Utah to regulate online RXs?

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For more than seven years, a company known as KwikMed.com enjoyed the unique status of being the only government sanctioned online pharmacy in the country that could prescribe Viagra and other so-called lifestyle drugs over the Internet.

That one-of-a-kind arrangement is likely to change, as other entities are seeking approval from the state to do the same, and a Utah County lawmaker plans to sponsor legislation to set clear regulations for companies that want in on the lucrative business.

"The primary interest of the Legislature would be to establish a uniform statutory framework for the regulation and oversight of online pharmacy operations ... and making it a level playing field for all participants," said Sen. Curt Bramble, R-Provo.

In doing so, Utah could become home to a number of new, state-sanctioned online pharmacies and the only state in the country that allows medicine to be prescribed online.

It could also have ramifications well beyond Utah's borders, since the companies interested in the business already ship to most of the United States.

Web sites such as Drugstore.com require a patient to submit a prescription from a doctor. Others operate illicit, unregulated pharmacies, some of them based offshore.

"Utah has established a fabulous framework in that they have acknowledged that this is going to happen over the Internet and they're trying to legitimize it," said Tanya Malik, CEO of the North Carolina-based Medical Web, which has been negotiating with the state for years. "Really this is the wave of the future. ... Utah's leading the way and it's kind of unique that it is."

However, the practice of issuing online prescriptions has been criticized by the National Association of Boards of Pharmacy and the Utah Medical Association.

"Online prescriptions, absent a physical examination of a patient, do not meet the standard of care and in some states are illegal," said Carmen Catizone, executive director of the NABP. "For all of the sites, KwikMed included, if there's not a physical examination, that prescription is invalid."

And Michelle McOmber, CEO of the Utah Medical Association, said her group has been uncomfortable with online prescriptions for years "because you have no required patient-prescriber relationship."

"It's just not a smart practice. I don't think it's a step forward for patient safety. I think it's a step backward," she said.

Utah's emergence as the home for online pharmacies stems from a law that was unclear on whether online pharmacies should be allowed. After intense negotiations, the Division of Occupational and Professional Licensing reached a consent agreement in 2002 allowing KwikMed to prescribe certain "lifestyle drugs" online -- things like erectile dysfunction treatment, and hair restoration or smoking cessation drugs -- and have them delivered to customers' homes.

That includes the drugs Chantix, which the U.S. Food and Drug Administration warned last April may have serious side effects on a patient's mental health, including depression and potentially suicide.

State Sen. Pete Knudson, an orthodontist and Republican from Brigham City, sponsored legislation in 2007 to tighten Utah's law and restrict the online prescriptions, but his efforts failed. For the past two years, other companies have tried to negotiate similar agreements with the state. But Mark Steinagel, Division of Occupational and Professional Licensing director, said the case-by-case negotiations with companies seeking different conditions and permissions for different medications was impractical.

"Some that were better negotiators were going to get a better agreement and we were going to have four different agreements in place," Steinagel said.

So the division spent months drafting clear guidelines for companies seeking to operate an online pharmacy. The rule was taking shape, but Bramble asked the division to hold off to give the Legislature time to give the state legal authority to regulate the Web sites, not just the physicians.

In a letter last week, Steinagel said he would await legislative action, but could still enact a final rule for the pharmacies in April if lawmakers do not act.

Peter Ax, CEO of KwikMed, supports Utah's efforts to regulate the industry and help build its credibility.

"We've worked very, very hard to take what was sort of a rogue-type industry and develop it into something that is regulated, is safe, is an alternative mechanism for the delivery of health care that ultimately will be significantly less expensive," Ax said. "We always support regulation."

One entity that wants to get into the online prescription business is Planned Parenthood of Utah.

"Our intention is to make sure women, who are in rural areas, can obtain family planning birth control quickly and easily," said Melissa Bird, executive director of the Planned Parenthood Action Council. She said doctors typically don't require a physician's visit to prescribe hormonal birth control.

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