Guidelines for ethical_interactions

Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Key Words: American College of Clinical Pharmacy, ACCP, conflict ofinterest, ethical interactions, industry interactions, professional relationships,gifts, disclosure.(Pharmacotherapy 2008;28(3):410–420)

This position paper is an update to the originalpaper developed by the American College ofClinical Pharmacy (ACCP), Pharmacists and thePharmaceutical Industry—Guidelines for EthicalInteractions, published in 1993.1 The title hasbeen changed to reflect the increased scope of itscontent. In addition to interactions with thepharmaceutical industry, pharmacists routinelyinteract professionally with a variety of vendors,including drug wholesalers, devicemanufacturers, computer hardware and softwaremanufacturers, and other technology entities.Businesses and manufacturers not generallyperceived by pharmacists as being part of theindustrial sector, such as for-profit medicaleducation and communication companies, alsoare included. Because ethical considerations arenot limited to one industry sector, the followingguidelines should be applicable to any situation.

In addition to expanding the guidelines to all

industry sectors, this update recognizes new andrevised federal and organizational guidelines forindustry that address real and perceived ethicalconflicts with health care professionals. Theseguidelines include the Pharmaceutical Researchand Manufacturers of America (PhRMA) Code onInteractions with Healthcare Professionalspublished in 2002,2 the United States Departmentof Health and Human Services Office of InspectorGeneral’s (OIG) Compliance Program Guidancefor Pharmaceutical Manufacturers published in2003,3 the Standards for Commercial Supportfrom the Accreditation Council for ContinuingMedical Education (ACCME) to Ensure theIndependence of CME Activities published in2004,4 and the Accreditation Council onPharmaceutical Education (ACPE) update totheir Criteria for Quality and InterpretiveGuidelines related to commercial support ofcontinuing education activities approved at theend of 2006.5

The ACCP recognizes that certain relationshipsbetween industry and pharmacists are ethicallyappropriate, often beneficial, and unavoidable.The challenge for pharmacists is to ensure thoserelationships remain within acceptableboundaries and to avoid inappropriateinteractions that have the potential to impactnegatively on each of us, as well as our professionand, most important, our patients. As our rolesas pharmacists evolve, we will continue to bechallenged by ethical dilemmas. Pharmacistsshould familiarize themselves with the newguidelines, as well as the position statementsoutlined in this document, to ensure that theyhave a sound decision-making framework whenconfronted with an ethical dilemma.

This document was written by the 2003 ACCP Public andProfessional Affairs Committee: Randy C. Hatton,Pharm.D., FCCP, BCPS, Co-chair; Mary L. Chavez,Pharm.D., Co-chair; Eric Jackson, Pharm.D., BCPS; JulieMaurey, Pharm.D., FCCP, BCPS; Steven L. Barriere,Pharm.D., FCCP; Rachel Couchenour, Pharm.D., BCPS,CDE; Ronald P. Evens, Pharm.D., FCCP; Karen Gunning,Pharm.D. BCPS; Anne L. Hume, Pharm.D., FCCP, BCPS;Lisa C. Hutchison, Pharm.D., M.P.H., BCPS; Gary R.Matzke, Pharm.D., FCP, FCCP; John A. Noviasky, Pharm.D.;Raylene M. Rospond, Pharm.D., FCCP, BCPS; Judy ShepardKelloway, Pharm.D.; James G. Stevenson, Pharm.D.; R. PeteVanderveen, Ph.D., BCPP; Catherine N. Verme-Gibboney,Pharm.D.; Debra Walters, B.S. Approved by the ACCPBoard of Regents on July 25, 2007; final revision received onAugust 3, 2007.

Address reprint requests to the American College ofClinical Pharmacy, 13000 West 87th Street Parkway, Lenexa,KS 66215; e-mail: [email protected]; or download fromhttp://www.accp.com.

PHARMACISTS AND INDUSTRY: GUIDELINES FOR ETHICAL INTERACTIONS ACCP

Guideline 1

As health care professionals responsible formanaging drug therapy, the welfare of patientsshould be the pharmacist’s primary concern in allaspects of pharmacy practice, including interactionswith industry.

