Online prescribing convictions sign of federal scrutiny
■ Government action against Internet pharmacies and physicians working with them is expected to increase. Federal legislation proposes to address the issue.
By Amy Lynn Sorrel — Posted March 26, 2007
The recent sentencing of a ninth doctor in a probe of online prescribing suggests that the federal government is stepping up efforts to crack down not just on the Internet companies running the show, but also physicians who work with them, experts say.
The government accuses the doctors involved in the case of conspiring to dispense schedule III and schedule IV pain and anti-anxiety medications without a legitimate medical purpose and outside the usual course of medical practice, court records show.
The nine doctors, all sentenced within the last year, received either jail time or probation, in addition to hefty fines for the money they earned working for various Internet companies. Three other physicians also have pleaded guilty to related charges and await sentencing, according to the U.S. attorney for the Northern District of Iowa. The Iowa district is handling the national case because it began with the investigation of a pharmacy based in that state. It involves doctors from Connecticut, Florida, Illinois, Louisiana, New York and Pennsylvania.
The government declined to comment. Attorneys for the doctors could not be reached for a response.
The federal government typically takes on Internet prescribing cases when a controlled substance is involved, experts say. Given the proliferation of online pharmacies over the last three years and factors that make it difficult for states to prosecute these cases, some experts say they expect heightened federal scrutiny of the entities and doctors working with them.
State medical boards, which regulate the practice on the state level, continue to monitor and discipline doctors who improperly prescribe drugs online without first examining the patient. American Medical Association policy requires that "physicians who prescribe medications via the Internet shall establish, or have established, a valid patient-physician relationship." This includes a medical history and physical exam.
Experts say it is difficult to track just how many doctors are approving prescriptions via largely unregulated "rogue" Internet pharmacies.
Jurisdictional issues make it difficult for state medical boards and state law enforcement to go after doctors prescribing from out of state. In addition, states have varying board regulations or statutes governing the practice. Patrick J. Egan, a health care and criminal lawyer, said the federal government could be ramping up its activities to fill that void.
A nationwide task force created in 2005 to address the problems helped bring federal officials up to speed, and they have been vigilantly increasing investigations of these pharmacies, he said. Physicians aren't immune from this new scrutiny, he said.
"The crux of the issue is it's the doctors who are most at risk in these particular investigations because the operators of the Internet pharmacy are generally able to hide their whereabouts," said Egan, a partner with Fox Rothschild LLP in Philadelphia.
Doctors need to take particular care when prescribing controlled substances over the Internet, experts said. No federal statute makes it illegal to write a regular prescription based on an online questionnaire, Egan explained, but prescriptions for controlled drugs must be written in the ordinary course of the doctor-patient relationship. "The problem is [the government] never define[s] what that is," he said. So doctors could get caught in a "grey area" thinking it's OK to approve a prescription based on an electronic consultation.
"But the [Drug Enforcement Administration] has taken the position that any written prescription based on an online questionnaire is invalid, and if you have an invalid prescription for a controlled substance, that's drug dealing," Egan warned.
Recently introduced federal legislation aims to address some of the problems with online prescribing and could strengthen federal and state efforts to rein in unregulated Internet pharmacies, experts say.
One measure, introduced in January, would define a "qualifying medical relationship" for the purposes of online prescribing as at least one in-person medical evaluation of the patient by his or her doctor or a covering physician. It also would give state attorneys general the power to get a nationwide court injunction to stop the operation of an Internet pharmacy or force it to comply with the law. It would allow them to bring a civil action against any parties involved.
A second measure, put forth in February, would force Internet pharmacies to register with the Dept. of Health and Human Services and would require doctors to perform a documented patient evaluation before issuing an online prescription. The Federation of State Medical Boards supports the two bills.
Experts say there are legitimate uses of the Internet, and physicians and patients should not necessarily be afraid of it.
Many doctors are using the Internet to allow existing patients to request and refill prescriptions through an e-mail system, noted FSMB President and CEO James N. Thompson, MD. He uses the Internet to get prescription refills through his doctor. That practice is not the subject of the stepped-up scrutiny.
"The fact is physicians all need to be aware that there needs to be a doctor-patient relationship prior to prescribing online," Dr. Thompson said.
Doctors also should be aware of laws and regulations in their states. If they follow appropriate guidelines, the practice can be a convenient tool, he said.
Attorney Robert M. Wolin, an expert in pharmacy regulation with Baker Hostetler in Houston, warned that medical liability risks increase for doctors when they issue a prescription based on an online consultation. If doctors are considering forming a relationship with an online pharmacy, they should seek legal counsel, he said. Physicians also should verify the pharmacy's state registration.
When it comes to prescribing controlled drugs for an Internet company, however, given the government's heightened scrutiny, Egan's advice is "Don't do it."