Draft ASHP Guidelines on Pharmacists Relationships with Industry 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Pharmacists can choose to pursue an ethic that reciprocates trust with trustworthy behavior. Pharmacists stand to benefit individually and professionally by having a widely accepted, intrinsic set of ethical standards reflecting fidelity to patients, rather than having ethical behavior that is imposed by regulatory authorities in the wake of scandals attracting negative media attention. David Banks 1 Pharmacists, like other healthcare providers, have a paradoxical relationship with drug and device manufacturers. 1 Drug products and delivery devices are essential to the care that pharmacists provide to patients. Drug manufacturers and other healthcare businesses (e.g., information technology and automation companies) create innovative treatments, promote the development and dissemination of information about the safe and effective use of their products of a safer and more effective medication-use process, and often provide valuable information for pharmacists and free or low-cost treatment for patients. Although the interests of these businesses often coincide with those of patients, healthcare practitioners recognize that these organizations are for-profit entities whose overriding interest in maximizing sales may lead to tragic results. 2 There has been a continuing growth of interest in addressing the potential for conflicts of interest in the practice of healthcare. 3 In 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA) published its first Code on Interactions with Healthcare Professionals 4 ; that document was updated in 2008 and took effect in January 2009. 5 The Department of Health and Human Services Office of the Inspector General (OIG) issued its Compliance Program Guidance for Pharmaceutical Manufacturers in 2003. 6 In 2004, the Accreditation Council for Continuing Medical Education (ACCME) published guidance related to commercial support of continuing education, and in 2014 the Accreditation Council for Pharmacy Education (ACPE) updated its guidance on the topic, adapted from the ACCME standards. 7,8 The American College of Clinical Pharmacy (ACCP) updated its guidelines on ethical interactions with industry in 2008. 9 The Physician Payments Sunshine Act of 2009 mandated that manufacturers report all financial support given to physicians or hospitals that accept federal reimbursement through Medicare and Medicaid in order to address conflicts of interest. 10 Within the same year, the Institute of Medicine (IOM) published its report, Conflict of Interest in Medical Research, Education, and Practice. 11 These reports characterized pharmacists as an adjacent profession that should follow the physician model managing conflicts of interest. The IOM also recommended that policies and procedures address accountability in the instance that a This draft document is intended for review purposes only. It is not official ASHP policy. This document may not be reproduced, circulated, or quoted (except for review purposes) without prior written permission from ASHP.
Draft ASHP Guidelines on Pharmacists Relationships with Industry 2 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 breach is made. A parallel organization, the Advanced Medical Technology Association, published guidelines for interactions with healthcare professionals in the same year. 12 Pharmacists practices should be guided by what is best for patients. 13 Their judgment and the appearance of their objectivity should not be influenced by gifts or other benefits from commercial interests. ASHP recognizes that relationships between pharmacists and commercial interest are inevitable. Keeping these relationships ethical will prove beneficial to patients, pharmacists, and industry. Pharmacists have a professional obligation to be vigilant regarding any potential relationship that could result in a real or perceived conflict of interest. They must also consider how such an association could undermine their relationships with patients and colleagues or tarnish the reputation of pharmacy as a profession. The purpose of these guidelines is to outline policies and procedures that should guide pharmacists relationships with industry. These guidelines apply to any interaction between a healthcare-related proprietary entity and a pharmacist that might cause or appear to cause a conflict of interest. The guidelines address gifts, hospitality, and travel; educational programs; consultancy and research arrangements; disclosure; and activities of vendors representatives. ASHP has attempted to make these guidelines consistent with other organizations guidance on relations with industry. Where there are differences, or where guidance is lacking, pharmacists should apply their professional judgment. Defining Conflict of Interest Definitions of conflict of interest vary, but there is general agreement that a conflict of interest contains two elements: the presence of interests other than those dictated by professional responsibility and the opportunity to take actions that would further those interests. A conflict of interest arises when a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties. 14 A private interest is an interest based on a relationship with another person or organization, 1 such as an interest in the success of a friend, a non-spouse family member, or an organization. A personal interest is a self-interest and may involve financial or other personal incentives (e.g., recognition or advancement). A conflict of interest arises when these interests affect or appear to affect actions taken on behalf of the person whose interest the professional is entrusted with (in the case of pharmacists, the patient). For example, ACPE considers financial relationships to create actual conflicts of interest when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CPE [continuing professional education] about the products or services of that commercial interest. 7 Because it is only human nature to overestimate one s ability to identify and address potential conflicts of interest, hospitals and health systems must develop and enforce policies and procedures regarding employee conflicts of interest. Pharmacists should take a leadership
