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The overall goal of this program will be to improve advance practice nurse (APN) awareness of drug
development and pharmaceutical marketing practices and to positively impact prescribing behaviors as a
1) Objectives :
2. To increase APNs knowledge and awareness of FDA drug approval, monitoring, and processes
3. To increase APN awareness and knowledge concerning the impact of pharmaceutical marketing
on prescribing behaviors
APNs
* Advanced practice nurse (APN) will be defined for the purposes of this grant as any advanced practice
nurse that holds, by virtue of state practice acts, authority to prescribe medications, i.e. nurse practitioners,
nurse-midwives and psychiatric nurse clinicians/nurse practitioners
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The process, extent and effect of pharmaceutical marketing that is directed to physician
prescribers has been extensively documented in the medical literature (Avorn & Solomon, 2000; Chew et
al., 2000; Goodman, 2001; Wazana, 2000). Overall, all of these studies describe the impact that
While there has been extensive empirical data reported on the effect that pharmaceutical marketing has
on physician prescribing behavior, there has been an almost virtual paucity of empirical data on APN
prescribing behaviors in relation to pharmaceutical marketing. Several authors have discussed the ethical
implications of pharmaceutical marketing activities as it relates to APNs (Stokamer, 2003; Crigger, 2005;
Kessenich, 2000). However, there have been only two empirical studies that have documented influence
inappropriate use of highly marketed antibiotics (broad-spectrum) by nurse practitioners (Ladd, 2005). This
dearth of data in the context of APN prescribing is striking considering that, in 2005, there are an estimated
115,000 practicing nurse practitioners (which is comparable to the total number of family physicians) and
there will be an estimated 190,000 advanced practice nurse prescribers by the year 2015 (Cooper, 2001).
In summary, advanced practice nurses have heretofore been operating in the sidelines or “under the
radar” as they relate to programs that are focused on reducing non-scientific prescribing and awareness of
pharmaceutical marketing techniques. Therefore, the purpose of this program will be to present and
evaluate an online educational program to a national audience of APN prescribers and students that will
detail the extent and effect that pharmaceutical marketing may have on APN prescribing behaviors.
Moreover, it’s intent will be to increase nursing prescribers knowledge in order to effect behavioral change
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3) Methods
General Considerations:
On-line education is an innovative and growing method that is used to offer continuing education to
health care professionals (Cobb, 2004). There have been a number of studies that have documented that
web-based technology is a viable and effective option for providing continuing education to post-degree
students (Mills, 2000; Woo & Kimmick, 2000). Moreover, web-based continuing education has been used
successfully to teach complex material and to disseminate evidence-based guidelines (Harris, Salashe, &
Phase I: Development
Development of On-line Continuing Education Curriculum (Objective 1): Using the MGH Institute of
interactive program will be developed in concert with our in-house information technology department and
will be supervised by the Director of Information Technology Denis Stratford. Faculty from the MGH
Institute of Health Professions (nursing, clinical research, information technology and curriculum
development), in consultation with pharmacy professionals from the Massachusetts General Hospital will
develop the on-line curriculum. The curriculum will be based on the MGH Institute of Health Professions’
pedagogical model of evidenced based practice in a multidisciplinary setting. The curriculum expert at our
The format of the program will include four modules that will be enhanced by a multimedia presentation
of on-line video, pod-casts, interactive case studies, downloaded clinical tools, and links to peer-reviewed
literature. The video material will be presented in a documentary format and will include content interviews
with experts and opinion leaders from the fields of medicine, nursing, pharmacology and marketing. The
video documentaries will be presented in a visually appealing format that will include pertinent graphics,
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film and commercial clips (when licensure is available) and will be produced by a professional production
company with prior experience in this field (see Attachment F). In addition to the thirty-minute video
documentary, each of the four modules will include the following components:
• Downloadable clinical tools (check-off lists of questions or “talking points”) to be used when
The content of each module will be supervised by the Program Director, Dr. Ladd and the program
Module 1 (Objective 2) “Why and how are drugs approved?” :Overview of drug research and
In consultation with the pharmacy content expert, as well as input from FDA personnel and other policy
experts, a 30minute video will be produced in a documentary format. Specific content will include
information on drug review and related activities by the FDA and interviews with physicians/policy experts
Module 2 (Objective 3). “There’s no such thing as a free lunch…or dinner”: Overview of
pharmaceutical marketing practices, scientific evidence on the effect of marketing methods on prescribing
behavior (drug samples, free meals, interactions with drug industry representatives, industry sponsored
The thirty-minute documentary will include interviews with physician and nurse prescribers,
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graphics and visuals of the marketing process, sample closets, pharmaceutical gifts, etc. will augment the
content interviews. The development of this module will occur with input from the documentary’s producer,
Ms. Slattery-Moschkau.
