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DIRECT-TO-CONSUMER DRUG PROMOTION:
PATIENT ATTITUDES AND BEHAVIORS REGARDING
DRUG ADVERTISEMENTS
By
Jeffrey R. Larson, RN, BSN
Submitted in Partial Fulfillment of the Requirements for
The Master of Science in Nursing Degree
Edinboro University of Pennsylvania
Approved by:
Judith Schilling, CRNP, PhD fl
Committee Chairperson
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^t^eTyeisel, PhD, RN
Committee Member
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D^fcbi^^hD, RN
Committee Member
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Abstract
Direct To Consumer Drug Promotion: Patient Attitudes and Behaviors Regarding
Drug Advertisements
Since the U.S. Food and Drug Administration (FDA) relaxed its restrictions on
broadcast TV advertising of pharmaceutical products in 1997, direct-to-consumer (DTC)
advertising has boomed. DTC drug ads can encourage dialogue between patients and
their health care providers (Morgan and Levy, 1998), which can strengthen the patient
provider bond if the patient gains a sense of participation in his health care (Woodward,
1996). However, these ads can also strain this relationship when the provider does not
prescribe the requested drug (Gelles, 1997). With DTC drug ads having such an impact
on the patient-provider relationship, it is important to understand the patient attitudes and
behaviors that are a result of DTC drug ads. Nurse practitioners are in a position to
educate patients who may have misconceptions resulting from DTC ads.
The purpose of this research is to survey health care consumers in order to
determine their experiences with DTC drug advertisements, any actions they may have
taken as a result of these ads, their attitudes and beliefs regarding DTC drug advertising,
and the influence of DTC drug ads on the patient’s perception of the patient-provider
relationship. Patients in a rural primary care facility in western New York state completed
a self-administered questionnaire. The survey collected demographic information and
investigated the respondents’ attitudes and behaviors associated with DTC
advertisements. A total of 188 questionnaires were returned. Due to attrition, 137
questionnaires were included in the final analysis. Of the sample population (A=137),
90.51% had been exposed to DTC drug ads. Television was cited most frequently
ii
(97.58%) as the source of DTC drug ads. Only 5% of subjects indicated they would not
talk with their health care provider about an ad because of trust issues.
In summary, exposure to DTC drug ads is high, with television and magazines
being the leading sources of these ads. While the study results show no adverse effects on
the patient-provider relationship, the continued rise and evolution of DTC advertising
may have an effect on the patient-provider relationship. This provides nurse practitioners
with an opportunity to educate patients about prescription drugs. Suggestions are offered
for future research of DTC drug advertising.
iii
Acknowledgements
I would like to express my most sincere appreciation to all those people who
helped me complete this research project. Thank you to the entire committee for your
patience with my procrastination. To Dr. Judith Schilling, thank you for being the
chairperson of this committee, and for helping me bring this project to a successfill
completion. To Dr. Janet Geisel, thank you for encouraging me to pursue this research
project, and for your knowledge of the research process. To Dr. Debra Kubinski, thank
you for your many words of encouragement, and for being readily available to discuss
this project as it was evolving. Thank you to Chris Flanders, FNP and the staff at the
Sherman, NY office of Westfield Family Physicians for their assistance and support of
this project. And last, but certainly not least, thank you to my wife Lisa, who I’m sure I
left around here somewhere. You have shown me undying support in my pursuit of this
project. Because of this project, you have spent many hours and days without me and you
must be wondering if you really have a husband. You do. I love you. Once again, thank
you, Lisa, for all you have done throughout this endeavor. This project received partial
support from Nu Theta Chapter of Sigma Theta Tau in May 2001.
iv
Table of Contents
Contents
Page
Abstract ...
i
Acknowledgements
iii
List of Tables
Chapter 1: Introduction
Background of the Problem
,vii
1
1
Direct-to-consumer (DTC) Advertising Boom
1
Effect on Patients
1
Problem Statement
2
Theoretical Framework
.4
Statement of the Purpose
5
Assumptions
6
Limitations
6
Definition of Terms
6
Summary
7
Chapter 2: Review of the Literature
History...
Regulation of DTC Advertising
DTC Spending
DTC Research
The Time, Inc. studies
The Prevention Magazine studies
8
8
10
11
12
12
13
V
Contents
The Food and Drug Administration (FDA) study
Page
14
Effects of DTC Advertising
16
Summary
19
Chapter 3: Methodology
.21
Research Questions
21
Research Design
21
Sample, Setting, and Procedure
22
Instrumentation
22
Protection of Human Rights
Pilot Study
23
Data Analysis
24
Summary
24
Chapter 4: Findings
26
Sample
Results
26
DTC Exposure
Demographics
Perceived Overall Health
30
Perceived Knowledge of Health and Medicines
DTC Sources...
DTC-Related Behaviors
Patient Attitudes...
32
vi
Contents
DTC’s Influence on the Patient-provider Relationship
Summary
Page
38
39
Chapter 5: Discussion
41
DTC Exposure
.41
Demographics
41
Perceived Overall Health Status
42
Perceived Knowledge of Health and Medicines
42
Sources of DTC Advertising
43
Patient Behaviors
.43
Patient Attitudes
44
The Patient-Provider Relationship
.47
Conclusions
.48
Limitations of the Study
.49
Recommendations for Further Study
50
References
51
Appendix A: Policy Statements on Product-Specific Direct-to-Consumer
Advertising of Prescription Drugs
56
Appendix B: Direct-to-Consumer Drug Advertising Survey
59
Appendix C: Additional Data
70
vii
List of Tables
Tables
Page
1: Comparison of Total Sample (A=137) by Gender: DTC Exposure............
.27
2: Comparison of Total Sample by Age: DTC Exposure................................
.28
3: Comparison of Total Sample by Marital Status: DTC Exposure................
.29
4: Comparison of Total Sample by Highest Education Level: DTC Exposure
30
5: Likert Multiple Choice Rating of Perceived Overall Health on the Day the
Survey was Taken and DTC Exposure
31
6: Likert Multiple Choice Rating of Self Perception of Knowledge About Health and
Medicines and DTC Exposure
32
7: Sources of DTC Drug Ads as Reported by Survey Subjects (jV=124)
33
8: Source of Information That Caused Subjects to Ask Their Health Care Provider
.35
About a Prescription Drug (7V=110)
9: Likelihood That Subjects Would Talk to Their Health Care Provider About an Ad
for a Drug That Treats a Condition That is Bothersome to the Subject (AT=112)
36
10: Likert Multiple Choice Rating: I Like Seeing Advertisements for
37
Prescription Drugs (Question 18)......................
11: Satisfaction With Health Care Provider’s Reaction to a Question About a Drug
.40
1
Chapter 1
Introduction
This chapter provides a brief overview of direct-to-consumer (DTC) advertising
of drugs and the related problems. Dorothea Orem’s self-care deficit theory of nursing
(Orem, 2001) supplies the conceptual framework for this research. Her core concepts of
self-care, self-care agency, nursing agency, and nursing systems are employed in the
conceptual framework. The background of the problem, problem statement, purpose of
the study, assumptions, and limitations are also included in this chapter.
Background of the Problem
DTC drug advertising has existed since the early 1980s (Board of Trustees of the
American Medical Association, 1999). It has been a controversial subject since its
inception and its recent growth has elevated the controversy surrounding it.
Direct-to-consumer (DTC) advertising boom. Since the U.S. Food and Drug
Administration (FDA) relaxed its restrictions on broadcast television advertising in 1997,
DTC advertising has boomed and DTC spending has steadily increased (Goetzl, 2000a;
Goetzl, 2000b; Goetzl, 2000c). Goetzl (2000b; 2000c) found that DTC drug advertising
had nearly doubled from $1 billion in 1997 to $1.8 billion in 1999. This steady increase
in DTC drug advertising expenditures suggests that DTC advertising of drugs is effective
(Goetzl, 2000a; Goetzl, 2000b; Goetzl, 2000c; Meyer, 1998).
Effect on patients. Defenders of DTC drug promotion claim that the
advertisements make patients aware of medical problems and potential treatments,
thereby encouraging more patients to seek medical attention from their providers (Allen,
1997; Gelles, 1997; Morgan & Levy, 1998). However, problems can arise when a patient
2
has too much information and not enough ability to interpret that information
appropriately (Borzo, 1997). Such patients may self-diagnose, may believe that a certain
medication is what they need, and may become upset if a clinician does not prescribe the
drug seen in an advertisement (Gelles, 1997). This can lead to undue strain on the patient
provider relationship (Tyler & Cooper, 1997).
Problem Statement
In the United States, DTC advertising of prescription drugs is a multi-million
dollar industry, is having a major impact on the way consumers receive information on
drugs (Morgan & Levy, 1998; Tyler & Cooper, 1998) and, in some cases, impacts how
some health care providers prescribe medicines (Colford, 1997; Gelles, 1997; Sherr &
Hoffmann, 1997; Tanouye, 1997). With so much being spent on DTC drug advertising, it
is easy to see why a great many consumers receive prescription drug information via
DTC advertising (Colford, 1997; Gorov, 1997; Tyler & Cooper, 1997). One of the results
of this mass dissemination of drug information is a higher level of consumer awareness.
With so many patients being educated through DTC advertising, there has been an
effect on the manner in which they approach their health care providers (Gelles, 1997).
These patients typically arrive at their provider’s office with an idea of what is ailing
them and what medicine is appropriate for that ailment. Often, the consumer has been
drawn in by the advertising pitch and has not noticed the list of the drug s side effects
presented in the ad (Borzo, 1997). Everett (1991) suggests this may be especially true in
the case of the older patient because they are more likely to be less rational in their
interpretation of advertisements and rely upon brand names when selecting a drug.
3
The recent focus on customer service and patient satisfaction may cause some
health care providers to feel compelled to submit to their patients’ medication requests
(Colford, 1997, Lau, 1998, Tanouye, 1997). With their incomes becoming more and
more strained by managed care cost cutting, providers cannot afford to lose patients (Lau,
1998; Tanouye, 1997).
In 1993, the American Medical Association (AMA), in consultation with the
FDA, developed a set of guidelines for DTC drug advertising. In 1999, the Board of
Trustees of the AMA used those guidelines to draft a list of policy statements for DTC
drug advertising and recommended that these policy statements be adopted by their
membership.
DTC drug promotion is a growing marketing technique that will have a greater
impact as the American baby-boomer population ages (Rosenberg, 2000). This will result
in a greater amount of DTC drug ads aimed at their health care dollars. With this in mind,
it is necessary to determine the attitudes and behaviors resulting from the flood of DTC
drug advertisements.
The mass distribution of drug information resulting from DTC drug advertising
can create well-informed patients and enhance the dialogue between nurse practitioners
and their patients. However, DTC drug advertising also creates some concerns for nurse
practitioners. Patients armed with information from DTC drug advertisements may
pressure nurse practitioners to prescribe medicines they’ve seen advertised. Nurse
practitioners may find themselves confronted by patients who know more about a drug or
treatment than they do. The nurse practitioner-patient relationship may also grow weaker
when nurse practitioners refuse patient requests.
4
There is limited research of DTC drug advertising and this researcher found no
nursing research of this topic. Because nurse practitioners have prescriptive authority,
and are likely to be affected by DTC drug advertising, it is important for them to
investigate patient attitudes and behaviors regarding DTC drug ads, as well as the effects
of these ads on the patent-provider relationship.
Theoretical Framework
This research employs Dorothea Orem’s self-care deficit theory of nursing as its
conceptual basis (Orem, 2001). More specifically, it applies four of the six core concepts
of Orem’s theory: (a) self-care, (b) self-care agency, (c) nursing agency, and (d) nursing
systems. Orem (2001) described self-care as activities that individuals initiate and carry
out in order to maintain their own life, health, and well-being.
Self-care agency is the ability of individuals to engage in self-care (Hartweg,
1991). The person who engages in self-care is called the self-care agent. A mature
individual possesses the capability to determine self-care needs, decide what action is
necessary, and perform the appropriate activities to meet self-care needs.
Nursing agency is the attribute of nurses to identify the self-care demands and
needs of others, to help others recognize and meet their self-care demands, and to help
others in developing self-care agency (Orem, 2001). In situations in which the individual
is unable to meet self-care demands, there exists a self-care deficit and an opportunity for
a relationship with nursing agency.
Orem’s concept of nursing systems is divided into three types: (a) wholly
compensatory, (b) partly compensatory, and (c) supportive-educative. This research
utilizes the supportive-educative nursing system as its focus. In a supportive-educative
5
nursing system, the patient performs the actions, and the nurse practitioner supports,
guides, assists, teaches, and provides a therapeutic environment (Hartweg, 1991).
“i
Orem s self-care deficit theory of nursing provides a general framework to direct
nursing action (Marriner, 1986, p. 125). Orem’s theory helps the nurse identify the
individual s need for nursing by evaluating their ability to engage in self-care or their
level of self-care deficit. The nurse practitioner can then employ nursing systems to
restore or improve the individual’s ability to practice self-care.
The abundance of DTC drug advertisements that exists in the American media has
resulted in consumer confusion, an increase in unnecessary physician office visits, and, in
some cases, a strain in the patient-provider relationship (Gelles, 1997; Sherr & Hoffinan,
1997; Tyler & Cooper, 1997). This has created an opportunity for the nurse practitioner
to help health care consumers perform self-care and to engage in nursing agency by
assisting consumers (self-care agents) through use of the supportive-educative nursing
system. By studying the attitudes and behaviors caused by DTC drug advertising, nurse
practitioners can better understand the motivations and beliefs behind patients’ DTC
generated drug requests.
Statement of the Purpose
The purpose of this research was to survey health care consumers in order to
determine their experiences with DTC drug advertisements, including exposure to DTC
drug ads and any action they may have taken as a result of these ads. The survey also
focused on the respondents’ attitudes and beliefs regarding DTC drug advertising and the
influence of DTC drug ads on the patient’s perception of the patient-provider
relationship.
6
Assumptions
For the purposes of this research project, the following assumptions were made:
1. The survey respondents are capable of reading and understanding spoken
English and comprehending the survey and the information contained in DTC drug
advertisements whether printed, televised, or broadcast by radio.
2. The patient/health care consumer is exposed to and reads/views/listens to DTC
drug advertisements.
3. Research subjects will answer all survey questions honestly.
4. Unanswered survey questions are categorized as “Refused to answer”.
Limitations
The limitations of the study were identified as follows:
1. The research respondents were comprised of a convenience sample in a
primary care practice in western New York state. As a result, survey results may not
apply to other populations.
2. The research instrument was researcher-adapted to be used as a self-
administered questionnaire. It was adapted from a telephone survey used in a 1999 FDA
study of DTC drug advertising.
Definition of Terms
The following terms have been defined for this study:
1. Direct-to-consumer (DTC) drug advertising is product-specific advertising in
print and broadcast media aimed directly at consumers. Such advertisements contain
information on the brand name pharmaceutical product, including claims of effectiveness
7
specific disease(s) or medical condition(s), as well as risk information (Board of
Trustees, 1999).
2. Health care consumer is anyone who seeks or purchases health care.
3. Health care provider is any physician, nurse practitioner, or physician’s
assistant with the authority to prescribe medicines and medical treatments.
4. Prescription drugs are those medicines that can only be legally obtained with a
prescription from someone who has the authority to prescribe medicines (e.g., physicians
or nurse practitioners).
Summary
DTC drug advertising has escalated sincel997 when the FDA loosened its
restrictions on this type of advertising (Goetzl, 2000b; Goetzl, 2000c). DTC drug
advertisements can have both positive and negative effects on consumers (Gelles, 1997)
and their relationship with their health care provider (Tyler & Cooper, 1997). Dorothea
Orem’s (2001) self-care deficit nursing theory, with an emphasis on self-care agency,
provides the theoretical framework for this study. The purpose of this study is to
determine patients’ attitudes and behaviors toward prescription drugs as a result of
DTC drug promotion by means of a self-administered survey. The study will also
attempt to determine the effect of DTC drug ads on the patient-provider relationship.
The assumptions, limitations, and definitions of terms are also presented.
8
Chapter 2
Review of the Literature
This chapter presents a brief history of direct-to-consumer (DTC) drug advertising
and promotion of drugs. A review of the literature concerning DTC drug promotion,
government regulation of DTC drug advertising, data on DTC spending, and the effects
of DTC drug promotion on consumers, clinicians, and managed care organizations
(MCO) are presented. Although limited in number, studies regarding DTC drug
promotion and the patient-provider relationship are also discussed.
