices and best prices should see the light of day.

MILT is a new labeling software for hospital pharmacies.

CMS' ruling that Aranesp and Procrit are functionally equivalent so they should get the same reimbursement is creating a stir among drug companies which feel that one product has more advantages than the other and should deserve more payment.

Reaction by Medicine Shoppe franchisees over rumour that Cardinal Health is in discussions to sell franchises to CVS.

Blue Cross Blue Shield of Massachusetts pilots new phone system Blue Phone to answer patients pharmacy benefit questions at Brooks and Stop& Shop stores.

Any Medicare prescription drug program must protect the access of rural beneficiaries to rural pharmacies, according to a report by the National Rural Health Association.

Pharmacies should stop selling cigarettes.

What marketing practices are allowed under HIPAA?

Fabrazyme and Aldurazyme from Genzyme are approved for marketing.