Download About the progrAm introDuction

WORKSHOP GUIDE
Introduction
About the program
Over 10 billion dollars a year are spent marketing to prescribers1
which has been shown to have a significant influence on prescribing.2
However, many clinicians are not aware of this potential influence
on their own prescribing behaviors.1 Training on pharmaceutical
company – prescriber interactions has been identified as an area
missing in medical education; 90% of physicians surveyed felt
they have received insufficient training about how to interact with
drug company representatives.3 Fortunately educational programs
have been shown to promote more awareness of the impact of
industry marketing on prescribing.4
The Program in Wise Prescribing consists of two 60-minute
workshops to provide education to health care professionals
and students about pharmaceutical marketing. One workshop
is on marketing to prescribers. It includes an actor playing the
role of a drug company representative promoting a product.
This method has been used before and shown to be an effective
method of educating prescribers about marketing to the profession.4 The workshop focuses on the effectiveness of advertising,
salesperson strategies of the representatives, and good sources
of less bias information about treatments. The other workshop
is on direct-to-consumer marketing. It too includes an actor,
this time playing the role of a patient asking for an advertised
medication. This workshop reviews the impact of marketing to
consumers, ways of effectively handling patient requests, and
less bias sources of patient information.
Another marketing strategy that the pharmaceutical industry
invests heavily in is direct-to-consumer advertising. In 2004, over
4 billion dollars were spent advertising medications to consumers –
up from $985 million in 1996.5 This has also been shown to have
a significant impact on prescribing. For example, for every $1000
spent advertising cholesterol-lowering drugs, there were 32
more people diagnosed with hyperlipidemia and 41 cholesterol
lowering prescriptions written.6 One of the concerns raised by
direct-to-consumer advertising is that patients will make requests
for inappropriate medications they saw on television and pressure
clinicians to prescribe these medications. This concern is supported
by research showing that 50% of patients said they would see
another physician or at least be disappointed if they were not
given a prescription for a medication they requested. 7
These workshops are intended to be flexible and work well using
the “lunch and learn” model. For the optimal effectiveness,
between 4 and 20 is the recommended audience size.
Purpose of the DVD and workshop guide
The purpose of this DVD is to provide health educators with the
necessary knowledge and resources to develop and conduct their
own workshops using the Program in Wise Prescribing (PWP)
format. The health educator does not have to be a clinician, but
should have experience running workshops for health care
professionals and students.
The Program in Wise Prescribing is a response to these challenges
by providing prescribers with information about pharmaceutical
marketing. The goal is to raise awareness about the marketing
impact, review marketing strategies, and discuss appropriate
The DVD and workshop guide will complement each other. The
responses, enabling clinicians to make more informed decisions
about how to respond to pharmaceutical marketing they encounter. DVD contains tips on running a successful workshop and video
of actors playing the roles of a pharmaceutical representative
and a patient asking for a medication seen on television. The
DVD also includes an explanation of the marketing practices of
representatives and communication strategies that can be used
with patients. This workshop guide does not duplicate that
information, but instead contains “tips for specific sections.”
This details our step-by-step approach for running each of the
OFFICE OF PRIMARY CARE
workshops, organized by the appendices in the handouts.
1.
2.
3.
4.
5.
6.
7.
Sierles FS, Brodkey AC, Cleary LM, et al. Medical students’ exposure to and attitudes about drug company interactions. JAMA 2005;294:1034-1042.
Chren MM, Landefeld CS, Physicians behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 1994;271:684-689.
McKinney WP, Schiedermayer DL, Lurie N, Simpson DE, Goodman JL, Rich EC. Attitudes of internal medicine faculty and residents towards professional interaction with pharmaceutical sales
representatives. JAMA. 1990;264:1693-1697.
Wilkes MS, Hoffman JR. An innovative approach to educating medical students about pharmaceutical promotion. Acad Med 2001;76:1271-1277.
Donohue JM. Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. NEJM 2007;357:637-81.
Zachry Wmr, Shepherd MD, Hinich MJ, et al. Relationship between direct-to-consumer advertising and physician diagnosing and prescribing. Am J Health Syst Pharm 2002;59:42-9.
Bell RA, Wilkes MA, Kravitz RL. Advertisement-induced prescription drug requests: patients’ anticipated reactions to a physician who refuses. J Fam Pract 1999;48:446-452.
