Online pharmacies step up efforts to reach your patients
As authorities go after 'outlaw' sites, other e-pharmacies are changing the doctor-patient relationship
From the November 1999 ACP-ASIM Observer, copyright © 1999 by the American College of Physicians-American Society of Internal Medicine.
By Phyllis Maguire
A consumer logs on to one of the growing number of online pharmacies and orders a diet drug, getting it delivered to her home in a matter of days. The problem is that she is an anorexic who has bought the drug without talking to a doctor, a pharmacist or any other type of health care provider.
State and federal regulators say that the proliferation of such outlaw sites, which skirt prescribing laws and regulations, is a growing public health threat. Officials worry that these sites are putting powerful drugs into the hands of the wrong people, and they're looking for ways to shut them down.
At the same time, investors are flocking to legitimate pharmacy sites like Drugstore.com and PlanetRX, which cater to patients who have seen a doctor and already have a prescription in hand. These sites are pouring cash into advertising campaigns that tout the benefits of online drugstores and hope to raise public awareness of "e-pharmacies."
While most consumers have yet to begin purchasing prescription drugs from these sites, analysts say that physicians can expect more patients to begin asking about the pros and cons of ordering drugs online. That discussion is bound to raise questions about the doctor-patient relationship—whether patients need to speak to their doctor in person to get a prescription refill, for example—and how the Internet may change that relationship.
Skirting the law
At one end of the online pharmacy spectrum are Web sites outside the United States that illegally ship drug orders here. Consumers simply log on and order drugs without talking to a physician or any health care provider. These sites, which clearly violate a number of laws, stay in business by taking advantage of the Internet's lack of boundaries and regulations.
Outlaw sites regularly ship orders of contaminated or subpotent drugs, as well as expired or unapproved medications and controlled substances. Consumers can freely order substances like GBL, for example, a chemical used to make the date-rape drug GHB. A recent U.S. News & World Report investigation found that such sites also ship addictive narcotics like codipront and contugesic, as well as drugs that need close medical monitoring such as inderal and prednisolone.
According to the FDA, the easy availability of such substances makes outlaw Web sites the nation's most serious online public health threat. The FDA is now working with the Federal Trade Commission, the FBI, the Drug Enforcement Administration and the U.S. Customs and Postal Services to try to shut such sites down. Another federal group, the Working Group on Lawful Conduct on the Internet, is setting policies on unlawful Web conduct and product sales, including prescription drugs, with a report due next month.
Officials point to the case of a 16 year old boy who, working with investigators in Kansas, was able to buy both Meridia and Viagra online.
Then there is the murky type of Web site that employs anonymous physicians to review online patient "questionnaires" and to rubberstamp prescription requests. Many of these sites are located in the United States and offer only a few prescription drugs. Viagra is their biggest seller, but other "lifestyle" drugs like Propecia and Xenical are also available. (Analysts estimate that roughly 400 sites fall into both of the above categories.)
To order a drug from such sites, patients typically pay a "consultation" fee of about $70, as well as prescription and shipping charges. The site's physicians and pharmacists never actually meet their "patients," however, a practice that most regulators agree is unethical. Without a face-to-face consultation and exam, critics say, doctors prescribing online don't know if patients are overreporting their weight to get diet drugs, for example, or omitting important details of their medical history.
The authors of an Annals of Internal Medicine article to be published next month and now posted on ACP-ASIM Online found that such sites charge more for drugs than local pharmacies and allow patients to make a dangerous end-run around physician and pharmacy practice standards. An accompanying editorial pointed out that physicians and pharmacists who work at such sites have a conflict of interest because they get consultation fees only when a prescription is dispensed.
At the other end of the e-pharmacy spectrum are legitimate virtual pharmacies, which fill prescriptions that are e-mailed, faxed or phoned in from a physician. These sites have pharmacy licenses in every U.S. state and verify all prescriptions with the signing physician.
The idea behind virtual pharmacies is simple: Many consumers prefer to shop online and not have to go to the pharmacy to drop off a prescription. Refills can be authorized through electronic communications between physicians and pharmacists, and consumers would find it as convenient to buy prescriptions online as books or airline tickets.
Yet these sites suffered a payment glitch: Until now, most of them have not been connected to prescription plans, so consumers have had to pay for prescriptions out-of-pocket.
