New study by prescription manager Medco Health solutions Inc. claims that parents of children who take ADHD medicine end up taking the drugs themselves. The study examined the prescriptions of 107,000 children and their parents last year.

The study also found that if one twin is taking ADHD medicine, it is more likely that the other would also take it than non-twin siblings.

Impulsiveness, hyperactivity and inattention are some of the symptoms of ADHD. Robert Epstein, chief medical officer at Medco said that although in childhood boys are more affected than girls, in adulthood the difference was not much.

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based internet pharmacy RxNorth.com is shutting down its distribution operation there and moving it to a Winnipeg company, due to American concerns over drug safety.

RxNorth.com, which is operated by Mediplan Global Health Inc., will transfer its operation to another company, CanadaDrugs.com, which is based in Winnipeg.

About 20 pharmacists and support staff are affected by the move, which does not affect the pharmacy's call centre in Minnedosa. At one point, the operation employed up to 200 people in Minnedosa.

Minnedosa Mayor Duane Lacoste said Wednesday he was sorry to see the company scale back its presence in the town, which is located 45 kilometres north of Brandon.

"They certainly were an excellent corporate citizen to our community," Lacoste said.

"They provided, of course, employment opportunities for all of these people. They provided funding for amateur sports, provided a large cash grant to our golf course."

The company says the latest move is being made to satisfy safety concerns of American regulators.

In late August, the U.S. Food and Drug Administration advised American consumers not to purchase several popular prescription drugs from RxNorth.com and other websites that have their orders filled by Mediplan Global Health, also known as Mediplan Prescription Plus Pharmacy.

The USDA claims the drugs shipped by Mediplan, including Celebrex, Lipitor and Propecia, are counterfeit. A Mediplan official called the allegations "completely false."

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Over-the-counter antihistamine drugs used to treat heartburn and acid reflux might be useful against chronic heart failure, a Japanese study suggests.

It's a small study, including only 50 patients. But the results point to possible benefits for many of the 23 million Americans with heart failure, a potentially fatal condition in which the heart cannot pump blood effectively, said a report in the Oct. 3 issue of the Journal of the American College of Cardiology.

"It's still very early, because we know very little about who might benefit from it or what drugs might be best," said Dr. W.H. Wilson Tang, an assistant professor of medicine at the Cleveland Clinic and co-author of an accompanying editorial in the journal. "It is an important thing to validate this data."

The initial work focused on the drug Pepcid, because a major study of medical databases by a group led by Dr. Masafumi Kitakaze of Japan's National Cardiovascular Center found that people with heart failure who were also taking the antihistamine appeared to have fewer heart failure symptoms.

The researchers were looking for such a relationship because previous research pointed to a role of histamine in heart failure. The same type of chemical reaction that allows stomach acid to cause heartburn and ulcers also seems to damage and weaken diseased hearts. Blocking this process with Pepcid might help to slow the progression of chronic heart failure, the researchers theorized.

The biological chemistry is complex, but the basic idea is that one kind of histamine can accelerate the damage done to heart cells, so that blocking the activity of histamine can protect those cells.

Half the patients in the Japanese trial were given Pepcid along with regular therapy. The other half got an alternative heartburn medicine called teprenone, whose protective effect does not involve histamine. Examinations by three cardiologists after 24 weeks found less-severe symptoms in those getting Pepcid.

"Now we need to conduct a large-scale trial to confirm the present findings," Kitakaze said in a statement. "The large-scale trial based on the results of our present research may not help current heart-failure patients because it takes time, but we hope it helps our children and grandchildren and others in the future."

The key point, Tang said, is that the Japanese researchers "found some objective benefit of using this histamine blocker versus another reflux drug that doesn't act on this mechanism."

Further studies are essential not only to determine whether all antihistamine drugs might have some value against heart failure but also to identify drugs that might work best for specific patients, he said.

"It is intriguing because this work indicates that an inflammatory cell mechanism may be pertinent in heart failure," Tang said.

But it's much too early for people with heart failure to take antihistamines because of the many uncertainties that exist, he said.

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Pfizer claims it is the first pharmaceutical company with a program of this type, focused on EPC authentication as a means of deterring counterfeiting. However, Wal-Mart now requires its top 300 suppliers to tag cases and pallets of select goods, and over 24 drug providers tag bulk containers of Schedule II drugs, prescription painkillers and drugs of abuse.


A pharmaceutical giant has announced it is using radio frequency identification (RFID) to fight pharmaceutical fakes.

Pfizer (NYSE: PFE) has initiated a tag application-verification process for Viagra sold in the United States. As each bottle is packaged, a label with an integrated passive high-frequency tag is applied. An RFID interrogator encodes an electronic product code (EPC) to each label, after which a second interrogator verifies the tag has been successfully encoded. It also reads the unique ID stored on the tag's chip, enabling Pfizer to record chip ID and EPC in a database.


Authenticity Checked

Pfizer sells five different stock-keeping units (SKUs) of Viagra -- several million units per year in the U.S. The company is also tagging the SKUs at the case and pallet levels.

Upon receipt, wholesalers and pharmacies will use an RFID interrogator linked to the pharmaceutical company's RxAuthentication Service over a secure Internet connection to verify the authenticity of each tag's unique EPC and chip ID.

If the EPC was not issued by Pfizer, or if the chip ID does not match Pfizer's records, the service sends a notice to quarantine the product, and to Pfizer's Medical Information Services employees, who process suspected cases of counterfeit drugs. The MIS employees then ask the druggist or wholesaler to send the suspected bottle to Pfizer for investigation.

