PHARMACY

Lifting state barriers on the types of vaccinations Rx can deliver equals greater access

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT — The release by Walgreens of case studies that detail how retail pharmacy can expand access to immunizations is obviously important on several fronts, but it really makes one stop and wonder: What could be done if laws didn’t vary by state in terms of what types of vaccinations pharmacists can deliver?

(THE NEWS: Walgreens immunization studies: Pharmacy instrumental in helping states combat disease. For the full story, click here)

The studies demonstrated the impact of three Walgreens initiatives aimed at increasing immunization rates: off-clinic hour vaccine administration (defined as times when traditional physician offices and clinics are closed), a pharmacist-led meningitis vaccination program and expansion of access to immunization services in underserved areas.

The results? Impressive. For example, a pharmacist-led meningitis vaccination program in Texas drove the number of vaccinations provided by Walgreens pharmacists dramatically year over year from 41 in January 2011 to 11,229 in January 2012. The program was implemented in support of a Texas state mandate requiring all college students younger than 30 years of age to be immunized for meningitis before the January 2012 semester and clearly demonstrates that community pharmacies can support state government initiatives and improve public health.

Then there’s pertussis. Many cases of pertussis are not diagnosed and so are not reported. Yet over the past five years, between 10,000 and 27,000 cases have been reported each year. According to the Centers for Disease Control and Prevention, the last peak year nationally was in 2010 when more than 27,000 cases were reported.

Or what about pneumococcal vaccines? The Centers for Disease Control and Prevention stated that all adults 65 years of age and older should receive the PPSV vaccine. However, the CDC indicated that the percent of adults 65 years and older who had ever received a pneumococcal vaccination is only 59%.

Again, just imagine what could be done if laws didn’t vary by state in terms of what types of vaccinations pharmacists can deliver.

Clearly, there’s a need for greater education on the importance of immunizations and a need for greater access. Lifting the barriers for those pharmacists who practice in states that have such restrictions is a big step in the right direction.

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PHARMACY

Par launches generic version of Provigil

BY Alaric DeArment

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

The launch occurred under an agreement between the Federal Trade Commission and Teva Pharmaceutical Industries, which acquired Cephalon, the maker of Provigil, in October 2011. On Thursday, Teva — which launched an authorized generic version of Provigil on March 29 — said the Food and Drug Administration has found it was the sole first filer of a regulatory approval application for generic Provigil.

Mylan sued the FDA in a federal court in response to the decision, saying that Teva had forfeited its right to submit an approval application for generic Provigil that challenged what was now its own patent, and that Mylan should be recognized as the first-to-file company instead.

Provigil has annual sales of about $1.1 billion, according to IMS Health.


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Teva entitled to exclusivity on Provigil, FDA decides

BY Alaric DeArment

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

Teva said the FDA granted it 180 days of market exclusivity for a generic version of Cephalon’s Provigil (modafinil) after determining that it was the sole first-to-file company; under FDA regulations, the first company to successfully file for approval of a generic version of a drug with a Paragraph IV certification — a legal assertion that the drug’s patents are invalid, enforceable or are not infringed — gets 180 days of exclusivity in which to compete directly against the branded version.

Teva launched an authorized generic version of Provigil at the end of March and said it also expects Par Pharmaceutical to launch a generic version of Provigil on Friday under an agreement with the Federal Trade Commission related to Teva’s October 2011 acquisition of Cephalon. An authorized generic is the branded version of the drug marketed under its generic name at a reduced price.

In response to the FDA’s decision, Mylan filed suit against the agency on Thursday in the U.S. District Court for the District of Columbia seeking to overturn it. Mylan said that Teva could no longer submit an approval application with a Paragraph IV certification due to its acquisition of Cephalon because it could not infringe its own patents. Mylan said that it should be considered the first-to-file company and that Cephalon had previously agreed to its launch of a generic version of Provigil no later than this Friday.

Provigil, which is used to treat conditions like shift work sleep disorder and narcolepsy, had annual sales of about $1.1 billion, according to IMS Health.

 


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