Draft ASHP Guidelines on Pharmacists Relationships with Industry 3 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 role in developing and enforcing those policies and procedures for pharmacy staff, recognizing that different responsibilities will require different approaches to conflict of interest management and resolution. In all cases, however, pharmacists should recognize that even the appearance of a conflict of interest is sufficient to warrant a deterrent policy and that mere disclosure of a conflict of interest does not resolve the conflict. Gifts, Hospitality, and Subsidies Gifts, hospitality, or subsidies offered to pharmacists by industry (whether offered directly by a vendor, through intermediaries, or from a company) should not be accepted. Acceptance might influence or appear to influence the objectivity of clinical judgment or drug product selection and procurement. Additionally, PhRMA code prohibits the distribution of gifts that might induce conflict of interest, such as entertainment or recreation items. 5 Public opinion of healthcare professionals dedication to patient welfare above all else may be undermined if that care is perceived to be influenced by industry gifts. 13 It is human nature for the recipient of a gift from a company sales representative to associate feelings about the gift or the representative with feelings about the company s product. Research has also shown a positive correlation between gift value and level of influence from industry. 15 Pharmacists have a responsibility to resolve even the appearance of conflicts of interest regarding their care for patients. Pharmacists should ensure that they are knowledgeable about relevant research on the risks and benefits of pharmaceutical and other products, and they should base their choices on this knowledge. 16 Personal or institutional gifts with conditions attached, such as gifts for top purchasers of a company s product, are not acceptable. 14 This prohibition includes personal discounts, educational grants, and contracts for research on a manufacturer s products. Detailed guidance for the pharmaceutical industry on appropriate interactions with healthcare professionals 5 and on preventing fraud and abuse in federal healthcare programs 6 has been published. Federal guidance to manufacturers suggests that they consider whether their practices or arrangements have the potential to increase costs to federal healthcare programs or their beneficiaries or could be construed as disguised discounts designed to circumvent the Medicaid Rebate Program Best Price calculation. 6 Pharmacists, as formulary decision-makers and purchasers, are in a position to generate federal healthcare business for manufacturers. Pharmacists should be aware that the federal anti-kickback statute makes it illegal for companies to offer anything of value in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or ordering of any item or service reimbursable in whole or in part by a federal healthcare program. 6 Purchasers should be aware of their obligations in reporting discounts and submitting claims to federal programs.
Draft ASHP Guidelines on Pharmacists Relationships with Industry 4 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 Hospital and health-system policies should prohibit gifts to pharmacists, although some institutions may make exception for small gifts that advance education about disease or treatment. If the organization's policy permits such education-related gifts, those gifts should not be of substantial value (less than $100), and the same policies should apply whether the gifts are offered directly by a vendor, through intermediaries, or from the company. PhRMA no longer considers it appropriate for items such as pens, notepads, and calendars to be distributed to healthcare professionals. 5 PhRMA guidelines stipulate that informational presentations should be limited to inoffice or in-hospital settings. 5 Pharmacists should not attend such events elsewhere, except as described in these guidelines. Although PhRMA guidelines permit company representatives to provide healthcare professionals and their staff with occasional, modest meals during these educational presentations, ASHP believes industry representatives should be prohibited from providing food in the workplace. If allowed, such food should be of nominal value and accepted only on an occasional basis. 12 Mechanisms must be in place to ensure that the educational purpose of such events is fulfilled 5 and that interactions between vendors and healthcare professionals and staff are appropriate. Continuing Education Guidance on subsidies for educational activities applies regardless of the setting in which, or the medium through which, the educational activity is offered. 16 ACPE no longer accredits pharmaceutical and biomedical device manufacturers as providers of continuing education (CE). 8 Educational grants from industry to CE providers to underwrite the costs of conferences, professional meetings, or staff development programs may contribute to the improvement of patient care and are permissible in certain cases. CE providers that accept industry funding for programs must develop and enforce strict policies for maintaining complete control of the program and its content. This includes identification of CE needs, determination of educational objectives, selection and presentation of content, selection of materials, selection of speakers, selection of venue, selection of all persons and organizations that will be in a position to influence the content of the CE (e.g., reviewers, planners, faculty), selection of educational methods, and evaluation of the activity. 5,7 The CE provider should require all persons contributing to the content of an educational activity to disclose all relevant financial and other relationships with commercial interests. The CE content, format of the activity and its related materials must promote improvements or quality in healthcare rather than promoting a commercial product or interest. 7 Presentations must give a fair, balanced, and unbiased view of potential options based on the evidence. Educational presentations from industry should not be product-specific; the use of generic names is required. 7 It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and reimbursement for reasonable travel, lodging, and meal expenses directly from the CE