There is also a version of the RxAuthentication process that allows wholesalers processing cases or pallets to verify the EPCs encoded to the case and pallet tags.

Pfizer claims it is the first pharmaceutical company with a program of this type, focused on EPC authentication as a means of deterring counterfeiting. However, Wal-Mart (NYSE: WMT)  now requires its top 300 suppliers to tag cases and pallets of select goods. Over 24 drug providers tag bulk containers of Schedule II drugs, prescription painkillers and drugs of abuse shipped to the retailer's pharmaceutical distribution centers.
FDA Approved

The U.S. Food and Drug Administration  (FDA) has endorsed the use of RFID as a means of authenticating and tracking individual containers of drugs throughout the supply chain, in order to create an e-pedigree showing each bottle's chain of custody. But Pfizer says it, and its distributors, wholesalers, and other supply chain partners, are not yet prepared to roll out an e-pedigree system.

Systech, a provider of automated packaging and data collection systems, worked with Tagsys and Pfizer to design the automated tagging process. Pfizer worked with SupplyScape, a creator of pharmaceutical supply chain software, to deploy the RxAuthentication Service.

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Newly approved drugs in the U.S. should carry a warning that their safety isn't guaranteed, the medications should be reviewed in five years, and they shouldn't be advertised for two years, according to a report released Friday.

The report, released by the U.S. Institute of Medicine, said the Food and Drug Administration hasn't done enough to oversee new drug safety. The institute said the medications should carry a symbol, such as a black triangle, indicating they might not be safe. It also suggests agency rules be enforceable with fines.

The FDA asked the institute for the study in 2004 after Merck & Co. withdrew its painkiller Vioxx, linked with higher risks of heart attack and stroke. Sen. Charles Grassley (R-Iowa), other members of Congress and consumer groups criticized the FDA for its oversight of Vioxx after the drug was approved.

"This report should be a watershed moment for FDA reform," said Grassley. "Public safety is at stake, along with the credibility of our nation's drug-safety agency."

FDA spokeswoman Susan Bro said the agency has "done a lot of work over the past two years to improve the drug-safety enterprise at FDA." The agency recognizes that more needs to be done, she said.

The study was completed by a panel of 15 independent doctors, scientists and other advisers assembled by the Institute of Medicine, which is part of the congressionally chartered National Academy of Sciences.

The FDA and several other government agencies contributed $1.8 million to cover costs associated with the study, said Christine Stencel, a spokeswoman for the Institute of Medicine.

The report takes a wide-ranging look at the FDA's oversight and says the agency needs more regulatory authority, including the ability to impose fines to ensure companies comply with labeling changes and conditions imposed on new products.

Although the report urges that drugmakers not be allowed to advertise their products to consumers in their first two years on the market, it said there might be legal questions that would limit such a move.

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Republicans in the U.S. House of Representatives tentatively agreed Thursday to prohibit Customs agents from seizing prescription drugs Americans buy in Canada and take back into the United States.

The deal would let Americans carry up to a 90-day supply of medication back to the United States from Canada without being stopped by Customs agents, House and Senate Republicans said. But it would not let Americans purchase cheaper prescriptions over the Internet or by mail-order, officials said.

"This really breaks the dam and it shows that it's only a matter of time before we pass a full-blown reimportation bill," said Senator David Vitter, a Louisiana Republican, who led the fight in the Senate to prohibit the Homeland Security Department from seizing prescription drugs being carried over the border. U.S. Customs and Border Protection is an arm of the Homeland Security Department.

Vitter acknowledged sales of drugs though mail order or through the Internet are significant.

But he added: "I think support for that is going to continue and going to continue to grow, no matter what this bill says or doesn't say."

President George W. Bush has rejected repeated congressional efforts to lift the ban on prescription imports. Medications are generally cheaper in Canada because of government price controls.

While importing drugs into the United States is illegal, the U.S. Food and Drug Administration generally has not stopped small amounts of medicine purchased for personal use. But U.S. Customs officials began intercepting imported prescription drugs two years ago and has seized more than 34,000 packages of drugs over the last year.

The pre-election controversy over the new rule threatened to split House Republican leadership who oppose lifting the import ban and rank-and-file Republican legislators who want to help elderly voters buy cheaper drugs.

However, many Customs agents already allow prescription drugs into the U.S. from Canada because they don't rigorously search people and cars for them.

Opponents said importing drugs that do not have FDA approval could be unsafe for consumers. The FDA says it cannot guarantee the safety of imported drugs.

Representatives for the pharmaceutical industry claimed Canadian Internet pharmacies, for example, have been known to sell fake and potentially unsafe medicines to unknowing American consumers through other countries.

"Americans should look at much safer alternatives that already exist and are proving to be incredibly effective here at home," said Ken Johnson, senior vice-president for the Pharmaceutical Research and Manufacturers of America, or PhRMA.

According to the Congressional Budget Office, brand-name drugs cost, on average, 35 to 55 per cent less in other industrialized countries than they do in the United States. Supporters of importing drugs contend that the U.S. is subsidizing the cost of medicine for the rest of the world.

The prescription drug policy shift would be included in a US$33.7 billion bill to fund the Homeland Security Department next year. Legislators who control the department's spending levels will meet Monday to debate other last-minute changes to the legislation, which has also been stymied by proposals to give Homeland Security regulatory oversight of security measures at chemical plants.

Legislators were negotiating whether to let the department require some high-risk chemical facilities to use nontoxic materials that would be more expensive but safer to the public if there is a release. The chemical industry strongly opposes such a requirement, and environmentalists have been pushing for it just as vociferously.

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