The Drug Enforcement Agency unveiled a new proposal on Wednesday intended to make certain powerful painkillers more easily available to patients with legitimate medical needs.

The new plan would extend the maximum prescription length for some pain medications from the current 30-day supply to a 90-day supply.

Speaking at a press conference, DEA administrator Karen Tandy called the announcement "a good news day for people who are in chronic pain and need these drugs."

Experts in the field see the proposal as a long-awaited change that would update problematic regulations.

Rollin Gallagher, director of the Center for Pain Medicine, Research and Policy at the University of Pennsylvania, told ABC News, "These new rules will enable many more patients with severe pain to obtain proper treatment and prevent the consequences of pain."

Current laws do not allow prescriptions for Schedule II drugs, such as Oxycontin and Vicodin, to be refilled. This means patients must visit the doctor every month to obtain a new 30-day prescription. Such frequent visits can be a burden on patients and physicians alike, and also prove costly.

Plus, the current system doesn't indicate if doctors can issue multiple prescriptions during one office visit. This creates a potential for doctors to violate DEA regulations and possibly lose their licenses.

The new plan clarifies the rules, allowing doctors to issue multiple 90-day prescriptions for these drugs at one office visit. To prevent abuse, the new proposal controls the number of doses issued with each trip to the pharmacy. It allows for the 90-day prescription to be filled in three stages, with a month's supply available immediately, and then again after 30 days, and again after 60 days.

"The ability to prescribe a 90-day supply will greatly improve our ability to manage pain without forcing the patient to repeatedly make unnecessary doctor visits and trips to the pharmacy," Dr. Fredrick Burgess of Brown University Medical School told ABC News.

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Representatives of the British biotechnology firm GW Pharmaceuticals filed a request this week with European and UK drug regulators for approval of Sativex, an oral spray consisting of natural cannabis extracts, for the symptomatic treatment of Multiple Sclerosis (MS). Sativex is currently available by prescription in Canada and on a limited basis in Spain and Great Britain for patients suffering from neuropathic pain, Multiple Sclerosis, and other conditions.

Regulators from the United Kingdom, Denmark, Spain, and the Netherlands will review the request, which includes clinical data on the use of Sativex in nearly 700 patients with MS. In clinical trials, Sativex has been demonstrated to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.

British drug regulators will consult with officials from each of the three countries before rendering a decision. If the UK endorses the drug, it will receive simultaneous regulatory approval from all three nations.

GW officials initially sought to gain approval for Sativex in 2003, but were told by British drug regulators that further clinical evidence of the drug's efficacy was necessary before they would consider approving it for licensing in the UK.

Separate clinical trials investigating the use of Sativex for the treatment of peripheral neuropathic pain and cancer pain are ongoing.

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Patients taking newer blood pressure drugs have a decreased risk of developing diabetes, according to an analysis of the biggest clinical trial in Europe. The study found that only 8 percent of the people on newer medicines developed diabetes as against 11.4 percent of those on older drugs.

The study involved 19,000 people. The study compared drugs like Norvasc and Coversyl with a beta-blocker and a diuretic. Norvasc is amlodipine, while Coversyl is perindopril. Professor Peter Sever of Imperial College in London, co-chairman of the study, said the findings underlined the fact that beta-blockers were no longer effecting in treating blood pressure.

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If the condom breaks, what's the plan?

Before late August, women could get the morning-after pill commonly known as "Plan B" only by prescription.

Aug. 24, however, the FDA approved the sale of Plan B over the counter to women 18 years and older. Women younger than 18 must still get a prescription from a doctor.

According to the FDA's Web site, the company Duramed will distribute Plan B with an extensive label including a toll-free number for questions about Plan B.

Duramed is also making efforts to ensure Plan B is only sold at pharmacies, licensed drug wholesalers and clinics with licensed healthcare practitioners, like the University's Student Health Center. Additionally, Plan B will only be stocked behind a pharmacy's counter and will require proof of age to purchase.

Christine Peterson, director of gynecology at Student Health, said not much will change at the University.