Pharmacists should act with honesty andintegrity in all professional relationships to fulfilltheir responsibilities as described in article IV ofthe pharmacists’ code of ethics.6 The culture ofhonesty and integrity is important to the successof the profession of Pharmacy. As a valuedmember of the health care team, pharmacistsshould apply their knowledge, experience, andskills to ensure optimal drug therapy outcomesand thereby improve the quality of life of thepatients they serve. In addition, pharmacistsshould manage products and services in a fiscallyresponsible manner in order to provide cost-effective quality health care.7–9

Guideline 2

Pharmacists should not solicit or accept giftsfrom industry that might influence or appear toinfluence objectivity, independence, or fairness inclinical and professional judgment.

The most contentious issue that sparks discus-sion about the appropriateness of behaviorbetween industry and health care professionals isgifts. Gifts include monetary remuneration, aswell as attendance at social events, hospitality,trips, acceptance of material items, and subsidiesin any form. Many health professionals continueto believe that industry gifts do not influencetheir behavior, despite mounting evidence to thecontrary.10–15 Despite the recent publication ofmultiple guidelines,2–5 numerous articles inmedicine,12, 14, 15, 16–29 nursing,30 dental,31 andpharmacy32, 33 literature continue to documentthe ethical dilemma associated with industry giftsto health care professionals. Individualapproaches and recommendations from theliterature range from complete avoidance nowvoiced by many individuals and organizations,12,

14, 18, 19, 26–28, 34, 35 through a gradient of acceptancebased on factors such as type of gift or cost.20, 36, 37

The ACCP suggests that, when confronted withethical dilemmas regarding gifts, pharmacistsshould exercise sound and practical judgment.The acceptance of gifts that influence or evenappear to influence objectivity, independence, orfairness in clinical and professional judgmentconstitutes a conflict of interest. Gifts that are

not directly beneficial to patient care, education,or research should not be accepted; some arguethat this applies to even small gifts, such as pens,pads, and paper-weights.12, 14, 18, 21, 34 In addition,the following points should be considered beforeaccepting any gift:

• Whenever a gift is offered, ask yourself whatthe purpose of the gift is and does the gifttruly benefit your patients in some manner.Social scientists caution that acceptance of agift, even one of minor value, obligates therecipient to reciprocate in a like manner.13, 14

• The American College of Physicians36

suggests that, as an informal measure of thepropriety of accepting a gift from industry,the following questions be addressed openlyand reasonably: What would my patientsthink about this arrangement? What is thepurpose of the industry offer? What wouldmy colleagues think about this offer?

• Individuals may not appreciate their owninability to assess the potential for conflictsof interest. In a survey of medical residents,61% of respondents described themselves asnot being vulnerable to the influences ofindustry marketing efforts, although only16% had the same high regard for theirpeers.38 Although a similar study has notbeen conducted with pharmacists, there islittle reason to suspect the outcome woulddiffer. Because ethics deals with perception,the risk for underestimating the potential forconflicts of interest is always present.

• Despite physicians’ confidence that industryinteractions have no effect on their behavior,results from numerous studies contradictthat belief. As summarized in a compre-hensive review of the studies evaluating theimpact of industry interaction on physicianbehavior published in 2000, a strongcorrelation does exist between industrybenefits and positive product endorsement,including influences on prescribing practices,formulary choices, and assessment of infor-mation provided by sales representatives.10

Pharmacists would likely espouse similarsentiments.

In 2002, the PhRMA adopted a voluntary codeto guide interactions between member companiesand health care professionals.2 The issue of giftsis pervasive throughout the code and includesthe following guidance specific to gift giving:“No grants, scholarships, subsidies, support,consulting contracts, or educational or practice-

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PHARMACOTHERAPY Volume 28, Number 3, 2008

related items should be provided or offered to ahealth care professional in exchange forprescribing products or for a commitment tocontinue prescribing products. Nothing shouldbe offered or provided in a manner or onconditions that would interfere with theindependence of a health care professional’sprescribing practice.” The following year, theDepartment of Health and Human Services OIGpublished their Compliance Program Guidancefor Pharmaceutical Manufacturers.3 The OIGguidance asserts that gifts, entertainment, andpersonal service compensation “have a highpotential for fraud and abuse and, historically,have generated a substantial number of anti-kickback convictions.” The document thennotes that compliance with the PhRMA code“will substantially reduce the risk of fraud andabuse.” It should be noted that both the PhRMAand OIG guidelines are self-regulatory, with nocomplaints procedure or sanctions for non-compliance outlined when violations areidentified.15, 39 Nonetheless, the pharmaceuticalindustry in general reacted to both sets ofguidelines by implementing new procedures forhealth care professional interactions, includingthe development and implementation ofcompliance programs.15, 39 In addition, severalstates have enacted legislation that mandatesdisclosure of payments made to health careprofessionals by pharmaceutical companies.15, 17, 39

