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Ethics in cosmetic dermatology
Clinics in Dermatology (2012) 30, 522–527
Ethics in cosmetic dermatology Leslie Baumann, MD ⁎ Baumann Cosmetic and Research Institute, Miami Beach, FL 33140-2910, USA
Abstract The dispensing of nonprescription skin products by dermatologists and the performance of ineffective cosmetic procedures are the most controversial subjects associated with the practice of cosmetic dermatology. These topics have been hotly debated within the profession for several decades, with each side presenting cogent arguments. The debate is also characterized by strong passion and emotions on both sides that are not easily reconciled. Dermatologists and their patients are best served by an objective, organized approach to clearly delineating the various aspects of these issues and providing guidelines for practitioners that can be shared with patients. © 2012 Elsevier Inc. All rights reserved.
Exemplary case A 30-year-old woman presented with melasma after having seen two other dermatologists. She had received a series of intense pulsed light treatments and treatment with a fractionated laser. In her opinion, these therapeutic approaches exacerbated her melasma. She incurred bills totaling $4,000 from these treatments. According to the patient, her previous doctors did not discuss with her the importance of sunscreen and the role of birth control pills in her cutaneous condition, and she was never given a prescription or recommendation for a topical skin lightener; however, the practitioners had sold her more than $400 worth of skin care products, none of which contained ingredients appropriate for the treatment of melasma. The first step with this patient was to educate her about sunscreens, sun avoidance, and skin-lightening options. I recommended a prescription hydroquinone-containing product to be used for 3 months, followed by a 1-month respite. She was referred to her obstetrician/gynecologist for a different contraceptive option. She was instructed to discontinue facial waxing and facial steaming and to avoid other forms of heat on the face when possible. Although a series of chemical peels could be considered, these were not recommended. The patient's melasma cleared in 3 months. ⁎ Corresponding author. Tel.: +1 305 532 5552; fax: +1 305 534 5224. E-mail address: [email protected]. 0738-081X/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.clindermatol.2011.06.023
The point of this case study is that this patient was originally treated with the option that made the most profit for the physician and provided a short-term benefit rather than the less expensive and more effective option in the long term.
Introduction Cosmetic dermatologists have the goal of improving their patient's appearance and skin health, but all too often, financial motivation can cloud their judgment. This is because there is a very high demand for cosmetic procedures and there is much competition to provide the newest and “trendiest” procedures. A successful cosmetic dermatologist must be a scientist, a marketer, an artist, and a business person. In contrast to other subspecialties in dermatology, cosmetic dermatologists need to advertise, hire public relations specialists, and perform other functions that are traditionally out of the scope of the medical field in order to attract new patients. To make matters worse, nondermatologists, such as obstetricians/gynecologists, dentists, pediatricians, and even radiologists, are entering the field because they perceive it as easy and as a way to avoid dealing with insurance companies. The main reason there are so many ethical debates in the cosmetic dermatology world is that there are just so many opportunities to make money and some of these opportunities walk the ethical tightrope. For example, whether to sell
Ethics in cosmetic dermatology skin care products in a physician's office has been a hotly debated question within the dermatologic and wider medical community for several decades. The expression “office dispensing” entered the vernacular in 1998 when it began appearing in the comments and editorial sections of esteemed dermatologic journals. In March 1999, Dr. Richard C. Miller launched an impassioned months-long discussion published in the “Issues in Dermatology” section of the Archives of Dermatology in which he contended that the profit motive is the primary incentive for physicians offering their own line of products.1 The popularity of in-office dispensing, though, suggests that many practitioners feel otherwise, and deep convictions persist on both sides of the issue. Essentially, advocates of in-office dispensing argue that the practice provides a valuable service to patients.2-5 Detractors, on the other hand, suggest that, as Miller opined, dispensing is profit-driven, fraudulent, and undermines the trust necessary in the doctor–patient relationship.1,6,7 The focus of this article will be to objectively assess the diametrically opposed arguments on the subject of inoffice dispensing of skin care products. The same arguments that are made about the ethics of selling skin care products pertain to the ethics of selling ineffective office procedures or performing procedures that the patient does not need or that will actually worsen the patient's appearance. One only has to turn on the television to realize that many doctors are not providing the best aesthetic care to their patients. Whether it was a dermatologist or another type of medical or nonmedical specialty that provided these treatments, certainly the Hippocratic oath, “Do no harm” was ignored with the promise of financial success. Of course there is nothing wrong with having a financially successful medical practice as long as the patient has not been taken advantage of and been led to believe that ineffective products or procedures are necessary. This discussion will include a review of the current status of office dispensing, the positions of pertinent professional medical organizations, and the potential effects of merchandising on the physician–patient relationship.
Popularity of and rationale for in-office dispensing At the time that the expression “office dispensing” came to the fore, it was estimated that anywhere from 40% to 70% of dermatologists were actually selling skin care products in their practices.8,9 A survey of the California Dermatology Society conducted in September 1998, in which 297 members (26% of the members) responded, offered a view of what in retrospect appears to have been an emerging attitude. Of those who answered the questionnaire, 247 (83%) thought it was ethical to sell
523 Table 1
Advantages of dispensing
(A) Potential overall advantages stemming from in-office dispensing 1. Patient convenience 2. Increased likelihood of compliance 3. Ensure that most appropriate products are purchased 4. Ensure product quality (ie, ingredients, formulation or concentration, storage) 5. Potential staff incentive 6. Boost to physician's income 7. Forces physician to stay updated on product innovations (B) Motivations to patients for purchasing in-office products 1. Physician knowledge 2. Trust
nonprescription products from their offices; 205 (69%) were already engaged in the practice.10 It is well known that the numbers have increased in the ensuing decade and continue to increase for the reasons listed in Table 1A. Most U.S. states prohibit the vending of prescription drugs directly from a doctor's office; however, this practice is allowed in Florida and a few other states. Most practices that sell products do not sell prescription products but instead sell over-the-counter (OTC) skin care formulations. These may be formulated by the physician, private labeled by a manufacturing company with the physician's name, or may be an unrelated brand. The profit margins differ depending on the type of products sold in the practice. The standard products sold in an in-office dispensing assortment include antiaging formulations, moisturizers, sunscreens, cleansers, and acne products.5 A dermatologist with the appropriate business license can sell such products as found in major retailing stores or opt to develop a line of skin care products available only at her or his office. The rationales for offering in-office dispensing include providing patients with the convenience of one-stop shopping, increasing the likelihood of compliance by providing appropriate products directly to patients, supplementing the income of the physician, and forcing oneself to stay current on product formulations.4,5,11,12 There are decided advantages for patients, too (Table 1B). The arguments against in-office dispensing boil down to ethical conflicts of interest and the potential compromise of the physician–patient relationship13,14 (Table 2). Thus, the compelling question for the dermatologist who is weighing these positions might be: “Will my patients benefit from buying skin care products directly from me in a way that they would not otherwise?” Related questions that get to the heart of the matter include: Are the products sold in a physician's office superior to those available elsewhere? Is the product selection experience provided by a dermatologist superior to self-directed purchasing at a retail establishment? If it is the latter, might dermatologists deliver such an experience without dispensing products from their offices?