Virtual pharmacies have cut deals with pharmacy benefit management companies (PBMs) and national drug chains so they can accept consumers' insurance plans, swapping the Internet space that PBMs coveted for patients with prescription coverage. When the dust from this summer's deals settled, CVS Corp. owned Soma.com, PBM giant Express Scripts Inc. had a stake in PlanetRX, and Rite Aid Corp. scooped up a portion of Drugstore.com. (For more on these online drugstores, see "A look at the major e-pharmacy players")
Legitimate sites are also spending an estimated $150 million this year on advertising, but consumers still aren't biting. According to a survey from Cyber Dialogue, a Manhattan-based company that tracks Internet commerce, half of all online users are satisfied with traditional ways of getting prescriptions. And since legitimate e-pharmacies are still figuring out how to streamline their delivery systems, consumers sometimes have to wait more than a week for prescriptions to arrive. While e-pharmacies have diverted a trickle of refills from mail-order companies, they have yet to attract substantial numbers of first prescriptions.
As legitimate online pharmacies battle for consumers, online sites that ask patients to fill out questionnaires before dispensing drugs are attracting the attention of another group: state licensing boards and regulators. Licensing boards in a number of states argue that physicians who prescribe drugs over the Internet must be licensed to practice medicine in the patient's home state—or face prosecution.
In Kansas, the state licensing board has obtained injunctions against three out-of-state physicians for approving prescriptions online for Kansas consumers. According to Mark W. Stafford, JD, general counsel of the Kansas State Board of Healing Arts, such physicians are not practicing medicine or issuing valid prescriptions. Instead, he said, they are acting as little more than Internet telemarketers, reducing prescription drugs to on-demand items.
Licensing boards in Colorado, Washington, Arizona, Wisconsin, Illinois and California have taken similar actions against physicians or are considering doing so. Some boards have sent "cease and desist" letters to licensed physicians for prescribing out-of-state online, and physicians have been fined as much as $1,000 and had their licenses temporarily suspended by their home boards.
State boards are also joining forces to put the squeeze on physicians prescribing via the Internet. One Arizona doctor, who did not have a license to practice in Kansas, was sued by that state for prescribing to a Kansas consumer. He was also disciplined by the licensing board in Arizona for issuing a prescription in a state in which he wasn't licensed.
In addition, the Kansas attorney general's office has filed suit against eight prescription Web sites for violating consumer protection laws, arguing that the statutes that mandate state licenses for physicians and pharmacists are designed to protect consumers. As evidence, officials point to the case of a 16-year old boy who, working with state investigators, was able to buy both Meridia and Viagra online, even though he listed his actual age on his online questionnaire.
Federal agencies are also cracking down on physicians who prescribe over the Internet without an established physician-patient relationship. According to the federal Food, Drug and Cosmetic Act, physicians can prescribe drugs only with valid prescriptions. "One of the things we look at [in deciding if a prescription is valid] is whether there is a genuine practitioner-patient relationship," explained Jeffrey E. Shuren, MD, JD, a medical officer for the FDA. "Arguably, if the only contact you have is online, it may not be a genuine relationship." By claiming that prescribing to strangers online violates federal law, the FDA may slap cyber-docs with criminal charges.
Congress is considering an Internet pharmacy consumer protection bill that would make posting the names and qualifications for both physicians and pharmacists on such sites mandatory.
Organized medicine has also weighed in. At its fall meeting, (see "Governors debate tort reform, online prescribing"), the College's Board of Governors passed a resolution urging members not to prescribe medications online or be associated with companies that do. The resolution will be considered by the Board of Regents.
The majority of online physician's patients are 'doctor shy,' such as men who have trouble admitting they are depressed.
To help consumers recognize legitimate sites, the National Association of Boards of Pharmacy has launched its Verified Internet Pharmacy Practice Sites (VIPPS) certification program. VIPPS seals—which are displayed on awardees' sites—will be given only to those online pharmacies that receive prescriptions from patients' physicians, not from doctors employed by the sites themselves. The NABP has so far awarded three VIPPS certificates, with a dozen others pending. (More information on the program is available at www.nabp.net.)
Can it work?
Most physicians agree that outlaw e-pharmacies that blindly fill prescriptions for all comers should be eradicated, and many would like to ban online prescribing altogether.