Unfortunately, preliminary inspection of staterecords after legislation was enacted in the statesof Vermont and Minnesota revealed a largenumber of such payments still exceeding the$100 limit.40, 41

Appropriate Gifts (per the PhRMA code)

Gifts of a minimal (< $100) value (e.g., pens,pads, cups, and paperweights) are acceptable,although any potential for undue influence mustalways be considered. Educational materialssuch as slides, patient information guides,monographs, or books are acceptable gifts, aslong as they promote objective and scientificknowledge that will benefit patient care.Although these types of gifts may be acceptableunder the PhRMA code, the pharmacist must becognizant of the potential for lack of completenessor bias in the content of material supplied by thesponsor. The use of these materials must bewithin the full discretion of the pharmacist.

Industry-sponsored activities are consideredgifts and must be no more than modest in scope

(e.g., a meal without entertainment or recreationalevent). Social activities should only be associatedwith continuing education events. Reimbursementof travel, lodging, and dining expenses, and anappropriate honorarium are acceptable for actingas a consultant, expert, or specialist. (A consultant,expert, or specialist has special knowledge,experiences, or functions within a health caresystem or with drug products, diseases, or patientcare that are of significant value to industry toassist with their research, patient care, education,or marketing goals.) Reimbursement and anhonorarium are also acceptable for providing aservice (including a wide range of activities, suchas speaking and moderating educational programs,administrating clinical, pharmacoeconomics, orother research studies, evaluating drug utilizationreviews, and serving on advisory boards, expertpanels, or focus groups) and attending aninvestigator (training) meeting. An educationalgrant may be used to lower the overall registrationfee for all meeting participants.

Inappropriate Gifts (per the PhRMA code)

The temporal relationship of any gift, even ifminimal, to key decision-makers (e.g., thoseinvolved in formulary product decisions),consultants, experts, and specialists is a majorcomponent in determining the potential forundue influence of the gift. Any cash paymentnot associated with provision of a service shouldbe considered an unacceptable gift. Expensivegifts are never appropriate. Invitations to socialevents not associated with educational eventsshould not be accepted. Provision of entertainmentby industry is also not acceptable. Items intendedfor personal benefit (such as floral arrangements,artwork, music CDs, or tickets to a sportingevent) should not be accepted by pharmacists.

Prepaid travel to an industry-sponsoredsymposium and lodging for solely attending sucha symposium are considered expensive gifts andare unacceptable. Pharmacists should not acceptgifts, monetary or otherwise, as reimbursementfor their professional time for solely attendingmeetings. In addition, pharmacists should notaccept the cost of meeting registration. Traveland related expenses to visit a company shouldbe associated with a service being provided;otherwise, they are considered expensive gifts.As a meeting attendee, pharmacists should notaccept donation of money or gifts to a charity inlieu of payment; this should be considered thesame as a direct payment.

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The acceptance of any (even if modest) gift orcompensation, such as research grants, inconjunction with drug purchases is notacceptable. Pharmacists should never accept giftsor any compensation from industry based onclinical practices involving any recommendations(e.g., formulary decisions, product choices forpatients, or dispensing practices). Evenunrestricted educational or research grants givenin close proximity to key decisions or recommen-dations may appear to be undue influence andshould be considered unacceptable.

Guideline 3

Pharmacists should disclose financial,consulting, or other relationships that are orappear to constitute conflicts of interest.Although disclosure is an important tool in themanagement of potential conflicts of interest, itdoes not absolve pharmacists from avoidingsituations in which potential conflicts wouldmake their participation inappropriate.

Pharmacists should recognize the potential forconflicts of interest arising from their financialrelationships with industry. A conflict of interestis a set of conditions in which professionaljudgment concerning a primary interest (e.g.,research or patient welfare) tends to be undulyinfluenced by a secondary interest (e.g., financialgain).42 Disclosures of real, potential, andperceived conflicts of interest are in the bestinterest of patients and thus in the best interest ofpharmacists. In the case of publications andpresentations, disclosure allows the reader orlistener to decide whether or not the real orpotential conflict might influence the content.Conflicts of interest can take a variety of forms,with some more obvious than others. Examplesof such relationships that could be perceived byour patients or colleagues as potential conflicts ofinterest include employment, consultancies,honoraria, stock ownership or options (excludingdiversified mutual funds; sector funds with largeholdings in a few companies could be a problem),expert testimony, grants received, grants pending,patents received, patents pending, royalties, orany other financial relationships of significance,including those that may be held by thepharmacist’s spouse or dependent children.Although the presence of a potential conflict ofinterest “does not necessarily result in anoutcome different than the result would havebeen without a conflict,…the potential fordiffering results is the problem at hand.”9