524 Table 2
L. Baumann Perceived disadvantages of in-office dispensing
1. Conflict of interest 2. Impact on doctor–patient relationship 3. Compulsion to sell/impact of profit incentive to physician and/or staff 4. Added business and operational burden
Professional organizations weigh in Two professional medical organizations have issued noteworthy opinion statements regarding the practice of inoffice dispensing. In both cases, both organizations, the American Medical Association (AMA) and the American Academy of Dermatology (AAD), rightly place the best interests of patients as the primary concern. The AMA avows that in-office dispensing presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.15 With such a stern admonition in place, the AMA advises physicians who choose to sell products from the office to preserve medical ethics by not selling any product the beneficial claims for which lack scientific validity, taking steps to minimize financial conflicts of interest, disclosing to the patient the nature of their financial arrangement with the manufacturer and the availability of the product or other equivalent products elsewhere, and urging manufacturers to make products of established benefits more widely accessible to patients. In December 2000, the AMA released an addendum to its statement encouraging physicians to apply these guidelines to medical practice Web sites (Table 3).
Table 3 Summary of the American Medical Association position on in-office sales The in-office sale of products: 1. Presents a financial conflict of interest 2. Risks placing undue pressure on the patient 3. Threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own For those physicians who choose to dispense, the American Medical Association advises the following to preserve medical ethics: 1. Do not sell any product whose claims of benefit lack scientific validity 2. Minimize conflicts of interest 3. Disclose to the patient the nature of your financial arrangement with the manufacturer 4. Disclose the availability of the product or other equivalent products elsewhere 5. Encourage manufacturers to develop products of established benefits more widely accessible to patients
Table 4 American Academy of Dermatology position statement on dispensing16, a • Dermatologists should not dispense or supply drugs, remedies, or appliances unless it is manifestly in the best interest of their patients. • Dermatologists who dispense in office should do so in a manner with the best interest of their patient as their highest priority, as it is in all other aspects of dermatologic practice. • It is ethical to dispense, by sale, prescription or nonprescription drugs, to patients in a dermatologist's office except in the following circumstances: 1. When the dermatologist places his/her own financial interests above the welfare of his/her patients. 2. When creating an atmosphere which is coercive to patients such that they feel compelled to purchase drugs from the dermatologist. 3. When dispensing drugs under a dermatologist's private label without clearly listing the ingredients, including generic names of the drugs. 4. When dispensing to patients drugs which are easily available at proprietary pharmacies without advising patients of this availability. 5. When representing drugs as being a special formula not elsewhere available, when this is not the case. 6. When selling health-related products whose claims of benefit lack validity. 7. When refusing to give refills of drugs except when they are purchased from the dermatologist. 8. When charging patients at an excessive mark-up rate. a
Approved by the Board of Directors October 12, 1998; amended by the Board of Directors September 26, 1999.
The position of the AAD is more specific, offering guidelines without judgments. The AAD finds that it is ethical to offer in-office dispensing, as long as it is conducted in the best interests of the patient16 (Table 4).
Regulations and price Proponents of in-office dispensing typically consider the practice as a logical extension of topical treatment approaches.2 In fact, in the example case at the beginning of this article, the patient would have fared better by being sold skin care products and receiving sun avoidance education than the result achieved after receiving several expensive procedures. Ethical physicians may sell highquality products with known scientific validity, especially products with key ingredients unavailable in retail stores.5 Those opposed to in-office dispensing often claim that there are few, if any, non-OTC products and/or ingredients in physician-sold lines that are so unique or represent such significant upgrades over products available on the mass market to justify the practice of in-office sales. In the U.S., there are no regulations or legislation to prevent mass-market brands from using the same concentrations of key active ingredients as in the physician-dispensed brands. In some
Ethics in cosmetic dermatology cases, products sold in doctors' offices are identical formulations to those in retail stores. The primary difference may be packaging. The significance of active ingredients and their regulation is an important tangential issue here. Personal care products are classified, according to the U.S. Food and Drug Administration (FDA), as drugs, cosmetics, or both. Antidandruff shampoos and moisturizers with skin protection factor (SPF) are classified as both, for example. “Cosmeceuticals,” a term coined by the late Dr. Albert Kligman more than a quarter of a century ago, refers to skin care products labeled as cosmetics, not regulated as drugs, that may confer biologic activity.17 Companies are therefore able to skirt regulatory action by manipulating labels. For instance, although retinol is known to influence retinoic acid receptors, yielding biologic activity, retinol, a popular ingredient contained in numerous cosmetics, is often listed as an inactive ingredient on product labels, thus immune from action by the FDA. In other words, the skin care formulation would be labeled as a drug and made available only by prescription if the retinol-containing product claimed to “increase collagen production.” When the retinol-containing product does not contain this claim, it can be labeled and sold as a cosmetic product. Essentially, it is the claim of the product that determines whether it is regulated as a drug rather than the biologic activity of the product. Many products claim to “improve the appearance of wrinkles,” which is consistent with a cosmetic claim even if the product is known to increase the production of elastin. The cosmetic company would not be allowed to make a claim that its product increases the production of elastin. This dynamic explains the lack of well-designed studies establishing the efficacy of cosmeceuticals. The companies actually have an incentive not to prove that their products have biologic activity. This puts ethical physicians in a bind. They want to sell only products proven to be efficacious, but the proof is either not there or is proprietary and not shared by the company.13 Price and the profit motive in many business decisions is another prominent issue in this debate. In most circumstances, one would expect that anyone deciding to sell any kind of merchandise would expect to make a profit. Does such action transform a physician into a merchant, Miller wondered.1 Can doctors justify office vending if they are just breaking even? Would a lack of a profit—breaking even or taking a loss—eliminate ethical considerations if the physician in this scenario were interested only in facilitating product selection and increasing the chances of compliance among her or his patients? If the physician is seeking a profit, how much profit is justifiable or defensible? Most manufacturers recommend that physicians double the wholesale price of the product to obtain the retail price. Although this would appear to be a 100% profit, manufacturers have already ensured themselves a 200% to 500% profit margin; thus, the dispensing physician, in acting like a retailer, might be offering a product at 300% to 600% above
525 its original wholesale cost.13 The time cost of the patient going to the store, trying to find the correct product, possibly buying the wrong product and using it, thus delaying their care and incurring the cost of another office visit, offsets the cost of the mark-up of the product. In addition, the patient would likely save money by eliminating the purchase of unnecessary and incorrect skin care. It really all depends on the integrity of the physician. If the physician does not recommend unnecessary products, such as a separate neck cream, and offers reasonably priced products, then patients surely benefit compared with when they shop alone and are sold scores of unnecessary and expensive products by a commissioned salesperson.