Module 3 (Objective 4): “Is this the right thing to do?: Overview, discussion and presentation of
opposing views regarding the ethical dimensions of pharmaceutical marketing and direct-to-consumer
advertising; conflict of interest debate; effect on costs to patients and health care system as a whole.
The thirty-minute documentary will include interviews with an ethicist, policy researchers with experience
and knowledge of direct-to-consumer advertising, advanced practice nurse and physician prescribers, and
pharmaceutical representatives.
Module 4 (Objective 5): “How can I improve my practice?”: Overview of strategies to improve
Based on input from our content experts Dr. Boepple, Dr. Mahoney and Dr. Ladd, the dimensions of
evidence based prescribing will be developed in the video documentary. Interviews with pharmacy, nursing
Staff will promote the Pharmaceutical Practice Program in a variety of venues i.e. national APN
conferences across the country and direct web-links through advanced practice nurse organizations.
Examples of conferences in which conference floor space will be rented to promote the program: American
Academy of Nurse Practitioners, American College of Nurse Practitioners, University of Colorado, Keystone
Conference, American College of Nurse Midwives, National Association of Pediatric Nurse Associates and
Practitioners, National Association of Nurse Practitioners in Women’s Health, American Psychiatric Nurses
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Association, Nurse Practitioner Associates for Continuing Education. Also, ads will be place in major US
APN journals, and Google (and other search-engine) links will be hosted. Additionally, a letter with an
accompanying brochure describing the program will be sent to graduate schools of nursing across the
country. The letter will outline the online Pharmaceutical Practice Program as well as offer the content for
use in their pharmacology education for advanced practice nurses. Free access to the web site will be
reinforced.
Finally, an in-kind monetary incentive of a $50 Amazon gift certificate plus free continuing education
(CE) units will be provided to encourage participation in and completion of the program. Monetary and in-
kind incentives have been shown to yield significantly higher response in survey research (Ulrich et al.,
2005). The MGH Institute of Health Professions Graduate Program in Nursing is accredited as a provider
The on-line Pharmaceutical Practice program will be posted on the MGH Institute of Health Professions
web site when curriculum is completed and sufficient marketing has taken place. The MGH Institute of
Health Professions has an existing structure and process for offering continuing education credits on their
distance learning platform. The existing continuing education template will be adapted by the information
technology department to attract new users and ensure seamless completion and management of pertinent
data. Information technology professionals will monitor the web site on a continuous basis.
Pre and post test measurement (Objective 5): A modified version of Kirkpatrick’s Model of Summative
Evaluation will be the primary measure to evaluate the objectives of this program (Curran & Fleet, 2005;
Kirkpatrick, 1994). This model consists of four levels of evaluation: learner satisfaction (reaction), learning
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outcomes (learning), performance improvement (behavior) and patient/health outcomes (results). The last
level will not be evaluated in this project because of scope and time restrictions, however, it will be
considered for future program and research planning. Learning outcomes will be tested with a four
question multiple-choice format. Attitude/behavior evaluation and learner outcome (learning) questions will
be designed with a Lickert five point scale format. Attitude/behavior questions will be adapted from the
McMaster instrument (Agrawal, Saluja, & Kaczorowski, 2004) which measured attitudes of pharmaceutical
marketing activities before and after an educational program directed at medical residents.
