Oversight plays catch-up to Internet pharmacy
NABP offers standards for on-line services
Industry and government regulators have begun scrambling to oversee the exploding on-line pharmacy market.
Already this year, a half dozen high-profile Internet pharmacies have become available, offering new and refill prescription delivery, e-mail patient reminders, 24-hour pharmacist consultation, links to informational data bases, and sales of herbals and traditional drug store health and beauty products. A majority of the sites require physician confirmation after an on-line order is placed, but many less-reputable sites don’t, which has largely spurred the rush to regulate.
As an extension of established telemedicine or mail-order pharmacy, the on-line market has some hospital pharmacists concerned about the possible widening of the information gap. "It’s another reason to be very careful about a patient’s drug history, current medications, and any problems they’ve had," says Nancy Jordan, PharmD, BCPS, director of drug information services at Holyoke (MA) Hospital. "More and more, it’s hard to keep up with how much home care is being done, whether it’s by over-the-counter herbals, mail orders or, now, on-line delivery," she says.
The companies behind the sites — ranging from startups to pharmacy benefit managers to drugstore chains like Drug Emporium — have secured working agreements with insurers in which plans are billed and co-payments are charged to credit card accounts. Internet sites also have had quick success with drug distribution sites while receiving regulatory approval to operate from individual state pharmacy boards.
One on-line service, DrugEmporium.com, has partnered with the established and popular drkoop.com, which carries the cachet of former U.S. Surgeon General C. Everett Koop. The Koop site offers drug recommendations for specific disease states and related health care information. As for Jordan’s concerns about securing complete patient drug regimens to avoid harmful reactions, drkoop.com counters with its Drug Checker service, an integrated database that reviews regimens for possible adverse reactions.
But two larger concerns have industry organizations and federal regulators worried that sites offering virtual consultations with physicians can thwart traditional doctor-patient relationships and that some opportunistic drug companies will place ads on the sites.
This summer, PlanetRx.com announced a deal whereby drug company Parke-Davis will exclusively partner with the service. PlanetRx.com will offer links to sites dealing with a variety of specific disease states; those sites will include ads for Parke-Davis drugs.
Criticism that the plan presents a conflict of interest by comparing the ads to displays in "brick-and-mortar" drug stores or in health care magazines. "People have to realize that accessing an on-line pharmacy is just like walking into the corner drug store," says Mitchell Reed of the on-line pharmacy soma.com, which also debuted this year. "There are some medical conditions for which only one drug is appropriate and there is no conflict, but we do have to be very careful that a dispensing pharmacy does not become an advertising billboard," he says.
AMA writing prescribing rules
On the issue of virtual consultations, the House Commerce Committee has directed the General Accounting Office to undertake a review of Internet pharmacy sales to confirm that physicians are signing off on prescriptions being sought by consumers.
The American Medical Association, voicing the same concern over the availability of on-line drugs without a consultation or a prescription on some sites, was readying its own set of physician prescribing rules for its annual conference in Chicago as this issue of Drug Utilization Review went to press.
Organizations like the National Association of Chain Drug Stores (NACDS) are neither condemning nor applauding the sites, pointing out that with a projected delivery time of three to five days, on-line pharmacies likely will concentrate on refill and maintenance customers, which constitutes 75% of the prescription market, according to NACDS.
The National Association of Boards of Pharmacy (NABP) has launched an oversight registration campaign that aims to separate legitimate sites from those resembling on-line telemarketing by offering virtual consultations with physicians.
"While a growing number of legitimate sites are coming on-line to dispense prescriptions and over-the-counter medications, the medium has attracted a visible band of unlicensed and unscrupulous people interested in a quick profit," says NABP president Kevin Kinkdale. "These sites operate for a short time at one address, disappear, and set up under another name to escape detection."
For discerning consumers, it may be easy to be wary of sites called "Viagra Online" or "MD Healthline," which offers only Viagra and Celebrex and a physician’s consultation fee of $65. Ordering drugs from the MD Healthline site, previously known as MD Pharmacy, is as easy as one, two, three: Simply read and agree to a liability waiver, complete a "medical consultation form," and "receive your order within a few days," the site advertises.
Another site, called "First Pharmacy of the Internet," says it can supply any prescription medication, "however we specialize in those medications which are difficult to obtain in some countries."
Confidentiality also an issue
But even for sites everyone agrees are legitimate — those that verify or require patient verification with a prescriber, for example — there are still issues of patient confidentiality (see related article, p. 117) and unauthorized or unknown drug switching.
Akin to a seal of approval, the NABP’s Verified Internet Pharmacy Practice Sites (VIPPS) program is an ambitious undertaking the organization plans to have running on its own Web site by the end of this year.
The program essentially will offer a public list of on-line pharmacies NABP has reviewed and accepted as legitimate VIPPS sites. Along with being listed with NABP, accepted sites will be allowed to display a VIPPS seal.