The practice of in-office dispensing Supporters of in-office dispensing suggest that sales conducted in a highly professional manner, devoid of pressure tactics, can benefit patients and physicians alike. This is one of the numerous concerns among those opposed to in-office vending: patients may feel intimidated or coerced into buying products dispensed in their dermatologist's office. Indeed, aggressive selling techniques have the potential to leave the patient feeling obligated to purchase a recommended product to achieve the desired clinical outcome and maintain good standing with the physician or her or his staff. Such a scenario can unfold because of a financial incentive offered to staff. Thus, a persistent office staff member motivated by such an incentive can easily use persuasive selling practices or cajolery. Unfortunately, with the financial inducement in place, staff might encourage the purchasing of unneeded products and may even make false claims in the process. This would clearly call into question the whole dynamic of giving financial incentives to staff members as well as their role in the dispensing program. In many cases, a physician employs an aesthetician who makes the skin care recommendations and often works on commission. Physicians must decide for themselves how they want to handle this. Some physicians have suggested that an alternate approach to eliminate this problem is to pay the entire staff a bonus above a selected sales threshold. Some practices do not offer a financial incentive at all to avoid this ethical dilemma.
The physician–patient relationship There is a paucity of research investigating the motivations of physicians who choose to sell products in their practices and the patients who opt to buy skin products in this venue. A notable exception is a 1998 report by WestwoodSquibb Pharmaceuticals Inc (Buffalo, NY), in which 30 dermatologists involved in direct selling, 20 dermatologists who where not involved in direct selling, 22 patients who
526 purchased products from their dermatologists' offices, and 25 office managers were interviewed.14,18 “Trust” was cited by 23 of the 30 physicians (77%) who sell from the office and “convenience” by 6 of the 30 (20%) as the primary reasons patients buy skin care products at their offices. “Physician knowledge” was identified by 12 of the 22 patients (55%), with 6 of 22 (27%) also mentioning “trust” as the main reasons for making in-office purchases (Table 1B). Significantly, no patients reported feeling coerced by their dermatologist into buying products. Asked about the disadvantages of in-office dispensing, 14 of the 20 physicians (70%) who do not sell products referred to “ethical issues or conflicts of interest” and 11 of 20 (55%) more obliquely complained that being involved in the business aspect of office dispensing was a disadvantage (Table 2). Although this was a small study, trust and patients' perceptions of physicians' knowledge can be gleaned as the chief reasons patients are inclined to make purchases in their doctors' offices. Such findings can be used by either camp in the debate on dispensing, as trust and respect for a physician's expertise are key elements in the doctor–patient relationship and should never be breached. Those opposed to office dispensing might argue that for this reason, dispensing should not be considered because it adds an uncomfortable element of commercialism into the practice of which patients might be justifiably wary. Further, if product usage fails to achieve the expected and desired result, doubt may be introduced into the physician–patient relationship. Conversely, the trust and confidence that patients place in their physicians and their specialized knowledge can be seen as an argument for physicians to offer in-office dispensing to accommodate their patients' needs. In this scenario, physicians' knowledge of the chemistry and effects of their products as well as their belief in the efficacy of the products and the validity of product claims is essential. Further, the in-office dispensing roles of nonphysicians, who lack such specialized knowledge, should be carefully reconsidered. The protection and preservation of the physician–patient relationship in the practice of medicine, whether or not it includes office-based dispensing, is a cornerstone of clinical medicine and the foundation on which all ethical judgments should be made. One solution that helps to solve this issue is to survey patients and ask them if they think you should dispense products in your practice. In 2005, while at the University of Miami, we surveyed 500 of our patients and surprisingly discovered that 100% of them preferred that we dispense skin care products. The most common reason given was “to ensure that we are using the proper products.” Some question whether those who opt to vend cosmeceuticals from the office can be objective about these products, while also acknowledging the availability of equivalent formulations elsewhere. If one is practicing ethically, presenting an objective description of one's products as well as others should be not be challenging, as the physician's goal in this case is to educate the patient and
L. Baumann assist in selecting the most suitable product(s) without concern for whether it results in a sale.
Issues, guidelines, and warnings on dispensing Services and obligations: What to offer, what to claim As dermatologists, it is incumbent upon us to offer only services and procedures that have been demonstrated, through evidence-based medicine, as effective. Offering all among the ever-increasing and dizzying assortment of products and procedures simply to make money is not an ethical reason. For example, many dubious procedures are presented as sufficient to achieve photorejuvenation, stretch mark improvement, fat loss, or to reduce cellulite. Performing a procedure that does not work or selling products that are unvetted and unproven puts our patients' trust in us at risk. Similarly, profit margins should not guide one's practice. For example, a given company may offer the least expensive price for a dermal filling agent. This does not necessarily mean that it is the best product for your patients. It is better to strive not for the quick buck but for longterm trust in the physician–patient relationship. It is certainly improper to overfill the patient's face with a dermal filler or to perform other unnecessary cosmetic procedures with increasing profitability as the main goal. One only has to look at pictures of Michael Jackson and many others who have been taken advantage of in this regard to see the ethical lapses of some treating physicians. When considering what to claim about products and procedures, it is best to underpromise and overdeliver. Physicians should write their own information sheets for patients rather than present the exaggerated marketing claims material produced by manufacturers. It is also best to be honest about success rates. Although marketing classes exhort “sell, sell sell,” it is imperative to remember that the patient–physician relationship is a long-term one and does not end at the point of sale. Patients know when they are being taken advantage of and a lack of ethics is often apparent to them. Cosmetic dermatology is very competitive as more and more physicians enter the field. It is crucial that one does not try to promote his or her practice by undermining colleagues and by criticizing others' work. A physician may be perfectly ethical in recommending products and procedures but may cross the line when asked about another colleague's work. Ethical behavior should extend outside the office as well as inside the office. Patient confidentiality is of course a crucial point. Although Health Insurance Portability and Accountability Act laws are clear, physicians are still seen bragging about their celebrity clients on television. This is inexcusable. The celebrity has the right to reveal who their physician is if they choose, but it is unprofessional for the physician to reveal a patient's identity. Financial disclosure is becoming an important topic, especially with Senator Grassley's legislation in the Senate.