Pharmacists who have financial or otherpersonal arrangements with industry, whether asspeakers, consultants, or investors, should notcompromise their objective clinical judgment orthe best interests of their patients as a result ofthese arrangements. Pharmacist relationshipswith industry and other entities should betransparent and available for examination by thepublic and members of the profession. Prior toany interactions, pharmacists should make agood-faith effort to evaluate the potential forinfluence and determine which relationships areethically appropriate, and should not enter intorelationships that could affect objectivity indecision-making. For example, pharmacistsinvolved in formulary or drug-purchasingdecisions should not make decisions based onrelationships (e.g., owning stock or havingprevious or ongoing financial support) withindustry. Drug products should be chosen on thebasis of their therapeutic value, potential benefitto patients, and cost.

Disclosure of all interactions with industry is akey component for managing potential conflictsof interest.43 Disclosure is vital to ensure thetrust of the public and the trust of colleagues inpharmacy and other health professions.Pharmacists and other health care professionalsshould comply with disclosure policies establishedby their institution, as well as other relevant thirdparties (e.g., journal editors or professional orinstitutional committees). Pharmacists have theresponsibility to know, understand, and followthe requirements for disclosure associated witheach professional activity undertaken. Disclosureof all relationships with industry should bemandatory when undertaking any activityinvolving decision-making so that colleagues,students, trainees, and patients can evaluate theseactivities for themselves.

Although disclosure is an important tool in themanagement of potential conflicts of interest, itdoes not absolve pharmacists from avoidingsituations in which potential conflicts wouldmake their participation inappropriate.28, 33, 42, 43

For example, disclosure of a relationshipfollowed by a passionate appeal to support aproduct for which the pharmacist has arelationship with the manufacturer is stillinappropriate. Whenever possible, pharmacistsshould recuse themselves from all deliberationsand decisions when these situations arise.

The OIG guidelines identify specific financialarrangements between industry and health careprofessionals that may present a significant

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potential for abuse.3 Specific individuals orentities with special influence are also identified,including purchasers, benefit managers,formulary committee members, and grouppurchasing organizations. The guidelines offerthe following questions to help identifyproblematic arrangements:

• Does the arrangement or practice have thepotential to interfere with, or skew, clinicaldecision-making?

• Does the arrangement or practice have apotential to increase costs to the federalhealth care programs, beneficiaries, orenrollees?

• Does the arrangement or practice have apotential to increase the risk of overutili-zation or inappropriate utilization?

• Does the arrangement or practice raisepatient safety or quality-of-care concerns?

Guideline 4

Pharmacists who make decisions regarding thepurchase, prescribing, or use of drugs or devicesby others through formulary committeedeliberations, clinical practice guidelinedevelopment, or administrative responsibilitiesshould avoid financial, consulting, or otherrelationships with industry that are or appear toconstitute conflicts of interest. Pharmacists mayserve as expert consultants at the request offormulary committees and clinical practiceguideline panels; however, those with industryrelationships should not participate in the finaldeliberations or vote. Furthermore, expertconsultants must disclose all relationships withindustry that might influence or appear toinfluence their objectivity.

Pharmacists may serve on committees, boards,and councils or have administrative responsi-bilities that determine specific drugs or devices tobe purchased, prescribed, preferred, and/orrecommended for use by individuals andorganizations. In these activities, pharmacistsmust be guided by principles of honesty, fairness,and objectivity.