. The goal of the program will be to enroll and receive completed surveys from 500 participants.
Sample size is estimated based on having sufficient power to detect small changes in the primary outcome
measure of knowledge, while having adequate power to address the secondary outcome of behavioral
A pre-test survey will be completed by the participant prior to starting the Pharmacy Education
Program. A post intervention on-line survey will occur immediately upon completion of the program and
again after 8 weeks. The eight-week post intervention survey will contain questions that will evaluate
performance improvement (behavior) measures. After completion of this final survey, an Amazon.com gift
certificate access number will be automatically generated and emailed to participants. Continuing education
Data analysis: Mean scores for Learner Satisfaction measures and performance improvement questions
(Lickert scale) will be calculated. For sets of Likert-scale questions, differences before and after intervention
will be tested using multivariate analysis of variance. For analysis of single items, paired t-tests will be
done and considered significant at a level p < .05. Univariate statistics will be used to analyze learning
outcomes questions.
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Upon completion of the program and loss of funding, it will be the goal of the MGH Institute to continue
and modify the web-based program so that it can be targeted to a wider audience of prescribers. For a
nominal fee to process CE and CME credits, the program could easily be offered to medical student and
physician prescriber audiences. It is the intent of the MGH Institute of Health Professions to maintain the
program in the public domain and it will remain on our distance learning platform for use by both nurse and
a) Potential Barrier: High intensity drug company marketing directed to advance practice nurses.
all 50 states and are an import and growing force of prescribers of medications (Kaplan & Brown, 2004).
APNs frequently attend drug company sponsored events to obtain free CE credits, encounter
pharmaceutical representatives in their practice settings, and receive free gifts and other embossed items.
Strategy: As noted above, in order to compete with pharmaceutical company incentives for time and
attention, monetary incentives will be used to encourage APNs to participate in the program. Also,
participants will be offered free CE units in accordance to the hours that are completed. Participants,
however, will not be included in the final data analysis if they have not completed the eight-week post
program survey.
Rationale: While the World Wide Web is ubiquitous in today’s heath care environment, some
learners may not feel sufficiently skilled in the use of computer and web-based technology (Curran-Smith &
Best, 2004).
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Strategy: Instructional design considerations will be based on the MGH Institutes successful online
education program. In house information technology experts will be involved in the design and integration
of the interactive and multimedia components of the program. Hundreds of new students each year are
helped to use computer based learning programs at our institution and support will be available 24 hours a
day, seven days a week. Overall, consideration will be taken for the wide range of demographics and
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The dissemination of the educational program will be implemented with the consultation and support of
the National Organization of Nurse Practitioner Faculties (NONPF). NONPF is the only national nursing
organization that develops competencies, curriculum guidelines, and program standards to promote quality
educational preparation of nurse practitioners. They have significant content expertise within the
organization relative to NP related curriculum, and have a broad network of collaborative relationships with
nursing and other health care organizations. In general, NONPF is considered by many in the field to be on
the forefront of the “diffusion of innovation” in terms of advance practice nursing education and practice
trends.
NONPF proposes to provide three types of services within the consultative relationship of the program.
1. Direct Consultation: NONPF will identify content and technical experts to provide review of the
modules and other materials that are developed through the program and will provide feedback on
2. Dissemination: NONPF will provide services related to dissemination which may include links on
their website to direct academic faculty across the country to the Web-based program, e-bulletin
announcements of the release of modules and articles in the organization’s newsletter. They will
continue to provide dissemination support after the grant period has ended. Additional
dissemination strategies will be discussed during the two year grant period.
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3. National Conference or symposium: NONPF will organize and sponsor a pre-conference session,
symposium or workshop on the dimensions of non-evidence based prescribing i.e. the potential
considerations.