Ethics in cosmetic dermatology Although the legislation has not yet passed, ethically, doctors who dispense products and perform procedures from the office should provide financial disclosures and conflict-ofinterest statements to all patients. For example, if a doctor is a consultant for Allergan and chooses Botox for a patient rather than Dysport, the relationship to Allergan should be disclosed. Many doctors are now disclosing their financial conflicts on their Web site. In my practice, a list of all the companies for which I consult and for which I have conducted trials is provided to patients so they are informed about any appearances of potential financial conflicts. Patients are asked to initial the financial disclosure form to indicate that they have been informed. When in doubt about what to do, it is best to keep in mind that our patients trust us and that we must continue to earn and value that trust and not do anything to take advantage of the patient–physician relationship. The most important step is to offer only procedures that are both safe and effective. If your first goal is to make money, then you must question your ethics. Your first goal should be to provide good, honest, and skilled care; that is what separates dermatologists from the other specialties that are jumping on the cosmetic bandwagon in order to make money.
Future considerations The discipline-wide debate over whether it is ethical to offer in-office dispensing has been waged for decades, and thus for more than one generation of dermatologists, and has been internally weighed by countless practitioners through the years. This scenario does not appear likely to change any time soon. Are there actions that we can take collectively, beyond the guidelines set by the AAD and AMA and perhaps additional codes of conduct employed on an individual basis, that can further ensure proper conduct as well as safety and efficacy for patients? Draelos recently suggested a compelling proposal: the creation of a physician board that would approve products for in-office dispensing in a fashion akin to FDA drug approvals [13]. She described this board as one that would evaluate research provided by manufacturers to assess product efficacy and would be responsible for issuing performance guidelines based on strict scientific studies and preestablished goals. Such a proposal warrants serious consideration. It is certainly within the purview of our profession to develop such a structure, particularly given the low likelihood of cosmeceutical regulation.
Conclusions There are many opportunities for financial gain in the cosmetic dermatology world and ethics are challenged on a daily basis. Procedures that do not work but bring in money enter the market every month. Aestheticians and physician assistants are hired and may be paid on an incentive basis.
527 “Do I need Botox?” is a question heard daily as well as “Is eye cream necessary?” There are valid reasons on both sides of the debate whether or not to provide in-office dispensing to dermatology patients. All of these arguments are worth addressing in the literature, conferences and meetings, and other large official gatherings, as well as in smaller discussions with colleagues. Of course, individual practitioners must also consider these issues alone and decide after thoughtful analysis what makes the most sense, or feels most right, to them. For those who decide to offer office dispensing, the question is not whether or not dispensing is ethical but how to go about dispensing in an ethical manner. The preservation of the patient's trust and of the sanctity of the physician–patient relationship should be placed on a par with patient welfare as the highest priorities.
References 1. Miller RC. Dermatologists should guard their patients' purse, not pick their pockets! Arch Dermatol 1999;135:255-6. 2. Gormley DE. There is nothing wrong with dermatologists selling products to patients! Arch Dermatol 1999;135:765-6. 3. Milstein E. The sale of products benefits patients and doctors alike. Arch Dermatol 1999;135:851. 4. Gold MH. The ethical dispensing of nonprescription skin care medications is useful as we approach the new millennium. Arch Dermatol 1999;135:851-2. 5. Farris PK. Office dispensing: a responsible approach. Semin Cutan Med Surg 2000;19:195-200. 6. Epstein E. Are we consultants or peddlers? Arch Dermatol 1998;134:500-9. 7. Lombardo PC. The American academy of dermatology should not endorse product sales from physician's offices. Arch Dermatol 1999;135:995. 8. Hastings Healthcare Group. A quantitative assessment of the skin care market: dermatologists and plastic surgeons. Research Triangle Park, NC: Glaxo Dermatology; 1998. p. 1-4. 9. Lamberg L. Sunscreen, in-office dispensing, surgery debated at annual dermatology meeting. JAMA 1999;281:1363-4. 10. DeMars SC. Calif Dermatol Soc Nwslett 1999. 11. Farber H. Norton l. Should dermatologists dispense cosmetics? Skin Aging 1998;6:74-7. 12. Draelos ZD. Controversies surrounding in-office dispensing. Dermatol Surg 1998;24:781-3. 13. Draelos ZD. The dermatology dispensing debate. Skin Therapy Lett 2007;12:1-3. 14. Ogbogu P, Fleischer Jr AB, Brodell RT, Bhalla G, Draelos ZD, Feldman SR. Physicians' and patients' perspectives on office-based dispensing. The central role of the physician-patient relationship. Arch Dermatol 2001;137:151-4. 15. American Medical Association, Council on Ethical and Judicial Affairs. Sale of health-related products from physicians' offices (E-8.063). Issued December 1999, adopted June 1999. Available at: http://www. ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/ HnE/E-8.063.HTM. Accessed June 24, 2008. 16. American Academy of Dermatology and AAD Association. Position statement on dispensing. Approved by the Board of Directors October 12, 1998; amended by the Board of Directors September 26, 1999. Available at: http://www.aad.org/NR/rdonlyres/FCAAC923-3F36-4B36-8C35945472973888/0/Dispensing.pdf. Accessed June 24, 2008. 17. Kligman A. Cosmeceuticals: do we need a new category? In: Elsner P, Maibach H, editors. Cosmeceuticals. New York: Marcel Dekker Inc; 2000. p. 1. 18. Castanedo-Tardan MP, Baumann L. Ethics of selling skin care. Clin Dermatol 2009;27:355-8.