University of Vermont College of Medicine Office of Primary Care www.med.uvm.edu/opc
1
Consumer Marketing Workshop
Checklist:
nDVD
nTV with DVD player or
computer with projector
nHandouts
nFeedback form
nPre-test
PHARMACEUTiCA
l COMPAn
y COnsumer
marketing
A Workshop from the
Program in Wise Presc
The Program in
ribing
Wise
Prescribing is a
initiative funded
University of Vermont
by the Attorney
General Consumer
Grant Program.
appendix 1: neurOn
The
and
tin settlement
on consumer and impact of drug company marketing Prescriber
prescriber behavior
strategies
the proper approach
On May 13, 2004,
is well
Warner-lambert,
for limiting marketing understood. However, into
on inappropriate
a division of Pfizer,
an Assurance of
’s negative impact
and
inc., entered
remains controvers needlessly expensive use of
the Attorneys GeneralVoluntary Compliance/Discontin
medications
uance with
ial. The Program
approach centers
to settle allegations of 50 States and the District
in
of Columbia
on raising awareness Wise Prescribing
effectiveness of
marketing campaignthat Warner-lambert conducted
about the methods
pharmaceutical
an unlawful
and
marketing.
campaign consisted for the drug neurontin1. The
unlawful
of the combinatio
Contact
and illegal promotion
n of misleading
strategies
of neurontin for
Richard G. Pinckney,
off-label uses.
University of VermontMD, MPH
Pharmaceutical
companies seeking
College of Medicine
Office of Primary
medication must
FDA
Care & Area Health
specify the intended approval for a new
1 South Prospect Street,
support claims
Education Centers
use of that product
for
that
(AHEC)
use with research.
and
UHC, Arnold 5
Burlington, VT
not be marketed
The medication
05401
or promoted for
may
Tel:
any other uses
FDA approval.1
(802) 656-2179
While
without
Fax:
off-label use, drug clinicians may prescribe medication further
(802) 656-3016
companies may
s for
E-mail: richard.pin
off-label prescribing
not market drugs
[email protected]
to influence
.
Web: www.med.
uvm.edu/opc
Although Warner-la
Objectives
adjunctive therapy mbert only received FDA approval
in the treatment
for
1. Understand
in patients over
of partial complex
the history of drug
age 12, they promoted
seizures
for a variety of
development and
conditions including:1 off-label use of neurontin
rationale
• Bipolar disorder
for detailing pharmaceu
• Migraines
ticals
• neuropathic
to consumers
pain • First
• AlS
line Rx of seizures
2. Understand
the potential
• ADD
Warner-lambert
advantages and
accomplished this
disadvantages
• detailing by
using multiple
direct-to-consumer
pharmaceutical
strategies:
advertising
representatives
3. Raise awareness
or misleading
including false
statements about
of research
neurontin’s efficacy
evidence on impact
approval for off-label
and FDA
of direct-touses.1
• Hiring influentia
consumer advertising
l doctors as speakers
4. Respond constructiv
exchange for generous
for neurontin
in
ely to
• Organized teleconfer honoraria, stipends, and
patient requests
2
grants.
for medication
s
they have seen
to steer the discussionences using moderators encourage
on advertisements
d
toward off-label
5. Become aware
• influenced
use.2
unrestricted education
of patient resources
for information
sales for off-label
al programs to
on treatment
increase
use.2
• Organized
advisory boards
and consultant
included “hard
meetings that
hitting” educationa
neurontin.2
l sessions promoting
• Withholding
negative studies
from publication 2
• ghost writing
.
review
promoting neurontin articles, and letters to the editor
and
having
2
a professor sign
author.
as the
OFFICE OF
PRIMARY CARE
University of Vermont
College of Medicine
Office of Primary
Care and AHEC
www.med.uvm.edu/op
c
60-minute outline:
10 minutes....................................................Introduction: Appendix 1
10 minutes......................... Effectiveness of marketing: Appendix 2
10 minutes............... Pros and cons of DTC marketing: Appendix 3
20 minutes.............. Strategies for handling requests: Appendix 4
5 minutes....Better sources for consumer information: Handout
5 minutes......................................Closing comments and questions
1
General comments:
Most clinicians really identify with how effective direct-toconsumer marketing is, because patients are asking about the
medications. The challenge of running this workshop is for
clinicians to recognize the valuable role they play in turning
pharmaceutical marketing into an opportunity to discuss
unrecognized patient symptoms/complaints and a range
of treatment options. We tend to generate a lot of audience
participation in the beginning of this workshop, often
abandoning the handouts for long periods of time.
Suggestions specific sections:
Introduction: Appendix 1
If an audience will receive both workshops, we usually do
a straightforward introduction and leave out Appendix 1,
as the material is not as pertinent to consumer marketing.
