Pharmaceutical News: Kansas launches pharmacy tracking system

Kansas launches pharmacy tracking system

TOPEKA | Kansas officials on Monday launched a new, electronic system designed to better track the sale of pharmaceuticals used in making methamphetamine.

Attorney General Derek Schmidt and representatives of the Board of Pharmacy said the new system, the National Precursor Log Exchange, instantly records sales of nonprescription drugs containing pseudoephedrine — a key ingredient in meth.

It’s the latest tool in the state’s campaign to reduce the production and sale of meth. Participation in the system was enabled by legislation passed by lawmakers earlier this year.

“Kansas has a serious methamphetamine problem,” Schmidt said.

Kansas joins nearly a dozen states that operate the electronic tracking system, including Arkansas and Missouri.

Much of the effort has focused on retail sales of pseudoephedrine. The decongestant is found in many cold and allergy medicines, but it’s also a key ingredient in meth.

Kansas passed a law in 2005 limiting the quantity of such nonprescription remedies that people can buy at one time. The medicines are kept behind pharmacy counters, and buyers have to sign a special register.

Schmidt said that law, passed before a similar federal law, has reduced the number of clandestine meth labs seized by law enforcement. He said the numbers have dropped from as high as 850 lab seizures annually in the late 1990s to between 120 and 150 presently.

“We’re not just starting this conversation today,” Schmidt said, a former state senator who helped write the 2005 Kansas law. “This doesn’t change that law.”

The new system replaces the paper tracking where customers were required to sign a log at the counter when purchasing the drugs. There is no cost for pharmacies to join the system, the senator said, with the cost of the new software required being funded by pharmaceutical manufacturers.

“We expect 100 percent participation,” said David Schoech, a Columbus pharmacist and member of the state board.

He said pharmacies could opt out, but then would have to either stop selling the medications entirely or require a prescription from a physician.

Sen. Vicki Schmidt, a Topeka Republican and pharmacist, said the new system will block those who abused the paper system by going from location to location to purchase the products to avoid the 9 gram limits per month at each store.

“It is the culmination of four years of work that will help track the sales of these methamphetamine precursor drugs,” she said.

The senator said some states, including Kansas, are considering passing a law requiring a prescription to purchase pseudoephedrine products. Oregon and Mississippi recently passed such laws. Pharmacists and law enforcement will know if someone has already purchased their limit for the month in any of the participating states and instantly block the sale.

The attorney general said the new system saves time for law enforcement that otherwise would have to go from pharmacy to pharmacy to gather the paper logs and enter the information in a database. The information will now be available instantly for routine checks and follow-up investigations.

Baxter Announces the Acquisition of Prism Pharmaceuticals

Baxter International Inc. (NYSE:BAX) announced today that it has entered into a definitive agreement to acquire privately-held Prism Pharmaceuticals, Inc., a specialty pharmaceutical company based in King of Prussia, PA. Prism Pharmaceuticals has developed and received U.S. Food and Drug Administration (FDA) approval for multiple presentations of NEXTERONE® (amiodarone HCl), an antiarrhythmic agent. The NEXTERONE product portfolio, which does not contain polysorbate 80 or benzyl alcohol, includes the first and only ready-to-use premixed intravenous (IV) bag formulations as well as vials and a pre-filled syringe.

The terms of the agreement include a total consideration of up to $338 million, consisting of an upfront cash payment of $170 million at closing and up to $168 million in future sales-based milestone payments. The transaction is expected to close in the second quarter of 2011, subject to customary closing conditions and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. This transaction is not expected to have a material impact on Baxter’s 2011 financial results.

The NEXTERONE premixed IV formulations were recently approved by the FDA in two ready-to-use dosage forms: 150 mg in a 100 mL flexible container for rapid 10-minute loading infusion and 360 mg in a 200 mL flexible container for subsequent loading and maintenance infusions. These ready-to-use formats require no admixing, eliminating potential medication errors associated with compounding. In addition, NEXTERONE can be stored at room temperature during its two year shelf life and fits in automated dispensing cabinets and crash carts, putting the product in patient care areas ready for use during acute, time sensitive and life-threatening situations. Prior to entering into the definitive agreement to acquire the company, Baxter was the contract manufacturer selected by Prism to manufacture the premixed IV bags using Baxter’s proprietary GALAXY container technology and the prefilled syringe.

“NEXTERONE is a great addition to our leading portfolio of premix drugs and solutions for the acute care setting. It offers clinicians a unique, ready-to-use antiarrhythmic agent for critical and time sensitive situations, while also providing convenience to caregivers and value to pharmacists,” said Robert M. Davis, president of Baxter’s Medical Products business. “Based on our strong hospital relationships and familiarity with the product, Baxter is well-positioned to launch the ready-to-use presentations of NEXTERONE.”

“The development and approval of NEXTERONE has been Prism’s greatest achievement,” said Warren Cooper, CEO of Prism Pharmaceuticals. “We look forward to Baxter’s success in launching this product, which will benefit clinicians and the patients they serve.”

Amiodarone is an antiarrhythmic medication used for ventricular tachyarrhythmias, or fast forms of irregular heartbeat. NEXTERONE Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Important Safety Information about NEXTERONE

NEXTERONE is contraindicated in patients with: known hypersensitivity to any of the components of NEXTERONE, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree atrio-ventricular (AV) block unless a functioning pacemaker is available. If hypotension occurs, treat initially by slowing the infusion; additional standard therapy may be needed, including the following: vasopressor drugs, positive inotropic agents, and volume expansion. If bradycardia and AV block occur, treat by slowing the infusion rate or discontinuing NEXTERONE. The most common adverse reactions (1-2 percent) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, ventricular tachycardia (VT), and cardiogenic shock. Other important adverse reactions are torsade de pointes (TdP), congestive heart failure, pulmonary disorders, and liver function test abnormalities.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning agreements entered into between the company and Prism Pharmaceuticals, Inc., including expectations with respect to the closing of the transaction and product launches. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues; failure to obtain the necessary consents or to satisfy other closing conditions; and other risks identified in the company’s most recent filing on Form 10-K and other SEC filings, all of which are available on the company’s website. The company does not undertake to update its forward-looking statements.

Bexion Pharmaceuticals Receives Outstanding Biotech Innovation Award

Bexion Pharmaceuticals was named the Biotech Innovation Award winner at the Cincinnati USA Innovation Awards program sponsored by the Cincinnati Business Courier, the Cincinnati USA Regional Chamber and CincyTech. The Innovation Awards celebrate outstanding innovation and the companies and people who have shown how new ideas can be developed into fuel for the regional Tri-State (Ohio/Kentucky/Indiana) economic engine.

“The Bexion team is honored to be the very first winner of the Biotech Innovation Award,” stated Dr. Ray Takigiku, co-founder and CEO of Bexion. “Cancer treatment and diagnosis is in dire need of innovation. We believe, and the award judges appear to agree, that our approach represents an entirely new, exciting and potentially paradigm-shifting approach to the treatment of cancer.”

Bexion is developing BXQ-350 nanovesicles as a potential treatment for the form of brain cancer called glioblastoma. BXQ-350 nanovesicles have an affinity for the membrane patches that are common in many types of tumor cells including glioblastoma cells. Bexion’s studies have shown effectiveness in the laboratory in multiple animal tumor models, and across a remarkable range of tumors in the test tube.

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