History
DTC drug advertising is a relatively new area of marketing, and the advertising of
drugs using DTC promotion presents the United States Food and Drug Administration
(FDA) with many challenges. In May 1983, Boots Pharmaceuticals was the first company
to use DTC advertising in promoting its Rufen brand of ibuprofen (Food and Drug
Administration [FDA], 2000a). The FDA was concerned that consumers would not be
able to read the long list of side effects that was quickly flashed on the screen, and it took
action against the commercial. It was soon replaced with an acceptable version.
That same year, because the FDA lacked a formal policy regarding DTC drug
advertising, it called for a voluntary moratorium on DTC drug advertising campaigns for
pharmaceutical products (Pines, 1997). This moratorium was called to provide time for
dialogue among consumers, health professionals, and the pharmaceutical industry (Pines,
1997). It was also thought that the moratorium would allow time for research regarding
DTC drug advertising, and that this research would yield some answers to many of the
questions concerning DTC drug advertising (Gilgore, 1991).
9
The FDA withdrew this moratorium in 1985 and announced that the standards
that applied to physician-directed advertisements would also be applied to DTC
advertisements. These were the standards of fair balance, full disclosure, and the
inclusion of a brief summary of the FDA-approved package insert (Withdrawal of
moratorium, 1985; Gilgore, 1991).
In August 1997, The FDA promulgated a draft Guidance that changed the
requirements for prescription drug advertisements. These requirements applied to radio,
television, and telephone communication system advertisements (FDA, 2000b). The
Guidance was drafted to provide consumers with adequate risk information and to afford
them the ability to make informed decisions. While the Guidance does not change any
FDA regulations, it does provide a structural basis for broadcast advertisements that
assists manufacturers in complying with regulatory objectives (Wechsler, 1997).
Currently, the Guidance remains in draft form (FDA, 2000b). The FDA’s
Division of Drug Marketing, Advertising, and Communications (DDMAC) has requested
feedback on the Guidance concerning the following issues: (a) the effects of DTC
promotion on the public health, (b) the degree to which consumers are taking advantage
of the mechanisms for obtaining approved package labeling in connection with broadcast
advertisements, and (c) how risk messages can best be integrated into broadcast
advertisements.
Since putting the draft Guidance into effect in 1997, the FDA has given no
indication that it is ready to promulgate permanent guidelines (FDA, 2000b). Therefore,
the draft Guidance should be treated as guidelines by the pharmaceutical industry (Borzo,
1997).
10
Regulation of DTC Advertising
DTC drug promotion is regulated by two federal agencies: the FDA and the
Federal Trade Commission (Food and Drugs, 1999a; Food and Drugs, 1999b). The
FDA’s regulation of the development, distribution, and promotion of pharmaceutical
products is authorized by the Food, Drug, and Cosmetic Act (FDCA) (Food and Drugs,
1999b). The FDA is responsible for monitoring DTC drug advertisements, and for
reviewing all such advertisements prior to their media release. This review process
includes statutory requirements that all advertisements contain fair balance of risk and
benefit information, prominent display of risk information in the main body of the
advertisement, and a brief summary of product indications, contraindications, warnings,
adverse reactions, and overdoses (Dickinson, 1994; Kessler & Pines, 1990).
The FDA maintains jurisdiction over the promotion of prescription drugs (Food
and Drugs, 1999a) while the Federal Trade Commission maintains jurisdiction over the
promotion of over-the-counter (OTC) drugs (Commerce and Trade, 1999). The Federal
Trade Commission receives its authority to regulate DTC advertising from the Lanham
Act of 1946.
The two agencies often cooperate on advertising issues but utilize separate
authority and legal mechanisms to exercise their respective authorities (Pines, 1997). The
Federal Trade Commission routinely relies on industry self-regulation regarding
advertising (Commerce and Trade, 1999). The FDA, however, utilizes a hands-on style
and is more observant in its regulation of the advertising industry (Horton & Hastings,
1998).
11
The American Medical Association (AMA) had opposed DTC advertising of
prescription drugs until 1992 (Marx, 1996; Board of Trustees, 1999). That year, the AMA
collaborated with the FDA to issue guidelines for DTC advertising that called for
accurate information and fair balance of benefit and risk information (Pirisi, 1999). In
1999, the Board of Trustees of the AMA recommended adoption of a list of policy
statements on DTC advertising by its membership (Appendix A).
DTC Spending
Nationwide, spending on DTC drug advertising has increased since the FDA
relaxed it restrictions on broadcast television advertisements (Goetzl, 2000b). IMS Health
consultancy figures show that DTC television expenditures for 1996 were $220 million.
In 1997, the year the FDA made the change midyear, expenditures grew to $310 million.
In 1998, they climbed to $664 million, and then jumped to $1.1 billion in 1999 (Goetzl,
2000b).
Goetzl (2000c) found that overall DTC spending had nearly doubled from $1
billion in 1997 to $1.8 billion inl999. This steady increase in DTC expenditures suggests
that DTC advertising of drugs is effective.
Americans over the age of 50 purchase over 77% of all prescription products
(Rosenberg, 2000). With the mature consumer spending more than $20 billion per year
on prescription drugs, it follows that pharmaceutical marketers should focus their efforts
on them.
Another leading factor contributing to the increase in DTC spending is the spread
of managed care. Managed care has made it increasingly difficult for pharmaceutical
marketers to reach prescribers (Wechsler, 1997). Pharmaceutical companies believe that
12
they can increase their market shares if they can reach both the prescriber and the
consumer (Gelles, 1997).
PTC Research
To date, there have been few studies focusing on the effects of DTC drug
promotion on patients and providers. The most notable studies were conducted by Time,
Inc. (Sibley, 2000), Prevention Magazine (Prevention Magazine, 1998; Prevention
Magazine, 1999), and the FDA (FDA, 2000c).
The Time, Inc, studies. In March and April of 1998, Time, Inc. conducted a
telephone survey of 1500 adults, aged 18 or older. The study, titled, “1998 Direct-toConsumer Advertising Study: Consumer and Physician Attitudes” looked at the effects of
PTC drug promotion on consumers and physicians (Sibley, 2000). In March and April of
1999, Time, Inc. conducted another telephone survey titled, “1999 Consumer Attitudes
Toward Pirect-to-Consumer Advertising.” This survey of 1000 adults, aged 18 or older,
focused on consumer attitudes toward PTC advertising (Sibley, 2000).
The Time, Inc. studies suggested that PTC drug advertising has not damaged the
patient-provider relationship. The 1998 Time, Inc. (Sibley, 2000) study found that 84% of
respondents agreed that, “My doctor knows what is best.” Eighty percent of respondents
in the 1999 Time, Inc. study echoed this attitude (Sibley, 2000).
Time Inc.’s 1998 study found that 28% of respondents would switch doctors to
get a desired medication (Sibley, 2000). The 1999 Time, Inc. study (Sibley, 2000)
explored this issue in the context of the seriousness of the condition involved. When
asked whether they would switch doctors if they didn’t get the requested drug, 50% of
respondents agreed they would switch doctors if the condition were something less
13
serious such as heartbum, allergies, or migraines. Twenty-four percent of respondents
agreed they would switch doctors if they didn’t receive the requested medication for a
more serious illness like depression.
The Prevention Magazine studies. In March and April of 1998, Prevention
Magazine conducted a study titled, ccNational Survey of Consumer Reactions to Directto-Consumer Advertising” (Prevention Magazine, 1998). This study was a telephone
survey of 1200 adults aged 18 or older. In 1999, Prevention Magazine conducted a
follow-up study titled, “Year Two: A National Survey of Consumer Reactions to Direct-
to-Consumer Advertising” (Prevention Magazine 1999). This study was also a telephone
survey of 1200 adults aged 18 or older. The studies attempted to track consumer
awareness of DTC drug advertising and to assess DTC’s effectiveness as a means of
promoting prescription medicines and public health (Prevention Magazine, 1998;
Prevention Magazine, 1999).
The two Prevention studies found that, overall, consumers are positive about DTC
drug advertisements because they provide them with the information to meet their self-
care needs Prevention ’s 1998 survey found that 74% of respondents felt that DTC drug
ads allow people to be more involved in their health care (Prevention Magazine, 1998). In
the 1999 survey, 76% of respondents expressed this attitude (Prevention Magazine,
1999). When asked about the presence of information about risks and benefits in DTC
drug ads, 67% of respondents in the 1998 survey (Prevention Magazine, 1998) and 72%
of respondents in the 1999 survey (Prevention Magazine, 1999) agreed that DTC drug
ads educate people about the risks and benefits of prescription drugs. The 1998 survey
(Prevention Magazine, 1998) also found that 59% of respondents felt that DTC drug ads
14
help people make their own decisions about prescription medicines. In the 1999 survey
(Prevention Magazine, 1999) this number rose to 63%.
The Prevention studies (Prevention Magazine, 1998; Prevention Magazine, 1999;
Sibley, 2000) also found that some consumers believed that DTC drug advertisements
may help boost compliance with their medication regimens. Prevention ’s 1998
(Prevention Magazine, 1998; Sibley, 2000) study found that 25% of respondents believed
that DTC drug advertisements made them more likely to take their medicines and
reminded them to refill prescriptions. Prevention ’s 1999 study (Prevention Magazine,
1999; Sibley, 2000) found an increase in that number with 31% of respondents saying
that DTC drug advertisements made them more likely to take their medicines and 33% of
respondents saying DTC drug advertisements reminded them to have their prescriptions
refilled.
On the negative side, 55% of respondents Prevention’s 1998 survey (Prevention
Magazine, 1998) felt that DTC drug ads make prescription drugs seem harmless while
49% of respondents in the 1999 survey (Prevention Magazine, 1999) felt this way. Also,
38% of respondents in the 1998 survey (Prevention Magazine, 1998) and 39% of 1999
survey respondents (Prevention Magazine, 1999) felt that DTC drug ads cause tension
between doctors and their patients.
The Food and Drug Administration (FDA) study. In 1999, the FDA conducted a
telephone survey of 1081 health care consumers to determine attitudes and behaviors
resulting from DTC drug promotion (FDA, 2000c). This study focused on people
(n=960) who had seen a doctor in the last 3 months but also reported results on
respondents (m=121) who had not seen a doctor in the last 3 months.
15
The FDA study (FDA, 2000c) found that television (94%) and magazines (66%)
were the most frequent sources of DTC advertisements among respondents who had seen
a doctor in the last 3 months. This held true among respondents who had not seen a
doctor in the last 3 months also with 96% of respondents citing television, and 58% citing
magazines as primary sources of DTC advertisements.
When asked, Has an advertisement for a prescription drug has ever caused you to
ask a doctor about a medical condition or illness of your own that you had not talked to a
doctor about before?” 27% of respondents who had seen a doctor in the last 3 months
(>7-688) answered “Yes” and 72% answered “No”. Of those who had not seen a doctor in
the last 3 months (>7=83), 8% answered “Yes” and 92% answered “No” (FDA, 2000c).
When respondents to the FDA survey (FDA, 2000c) were asked whether they like
seeing advertisements for prescription drugs, 21% of those who had seen a doctor in the
last 3 months (>7=711) answered, “Agree strongly”, 31% answered, “Agree somewhat”,
while 16% answered, “Disagree strongly.” Eighteen percent of respondents who had not
seen a doctor in the last 3 months (>7—89) answered, Agree strongly9,26% answered,
“Agree somewhat”, and 19% answered, “Disagree strongly.
When asked if they felt that advertisements for prescription drugs help them make
better decisions about their health, 18% of respondents who had seen a doctor in the last
3 months (n=71 1) answered, “Agree strongly”, 29% answered, “Agree somewhat”, and
21% answered, “Disagree strongly” (FDA, 2000c). Of those who had not seen a doctor in
the last 3 months (n=89), 13% answered, “Agree strongly”, 28% answered, “Agree
somewhat”, and 16% answered, “Disagree strongly.”
16
The FDA study (FDA, 2000c) also found that, among respondents (w=71 l)who
had seen a doctor in the last 3 months, 3% “Agreed strongly”, 15% “Disagreed
somewhat , and 72% “Disagreed strongly” that they would not talk with their doctor
about a prescription drug advertisement because it would seem like they did not trust
their doctor. When this question was asked of respondents (n=89) who had not seen a
doctor in the last 3 months, 3% answered, “Agree strongly”, 21% answered, “Disagree
somewhat”, and 66% answered, “Disagree strongly.”
Effects of DTC Advertising
DTC advertising can have a positive effect on consumer education and health care
seeking behaviors (Tyler & Cooper, 1997; Morgan & Levy, 1998). The primary effect of
DTC advertising is a heightened consumer awareness of the drugs available to them and
an increased interaction with their health care provider if they learn of a drug that they
believe may treat their medical problem.
DTC advertisements also are directed at the consumer’s need for control, personal
fulfillment, and freedom, as well as their fears (Allen, 1997). DTC advertisements use
this strategy to motivate consumers to make further inquiries about their product.
Prevention ’s 1999 survey (Prevention Magazine, 1999) found that 76% of consumers
agreed that DTC drug advertisements helped them to be more involved in their health
care, 72% of consumers agreed that DTC drug advertisements educated them about risks
and benefits of prescription drugs, and 63% of consumers agreed that DTC drug
advertisements help people make their own decisions about prescription medicines.
One of the best arguments defending DTC drug promotion is the claim that these
advertisements alert consumers to medical problems and potential treatments, thereby
17
moving those who need medical attention to visit their health care provider (Gelles,
1997). Many of these advertisements encourage consumers to see their doctor if they
believe the advertised drug may help them (Morgan & Levy, 1998). Time, Inc.’s 1998
survey found that DTC advertising led 13% of consumers to speak with their health care
provider about a medical condition not previously discussed (Sibley, 2000). The FDA’s
survey in 1999 (FDA, 2000c) found that DTC advertising resulted in 27% of consumers
speaking with their health care provider about a medical condition not previously
discussed.
The Prevention studies (Prevention Magazine, 1998; Prevention Magazine, 1999)
also found that some consumers believed that DTC drug advertisements may help boost
compliance with their medication regimens. Prevention’s 1998 (Prevention Magazine,
1998) study found that 25% of respondents believed that DTC drug advertisements made
them more likely to take their medicines and reminded them to refill prescriptions.
Prevention’s 1999 study (Prevention Magazine, 1999) found an increase in that number
with 31% of respondents saying that DTC drug advertisements make them more likely to
take their medicines and 33% of respondents saying DTC drug advertisements reminded
them to have their prescriptions refilled.
DTC advertising can also cause problems for health care consumers (Gelles,
1997). Patients may self-diagnose and approach their health care provider about a
particular medication they saw in an ad, and that they believe they need. If the provider
does not prescribe the requested medication, the patient may become upset. If this occurs,
the patient-provider relationship may become strained and the patient’s trust in the
provider damaged (Tyler & Cooper, 1997).
18
e may also be times when a provider does not question the patient’s request
for a medication, fails to give a full clinical evaluation, and prescribes the drug (Gelles,
1997). If the wrong drug is prescribed, the patient could be harmed due to a drug
interaction, masking of the symptoms of a comorbidity, or an undetected contraindication
to the prescribed drug.
Detractors of DTC advertising believe that drug advertisements increase the use
of prescription drugs by distorting patient-provider relationships (Gelles, 1997). They
believe the advertisements’ primary goal is to sell drugs and that they are poor sources of
patient education. They also point out that the advertisements do not discuss alternative
drugs or treatments. These factors can cause the provider to spend increased amounts of
time educating their patients with appropriate information. Studies show that DTC
advertising leads to increased patient loads and increased time spent explaining the
benefits and risks of a specific drug and formulary restrictions if the requested drug is not
on the patient’s health plan formulary (Sherr & Hoffman, 1997).
In the end, the provider decides whether the medicine will be prescribed and it is
the provider’s signature that is required before the medication will be dispensed
(Tanouye, 1997). This affords the provider primary authority and power over what will
be prescribed.
Summary
DTC advertising is a relatively new marketing approach that is rapidly
proliferating and evolving. DTC drug ads first surfaced in 1983. Shortly thereafter, in the
interest of consumer protection, the FDA called for a moratorium on DTC advertising
(Pines, 1997). In 1993, the FDA, in collaboration with the AMA, developed a set of
19
guidelines for DTC advertising (Board of Trustees, 1999). In 1997, the FDA presented
these guidelines as the Draft Guidance for Industry (FDA, 2000b). This Guidance was
not a set of regulations, but rather a blueprint that the pharmaceutical marketing industry
could follow in developing DTC advertisements. In 1999, the Board of Trustees of the
AMA called for its membership to adopt a set of policy statements regarding DTC
advertising. These policy statements were analogous to the Draft Guidance set forth by
the FDA.
