HEALTH

Britain’s pharmaceutical society supports U.K.’s decision on oral contraception

BY Michael Johnsen

LONDON The Royal Pharmaceutical Society of Great Britain supports the U.K. Department of Health’s recent decision to pilot the availability of oral contraception through Patient Group Directions, which are written instructions for dispensing of medicines to groups of patients without a prescription, the association announced Wednesday.

There is a direct correlation in the United States to how the emergency contraception Plan B was available to consumers, before it was switched to a dual OTC/Rx status by the U.S. Food and Drug Administration last year, in several states through a standing prescription, where pharmacists counseled patients and determined whether to dispense or not dispense the emergency contraceptive. The U.K. pilot may set the stage for consideration of oral contraceptives (not emergency contraceptives) in the U.S., especially as the FDA is currently researching the possible merits of a behind-the-counter system in this country.

“Pharmacists are experts in medicines and have a track record of supplying medicines such as emergency hormonal oral contraception via Patient Group Directions and also over-the-counter, stated David Pruce, director of practice and quality improvement at the Royal Pharmaceutical Society of Great Britain. “As such, they have clinical skills and expertise that will help them provide information and advice to women to ensure the appropriate use of oral contraception.”

In addition, the supply of oral contraception via PGDs would widen and improve patient choice, access and convenience, he said. “The necessary health checks such as blood pressure testing and healthy lifestyle checks are already a part of pharmacist’s extended role.”

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Study shows Americans prefer OTC cholesterol drug over prescription

BY Michael Johnsen

WASHINGTON According to data released by the National Consumers League Wednesday, Americans with unhealthy cholesterol levels would still be more likely to consider taking an over-the-counter statin option than a prescription product, although the likelihood to purchase an OTC has decreased since the subject was debated in 2005.

Overall, 82 percent of those surveyed responded that an OTC statin would be preferable to a prescription statin. For those respondents who say they are more likely to consider taking the OTC product than an Rx product, the OTC is more appealing largely because of convenience factors.

The general opinion among consumers is that OTC statins would be viewed as safer, more natural, more suitable for someone who takes charge of his or her health, and less likely to cause side effects than Rx statins, despite the fact that those OTC statins would in fact be lower-dose versions of those same Rx statins.

Those who prefer the Rx option have a greater trust in the product and the fact that a doctor prescribed it. The Rx version is generally viewed by at-risk respondents as more effective, more reliable, more trustworthy and more suitable for someone in poor health than is an OTC statin.

Those most inclined to use the OTC statin include individuals with greater levels of concern about cholesterol, those with higher known cholesterol levels, and those who take vitamins or supplements on a daily basis. As many as 98 percent of those who reported being most concerned about their cholesterol indicated that the OTC product would be appropriate for someone with health care needs much like their own. And 94 percent of all respondents reported that the OTC product would be appropriate for someone who takes charge of his or her health.

Appropriately self-selecting was one of the key factors that scuttled the last Mevacor switch application in 2005. Merck is supposed to be updating its customer-usage surveys with better self-selection data to be presented before a Food and Drug Administration advisory committee meeting on Thursday.

The survey also found that people want to know more about OTC statins, and in fact, are more than three times as likely to seek out additional information about the OTC statin than the Rx statin (79 percent vs. 21 percent). They were also much more likely to discuss the OTC product than the Rx product with their doctor (64 percent vs. 36 percent).

Although the survey revealed a strong preference for the OTC option, it found a decline since 2004 in respondents who said they were very or extremely likely to use an OTC statin, from 20 percent in 2004 to 11 percent in 2007, a fact that may reinforce Merck’s updated self-selection usage studies.

“For the more than 100 million Americans who have high cholesterol, the challenge of keeping the bad number low and the good number high is a very real one,” stated Sally Greenberg, executive director of NCL. “In this atmosphere of increasing availability of medications without prescriptions, the introduction of an OTC statin could expand the total number of people getting treated for high cholesterol. Are consumers interested in an OTC statin option? According to our survey, they are.”

The survey was commissioned by NCL and conducted by Harris Interactive between Oct. 25 and Nov. 5. A total of 710 adult Americans at known moderate risk for high cholesterol participated.

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Life Tech introduces fertility supplement

BY Michael Johnsen

NEWPORT BEACH, Calif. Life Tech on Wednesday launched its Fertili-T supplement, a supplement formulated to support fertility, for both men and women.

The comprehensive product line is comprised of programs specifically designed for the varied conditions affecting fertility in approximately one in six American couples, including diagnosis of endometriosis, polycystic ovarian syndrome, uterine fibroids, male factor infertility and unexplained infertility.

“We’ve spent years developing Fertili-T to be effective for both men and women,” stated David Tieman, Life Tech co-founder and lead inventor. “After a development process involving extensive review of the leading published study results, our own ingredient analysis and clinical trials, we are confident that Fertili-T offers an evidence-based approach to preconception with the utmost product quality and safety assurance. …

“As a husband who has experienced the difficulty of infertility firsthand—personally familiar with both In Vitro Fertilization and miscarriage—the development of Fertili-T has become a passion for me,” Tieman said. “I’ve learned that there is no ‘one size fits all’ solution and it’s what has pushed me to use my extensive background in sciences and health to formulate a customized, all-natural line that really improves people’s chances of conception.”

Life Tech’s Fertili-T preconception supplement programs will be available for purchase online at www.Fertili-T.com beginning this month. Available in powder form or daily pill packets, the products are recommended for ages 25-45.

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