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November 2008 Drug News

AAP doubles vitamin D recommendation for children
The American Academy of Pediatrics has doubled its recommended dose of vitamin D for children, to 400 international units a day. The group says the dose should begin in the first few days of life and continue through adolescence to ward off rickets and other bone problems. Yahoo!/The Associated Press (10/13) , USA TODAY (10/11)

New Law Regulates Internet Drug Sales
A new law that regulates online pharmacies promises to give federal regulators, Internet companies and the medical profession a new weapon to stop the illicit flow of addictive drugs.
President Bush has signed into law the Ryan Haight Online Pharmacy Consumer Protection Act, which is designed to improve the safety of Internet pharmaceutical sales. The law, which Congress passed in late September, is named after a California teenager who died in 2001 from an overdose of prescription drugs.
The law requires a face-to-face meeting between patients and doctors in order for prescriptions to be valid. It also requires that prescriptions be written for “legitimate medical purpose” and increases penalties for the illegal sales of controlled substances over the Internet.
Before the law was enacted, the legal definition of what constitutes a prescription had been left to state pharmacy boards.
The abuse of addictive drugs such as Vicodin and OxyContin has become a nationwide epidemic, ensnaring not only patients, but also doctors, pharmacists, drug distributors and others involved in the Internet drug trade.
Christine Jones, general counsel for the Web hosting company Go Daddy, said the law will provide almost immediate results to stymie rogue Internet pharmacies. She said that in the first half of 2008, her company suspended more than 6,000 registered domain names that it suspected of being rogue pharmacies.
The new law requires any company selling pharmaceuticals online to procure a specific endorsement from the U.S. Drug Enforcement Administration.
In the past few years the federal government began to crack down on the illegal sales of drugs along the entire pharmaceutical supply chain. Last year, it suspended the controlled substance registration of three of Cardinal Health’s warehouses, claiming the Dublin drug distributor failed to notify the Drug Enforcement Administration of suspicious orders. Cardinal Health recently settled with the DEA, agreeing to pay $34 million in civil penalties as the suspensions were lifted. The Columbus Dispatch Oct. 17

Free Drug Samples May Not Be A Great Deal: Research
Free samples of prescription drugs may carry hidden costs for children and teens, according to research reported in Pediatrics. Among all U.S. residents under 18, one in 20 got at least one free drug sample in 2004. Lead author Sarah Cutrona, an internist at Cambridge Health Alliance in Massachusetts, claims that giving out free samples “encourages a casual attitude toward medications.” USA Today

New CDC Campaign Warns About Antibiotic Overprescribing
The Centers for Disease Control and Prevention (CDC) launched a campaign to warn about the growing problem of antibiotic resistance caused by overprescribing the drugs for common viral infections that are unaffected by antibiotics. “Antibiotic use is a serious problem and a threat to everyone’s health,” stated Dr. Lauri Hicks, medical director of CDC’s program called “Get Smart: Know When Antibiotics Work.” CDC Press Release

Business Negotiation Bill Advances
The House Judiciary Committee has formally cleared business negotiation rights legislation. The bill, H.R.971, earlier had been approved by the committee unanimously, but not officially reported to the House and placed on its calendar.
Of particular note, the committee report accompanying the bill contains strong language supporting the argument that independent pharmacies face unique market problems that require legislative action:
“Supporters of H.R. 971 expect that allowing pharmacists to bargain
collectively will enable the newly formed alliances to more equitably
compete with national chains and mail-order pharmacies.
“Because the purchase power of an independent community pharmacy
pales in comparison to that of a chain pharmacy, the independent
community pharmacies are often forced to accept the rates
that a Pharmacy Benefits Manager (PBM) offers, with no negotiation. If, for example, over half
of a pharmacy’s patrons have their prescription coverage administered
by one PBM, the pharmacy is left with little choice but to accept
the contract that the PBM offers.
“With an antitrust exemption to negotiate collectively, independent
pharmacies could pool their combined purchasing power to
negotiate lower drug purchasing plans with the PBMs. Because
PBMs would broker with a wider range of pharmacies, the marketplace
would become more competitive and pro-consumer.
“Independent pharmacists believe their situation is quite different
from a normal competitive marketplace: here, small independent
businesses must compete directly with much larger companies at
the retail level, with all retailers reimbursed by a few large middlemen
instead of the consumer.
“Of further concern is that one of the largest retail competitors
(CVS) also owns one of the largest PBMs (Caremark). The vertical
nature of this arrangement within the market creates concern at
several layers of the industry. There is great concern that a single,
dominant corporation has an exclusive role in determining a drug
formulary, the average wholesale price for those drugs in the greater market, and the
delivery of those drugs to consumers.”


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