Sunday, September 30, 2012

Proposed Legislation - Market-Based Pricing in Medicare for HME

WASHINGTON, Sept. 25, 2012: New Legislation Would Establish Market-Based Pricing in Medicare for Home Medical Equipment and Services | PRNewswire | Rock Hill Herald Online:

"The American Association for Homecare endorses a bill introduced last week in the House of Representatives that would implement market-based pricing for home medical equipment and services such as oxygen therapy, wheelchairs, and other durable medical equipment and services.

A bipartisan group of 14 Representatives in the House introduced a bill, H.R. 6490, that would establish a market pricing programas a budget-neutral replacement for the current, poorly-designed Medicare bidding program for home medical equipment and services. "

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Friday, September 28, 2012

ASHP Policy Analysis - Supply Chain Tracking

Review the new ASHP (American Society of Hospital-System Pharmacists) Policy Analysis on electronic tracking of medications to improve the integrity of the supply chain:
ASHP Policy Analysis - Following Pharmaceutical ProductsThrough the Supply Chain

It covers Pedigree, e-Pedigree, and Track-and-Trace. California and Florida laws are presented. Federal legislation is discussed.

Any implementation of a track-and-trace system would likely be driven in large part by manufacturers and wholesalers who would need to develop the technological capability to track drug products, as well as the ability of that technology to interface with various members of the supply chain.

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California e-Pedigree - Proposed Requirements - continued

The California Board of Pharmacy continues to consider presentations from individuals, entities and associations on issues affecting implementation of e-pedigree requirements, readiness to meet the staggered implementation dates, and supply chain security issues.

Here are the posted documents for the recently held meeting:
CA Board of Pharmacy - Enforcement Committee Meeting - September 11, 2012 - Meeting Materials

Comments were submitted by wholesalers, manufacturers, pharmacies, and other entities.  Background reading and materials are included in the meeting materials.

The board will also soon establish a section of the board’s website to contain items related to e-pedigree. One section will be a question and answer section. Questions submitted to the board will be answered in this area.

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Saturday, September 15, 2012

Walgreen Florida Facility Barred From Shipping Oxycodone

Walgreen Florida Facility Barred From Shipping Oxycodone - Bloomberg:

"Walgreen Co. (WAG) was blocked from shipping controlled substances from a distribution center in Jupiter, Florida, after a U.S. Drug Enforcement Administration probe into the sales of painkiller oxycodone found the facility posed a threat to public safety.

The Walgreen center was served today by the DEA with an immediate suspension order that bars it from handling controlled substances including oxycodone and hydrocodone, pending administrative proceedings by the agency, according to an agency statement. The Jupiter facility, one of a dozen owned and operated by Walgreen, has been the single largest distributor of oxycodone products in Florida since 2009, the DEA said."

. . . Earlier this week, DEA Administrator Michele Leonhart ordered that the controlled substance licenses for two CVS Caremark Corp. (CVS) pharmacies in Sanford, Florida be permanently revoked.

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Thursday, September 13, 2012

U.S. revoking 2 Florida CVS stores' controlled substance licenses

U.S. revoking 2 CVS stores' controlled substance licenses - South Florida Sun-Sentinel.com:

"The U.S. Drug Enforcement Administration is revoking the controlled substance licenses of two CVS Caremark Corp drugstores in Florida as part of a government crackdown on potentially addictive painkillers, especially oxycodone, according to a court filing.

The DEA has alleged the two stores, about 30 miles south of Orlando, were inappropriately filling prescriptions for oxycodone, which can be highly addictive, and also had suspicious sales of other controlled substances."

. . .  The DEA has increased its focus on drug wholesalers and pharmacies as it tries to battle what the Centers for Disease Control and Prevention call a prescription drug abuse "epidemic.

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California pharma wholesaler and the supply of black market drugs

The full article provides due diligence information that includes names of the 17 defendants (mostly Californians).

Pharmaceuticals: California pharma wholesaler and the supply of black market drugs / Pharmaceuticals / Health, Care & Pharma / Industries / The Chief Officers' Network - your business advantage - The Chief Offficers' Network:

"In a prosecution begun yesterday, US prosecutors have charged 17 people with offences under the Bank Secrecy Act which deals with money laundering. But underneath that headline is a more troubling story: the purchase and sale into legitimate distribution channels of drugs unauthorised pharmaceuticals."

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Tuesday, September 11, 2012

Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review

Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review - FDA Lawyers Blog:

"Regarding K-V's assertion that FDA would exercise broad enforcement discretion for compounded versions of Makena™, FDA stated:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intent to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion."

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Monday, September 10, 2012

SC company guilty of wholesaling $55 million in stolen drugs

SC company guilty of wholesaling $55 million in stolen drugs - FiercePharma Manufacturing:

"Federal authorities have caught up with a drug wholesaler who bought more than $55 million worth of stolen drugs, put them back into the legitimate supply chain, then falsified "drug pedigrees," to try and hide the scheme. The case is another in a series of arrests or convictions as it continues to press on cargo theft and warehouse crimes.

Altec Medical has been sentenced to pay a $2 million fine and forfeit $1 million after it was found buying the illegally obtained drugs, the FDA reports. Federal authorities say when the Easley, SC-based company bought the prescription medications from William D. Rodriguez, it knew he was fencing them from parties that obtained them illegally. Altec has also been placed on a year's probation.

The wholesaler and Rodriguez worked together to get the drugs back into the lawful channels and then cover up the paper trail. Rodriguez, who also has pleaded guilty but has yet to be sentenced, moved the drugs through companies in South Carolina that he controlled, which then sold them to Altec. Altec passed them off to legitimate drug distributors who sold them to pharmacies."

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