"For many years we've had emergency contraception very available," Peterson said. "For the last few years it's been available 24/7/365. It was a nuisance to get a prescription, but students could get it whenever they wanted."

Peterson said as of last Friday Student Health had not received the newly packaged Plan B, so it is still only available with a prescription.

Second-year College student Quinn Thomas said although the age limit quells some of her concerns, she still does not think Plan B should be available over-the-counter.

"It's not very socially responsible," Thomas said. "I feel by offering it over-the-counter and people know they have such an easily accessible backup, they will be less likely to [use other protection] that's healthier overall ... like abstinence or a condom, that prevents more than just pregnancy."

On the other hand, fourth-year Commerce student Jeff Barry said he supported the FDA's action.

"In my opinion, as long as Plan B is used as just that -- a backup plan -- I don't see any harm in selling it over the counter," Barry said. "I do think, though, that there should be some sort of education involved with it ... about basically what the morning-after pill is, the effects that it has on the body and the negative side effects [would] probably be beneficial information to have out there."

While Thomas said she believed the easier access to Plan B will increase the amount of women who engage in unprotected sex, Barry said he disagreed.

"I don't see it being a huge, nationwide, everyone's-going-to-start-having-tons-of-unprotected-sex-with-multiple-partners thing," Barry said.

Peterson said the biggest effect will be on the lower socioeconomic classes.

"This is very important for women who don't have easy access to medical care or who don't have the means to pay for prescriptions," Peterson said.

Peterson maintained that she believes Plan B would be continued to be viewed as a backup, not a first line of defense, and would therefore not affect the amount of unprotected sex.

"Whatever a person's Plan A is -- abstinence, etc. -- it will be cheaper and more effective than Plan B," Peterson said. "It needs to be the backup when one's own plan A fails."

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People at risk of heart disease and stroke will have increased access to cholesterol-lowering drugs from October 1, federal Health Minister Tony Abbott has announced.

The drugs will be available to people with a family history of the conditions or with diabetes complications, regardless of their cholesterol levels.

Higher risk patients will be able to access the drugs immediately but will have to maintain a good diet as part of their eligibility.

The drugs will become more available through the Pharmaceutical Benefits Scheme (PBS) to about 250,000 patients.

The scheme is expected to cost about $150 million over four years.

Cardiovascular disease is Australia's biggest health problem and leading cause of death, affecting 3.7 million people in 2003 and causing more than 38 per cent of all deaths, Mr Abbott said in a statement.

Rising blood-cholesterol levels increase the risk of cardiovascular disease.

Diabetes is a further concern because it magnifies the effect of elevated cholesterol and other risk factors.

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BBC Scotland has learned a review of the medical guidelines used by doctors to diagnose and treat ADHD will not be available until March 2008.

Parents groups and education experts have claimed children could be prescribed the medication needlessly.

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The federal government says fake versions of Lipitor and other prescription drugs are being found in Iowa and elsewhere -- which people apparently bought over the Internet from Canada. Monty Scheele, the pharmacies director for a Midwestern drug store chain, says it's not wise to gamble with your health.

Scheele says "When you're considering your health care and medications you're taking to improve or maintain your health, you certainly don't want to jeopardize that by using medications that you can't trust." He says pharmacies large and small are joining into a nationwide program that tracks drugs.

Scheele says "We can trace the route of the medication from our pharmacy to the wholesaler to the manufacturer." He says the tracking programs are extraordinarily valuable in maintaining the integrity of the medication.

Scheele says being able to look your pharmacist in the eye and get your questions answered locally is worth every penny. He says "Developing that trust and that relationship with your local pharmacist is the key. You've got to be able to trust someone with your health care, just like your physician and your dentist, you've got to develop that relationship with your pharmacy knowing that what they do behind the counter is going to optimize your health."

Scheele says his customers often ask him about the discount drugs on-line. He says "Counterfeit medications are alive and well and they're being sold on the Internet through mail order." The F-D-A says consumers who bought drugs through ten websites should not use the medications because they may not be safe. The sites include r-x-north-dot-com, canadian-drugstore-dot-com and r-x-by-fax-dot-com.