Ethics in cosmetic dermatology Leslie Baumann, MD ⁎ Baumann Cosmetic and Research Institute, Miami Beach, FL 33140-2910, USA
Abstract The dispensing of nonprescription skin products by dermatologists and the performance of ineffective cosmetic procedures are the most controversial subjects associated with the practice of cosmetic dermatology. These topics have been hotly debated within the profession for several decades, with each side presenting cogent arguments. The debate is also characterized by strong passion and emotions on both sides that are not easily reconciled. Dermatologists and their patients are best served by an objective, organized approach to clearly delineating the various aspects of these issues and providing guidelines for practitioners that can be shared with patients. © 2012 Elsevier Inc. All rights reserved.
Exemplary case A 30-year-old woman presented with melasma after having seen two other dermatologists. She had received a series of intense pulsed light treatments and treatment with a fractionated laser. In her opinion, these therapeutic approaches exacerbated her melasma. She incurred bills totaling $4,000 from these treatments. According to the patient, her previous doctors did not discuss with her the importance of sunscreen and the role of birth control pills in her cutaneous condition, and she was never given a prescription or recommendation for a topical skin lightener; however, the practitioners had sold her more than $400 worth of skin care products, none of which contained ingredients appropriate for the treatment of melasma. The first step with this patient was to educate her about sunscreens, sun avoidance, and skin-lightening options. I recommended a prescription hydroquinone-containing product to be used for 3 months, followed by a 1-month respite. She was referred to her obstetrician/gynecologist for a different contraceptive option. She was instructed to discontinue facial waxing and facial steaming and to avoid other forms of heat on the face when possible. Although a series of chemical peels could be considered, these were not recommended. The patient's melasma cleared in 3 months. ⁎ Corresponding author. Tel.: +1 305 532 5552; fax: +1 305 534 5224. E-mail address: [email protected]. 0738-081X/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.clindermatol.2011.06.023
The point of this case study is that this patient was originally treated with the option that made the most profit for the physician and provided a short-term benefit rather than the less expensive and more effective option in the long term.
Introduction Cosmetic dermatologists have the goal of improving their patient's appearance and skin health, but all too often, financial motivation can cloud their judgment. This is because there is a very high demand for cosmetic procedures and there is much competition to provide the newest and “trendiest” procedures. A successful cosmetic dermatologist must be a scientist, a marketer, an artist, and a business person. In contrast to other subspecialties in dermatology, cosmetic dermatologists need to advertise, hire public relations specialists, and perform other functions that are traditionally out of the scope of the medical field in order to attract new patients. To make matters worse, nondermatologists, such as obstetricians/gynecologists, dentists, pediatricians, and even radiologists, are entering the field because they perceive it as easy and as a way to avoid dealing with insurance companies. The main reason there are so many ethical debates in the cosmetic dermatology world is that there are just so many opportunities to make money and some of these opportunities walk the ethical tightrope. For example, whether to sell
Ethics in cosmetic dermatology skin care products in a physician's office has been a hotly debated question within the dermatologic and wider medical community for several decades. The expression “office dispensing” entered the vernacular in 1998 when it began appearing in the comments and editorial sections of esteemed dermatologic journals. In March 1999, Dr. Richard C. Miller launched an impassioned months-long discussion published in the “Issues in Dermatology” section of the Archives of Dermatology in which he contended that the profit motive is the primary incentive for physicians offering their own line of products.1 The popularity of in-office dispensing, though, suggests that many practitioners feel otherwise, and deep convictions persist on both sides of the issue. Essentially, advocates of in-office dispensing argue that the practice provides a valuable service to patients.2-5 Detractors, on the other hand, suggest that, as Miller opined, dispensing is profit-driven, fraudulent, and undermines the trust necessary in the doctor–patient relationship.1,6,7 The focus of this article will be to objectively assess the diametrically opposed arguments on the subject of inoffice dispensing of skin care products. The same arguments that are made about the ethics of selling skin care products pertain to the ethics of selling ineffective office procedures or performing procedures that the patient does not need or that will actually worsen the patient's appearance. One only has to turn on the television to realize that many doctors are not providing the best aesthetic care to their patients. Whether it was a dermatologist or another type of medical or nonmedical specialty that provided these treatments, certainly the Hippocratic oath, “Do no harm” was ignored with the promise of financial success. Of course there is nothing wrong with having a financially successful medical practice as long as the patient has not been taken advantage of and been led to believe that ineffective products or procedures are necessary. This discussion will include a review of the current status of office dispensing, the positions of pertinent professional medical organizations, and the potential effects of merchandising on the physician–patient relationship.
Popularity of and rationale for in-office dispensing At the time that the expression “office dispensing” came to the fore, it was estimated that anywhere from 40% to 70% of dermatologists were actually selling skin care products in their practices.8,9 A survey of the California Dermatology Society conducted in September 1998, in which 297 members (26% of the members) responded, offered a view of what in retrospect appears to have been an emerging attitude. Of those who answered the questionnaire, 247 (83%) thought it was ethical to sell
523 Table 1
Advantages of dispensing
(A) Potential overall advantages stemming from in-office dispensing 1. Patient convenience 2. Increased likelihood of compliance 3. Ensure that most appropriate products are purchased 4. Ensure product quality (ie, ingredients, formulation or concentration, storage) 5. Potential staff incentive 6. Boost to physician's income 7. Forces physician to stay updated on product innovations (B) Motivations to patients for purchasing in-office products 1. Physician knowledge 2. Trust
nonprescription products from their offices; 205 (69%) were already engaged in the practice.10 It is well known that the numbers have increased in the ensuing decade and continue to increase for the reasons listed in Table 1A. Most U.S. states prohibit the vending of prescription drugs directly from a doctor's office; however, this practice is allowed in Florida and a few other states. Most practices that sell products do not sell prescription products but instead sell over-the-counter (OTC) skin care formulations. These may be formulated by the physician, private labeled by a manufacturing company with the physician's name, or may be an unrelated brand. The profit margins differ depending on the type of products sold in the practice. The standard products sold in an in-office dispensing assortment include antiaging formulations, moisturizers, sunscreens, cleansers, and acne products.5 A dermatologist with the appropriate business license can sell such products as found in major retailing stores or opt to develop a line of skin care products available only at her or his office. The rationales for offering in-office dispensing include providing patients with the convenience of one-stop shopping, increasing the likelihood of compliance by providing appropriate products directly to patients, supplementing the income of the physician, and forcing oneself to stay current on product formulations.4,5,11,12 There are decided advantages for patients, too (Table 1B). The arguments against in-office dispensing boil down to ethical conflicts of interest and the potential compromise of the physician–patient relationship13,14 (Table 2). Thus, the compelling question for the dermatologist who is weighing these positions might be: “Will my patients benefit from buying skin care products directly from me in a way that they would not otherwise?” Related questions that get to the heart of the matter include: Are the products sold in a physician's office superior to those available elsewhere? Is the product selection experience provided by a dermatologist superior to self-directed purchasing at a retail establishment? If it is the latter, might dermatologists deliver such an experience without dispensing products from their offices?