Both the FDA and the Federal Trade Commission regulate DTC advertising
(Food and Drugs, 1999a; Food and Drugs, 1999b; Commerce and Trade, 1999). The
FDA, as set forth by the Food, Drug, and Cosmetic Act, maintains jurisdiction of
prescription drug promotion, while the FTC, as mandated by the Lanham Act of 1946,
has jurisdiction over OTC drugs and products.
Relatively few studies have focused on the effects of DTC drug promotion on
health care consumers and the patient-provider relationship. Studies by Time, Inc.,
Prevention Magazine, and the FDA have been presented in this chapter.
DTC advertising affects both the patient and the health care provider and the
relationship between them (Tyler & Cooper, 1997). Proponents of DTC advertising claim
that DTC advertisements create better-educated consumers and may spur consumers to
seek treatments of which they were not aware prior to DTC exposure (Gelles, 1997; Sherr
& Hoffinan, 1997; Tyler & Cooper, 1997; Morgan & Levy, 1998; Prevention Magazine,
1998; Prevention Magazine, 1999; Food and Drug Administration, 2000c; Sibley, 2000).
Critics of DTC advertising argue that these advertisements are not of high educative
20
value, confuse consumers, are biased, and may cause consumers to make erroneous self
diagnoses (“Changing the Doctor,” 1997; Gelles, 1997; Sibley, 2000).
Furthermore, DTC drug advertisements can wreak havoc in the health care
provider’s office by clogging the office with unnecessary visits (Sherr & Hoffinan, 1997).
It can also take a lot of time on the part of providers to explain to patients about health
plan formularies, the inappropriateness of the requested drug, and the efficacy of
alternative treatments. In addition, the patient may become upset by the provider’s
reluctance or refusal to prescribe the advertised drug. This can put a strain on the patient
provider relationship and lead to patient distrust of the provider.
The studies presented in this chapter suggest that DTC drug advertising is
reaching a great portion of the American population. The high level of exposure to DTC
drug promotion is affecting the way patients approach and interact with their health care
providers. DTC drug ads are catalysts for patient-provider discussions about drugs. They
are also the basis for many prescription drug requests. Ultimately, it’s the provider’s
decision whether a prescription will be written and this authority gives the provider final
determination over the effect of DTC advertising.
21
Chapter 3
Methodology
This chapter presents the methodology used in this study. A self-administered
questionnaire was used to collect information concerning demographics, exposure to
DTC drug advertising, sources of DTC drug ads, behaviors resulting from DTC drug ads,
respondents’ attitudes toward DTC drug advertising, and the patient’s perspective of the
effect of DTC drug ads on the patient-provider relationship.
Research Questions
The research questions were as follows:
1. Who is exposed to DTC drug advertisements?
2. What types of media are responsible for patients’ exposure to DTC drug
advertisements?
3. What consumer/patient health care related behaviors are a result of DTC drug
advertisements?
4. What are the attitudes of patients toward DTC drug advertising and
prescription drugs?
5. What is the influence of DTC drug advertisements on the patient’s perception
of the patient-provider relationship?
Research Design
This was a quantitative study utilizing a descriptive survey research design. This
research study used survey questions Irom a 1999 telephone survey conducted by the
U.S. Food and Drug Administration. This researcher revised the original FDA survey so
that it could be used as a self-administered questionnaire. This survey helped to identity
22
some of the attitudes of consumers regarding DTC drug advertisements. In addition, it
collected information on
consumers’ behaviors resulting from exposure to DTC drug
advertisements, as well as information regarding the patient’s perspective of the effects of
DTC drug ads on the patient-provider relationship.
Sample, Setting, and Procedure
The target sample consisted of English speaking patients over the age of 18 who
were seen in the Sherman, NY office of a rural primary care medical practice in
Chautauqua County, NY, during the month of March 2001. The study population
included adults visiting the offices for any primary care reason. Participants were given
the questionnaire as they registered for their visit and were asked to complete it while
waiting for their examination. They then returned the questionnaire when called into an
examination room. The office receptionists collected the completed surveys and placed
them in a secure area until collected by the researcher.
Instrumentation
The research tool used in this study was based on the telephone survey used by
the FDA’s 1999 study, “Attitudes and Behaviors Associated with Direct-to-Consumer
(DTC) Promotion of Prescription Drugs” (FDA, 2000c). The FDA’s survey is the
property of the United States government and considered public domain. The researcher
modified the FDA’s survey for use as a self-administered questionnaire (Appendix B).
The questionnaire included a cover letter (Appendix B) explaining the purpose of the
study, and instructions for completing the survey.
The survey used in this study consisted of 45 quest!ions. The first seven questions
collected demographic information, including perceived overall health status and
23
perceived knowledge about health and medicine. The next question was a dichotomous
question that asked whether respondents could recall ever seeing or hearing an
advertisement for a prescription drug. If a subject answered “No” to this question, they
were finished with the survey. Questions 9 through 17 addressed sources of exposure to
DTC drug advertisements, information included in DTC drug advertisements, and
whether subjects sought further information on drugs as a result of DTC drug
advertisements. Questions 18 through 29 were Likert multiple-choice questions
addressing subjects’ attitudes toward DTC drug advertisements. The final sixteen
questions addressed the effect of DTC drug advertisements on the patient-provider
interaction and the patient-provider relationship from the patient’s perspective.
Protection of Human Rights
The face sheet of the survey (Appendix B) includes an introduction and
explanation of the purpose of the study. Potential participants were informed that
participation was strictly voluntary and that participation or nonparticipation would have
no effect on their care. Completion and submission of the survey implied informed
consent. No names, numbers, or identifying information was required on the survey and
all data remained anonymous. Only grouped data was reported. The completed surveys
remain in a locked file.
Pilot Study
A pilot study to assess the readability of the survey, to identify any unclear
questions or instructions, and to estimate the amount of time it took to complete the
survey was conducted at the social center of the Erie Center on Health and Aging. The
population included a group of 10 men and women aged 65 or older. A total of 10
24
surveys were distributed and W surveys were competed and returned. The survey took
an average of 16.2 minutes to complete.
As a result of the pilot study, a statement informing subjects that there were
survey questions on both sides of the pages of the survey was added at the beginning of
the survey. It was also determined that Question 17 required a ninth possible response for
subjects who have never looked for more information about a drug because of an
advertisement. In addition, several subjects in the pilot study commented that the survey
was too long.
Data Analysis
The survey results were analyzed using descriptive statistics. Frequency
distributions were used to report responses to dichotomous and multiple-choice
questions. A Likert scale question regarding overall perceived health status was also
analyzed and reported as distributions within the five possible responses. All data were
also analyzed and reported as frequency distributions among demographic groups. All
statistics were calculated using StatView software by Abacus Concepts, Inc.
Summary
A goal of this research study was to determine the patient attitudes and behaviors
associated with DTC drug advertising. Another goal was to determine the types and
levels of exposure to DTC drug advertisements. The survey design, pilot study, and data
analysis for this study have
been described. Due to the recent escalation in DTC drug
promotion, patients are coming to
their health care providers armed with a wealth of
information about drugs and treatments.
In some cases, these patients have a distorted
sense of the information they have received 6- DTC advertisements. In such
25
situations, nurse practitioners must implement patient education strategies that can re
educate the patient with the appropriate information.
26
Chapter 4
Findings
This chapter presents the results of a researcher-developed survey
(Appendix B) concerning patient attitudes and behaviors related to DTC drug
advertising. The results were analyzed using descriptive statistics and were reported as
frequency distributions. Results were reported as total population and as demographic
subsets of gender, age, marital status, and educational level. Perceived overall health
status, and perceived level of knowledge about health and medicines were also analyzed
and reported. Additional data are displayed in Appendix C.
Sample
The questionnaires were distributed to adults equal to or over the age of 18, who
visited a primary care practice office in Sherman, New York during a 2 week period in
March 2001. The questionnaires were completed while the patients waited to be called
into an examination room, and took about 15 minutes to complete. One-hundred-eighty-
eight completed questionnaires were returned to the researcher. The office receptionists
were questioned regarding distribution of the questionnaire. There was no clear reason to
believe that anyone who received a questionnaire did not return it. Due to gross
inconsistencies in the responses on some of the surveys, 51 surveys were discounted in
the final analysis, resulting in a final population of 137 subjects.
Results
The results are reported in total number and percentages of the total subject
population and the aforementioned demographic subsets. Percentages are rounded to the
27
nearest whole percentage. The results
are not analyzed by ethnicity as all but 2 subjects
reported their ethnicity as “White”.
PTC Exposure
To answer the first survey question, “Who is exposed to PTC drug
advertisements? the results were analyzed for demographic characteristics. The subjects’
exposure to PTC drug ads and their perceived health status were also analyzed.
Pemo graphics. In the total sample population, females comprised 77%, and males
comprised 23% (Table 1). Of the total sample (7V==137), 91% (m—124) reported seeing an
advertisement for a prescription drug. Seventy-seven percent (n=96) of the female
subgroup reported seeing an advertisement for a prescription drug, while 23% (n=28) of
the male subgroup reported the same. Nine percent (n=13) of the total sample reported
they had never seen an ad for a prescription drug. Of those who reported never seeing an
ad for a prescription drug, 69% (m=9) were females, and 31% (n~4) were males.
Table 1
Comparison of Total Sample (AM37) by Gender: PTC Exposure
Total
Gender
Exposed to PTC
Unexposed to PTC
n
(%)
n
(%)
n
(%)
105
(77)
96 (77)
9
(69)
Male
32
(23)
28
Totals
137
Female
(23)
124
Note. All percentages are calculated within groups.
4 (31)
13
28
Age comparison of the sample population showed that 33% of subjects age 18 to
39 years (m-124) had seen an advertisement for a prescription drug (Table 2), while 55%
of subjects age 40 to 64 years, and 12% of subjects age 65 or older reported the same.
Table 2
Comparison of Total Sample by Age: PTC Exposure
Age
Total
Exposed to PTC
Unexposed to PTC
(%)
«
(%)
n
(%)
n
18-39
47
(34)
41
(33)
6 (46)
40-64
72
(53)
68 (55)
4 (31)
65+
18
(13)
15 (12)
3
137
Totals
124
(23)
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
Comparison of marital status among survey subjects showed 77% of subjects who
reported seeing a prescription drug ad were married, 7% were single, 7% were widowed,
6% were divorced, and 2% were separated (Table 3). These figures closely mirrored the
composition of the total sample population. Of those who reported not seeing a
prescription drug ad, 77% were married, 15% were single, and 8% were widowed.
29
Table 3
Comparison of Total Sample by Marital Statin
is: J)TC Exposure
Marital status
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
(%)
105
(77)
95
(77)
10
(77)
Single
11
(8)
9
(7)
2
(15)
Widowed
10
(7)
9
(7)
1
(8)
Divorced
8
(6)
8
(6)
0
(0)
Separated
3
(2)
3
(2)
0
(0)
Married
137
Totals
124
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
The sample population had a reasonably high level of education given the rural
setting in which the population resided. Twenty-nine percent of the total sample (N 137)
had completed high school and 33% had gone beyond high school by completing
business or technical school (Table 4). In addition, 21% of the total sample had
completed college, and 9% had completed graduate school or more. Of those who
reported seeing a prescription drug ad, 2% had completed grade school or less, 3% had
completed some high school, 28% had completed high school, 35% had completed
business or technical school, 23% had completed college, and 10% had completed
graduate school or more. Interestingly, of those subjects who reported never seeing a
30
prescription drug ad, one had completed coilege, and one bad compieted graduate school
or more.
Table 4
Comparison of Total Sample by Highest Education Level: PTC Exposure
Educational level
Total
Exposed to PTC
Unexposed to PTC
n
(%)
n
(%)
n
(%)
Grade school or less
3
(2)
2
(2)
1
(8)
Some high school
7
(5)
4
(3)
3 (23)
Completed high school
40 (29)
35 (28)
5 (38)
Business or tech, school
45 (33)
43
(35)
2 (15)
Completed college
29 (21)
28 (23)
1
(8)
Graduate school or more
13
12 (10)
1
(8)
(9)
137
Totals
124
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
Perceived Overall Health. Question 6 asked subjects to rate their overall health
using a Likert multiple-choice scale. Within the subgroup of subjects who had seen a
prescription drug ad, only 1% of subjects (»=123) reported “poor" health (Table 5) . The
majority of subjects who had seen a prescription drug ad reported their health as being
“very good” (37%), and “good” (39%).
31
Table 5
Likert Multiple ChoiceRating of Perceived Overall Health on the Dav the Survev was
Taken and DTC Exposure
Overall health
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
Excellent
12
(9)
11
(9)
1
(8)
Very good
49
(36)
46
(37)
3
(23)
Good
53
(39)
48
(39)
5
(38)
Fair
21
(15)
17
(14)
4
(31)
1
(1)
1
(1)
0
(0)
Poor
136
Totals
123
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding. One survey was discounted due to multiple answers regarding health status.
Perceived Knowledge of Health and Medicines. In Question 7, subjects were
asked to rate their knowledge of health and medicines. Of the total sample (V=137), 71%
felt they were
“somewhat knowledgeable,” and 23% felt they were “very knowledgeable”
(Table 6). These percentages were mirrored in the subgroup of subjects who had seen a
prescription drug (w-124).
32
Table 6
Likert Multiple Choice Rating Self Perception of Knowled-e Atom He.HI, and
Medicines and DTC Exposure
Knowledge level
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
(%)
3
(2)
3
(2)
0
(0)
Very knowledgeable
31
(23)
28
(23)
3
(23)
Somewhat knowledgeable
97
(71)
88
(71)
9
(69)
Not at all knowledgeable
6
(4)
5
(4)
1
(8)
Extremely knowledgeable
137
Totals
124
13
Note. All percentages are calculated within groups.
DTC Sources
Subjects who reported seeing an ad for a prescription drug were asked to identify
the types of media responsible for the ads they had seen. Question 9 offered subjects
seven types of media from which they could choose more than one answer. Expectedly,
prescription drug ads were most frequently seen on television (98%) and in magazines
(91%) (Table 7). A considerably lower frequency of exposure via the internet (15%) was
reported.
33
Table 7
Sources of DTC PngAfagBaateltejgve, Subjects W-! M
Source
n
(%)
121
(98)
41
(33)
Magazine
113
(91)
Newspaper
35
(28)
Internet
19
(15)
Letter, flyer, or announcement you got in the mail
32
(26)
7
(6)
Television
Radio
Anywhere else
Notes. Results reported as frequencies among total responses. Subjects could select more
than one answer to this question. Therefore, percentages will not total 100.
DTC-Related Behaviors
Questions 30, 32, 33, 38, 39, and 44 dealt with subjects’ behaviors related to DTC
drug ads. When asked if a drug ad has ever caused them to ask their health care provider
about a condition or illness that they had not previously discussed, 24% (n=l 19) of
subjects replied, “Yes,” and 76% replied, "No .
Sixty-two percent (m=1 17) of respondents answered “Yes,” and 38% answered
“No” when asked if they ever read, heard, or saw something that made them think about a
question they wanted to ask their health care provider about a prescription drug. Of those
that answered, “Yes” to this question, 44% identified an ad on television or radio, and
24% identified an ad in a tnagazine or newspaper as reading to a ptesc.ip.ion drug
34
question for their health care provider (Table 8). ^ingjy, 29% reported something a
friend, relative, or netghbor said as leading to a prescription drug question for their health
care provider.
Forty-six percent of subjects (n=l 17) reported they had asked their health care
provider about a specific brand of prescription drug. When asked if they ever mentioned
a drug ad to their health care provider, or if they ever brought information about a drug
with them to a visit with their health care provider, 27% (w=l 16) had mentioned an ad,
5% had brought information with them, 7% had done both, and 61% had never
mentioned an ad nor brought drug information with them to a visit.
Question 44 attempted to determine the likelihood that subjects would approach
their health care providers if they saw an ad for a drug that treats a condition that was
bothersome to them. Most subjects reported they would talk with their health care
provider about such an ad. Fifty-five percent (w~l 12) reported they would be, “very
likely,” and 32% would be, “somewhat likely” to talk with their provider about an ad for
a drug that treated a condition which was bothering them (Table 9).