Draft ASHP Guidelines on Pharmacists Relationships with Industry 5 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 provider. Accredited CE providers must have written policies and procedures governing honoraria and expense reimbursement for CE planners, faculty, and authors. Presentation of a poster does not in itself qualify a person as a faculty member for the purpose of these guidelines, but if ACPE-accredited CE is offered for the poster, all ACPE standards apply. Commercial support must take the form of educational grants to providers, and payment to practitioners should come directly from the provider or from the provider s joint sponsors or educational partners. 7 Pharmacists, pharmacy students, residents, and fellows attending a conference or program should not accept, directly or indirectly, industry payments to defray the costs of attending the conference. Contributions from industry to special or educational funds for pharmacy staff development are permissible as long as decisions regarding expenses from these funds are made by the healthcare institution and approved by the department of pharmacy. Approval by the next-higher management tier is also recommended. Pharmacists attending conferences or meetings should not accept direct subsidies from industry to pay the costs of travel, lodging, or other personal expenses, nor should they accept subsidies to compensate for their time. Pharmacists attending CE activities should not accept industry subsidies regardless of whether the source is a company s sales division, educational division, or other section of the company. 16 Honoraria should not be accepted for visits to tour a company or learn about its products. 16 Except for modest meals or social events held as part of the CE activities, they are attending, pharmacists should not accept subsidies for hospitality. 16 The primary activity at CE conferences should be educational, and educational activities should account for a substantial majority of the total conference time. 16 Social events or meals at CE activities should not compete with or take precedence over the educational events. 7 Product Promotion Product-promotion material or product-specific advertisement of any type is prohibited in or during CE activities. 7 The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. 7 Payments by companies to providers for commercial exhibits and advertisements are not considered commercial support for CE activities, but providers are expected to use sound practices with respect to these promotional activities, keeping them separate from CE. 7 Consultants and Advisory Arrangements Consultants who provide genuine services for industry may receive reasonable compensation and accept reimbursement for travel, lodging, and meal expenses related to providing those services. Token consulting or advisory arrangements cannot be used to justify compensating pharmacists for their time, travel, lodging, and other out-of-pocket expenses. A bona fide
Draft ASHP Guidelines on Pharmacists Relationships with Industry 6 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 consulting arrangement would, for example, clearly identifies the need for the consultant s services and a written contract specifies the nature of the services to be provided and the basis for payment for these services. 5 The criteria for selecting consultants would be directly related to the identified purpose (i.e., the consultant must have the expertise or experience being sought), and consultants should be selected by persons with the appropriate expertise to determine whether an individual meets those criteria. 5 PhRMA code states that the number of professionals compensated for consulting roles is no more than necessary. 5 The venue and circumstances of meetings between industry representatives and consultants must be "conducive to the consulting service," and the primary focus of such meetings must be activities related to those services. 5 The PhRMA Code states that resorts are not appropriate venues for such meetings. 5 Participation in speaker programs is a form of consultancy and is the subject of specific provisions of the PhRMA Code. 5 Some organizations have concluded that, in general, payment of expenses for speaker training sessions is not appropriate. 16 Health systems should not permit pharmacists to participate in company-sponsored speaker programs. Pharmacists who serve as consultants or advisors to industry while serving on or advising committees that determine formularies or develop clinical practice guidelines have an obligation to disclose and resolve any potential conflicts of interest between those roles. 17 Clinical Research Pharmacists who participate in practice-based research on pharmaceuticals, devices, or other topics should conduct their activities in accord with basic precepts of accepted scientific methodology. Practice-based drug studies that are, in effect, promotional schemes to increase the use of a product or program are unacceptable. When a company convenes a group to recruit clinical investigators or convenes a group of investigators to discuss their results, pharmacist investigators may accept payment of reasonable travel expenses if these meetings serve a genuine research purpose. Compensation for time and travel expenses to participate in a focus group may be appropriate if the focus group serves a genuine and exclusive research purpose and is not used for promotional purposes. 16 (Here, research does not include marketing research.) In evaluating the propriety of such meetings, pharmacists should consider whether the meeting is to improve research knowledge or to adjust studies to meet a company s marketing agenda. Remuneration for participating in industry-sponsored clinical research and publishing should follow accepted ethical standards. An extensive discussion of these topics is available in the American College of Clinical Pharmacy s position paper on industry relations. 9 Pharmacists should never accept authorship for ghost-written publications.
