Case - University of Massachusetts Medical School

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Transcript Case - University of Massachusetts Medical School

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The contents
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accurate
at the
time of publication.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
1. I sometimes feel manipulated by pharmaceutical representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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2. I usually feel that I am in control when interacting with pharmaceutical
representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
3. I wish I could be more assertive in my dealings with pharmaceutical
representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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4. I know how to get the information that I need from a pharmaceutical
representative.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hello Dr. Smith, I’m Constance Ramos with GBU Pharmaceuticals. I’d
like to talk with you for a couple of minutes about our new therapeutic agent
GUDAZNU, if you could spare the time. I know that your patient population would
benefit tremendously from this treatment.”
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5. How might you respond to this pharm rep? Please enter your answer below.
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hi Dr. Smith, Constance Ramos from GBU Pharmaceuticals. I’ve just
come from your spine clinic where I was talking with Dr. Bakki about GUDAZNU
for pain control. He is recommending it for many of his patients. I wonder if you
have a minute to talk with me about how it might help in your own practice?”
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6. How might you respond to this pharm rep? Please enter your answer below.
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UMASS MEDICAL SCHOOL
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Provider – Pharmaceutical
Representative (PR) Communication
Objectives
• Understand why prescribers need to
manage pharmaceutical rep interactions
• Identify challenging elements in these
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interactions
• Empower prescribers to control these
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interactions
• Use the 5-minute pharmaceutical
representative interaction model
UMASS MEDICAL SCHOOL
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Provider-Pharm Rep Interaction
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Does
sound
familiar
to style
you?
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title
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Perceived influence of pharm
reps on prescribing practices
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Steinman MA, et al. Am J Med. 2001;110(7):551-557.
UMASS MEDICAL SCHOOL
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Percent of respondents who agreed the following
gifts were inappropriate
80
Percent of respondents
70
60
50
40
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Patients
Physicians
30
20
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10
0
Trip
Dinner
Lunch
Mug
Drug
Sample
Large
Text
Pen
Gibbons RV, et al. J Gen Intern Med. 1998;13(3):151-154.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Do you think accepting gifts might
influence your patient relationships?
(Please enter your answer below)
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
How about
circumstance?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Provider-Pharm Rep Interaction
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Does offering CME credit change this?
(Please enter your answer below)
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UMASS MEDICAL SCHOOL
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Percent of respondents who agreed the following
gifts were influential
Percent of respondents
60
50
40
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Patients
Physicians
30
20
10
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0
Trip
Dinner
Lunch
Mug
Drug
Sample
Large
Text
Pen
Gibbons RV, et al. J Gen Intern Med. 1998;13(3):151-154.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Making the CA$E for Drug
Company Dependence
• Have you ever prescribed a Cox-2 inhibitor?
• Do you get Annoyed by people who complain
about
lunches
& freeMaster
gifts?
If you
answered
yes to title
1 or more
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style
• Have
you feltquestions,
guilty about receiving
$ from
of these
you may
want
pharmaceutical
companies?
Lunches
or
to
reconsider
your
practice!
ClickGifts?
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dinners?
• Do you drink your morning Eye-opener -- coffee
-- out of a pharmaceutical company ‘branded’
mug?
Adapted from: No Free Lunch. Available at: www.nofreelunch.org
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Job Training
“While it’s the doctors’ job to treat patients
“…change
prescribing
habitsit’s
of my job
and not tothe
justify
their actions,
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physicians.”
to constantly sway the doctors.
It’s a job
-James Reidy
I’m paid and trained to do. Doctors are
neither
trained
paid to
negotiate.“
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-Shahram Ahari
Fugh-Berman A, et al. PLoS Med. 2007;4(4):e150.
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Focus group data
“They stopped allowing reps in my office and this one
had information for me, so I told her she could join me
for a run. She went not only the extra mile, but an
extra 2 miles and talked to me about the product the
whole way. That was really helpful. You bet I still see
her any time she wants to see me.”
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“Sometimes
we don’t even
talk about
drugs, we just
chat about the kids and it’s good to have a relaxed
and friendly lunch.”
“I must
admit that for
all the years
that I have been
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prescribing drugs and practicing, I have always been
conflicted about that, especially when I look at the drug
sample closet and some of the perks that some of the
physicians get, I admit to being conflicted about that
aspect of marketing.”
Fischer MA, et al. Unpublished data; Manuscript in submission.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
5 Minute Pharm Rep Interaction
1. Take Control
2. Learn the Indications
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3. Determine the Clinical Benefits and Safety
4. Compare
toedit
Other
Medications
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5. Consider Patient and Company Factors
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Take Control
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Policy Details
• If you decide to allow pharm rep visits
– What is the specific reason?
– Will they have free access or scheduled
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appointments?
– Can they bring food? Samples?
– What
areas
of the
clinic can
they visit?
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– Can they bring gifts and give-aways for staff
or patients?
– What about off-site CME or CEU programs?
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
1. Take Control
• Determine your own level of comfort with this
power
toown
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style
• Click
Know your
personal
bias and
preference
• Be clear about how much time you have to
spend
andto
where
will meet
withstyle
the pharm
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edit you
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subtitle
reps
UMASS MEDICAL SCHOOL
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Learn the Indications
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2. Learn the Indications
• What is the approved indication for this
medication?
• Which
patient
population
it
Clickspecific
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title will
style
benefit?
• Does this medication fit an otherwise
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unmet
need?
• When does the patent expire? Or is there
a generic available?
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Determine the Clinical Benefits
and Safety
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
3. Determine the Clinical Benefits
and Safety
• What are the specific clinical benefits?
• IsClick
there any
primary
data?
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title style
• What are the most serious side effects?
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• Which
aretothe
most
problematic
for
patients?
• Are there any ongoing phase 4 trials?
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Compare to Other Medications
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4. Compare to Other Medications
• What differentiates your product from its
competitors?
• How does it compare to other medications with
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respect
–
–
–
–
Efficacy?
Contraindications?
Side
effects?
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Cost and formulary coverage?
style
• Are there any head-to-head trials of your
medication and the gold standard?
UMASS MEDICAL SCHOOL
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Consider Patient and Company
Factors
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
5. Consider Patient and Company
Factors
• Does your company have an indigent patient
program? How does a patient apply?
• Does your company provide CME programs?
•
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Has your company ever been cited by the FDA
for off label marketing?
• WhatClick
percentage
your company’s
revenue is
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spent on researching new molecules?
• To understand why this is important please see
our module on the pharmaceutical development
cycle
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Which of these skills do you think
would be most helpful?
(Please enter your answer below)
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Key Points
• Pharm reps are trained and paid to impact
prescribing
• Prescribers
the Master
power in pharm
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interactions
• Personal and organizational policies may help
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• Controlling interactions and using specific
questions may improve appropriate prescribing
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Key Points
– 5 Minute Pharm Rep Interaction
• Take Control
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• Learn the Indications
• Determine the Clinical Benefits and Safety
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• Compare to Other Medications
• Consider Patient and Company Factors
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Recommendations
Help to develop or reinforce local policy for
interacting with pharmaceutical reps
Ensure all
of the interactions
meet
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specific objectives
Identify and use independent, reliable
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subtitle
resources
foredit
patient
education
andstyle
continuing
medical education
Practice using the 5-minute PR interaction
model
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
References

