Mail-Order Medicine: Prescribe With Caution

Nina Pullano

June 19, 2019

The ads on the New York City subway last summer were hard to miss: An oyster positioned between the words "modern rocketry." A drooping cactus: "hard made easy." A rigid cactus so explicit it needs no caption.

The suggestive billboards for the company hims are selling prescription drugs for erectile dysfunction. Hims also sells prescription hair loss medication, while its recent spinoff hers offers emergency contraceptives and female libido drugs. Both brands — styled all lowercase — also offer prescriptions for skin products that promise to combat acne and aging.

A growing number of clinicians are working with online direct-to-consumer (DTC) health companies like hims and hers. Physicians can supplement income and create a more flexible schedule working with DTC telemedicine platforms, but the Federation of State Medical Boards (FSMB) and others urge caution about sites that may not lend themselves to long-term doctor-patient relationships. At least one doctor lost his license after prescribing drugs with only the patient information from an online questionnaire. "The physician is ultimately accountable," said Lisa Robin, MLA, chief advocacy officer of the FSMB.

As telemedicine increases in popularity, doctors don't necessarily need to meet with patients in person to form a good medical relationship. But it's important that doctors and patients verify each other's identity and clearly establish a relationship before a doctor diagnoses or treats a patient, according to the FSMB telemedicine guidelines.

"Whatever that interaction is — if it's in a virtual environment, it should be held to the same standards as an in-person evaluation," Robin said. "I think there are platforms that do that and do that quite well."

Some DTC companies provide a platform for doctors to meet with patients via videoconference and messaging systems. Others, like the tandem hims and hers, sell only "lifestyle" medications — sometimes advertising off-label uses — for specific concerns, such as erectile dysfunction, birth control, and hair loss.

With hims, patients select their drug of choice and provide credit card information, then fill out a medical history form. If they're buying hair loss or acne prescriptions, they're asked to submit a photo. Within 48 hours, a doctor sends a message introducing himself, said Adrian Rawlinson, MD, vice president of medical affairs for hims and hers.

Rawlinson said the vast majority of consults will include at least one or two questions and answers between doctor and patient. But sometimes the prescription is approved right away, and the doctor simply directs the patient to online resources with more information. The patient then confirms the prescription, and the order is processed.

Doctor-patient relationships based solely on an online questionnaire don't constitute an acceptable standard of care, according to the FSMB. Neglecting to build a consistent relationship can endanger patients, Robin says, and puts physicians' licenses at risk.

Undercover "Patients"

Earlier this year, the California State Medical Board took action against a physician, who subsequently surrendered his medical license, after he prescribed emergency contraceptives and erectile dysfunction medication through an online platform without gathering sufficient health information from patients.

In an undercover investigation, board members posed as patients, filling out online questionnaires to obtain medication using the platform KwikMed. The board determined that the physician, Richard Holmes, MD, failed to meet the standard of care in dealing with each "patient."

The California medical board decision stated that Holmes departed from the standard of care in prescribing emergency contraception to someone who stated in a questionnaire that she did not know whether she was pregnant and that she was obtaining emergency birth control for someone else. In the case of erectile dysfunction medication, the board complaint said that Holmes neglected to conduct a physical examination.

Holmes' lawyer did not respond to requests for comment.

The board cited Holmes for gross negligence, repeated negligent acts, incompetence, and furnishing dangerous drugs without examination.

The complaint addressed a failure to meet the standard of care, rather than the nature of DTC medicine, said Carlos Villatoro, public information officer for the California State Medical Board. "It all boils down to the standard of care," Villatoro said. "There is no one-size-fits-all answer for defining the standard of care."

Villatoro echoed the FSMB's Robin in saying that, in DTC telemedicine, the same standards apply. "With every new technology, there are challenges," Villatoro said. "I think it's helpful for the physicians to follow the standard of care as if the patient were in their office."

In a letter published in April in the Journal of the American Medical Association, researchers found a low risk for malpractice related to DTC telemedicine. They looked at 1 month of data from 2018 and found no medical malpractice claims in 551 observed cases. However, the findings have clear limitations. "I don't know that I would take a great deal of comfort in looking at a month's worth of data," Robin said.