Patient Attitudes
Survey questions 18 through 29 explored subjects’ attitudes regarding drug
advertisements. Subjects’ attitudes regarding statements about drug advertisements were
measured using Likert scale multiple-choice questions. Subjects’ responses about
whether they liked seeing ads for prescription drugs formed a normal distribution with
most subjects neither agreeing nor disagreeing withthe statement (Table 10).
35
Table 8
Source of Information That.CausedSubjectsto.Ask Their Health C.re Provider Abort a
Prescription Drug (7V=110)
Source
n
(%)
An ad on television or radio
48
(44)
An ad in a magazine or newspaper
26
(24)
or radio, or mention in a talk show
24
(22)
An article in a magazine or newspaper
21
(19)
6
(5)
32
(29)
provider other than your own
7
(6)
Something you saw on the internet
5
(6)
Something else
8
(7)
36
(33)
A news or educational program on TV
Something you received in the mail
Something a friend, relative, or
neighbor said
A talk you had with a health care
Never had a question about a
prescription drug
Notes. Results reported as frequencies among total responses. Subjects could seieel more
than one answer to this question, therefore, percentages »11 not total 100. Fourteen
subjects did not answer this question.
36
Table 9
Ad for.
Drug That_Jreats . Conditional Bothersome to th.
Likelihood
n
(%)
Very likely
62
(55)
Somewhat likely
36
(32)
Neither likely nor unlikely
6
(5)
Somewhat unlikely
6
(5)
Very unlikely
2
(2)
rfel 1„
112
Total
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding. Eleven subjects did not answer this question. One survey was discounted due
to multiple answers.
Fifty percent of subjects (n=122) agreed somewhat, and 24% agreed strongly that
prescription drug ads help make them more aware of new drugs. In contrast, only 5%
disagreed somewhat, and 2% disagreed strongly with this statement.
The majority of subjects agreed that prescription drug ads do not give enough
possible benefits and positive effects of using the drug. Forty
information about the pi
percent («=121) agreed somewhat with this statement, and 13% agreed strongly. Twenty-
;ed with this statement.
five percent neither agreed nor disagree
37
Table 10
Likert Multiple Choice RatjiJJ^^^gia&Ad^
Prescription Drugs
(Questionl8)
Rating
Total
n
(%)
Agree strongly
10
(8)
Agree somewhat
21
(17)
Neither agree nor disagree
65
(53)
Disagree somewhat
16
(13)
Disagree strongly
11
(9)
Total
123
Notes. Percentages may not total 100 due to rounding. One subject did not answer this
question.
Nearly the same percentage of subjects agreed that prescription drug ads do not
give enough information about the possible risks and negative effects of using the drug.
Regarding this statement, 15% (n=121) agreed strongly, 40% agreed somewhat, 25%
neither agreed nor disagreed, 15% disagreed somewhat, and 7% disagreed strongly.
When asked whether prescription drug ads make it seem like a health care
provider is not needed to decide if a drug is right for them, slightly more subjects
disagreed than agreed. Twenty-four percent („=120) of subjects disced somewhat with
this statement, and 2>% disagreed strongly. Converse!,, 28% agreed somewhat, and 15%
agreed strongly.
38
A high percentage of subjects agreed th,
information for them to decide whether they should diMSS the drag with their heahh
care provider. Forty-two percent of subjects („-! 18)
somewhM>
,?%
strongly with this statement, in contrast, only 10% disagreed somewhat, and 7%
disagreed strongly.
Many subjects (45%) („=119) neither agreed nor disagreed with the statement,
tc
Advertisements for prescription drugs help me make better decisions about my health”.
However, more subjects agreed with this statement than disagreed. Twenty-six percent
agreed somewhat, and 5% agreed strongly, while 13% disagreed somewhat, and 11%
disagreed strongly with this statement.
When asked whether they feel advertisements for prescription drugs help them
have better discussions about their health with their health care provider, most subjects
agreed they do. Forty-two percent (w=l 19) agreed somewhat, and 7% agreed strongly.
Only 9% disagreed somewhat, and 5% disagreed strongly with this statement.
A markedly low percentage of subjects agreed with the statement, “I would not
talk with my health care provider about an advertisement for a prescription drug, because
it would seem like I did not trust him/her.” Three percent agreed somewhat with this
statement, and 2% agreed strongly. On the other hand, 22% disagreed somewhat, and
49% disagreed strongly, while 24% neither agreed nor disagreed.
DTC’s Influence on the PatienkprovidgrRelatign^
When subjects were asked about their health care provider’s responses to their
mention of a drug advertisement, most reported fovorabie responses horn their health
39
care provider. Only 2% of subjects (n=l 09)
reported their provider seemed angry or upset
when asked about an advertised drug.
Subjects were then asked to rate their level of satisfaction with their health care
provider s response to a question about a drug. Fifty-thn*ee percent of subjects (w=109)
were satisfied (Table 11).
Subjects were asked what actions their provider took in response to their drug
questions. Subjects (n—105) reported that their providers usually recommended a
different prescription drug (28%), or prescribed the drug in question (23%). According to
survey subjects (n=98), when a health care provider did not prescribe the drug they asked
about, the provider often explained the reason (43%). The most frequent reasons cited for
not prescribing the drug in question were: (a) the drug was not right for them (23%), (b) a
less expensive drug was available (15%), and (c) the subject was unaware of the drug’s
side effects (13%).
Summary
The results from a researcher-developed survey (Appendix B) concerning patient
experiences with DTC drug advertising were presented. The sample population consisted
of adult patients in a rural primary care practice in western state. Results were presented
as the total sample (A=137), those exposed to DTC drug ads (»-124), and those who
have never seen DTC drug ads (rt-U). Results were grouped and reported according to
research questions. Additional data are presented in Appendix C.
40
Table 11
Satisfcliw With Health CjeJMdofsteiion to „ (ju Satisfaction level
Total
n
(%)
Very satisfied
23
(21)
Satisfied
35
(32)
Neither satisfied nor unsatisfied
4
(4)
Unsatisfied
0
(0)
Very unsatisfied
0
(0)
47
(43)
Have never asked about a prescription drug
Total
109
Notes. Fourteen subjects did not answer this question. One survey was voided due to
multiple answers.
41
Chapter 5
Discussion
This study was conducted in a turn! ptim,„ care practice in western New York
state during March 2001. A msearohcr-develeped survey was admmistered to:
(a) determine the demographic make-up of those people exposed to DTC drug
advertising, (b) identify the sources of DTC drug advertising, (c) identify patient
behaviors associated with DTC drug advertisements, (d) explore patient attitudes
regarding DTC drug advertisements, and (e) reveal the influence of DTC drug advertising
on the patient-provider relationship from the patient’s perspective. Because the survey
used in this study was based on the survey used in the 1999 FDA study (FDA, 2000c)
mentioned in the literature review, this chapter focuses on comparisons between this
study and the FDA study.
PTC Exposure
To answer the first research question about who is exposed to DTC drug
advertising, the demographic information obtained from the surveys is discussed.
. Demographics, perceived overall health status, and perceived knowledge of health and
medicines are discussed.
Demographics. Of the total sample, 77% were female and 23% were male
(Table 1). Ninety-one percent of females and 88% of males reported seeing mt ad for a
prescription drug. Due to th. predominantly femaie make-up of the sampfe population,
these figures are skewed and cannot be applied to the general population. The >999
Prevention study (Prevention Maga«, 1999) found 83% of females (n=660), and 80%
of males (n-545) had seen an advertisement for a prescnptto
g
42
Thkty percent of 18 to 39 year olds had seen a prescriptio„ drag „
40 to 64 year olds. and 11% of those 65 years or older reporthtg the same (Table 2).
Within the subgroup of subjects reporting they w see„ a
percentages are approximately the same.
The sample subgroup of those who had seen a prescription drug ad can be
characterized as highly educated. Sixty-three percent had received post-secondary
education (Table 4). The FDA’s study population (FDA, 2000c) showed a somewhat
different distribution of educational levels among those who had seen a prescription drug
ad. In its study, the FDA found that only 41% had received post-secondary education. It
is important to note that the FDA study was conducted nationwide.
Perceived Overall Health. Subjects’ perceived overall health was measured using
a Likert scale multiple-choice question. Of those who had seen a prescription drug ad,
76% reported being in good health or very good health (Table 5). In comparison, the
FDA study (FDA, 2000c) found 59% of subjects reported being in good health or very
good health.
Perceived Knowledge of Health and Medicines. Among those subjects who had
seen a prescription drug advertisement, most believed they were somewhat
knowledgeable regarding health and medicines (71%) (Table 6). Twenty-three percent of
this subgroup reported being very knowledgeable about health and medicines. The FDA
study (FDA, 2000c) found 59% of subjects who had seen a prescription drug ad reported
being somewhat knowledgeable about health and medicines, and 29% reported being
.cry knowledgeable. Once again, it is important not. that the FDA study used a
nationwide sample population.
43
Sources of PTC Drug Advertising
This study found tension and magazines to
the leadi„g
0£DTC
advertisements with over 90% of subjects identifying tlKm K Mmces (Tabfc ?)
as a source of DTC ads, was reported as a distant third. The EDA study (FDA, 2000c)
found a similar ranking to these DTC sources.
Patient Behaviors
In this study, 24% of subjects who had seen a prescription drug ad have been
motivated by a drug ad to talk with their health care provider about a condition or illness
they had not previously discussed. This held true for 27% of subjects (n=688) in the FDA
study (FDA, 2000c). Sixty-two percent of subjects in this study had read, heard, or seen
something that made them think of a question for their health care provider. Only 21% of
subjects (72=960) in the FDA study (FDA, 2000c) answered “Yes” to this question. In this
study, those who answered “Yes” to this question identified an ad on television or radio
(44%), something a friend, relative, or neighbor said (29%), and an ad in a magazine or
newspaper (24%) as being the leading reasons for their question (Table 8).
Forty-six percent of subjects in this study had asked their health care provider
about a specific brand of prescription drug. In comparison, 32% of subjects (w=632) in
the FDA study (FDA, 2000c) had asked their provider about a specific brand of
prescription drug.
This study found 27% had mentioned an ad, 5% had brought information with
them, 7% had done both, and 61 % had never mentioned an ad nor broug
information with them to a visit. These percentages are much higher than the FDA
study's fttdings. Eight percent of ejects (^) h the FDA stud, (FDA. 2000c) had
44
mentioned an ad, 4% had brought infonMion
had never mentioned an ad nor brought drug information
them * *
health care provider.
Subjects in this study were asked about the iikelihood that they would talk to their
health care provider if they saw an ad for a drug that treated a condition that was
bothering them. Filly-five percent reported they would be very likely, and 32% reported
they would be somewhat likely to talk with their health care provider about such a drug
(Table 9). The FDA study (FDA, 2000c) found similar results with this question, with
54% of subjects (h=607) reporting they would be very likely, and 26% reporting they
would be somewhat likely to talk with their health care provider in this situation.
Patient Attitudes
Subjects’ attitudes regarding prescription drug advertisements were explored
using a series of Likert scale multiple-choice questions. This study found most subjects
(53%) neither agreed nor disagreed with the statement, “I like seeing advertisements for
prescription drugs” (Table 10). Those subjects that agreed, and those that disagreed with
this statement were evenly distributed on either side of the curve. Responses to this
statement were quite different in the FDA study (FDA, 2000c). That study («=711) found
52% of subjects agreed with this statement.
Fifty percent of subjects in this study agreed somewhat, and 24% agreed strongly
tat prescription drug ads help make them more aware of new drugs. The FDA study
(FDA, 2000c) found slightly higher percentages for this statement. The FDA study foun
39% (n=711) of subjects agreed somewhat, and 47% agreed strongly that preset,p.i.n
drug advertisements help make them aware of ne
45
Forty percent of subjects fit this stud, agreed somewhat with the statemen,
-Advertisements for prescription drugs do not give enough
possible benefits and positive effects of using the
abM the
wUe n%
These results differed somewhat from the FDA study's (FDA 2000c) findings th., 28%
of subjects (tt-711) agreed somewhat, and 21% agreed slmugjy. Th., study
f„md
23% of subjects disagreed somewhat, and 16% disagreed strongly wdththia statement.
Subjects were also asked about their attitude regarding the statement,
“Advertisements for prescription drugs do not give enough information about the
possible risks and negative effects of using the drug.” Regarding this statement, 15% of
subjects in this study agreed strongly, and 40% agreed somewhat. Twenty-six percent of
subjects (n=711) agreed strongly, and 32% agreed somewhat in the FDA study (FDA,
2000c).
Slightly more subjects in this study disagreed than agreed with the statement,
“Advertisements for prescription drugs make it seem like a health care provider is not
needed to decide whether a drug is right for me.” Twenty-four percent of subjects
disagreed somewhat with this statement, and 21% disagreed strongly. Conversely, 28/o
agreed somewhat, and 15% agreed strongly. This finding is in contrast
study's (FDA, 2000c) findings. That study («=711) found a greater percentage of subjects
disagreed with this statement, with 21% of subjects disagreeing somewhat, and 49%
disagreeing strongly.
Forty-two percent of subjects in this study agreed — and 17% agreed
strongly with the statement, ‘Advertisements for prescription dnrgs give enough
information for me to decide whether I should discuss the drug with a health care
46
provider.” Only 10% disagreed somewhat, «d 7% dtagreed 9rong|y
More subjects m the FDA study (FDA, 2000c) agreed * this statement
that study revealed 42% of subjects
„ agreed
with this statement.
Forty-five percent of subjects in this study
statement, “Advertisements for prescription drugs help me make better decisions about
my health.” However, this study found more subjects agreed with this statement than
disagreed. Twenty-six percent agreed somewhat, and 5% agreed strongly, while 13%
disagreed somewhat, and 11% disagreed strongly with this statement. Twenty-nine
percent of subjects (n=711) in the FDA study (FDA, 2000c), agreed somewhat with this
statement. However, that study found 21% disagreed strongly.
Most subjects in this study agreed with the statement, “Advertisements for
prescription drugs help me have better discussions with my health care provider about my
health.” Forty-two percent agreed somewhat, and 7% agreed strongly. This was also
found to be true in the FDA study (FDA, 2000c). Thirty-six percent of subjects (n=711)
in the FDA study agreed somewhat with this statement, while 26% agreed strongly.
A very low percentage of subjects in this study agreed with the statement, "1
would not talk with my health care provider about an advertisement lor a prescription
drug, because it would seem like I did not trust him/her.” Three percent agreed somewhat
with this statement, and 2% agreed strongly. In sharp contrast, 22% disagreed somewhat,
and 49% disagreed strong^, while 24% neither agreed nor disagreed. While subjects in
the FDA study (FDA, 2000c) echoed the findings in this study, an
47
percentage disagreed with this stati
ement. That study found 15% of subjects (n=711)
disagreed somewhat with this statement,
and 72% disagreed strongly.
The Patient-Provider Relationship
Subjects in this study were asked about their health care provider’s responses to
their mention of a drug advertisement. Most subjects reported fevorable responses Sum
their health care provider. Two percent of subjects reported their provider seeming angry
or upset when asked about an advertised drug. A comparable 2% of subjects (n=220) in
the FDA study (FDA, 2000c) reported their health care provider seemed to get angry or
upset.
Subjects were then asked to rate their level of satisfaction with their health care
provider’s response to a question about a drug. The majority of subjects were satisfied
(32%), or very satisfied (21%) (Table 11). Thirty-seven percent of subjects (w=220) in the
FDA study (FDA, 2000c) were satisfied with their provider’s response, and 48% were
very satisfied.
When asked what actions their provider took in response to their drug questions,
subjects reported that their providers usually recommended a different prescription drug
(28%), or prescribed the drug in question (23%). Subjects in the FDA study (FDA,
,viders most frequently prescribed the drug in question
2000c) (n=220) reported that pro
’ ion drug (32%), and recommended changes m
(50%), recommended a different prescription
behavior or lifestyle (29%).