Fischer MA, Keough ME, Baril J, Saccocio L, Mazor KM, Ladd E, Von Worley A, Gurwitz J. Attitudes of
prescribers towards pharmaceutical marketing: needs assessment and implications for training and policy.
Unpublished data; Manuscript in submission.

Fugh-Berman A, Ahari S. Following the script: how drug reps make friends and influence doctors. PLoS Med.
2007;4(4):e150.

Gibbons RV, Landry FJ, Blouch DL, Jones DL, Williams FK, Lucey CR, Kroenke K. A comparison of
physicians' and patients' attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998;13(3):151154.

No Free Lunch. Available at: www.nofreelunch.org

Partners HealthCare. Policy on interactions with pharmaceutical and medical device companies. Available at:
http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Device%20Companies.pdf
Accessed August 21, 2008.

Stanford School of Medicine. Policy and guidelines for interactions between the Stanford University School of
Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the pharmaceutical,
biotech, medical device, and hospital and research equipment and supplies industries ("Industry"). Available
at: http://med.stanford.edu/coi/siip/policy.html Accessed August 20, 2008.
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
Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine
housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110(7):551-557.

UMass Memorial Medical Center. Policy Manual. # 1143 Policy on Vendor Relationships. Effective Date:
7/1/2008. Available at:
http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Policy%20on%20Vendor%20Re
lationships.pdf Accessed August 18, 2008.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Resources
•
•
Consumer Reports Best Buy Drugs
http://www.consumerreports.org/health/best-buy-drugs/index.htm
•
•
Journal Watch
http://www.jwatch.org/
•
•
Medical Letter
http://www.medicalletter.org/
•
•
Medline (through the U.S. National Library of Medicine)
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed
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Attorney General Consumer and Prescriber Education Grant Program Initiated Resources
http://www.rxfacts.org/
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•
Brigham & Women's Hospital
•
Georgetown University
http://www.pharmedout.org/
•
MGH Institute of Health Professionals
http://www.perxinfo.org/perx.html
•
University of Kentucky
http://www.cecentral.com/
•
University of North Carolina, Chapel Hill
http://harryguess.unc.edu/
•
University of Massachusetts Medical School/
Meyers Primary Care Institute
http://www.umassmed.edu/meyers/index.aspx
UMASS MEDICAL SCHOOL
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Resources
Institutions with Available Policies
 Partners HealthCare

http://www.partners.org/vendor/Interactions%20w%20Pharm%20and%20Devic
e%20Companies.pdf
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 Stanford School of Medicine

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http://med.stanford.edu/coi/siip/policy.html
 UMass Memorial Health Care

