PHARMACY

California e-pedigree requirements delayed until 2011

BY Adam Kraemer

ALEXANDRIA, Va. The California Board of Pharmacy Tuesday voted to delay implementation of statutory electronic pedigree requirements for prescription drugs from 2009 until 2011.

The law, originally intended to take effect Jan. 1, 2009, would have required that anyone transferring a prescription drug, including wholesalers and pharmacies, provide an electronic form with information about changes in ownership of the drug up and down the supply chain. It would have required companies to track even individual small packages of drugs.

In January, Steve Perlowski, vice president of industry affairs for the National Association of Chain Drug Stores, spoke on behalf of the NACDS before the board. Due to what NACDS called “the extraordinary demands of meeting electronic pedigree requirements,” the organization had requested that implementation be delayed two years for manufacturers and wholesalers, until Jan. 1, 2011, with an additional year for retail pharmacies and pharmacy distribution centers.

Addressing the delay, William Powers, president of the board, said in a letter Tuesday that many companies had reported they still would not be ready to implement the new standard in 2009, but felt they could do it with the extra time.

During his testimony in January, Perlowski explained NACDS’ position. “Our fear is that as manufacturers attempt to manage their costs associated with applying a serialized number to each product, they will each, inevitably, come up with their own solution, leading to multiple solutions in the supply chain,” he said. “Implementing just one solution will be difficult. Complying with multiple solutions is beyond the abilities of many if not all dispensing points—including retail pharmacy, hospitals, clinics, mail order facilities and physicians.”

Steve Anderson, president and chief executive officer of NACDS, released a statement Tuesday on his organization’s behalf, applauding the board’s decision. “We are committed to working to ensure the safety of prescription medications,” he stated. “Our industry and our partners throughout the prescription drug supply chain have been working tirelessly to achieve a workable solution. However, more time is needed for everyone involved to comply with the state’s pedigree law.”

Anderson’s statement pointed to the efforts of NACDS and its partners in this matter. “In January of this year, together with the California Pharmacists Association and the California Retailers Association, NACDS sent a letter to the California State Board of Pharmacy articulating the critical need for a delay to ensure successful implementation for pharmacies and the patients they serve,” Anderson said. “In addition, NACDS and both California associations testified before the California State Board of Pharmacy earlier this year addressing concerns about a rapid implementation of the pedigree requirements.

“CPhA worked tirelessly on behalf of patients and its members to help achieve the delay in the electronic pedigree,” said Kathy Lynch, vice president of Government Affairs for CPhA. “Today’s vote will provide more time to ensure a successful implementation for all concerned and especially pharmacies. We applaud the Board of Pharmacy for acknowledging the hurdles that exist and we will continue to work with our partners and the board to find an electronic pedigree standard that will ensure patient safety.”

In his January testimony, Perlowski, too, had discussed chain pharmacy’s efforts to work with other partners in the pharmaceutical supply chain to develop viable pedigree solutions. He also requested that steps be taken to ease the transition to electronic pedigree, including the continued use of inference—assuming that a trusted manufacturer has shipped the correct drugs, based on shipping documents and a case coding— and the grandfathering of all medications in the supply chain for two years after the compliance date.

“We applaud the California State Board of Pharmacy for their prudent decision to delay the implementation of e-pedigree,” Bruce Roberts, executive vice president and chief executive officer of the National Community Pharmacists Association stated in response to the decision. “While we certainly support the concept of using track-and-trace technology to limit the fraud and abuse of prescription drugs, the 2009 deadline was a logistical impossibility that lacked specificity for the affected parties. We hope the delay will allow those lingering issues to be addressed, including providing financial relief for community pharmacies that would be required to buy the expensive equipment for this unfunded mandate. The NCPA remains committed to offering whatever assistance is needed to make the new 2011 implementation deadline as smooth and practical as possible.”  

“While there are still many hurdles ahead,” Anderson’s Tuesday statement concluded, “we appreciate the board’s acknowledgement of the challenges facing manufacturers, distributors and pharmacies, and we will continue working with the board to meet this goal and ensure patient safety.”

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Study offers insights into cell growth ‘on/off’ switch

BY Drew Buono

DURHAM, N.C. According to a study published in the April issue of the journal Nature Cell Biology, new information has been found about an on-off switch that controls cell growth could one day help identify targets for drugs to treat cancer and other diseases that involve unnatural cell growth.

If the switch is “on,” then a cell will divide, even if it’s damaged or the signal to grow disappears, according to researchers at the Duke Institute for Genome Sciences and Policy.

The on-off switch is part of the pathway that controls cell division, the process that creates new cells. Before a cell divides, it goes through a checklist to make sure everything is in order. If the cell senses a problem early on, it can halt the process. But once the cell passes what’s called the restriction point, it can no longer stop division. This on-off switch controls the restriction point and therefore plays an important role in cell growth, according to the study.

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Biotech firms spent $58.8 billion on R&D in 2007

BY Drew Buono

SAN FRANCISCO According to an analysis by Burrill and Company and the Pharmaceutical Research and Manufacturers of America, the biotech industry’s investment into research and development of new medicines was $58.8 billion in 2007.

The report also showed the PhRMA-member companies spent about $44.5 billion on research and development last year by themselves; this was a slight increase from the record number of 2006 which was $43 billion. Non-PhRMA companies spent about $14.3 billion, up from $12.2 billion in 2006.

“America’s biopharmaceutical research companies continue to pave the way for the development of future treatments and cures,” said PhRMA president and chief executive Billy Tauzin. “Simply put, R&D is the lifeblood of U.S. pharmaceutical innovators. Last year’s investment builds on over 25 years of growth in R&D spending as our researchers continue the search for new and improved therapies to tackle a wide range of diseases and conditions such as cancer, heart disease, HIV/AIDS and Alzheimer’s.”

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