But the Federation of State Medical Boards (FSMB), for one, isn't so sure that prescribing online without an established physician-patient relationship should be considered unprofessional conduct. "This clearly is a medium that can enhance communications between physicians and patients," said Dale L. Austin, FSMB's deputy executive vice president. "One of the challenges is thinking this all through and not jumping too quickly to put a Band-Aid in place that may restrict an evolving medium."
A case in point is the CyberDocsMD Inc. site (www.cyberdocs.com), a site that provides online consultations with physicians and fills prescriptions. The site, which was started in 1996 by three emergency medicine specialists, lists the names and qualifications for each of more than 40 board-certified physician consultants. It also clearly states that CyberDocs can prescribe only to patients who live in the same state in which they're licensed. (They can also prescribe to patients outside the United States.)
Norman I. Goldstein, ACP-ASIM Member, an internist in Westminster, Md., and a CyberDocs internal medicine consultant, said that he spends most of his time online listening to patient symptoms and giving advice, which always includes the suggestion to see a local provider. He said the majority of his online patients are "doctor shy," such as men who have trouble admitting that they are depressed or are seeking a second opinion.
His online prescription policy is "very selective," Dr. Goldstein said. "I would never prescribe narcotics or a medication that required monitoring." Without such conservatism, he agreed that prescribing online can be "very dangerous." But he is convinced that the Internet holds the key to future physician-patient communications, particularly with innovations in Internet audio and video.
"If I can see and hear a person and prescribe for them online, and the entire transaction takes far less time, costs less and takes place in a safe setting, then that is the way to go," Dr. Goldstein said. "Costs are absolutely impossible for primary care people, and it is driving all of us out of practice. Unless we can offer these kinds of options, we're not going to survive."
Others caution that the growth of Internet prescribing offers some important lessons about real-time medical delivery. Gordon D. Schiff, ACP-ASIM Member, director of clinical quality research for Cook County Hospital in Chicago, said that while he deplores online "Viagra mills" and the doctors who work for them, they are evidence that traditional physician-patient relationships are eroding. As consumers switch managed care plans every year, he pointed out, going online for a prescription may not be much different from picking a new doctor's name out of a network directory.
He finds it conceivable that a well-run pharmacy site could offer more, not less, personalized attention than an in-person visit—as long as reliable questionnaires could ensure careful evaluations. "I would certainly prefer a well-structured, standardized questionnaire, even if the encounter wasn't face-to-face, to a rushed office visit for a prescription," Dr. Schiff said.
"These [sites] may be symptoms of a lack of intimacy and continuity between patients and doctors," he continued. "We need to address the underlying problem, not just the symptoms."
A look at the major e-pharmacy players
Here is a short list of pharmacy Web sites that provide medications only to those patients who have already seen a physician:
Soma.com, one of the first online drugstores, was recently bought by America's largest pharmacy CVS Corp., which changed the site's name to CVS.com. Consumers get the convenience of ordering online and picking up prescriptions at one of CVS's 4,100 locations, saving them shipping fees and days of waiting. CVS com. is now allied with Merck-Medco Managed Care LLC, the nations's largest pharmacy benefit management (PBM) firm.
PBM giant Express Scripts Inc. launched yourPharmacy.com this summer for its 45 million members. One month later, it sold the site for a stake in a bigger e-pharmacy: PlanetRX.com. The new PlanetRX site allows consumers to tap into prescription benefit plans, instead of making them pay out-of-pocket and then try to get reimbursed. Express Scripts—like other corporate partners—is playing e-pharmacy hardball, refusing to reimburse members for drug purchases made through other pharmacy sites.
With its investment from Rite Aid Corp., Drugstore.com feels it has the best of both drug chain and PBM worlds. The site's users can pick up products they order at any of Rite Aid's 3,800 locations. And Drugstore.com is automatically tied into the 50-million member reimbursement plans covered by Rite Aid's PCS Health Systems.
Alarmed by the growing dominance of chain stores on the Web, the National Community Pharmacists Association (NCPA) created CornerDrugstore.com. Consumers can connect to their local pharmacy through the CornerDrugstore.com site and order from pharmacists who already have their insurance and medication information. Another advantage: roughly 85% of community pharmacists make home or office prescription deliveries the same day they're ordered, an option that most chain stores do not offer.
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