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Prescription drugs shipped to the U.S. from Canada through certain Web sites operated by Manitoba-based Mediplan Prescription Plus Pharmacy might be counterfeit and should not be used by U.S. consumers because the medications might not be safe, FDA said on Wednesday, the Washington Times reports (Washington Times, 8/31). Mediplan, which was founded in 1999, is one of the largest Internet pharmacies in Canada and is "considered the first Internet pharmacy," according to USA Today. FDA said agency testing found that versions of 10 drugs that were ordered through Mediplan Web sites and seized by U.S. officials during the past few weeks did not contain the correct amounts of active ingredients. Some also were shipped from countries other than Canada. The drugs are considered counterfeit because they are marketed as brand-name products when they actually are not, FDA said. The drugs -- which were ordered from RxNorth.com, Canadiandrugstore.com and other Web sites -- were sold as Actonel, Arimidex, Crestor, Celebrex, Zetia, Diovan, Hyzaar, Lipitor, Nexium and Propecia, FDA said. Randall Lutter, FDA associate commissioner for policy and planning, said, "All of these products are intrinsically deceitful." Lutter did not specify the amount of active ingredients in the seized drugs or which countries they were shipped from (Appleby, USA Today, 8/31). Prescription drug reimportation is illegal under U.S. law. FDA has said it cannot guarantee the safety or efficacy of reimported drugs, but the agency generally has not stopped U.S. residents from ordering prescription drugs from abroad for personal use.

Canadian Reaction
Health Canada spokesperson Paul Duchesne said, "Health Canada is aware of the issue. We are investigating, and if there are any safety concerns, we will be sure to alert the public" (Washington Times, 8/31). Mediplan founder Andrew Strempler said, "We test our products and stand behind our products," adding that Canada, the United Kingdom and Australia are the main sources of medications sold on his company's Web sites. He said, "We were the first to do this. So we've created quite a stir with the pharmaceutical industry." Andy Troszok, immediate past president of the Canadian International Pharmacy Association, said FDA "has tended to take the evidence and skew it in a fashion to say Canadian pharmaceuticals are unsafe, which is completely contrary to the evidence." Troszok added that CIPA takes "very seriously any allegation of counterfeiting" and that Mediplan is a member in good standing with the association. He said, "We'd like to see the evidence behind the charges," adding that he could not comment further until he learns more about the allegations (USA Today, 8/31).

Poll
About two-thirds of U.S. residents believe that a federal law against the purchase of prescription drugs from Canada seeks to protect the profits of pharmaceutical companies, compared with 9% who believe that the law helps protect residents from potentially harmful medications, according to a recent WSJ.com/Harris Interactive poll, the Wall Street Journal Online reports. The online poll surveyed 2,295 U.S. adults from Aug. 23 through Aug 25. The poll finds that more than three-fourths of respondents agree that the seizure of prescription drugs purchased from Canada jeopardized the health of some U.S. residents, compared with 15% who disagree. In addition, 84% of respondents believe that the federal government should allow the purchase of prescription drugs from Canada, provided that the medication have approval from Health Canada, compared with 9% who do not, according to the poll. The poll also finds that Hispanic respondents and respondents who live in the western U.S. are most likely to have purchased prescription drugs from abroad and that black respondents and those who live in the eastern or midwestern U.S. are least likely to have purchased medications from abroad (Bright, Wall Street Journal Online, 8/31).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org , a free service of The Henry J. Kaiser Family Foundation

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Concerns that the newer rheumatoid arthritis drugs used to treat the sickest patients increase cancer risk aren't supported, according to a new study.

The findings should reassure patients who take Enbrel, Remicade, or Humira. All of these drugs are so-called biologics — meaning they are derived from living organisms. They are known as necrosis factor (TNF)-blocking biologics.

"If there is a [cancer] risk, this study supports the conclusion that it is a small one," says researcher Soko Setoguchi, M.D., DrPh, of Harvard Medical School's Brigham and Women's Hospital.

Rheumatoid arthritis patients do have a higher than normal risk for developing certain cancers, especially cancers known as lymphomas. But it has been unclear if this elevated risk is due to the disease itself or to the drugs used to treat it.