http://www.umassmemorial.org/workfiles/Med%20Center%20PDFs/1143%20Po
licy%20on%20Vendor%20Relationships.pdf
UMASS MEDICAL SCHOOL
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Resources
Policy Checklist
First check to see if your organization or sponsor has a policy for
interacting with PRs. Does it cover all of the necessary features?
What is the specific reason? Will they have free access or scheduled
appointments? Can they bring food? Can they bring samples? What
areas of the clinic can they visit? Can they bring gifts and give-aways
for staff or patients?
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Before implementing a new policy, consider the risks and benefits of
such a policy to both your interactions with PR and patients
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Develop your own personal policy for interactions with PRs (CME, dinner
programs, etc)
If necessary, work with your office team to develop a policy with broad
acceptance (school, hospital, organization, etc)
UMASS MEDICAL SCHOOL
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Resources
Additional Learning Modules in This Series
 Communicating with Patients
 Evidence-Based Medicine (EBM)
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 Organizational Influences on Prescribing
 Pharmaceutical Development and Regulation
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 Pharmaceutical
Marketing
 Links to Web-Access and Downloadable Versions Available at:
http://www.umassmed.edu/meyers/index.aspx
UMASS MEDICAL SCHOOL
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Questions
1. On average, patients believe that drug samples are more likely to influence
prescribing than physicians.
A. True
B. False
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
1. A: False.
Patients and physician responses were about equal according to a study
published in JGIM in 1998, with approximately 22% of patients and 27% of
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physicians feeling drug samples were influential. Both groups felt that trips
or dinners were even more inappropriate.
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
2. Independent online or print resources useful education handouts to support
your communication.
A. True
B. False
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UMASS MEDICAL SCHOOL
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Answer
2. A: True.
These resources should be free of bias from sponsoring
organizations. Please review the resources section at the end of the module
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for suggested unbiased sites.
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Questions
3. Which of the following questions most demonstrates learn the indications?
A. Does your company have an indigent patient program?
B. Are there any head-to-head trials of your medication and the gold
standard?
C. Does this medication fit an otherwise unmet need?
D. What are the most serious side effects of your medication?
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UMASS MEDICAL SCHOOL
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Answer
3. C: Does this medication fit an otherwise unmet need?
This question helps you to understand the best use for a pharmaceutical
agent. You can also ask what the FDA approved indications are. The others
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may also be important to help you take control meetings with pharmaceutical
representatives.
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UMASS MEDICAL SCHOOL
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Questions
4. Which of the following questions most demonstrates determine clinical
benefits and safety?
A. Does your company have an indigent patient program?
B. Are there any head-to-head trials of your medication and the gold
standard?
C. Does this medication fit an otherwise unmet need?
D. What are the most serious side effects of your medication?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
4. D: What are the most serious side effects of your
medication?
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resolve over time.
You may also ask what the most common side effects are or whether they
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
5. Which of the following questions most demonstrates compare to other
medications?
A. Does your company have an indigent patient program?
B. Are there any head-to-head trials of your medication and the gold
standard?
C. Does this medication fit an otherwise unmet need?
D. What are the most serious side effects of your medication?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
5. B: Are there any head-to-head trials of your medication
and the gold standard?
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standard. Please see our EBM module for more information regarding
Recall that many new drugs are compared to placebo rather than gold
pharmaceutical trials.
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UMASS MEDICAL SCHOOL
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Questions
6. Which of the following questions most demonstrates consider patient and
company factors?
A. Does your company have an indigent patient program?
B. Are there any head-to-head trials of your medication and the gold
standard?
C. Does this medication fit an otherwise unmet need?
D. What are the most serious side effects of your medication?
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UMASS MEDICAL SCHOOL
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Answer
6. A: Does your company have an indigent patient
program?
These can be very helpful in facilitating patient use of
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appropriate medications that may otherwise be prohibitively expensive.
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UMASS MEDICAL SCHOOL
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Questions
7. A prescriber can take control of interactions with pharmaceutical
representatives by:
A. Declining to meet with them.
B. Determining specific objectives to meeting with them and ensuring all
interactions support those objectives.
C. Following the 5-minute pharm rep interaction model.
D. Developing or supporting a local policy that limits undue influence of
