Internet pharmacies: who's minding the store?

You make an appointment to see your doctor, who examines you, discusses treatment options, then writes a prescription for an FDA-approved drug. You take the prescription to the local pharmacy, where a registered pharmacist fills it and cautions you not to take aspirin or drink alcohol while on the medication.

That's how it used to be. But now you might click on a pharmacy Web site and use the keyboard to type the answers to a brief medical questionnaire. A doctor employed by the pharmacy prescribes the medication with no physical exam.

While Internet pharmacies offer the convenience of ordering prescriptions shipped to your door, this may come at the price of safety. State and federal safeguards built into the first scenario may be absent from the second. The Internet pharmacy doctor or pharmacist may not be qualified or licensed to practice in your state.

There is little oversight to guard against consumer harm, because the new pharmacy medium crosses state lines and blurs jurisdictional authority. "Rogue sites" that are shut down by one state can easily reopen in another jurisdiction.

Some online pharmacies essentially sell prescription drugs without a prescription. The drug the patient receives could be an unapproved new drug, improperly manufactured to be sub- or super-potent, contaminated or outdated, marketed with fraudulent health claims, or a counterfeit drug with inert ingredients. The pharmacist often doesn't know contraindications for a prescribed drug without a complete patient medical history. And, of course, the consumer can lie on the pharmacy's online questionnaire.

A Michigan TV news investigative team typed false information into an online questionnaire and received prescription Viagra--an impotence drug--for a cat.

"What we're seeing is a greater and greater corporate dominance of the retail pharmacy business. What they've done is taken away the corner drugstore and replaced it with a system that emphasizes profit and volume," said Craig Smith, a Dallas attorney and cochair of ATLA's pharmacy litigation group. "With Internet pharmacists, we have a further removal of the pharmacist from the professional duties that they've been trained to fulfill."

No one knows how big the online pharmacy business is. According to the National Association of Boards of Pharmacy, store pharmacies dispensed 3 billion prescriptions in 1999. Larry Sasich, a licensed pharmacist who works with the Washington, D.C.-based Public Health Research Group at Public Citizen, said that about 15 percent of all prescriptions are now dispensed by mail-order pharmacies.

The number of consumers using the Internet to find health and medical information rose from 3.2 million in 1995 to 22.3 million in 1998, according to Peter Neupert, president and CEO of Drugstore.com. He predicted the online prescription drug market will grow from almost nothing in 1998 to $15 billion by 2004.

The American Medical Association (AMA) says "every state medical board agrees that prescribing drugs without physically examining a patient or reviewing his or her medical records is, in most cases, practicing medicine at a level far below the acceptable standard of care," but no state laws directly address the issue of Internet prescribing.

AMA guidelines state that before prescribing a medication, a doctor should obtain a medical history, examine the patient physically, discuss treatment options, inform the patient about the risks and benefits of the medicine, and provide for follow-up care. New guidelines drafted in 1999 specifically address Internet prescriptions, stating that doctors who prescribe over the Internet should follow the same minimum standards of care.

Reputable Internet pharmacies fill prescriptions sent by patients after they see their doctor. These pharmacies display a seal of approval from the pharmacy boards association, which sponsors the Verified Internet Pharmacy Practice Site (VIPPS) at http://www.nabp.net/. The site was launched in February 1999, after a board association survey found many online pharmacies that claimed authorization to ship medications to all 50 states but were only licensed in a few states.

To become certified by VIPPS, an online pharmacy must meet the licensing and inspection requirements in the state where it is located and in each state to which it dispenses pharmaceuticals. It must protect a patient's right to privacy, ensure authentication and security of prescription orders, adhere to a recognized quality assurance policy, and provide a way for patients to have questions answered by a pharmacist. To date, only a few online pharmacies have received VIPPS approval.

These pharmacies are the exception. The Internet is becoming a new marketplace for sales that are already illegal, such as prescription drugs without a valid prescription or products marketed with fraudulent health claims. The U.S. House Subcommittee on Oversight and Investigation reported an estimated 400 Web sites selling instant prescriptions.

Pharmacies based outside the United States are not subject to accountability or safeguards. Offshore pharmacies may ship drugs without prescriptions or even doctor involvement, and the drugs may not be FDA-approved. It is illegal for a foreign pharmacy to ship such drugs into the country, but since offshore pharmacies don't have to comply with U.S. laws and federal regulators don't have jurisdiction over foreign operations, tracking down companies and subjecting them to U.S. standards is difficult.

Investigations under way

Just as there are no hard data on Internet pharmacies, there are few cases under regulatory review or in litigation.