We then engage the audience by asking, “In 1997 regulations were changed so that pharmaceutical companies can advertise medications through broadcast media. What are some of the changes you have seen in your medical practice as a result of this?”
The effectiveness of marketing: Appendix 2
The key message of this appendix is the effectiveness of directto-consumer marketing.
To enter into this discussion we ask, “What is your sense of how
effective these advertisements are?” We tend to quote the studies
from this appendix to validate what audience members say. The
most common articles we mention are the Donahue study and
the Zachry study, as these really drive home the effectiveness of
the direct-to-consumer advertising.
Pros and cons of direct-to-consumer marketing: Appendix 3
We often ask, “What are some of the advantages and disadvantages of this kind of advertising?” Here are some common points from
audience and the literature.
Pros:
• Patients with undiagnosed problems come in for evaluation
• Stigma of certain diseases lowered, i.e. depression, ED
• Patients more informed of potential treatments
Cons:
• Patients put pressure on clinicians to get meds
(Bell and Mintzes articles)
• Physicians fill most requests (75%) only about half of which
are appropriate
• It takes time to talk to patients about these requests
Strategies for handling requests: Appendix 4
The key message from this
section is that there are ways
we respond to medication
requests that can be very
helpful and enjoyable. We
ask, “What are some of the strategies that have worked best for you in handling patient requests for medications?”
After this discussion we then
introduce the content in
Appendix 4. We mention that
there is no published research
about the best ways to have
conversations with patients
about medication requests.
The sources for our outlined
approaches are adapted from two previously validated methods
that are similar to advertised medication requests – handling
antibiotic requests and motivational interviewing. Since there
is no literature to support their use for handling medication
requests, we often refer to them as “options to consider.”
Better sources for consumer information: Appendix 5
This is a patient handout that clinicians can give patients. It
provides summaries of websites that may serve as an alternative
to commercials for acquiring treatment options.
Post session checklist:
nAnalyze feedback forms – modify workshop delivery
nSend Post-test
nSend a follow-up reminder for Post-test
nAnalysis of post-test findings – modify workshop delivery
University of Vermont College of Medicine Office of Primary Care www.med.uvm.edu/opc
2
Prescriber Marketing Workshop
Pre session checklist:
nDVD
nTV with DVD player or
computer with projector
nHandouts
nFeedback form
nPre-test
PHARMACEUTiCA
l COMPAn
y PresCriber
Marketing
A Workshop from the
Program in Wise Presc
The Program in
ribing
Wise
Prescribing is a
funded by the
University of Vermont
Attorney
Program. The impact General Consumer and Prescriberinitiative aPPendix 1:
neurOntin settleM
of drug company
Grant
consumer and
marketing strategies
ent
prescriber behavior
on
the proper approach
On May 13, 2004,
is well
Warner-lambert,
for limiting marketingunderstood. However,
on inappropriate
into an Assurance
a division of Pfizer,
’s negative impact
and
of
inc., entered
remains controvers needlessly expensive use of
the Attorneys GeneralVoluntary Compliance/Discontin
medications
uance with
ial. The Program
centers on raising
to settle allegations of 50 States and the District
in Wise Prescribing
of Columbia
awareness about
that Warner-la
approach marketing
of pharmaceutical
the methods and
mbert conducted
campaign
effectiveness
marketing.
an unlawful
campaign consisted for the drug neurontin1. The
unlawful
of the combinatio
Contact
and illegal promotion
n of misleading
strategies
of neurontin for
Richard G. Pinckney,
off-label uses.
University of VermontMD, MPH
Pharmaceutical
companies seeking
College of Medicine
Office of Primary
medication must
FDA
Care & Area Health
specify the intended approval for a new
1 South Prospect Street,
support claims
Education Centers
use
of
that
for that use with
product
(AHEC)
UHC, Arnold 5
research. The medication and
Burlington, VT
not be marketed
05401
or promoted for
may
Tel:
any other uses
FDA approval.1
(802) 656-2179
While
without
Fax:
off-label use, drug clinicians may prescribe medication further
(802) 656-3016
companies may
s for
E-mail: richard.pin
off-label prescribing
not market drugs
to influence
.