The pharmacist’s role on a formularycommittee, including full voting privileges, isparticularly critical, as decisions made by thecommittee determine which products areavailable within the health care system. Thesedecisions ultimately affect the quality of patientcare by influencing the practices of prescribers,especially physicians in residency training

programs. As noted previously, the OIGguidelines have identified membership on aformulary committee as a position withsignificant potential for abuse.3 A pharmacist isusually responsible for developing the agenda,presenting clinical and economic information,and composing the minutes for the formularycommittees—all of which are activities at risk forinfluence from vendors and the health careindustry.44, 45 Pharmacists must fulfill theseresponsibilities without bias to ensure integrity inthe committee decision-making process.Pharmacists involved with formulary committeesalso should assist with the development of apolicy (if none exists) on disclosing potentialconflicts of interest for committee members toavoid any appearance of impropriety withdeliberations and requiring members to abstainfrom voting when a true conflict of interest existswith the product under discussion, the class ofproducts, or a competitive product.46–48

Pharmacists are also involved in the develop-ment of clinical practice guidelines that addressprevention, prophylaxis, and treatment. Theseguidelines may be institution specific, regional,national, or international in scope. As such, theyguide drug therapy decisions for large numbersof patients and influence the prescribingpractices of many providers. Pharmacists mustmaintain a strong commitment to use evidence-based evaluations in developing drug useguidelines and strive to achieve optimaloutcomes. Once again, disclosure of allrelationships with industry should be mandatoryfor all participants involved in developing thepractice guideline, and the potential conflicts ofinterest should be published as a component ofthe practice guideline.49, 50

This guidance does not prevent clinicalpharmacists with industry relationships fromproviding input into formulary or guidelinedevelopment decisions. As experts in therapeuticsand investigators in clinical studies, includingindustry-sponsored studies, clinical pharmacistsare often requested by formulary committees andpractice guideline development panels to serve asexpert consultants. After providing experttestimony, these individuals should notparticipate in the final decision-making processor vote. Final decisions should be made bycommittee members without any relationshipsthat could be perceived as a conflict of interest.As discussed above, industry relationships for allparticipants that might influence or appear toinfluence their objectivity, including those

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providing expert testimony, should be disclosedduring the deliberations and included in anypublication summarizing the final decisions.

Guideline 5

Pharmacists who are members of an institu-tional review board (IRB) should avoid any real,potential, or perceived conflicts of interest thatcould occur in connection with industry-relatedmatters before the IRB.

Federal regulations have empowered IRBs toreview and then approve, require modifications,or disapprove any human-subject research.51

There are specific federal regulations governingmembership of IRBs.52 The IRB is also requiredto ensure its members do not have conflicts ofinterests that would impair their ability to make afair and reasonable judgment concerning aprotocol under review.

Pharmacists participating as a member of anIRB should assess research protocols, drugtherapy, and patient risk in a fair and unbiasedmanner. Pharmacists, as a result of their clinicalexpertise in pharmacotherapy and involvementin research, often participate in the IRB as chairs,members, or presenters. Conflicts of interest canoccur when an IRB member has a financialinterest or any other professional or personalrelationship with industry that may compromisehis/her independent judgment in safeguardingthe rights and welfare of the research subjects.Conflicts of interest have the potential to directlyaffect the design, execution, interpretation,and/or approval of a study. Conflict of interest byan investigator of a clinical study or member ofan oversight committee can result in regulatoryaction, negative publicity, and lawsuits.53 For thepharmacist member of an IRB, full disclosure tothe chair and/or IRB committee prior to anyaction on a research project is vital. As a result ofthe disclosure, the pharmacist may be required toabstain from voting if he/she or his/herimmediate family members have a financialrelationship with any company sponsoring aproposed study. In addition, if the pharmacisthas access to confidential information, he/shemust adhere to IRB policies and the U.S. Foodand Drug Administration regulations.

Guideline 6

Pharmacists who participate in industry-associated research should only do so if thatresearch meets accepted ethical, regulatory, andscientific standards.

The ACCP white paper, Ethical Issues Relatedto Clinical Pharmacy Research, originallypublished in 1993,54 has recently been revised.55

The discussion below highlights some of theissues addressed in the paper that relate topharmacist-industry interactions.

Pharmacists participate in research on manylevels beginning with hypothesis generationthrough publication of study results.Pharmacists must conduct high-quality clinical,translational, or health-system research accordingto established ethical, regulatory, and scientificstandards to maintain credibility as competentscientific investigators. Pharmacists should notbe involved in research in which the sponsorimposes any obstacle to publication of the studyresults. Research whose primary purpose ispromotion of a drug product or device is notlegitimate and does not hold patient welfare inthe highest regard. As an example, pharmacistsshould not participate in studies for which theprimary purpose is to familiarize prescribers withspecific drug products (i.e., marketing or“seeding” studies).