Mitigating malpractice risk shouldn't be mistaken for good medical practice. "Sometimes filling out an Internet form gets all the information you need" to justify a legal defense, says Russell Kohl, MD, vice speaker of the American Academy of Family Physicians Congress of Delegates. "That should never be confused with a patient actually understanding what's going on."

The Rise of DTC Medicine

If DTC medicine is on the rise, it's part of a broad increase in telemedicine overall. By one measure, 1 in 5 physicians are using telemedicine, and the number is only expected to grow. Clinician burnout and wanting to make healthcare more accessible are common reasons physicians work in telemedicine, according to Enzyme Health, a staffing company for telemedicine jobs. Physicians typically earn about $15 to $30 per remote visit and can complete three to five video visits per hour, making $100 to $150 per hour, according to the company's website.

At Ro, the umbrella group for Roman, Rory, and Zero, which approach DTC telemedicine in a way similar to hims and hers, nearly all physicians treat their work as supplemental and still meet with patients in person. The company encourages patients to see in-person clinicians, too, and to apprise them of any medications they've started taking through Ro. Medications range from drugs for erectile dysfunction to menopause symptoms to smoking cessation.

"We know that we're a complement to in-person care, we're not a replacement," said Melynda Barnes, MD, associate clinical director at Ro. If a patient's case isn't appropriate for telemedicine, Barnes said doctors will refer the patient to an in-person physician. She also said Ro is discussing ways to communicate directly with patients' primary care physicians.

Hims and hers send patients a message asking them to communicate with their doctor after they receive a prescription, Rawlinson said, but many of their patients don't have a primary care doctor to begin with. "That can be a problem," he said. To address it, the company sends links to resources for patients to find a doctor.

Rawlinson acknowledges that patients could receive hims or hers prescriptions and decide not to tell their doctor, but notes that a patient could do the same thing in dealing with brick-and-mortar doctors' offices. "It's just another physician in the mix," Rawlinson said. "I don't think we can say that we can solve that problem."

In fact, Rawlinson said, the anonymity is part of hims' and hers' appeal — in addition to convenience. "Some people don't want to go to the pharmacy, some people don't want to divulge it to their regular primary care doctor," Rawlinson noted.

That's precisely why there is a potential for risk with these companies, according to the FSMB and the AAFP. "If there's something you can't talk to your doctor about, then that's not a therapeutic relationship," the AAFP's Kohl said.

Fractured Healthcare

Splitting up healthcare has potential for doctors to miss big health cues.

"Every physician has stories of someone who came in with something that wasn't supposed to be anything, and it turned out to be something really bad," Kohl said — and lifestyle medications tend to be the most frequent source of these stories. Vascular problems that can cause erectile dysfunction, for example, could indicate risk for a heart attack or stroke.

And prescribing medication without a full view of a patient can lead to adverse drug interactions, which account for 1.3 million emergency department visits each year, according to the Centers for Disease Control and Prevention.

Hims' rate of rejection suggests the significance of a more comprehensive doctor-patient relationship. The company rejects twice as many prescriptions for hair loss treatments, which require a photo, than it does prescriptions for erectile dysfunction medication, according to Rawlinson.

Rawlinson denies that hims and hers are questionnaire-based, despite acknowledging that sometimes doctors prescribe medicine on the basis of an initial form the patients fill out, without follow-up questions. "What we're doing is providing a consult, we're providing a chain of communication between a patient and physician," Rawlinson said. "There has to be this chain of care that is created."

Experts are clear that it's not illegal to prescribe most medications without interacting face to face. The only restriction at the federal level is a 2008 amendment to the Controlled Substances Act that makes the practice illegal for controlled substances, including pain and anxiety medications.

Drugs such as birth control and acne medications aren't covered under federal law, but state laws vary. Only about half of US states allow drugs to be prescribed online. Like federal law, states can allow some online prescriptions but ban others.

Many DTC companies thus limit prescriptions to certain states, according to the companies' websites. But the questionnaire-only prescription model may still be problematic.

"You can't comfortably say that these are operating within the standards of the state," the FSMB's Robin said. There are still "unanswered questions" about the regulation of DTC prescription companies, she said, and the FSMB and state medical boards themselves are actively discussing future regulatory practices.

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