In March, the United States helped close the first case against a foreign Web site. Twenty-two people were arrested in Thailand and face up to five years in prison for violating Thai export regulations by selling prescription drugs on the Internet and exporting them to the United States. A joint operation by U.S. and Thai customs agents traced tranquilizers, steroids, and diet pills to three Thai Internet pharmacies that mailed the drugs overseas, mostly to the United States. Six U.S. customers were arrested for buying medication illegally, and seven related Web sites were shut down.

The Federal Trade Commission (FTC) launched "Operation Cure-All" last July. It has identified about 600 sites using questionable promotions for products and treatments to cure diseases. The commission has charged four companies with making deceptive health claims.

By March 2000, the FDA reported conducting 134 Internet-related investigations into criminal activity (54 deal with prescription drugs, 80 with health fraud or unapproved drugs), with 36 arrests and 17 convictions. Forty sites are under active review for regulatory or civil action, and regulatory action has been taken on 49 sites.

Meanwhile, licensing boards in at least a dozen states have investigated online pharmacies. Attorneys general in Illinois, Kansas, and Missouri have taken enforcement action against doctors or pharmacies that prescribe for residents in a different state without the proper authority to do so.

Last December, Michigan Attorney General Jennifer Granholm filed notices of intended action against 10 online pharmacies for illegally sending prescription-only drugs to in-state customers without an appropriate prescription or physician supervision. Because the sites gave the false impression that an online consultation form is an adequate substitute for a doctor's examination and failed to disclose that the physicians and pharmacies are not Michigan-licensed, they violated the state Consumer Protection Act, Granholm said.

Jurisdiction

Jurisdiction is one issue that is muddied by the limitless reach of the Internet. "One question is whether the Web site is subject to personal jurisdiction in the state where the patient is," said Patrick Malone, a plaintiff attorney in Washington, D.C. "If the site is actually selling the patient something, it probably would be."

Generally, he said, any "active" site--one that allows consumers to sign up for services, transmit a credit card number, and buy products--creates enough contacts with a user's state that the company is subject to suit in that state.

Plaintiff attorneys speculate that potential causes of action against online pharmacies might include the following.

* Violation of state board licencing requirements. The AMA says, "Under existing law in the majority of states, prescribing drugs to a patient outside the state where the physician is licensed is considered the unlicensed practice of medicine." In addition, doctors who prescribe without sufficient patient contact risk ethical, regulatory, and legal challenges from licensing authorities.

* Health fraud. The sale of a prescription drug without a valid prescription is considered fraud, and the practice is subject to FDA action. Pharmacies that do this may also be violating state practice-of-medicine guidelines.

* Professional liability. Internet pharmacies face insurance, license to practice, and negligence issues. Pharmacies must be able to verify that a prescription is valid, that it has been appropriately written, and that the physician has the appropriate licenses--which is harder to prove given the Internet's global reach.

* Personal injury. Pharmacies may be held liable for injury to a patient who relies on provided health product information that may be inaccurate or incomplete. State consumer protection commissions or the FTC may take action against the pharmacy for giving misleading, false, or incomplete health product information.

* Privacy infringement. There is potential liability for damages caused by the inappropriate disclosure of patient information when Internet transactions are involved.

Expanding enforcement

"The federal government has to be involved [with pharmacy regulation] because it's a national issue--products are crossing state lines," said Public Citizen's Sasich. "Regulatory oversight by the government requires some teeth, otherwise it's not effective. That would mean giving the FDA some power to take action."

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency wants to enforce existing regulatory provisions without putting more burdensome restrictions on legitimate electronic commerce. She said the agency will expand enforcement efforts against illegal online sales, work with federal and state agencies to coordinate enforcement efforts, meet with state officials to discuss regulation, and expand public outreach to warn consumers.

The issue has not escaped the attention of Congress. The Internet Pharmacy Consumer Protection Act of 1999 (H.R. 2763) was introduced in August. The bill would amend the Food, Drug, and Cosmetic Act to require online pharmacies to post the name, address, phone number, and business location of the principal practitioner and the states in which the pharmacy, pharmacist, and consulting physician are licensed to practice.

In December, President Clinton added an initiative to the fiscal year 2001 budget to protect consumers from the illegal sale of pharmaceuticals over the Internet. A $10 million fund would help establish federal requirements for Internet pharmacies to ensure that they comply with state and federal laws. The initiative would also create new civil penalties of up to $500,000 per violation for the sale of prescription drugs without a valid prescription, give the FDA the subpoena power to conduct investigations, expand federal enforcement efforts, and fund a public education campaign.

"These are problems that were never conceived of prior to the advent of the Internet," said Dallas attorney Smith. "The legislation and regulations we have were not designed for this type of application, and we've got some holes that need to be filled."