524 Table 2
L. Baumann Perceived disadvantages of in-office dispensing
1. Conflict of interest 2. Impact on doctor–patient relationship 3. Compulsion to sell/impact of profit incentive to physician and/or staff 4. Added business and operational burden
Professional organizations weigh in Two professional medical organizations have issued noteworthy opinion statements regarding the practice of inoffice dispensing. In both cases, both organizations, the American Medical Association (AMA) and the American Academy of Dermatology (AAD), rightly place the best interests of patients as the primary concern. The AMA avows that in-office dispensing presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.15 With such a stern admonition in place, the AMA advises physicians who choose to sell products from the office to preserve medical ethics by not selling any product the beneficial claims for which lack scientific validity, taking steps to minimize financial conflicts of interest, disclosing to the patient the nature of their financial arrangement with the manufacturer and the availability of the product or other equivalent products elsewhere, and urging manufacturers to make products of established benefits more widely accessible to patients. In December 2000, the AMA released an addendum to its statement encouraging physicians to apply these guidelines to medical practice Web sites (Table 3).
Table 3 Summary of the American Medical Association position on in-office sales The in-office sale of products: 1. Presents a financial conflict of interest 2. Risks placing undue pressure on the patient 3. Threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own For those physicians who choose to dispense, the American Medical Association advises the following to preserve medical ethics: 1. Do not sell any product whose claims of benefit lack scientific validity 2. Minimize conflicts of interest 3. Disclose to the patient the nature of your financial arrangement with the manufacturer 4. Disclose the availability of the product or other equivalent products elsewhere 5. Encourage manufacturers to develop products of established benefits more widely accessible to patients
Table 4 American Academy of Dermatology position statement on dispensing16, a • Dermatologists should not dispense or supply drugs, remedies, or appliances unless it is manifestly in the best interest of their patients. • Dermatologists who dispense in office should do so in a manner with the best interest of their patient as their highest priority, as it is in all other aspects of dermatologic practice. • It is ethical to dispense, by sale, prescription or nonprescription drugs, to patients in a dermatologist's office except in the following circumstances: 1. When the dermatologist places his/her own financial interests above the welfare of his/her patients. 2. When creating an atmosphere which is coercive to patients such that they feel compelled to purchase drugs from the dermatologist. 3. When dispensing drugs under a dermatologist's private label without clearly listing the ingredients, including generic names of the drugs. 4. When dispensing to patients drugs which are easily available at proprietary pharmacies without advising patients of this availability. 5. When representing drugs as being a special formula not elsewhere available, when this is not the case. 6. When selling health-related products whose claims of benefit lack validity. 7. When refusing to give refills of drugs except when they are purchased from the dermatologist. 8. When charging patients at an excessive mark-up rate. a
Approved by the Board of Directors October 12, 1998; amended by the Board of Directors September 26, 1999.
The position of the AAD is more specific, offering guidelines without judgments. The AAD finds that it is ethical to offer in-office dispensing, as long as it is conducted in the best interests of the patient16 (Table 4).
Regulations and price Proponents of in-office dispensing typically consider the practice as a logical extension of topical treatment approaches.2 In fact, in the example case at the beginning of this article, the patient would have fared better by being sold skin care products and receiving sun avoidance education than the result achieved after receiving several expensive procedures. Ethical physicians may sell highquality products with known scientific validity, especially products with key ingredients unavailable in retail stores.5 Those opposed to in-office dispensing often claim that there are few, if any, non-OTC products and/or ingredients in physician-sold lines that are so unique or represent such significant upgrades over products available on the mass market to justify the practice of in-office sales. In the U.S., there are no regulations or legislation to prevent mass-market brands from using the same concentrations of key active ingredients as in the physician-dispensed brands. In some
Ethics in cosmetic dermatology cases, products sold in doctors' offices are identical formulations to those in retail stores. The primary difference may be packaging. The significance of active ingredients and their regulation is an important tangential issue here. Personal care products are classified, according to the U.S. Food and Drug Administration (FDA), as drugs, cosmetics, or both. Antidandruff shampoos and moisturizers with skin protection factor (SPF) are classified as both, for example. “Cosmeceuticals,” a term coined by the late Dr. Albert Kligman more than a quarter of a century ago, refers to skin care products labeled as cosmetics, not regulated as drugs, that may confer biologic activity.17 Companies are therefore able to skirt regulatory action by manipulating labels. For instance, although retinol is known to influence retinoic acid receptors, yielding biologic activity, retinol, a popular ingredient contained in numerous cosmetics, is often listed as an inactive ingredient on product labels, thus immune from action by the FDA. In other words, the skin care formulation would be labeled as a drug and made available only by prescription if the retinol-containing product claimed to “increase collagen production.” When the retinol-containing product does not contain this claim, it can be labeled and sold as a cosmetic product. Essentially, it is the claim of the product that determines whether it is regulated as a drug rather than the biologic activity of the product. Many products claim to “improve the appearance of wrinkles,” which is consistent with a cosmetic claim even if the product is known to increase the production of elastin. The cosmetic company would not be allowed to make a claim that its product increases the production of elastin. This dynamic explains the lack of well-designed studies establishing the efficacy of cosmeceuticals. The companies actually have an incentive not to prove that their products have biologic activity. This puts ethical physicians in a bind. They want to sell only products proven to be efficacious, but the proof is either not there or is proprietary and not shared by the company.13 Price and the profit motive in many business decisions is another prominent issue in this debate. In most circumstances, one would expect that anyone deciding to sell any kind of merchandise would expect to make a profit. Does such action transform a physician into a merchant, Miller wondered.1 Can doctors justify office vending if they are just breaking even? Would a lack of a profit—breaking even or taking a loss—eliminate ethical considerations if the physician in this scenario were interested only in facilitating product selection and increasing the chances of compliance among her or his patients? If the physician is seeking a profit, how much profit is justifiable or defensible? Most manufacturers recommend that physicians double the wholesale price of the product to obtain the retail price. Although this would appear to be a 100% profit, manufacturers have already ensured themselves a 200% to 500% profit margin; thus, the dispensing physician, in acting like a retailer, might be offering a product at 300% to 600% above
525 its original wholesale cost.13 The time cost of the patient going to the store, trying to find the correct product, possibly buying the wrong product and using it, thus delaying their care and incurring the cost of another office visit, offsets the cost of the mark-up of the product. In addition, the patient would likely save money by eliminating the purchase of unnecessary and incorrect skin care. It really all depends on the integrity of the physician. If the physician does not recommend unnecessary products, such as a separate neck cream, and offers reasonably priced products, then patients surely benefit compared with when they shop alone and are sold scores of unnecessary and expensive products by a commissioned salesperson.