Draft ASHP Guidelines on Pharmacists Relationships with Industry 7 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 Disclosure To fully inform audiences or users, those in a position to influence CE content should disclose all potential conflicts of interest (e.g., industry-sponsored consultant, speaker, or research funding arrangements). The PhRMA code recommends continuing disclosure for at least two years beyond agreement completion. 5 CE providers are required by accrediting agencies such as ACCME and ACPE to disclose to learners the source of all support from commercial interests. Providers should be able to show that all persons in a position to influence the content have disclosed to the provider all relevant financial relationships with any commercial interests. A mechanism must be in place for identifying and resolving all conflicts of interest in advance of the activity, including the possibility of disqualifying a potential speaker. Mere disclosure does not resolve a conflict of interest. Pharmacists involved in making formulary and medication-use decisions (e.g., members of and presenters to the pharmacy and therapeutics committee) have special obligations regarding conflicts of interest that are detailed in the ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System. 17 In addition, to provide an exemplary environment for learning and model appropriate behaviors, pharmacy residency preceptors and college of pharmacy faculty have an obligation to disclose potential conflicts of interests to their residents and students. Activities of Vendors Representatives ASHP recommends that health-system pharmacies develop specific policies and procedures for the activities of vendors representatives in their facilities. Policies should ensure that pharmacists practice and decision-making are in the best interests of patients and are not inappropriately influenced by industry representatives, as well as to make the best use of healthcare providers time and protect patients privacy. Vendors representatives are defined, for purposes of this document, as agents who promote products and provide information and services to healthcare providers on behalf of manufacturers and suppliers. These guidelines pertain to the activities of vendors who serve and interact with personnel in organized healthcare systems with respect to drug products; drug-related devices; and other equipment, supplies, and services purchased by pharmacies. Each health-system setting should develop its own specific policies and procedures relating to the activities of vendors representatives. The ASHP Guidelines for Selecting Pharmaceutical Manufacturers and Suppliers 18 and setting-specific conflict-of-interest policies may be helpful in the development of vendor relations policies and procedures. The policies and procedures should be developed by the setting s pharmacy and therapeutics committee (or equivalent body) and approved by higher authorities in the setting as required. Depending on the setting, policies and procedures may include the following:
Draft ASHP Guidelines on Pharmacists Relationships with Industry 8 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 1. A defined scope of applicability. The vendors representatives to which any policies and procedures apply should be defined by the individual setting. For example, if the policies and procedures are applicable only to drug-product vendors representatives and not to those promoting medical surgical supplies, packaging equipment, or drug administration devices, this should be clearly stated. 2. Orientation of representatives. In some individual settings, vendors representatives receive an orientation packet upon their initial visit to the setting. Such a packet should contain a copy of the setting s policies and procedures concerning vendors. 3. Directory. In some settings, a file of current vendor contact information is maintained in the pharmacy or other designated department. A form or system for recording such information might include the following: The vendor s name, address, and e-mail and website addresses; The name, address, telephone numbers, answering service number (if any), e- mail address, and drug-product assignment (purview) of each representative; The name, address, telephone number, and e-mail address of the representative s manager; The names, telephone numbers, e-mail addresses, and emergency telephone numbers of the vendor s directors of distribution, sales, and product information (titles may vary); and The names, telephone numbers, and e-mail addresses of the vendor s medical director and research director (titles may vary). 4. Availability of vendor-contact information to professionals in the setting. In some settings, the pharmacy department is permitted to provide professional staff with the information in item 3 upon request. 5. Registration while on premises. Vendors representatives should be required to register with the pharmacy department, other designated department or system upon each visit. At such time, the vendors representatives should document the time and location of their appointments. A dated name badge should be prominently worn along with the representative s current vendor-supplied name tag (if any). 6. Permitted locations. All vendors should be restricted from patient care and pharmacy storage and work areas unless their presence is required for a specific need (e.g., demonstrating equipment). At such times the vendor should be accompanied and not allowed access to patient information or allowed to contact healthcare providers outside the specific identified need. 7. Appointments. Representatives should schedule appointments with appropriate healthcare providers. General access to healthcare facilities (i.e., without a specific appointment) should be prohibited.