Disproportionate fees for collection of patientdata in a research study should lead one toevaluate closely the purpose of the study, asexcessive compensation for conducting a studyconstitutes a gift. Payments to patients, subjects,or health professionals participating in studiesshould be reasonable and represent appropriatereimbursement for time and expenses (e.g.,parking, travel). If allowed by the grantingagency, money that remains after all studyexpenses (such as investigator and coordinatorsalaries and overhead) have been paid should berestricted to support research training programs(e.g., residencies, fellowships, graduateprograms), enhance the educational or researchmission of the institution, or improve patientcare directly. Reimbursement of expenses forpharmacists attending clinical investigators’meetings is appropriate; however, study sponsorsshould avoid extravagance when choosing thesetting for a meeting, and expenses should coverthe period of the meeting and the investigatorsonly.

Pharmacists involved in clinical researchshould also follow all pertinent federal and statedisclosure guidelines. The 1995 federalguidelines for disclosure state that “allinvestigators must disclose significant financialinterests that would ‘reasonably’ appear related tothe sponsored research…significant is defined as$10,000 per year in income or 5% equity in a

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company…This applies to the investigator,spouse, and dependent children.”56 Fulldisclosure of financial support for a researchproject should be made at the time of publicationor presentation of study results.57

Most hospitals and other health careinstitutions have ongoing clinical trials, and thepharmacy staff may be involved in providingservices related to the studies. The pharmacistproviding these types of services should ensurethat informed consent has been obtained from allstudy patients and that the study is beingconducted in an ethical manner.

Guideline 7

Pharmacists should only participate as authorsfor publications that meet accepted ethical,regulatory, and scientific standards. In addition,pharmacists who serve as peer reviewers shoulddisclose any conflicts of interest and/or recusethemselves from reviewing a manuscript forwhich they have a relationship with a sponsor orcompetitor of the sponsor.

Publication of research results, editorials, andreview articles is an important component of anacademic or research pharmacist’s professionallife. Collaboration with industry may benecessary in these writing endeavors. Guidelinesfor author responsibilities when submitting anarticle linked to industry are available from theInternational Committee of Medical JournalEditors.58 The guidelines address ethicalconsiderations in the conduct and reporting ofresearch and include such topics as definingauthorship, editorial freedom, peer review,conflicts of interest, and privacy and confiden-tiality. An ad hoc industry group also drafted apublication guideline, Good Publication PracticeGuidelines for Pharmaceutical Companies,designed to establish standards for thepublication of industry-sponsored trials.59 Thisguide addresses publication standards, relation-ships between the company and externalinvestigators, authorship, and ghost writers.

Pharmacists should understand that if theymeet the criteria to be a study author, they acceptresponsibility for conducting the study, ensuringthat they had full access to all of the data, andactively participated in the decision to publishthe study results.58 When publishing articles inpeer-reviewed pharmacy or medical journals,pharmacists should consider themselves authorsonly if criteria for authorship are met and maytake credit only for work they have done

themselves; taking public credit for workprepared by others (e.g., ghost writers) isunacceptable.58, 59 Pharmacists should requestpeer review of their work prior to publication.

Full disclosure is mandatory whenever phar-macists are paid by industry (e.g., pharmaceuticalcompanies or medical education companies) toprepare articles for publication.57–59 Disclosure ofpotential conflicts of interest is a well-definedcomponent of the International Committee ofMedical Journal Editors’ requirements formanuscripts submitted to biomedical journals,stated as follows: “Public trust in the peer reviewprocess and the credibility of published articlesdepend in part on how well conflict of interest ishandled during writing, peer review, and editorialdecision-making. Conflict of interest exists whenan author (or the author’s institution), reviewer,or editor has financial or personal relationshipsthat inappropriately influence (bias) his or heractions (such relationships are also known asdual commitments, competing interests, orcompeting loyalties). These relationships varyfrom those with negligible potential to those withgreat potential to influence judgment, and not allrelationships represent true conflict of interest.The potential for conflict of interest can existwhether or not an individual believes that therelationship affects his or her scientific judgment.Financial relationships (such as employment,consultancies, stock ownership, honoraria, paidexpert testimony) are the most easily identifiableconflicts of interest and the most likely toundermine the credibility of the journal, theauthors, and of science itself. However, conflictscan occur for other reasons, such as personalrelationships, academic competition, andintellectual passion. All participants in the peerreview and publication process must disclose allrelationships that could be viewed as presenting apotential conflict of interest.”58

This definition serves as the basis for thedisclosure requirements for many majorbiomedical journals. Most pharmacy journalsalso adhere to these requirements, but specificinstructions on disclosure of conflicts of interestare often vague or absent. Journal editorsrecognize that industry ties or involvement donot automatically produce loss of objectivity,60

and that industry connections may provideaccess to data not otherwise available. However,full disclosure of potential conflicts of interestallows the reader to use the information inassessing the merits of any article.