Studies examining the highly effective TNF-blocking drugs have been mixed. A widely-reported analysis by researchers from the Mayo Clinic published late last spring found a threefold increase in cancer risk among patients who took Remicade and Humira. That analysis didn't look at Enbrel.

The Mayo Clinic research weighed data from nine studies that compared biologic treatments to placebo.

In the newly published study, Setoguchi and colleagues compared the biologic drugs to the traditional rheumatoid arthritis drug, methotrexate.

Drugs like methotrexate are known as disease-modifying antirheumatic drugs. They slow down rheumatoid arthritis and improve quality of life for most people.

In the Harvard study, 1,152 patients took a TNF-blocking biologic, while 7,306 took methotrexate.
The patients were all 65 or older. They were identified through insurance databases in New Jersey, Pennsylvania, and British Columbia, Canada.

Even though the biologic users tended to have more severe rheumatoid arthritis than those who took methotrexate, the researchers found no significant difference in cancer risk between the two groups. The biologic users were followed for an average of 2.6 years, compared to 4.2 years for patients taking methotrexate. Setoguchi tells WebMD the researchers will continue to follow study subjects.

"We will need longer follow-up with a larger number of patients to provide precise answers," she says. "Until then, this issue [cancer risk] should be part of the decision-making process for patients who consider taking these drugs."

Dallas rheumatologist John J. Cush, M.D., tells WebMD that rather than increasing cancer risk, TNF-blocking drugs may actually lower it, as well as the risk for other diseases, because the drugs target inflammation.

Rheumatoid arthritis is a degenerative autoimmune disease caused by chronic inflammation. It is most commonly associated with the joints, but it can affect other areas of the body as well.

Meanwhile, inflammation has also been implicated as a possible cause of certain cancers, and even heart disease.

"A question that is just as important as 'What is the risk of this therapy?' is 'What is the risk of this disease?'" says Cush, chief of rheumatology and clinical immunology at Presbyterian Hospital in Dallas. "Depending on how you view the studies, there is either no risk or a marginally increased risk of lymphoma associated with taking these drugs. But we know that they have a dramatic impact on quality of life for many rheumatoid arthritis patients who are disabled by the disease."

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With all the prescription drugs on the market today, keeping up with medications is challenging even for the most experienced physicians. For new doctors, it may be impossible.

According to new research out of England, physicians just entering practice today are being asked to know more about all these drugs at the same time they are receiving less education on the practice of prescribing. The reason: there are not enough pharmacologists and clinical pharmacologists to provide the teaching.

The solution, write the authors, is for medical schools in the country to partner with other prescribers who can impart their knowledge to students. They also call for a national prescription form and computerized prescribing systems and guidelines and believe doctors should be routinely assessed for their competency in prescribing medications.

"Evidence of poor prescribing in the UK is abundant," write the researchers. "Effective treatments, such as angiotensin converting enzyme inhibitors for heart failure and statins for hyperlipidaemia, are often underprescribed. Prescription errors are common, especially when new doctors start work in hospitals." About 6.5 percent of hospital admissions are caused by adverse drug reactions which result in about a 0.15 percent mortality rate, report the researchers.

The authors emphasize prescribing problems are not confined to the England, citing a recent report from the Institutes of Medicine showing similar concerns in the United States.

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Non-prescription drugs will be on sale tomorrow in Carrefour hypermarkets, starting from the centre in Le Gru di Grugliasco (Turin); the hypermarkets of Assago and Limbiate (Milan) will follow, and then all the other Italian regions. Carrefour undertakes to guarantee a competitive price, offering 20-30 pct discounts, plus a further 5 pct for clients holding a special card. The non-prescription drugs to be offered will include all the ones provided for by the law, with the assistance of chemists. The opening hours will coincide with those of the hypermarket. "Since the deregulation decree was approved, we rushed to offer this service to our clients", said Didier Fleury, CEO of Carrefour Italia. "TOmorrow's opening is the result of an important team work - said Piermario Mocchi, director of the hypermarket division - we will offer about 2800 products in a specifically designed area".

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