Web: www.med. [email protected]
uvm.edu/opc
Although Warner-la
Objectives
adjunctive therapy mbert only received FDA approval
in the treatment
for
1. Understand
in patients over
of partial complex
drug developme
age 12, they promoted
seizures
nt
for a variety of
history and the
conditions including:1 off-label use of neurontin
rationale
• Bipolar disorder
for detailing pharmaceu
• Migraines
ticals
• neuropathic
to prescribers
pain • First
• AlS
line Rx of seizures
2. Understand
the potential
• ADD
Warner-lambert
advantages and
accomplished this
disadvantages
• detailing by
using multiple
of industry-prescriber
pharmaceutical
strategies:
representatives
interactions
or misleading
including false
statements about
3. Raise awareness
neurontin’s efficacy
approval for off-label
of research
and FDA
uses.1
• Hiring influentia
evidence on industry-p
l doctors as speakers
rescriber
interactions
exchange for generous
for neurontin
in
4. Recognize and
• Organized teleconfer honoraria, stipends, and
grants.2
respond
appropriately to
to steer the discussionences using moderators encourage
strategies
d
toward off-label
• influenced
used by industry
use.2
unrestricted education
representatives
5. Review less
sales for off-label
al programs to
biased resources
increase
use.2
for
• Organized
therapeutic options
advisory boards
and consultant
included “hard
meetings that
hitting” educationa
neurontin.2
l sessions promoting
• Withholding
negative studies
from publication 2
• ghost writing
.
review
promoting neurontin articles, and letters to the editor
and
having
a professor sign
author.2
as the
OFFICE OF
PRIMARY CARE
University of Vermont
College of Medicine
Office of Primary
Care and AHEC
60-minute outline:
10 minutes....................................................Introduction: Appendix 1
5 minutes............................ FDA approval process : Appendix 2
20 minutes..............................Marketing influence: Appendix 3
15 minutes.......... Drug rep salesperson strategies: Appendix 4
5 minutes..... Sources of prescribing information: Appendix 5
5 minutes.............................. Closing comments and questions
www.med.uvm.edu/op
c
1
General comments:
We begin with introducing ourselves and by stating that this is a
controversial topic. Our role is to generate discussion and review the
research on marketing influence. Our goal is to raise awareness rather
than tell people what to do. The workshop can serve as a catalyst for
future practice-wide discussion and review.
Suggestions for specific sections:
Introduction: Appendix 1
Appendix 1 is a summary of the Neurontin settlement. We think
it is important for the audience to be aware of some of the tactics
of pharmaceutical companies but going through this section in
too much detail can turn into a lecture and be a negative
way of starting out the workshop. We usually pick several
items from this page that we think are useful for the group. We
mention the settlement, how companies cannot advertise for
off-label uses, and several of the marketing strategies. By far the
strategy that has the most impact on audiences is ghost writing.
FDA Approval process: Appendix 2
We provide just a brief presentation of the steps a company
has to go through to bring a drug to market. A common question
that is asked is how much money is spent on research and
development compared to marketing. The answer is they
spend almost twice as much money on marketing compared
to research and development.8
Marketing influence: Appendix 3
The key message of this section is that marketing is effective,
many clinicians are probably in denial about this, and that a
significant number of patients think that it is not appropriate
for clinicians to receive gifts from pharmaceutical companies.
Since the clinicians that would benefit from this message the
most, may in fact be in denial, the information must be introduced
carefully. For this appendix we generate conversation by asking the
following questions:
Do you think marketing to clinicians is effective at changing prescribing?
How about pens, do you think that they are effective?
What is your sense of patient impressions about accepting gifts and food?
After each of these questions we facilitate a discussion and mention
literature from the appendix supporting audience comments.
Drug rep salesperson strategies: Appendix 4
The key message from this
appendix is that pharmaceutical
representatives use a variety
of communication skills that
can influence your use of their
medication. The DVD has video
clips of a pharmaceutical
representative sales pitch to
play for your audience. The
DVD also contains analysis for
you to become more familiar
with these methods.
Sources of prescribing
information: Appendix 5
The key message of this appendix
is that information sources
about medications vary
considerably and clinicians should be critical in their selection of
prescribing information. We often ask people for some of their
favorite sources of less bias information. This chart contains a list
of resources that we systematically reviewed for the potential that
bias could affect their information. Cochrane would be considered
a gold standard since all authors follow a protocol for collecting
studies and how to assimilate the findings. Review articles would
be considered high risk for bias since there is usually no protocol
for what articles are cited or how the information is to be
reviewed and authors may not have written the article at all,
i.e. it could be ghost written.
Post session checklist:
nAnalyze feedback forms – modify workshop delivery
nSend Post-test
nSend a follow-up reminder for Post-test
nAnalysis of post-test findings – modify workshop delivery
8. Gagnon MA, Lexchin J (2008) The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Med 5(1): e1 doi:10.1371/journal.pmed.0050001
University of Vermont College of Medicine Office of Primary Care www.med.uvm.edu/opc
3