The practice of in-office dispensing Supporters of in-office dispensing suggest that sales conducted in a highly professional manner, devoid of pressure tactics, can benefit patients and physicians alike. This is one of the numerous concerns among those opposed to in-office vending: patients may feel intimidated or coerced into buying products dispensed in their dermatologist's office. Indeed, aggressive selling techniques have the potential to leave the patient feeling obligated to purchase a recommended product to achieve the desired clinical outcome and maintain good standing with the physician or her or his staff. Such a scenario can unfold because of a financial incentive offered to staff. Thus, a persistent office staff member motivated by such an incentive can easily use persuasive selling practices or cajolery. Unfortunately, with the financial inducement in place, staff might encourage the purchasing of unneeded products and may even make false claims in the process. This would clearly call into question the whole dynamic of giving financial incentives to staff members as well as their role in the dispensing program. In many cases, a physician employs an aesthetician who makes the skin care recommendations and often works on commission. Physicians must decide for themselves how they want to handle this. Some physicians have suggested that an alternate approach to eliminate this problem is to pay the entire staff a bonus above a selected sales threshold. Some practices do not offer a financial incentive at all to avoid this ethical dilemma.
The physician–patient relationship There is a paucity of research investigating the motivations of physicians who choose to sell products in their practices and the patients who opt to buy skin products in this venue. A notable exception is a 1998 report by WestwoodSquibb Pharmaceuticals Inc (Buffalo, NY), in which 30 dermatologists involved in direct selling, 20 dermatologists who where not involved in direct selling, 22 patients who
526 purchased products from their dermatologists' offices, and 25 office managers were interviewed.14,18 “Trust” was cited by 23 of the 30 physicians (77%) who sell from the office and “convenience” by 6 of the 30 (20%) as the primary reasons patients buy skin care products at their offices. “Physician knowledge” was identified by 12 of the 22 patients (55%), with 6 of 22 (27%) also mentioning “trust” as the main reasons for making in-office purchases (Table 1B). Significantly, no patients reported feeling coerced by their dermatologist into buying products. Asked about the disadvantages of in-office dispensing, 14 of the 20 physicians (70%) who do not sell products referred to “ethical issues or conflicts of interest” and 11 of 20 (55%) more obliquely complained that being involved in the business aspect of office dispensing was a disadvantage (Table 2). Although this was a small study, trust and patients' perceptions of physicians' knowledge can be gleaned as the chief reasons patients are inclined to make purchases in their doctors' offices. Such findings can be used by either camp in the debate on dispensing, as trust and respect for a physician's expertise are key elements in the doctor–patient relationship and should never be breached. Those opposed to office dispensing might argue that for this reason, dispensing should not be considered because it adds an uncomfortable element of commercialism into the practice of which patients might be justifiably wary. Further, if product usage fails to achieve the expected and desired result, doubt may be introduced into the physician–patient relationship. Conversely, the trust and confidence that patients place in their physicians and their specialized knowledge can be seen as an argument for physicians to offer in-office dispensing to accommodate their patients' needs. In this scenario, physicians' knowledge of the chemistry and effects of their products as well as their belief in the efficacy of the products and the validity of product claims is essential. Further, the in-office dispensing roles of nonphysicians, who lack such specialized knowledge, should be carefully reconsidered. The protection and preservation of the physician–patient relationship in the practice of medicine, whether or not it includes office-based dispensing, is a cornerstone of clinical medicine and the foundation on which all ethical judgments should be made. One solution that helps to solve this issue is to survey patients and ask them if they think you should dispense products in your practice. In 2005, while at the University of Miami, we surveyed 500 of our patients and surprisingly discovered that 100% of them preferred that we dispense skin care products. The most common reason given was “to ensure that we are using the proper products.” Some question whether those who opt to vend cosmeceuticals from the office can be objective about these products, while also acknowledging the availability of equivalent formulations elsewhere. If one is practicing ethically, presenting an objective description of one's products as well as others should be not be challenging, as the physician's goal in this case is to educate the patient and
L. Baumann assist in selecting the most suitable product(s) without concern for whether it results in a sale.
Issues, guidelines, and warnings on dispensing Services and obligations: What to offer, what to claim As dermatologists, it is incumbent upon us to offer only services and procedures that have been demonstrated, through evidence-based medicine, as effective. Offering all among the ever-increasing and dizzying assortment of products and procedures simply to make money is not an ethical reason. For example, many dubious procedures are presented as sufficient to achieve photorejuvenation, stretch mark improvement, fat loss, or to reduce cellulite. Performing a procedure that does not work or selling products that are unvetted and unproven puts our patients' trust in us at risk. Similarly, profit margins should not guide one's practice. For example, a given company may offer the least expensive price for a dermal filling agent. This does not necessarily mean that it is the best product for your patients. It is better to strive not for the quick buck but for longterm trust in the physician–patient relationship. It is certainly improper to overfill the patient's face with a dermal filler or to perform other unnecessary cosmetic procedures with increasing profitability as the main goal. One only has to look at pictures of Michael Jackson and many others who have been taken advantage of in this regard to see the ethical lapses of some treating physicians. When considering what to claim about products and procedures, it is best to underpromise and overdeliver. Physicians should write their own information sheets for patients rather than present the exaggerated marketing claims material produced by manufacturers. It is also best to be honest about success rates. Although marketing classes exhort “sell, sell sell,” it is imperative to remember that the patient–physician relationship is a long-term one and does not end at the point of sale. Patients know when they are being taken advantage of and a lack of ethics is often apparent to them. Cosmetic dermatology is very competitive as more and more physicians enter the field. It is crucial that one does not try to promote his or her practice by undermining colleagues and by criticizing others' work. A physician may be perfectly ethical in recommending products and procedures but may cross the line when asked about another colleague's work. Ethical behavior should extend outside the office as well as inside the office. Patient confidentiality is of course a crucial point. Although Health Insurance Portability and Accountability Act laws are clear, physicians are still seen bragging about their celebrity clients on television. This is inexcusable. The celebrity has the right to reveal who their physician is if they choose, but it is unprofessional for the physician to reveal a patient's identity. Financial disclosure is becoming an important topic, especially with Senator Grassley's legislation in the Senate.
