What Do New PhRMA Guidelines Mean for Dermatology?

If not already apparent, changes are afoot in your medical practice and practices across the US, as the updated PhRMA Code on Interactions with Healthcare Professionals takes effect. Revisions to the previous Code will have numerous and varied consequences, some of which are quite obvious, while others may not be known for some time. Already, practices nationwide that literally have not ever had to purchase pens, notepaper, or facial tissues suddenly find themselves adding these and other miscellaneous items to their office supply orders. In coming months, medical professionals in all specialties will attend educational conferences where the exhibit halls may appear dramatically different from just the year before. The following is a look at some of the key changes set forth in the most recent version of the voluntary code with an analysis of potential effects on dermatology practices.

INFORMATION SESSIONS AND OFFICE-BASED EDUCATION
"…Company representatives may take the opportunity to present information during healthcare professionals' working day, including mealtimes. In connection with such presentations or discussions, it is appropriate for occasional meals to be offered as a business courtesy to the healthcare professionals as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals (a) are modest as judged by local standards; (b) are not part of an entertainment or recreational event; and (c) are provided in a manner conducive to informational communication."^*

What It Means. While the Code explicitly permits education sessions over lunch in a medical practice, specifics of the code may make compliance impractical for some offices and therefore may make such sessions increasingly rare. Care providers with packed patient schedules hardly ever have the time (or interest) to "sneak in" consultations with reps during regular clinic hours. Meetings over lunch can be convenient for both care providers and company reps.

But what constitutes a "modest" meal? Consider that there are about 50 employees in my practice. Costs for take-out from Boston Market for that many diners would quickly add up. So would such fare still be considered "modest"? What about practices located in more expensive areas of the country, such as Manhattan? Does the rep only provide meals for a handful of session attendees (such as only the prescription writers), thus alienating other staff and perhaps putting doctors and non-physician providers in an awkward position? (That would never fly in my office!) Or will reps simply abandon lunchtime presentations altogether?

What to Do. Communicate with the reps who visit your practice about your knowledge of the new Code and its impact. Some practices may implement a blanket prohibition on any food from reps. These practices may consider implementing a "brown bag" policy for educational programs in their practices where staff who attend are expected to bring their own lunch and the rep is requested to bring no food.

Whether your practice bans all food from reps or allows meals only for those attending information sessions, the net result is that many practice employees will no longer get free lunches, breakfasts, and snacks. Of course, the free food has always been just a perk of working in a medical practice, but it's a perk many employees may have come to take for granted. With that in mind, while practices are in no way responsible to feed staff, it may be worth considering ways that the practice can provide perks to show appreciation to staff or motivate particular actions. For instance, weekly staff meetings could be conducted over continental breakfast provided by the practice. Or if the practice meets a specific goal—maybe achieving a particular score on patient surveys—there may be a celebratory/reward luncheon.

ASSOCIATION MEETINGS AND EXHIBIT HALLS
"Third-party scientific and educational conferences or professional meetings can contribute to the improvement of patient care, and therefore, financial support from companies is appropriate…Since the giving of any subsidy directly to a healthcare professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the conference's sponsor, which, in turn, can use the money to reduce the overall conference registration fee for all attendees.

…Providing items for healthcare professionals' use that do not advance disease or treatment education—even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar "reminder" items with company or product logos)—may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues…It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities."

What It Means. Industry can and will continue to support conferences organized by professional associations such as the AAD, the Society of Dermatology Physician Assistants (SDPA), the Dermatology Nurses' Association (DNA), etc. Industry support is critical to the success of these meetings, which are quite expensive to produce and provide important educational and continuing education credit-earning opportunities to clinical care providers. However, some observers question the degree to which industry will continue to support smaller, independent conferences.

It's important to note that industry is still permitted to support smaller CME conferences, or as the language of the Code calls it Independent Medical Education (IME). As in the past, the Code stipulates conditions under which industry can support IME events. Industry sponsors must leave curriculum and faculty planning and recruitment entirely in the hands of independent contractors and provide no input; Grant-giving decisions should be independent of marketing personnel. The extent to which this idealistic goal is ever attained may be debated, but any attempt to improve and ensure the quality of CME is welcome.