pharm reps on prescribing.
E. All of the above.
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
7. E: All of the above.
The first step in the 5-minute PHARM REP interaction is Take Control.
Initially you must decide whether or not to allow pharmaceutical
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representative visits at all. If you or your group decide to allow
pharmaceutical representatives to market in your clinic, development of a
specific and consistent policy for yourself and your clinic may help you
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style
succeed in maximizing
and patient
benefit while
minimizing
inappropriate influence. While each of the selections may be helpful, we do
not expect that you will use each of them in every encounter.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hi Dr. Smith, Constance Ramos following up on our discussion last
month about GUDAZNU. Have you had a chance to try it on any patients yet? Can I
leave you a few coupons to help out with the initial prescription for your patients?”
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8. The pharmaceutical representative in this video is offering the provider
coupons to help patients get discounts on her drug. Which response best
demonstrates taking control?
A. Thank you, I am sure that these coupons will be helpful to my patients.
I’m glad to be able to offer them this assistance.
B. Thank you, I’ll be happy to use them with my patients who may have
difficulty affording your drug.
C. No thank you, I don’t accept coupons but you can leave them in the
waiting area for patients to access if you would like.
D. No thank you, since our last visit we have enacted a policy that we will
not meet with pharmaceutical representatives.
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
8. D: No thank you, since our last visit we have enacted a
policy that we will not meet with pharmaceutical
representatives.
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This response clearly shows that you have considered your policy since your
visit with the representative the prior month and have determined you will
take control by not continuing these interactions. The others offer a more
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passive response.
UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
9. In order to help build and maintain their own knowledge regarding
prescribing, providers should become comfortable with independent, reputable
online or print resources.
A. True
B. False
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UMASS MEDICAL SCHOOL
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Answer
9. A: True.
Please see the resources section at the end of each module for lists of
helpful resources.
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
10. One retired pharmaceutical representative described the unofficial job
description of a pharmaceutical representative as “chang[ing] the prescribing
habits of physicians.”
A. True
B. False
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Answer
10. A: True.
It is important for prescribers to understand this goal to help determine
whether they want to participate in meetings with pharmaceutical
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representatives.
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MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hello Dr. Smith, I’m Constance Ramos with GBU Pharmaceuticals. I’d
like to talk with you for a couple of minutes about our new therapeutic agent
GUDAZNU, if you could spare the time. I know that your patient population would
benefit tremendously from this treatment.”
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11. How might you respond to this introduction using the 5-minute pharm rep
interaction technique?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hi Dr. Smith, Constance Ramos from GBU Pharmaceuticals. We’re
hosting a CME dinner for GUDAZNU next week, would you be interested in
attending?”
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12. How might you respond to this pharmaceutical representative using the
principles of the 5-minute pharm rep interaction?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
Pharm Rep: “Hi Dr. Smith, Constance Ramos from GBU Pharmaceuticals. I’ve just
come from your spine clinic where I was talking with Dr. Bakki about GUDAZNU for
pain control. He is recommending it for many of his patients. I wonder if you have a
minute to talk with me about how it might help in your own practice?”
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13. Why do you think this pharmaceutical representative mentions your
colleague in the spine clinic when addressing you about her new drug?
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
14. I sometimes feel manipulated by pharmaceutical representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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15. I usually feel that I am in control when interacting with pharmaceutical
representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
16. I wish I could be more assertive in my dealings with pharmaceutical
representatives.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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17. I know how to get the information that I need from a pharmaceutical
representative.
A. Strongly Agree
B. Agree
C. Disagree
D. Strongly Disagree
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
18. Did completing this module help you to understand why prescribers need
to manage pharmaceutical rep interactions?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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19. Would you recommend this training module to a colleague?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE
Questions
20. Will you do anything differently in your practice as a result of this training
module?
A. Yes, definitely
B. Yes, probably
C. Probably not
D. Definitely not
E. Not sure
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21. Please tell us about any changes you are considering or planning:
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UMASS MEDICAL SCHOOL
MEYERS PRIMARY CARE INSTITUTE