A guide to ethics in 2002 and beyond

Optometric Management, Sep 2002 by Thomas, Jim

Recent laws and guidelines provide a blueprint for how optometrists and industry reps can maintain the highest standards.

On typical day in this case, Aust 8, 2002, headlines in the New York Times read:

"Students Use Web Sites to Cheat on Graduate Exams"

"Ex-Drug Executive Faces Charges of Insider Trading"

"Malicious Intent Evident in Recent Arrests in Texas."

Unethical and questionable practices appear to reach across every institution and industry, including healthcare. Last October, for example, TAP Pharmaceutical Products agreed to pay $875 million to resolve criminal charges and civil liabilities in connection with fraudulent drug pricing and marketing conduct.

The prosecution, which included a guilty plea from a physician, resuited in the largest criminal and civil recoveries in any healthcare fraud case in the country.

Missing from the headlines is the mention of questionable practices by optometrists. This is no accident, says Pat Cummings, O.D., EA.A.O., president of the American Optometric Association (AOA).

"Optometrists practice with the highest of ethical standards," he says. "The AOA has always supported ethical practices, and we support the new industry guidelines."

Industry observers warn, however, that temptation is never far away. One key to maintaining good conduct, ethically and legally, is to understand the current laws and ethical guidelines.

The guidelines that refer to gifts and compensation, summarized below, come from a variety of sources, including those listed in the box at the right.

The right prescription

The PhRMA voluntary code regarding interaction with healthcare professionals outlines how sales and marketing representatives should interact with all health professionals. Effective in July, the code addresses the following points:

Interactions. Interactions should inform doctors about products, science and/or education that benefit patients.

Presentations. They can include modest meals (by local standards) that are conducive to presentations. Meals with spouses or without a company representative are inappropriate, as are entertainment and recreational events.

Continuing education and professional meetings. Financial support is permissible; however, it should be given directly to the meeting sponsor, which can reduce the fee for all.

Companies should exercise no control over content, venue, faculty, educational methods or materials. Financial support should not be offered to non-faculty.

Support can be provided to the meeting's sponsor for modestly priced meals or receptions that benefit all attendees.

Consultants. Compensation is appropriate for healthcare professionals who act as consultants on behalf of a pharmaceutical manufacturer provided that:

A written contract specifies nature and payment of services.

A legitimate need for the service is identified in advance.

The criteria for selecting consultants is directly related to the identified purpose.

The number of consultants isn't greater than the number needed to achieve the purpose.

The retaining company makes appropriate use of the consultant's services.

The consulting services are the primary focus of the meeting.

It's inappropriate to pay honoraria or expenses to non-faculty or non-consultant attendees at company-sponsored meetings.

Speaker training. It's appropriate to reasonably compensate healthcare professionals for company-sponsored events if they receive extensive training that will result in service to the company.

Educational funds. Financial assistance for scholarship or educational funds is permitted as long as an academic or training institution independently selects the recipients.

I Items for personal benefit should never be offered. Items may be offered to healthcare professionals if they aren't substantial in value ($100 or less) and if they benefit the patient.

For example, a textbook involves a patient benefit; a CD player does not. Items of minimal value (pens, etc.) may be offered if they benefit the practice.

Payments - including cash or expenses - should never be offered except as compensation for bona fide services.

Representatives should offer nothing that would interfere with the independence of a professional's prescribing practices.

AMA

The major drug manufacturers, including those not represented by PhRMA, have adopted codes for marketing and sales reps. These are all consistent with guidelines that the AMA created in 1990 for physicians.

A few gray areas in the code require independent judgments.

Some of these include:

Charitable contributions on behalf of the physician. These may also represent a personal benefit to the physician. If the charity is predetermined without the physician's input, there appears to be little problem.

Contributions to pro fessional societies from industry. These could appear to affect the judgment of a physician.

Gift certificates. These are acceptable if they allow the physician to choose from: 1) patient care items that are of unsubstantial value or 2) practice items of minimal value. The certificate should not give the recipient such control as to make the gift similar to cash.