The anonymous nature of the peer review

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process makes it particularly vulnerable to thepossibility of industry-associated conflicts ofinterest. The reviewer could have an ongoingrelationship with the sponsor of the research or acompetitor of the research sponsor, which couldaffect the reviewer’s recommendation to theeditor (positively or negatively). Disclosure ofthese conflicts to the editor is appropriate.58

Declining the invitation to review a manuscriptfor which there is a potential conflict is areasonable option.

Guideline 8

Pharmacists participating in continuingeducation programs or preparing written materialon drug therapy should deliver fair and unbiasedpresentations. Pharmacists should disclose anyapparent or potential conflicts of interest. Thepresentation of continuing education free frombias is in the best interest of health care providersas well as patients.

One of the most common ways in whichindustry now interacts with practicing pharma-cists is through continuing education programs.The interaction can entail the pharmacist asfacilitator, organizer, presenter, and attendee ofthe continuing education program. The revised,voluntary PhRMA code outlines in detailacceptable procedures for industry support ofcontinuing education activities that allowindependence for the provider.2 The OIGguidelines state that companies face little risk ofnoncompliance if the recommendations providedby the PhRMA code are followed.3 More recently,the ACCME updated their guidance to enhanceand protect the independence and integrity ofCME activities.4 At its October 2006 boardmeeting, the ACPE approved an update to theirCriteria for Quality and Interpretive Guidelinesrelated to commercial support of continuingeducation activities.5 Providers have beenevaluated using the updated ACPE guidelinessince January 1, 2008. All of the revised andupdated guidelines provide consistent recom-mendations for industry, including for-profitmedical education and communicationcompanies, continuing education sponsors,speakers, and participants, which are reflected inthe discussion below.

The ACPE defines continuing education for theprofession of Pharmacy as “a structurededucational activity designed or intended tosupport the continuing development ofpharmacists and/or pharmacy technicians to

maintain and enhance their competence.Continuing pharmacy education should promoteproblem-solving and critical thinking and beapplicable to the practice of pharmacy.”61 Theeducational value of the continuing educationconference or activity must be the primaryconsideration in the pharmacist’s decision toattend or participate. Pharmacists choosingamong continuing education activities shouldassess their educational value and select onlythose activities that are of high quality, conductedby qualified faculty, and appropriate for thepharmacist’s professional needs. Althoughamenities unrelated to the educational purpose ofthe activity may play a role in the pharmacist’sdecision to participate, this should be consideredsecondarily. Pharmacists should claim creditcommensurate only with the actual time spentattending a continuing education activity or instudying the continuing education material.

Pharmacists who participate in industry-sponsored speakers’ bureau activities (e.g., acceptsupport and expenses for attendance at speakertraining or similar educational programsregarding specific statements about the industryproduct) should disclose this information in allof their activities relating to continuingeducation. In addition, any other conflicts ofinterest or biases, such as financial connection toa particular commercial firm or product, shouldbe disclosed by faculty members to the activity’ssponsor and to the audience. It is important tonote that the updated ACCME and ACPEstandards state that simple disclosure of potentialconflicts of interest by providers, speakers, andauthors of written materials is no longersufficient. In addition to the requirement that allrelevant financial relationships within the past 12months be revealed, conflicts of interest must beresolved before the continuing education activitybegins. The provider must be able to show thatall individuals involved in the educationalactivity disclosed all relevant financialrelationships with any commercial interest to theprovider. Any individual who refuses to discloserelevant financial relationships will bedisqualified from involvement with CMEactivities. Also of note, the ACCME and ACPEstandards define financial relationship as “asalary, royalty, intellectual property rights,consulting fee, honoraria, ownership interests, orother financial benefit.”4, 61 No minimum dollaramount is established in the updated standardsbecause the council has determined that“inherent in any amount is the incentive to

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maintain or increase the value of the relationship.”4

Pharmacists serving as presenters, moderators,or other faculty at an accredited ACPE or CMEprogram, or any other health professionalconference, should ensure that research findingsand therapeutic recommendations are based onscientifically accurate, up-to-date informationand are presented in a fair, balanced, andunbiased manner. The program developmentand execution should be consistent withguidelines outlined for ACPE or CME programs.It is the responsibility of sponsors, providers, andfaculty members to ensure that the guidelines aremet. Representatives of industry or otherfinancial contributors should not exert controlover the choice of moderators, presenters, orother faculty, or otherwise modify the content offaculty presentations. Funds from industry insupport of an ACPE or CME activity may beaccepted as long as the program provider controlsthe distribution of funds and the sponsor doesnot profit unfairly or charge a fee that is excessivefor the content and length of the program.