Ethics in cosmetic dermatology Although the legislation has not yet passed, ethically, doctors who dispense products and perform procedures from the office should provide financial disclosures and conflict-ofinterest statements to all patients. For example, if a doctor is a consultant for Allergan and chooses Botox for a patient rather than Dysport, the relationship to Allergan should be disclosed. Many doctors are now disclosing their financial conflicts on their Web site. In my practice, a list of all the companies for which I consult and for which I have conducted trials is provided to patients so they are informed about any appearances of potential financial conflicts. Patients are asked to initial the financial disclosure form to indicate that they have been informed. When in doubt about what to do, it is best to keep in mind that our patients trust us and that we must continue to earn and value that trust and not do anything to take advantage of the patient–physician relationship. The most important step is to offer only procedures that are both safe and effective. If your first goal is to make money, then you must question your ethics. Your first goal should be to provide good, honest, and skilled care; that is what separates dermatologists from the other specialties that are jumping on the cosmetic bandwagon in order to make money.
Future considerations The discipline-wide debate over whether it is ethical to offer in-office dispensing has been waged for decades, and thus for more than one generation of dermatologists, and has been internally weighed by countless practitioners through the years. This scenario does not appear likely to change any time soon. Are there actions that we can take collectively, beyond the guidelines set by the AAD and AMA and perhaps additional codes of conduct employed on an individual basis, that can further ensure proper conduct as well as safety and efficacy for patients? Draelos recently suggested a compelling proposal: the creation of a physician board that would approve products for in-office dispensing in a fashion akin to FDA drug approvals [13]. She described this board as one that would evaluate research provided by manufacturers to assess product efficacy and would be responsible for issuing performance guidelines based on strict scientific studies and preestablished goals. Such a proposal warrants serious consideration. It is certainly within the purview of our profession to develop such a structure, particularly given the low likelihood of cosmeceutical regulation.
Conclusions There are many opportunities for financial gain in the cosmetic dermatology world and ethics are challenged on a daily basis. Procedures that do not work but bring in money enter the market every month. Aestheticians and physician assistants are hired and may be paid on an incentive basis.
527 “Do I need Botox?” is a question heard daily as well as “Is eye cream necessary?” There are valid reasons on both sides of the debate whether or not to provide in-office dispensing to dermatology patients. All of these arguments are worth addressing in the literature, conferences and meetings, and other large official gatherings, as well as in smaller discussions with colleagues. Of course, individual practitioners must also consider these issues alone and decide after thoughtful analysis what makes the most sense, or feels most right, to them. For those who decide to offer office dispensing, the question is not whether or not dispensing is ethical but how to go about dispensing in an ethical manner. The preservation of the patient's trust and of the sanctity of the physician–patient relationship should be placed on a par with patient welfare as the highest priorities.
References 1. Miller RC. Dermatologists should guard their patients' purse, not pick their pockets! Arch Dermatol 1999;135:255-6. 2. Gormley DE. There is nothing wrong with dermatologists selling products to patients! Arch Dermatol 1999;135:765-6. 3. Milstein E. The sale of products benefits patients and doctors alike. Arch Dermatol 1999;135:851. 4. Gold MH. The ethical dispensing of nonprescription skin care medications is useful as we approach the new millennium. Arch Dermatol 1999;135:851-2. 5. Farris PK. Office dispensing: a responsible approach. Semin Cutan Med Surg 2000;19:195-200. 6. Epstein E. Are we consultants or peddlers? Arch Dermatol 1998;134:500-9. 7. Lombardo PC. The American academy of dermatology should not endorse product sales from physician's offices. Arch Dermatol 1999;135:995. 8. Hastings Healthcare Group. A quantitative assessment of the skin care market: dermatologists and plastic surgeons. Research Triangle Park, NC: Glaxo Dermatology; 1998. p. 1-4. 9. Lamberg L. Sunscreen, in-office dispensing, surgery debated at annual dermatology meeting. JAMA 1999;281:1363-4. 10. DeMars SC. Calif Dermatol Soc Nwslett 1999. 11. Farber H. Norton l. Should dermatologists dispense cosmetics? Skin Aging 1998;6:74-7. 12. Draelos ZD. Controversies surrounding in-office dispensing. Dermatol Surg 1998;24:781-3. 13. Draelos ZD. The dermatology dispensing debate. Skin Therapy Lett 2007;12:1-3. 14. Ogbogu P, Fleischer Jr AB, Brodell RT, Bhalla G, Draelos ZD, Feldman SR. Physicians' and patients' perspectives on office-based dispensing. The central role of the physician-patient relationship. Arch Dermatol 2001;137:151-4. 15. American Medical Association, Council on Ethical and Judicial Affairs. Sale of health-related products from physicians' offices (E-8.063). Issued December 1999, adopted June 1999. Available at: http://www. ama-assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/ HnE/E-8.063.HTM. Accessed June 24, 2008. 16. American Academy of Dermatology and AAD Association. Position statement on dispensing. Approved by the Board of Directors October 12, 1998; amended by the Board of Directors September 26, 1999. Available at: http://www.aad.org/NR/rdonlyres/FCAAC923-3F36-4B36-8C35945472973888/0/Dispensing.pdf. Accessed June 24, 2008. 17. Kligman A. Cosmeceuticals: do we need a new category? In: Elsner P, Maibach H, editors. Cosmeceuticals. New York: Marcel Dekker Inc; 2000. p. 1. 18. Castanedo-Tardan MP, Baumann L. Ethics of selling skin care. Clin Dermatol 2009;27:355-8.