When a heahh care pt^der does not prescribe the drug a subject asked about, the
according to 43% of subjects in this study. Subjects
provider often explained the reason,
in this study most frequently cited the following
their health care provider’s reasons
48
for not prescribing die drug they *datout; (i)fc
(b) a less expensive drug was available (15%) and
u>
(c) the subject was unaware of the
drug’s side effects (13%). The FDA study (FDA. 2000c) fomd 59% „f
w)
reporting they received an exp1Mio„ for not prescribmg a
provider. The most frequent reasons revealed in that stud
ly were: (a) the drug was not
right for the them (48%), (b) the doctor wanted th<
------ lem to take a different drug (35%), and
(c) the drug had side effects they were not aware of (29%).
Conclusions
Overall, the results of this study met the goal of answering the research questions.
The study met its goal of identifying the demographics of patients who have been
exposed to DTC drug advertising. It also met its goals of identifying the types of media
used for DTC drug advertising, patient behaviors related to DTC drug advertising, patient
attitudes regarding prescription drug advertisements, and the influence of DTC drug
advertising on the patient-provider relationship from the patient’s perspective.
The amount of money spent on DTC drug advertising is reflected in the
percentage of subjects in this study who had seen a prescription drug advertisement. DTC
drug advertisements were most frequently seen on television or in magazines. Subjects
were likely to talk with their health care provider about a prescription drag ad they had
seen. While most subjects in this study Mt DTC drug advertisements do not give enough
information about risks and benefits, they did agree these advertisements provide enough
information for them to decide if they should discuss the drug with their
• +u- ctndv DTC drug advertising has not damaged the
provider. Based on the findings in this study, D1 <- arug
patient-provider relationship.
49
Subjects in this study reported to DTC prescript™ drug ads
them
of new drugs, as weil as providing them with
discuss the drug with their health care provider. This study
found tta subjects
likely to discuss an advertised drug with their health care provider. These Mings
suggest that patients are likely to initiate a conversation about an advertised drug with
their health care provider. The patient who approaches their health care provider with a
question about an advertised drug is engaging in self-care agency and acting as the selfcare agent. The nurse practitioner, as health care provider, can assist this patient by using
the supportive-educative nursing system. This can be achieved by educating the patient
about the information they received in a DTC prescription drug ad. This study’s findings
suggest that the probability that patients will discuss advertised drugs with nurse
practitioners and other health care providers is high. This presents the opportunity for
health care providers, particularly nurse practitioners, to assist the patient, as self-care
agent, through use of the supportive-educative nursing system
Limitations of the Study
The size of this sample in this study was relatively small, and the results can only
be generalized to patients in the same geographic area. The ethnicity of the sample was
predominantly “White,” with only 2 subjects reporting their ethnicity as
Indian or Alaska Native.” In addition, a majority of the sample
<73%)'
,
“Too long” written on them by the subject. The
Two surveys had the comment 1
&
been the reason several surveys were not My
lengthiness of the survey may have
a„ examination room before completing the survey
completed. Subjects being called into
may be another explanation for incomplete surv y
50
The seffing in which the survey was administered ma
,
u.
influenced the
responses of some subjects. This may have „
...
subject was a patient at the
survey. An attempt to dispe! this concern was made by pra*8 „
in the cover letter to the questionnaire.
Recommendations for Further Study
To test its effectiveness as a tool for identifying attitudes and behaviors related to
DTC drug advertising, this survey should be tested on larger and more representative
populations. In its current state, the survey is lengthy and may be viewed by some
respondents as inconvenient to complete. Future studies may attempt to simplify and
condense the survey. However, doing so may compromise the comprehensiveness of the
survey as it is currently written. It would also be helpful to apply the McLaughlin SMOG
formula to the survey to test the grade-level difficulty of its readability.
51
References
Allen, M. C. (1997). Medicine goes Madison Avenue: An evaluation of the effect
of direct-to-consumer pharmaceutical advertising on the learned intermediary doctrine.
Campbell Law Review. 20, 113.
The Board of Trustees of the American Medical Association (1999). Direct-to-
consumer advertising of prescription drugs (B of T Report 38 - A-99) [Online],
Available:
http://www.ama-assn.org/meetmgs/public/aimual99/reports/oasite/bot/rtf7bot38.rtf [2000,
September 29].
Borzo, G. (1997, September 8). New FDA rules for advertising drugs on
television raises questions. American Medical News, 3.
Changing the doctor-patient relationship. (1997, May 14). Scott-Levin Press
Release. [Online]. Available:
http://www.scottlevin.com/news/view release.cfin?rid-5 1 [2000, December 2].
Colford, P. D. (1997, October 20). DTC ads: Just what the doctor ordered.
Mediaweek, 7, 46.
Commerce and Trade, 15 U.S.C. 52-55 (1994).
Dickinson, J. G. (1994). 16 do’s and don'ts from FDA. Medical Marketin&&
Media, 29(6), 40-41.
DTC advertising effective catalyst for consumer prescription choice. (1999,
July 19). Drug Store News, CP6.
Everett, S. E. (1991)- Lay audience response to prescription drug advertising.
Journal of Advertising Researching), 43 49.
52
Food
o and
an Drug
rug Administrate
Administration (2000a). Debate brewing on consumer ads for
prescription drugs. [Online]. Available:
http7/www.fda.gov/cder/about/histor y/page52.htm [2000, November 11].
Food and Drug Administration (2000b). Guidance for industry: Consumer-
directed broadcast advertisements. [Online]. Available:
http://www.fda.gov/cder/guidance/index.htm. [2000, November 15].
Food and Drug Administration (2000c). Attitudes and behaviors associated with
direct-to-consumer (DTC) promotion of prescription drugs: Main survey results.
[Online]. Available:
http://www.fda.gov/cder/ddmac/dtcindex.htm. [2000, October 17].
Food and Drugs, 21 U.S.C. 352 (1999a).
Food and Drugs, 21 U.S.C. 352(n) (1999b).
Gelles, J. (1997, September 6). Prescription-drug advertisements prompt cheers,
fears: Onslaught of television commercials may nudge people to go see their doctors, or it
might lead to abuse. The Seattle Times, p. A2.
Gilgore, L. S. (1991). A consideration of direct-to-consumer advertising of
prescription drugs and potential legal problems with the brief summary requirement. Is
the FDA’s regulatory authority illusory? Food, Drug, Cosmetic Law Journal, 46, 849,
855.
Goetzl, D. (2000a). DTC execs quick to learn upfront value. Advertising Age,
71(21), 58.
Goetzl D (2000b). New venture aims to measure effectiveness of DTC drug
work. Advertising Age, 71(23), 16-17.
53
Goetzl, D. (2000c). Pill chill. Advertising Age, 71(36) 1-2.
Gorov, L. (1997, October 13). AIDS drug makers aim pitch right at patients.
Boston Globe, p. Cl.
Hartweg, D. L. (1991). Dorothea Orem: Self-care deficit theory. Newbury Park,
CA: Sage Publications, Inc.
Horton, L. R., & Hastings, K. E. (1998). A plan that establishes a framework for
achieving mutual recognition of good manufacturing practice inspections. Food and Drug
Law Journal, 53, 527.
Kessler, D. A., & Pines, W. L. (1990). The federal regulation of prescription drug
advertising and promotion. Journal of the American Medical Association, 264, 2409-
2415.
Lau, G. (1998, May 18). Doc’s just an employee now. Forbes, 161(10), 162.
Marriner, A. (1986). Nursing theorists and their work. St. Louis: The
C.V. Mosby Company.
Marx, W. (1996). Shrinking the drug pipeline. Management Review, 85(4),
56-59.
Meyer, H. (1998, February 5). The pills that ate your profits. Hospital and Health
Networks, 19, 21.
Morgan, C., & Levy, D. (1998, January 19). To their health: Pharmaceutical firms
are increasing their use of direct-to-consumer advertising. Brandweek, 30.
Orem, D. E. (2001). Nursing: Concepts of practice (6th ed.). St. Louis. MO:
Mosby-Year Book.
54
Pines, W. L. (1997). New challenges for medical product promotion and its
regulation. Food and Drug Law Journal. 52.61 -67
Pinsi, A. (1999). Patient-directed drug advertising puts pressure on U.S. doctors.
The Lancet, 354, 1887.
Prevention Magazine (1998). National survey of consumer reactions to direct-toconsumer advertising. Emmaus, PA: Rodale Press.
Prevention Magazine (1999). Year two: A national survey of consumer reactions
to direct-to-consumer advertising. Emmaus, PA: Rodale Press.
Rosenberg, J. (2000). DTC ramps up for onslaught. Advertising Age, 71(29), 4.
Sherr, M. K., & Hoffman, D. C. (1997). Physicians—Gatekeepers to DTC
success. Pharmaceutical Executive, 17(10), 56.
Sibley, C. E. (2000). Research report: DTC advertising studies. [Online].
Available:
http://www.cohealthcom.org/pages/dtcadstudies.html . [2000, October 15].
Tanouye, E. (1997, December 22). Drug ads spur patients to demand more
prescriptions. Wall Street Journal, p. Bl.
Tyler, B. J., & Cooper, R. A. (1997). Blinded by the hype: Shifting the burden
when manufacturers engage in direct-to-consumer advertising of prescription drugs.
Vermont Law Review, 1073, 1099.
Wechsler, J. (1997, December 6). Direct-to-marketers: FDA talks to the industry.
Pharmaceutical Executive, 52.
Withdrawal of moratorium, 50 Fed. Reg.36,677 (1985).
55
Woodward, D. (1996). The new drug marketing: A consumer protection
perspective. Food and Drug Law Journal. 51. 637.
56
Appendix A
Policy Statements on Product-Specific Direct-to-Consumer
Advertising of Prescription Drugs
1. That the AMA support those product-specific DTC advertisements that follow
the guidelines for such advertisements that were developed by the AMA, in consultation
with the FDA, in 1993. The guidelines are as follows:
a) The advertisement should be disease-specific and enhance consumer
education;
b) The ad should convey a clear, accurate and responsible health education
message (i.e., information on the prevention or treatment of a disease,
disorder, or condition);
c) In all cases, the ad should refer patients to their physicians for more
information;
d) The ad should not encourage self-diagnosis and self-treatment, but
should identify the consumer population risk:
e) Discussion of the use of the drug product for the disease, disorder, or
condition should exhibit fair balance;
f) Warnings, precautions, and potential adverse reactions associated with
the drug product should be clearly explained so as to facilitate
communication between physician and patient;
g) No comparative claims can be made for the product. In the interest of
fair balance, alternative non-drug management options for the disease,
disorder, or condition can be included;
57
h) The brief summary information should be presented in language that
can be understood by the consumer;
i) The advertisement must comply with applicable FDA rules, regulations,
policies and guidelines as provided by their Division of Drug Marketing,
Advertising and Communications;
j) The ad should be part of a manufacturer’s education program that would
include collateral materials to educate both physician and consumer; and
k) The manufacturer should not run concurrent incentive programs for
physician prescribing and pharmacist dispensing.
2. That the AMA encourage the pharmaceutical industry to develop product
specific DTC advertisements, regardless of medium, that follow the above AMA
guidelines.
3. That the AMA encourage the FDA, other appropriate federal agencies, and the
pharmaceutical industry to conduct or fund research on the effect of DTCA, focusing on
its impact on the patient-physician relationship as well as overall health outcomes;
research results should be available to the public.
4. That the AMA encourage physicians to be familiar with the above AMA
guidelines for product-specific DTCA and with the recommendations of the Council on
Ethical and Judicial Affairs (CEJA) Report, “Direct-to-Consumer Advertisements of
Prescription Drugs,”
and to adhere to the ethical guidance provided in the CEJA report.
5. That the AMA continue to monitor DTCA, including new research findings,
and work with the FDA and the pharmaceutical industry to make policy changes
regarding DTCA, as necessary.
58
6. That the following AMA policies be rescinded: H-105.989; H-105.990; H-
105.991; H-105.994; H-105.998; and H-105.999. Policy H-105.993 is modified to delete
any reference to “prescription drugs.” (Board of Trustees, 1999).
59
Appendix B
Direct-to-Consumer Drug Advertising Survey
I would like to introduce myself. My name is Jeffrey R. Larson, RN, SRNP.
This survey is part of a research project I am completing for an
advanced nursing degree at Edinboro University of Pennsylvania. It will
provide information about the effect of drug advertisements on patient
attitudes and behaviors.
*********************$*****
This survey should take about 10 minutes to complete.
Please do not place your name on the survey.
All surveys will be kept strictly anonymous.
All information will be reported as group information.
Your care here will in no way be affected by your decision to participate or
your refusal to participate in this survey.
***************************
For your information, the results of this survey will be posted at the
reception desk in April of 2001.
If you have any questions regarding this research project, please call
Judith Schilling, CRNP, PhD at 814-732-2900.
Thank you very much for your participation.
60
Direct-to-Consumer Drug Advertising Survey
Please answer all questions to the best ofyour ability. Indicate your answer by circling
the number that corresponds with your answer. Depending on your answers, you may
be instructed to skip some questions. You may give more than one answer to some
questions. When you have completed the survey, please return it to the receptionist or
the nurse.
1. What is your gender?
1. Male
2. Female
2. What is your age?
1. 18-39
2. 40-64
3. 65+
3. What is your marital status?
1.
2.
3.
4.
5.
Married
Single
Widowed
Divorced
Separated
4. What is the last grade of school you completed?
1. Grade school or less
2. Some high school
3. Completed
high
--------—
o school
Beyond
high
school (business, technical, etc.)
4. ]
5. Completed college
6. Graduate school or more
5. Which of these best represents your ethnic group?
1. American Indian or Alaska Native
2.
3.
4.
5.
Asian
Black or African-American
Hispanic or Latino
Native Hawaiian or other Pacific Islander
6. White
61
6. Overall, would you say your health is:
1.
2.
3.
4.
5.
Excellent
Very good
Good
Fair
Poor
7. How knowledgeable would you say you are about health and medicines? Would
you say you are:
1.
2.
3.
4.
Extremely knowledgeable
Very knowledgeable
Somewhat knowledgeable
Not at all knowledgeable
8. Do you recall ever seeing or hearing an advertisement for a prescription drug?
1. Yes
2. No*
*If you answered ‘No’ to this question, you are finished with the survey.
Please return the survey to the receptionist. You may keep the pen in return
for your participation. Thank you very much for your participation.
9. Did you see or hear an advertisement for a prescription drug in any of the
following ways (You may circle more than one answer):
On television
On the radio
In a magazine
In a newspaper
On the internet
In
6. ] a letter, flyer, or announcement you got in the mail
7. Anywhere else
1.
2.
3.
4.
5.
10. How many different prescription drugs do you recall seeing advertised?
1.
2.
3.
4.
5.
None
1-3
4-6
7-9
10+
62
11' more
2.
3.
4.
5.
6.
7.
8.
9.
C°ntained
ab<>ut (*>« ™y circle
The benefits of the drug
Directions for use of the drug
Who should take the drug
Questions to ask the health care provider about the drug
What to do in case of an overdose
The risks or side effects of the drug
Who should not take the drug
Have never seen television ads for prescription drugs
12. How easy or difficult is it for you to tell whether an advertisement on television is
for a prescription drug? Would you say it is:
1.
2.
3.
4.
5.
6.
Very easy
Somewhat easy
Neither easy nor difficult
Somewhat difficult
Very difficult
Have never seen television ads for prescription drugs
13. How easy or difficult is it for you to tell whether an advertisement in a magazine
or newspaper is a prescription drug? Would you say it is:
1.
2.
3.
4.
5.
6.
Very easy
Somewhat easy
Neither easy nor difficult
Somewhat difficult
Very difficult
Have never seen magazine or newspaper ads for prescription drugs
14. Advertisements for prescription drugs in magazines and newspapers usually have
small print information that gives more details about the drug. How much, if any,
of the small print information in magazine or newspaper prescription drug
advertisements would you say you usually read? Would you say you.
1.
2.
3.
4.
5.
6.
7.
Read all of the information
Read almost all of the information
Read about half of the information
Read only a little of the information
Read none of the information
Didn’t even notice the information was there
Have never seen magazine/newspaper ads for prescription drugs
63
15. If you were especially interested in the advertised drug for some reason, how
much, if any, of the small print information would you read? Would you say you
would:
1.
2.
3.
4.
5.
6.
Read all of the information
Read almost all of the information
Read about half of the information
Read only a little of the information
Read none of the information
Have never seen magazine or newspaper ads for prescription drugs
16. Has an advertisement for a prescription drug ever caused you to look for more
information, for example, about the drug or about your health?
1. Yes
2. No
17. Did you look for further information (You may circle more than one answer)'.
1.
2.
3.
4.
5.
6.
7.
8.
