Health authority bans physician shadowing

In British Columbia's biggest health authority, the days when a pharmaceutical or medical equipment sales representative could scrub in and attend a surgery in an operating theatre, wander unattended through the emergency room or even be involved in the delivery of medications to patients, are now over.

Fraser Health issued a policy directive Sept. 5 banning sales visits with staff or physicians in clinical care areas. It also directed that such business meetings be conducted away from patients and outlawed preceptorships.

The memo marked a forceful change in Fraser Health policy and has ignited a discussion that has startled ethicists and administrators elsewhere in Canada. Said the memo: “Effective immediately, any representatives requesting or seeking clinical visits or preceptorships with Fraser Health Staff or Physicians that involve observation of patient care and/or indirect patient interaction will not be approved or supported.”

Authority officials said educational sessions by company representatives, which are often contracted as part of a purchase of equipment or drugs, are not affected. But the authority has banned “donations” of drugs or equipment to its public facilities.

Dr. Aaron Tejani, the coordinator of Clinical Research and Drug Information with Fraser Health Pharmacy Services, told CMAJ he crafted the new policy because of problems with sales representatives dating back several years. The last straw, he said, was the discovery that a pharmaceutical salesman was scrubbing in and attending surgeries and sometimes paying a surgeon a “preceptorship” that Tejani estimated was often about $1000 per day.

“An antibiotic is the latest example,” he said. “A drug representative for an antibiotic goes to a surgeon who might find the need to prescribe it, after he's completed a stomach surgery. He'll approach the surgeon and say, ‚I've been instructed by my company to get a better sense of your practice area, to know the ins and outs of what your life is like as a clinician, what problems you encounter, and where our products and our competitor's product play into post-surgical practice. We're willing to set up an agreement … would you do a preceptorship with me?'”

Tejani said surgeons might receive an unrestricted honoraria or an educational grant, as well as compensation for their time, to allow the sales representatives to watch their practice. In the past, a sales person would “scrub in with the surgeon, go into an OR, and watch an actual procedure whether it be a bypass procedure or bowel or whatever. They then may spend a few hours talking to the surgeon.”

The problems with the preceptorships are numerous and range from whether patient consent was obtained, to whether the sales representatives would respect confidentiality, Tejani said. “All it takes is for the [rep] to see the patient's name — what if it's their neighbour?”

The preceptorships also compromised other personnel, Tejani added. “If someone had a problem with it, if a nurse had an ethical issue with it, it might affect the morale in the department. Or during the procedure, it might be distracting, because you're dealing with an untrained person in a setting where you need to focus.”

Canada's Research-Based Pharmaceutical Companies' code of conduct defines preceptorships for health care professionals as “educational programs that should facilitate learning and transfer of skills and knowledge from 1 health care professional to another. These programs allow a local health care professional to spend time with a qualified expert in the field, to gain a better understanding and insight into a therapeutic area or disease state.”

The association policy, dated July 2007, also states, “In order to facilitate the transfer of knowledge and skills among qualified health care professionals, Members may support a preceptorship program. Reimbursement for the expert's travel and accommodation if necessary, and honoraria are acceptable. Participants in the program may not be reimbursed for any costs or provided honoraria. As an exception to the general principle, a maximum of 5 health care professionals, per calendar year, per brand, may participate in a preceptorship program in a recognized center of excellence. In this instance, travel and accommodation may be reimbursed.”

Tejani believes such preceptorships send “the wrong message that we're for hire. You can come in if you give us money.”

Commencing this fall, Fraser Health will also confine sales representatives to dealing with PhD pharmacologists every 2 weeks for informational sessions. The quality of information provided by each representative will be tracked. When it is determined to be comprehensive and objective, it will be passed on to the authority's pharmacists.

The goal is to avoid bias and promote best practices, says Dr. Peter Hill, vice president, Academics, Research & Clinical System Re-Design for Fraser Health. “We want evidence-based medical practices. We want evidence-based pharmacy practices.”

It's the essential nature of sales pitches “to advocate for a particular set of products. … It can't help but lead to bias,” Hill adds. “We would prefer in our organization that those biases are expressed in a place where our [experts] are more able and nimble to respond to any concerns.”

Fraser Health oversees 12 hospitals, serving 1.2 million residents of a vast swath of British Columbia, stretching from the municipality of Burnaby adjacent to Vancouver, south to the Canada–US border, and east to Manning Park.

The memo surprised some staff, including a chief of surgery, Dr. Peter Doris of Surrey, who wasn't aware of the problems identified by Tejani and Hill. But Doris approves of the memo, sent it along to staff and says he wouldn't have condoned preceptorships or sales visits in clinical care areas, had he known about them.

That such preceptorships even exist “is something that is really quite surprising,” said Dr. Brendan Leier, clinical ethicist and assistant professor at the University of Alberta Hospital. “It's been off the radar in the Canadian bioethics community.”

“The most striking thing is: what would ordinary people say?” Leier said, adding that the notion that a sales rep would scrub in and attend a surgery is “something the patient shouldn't have to worry about. And it's something that ordinary people would find beyond the pale.”

The University of Alberta's health region has “strict controls over who is allowed in an operating theatre,” although provision is made for educational representatives of drug or equipment suppliers to instruct staff on how to use new instruements, said Leier.

But there is a continuing dialogue at the University of Alberta about the ethics of hospitals accepting “gifts of drugs or surgical instruments or things like that,” Leier says.

At Fraser Health, such gifts have now been banned along with preceptorships. Hereafter, the authority will require that every drug and piece of equipment is purchased, complete with tracking data.

Until recently it was common, said Hill, for a company representative visiting an operating theatre to leave behind, for example, “1500 samples ... Over time, a product has been introduced into our inventory that we have no knowledge of, and a group of individuals might say, ‚we've been using this for a year, we just want you to buy more of it.'”

Fraser Health will no longer let products be “infiltrated” into its system, Hill says. “Materials brought into the OR ... end up being part of a surgical procedure, even placed into a patient, and we have no way of tracking where they came from and what sort of infection [prevention] might have been applied to them. We're concerned to protect our ORs from information that may not be accurate.”

Elsewhere in Canada there appears to be no consistent practice applied to preceptorships, on-site visits by sales reps or donations of equipment and drugs.

At the University Health Network in Toronto, Surgeon-in-Chief Dr. Bryce Taylor said in an email that “we do not accept gifts for O.R. equipment” and that he's never heard of a surgeon accepting money to allow a pharma rep to scrub in. Physician-in-Chief Dr. Michael Baker notes that, historically, pharmacy and equipment sales reps “were all over the place” — but for at least 10 years, the network's Toronto hospitals have tightly controlled access and don't even permit suppliers to donate pizza for lunch as part of their pitches.

Dr. Albert Eros says the Winnipeg Regional Health Authority does not “support a total ban on access to physicians — but within our system, we don't allow the drug reps on patient care areas, or wandering around like that. [Sales calls are] confined to specific meetings.”

Preceptorships, donations and sales calls are all part of a wider debate about ethical relationships between medical professionals and suppliers as well as efforts to more tightly control access to health care environments, protect patient and staff privacy, and uphold evolving ethical standards.

“It's not one of those issues that has jumped up in concert across Canada,” says Hill. “But I do think it's been an issue of concern in different organizations.”

“It's only relatively recently that people needed to wear a badge” at Fraser Health, he adds. At Fraser Health, “there is a history of all kinds of people walking in, sometimes dressed as members of religious orders, or clerics,” who turned out to be sales representatives.

Fraser Health has informed all suppliers that their reps must wear a vendor's badge — and that a third offence will result in revoked privileges.