Draft ASHP Guidelines on Pharmacists Relationships with Industry 9 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 8. Exhibits. Vendors may be allowed to distribute educational material by arranging for organized, scheduled exhibits. Policies and procedures concerning the times, places, content, and conduct of such events should be established. At no time should these exhibits occur in patient care areas. 9. Dissemination of educational materials. Vendors should provide education only about products that are on the formulary. Direct marketing to students without the presence of a faculty professional should be prohibited. 10. Samples. Every organization should have and enforce policies and procedures with respect to product samples. The use of drug samples within the institution should be eliminated to the extent possible. 19 11. Noncompliance. Policies and procedures should exist to address noncompliance with the policies and procedures by either vendors representatives or professional staff. 12. Research. Each setting should have policies and procedures concerning research to be conducted on its premises. Pharmacists and vendors representatives should clearly differentiate research from sales and promotional activities, applying appropriate policies and procedures accordingly. 20 Manufacturers contracting procedures should clearly separate the awarding of research contracts from the marketing or promotion of their products. 6 Conclusion Relationships between pharmacists and commercial interests are inevitable. Keeping these relationships ethical will benefit patients, pharmacists, and industry. These guidelines outline policies and procedures that should guide pharmacists relationships with industry, but they cannot address every circumstance. Where guidance is lacking, pharmacists should apply their professional judgment regarding any action that might cause or appear to cause a conflict of interest. References 1. Banks D. Pharmacists, pharmaceutical manufacturers, and conflicts of interest. Am J Health-Syst Pharm. 2005; 62:1827-32. 2. Avorn J. Dangerous deception -- hiding the evidence of adverse drug effects. N Engl J Med. 2006; 355:2169-71. 3. Brennan TA, Rothman DJ, Blank L et al. Health industry practices that create conflicts of interest. JAMA. 2006; 295:429-33. 4. PhRMA Code on Interactions with Healthcare Professionals. Washington, DC: Pharmaceutical Research and Manufacturers of America. Revised January 2004. 5. PhRMA Code on Interactions with Healthcare Professionals. Washington, DC: Pharmaceutical Research and Manufacturers of America. Revised January 2008. Available at: http://www.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf (accessed 2017 Aug 1).
Draft ASHP Guidelines on Pharmacists Relationships with Industry 10 6. Department of Health and Human Services Office of the Inspector General. OIG Compliance Program Guidance for Pharmaceutical Manufacturers. https://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf (accessed 2017 Aug 1). 7. Accreditation Council for Continuing Medical Education. Standards for Commercial Support: Standards to Ensure Independence in CME Activities (2004). www.accme.org/requirements/accreditation-requirements-cme-providers/standards-forcommercial-support (accessed 2017 Aug 1). 8. Accreditation Council for Pharmacy Education. ACPE Accreditation Standards for Continuing Pharmacy Education (CPE) Guidelines for Standards for Commercial Support- CPE Standard 5 (2014). https://www.acpe-accredit.org/pdf/guidelines for Standards for Commercial Support.pdf (accessed 2017 Aug 1). 9. American College of Clinical Pharmacy. Pharmacists and Industry: Guidelines for Ethical Interactions. Pharmacotherapy. 2008;28:410 20. 10. Physician Payments Sunshine Act Affordable Care Act Section 6002 Final Rule. Available at: https://www.cms.gov/openpayments/downloads/affordable-care-act-section-6002- Final-Rule.pdf (accessed 2017 Aug 2017). 11. Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies press: 2009. 12. Advanced Medical Technology Association. Code of Ethics on Interactions with Healthcare Professionals. http://advamed.org/res/112/advamed-code-of-ethics-on-interactionswith-health-care-professionals (accessed 1 Aug 2017). 13. Code of ethics for pharmacists. Available at: https://www.ashp.org/- /media/assets/policy-guidelines/docs/endorsed-documents-code-of-ethics-forpharmacists.ashx (accessed 1 Aug 2017). 14. MacDonald M. Ethics and conflicts of interest. http://ethics.ubc.ca/peoplemcdonaldconflict-htm/ (accessed 1 Aug 2017). 15. Perry JE, Cox D, Cox AD. Trust and transparency: patient perceptions of physicians financial relationships with pharmaceutical companies. J Law Med Ethics. 2014 Dec;42(4):475-91. 16. Council on Ethical and Judicial Affairs of the American Medical Association. Guidelines on gifts to physicians from industry: an update. Food Drug Law J. 2001; 56:27-40. 17. American Society of Health-System Pharmacists. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. Am J Health-Syst Pharm. 2008; 65:1272 83. 18. American Society of Hospital Pharmacists. ASHP Guidelines for Selecting Pharmaceutical Manufacturers and Suppliers. Am J Hosp Pharm. 1991; 48:523-4. 19. American Society of Hospital Pharmacists. ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals. Am J Health-Syst Pharm. 2013; 70:1619-30. 20. American Society of Hospital Pharmacists. ASHP Guidelines for Pharmaceutical Research in Organized Healthcare Settings. Am J Hosp Pharm. 1989; 46:129-30.