Faculty may accept reasonable honoraria andreimbursement for expenses. Receipt of paymentdisproportionate to the amount of effort and timerequired may be considered a gift and should beavoided. Pharmacists who are routinely invitedto speak or prepare written materials on behalf ofindustry may want to question their personalmotives and the motives of the sponsors whofund their work. A subtle bias may be occurring.If the presenter or writer does not deliver thecorrect message, he or she will not be asked againto perform sponsored work. Also, is theinvitation to give a presentation simply a meansfor providing a gift? This may be an issue toconsider if multiple presentations are given thatresult in considerable income.

Nonfaculty or nonauthor participants of acontinuing pharmacy education activity shouldnot accept reimbursement for travel, lodging,honoraria, or personal expenses. Pharmacistsshould be wary of the liberal use of the terms“consultation” as a means of providing a gift oftravel and lodging for a meeting and “consultingfee” as a means of providing a gift for attending asymposium at a meeting.

Guideline 9

Colleges of Pharmacy and postgraduatepharmacy training programs should incorporateformal instruction on professional ethics intotheir curricula for pharmacy students, residents,

fellows, graduate students, preceptors, andfaculty. These educational offerings shouldaddress appropriate relationships betweenpharmacists and industry. In addition, trainingprograms should develop guidelines or formalpolicies governing interactions between traineesand representatives of industry.

Interactions between pharmacists and industrybegin in pharmacy school, continue throughtraining programs, and persist throughout apharmacist’s career. Educating pharmacystudents early in the curriculum about theimportance of professional ethics can promoteand enhance their ethical behavior as practicingpharmacists.62 In addition to discrete course-work on pharmacy ethics, ethical issues sur-rounding interactions with industry should bediscussed across the professional degreecurriculum and especially during the advancedpractice experiences under the direction ofpractitioner role models. Moreover, continuingeducation of pharmacists at all stages of profes-sional development on specific issues relating toethical interactions between pharmacists andindustry will facilitate maintenance of highethical standards throughout the profession.

Training programs have unique characteristics,and residents and fellows would benefit frominstruction in professional ethics. Companiestarget training programs because it is moreefficient to approach groups than individuals andbecause faculty and preceptors are viewed asopinion leaders who can shape the behavior offuture pharmacists and pharmacy leaders. Thus,pharmacy training programs should includespecific learning or competency objectives onethical interactions between pharmacists andindustry, especially using discussion formats thatemphasize the subtleties of these interactions.Most important, directors of and preceptors intraining programs should lead by example andconduct their interactions with industryrepresentatives in a principled manner.

Guideline 10

Pharmacists should ensure that patientconfidentiality is maintained for all industryinteractions. The confidentiality of prescriberinformation should also be respected.

The Health Insurance Portability andAccountability Act (HIPAA), enacted in 1996,protects patients’ rights related to privacy andconfidentiality through legislation.63 Protectingpatients’ privacy and confidentiality is not only a

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legal concern, it is an ethical obligation for allhealth care professionals involved in patient care.Pharmacists must ensure that patient privacy andconfidentiality are maintained during anyinteraction with an industry representative,including representatives from the marketing,sales, or clinical research arms of the company.For example, meetings with industry represen-tatives should not be held in patient care areas,and patient information should be protected fromviewing. In addition, no patient informationshould be shared outside of a bona fiderelationship with industry representatives (e.g.,the medical division of a company involved in aresearch project or a technology companyinvolved in the implementation of a technologythat requires the industry representative to viewactual patient data). An industry representativewho observes ill patients just by being in apatient care area may be violating that patient’sprivacy because that industry representative isnow aware of that patient’s illness, which he orshe had no legitimate professional “need toknow.”

Pharmacists should not provide informationabout individual prescribers who order orprescribe particular products to any companythat will use it for commercial purposes (e.g.,sales or marketing), including vendors thatspecialize in collecting this type of data.64

Acknowledgment

The committee wishes to thank Nicola Dahl,Pharm.D., for her editorial assistance in preparing thefinal manuscript.

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