ethics and standards

The Realities of New Educational and Industry Standards

AdvaMed, PhRMA and COPE guidelines are transforming the relationship between vendors and health care professionals. Here's how.

Tara Rosenzweig, contributing editor

Many ophthalmic vendors have stopped the flow of pens, prescription pads, dinner invitations and other "giveaways" to doctors. These actions aren't the product of corporate belt-tightening or neglect by company sales representatives. Rather, new guidelines for industry and optometric education are transforming the relationship between vendors and healthcare professionals (HCPs). Consider the following:

► Three of the four major contact lens companies have adopted the Advanced Medical Technology Association's (Adva-Med's) Code of Ethics, a voluntary code which provides ethical standards for interactions among the medical device, technology companies and HCPs.

► Revisions to the 2002 New-Pharmaceutical Research and Manufacturers of America (PhRMA) Code of Ethics, which provides ethical standards for interactions between the pharmaceutical industry and HCPs, became effective in early 2009. All major pharmaceutical companies have adopted this voluntary code.

► The Council on Optometric Practitioner Education (COPE) has approved new standards for commercial support of continuing education (CE) courses. COPE expects full compliance with the new standards by Jan. 1, 2011.

Cause for confusion

In addition to their considerable impact on the relationship between vendors and HCPs , the AdvaMed and PhRMA Code of Ethics as well as COPE standards are causing confusion among HCPs, says Dwight Akerman, O.D., F.A.A.O., director of Professional Affairs and Programs, Americas Region, at CIBA Vision.

"Pharma companies have adopted PhRMA Code of Ethics, medical device companies are adopting AdvaMed Code of Ethics, but frame and lens companies, as well as many ophthalmic equipment companies have promotional practices, which are at odds with these codes," Dr. Akerman says. "This creates confusion for healthcare professionals."

To clear up this confusion, HCPs should understand exactly why AdvaMed and PhRMA guidelines prohibit manufacturers from offering the perks that many enjoyed in the past.

"These new guidelines and standards drive transparency, which in turn can help remediate any real or perceived undue influence over the selection and prescriptions of company products for any reason other than the clinical benefit," says Paul Lawrance, vice president of Compliance and Ethics at Vistakon.

A closer look at each of the three standards reveals the benefits, challenges and points of confusion that will impact optometry in the coming years.

AdvaMed decoded

In addition to ensuring HCP objectivity in prescribing to patients and increasing the transparency of interactions between HCPs and manufacturers, the AdvaMed "Code of Ethics on Interactions with Health Care Professionals" aims to eliminate any perception that vendors are "buying business" through offering free products, meals or gifts to HCPs.

Adhering to the AdvaMed code, then, contact lens manufacturers can no longer fly optometrists in for presentations, pay for air or ground transportation, accommodations or meals. Vendors also cannot give gifts to O.D.s unless they have educational value to the patient.

The AdvaMed code does allow companies to provide conference grants, provided that the meeting is "primarily dedicated to promoting objective scientific and educational activities and discourse." Companies may also provide meals and refreshments that are "moderate in value, subordinate in time and focus to the conference, and clearly separate from the continuing medical education portion of the conference."

It's important to note that the AdvaMed Code of Ethics applies only to medical device manufacturers, so most ophthalmic equipment, spectacle lens or frame manufacturers do not adhere to the AdvaMed Code.

While the AdvaMed Code of Ethics is voluntary, most major contact lens companies have adopted it because the industry wants to clearly signal it supports ethical conduct with respect to interactions with eyecare professionals, explains Dr. Akerman. Adhering to the AdvaMed Code of Ethics lessens the risk of legislative intervention and allows the industry to self-regulate.

Jim Mazzo, president of Abbott Medical Optics, Inc., and chairman of AdvaMed, agrees with Dr. Akerman. "These standards help not only to prevent conflicts of interest between the healthcare provider and the manufacturer, but also to alleviate the perception of improprieties," he says. "This is accomplished through more robust documentation of relationships, establishment of processes and various monitoring and compliance efforts to make sure that both industry reps and healthcare professionals are educated about the policies."

The PhRMA prescription

The PhRMA code, adopted by pharmaceutical companies, such as Alcon and Allergan, shares goals similar to the AdvaMed guidelines. Under this code, vendors are prohibited from providing non-educational gifts to HCPs, such as pens and mugs, as well as free restaurant meals and any entertainment or recreational "benefits." Vendors may, however, occasionally provide "modest" in-office meals in combination with informational presentations. The PhRMA code also requires companies to ensure their reps are trained in and follow all applicable laws, regulations and industry codes of practice governing their interactions with HCPs.

The new code has changed how industry reps work with O.D.s. "The biggest change for Bausch + Lomb reps focused around not providing meals to HCPs outside of the office and/or hospital setting," says Perry Sternberg, vice president of Sales and Marketing at Bausch + Lomb (B+L).

He notes that the change initially impacted B+L's reps' ability to develop personal relationships with customers. In order to overcome this challenge, Mr. Sternberg says, "The field [reps] focused on delivering highly effective in-office product discussions either through a one-on-one interaction with the HCP or over lunch with the HCPs."

In addition to talking one-on-one with optometrists to provide product information, speaker programs offer vendors another avenue for reaching ECPs, says Mr. Sternberg.