In a reference book
In a magazine or newspaper
On the internet
By asking a friend, relative, or neighbor
By calling the 1-800 number in the ad
By talking to a pharmacist
By talking to your health care provider
By talking to a health care provider other than your own health care
provider
18.1 like seeing advertisements for prescription drugs.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
19. Advertisements for prescriptions drugs help make me aware of new drugs.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
64
20. Advertisements for prescription drugs do not give enough information about the
possible benefits and positive effects of using the drug.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
21. Advertisements for prescription drugs make the drugs seem better than they really
are.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
22. Advertisements for prescription drugs make the drugs seem more dangerous than
they really are.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
23. Advertisements for prescription drugs do not give enough information about the
possible risks and negative effects of using the drug.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
24. Advertisements for prescription drugs make it seem like a health care provider is
not needed to decide whether a drug is right for me.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
65
25. Advertisements for prescription drugs give enough information for me to decide
whether I should discuss the drug with a health care provider.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
26. Advertisements for prescription drugs help me make better decisions about my
health.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
27. Advertisements for prescription drugs help me have better discussions with my
health care provider about my health.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
28. Only the safest prescription drugs are allowed to be advertised to the public.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
29.1 would not talk with my health care provider about an advertisement for a
prescription drug, because it would seem like I did not trust him/her.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
66
30. Has an advertisement for a prescription drug ever caused you to ask a health care
provider about a medical condition or illness of your own that you had not talked
about to a health care provider before?
1. Yes
2. No
31. At any of the visits to your health care provider, was there any conversation about
a prescription drug?
1. Yes
2. No
32. Did you ever read, hear, or see anything that made you think about a question you
wanted to ask your health care provider about a prescription drug?
1. Yes
2. No
33. Think about what it was that you read, heard, or saw that made you think about
that question. Was it because of (You may circle more than one answer)'.
1. An advertisement on television or radio
2. An advertisement in a magazine or newspaper
3. A news or educational program on TV or radio, or mention in a talk show
4. An article in a magazine or newspaper
5. Something you received in the mail
6. Something a friend, relative, or neighbor said
7. A talk you had with a health care provider other than your own
8. Something you saw on the internet
9. Something else
10. Never had a question about a prescription drug
34. Are you currently taking one or more prescription drugs?
1. Yes
2. No
35. Before any visits to your health care provider, did you ever think he/she might:
1.
2.
3.
4.
Switch your current drug to a new drug
Keep you on your current drug
Start you on a new drug for a different condition
I’m not taking any prescription drugs
36. Think about what it was that made you think your health care provider might put
you on a new prescription drug. Was it because of (Tom may circle more than
one answer):
1. An advertisement on television or radio
2. An advertisement in a magazine
3. A news or educational program on TV or radio, or mention in a talk show
4. An article in a magazine or newspaper
5. A previous prescription for the same condition
6. Something you received in the mail
7. Something a friend, relative, or neighbor said
8. A talk you had with a health care provider other than your own
9. Something you saw on the internet
10. Something else
11. Have never thought my provider would put me on a new drug
37. Have you ever asked your health care provider whether there is a prescription
drug to treat your condition?
1. Yes
2. No
38. Have you ever asked your health care provider about a specific brand of
prescription drug?
1. Yes
2. No
39. Have you ever mentioned an advertisement you saw or heard for a drug, or did
you bring any information about a drug with you?
1.
2.
3.
4.
Yes, I mentioned an ad I saw or heard
Yes, I brought something about the drug with me
Yes, both
No
40. Which, if any, of these possible reactions did your health care provider have when
you asked about the drug? {You may circle more than one answer)-.
1.
2.
3.
4.
5.
He/she seemed to get angry or upset
He/she seemed to react like it was an ordinary part of the visit
He/she seemed to welcome my question
He/she discussed the drug with me
Have never asked about a prescription drug
68
41. How did you feel about your health care provider’s reactions when you asked
about the drug? Were you:
1.
2.
3.
4.
5.
6.
Very satisfied
Satisfied
Neither satisfied nor unsatisfied
Unsatisfied
Very unsatisfied
Have never asked about a prescription drug
42. Did your health care provider do one or more of the following (You may circle
more than one answer)'.
1.
2.
3.
4.
5.
6.
Give you the prescription drug you asked about
Recommend a different prescription drug
Recommend an over-the-counter drug
Recommend no drug
Recommend that you make changes in your behavior or lifestyle
Have never asked about a prescription drug
43. Did your health care provider tell you why he/she didn’t prescribe the drug you
asked about?
1. Yes. Was it because (You may circle more than one answer)'.
• The drug was not right for you
• The provider wanted you to take a different drug
• The drug had side effects you were not aware of
• You did not have the condition the drug is used to treat
• A less expensive drug was available
• The provider said you didn’t need a prescription drug
• The provider said you could use an over-the-counter drug
• Some other reason
2. No
3. Have never asked about a prescription drug
44. If you saw an advertisement for a drug that treats a condition that was bothering
you, how likely would you be to talk to your health care provider about the drug?
1.
2.
3.
4.
5.
Very likely
Somewhat likely
Neither likely nor unlikely
Somewhat unlikely
Very unlikely
69
45. Which, if any, of these possible reactions do you think your health care provider
would have if you asked about a prescription drug you had seen advertised? (You
may circle more than one answer) ’.
1.
2.
3.
4.
5.
He/she would get angry or upset
He/she would react like it was an ordinary part of the visit
He/she would welcome my question
He/she would discuss the drug with me
None of the above
Thank you for completing this survey. You may keep the pen in return for your
participation. Please return the survey to the receptionist or the nurse.
70
Appendix C
Additional Data
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□
PATIENT ATTITUDES AND BEHAVIORS REGARDING
DRUG ADVERTISEMENTS
By
Jeffrey R. Larson, RN, BSN
Submitted in Partial Fulfillment of the Requirements for
The Master of Science in Nursing Degree
Edinboro University of Pennsylvania
Approved by:
Judith Schilling, CRNP, PhD fl
Committee Chairperson
z/)7_
^t^eTyeisel, PhD, RN
Committee Member
-
Date
d/
D^fcbi^^hD, RN
Committee Member
p
i
Abstract
Direct To Consumer Drug Promotion: Patient Attitudes and Behaviors Regarding
Drug Advertisements
Since the U.S. Food and Drug Administration (FDA) relaxed its restrictions on
broadcast TV advertising of pharmaceutical products in 1997, direct-to-consumer (DTC)
advertising has boomed. DTC drug ads can encourage dialogue between patients and
their health care providers (Morgan and Levy, 1998), which can strengthen the patient
provider bond if the patient gains a sense of participation in his health care (Woodward,
1996). However, these ads can also strain this relationship when the provider does not
prescribe the requested drug (Gelles, 1997). With DTC drug ads having such an impact
on the patient-provider relationship, it is important to understand the patient attitudes and
behaviors that are a result of DTC drug ads. Nurse practitioners are in a position to
educate patients who may have misconceptions resulting from DTC ads.
The purpose of this research is to survey health care consumers in order to
determine their experiences with DTC drug advertisements, any actions they may have
taken as a result of these ads, their attitudes and beliefs regarding DTC drug advertising,
and the influence of DTC drug ads on the patient’s perception of the patient-provider
relationship. Patients in a rural primary care facility in western New York state completed
a self-administered questionnaire. The survey collected demographic information and
investigated the respondents’ attitudes and behaviors associated with DTC
advertisements. A total of 188 questionnaires were returned. Due to attrition, 137
questionnaires were included in the final analysis. Of the sample population (A=137),
90.51% had been exposed to DTC drug ads. Television was cited most frequently
ii
(97.58%) as the source of DTC drug ads. Only 5% of subjects indicated they would not
talk with their health care provider about an ad because of trust issues.
In summary, exposure to DTC drug ads is high, with television and magazines
being the leading sources of these ads. While the study results show no adverse effects on
the patient-provider relationship, the continued rise and evolution of DTC advertising
may have an effect on the patient-provider relationship. This provides nurse practitioners
with an opportunity to educate patients about prescription drugs. Suggestions are offered
for future research of DTC drug advertising.
iii
Acknowledgements
I would like to express my most sincere appreciation to all those people who
helped me complete this research project. Thank you to the entire committee for your
patience with my procrastination. To Dr. Judith Schilling, thank you for being the
chairperson of this committee, and for helping me bring this project to a successfill
completion. To Dr. Janet Geisel, thank you for encouraging me to pursue this research
project, and for your knowledge of the research process. To Dr. Debra Kubinski, thank
you for your many words of encouragement, and for being readily available to discuss
this project as it was evolving. Thank you to Chris Flanders, FNP and the staff at the
Sherman, NY office of Westfield Family Physicians for their assistance and support of
this project. And last, but certainly not least, thank you to my wife Lisa, who I’m sure I
left around here somewhere. You have shown me undying support in my pursuit of this
project. Because of this project, you have spent many hours and days without me and you
must be wondering if you really have a husband. You do. I love you. Once again, thank
you, Lisa, for all you have done throughout this endeavor. This project received partial
support from Nu Theta Chapter of Sigma Theta Tau in May 2001.
iv
Table of Contents
Contents
Page
Abstract ...
i
Acknowledgements
iii
List of Tables
Chapter 1: Introduction
Background of the Problem
,vii
1
1
Direct-to-consumer (DTC) Advertising Boom
1
Effect on Patients
1
Problem Statement
2
Theoretical Framework
.4
Statement of the Purpose
5
Assumptions
6
Limitations
6
Definition of Terms
6
Summary
7
Chapter 2: Review of the Literature
History...
Regulation of DTC Advertising
DTC Spending
DTC Research
The Time, Inc. studies
The Prevention Magazine studies
8
8
10
11
12
12
13
V
Contents
The Food and Drug Administration (FDA) study
Page
14
Effects of DTC Advertising
16
Summary
19
Chapter 3: Methodology
.21
Research Questions
21
Research Design
21
Sample, Setting, and Procedure
22
Instrumentation
22
Protection of Human Rights
Pilot Study
23
Data Analysis
24
Summary
24
Chapter 4: Findings
26
Sample
Results
26
DTC Exposure
Demographics
Perceived Overall Health
30
Perceived Knowledge of Health and Medicines
DTC Sources...
DTC-Related Behaviors
Patient Attitudes...
32
vi
Contents
DTC’s Influence on the Patient-provider Relationship
Summary
Page
38
39
Chapter 5: Discussion
41
DTC Exposure
.41
Demographics
41
Perceived Overall Health Status
42
Perceived Knowledge of Health and Medicines
42
Sources of DTC Advertising
43
Patient Behaviors
.43
Patient Attitudes
44
The Patient-Provider Relationship
.47
Conclusions
.48
Limitations of the Study
.49
Recommendations for Further Study
50
References
51
Appendix A: Policy Statements on Product-Specific Direct-to-Consumer
Advertising of Prescription Drugs
56
Appendix B: Direct-to-Consumer Drug Advertising Survey
59
Appendix C: Additional Data
70
vii
List of Tables
Tables
Page
1: Comparison of Total Sample (A=137) by Gender: DTC Exposure............
.27
2: Comparison of Total Sample by Age: DTC Exposure................................
.28
3: Comparison of Total Sample by Marital Status: DTC Exposure................
.29
4: Comparison of Total Sample by Highest Education Level: DTC Exposure
30
5: Likert Multiple Choice Rating of Perceived Overall Health on the Day the
Survey was Taken and DTC Exposure
31
6: Likert Multiple Choice Rating of Self Perception of Knowledge About Health and
Medicines and DTC Exposure
32
7: Sources of DTC Drug Ads as Reported by Survey Subjects (jV=124)
33
8: Source of Information That Caused Subjects to Ask Their Health Care Provider
.35
About a Prescription Drug (7V=110)
9: Likelihood That Subjects Would Talk to Their Health Care Provider About an Ad
for a Drug That Treats a Condition That is Bothersome to the Subject (AT=112)
36
10: Likert Multiple Choice Rating: I Like Seeing Advertisements for
37
Prescription Drugs (Question 18)......................
11: Satisfaction With Health Care Provider’s Reaction to a Question About a Drug
.40
1
Chapter 1
Introduction
This chapter provides a brief overview of direct-to-consumer (DTC) advertising
of drugs and the related problems. Dorothea Orem’s self-care deficit theory of nursing
(Orem, 2001) supplies the conceptual framework for this research. Her core concepts of
self-care, self-care agency, nursing agency, and nursing systems are employed in the
conceptual framework. The background of the problem, problem statement, purpose of
the study, assumptions, and limitations are also included in this chapter.
Background of the Problem
DTC drug advertising has existed since the early 1980s (Board of Trustees of the
American Medical Association, 1999). It has been a controversial subject since its
inception and its recent growth has elevated the controversy surrounding it.
Direct-to-consumer (DTC) advertising boom. Since the U.S. Food and Drug
Administration (FDA) relaxed its restrictions on broadcast television advertising in 1997,
DTC advertising has boomed and DTC spending has steadily increased (Goetzl, 2000a;
Goetzl, 2000b; Goetzl, 2000c). Goetzl (2000b; 2000c) found that DTC drug advertising
had nearly doubled from $1 billion in 1997 to $1.8 billion in 1999. This steady increase
in DTC drug advertising expenditures suggests that DTC advertising of drugs is effective
(Goetzl, 2000a; Goetzl, 2000b; Goetzl, 2000c; Meyer, 1998).
Effect on patients. Defenders of DTC drug promotion claim that the
advertisements make patients aware of medical problems and potential treatments,
thereby encouraging more patients to seek medical attention from their providers (Allen,
1997; Gelles, 1997; Morgan & Levy, 1998). However, problems can arise when a patient
2
has too much information and not enough ability to interpret that information
appropriately (Borzo, 1997). Such patients may self-diagnose, may believe that a certain
medication is what they need, and may become upset if a clinician does not prescribe the
drug seen in an advertisement (Gelles, 1997). This can lead to undue strain on the patient
provider relationship (Tyler & Cooper, 1997).
Problem Statement
In the United States, DTC advertising of prescription drugs is a multi-million
dollar industry, is having a major impact on the way consumers receive information on
drugs (Morgan & Levy, 1998; Tyler & Cooper, 1998) and, in some cases, impacts how
some health care providers prescribe medicines (Colford, 1997; Gelles, 1997; Sherr &
Hoffmann, 1997; Tanouye, 1997). With so much being spent on DTC drug advertising, it
is easy to see why a great many consumers receive prescription drug information via
DTC advertising (Colford, 1997; Gorov, 1997; Tyler & Cooper, 1997). One of the results
of this mass dissemination of drug information is a higher level of consumer awareness.
With so many patients being educated through DTC advertising, there has been an
effect on the manner in which they approach their health care providers (Gelles, 1997).
These patients typically arrive at their provider’s office with an idea of what is ailing
them and what medicine is appropriate for that ailment. Often, the consumer has been
drawn in by the advertising pitch and has not noticed the list of the drug s side effects
presented in the ad (Borzo, 1997). Everett (1991) suggests this may be especially true in
the case of the older patient because they are more likely to be less rational in their
interpretation of advertisements and rely upon brand names when selecting a drug.
3
The recent focus on customer service and patient satisfaction may cause some
health care providers to feel compelled to submit to their patients’ medication requests
(Colford, 1997, Lau, 1998, Tanouye, 1997). With their incomes becoming more and
more strained by managed care cost cutting, providers cannot afford to lose patients (Lau,
1998; Tanouye, 1997).
In 1993, the American Medical Association (AMA), in consultation with the
FDA, developed a set of guidelines for DTC drug advertising. In 1999, the Board of
Trustees of the AMA used those guidelines to draft a list of policy statements for DTC
drug advertising and recommended that these policy statements be adopted by their
membership.
DTC drug promotion is a growing marketing technique that will have a greater
impact as the American baby-boomer population ages (Rosenberg, 2000). This will result
in a greater amount of DTC drug ads aimed at their health care dollars. With this in mind,
it is necessary to determine the attitudes and behaviors resulting from the flood of DTC
drug advertisements.
The mass distribution of drug information resulting from DTC drug advertising
can create well-informed patients and enhance the dialogue between nurse practitioners
and their patients. However, DTC drug advertising also creates some concerns for nurse
practitioners. Patients armed with information from DTC drug advertisements may
pressure nurse practitioners to prescribe medicines they’ve seen advertised. Nurse
practitioners may find themselves confronted by patients who know more about a drug or
treatment than they do. The nurse practitioner-patient relationship may also grow weaker
when nurse practitioners refuse patient requests.