Regardless of what restrictions PhRMA, accrediting bodies, CME/IME providers, or medical associations may put in place, individual conference attendees ultimately are responsible to critically weigh any information or data presented to them. A bigger question is whether industry will provide sufficient support for smaller conferences and how industry will be represented at conferences big and small.

This month, dermatologists and dermatology care providers gather in San Francisco for the Annual Meeting of the AAD. In years past, attendees have flocked to the exhibit hall to learn about the latest therapies and products available for patients. There's no denying that a number of attendees have been quite pleased to collect various give-aways, from pens and note pads to product samples. Under the new Code, pharmaceutical companies are extremely limited in what they can give away. As noted above, pens, notepads, breath mints, key chains, even tissues are technically forbidden. Will pharmaceutical companies be able to compete with other exhibitors not bound by PhRMA regulations and thus able to distribute full-size product samples?

Most importantly, if PhRMA marketers and manufacturers experience decreased booth traffic and thus find diminished benefit in exhibiting, will they continue to do so? If they don't, will associations be able to afford the meetings they hold?

What to Do. In addition to sizable grants from manufacturers and marketers, revenues from the sale of exhibit hall space are essential to underwrite meetings and support the association throughout the year. Attendees are in no way obliged to visit the exhibit hall or to stop by the booths of individual companies, however, they should keep an open mind to the opportunity. From the clinician's and conference organizer's perspective, the exhibit hall should be used as another learning opportunity. Consider this an opportunity to learn about a new product or prescription. Often companies in the exhibit hall not only have their sales representatives present but also have medical directors or medical liaisons at the booth. These professionals are doctors, PAs, or pharmacists with an advanced understanding of their products. Take this opportunity to stop by to ask questions or pose scenarios that may be more complicated than what the average rep may be able to answer in your office. Additionally, you'll have more time here than you do in the quick office or lunch visit to ask the in-depth questions or hear more detailed information.

INFORMATIONAL DINNERS
"Inclusion of a healthcare professional's spouse or other guest in a meal accompanying an informational presentation made by or on behalf of a company is not appropriate. Offering "take-out" meals or meals to be eaten without a company representative being present (such as "dine & dash" programs) is not appropriate."

What It Means. Having been on both sides of the podium at educational dinners, I believe that a well planned and executed program can be an effective tool for imparting information and promoting an exchange of knowledge. The ability to bring one's spouse to such dinners in the past had been an attractive option, given that busy clinicians typically have a quite limited amount of "free time" to spend with family during the week, and they may not wish to abandon partners for a few hours on a weeknight.

What to Do. Thankfully, few care providers have abused dinners, ordering expensive bottles of wine and extravagant meals, although some have. Maintaining an appropriate attitude and respecting the spirit of these programs as primarily educational and not entertaining is essential for all attendees. Avoid potentially embarrassing situations by refraining from bringing any uninvited guest to a program.

This can be a wonderful opportunity to network with your colleagues or find your next employee! I know many PAs and supervising doctors who met at a pharmaceutical dinner. It's also a nice opportunity to spend time with a friend who's also a clinician. It's not the same as going with your spouse, but it may be a happy medium to attend with a pal from medical school who practices across town.

Keep an open mind to educational program invitations, whether they involve meals or not. Recognize that these programs often provide opportunities to acquire relevant new information and obtain practical, first-hand patient care advice from leading clinicians. But balance those needs against your personal needs and schedule. If you can't attend "off-hours" sessions, ascertain from your rep what other offerings may be available (webinars, on-line CME, etc.) that may provide the information you seek in a more personally convenient manner.

PRESCRIBER DATA
"Companies that choose to use non-patient identified prescriber data to facilitate communications with healthcare professionals should use this data responsibly. For example, companies should (a) respect the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about those policies; (d) maintain an internal contact person to handle inquiries regarding the use of the data; and (e) identify appropriate disciplinary actions for misuse of this data. In addition, companies should respect and abide by the wishes of any healthcare professional who asks that his or her prescriber data not be made available to company sales representatives."

What it Means. Every time a prescription is filled anywhere in the US, it is logged according to the DEA number of the prescriber. This information is then compiled and made available to third-party sources that track general prescribing trends as well as behaviors of individual prescribers. There is a billion dollar market for this data, much of which is sold to pharmaceutical marketers and manufacturers. Local reps are frequently evaluated and paid or bonused based on the overall number of "scripts" written for their product in their territory or based on trends for growth in prescribing in their territory.