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5) Timeline
MONTHS
2006/2007 2007/2008
Sept Dec Mar June Sept. Dec. March June Aug/Sept
Activity 1 3 6 9 12 15 18 21 24
PHASE I:
DEVELOPMENT
(Hire staff,
instrument &
curriculum
development)
PHASE II:
MARKETING
(dissemination,
promotion)
PHASE III:
IMPLEMENTATION
(enrollment,
collect data)
PHASE IV:
EVALUATION
(analyze data, present findings,
write final report)
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6) Bibliography/References
Agrawal, S., Saluja, I, & Kaczorowki, J. (2004). A prospective before and after trial of an educational
intervention about pharmaceutical marketing. Academic Medicine, 79, 1046-1051.
Avorn, J. & Solomon, D. (2000). Cultural and economic factors that (mis)shape antibiotic use: the
non-pharmacologic basis of therapeutics. Annals of Internal Medicine, 133 (2), 128-135.
Blunt, E. (2005). Do Pharma perks sway patient care? Holistic Nursing Practice, 19, 242.
Chew, L., O’Yeong, T., Hazlet, T., Bradley, K., Maynard, C. & Lessler, D. (2000). A physician
survey of the effect of drug sample availability on physician’s behavior. Journal of General
Internal Medicine, 15, 478 – 483.
Cobb, S. (2004). Internet continuing education for health care professionals: an integrative review.
Journal of Continuing Education in the Health Professions, 24, 171-80.
Cooper, R. (2001). Health care workforce for the twenty-first century: the impact of
non-physician clinicians. Annual Review of Medicine, 52, 51-61.
Curran, V. & Fleet, L. (2005). A review of evaluation outcomes of web-based continuing medical
education. Medical Education, 39, 561-67.
Curran-Smith, J. & Best, S. (2004). An experience with an online learning environment to support a
change in practice in an emergency department. Computers and Informatics in Nursing, 22,
107-110.
Harris, J., Salashce, S., & Harris, R. (2001). Can internet-based continuing medical education
improve physicians’skin cancer knowledge and skills? Journal of General Internal Medicine, 16,
50-61.
Kaplan, L. & Brown, M. (2004). Prescriptive authority and barriers to NP practice. Nurse
Practitioner, 29, 28 -35.
Kessenich, C. (2000). The garden of good and evil: pharmaceutical companies and the
perspective practices of PNPs. Journal of Pediatric Health Care, 14, 324-326.
Kirkpatrick, D. (1994). Evaluating Training Programs: The Four Levels. San Francisco:
Berrett-Koehler.
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LaBresh, K., Gliklich, R., Liljestrand, J., Peto, R., & Ellrodt, A. (2003). Using “get with the
Guidelines” to improve cardiovascular secondary prevention. Joint Commission Journal
On Quality and Safety, 29, 539-50.
Ladd, E. (2005). The use of antibiotics for viral upper respiratory tract infections: an
analysis of nurse practitioner and physician prescribing practices in ambulatory care: 1997-2001.
Journal of the American Academy of Nurse Practitioners, 17, 416-424.
Mills, A. (2000). Creating web-based, multimedia and interactive courses for distance learning.
Computers in Nursing, 3, 125-131.
Ulrich, C., Danis, M., Koziol, D., Garrett-Mayer, E., Hubbard, R., & Grady, C. (2005). Does it pay to
pay? A randomized trial of prepaid financial incentives and lottery incentives in surveys of
nonpysician healthcare professionals. Nursing Research, 54, 178-83.
Wazana, A. (2000). Physicians and the pharmaceutical industry: is a gift ever just a gift?
Journal of the American Medical Association, 283, 373 – 376.
Woo, M. & Kimmick, L. (2000). Comparison of internet versus lecture instructional methods for
teaching nursing research. Journal of Nursing Research, 3, 132-139.
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