4
There is limited research of DTC drug advertising and this researcher found no
nursing research of this topic. Because nurse practitioners have prescriptive authority,
and are likely to be affected by DTC drug advertising, it is important for them to
investigate patient attitudes and behaviors regarding DTC drug ads, as well as the effects
of these ads on the patent-provider relationship.
Theoretical Framework
This research employs Dorothea Orem’s self-care deficit theory of nursing as its
conceptual basis (Orem, 2001). More specifically, it applies four of the six core concepts
of Orem’s theory: (a) self-care, (b) self-care agency, (c) nursing agency, and (d) nursing
systems. Orem (2001) described self-care as activities that individuals initiate and carry
out in order to maintain their own life, health, and well-being.
Self-care agency is the ability of individuals to engage in self-care (Hartweg,
1991). The person who engages in self-care is called the self-care agent. A mature
individual possesses the capability to determine self-care needs, decide what action is
necessary, and perform the appropriate activities to meet self-care needs.
Nursing agency is the attribute of nurses to identify the self-care demands and
needs of others, to help others recognize and meet their self-care demands, and to help
others in developing self-care agency (Orem, 2001). In situations in which the individual
is unable to meet self-care demands, there exists a self-care deficit and an opportunity for
a relationship with nursing agency.
Orem’s concept of nursing systems is divided into three types: (a) wholly
compensatory, (b) partly compensatory, and (c) supportive-educative. This research
utilizes the supportive-educative nursing system as its focus. In a supportive-educative
5
nursing system, the patient performs the actions, and the nurse practitioner supports,
guides, assists, teaches, and provides a therapeutic environment (Hartweg, 1991).
“i
Orem s self-care deficit theory of nursing provides a general framework to direct
nursing action (Marriner, 1986, p. 125). Orem’s theory helps the nurse identify the
individual s need for nursing by evaluating their ability to engage in self-care or their
level of self-care deficit. The nurse practitioner can then employ nursing systems to
restore or improve the individual’s ability to practice self-care.
The abundance of DTC drug advertisements that exists in the American media has
resulted in consumer confusion, an increase in unnecessary physician office visits, and, in
some cases, a strain in the patient-provider relationship (Gelles, 1997; Sherr & Hoffinan,
1997; Tyler & Cooper, 1997). This has created an opportunity for the nurse practitioner
to help health care consumers perform self-care and to engage in nursing agency by
assisting consumers (self-care agents) through use of the supportive-educative nursing
system. By studying the attitudes and behaviors caused by DTC drug advertising, nurse
practitioners can better understand the motivations and beliefs behind patients’ DTC
generated drug requests.
Statement of the Purpose
The purpose of this research was to survey health care consumers in order to
determine their experiences with DTC drug advertisements, including exposure to DTC
drug ads and any action they may have taken as a result of these ads. The survey also
focused on the respondents’ attitudes and beliefs regarding DTC drug advertising and the
influence of DTC drug ads on the patient’s perception of the patient-provider
relationship.
6
Assumptions
For the purposes of this research project, the following assumptions were made:
1. The survey respondents are capable of reading and understanding spoken
English and comprehending the survey and the information contained in DTC drug
advertisements whether printed, televised, or broadcast by radio.
2. The patient/health care consumer is exposed to and reads/views/listens to DTC
drug advertisements.
3. Research subjects will answer all survey questions honestly.
4. Unanswered survey questions are categorized as “Refused to answer”.
Limitations
The limitations of the study were identified as follows:
1. The research respondents were comprised of a convenience sample in a
primary care practice in western New York state. As a result, survey results may not
apply to other populations.
2. The research instrument was researcher-adapted to be used as a self-
administered questionnaire. It was adapted from a telephone survey used in a 1999 FDA
study of DTC drug advertising.
Definition of Terms
The following terms have been defined for this study:
1. Direct-to-consumer (DTC) drug advertising is product-specific advertising in
print and broadcast media aimed directly at consumers. Such advertisements contain
information on the brand name pharmaceutical product, including claims of effectiveness
7
specific disease(s) or medical condition(s), as well as risk information (Board of
Trustees, 1999).
2. Health care consumer is anyone who seeks or purchases health care.
3. Health care provider is any physician, nurse practitioner, or physician’s
assistant with the authority to prescribe medicines and medical treatments.
4. Prescription drugs are those medicines that can only be legally obtained with a
prescription from someone who has the authority to prescribe medicines (e.g., physicians
or nurse practitioners).
Summary
DTC drug advertising has escalated sincel997 when the FDA loosened its
restrictions on this type of advertising (Goetzl, 2000b; Goetzl, 2000c). DTC drug
advertisements can have both positive and negative effects on consumers (Gelles, 1997)
and their relationship with their health care provider (Tyler & Cooper, 1997). Dorothea
Orem’s (2001) self-care deficit nursing theory, with an emphasis on self-care agency,
provides the theoretical framework for this study. The purpose of this study is to
determine patients’ attitudes and behaviors toward prescription drugs as a result of
DTC drug promotion by means of a self-administered survey. The study will also
attempt to determine the effect of DTC drug ads on the patient-provider relationship.
The assumptions, limitations, and definitions of terms are also presented.
8
Chapter 2
Review of the Literature
This chapter presents a brief history of direct-to-consumer (DTC) drug advertising
and promotion of drugs. A review of the literature concerning DTC drug promotion,
government regulation of DTC drug advertising, data on DTC spending, and the effects
of DTC drug promotion on consumers, clinicians, and managed care organizations
(MCO) are presented. Although limited in number, studies regarding DTC drug
promotion and the patient-provider relationship are also discussed.
History
DTC drug advertising is a relatively new area of marketing, and the advertising of
drugs using DTC promotion presents the United States Food and Drug Administration
(FDA) with many challenges. In May 1983, Boots Pharmaceuticals was the first company
to use DTC advertising in promoting its Rufen brand of ibuprofen (Food and Drug
Administration [FDA], 2000a). The FDA was concerned that consumers would not be
able to read the long list of side effects that was quickly flashed on the screen, and it took
action against the commercial. It was soon replaced with an acceptable version.
That same year, because the FDA lacked a formal policy regarding DTC drug
advertising, it called for a voluntary moratorium on DTC drug advertising campaigns for
pharmaceutical products (Pines, 1997). This moratorium was called to provide time for
dialogue among consumers, health professionals, and the pharmaceutical industry (Pines,
1997). It was also thought that the moratorium would allow time for research regarding
DTC drug advertising, and that this research would yield some answers to many of the
questions concerning DTC drug advertising (Gilgore, 1991).
9
The FDA withdrew this moratorium in 1985 and announced that the standards
that applied to physician-directed advertisements would also be applied to DTC
advertisements. These were the standards of fair balance, full disclosure, and the
inclusion of a brief summary of the FDA-approved package insert (Withdrawal of
moratorium, 1985; Gilgore, 1991).
In August 1997, The FDA promulgated a draft Guidance that changed the
requirements for prescription drug advertisements. These requirements applied to radio,
television, and telephone communication system advertisements (FDA, 2000b). The
Guidance was drafted to provide consumers with adequate risk information and to afford
them the ability to make informed decisions. While the Guidance does not change any
FDA regulations, it does provide a structural basis for broadcast advertisements that
assists manufacturers in complying with regulatory objectives (Wechsler, 1997).
Currently, the Guidance remains in draft form (FDA, 2000b). The FDA’s
Division of Drug Marketing, Advertising, and Communications (DDMAC) has requested
feedback on the Guidance concerning the following issues: (a) the effects of DTC
promotion on the public health, (b) the degree to which consumers are taking advantage
of the mechanisms for obtaining approved package labeling in connection with broadcast
advertisements, and (c) how risk messages can best be integrated into broadcast
advertisements.
Since putting the draft Guidance into effect in 1997, the FDA has given no
indication that it is ready to promulgate permanent guidelines (FDA, 2000b). Therefore,
the draft Guidance should be treated as guidelines by the pharmaceutical industry (Borzo,
1997).
10
Regulation of DTC Advertising
DTC drug promotion is regulated by two federal agencies: the FDA and the
Federal Trade Commission (Food and Drugs, 1999a; Food and Drugs, 1999b). The
FDA’s regulation of the development, distribution, and promotion of pharmaceutical
products is authorized by the Food, Drug, and Cosmetic Act (FDCA) (Food and Drugs,
1999b). The FDA is responsible for monitoring DTC drug advertisements, and for
reviewing all such advertisements prior to their media release. This review process
includes statutory requirements that all advertisements contain fair balance of risk and
benefit information, prominent display of risk information in the main body of the
advertisement, and a brief summary of product indications, contraindications, warnings,
adverse reactions, and overdoses (Dickinson, 1994; Kessler & Pines, 1990).
The FDA maintains jurisdiction over the promotion of prescription drugs (Food
and Drugs, 1999a) while the Federal Trade Commission maintains jurisdiction over the
promotion of over-the-counter (OTC) drugs (Commerce and Trade, 1999). The Federal
Trade Commission receives its authority to regulate DTC advertising from the Lanham
Act of 1946.
The two agencies often cooperate on advertising issues but utilize separate
authority and legal mechanisms to exercise their respective authorities (Pines, 1997). The
Federal Trade Commission routinely relies on industry self-regulation regarding
advertising (Commerce and Trade, 1999). The FDA, however, utilizes a hands-on style
and is more observant in its regulation of the advertising industry (Horton & Hastings,
1998).
11
The American Medical Association (AMA) had opposed DTC advertising of
prescription drugs until 1992 (Marx, 1996; Board of Trustees, 1999). That year, the AMA
collaborated with the FDA to issue guidelines for DTC advertising that called for
accurate information and fair balance of benefit and risk information (Pirisi, 1999). In
1999, the Board of Trustees of the AMA recommended adoption of a list of policy
statements on DTC advertising by its membership (Appendix A).
DTC Spending
Nationwide, spending on DTC drug advertising has increased since the FDA
relaxed it restrictions on broadcast television advertisements (Goetzl, 2000b). IMS Health
consultancy figures show that DTC television expenditures for 1996 were $220 million.
In 1997, the year the FDA made the change midyear, expenditures grew to $310 million.
In 1998, they climbed to $664 million, and then jumped to $1.1 billion in 1999 (Goetzl,
2000b).
Goetzl (2000c) found that overall DTC spending had nearly doubled from $1
billion in 1997 to $1.8 billion inl999. This steady increase in DTC expenditures suggests
that DTC advertising of drugs is effective.
Americans over the age of 50 purchase over 77% of all prescription products
(Rosenberg, 2000). With the mature consumer spending more than $20 billion per year
on prescription drugs, it follows that pharmaceutical marketers should focus their efforts
on them.
Another leading factor contributing to the increase in DTC spending is the spread
of managed care. Managed care has made it increasingly difficult for pharmaceutical
marketers to reach prescribers (Wechsler, 1997). Pharmaceutical companies believe that
12
they can increase their market shares if they can reach both the prescriber and the
consumer (Gelles, 1997).
PTC Research
To date, there have been few studies focusing on the effects of DTC drug
promotion on patients and providers. The most notable studies were conducted by Time,
Inc. (Sibley, 2000), Prevention Magazine (Prevention Magazine, 1998; Prevention
Magazine, 1999), and the FDA (FDA, 2000c).
The Time, Inc, studies. In March and April of 1998, Time, Inc. conducted a
telephone survey of 1500 adults, aged 18 or older. The study, titled, “1998 Direct-toConsumer Advertising Study: Consumer and Physician Attitudes” looked at the effects of
PTC drug promotion on consumers and physicians (Sibley, 2000). In March and April of
1999, Time, Inc. conducted another telephone survey titled, “1999 Consumer Attitudes
Toward Pirect-to-Consumer Advertising.” This survey of 1000 adults, aged 18 or older,
focused on consumer attitudes toward PTC advertising (Sibley, 2000).
The Time, Inc. studies suggested that PTC drug advertising has not damaged the
patient-provider relationship. The 1998 Time, Inc. (Sibley, 2000) study found that 84% of
respondents agreed that, “My doctor knows what is best.” Eighty percent of respondents
in the 1999 Time, Inc. study echoed this attitude (Sibley, 2000).
Time Inc.’s 1998 study found that 28% of respondents would switch doctors to
get a desired medication (Sibley, 2000). The 1999 Time, Inc. study (Sibley, 2000)
explored this issue in the context of the seriousness of the condition involved. When
asked whether they would switch doctors if they didn’t get the requested drug, 50% of
respondents agreed they would switch doctors if the condition were something less
13
serious such as heartbum, allergies, or migraines. Twenty-four percent of respondents
agreed they would switch doctors if they didn’t receive the requested medication for a
more serious illness like depression.
The Prevention Magazine studies. In March and April of 1998, Prevention
Magazine conducted a study titled, ccNational Survey of Consumer Reactions to Directto-Consumer Advertising” (Prevention Magazine, 1998). This study was a telephone
survey of 1200 adults aged 18 or older. In 1999, Prevention Magazine conducted a
follow-up study titled, “Year Two: A National Survey of Consumer Reactions to Direct-
to-Consumer Advertising” (Prevention Magazine 1999). This study was also a telephone
survey of 1200 adults aged 18 or older. The studies attempted to track consumer
awareness of DTC drug advertising and to assess DTC’s effectiveness as a means of
promoting prescription medicines and public health (Prevention Magazine, 1998;
Prevention Magazine, 1999).
The two Prevention studies found that, overall, consumers are positive about DTC
drug advertisements because they provide them with the information to meet their self-
care needs Prevention ’s 1998 survey found that 74% of respondents felt that DTC drug
ads allow people to be more involved in their health care (Prevention Magazine, 1998). In
the 1999 survey, 76% of respondents expressed this attitude (Prevention Magazine,
1999). When asked about the presence of information about risks and benefits in DTC
drug ads, 67% of respondents in the 1998 survey (Prevention Magazine, 1998) and 72%
of respondents in the 1999 survey (Prevention Magazine, 1999) agreed that DTC drug
ads educate people about the risks and benefits of prescription drugs. The 1998 survey
(Prevention Magazine, 1998) also found that 59% of respondents felt that DTC drug ads
14
help people make their own decisions about prescription medicines. In the 1999 survey
(Prevention Magazine, 1999) this number rose to 63%.
The Prevention studies (Prevention Magazine, 1998; Prevention Magazine, 1999;
Sibley, 2000) also found that some consumers believed that DTC drug advertisements
may help boost compliance with their medication regimens. Prevention ’s 1998
(Prevention Magazine, 1998; Sibley, 2000) study found that 25% of respondents believed
that DTC drug advertisements made them more likely to take their medicines and
reminded them to refill prescriptions. Prevention ’s 1999 study (Prevention Magazine,
1999; Sibley, 2000) found an increase in that number with 31% of respondents saying
that DTC drug advertisements made them more likely to take their medicines and 33% of
respondents saying DTC drug advertisements reminded them to have their prescriptions
refilled.
On the negative side, 55% of respondents Prevention’s 1998 survey (Prevention
Magazine, 1998) felt that DTC drug ads make prescription drugs seem harmless while
49% of respondents in the 1999 survey (Prevention Magazine, 1999) felt this way. Also,
38% of respondents in the 1998 survey (Prevention Magazine, 1998) and 39% of 1999
survey respondents (Prevention Magazine, 1999) felt that DTC drug ads cause tension
between doctors and their patients.
The Food and Drug Administration (FDA) study. In 1999, the FDA conducted a
telephone survey of 1081 health care consumers to determine attitudes and behaviors
resulting from DTC drug promotion (FDA, 2000c). This study focused on people
(n=960) who had seen a doctor in the last 3 months but also reported results on
respondents (m=121) who had not seen a doctor in the last 3 months.
15
The FDA study (FDA, 2000c) found that television (94%) and magazines (66%)
were the most frequent sources of DTC advertisements among respondents who had seen
a doctor in the last 3 months. This held true among respondents who had not seen a
doctor in the last 3 months also with 96% of respondents citing television, and 58% citing
magazines as primary sources of DTC advertisements.
When asked, Has an advertisement for a prescription drug has ever caused you to
ask a doctor about a medical condition or illness of your own that you had not talked to a
doctor about before?” 27% of respondents who had seen a doctor in the last 3 months
(>7-688) answered “Yes” and 72% answered “No”. Of those who had not seen a doctor in
the last 3 months (>7=83), 8% answered “Yes” and 92% answered “No” (FDA, 2000c).