"O.D.s can still attend educational programs, such as speaker programs, and receive information on B+L products from certified B+L speakers," he says. "I expect little impact on developing relationships with O.D.s as long as reps implement these two items effectively."

In some states, such as California, the PhRMA Code of Ethics is consider the law.

View from the practice

Have the changes in PhRMA and AdvaMed standards made a difference to optometrists in general? For some, the answer is not really.

"We may be fortunate, but sales representatives have always upheld the highest level of professional standards when meeting with myself, my partners and any of the office staff," says optometrist Mile Brujic of Premier Vision Group in Bowling Green, Ohio.

"Perhaps there are fewer supplier trinkets around the office, but it is pretty much business as usual around my office," says Kim Castleberry, O.D., and CEO of Plano Eye Associates in Texas.

On the other hand, Dr. Castleberry notes that O.D.s who took advantage of the more substantial perks offered by vendors may notice a difference. "I suppose if I accepted the free event tickets and dinners offered by some reps I might miss them now, but I did not take them before, and I don't miss them now," he says.

Dr. Castleberry adds that some O.D.s might "miss the information that came along with these ‘gifts.’"

"Hopefully, we all pay more attention to our reps as they are an invaluable resource that, in my opinion, just became more valuable," he says.

Mr. Lawrance recommends that during sales calls, doctors set expectations for sales representatives to clearly explain the clinical value of their companies' products. Otherwise, you, the doctor should "strongly evaluate why you would spend valuable time" with the sales rep, he says.

Optometists "COPE"

New standards for COPE-accredited CE are another effort to provide unbiased information to the optometric community. In a statement on the Association of Regulatory Boards of Optometry (ARBO) website, the organization says:"ARBO's commitment is to continue to provide salient and unbiased CE that is not influenced by any company, product or brand. Our responsibility is to provide and implement the standards necessary for establishing and protecting the integrity of optometric CE."

So what exactly are the changes to the CE standards? Here are the highlights, as outlined by ARBO and COPE:

► Commercial support for COPE-accredited CE can only be in the form of an educational grant to the COPE-approved administrator/ provider. Any product, service and instrument or device promotion must be clearly separated from the COPE-accredited course, and both commercial exhibits and ads must be physically separated from the course.

► All COPE-accredited courses are required to provide balanced coverage of treatment options and cannot promote specific proprietary business interests.

► CE instructors are not permitted to have assistance from any commercial interest in developing courses, and any ghostwriting must be disclosed to the CE administrator/provider as well as to learners.

COPE reports that other HCPs that adopted similar standards have actually seen an increase in corporate support for continuing education, and that optometry should not expect reduced commercial support of CE.

Mr. Lawrance notes that the new COPE regulations help companies to responsibly contribute to education. "The new COPE standards aim to protect professional education by ensuring the independence of such education," he says. "Through these mechanisms, we can create a safe environment for companies to continue to support education, and professional societies can continue to receive their support."

He adds that it's critical for doctors to receive quality education that meets their needs rather than the needs of manufacturers, and that requests for educational support should go through companies' professional education or medical affairs departments rather than sales and marketing departments.

Mr. Sternberg says that Bausch + Lomb didn't notice any significant changes as a result of following the new COPE regulations. In addition, Allergan reports that it is on board with the changes.

"Allergan believes that balanced, informative and transparent continuing educational programs are important to the advancement of the optometric profession," says Cathy Taylor, senior manager of Corporate Communications for the company.

Reactions to COPE Changes

Some O.D.s agree that the new COPE regulations are a positive change, but occasionally, there may be some drawbacks to the rules.

"COPE CE regulations are intended to provide transparency, fair balance and content free of commercial bias for COPE CE," says Dr. Castleberry. "This is good for a CE lecture, but sometimes we need to hear a sales pitch for a product we are interested in purchasing or prescribing. Industry reps will be even more valuable for this type of information, as we may not get it in COPE CE lectures in the future."

Kimberly Reed, O.D., associate professor at Nova Southeastern University in Fort Lauderdale, Fla., says that in past CE courses, sometimes the industry message rang too loudly.

"Clearly, something needed to be done regarding ‘sponsored’ CE meetings and events," she says. "Many times, a CE program felt more like a paid commercial advertisement than true education, and the new COPE regulations were designed to address those issues."

She adds a caveat, however: "Like all ‘regulations,’ though, the spirit and practicality of the rule can sometimes be overshadowed by a stricter-than-necessary view of the bigger picture."

The new rules should not pose much of an additional burden on CE instructors, says Dr. Brujic. While a number of rules "have now been more formally defined," many of these, such as financial disclosure, were already "assumed" and followed by educators, he says.

Of greater concern is the CE cost, says Dr. Brujic.

"With an increasing number of rules that will now be enforced and the presence of additional people required to administer CE, there is always the concern that the additional costs will be passed on to attendees," he says.

These COPE changes could, in fact, prompt O.D.s to seek information through non-COPEapproved CE opportunities. "I have already noticed an increase in non-COPE-approved CE events held by industry in the Dallas area, and the attendance is strong," says Dr. Castleberry. "I attended a medical retina conference recently with about 40 doctors who showed up for some serious OCT education hosted by an OCT supplier. Sometimes, doctors just want good information and don't care about the CE credit." OM