The program has two levels of oversight. On one hand, the VIPPS list will include only on-line pharmacies that have met individual state board standards. After that, services must apply to the VIPPS program and comply with a host of NABP criteria such as patient confidentiality, drug security, and assurance that the site offers consultation with a pharmacist and that NABP is able to confirm that all RPhs are licensed.
Because the Internet is borderless, the VIPPS program states that when conflicts between individual state laws and federal laws must be resolved, NABP generally will side with which ever law is more stringent.
The organization is working on safeguards for generic or therapeutic substitution allowed within existing guidelines that will speak to patient awareness, prescriber authorization, and third-party paying. Also on the drawing board are ways to track prescriptions so one person doesn’t submit a script to multiple on-line services.
Additionally, NABP says it will provide ways for patients to report any adverse reactions and for the member site to take action, as well as ways to ensure that drug utilization review occurs when necessary. Lastly, participating services must notify NABP of any informational changes to a Web site, or personnel changes such as the pharmacist-in-charge, to maintain its VIPPS endorsement. Details can be found at www.nabp.net.
Aside from the NABP’s efforts and the interpretation of existing licensing and approvals within state pharmacy boards for on-line pharmacy, oversight and regulation are largely in the rhetorical stage, with confidentiality, specific licensing, and traditional doctor-patient relationships getting most of the attention.
"Patient information, whether in electronic or paper format, has little or no federal protection," says Linda Kloss, executive vice president of the American Health Information Management Association, a Washington, DC, medical records oversight board. "The growth of on-line medical and pharmaceutical practices underscores the need for comprehensive and preemptive confidentiality legislation," she says.
"Sharing confidential information not only violates patient trust, it’s against the law and could put our pharmacy licenses in jeopardy," responds Tom Pigott, president of on-line provider soma. com in Seattle. He says the service uses multiple layers of passwords that match only certain personnel to certain records, as well as overall Web site encryption and secured servers to dissuade hackers, for example.
George Barrett, president of the Federation of State Medical Boards, has likened on-line pharmacy to telemedicine, but without the medicine. His organization fears that, unlike telemedicine, on-line prescribing could occur without an initial physician exam or diagnosis, laying to waste the traditional and ethical doctor-patient relationship.
The organization wants to see legislation ensuring that won’t happen, and it is endorsing the idea of specific licensing for on-line pharmacy similar to that used for mail-order pharmacy.
The American Medical Association agrees and has endorsed language affirming that prescribing is only legal after a doctor-patient relationship has been established in the flesh.
Already this year, the NABP says, five state pharmacy boards have submitted cases to medical boards of doctors prescribing through on-line services without ever seeing the patient.
Who’s who in on-line pharmacy
Pigott says soma.com has secured commitments from 20 insurance plans covering about 30 million people and has been approved for operation in 30 states. Services simply note on their Web sites in what states consumers can use them.
"We intend to work with third-party payers on the streamlining of claims processing, reducing the cost of prescription fulfillment, and improving patient outcomes," he says.
Pigott’s and other on-line services are also touting patient reminder capabilities as a selling point, noting the recent growth in studies showing the negative impact on patient health, hospitalizations, and overall health care dollars that noncompliance brings. His service has contracted with an automated dispensing firm in Ohio that will include a photo of the packaged drug on the label, along with dosage information.
Medicaledge.com, owned by Integrated Medical Technologies and based in Lawrence, NY, touts its physician referral and medical history registry as selling points, along with an informational database of brand name and generic drugs and links.
Medicaledge.com, calling its service the "Drug Stop," accepts a prescription and then sends the consumer phone and fax numbers a physician must use to confirm the prescription. Aside from narcotics and liquid formula tion, the company says it can deliver more than 200 types of drugs ranging from 30- to 90-day dosages covering anything from acne and allergies to HIV and prostate cancer.
The national PBM Express Scripts Inc. in St. Louis has gotten into the market with YourPharmacy.com, taking advantage of a built-in customer base of more than 30 million people. It also has launched DrugDigest.com as a companion informational site.
Express Scripts also is relying on its existing relationships within the health care industry and its experience in the clinical aspects of pharmacy to rise above the competition. "We intend to leverage our relationship with employers and managed care organizations and use the same facilities and safety checks used to send out more than 8 million prescriptions last year alone," says YourPharmacy.com president Gregg Rotenberg. "We expect to offer a screening to check for adverse reactions and for interactions with other prescription and nonprescription drugs," he says.
At the other end of the spectrum is Drugstore. com and PlanetRx.com, which bring no real pharmacy experience but a lot of business experience to the table. Drugstore.com was started by a former Microsoft executive, and Amazon.com quickly acquired 40% of the company. PlanetRx. com is being operated by a former official with Federal Express.
Drugstore.com is located in Microsoft’s homebase of Redmond, WA, while the Oakland, CA-based PlanetRx.com will distribute out of Memphis, TN, home of Federal Express’ main distribution arm.
[For more details, contact the National Association of Boards of Pharmacy at 700 Busse Highway, Park Ridge, IL 60068. Telephone: (847) 698-6227.]
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