Companies can also look at specific prescribing by an individual care provider to determine which products that provider is writing for and which competitive products he or she may be using.

What to Do. The very existence of the PhRMA code demonstrates that the relationship between industry and prescribers is by its nature complex and delicate. For most clinicians in day-to-day practice the toughest part is developing a fair, balanced, and mutually beneficial relationship with the local sales representative that calls on your office.

It's important to remember, above all else, that reps are working men and women who are typically just trying to do their job. They are generally on the lowest rung of their company's corporate ladder. Every rep deserves to be treated with respect. If you have a concern about a company's products or policies or a problem with the company, address the issue respectfully with the rep. While it may be appropriate to not see the rep, it is not appropriate to berate him or her for something outside of his/her control. In the event that you have a concern with a rep or his/her actions specifically, do not hesitate to address it with the individual directly and/or with his/her supervisor, as appropriate.

Generally problems with reps are rare. Developing a good relationship with a rep can be beneficial for a clinician. A rep may be able to provide you more samples or may have the ability to provide a trade size product for a patient who can't otherwise afford it.

Reps can be a source of information—both about a drug itself and programs that exist that allow patient access to the prescription. Consider that the reps for the biologics products provide a great deal of information about the efficacy, safety, and administration of these drugs, offering updates as new data emerge. Don't hesitate to ask your representative for help and information on insurance approval. These agents are still relatively new, and they can be much more complex to prescribe than a topical antimicrobial for acne. Remember, too, that the rep is just the first-line source of information. Company employees in research and development or medical affairs can also be available to address questions and concerns from prescribers. Often the rep will serve as the liaison to these sources.

Finally, be honest with your reps. Most of them receive or can review records of your prescribing habits. While it may seem expedient to dismiss the rep by telling him that write for his product or assuring her that you don't prefer the competitive brand, he or she is likely to learn the truth and will see you as dishonest. You don't need to give false assurances to a rep, nor do you need to justify your actions. It's perfectly acceptable to inform the rep that you simply do not write for their product and do not have time to discuss your rationale. Of course, if you have a rationale—no matter how trivial it may seem (maybe the competitive brand name is easier to recall or spell)—you might as well tell the rep. It will save him or her the time of trying to devise persuasive arguments and save you the trouble of pretending to listen.

Should you wish to keep your prescribing habits confidential from reps, contact the respective pharmaceutical companies to request that they not share your data. The rep can give you the contact information necessary to process that request. Physicians may also register through the AMA to protect the privacy of their prescribing data. Simply log on to ama-assn.org, and search for "Physician Data Restriction Program (PDRP)," to find the log-in page. Complaints about the use of prescribing data may also be registered through the site.

Of note, New Hampshire and Maine currently have laws that prevent the collection and sale of prescriber data, but these statutes are being challenged.

BALANCING ACT
That overall pharmaceutical company spending on gifts, meals, trips, and sundry other perks and bonuses to physicians had grown out of control in the past is rarely disputed (though it is worth noting that a small percentage of prescribers reaped the majority of the benefits). Some wonder if the proverbial pendulum is now swinging too far in the opposite direction, and when or if it will ever revert. The industry is performing a balancing act—actually numerous balancing acts: trying to maintain appropriate relationships with prescribers avoiding undue influences, seeking to be profitable in a struggling economy, striving to bring new products to market as the FDA increases scrutiny and pipelines are running dry.

The new Code ensures changes for the practice of dermatology. The discussion above highlights just some of the ways dermatology practitioners will be affected. The future is uncertain. Could these changes mean that pharmaceutical companies will cut jobs from their salesforce, contributing to the growing economic problems for the US?

To date, the pharmaceutical industry has taken the lead in regulating itself and proposing a framework for interactions. Perhaps in the coming months and years umbrella medical associations in concert with specialty organizations will take a lead in setting forth guidelines to preserve fair, balanced, and beneficial interactions between practitioners and industry. Appropriate relationships benefit both parties as well as patients.

Ms. Jacobson has no conflicts to disclose.

* Italicized text excerpted from Code On Interactions With Healthcare Professionals, available online from phrma.org.