When respondents to the FDA survey (FDA, 2000c) were asked whether they like
seeing advertisements for prescription drugs, 21% of those who had seen a doctor in the
last 3 months (>7=711) answered, “Agree strongly”, 31% answered, “Agree somewhat”,
while 16% answered, “Disagree strongly.” Eighteen percent of respondents who had not
seen a doctor in the last 3 months (>7—89) answered, Agree strongly9,26% answered,
“Agree somewhat”, and 19% answered, “Disagree strongly.
When asked if they felt that advertisements for prescription drugs help them make
better decisions about their health, 18% of respondents who had seen a doctor in the last
3 months (n=71 1) answered, “Agree strongly”, 29% answered, “Agree somewhat”, and
21% answered, “Disagree strongly” (FDA, 2000c). Of those who had not seen a doctor in
the last 3 months (n=89), 13% answered, “Agree strongly”, 28% answered, “Agree
somewhat”, and 16% answered, “Disagree strongly.”
16
The FDA study (FDA, 2000c) also found that, among respondents (w=71 l)who
had seen a doctor in the last 3 months, 3% “Agreed strongly”, 15% “Disagreed
somewhat , and 72% “Disagreed strongly” that they would not talk with their doctor
about a prescription drug advertisement because it would seem like they did not trust
their doctor. When this question was asked of respondents (n=89) who had not seen a
doctor in the last 3 months, 3% answered, “Agree strongly”, 21% answered, “Disagree
somewhat”, and 66% answered, “Disagree strongly.”
Effects of DTC Advertising
DTC advertising can have a positive effect on consumer education and health care
seeking behaviors (Tyler & Cooper, 1997; Morgan & Levy, 1998). The primary effect of
DTC advertising is a heightened consumer awareness of the drugs available to them and
an increased interaction with their health care provider if they learn of a drug that they
believe may treat their medical problem.
DTC advertisements also are directed at the consumer’s need for control, personal
fulfillment, and freedom, as well as their fears (Allen, 1997). DTC advertisements use
this strategy to motivate consumers to make further inquiries about their product.
Prevention ’s 1999 survey (Prevention Magazine, 1999) found that 76% of consumers
agreed that DTC drug advertisements helped them to be more involved in their health
care, 72% of consumers agreed that DTC drug advertisements educated them about risks
and benefits of prescription drugs, and 63% of consumers agreed that DTC drug
advertisements help people make their own decisions about prescription medicines.
One of the best arguments defending DTC drug promotion is the claim that these
advertisements alert consumers to medical problems and potential treatments, thereby
17
moving those who need medical attention to visit their health care provider (Gelles,
1997). Many of these advertisements encourage consumers to see their doctor if they
believe the advertised drug may help them (Morgan & Levy, 1998). Time, Inc.’s 1998
survey found that DTC advertising led 13% of consumers to speak with their health care
provider about a medical condition not previously discussed (Sibley, 2000). The FDA’s
survey in 1999 (FDA, 2000c) found that DTC advertising resulted in 27% of consumers
speaking with their health care provider about a medical condition not previously
discussed.
The Prevention studies (Prevention Magazine, 1998; Prevention Magazine, 1999)
also found that some consumers believed that DTC drug advertisements may help boost
compliance with their medication regimens. Prevention’s 1998 (Prevention Magazine,
1998) study found that 25% of respondents believed that DTC drug advertisements made
them more likely to take their medicines and reminded them to refill prescriptions.
Prevention’s 1999 study (Prevention Magazine, 1999) found an increase in that number
with 31% of respondents saying that DTC drug advertisements make them more likely to
take their medicines and 33% of respondents saying DTC drug advertisements reminded
them to have their prescriptions refilled.
DTC advertising can also cause problems for health care consumers (Gelles,
1997). Patients may self-diagnose and approach their health care provider about a
particular medication they saw in an ad, and that they believe they need. If the provider
does not prescribe the requested medication, the patient may become upset. If this occurs,
the patient-provider relationship may become strained and the patient’s trust in the
provider damaged (Tyler & Cooper, 1997).
18
e may also be times when a provider does not question the patient’s request
for a medication, fails to give a full clinical evaluation, and prescribes the drug (Gelles,
1997). If the wrong drug is prescribed, the patient could be harmed due to a drug
interaction, masking of the symptoms of a comorbidity, or an undetected contraindication
to the prescribed drug.
Detractors of DTC advertising believe that drug advertisements increase the use
of prescription drugs by distorting patient-provider relationships (Gelles, 1997). They
believe the advertisements’ primary goal is to sell drugs and that they are poor sources of
patient education. They also point out that the advertisements do not discuss alternative
drugs or treatments. These factors can cause the provider to spend increased amounts of
time educating their patients with appropriate information. Studies show that DTC
advertising leads to increased patient loads and increased time spent explaining the
benefits and risks of a specific drug and formulary restrictions if the requested drug is not
on the patient’s health plan formulary (Sherr & Hoffman, 1997).
In the end, the provider decides whether the medicine will be prescribed and it is
the provider’s signature that is required before the medication will be dispensed
(Tanouye, 1997). This affords the provider primary authority and power over what will
be prescribed.
Summary
DTC advertising is a relatively new marketing approach that is rapidly
proliferating and evolving. DTC drug ads first surfaced in 1983. Shortly thereafter, in the
interest of consumer protection, the FDA called for a moratorium on DTC advertising
(Pines, 1997). In 1993, the FDA, in collaboration with the AMA, developed a set of
19
guidelines for DTC advertising (Board of Trustees, 1999). In 1997, the FDA presented
these guidelines as the Draft Guidance for Industry (FDA, 2000b). This Guidance was
not a set of regulations, but rather a blueprint that the pharmaceutical marketing industry
could follow in developing DTC advertisements. In 1999, the Board of Trustees of the
AMA called for its membership to adopt a set of policy statements regarding DTC
advertising. These policy statements were analogous to the Draft Guidance set forth by
the FDA.
Both the FDA and the Federal Trade Commission regulate DTC advertising
(Food and Drugs, 1999a; Food and Drugs, 1999b; Commerce and Trade, 1999). The
FDA, as set forth by the Food, Drug, and Cosmetic Act, maintains jurisdiction of
prescription drug promotion, while the FTC, as mandated by the Lanham Act of 1946,
has jurisdiction over OTC drugs and products.
Relatively few studies have focused on the effects of DTC drug promotion on
health care consumers and the patient-provider relationship. Studies by Time, Inc.,
Prevention Magazine, and the FDA have been presented in this chapter.
DTC advertising affects both the patient and the health care provider and the
relationship between them (Tyler & Cooper, 1997). Proponents of DTC advertising claim
that DTC advertisements create better-educated consumers and may spur consumers to
seek treatments of which they were not aware prior to DTC exposure (Gelles, 1997; Sherr
& Hoffinan, 1997; Tyler & Cooper, 1997; Morgan & Levy, 1998; Prevention Magazine,
1998; Prevention Magazine, 1999; Food and Drug Administration, 2000c; Sibley, 2000).
Critics of DTC advertising argue that these advertisements are not of high educative
20
value, confuse consumers, are biased, and may cause consumers to make erroneous self
diagnoses (“Changing the Doctor,” 1997; Gelles, 1997; Sibley, 2000).
Furthermore, DTC drug advertisements can wreak havoc in the health care
provider’s office by clogging the office with unnecessary visits (Sherr & Hoffinan, 1997).
It can also take a lot of time on the part of providers to explain to patients about health
plan formularies, the inappropriateness of the requested drug, and the efficacy of
alternative treatments. In addition, the patient may become upset by the provider’s
reluctance or refusal to prescribe the advertised drug. This can put a strain on the patient
provider relationship and lead to patient distrust of the provider.
The studies presented in this chapter suggest that DTC drug advertising is
reaching a great portion of the American population. The high level of exposure to DTC
drug promotion is affecting the way patients approach and interact with their health care
providers. DTC drug ads are catalysts for patient-provider discussions about drugs. They
are also the basis for many prescription drug requests. Ultimately, it’s the provider’s
decision whether a prescription will be written and this authority gives the provider final
determination over the effect of DTC advertising.
21
Chapter 3
Methodology
This chapter presents the methodology used in this study. A self-administered
questionnaire was used to collect information concerning demographics, exposure to
DTC drug advertising, sources of DTC drug ads, behaviors resulting from DTC drug ads,
respondents’ attitudes toward DTC drug advertising, and the patient’s perspective of the
effect of DTC drug ads on the patient-provider relationship.
Research Questions
The research questions were as follows:
1. Who is exposed to DTC drug advertisements?
2. What types of media are responsible for patients’ exposure to DTC drug
advertisements?
3. What consumer/patient health care related behaviors are a result of DTC drug
advertisements?
4. What are the attitudes of patients toward DTC drug advertising and
prescription drugs?
5. What is the influence of DTC drug advertisements on the patient’s perception
of the patient-provider relationship?
Research Design
This was a quantitative study utilizing a descriptive survey research design. This
research study used survey questions Irom a 1999 telephone survey conducted by the
U.S. Food and Drug Administration. This researcher revised the original FDA survey so
that it could be used as a self-administered questionnaire. This survey helped to identity
22
some of the attitudes of consumers regarding DTC drug advertisements. In addition, it
collected information on
consumers’ behaviors resulting from exposure to DTC drug
advertisements, as well as information regarding the patient’s perspective of the effects of
DTC drug ads on the patient-provider relationship.
Sample, Setting, and Procedure
The target sample consisted of English speaking patients over the age of 18 who
were seen in the Sherman, NY office of a rural primary care medical practice in
Chautauqua County, NY, during the month of March 2001. The study population
included adults visiting the offices for any primary care reason. Participants were given
the questionnaire as they registered for their visit and were asked to complete it while
waiting for their examination. They then returned the questionnaire when called into an
examination room. The office receptionists collected the completed surveys and placed
them in a secure area until collected by the researcher.
Instrumentation
The research tool used in this study was based on the telephone survey used by
the FDA’s 1999 study, “Attitudes and Behaviors Associated with Direct-to-Consumer
(DTC) Promotion of Prescription Drugs” (FDA, 2000c). The FDA’s survey is the
property of the United States government and considered public domain. The researcher
modified the FDA’s survey for use as a self-administered questionnaire (Appendix B).
The questionnaire included a cover letter (Appendix B) explaining the purpose of the
study, and instructions for completing the survey.
The survey used in this study consisted of 45 quest!ions. The first seven questions
collected demographic information, including perceived overall health status and
23
perceived knowledge about health and medicine. The next question was a dichotomous
question that asked whether respondents could recall ever seeing or hearing an
advertisement for a prescription drug. If a subject answered “No” to this question, they
were finished with the survey. Questions 9 through 17 addressed sources of exposure to
DTC drug advertisements, information included in DTC drug advertisements, and
whether subjects sought further information on drugs as a result of DTC drug
advertisements. Questions 18 through 29 were Likert multiple-choice questions
addressing subjects’ attitudes toward DTC drug advertisements. The final sixteen
questions addressed the effect of DTC drug advertisements on the patient-provider
interaction and the patient-provider relationship from the patient’s perspective.
Protection of Human Rights
The face sheet of the survey (Appendix B) includes an introduction and
explanation of the purpose of the study. Potential participants were informed that
participation was strictly voluntary and that participation or nonparticipation would have
no effect on their care. Completion and submission of the survey implied informed
consent. No names, numbers, or identifying information was required on the survey and
all data remained anonymous. Only grouped data was reported. The completed surveys
remain in a locked file.
Pilot Study
A pilot study to assess the readability of the survey, to identify any unclear
questions or instructions, and to estimate the amount of time it took to complete the
survey was conducted at the social center of the Erie Center on Health and Aging. The
population included a group of 10 men and women aged 65 or older. A total of 10
24
surveys were distributed and W surveys were competed and returned. The survey took
an average of 16.2 minutes to complete.
As a result of the pilot study, a statement informing subjects that there were
survey questions on both sides of the pages of the survey was added at the beginning of
the survey. It was also determined that Question 17 required a ninth possible response for
subjects who have never looked for more information about a drug because of an
advertisement. In addition, several subjects in the pilot study commented that the survey
was too long.
Data Analysis
The survey results were analyzed using descriptive statistics. Frequency
distributions were used to report responses to dichotomous and multiple-choice
questions. A Likert scale question regarding overall perceived health status was also
analyzed and reported as distributions within the five possible responses. All data were
also analyzed and reported as frequency distributions among demographic groups. All
statistics were calculated using StatView software by Abacus Concepts, Inc.
Summary
A goal of this research study was to determine the patient attitudes and behaviors
associated with DTC drug advertising. Another goal was to determine the types and
levels of exposure to DTC drug advertisements. The survey design, pilot study, and data
analysis for this study have
been described. Due to the recent escalation in DTC drug
promotion, patients are coming to
their health care providers armed with a wealth of
information about drugs and treatments.
In some cases, these patients have a distorted
sense of the information they have received 6- DTC advertisements. In such
25
situations, nurse practitioners must implement patient education strategies that can re
educate the patient with the appropriate information.
26
Chapter 4
Findings
This chapter presents the results of a researcher-developed survey
(Appendix B) concerning patient attitudes and behaviors related to DTC drug
advertising. The results were analyzed using descriptive statistics and were reported as
frequency distributions. Results were reported as total population and as demographic
subsets of gender, age, marital status, and educational level. Perceived overall health
status, and perceived level of knowledge about health and medicines were also analyzed
and reported. Additional data are displayed in Appendix C.
Sample
The questionnaires were distributed to adults equal to or over the age of 18, who
visited a primary care practice office in Sherman, New York during a 2 week period in
March 2001. The questionnaires were completed while the patients waited to be called
into an examination room, and took about 15 minutes to complete. One-hundred-eighty-
eight completed questionnaires were returned to the researcher. The office receptionists
were questioned regarding distribution of the questionnaire. There was no clear reason to
believe that anyone who received a questionnaire did not return it. Due to gross
inconsistencies in the responses on some of the surveys, 51 surveys were discounted in
the final analysis, resulting in a final population of 137 subjects.
Results
The results are reported in total number and percentages of the total subject
population and the aforementioned demographic subsets. Percentages are rounded to the
27
nearest whole percentage. The results
are not analyzed by ethnicity as all but 2 subjects
reported their ethnicity as “White”.
PTC Exposure
To answer the first survey question, “Who is exposed to PTC drug
advertisements? the results were analyzed for demographic characteristics. The subjects’
exposure to PTC drug ads and their perceived health status were also analyzed.
Pemo graphics. In the total sample population, females comprised 77%, and males
comprised 23% (Table 1). Of the total sample (7V==137), 91% (m—124) reported seeing an
advertisement for a prescription drug. Seventy-seven percent (n=96) of the female
subgroup reported seeing an advertisement for a prescription drug, while 23% (n=28) of
the male subgroup reported the same. Nine percent (n=13) of the total sample reported
they had never seen an ad for a prescription drug. Of those who reported never seeing an
ad for a prescription drug, 69% (m=9) were females, and 31% (n~4) were males.
Table 1
Comparison of Total Sample (AM37) by Gender: PTC Exposure
Total
Gender
Exposed to PTC
Unexposed to PTC
n
(%)
n
(%)
n
(%)
105
(77)
96 (77)
9
(69)
Male
32
(23)
28
Totals
137
Female
(23)
124
Note. All percentages are calculated within groups.
4 (31)
13
28
Age comparison of the sample population showed that 33% of subjects age 18 to
39 years (m-124) had seen an advertisement for a prescription drug (Table 2), while 55%
of subjects age 40 to 64 years, and 12% of subjects age 65 or older reported the same.
Table 2
Comparison of Total Sample by Age: PTC Exposure
Age
Total
Exposed to PTC
Unexposed to PTC
(%)
«
(%)
n
(%)
n
18-39
47
(34)
41
(33)
6 (46)
40-64
72
(53)
68 (55)
4 (31)
65+
18
(13)
15 (12)
3
137
Totals
124
(23)
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
Comparison of marital status among survey subjects showed 77% of subjects who
reported seeing a prescription drug ad were married, 7% were single, 7% were widowed,
6% were divorced, and 2% were separated (Table 3). These figures closely mirrored the
composition of the total sample population. Of those who reported not seeing a
prescription drug ad, 77% were married, 15% were single, and 8% were widowed.
29
Table 3
Comparison of Total Sample by Marital Statin
is: J)TC Exposure
Marital status
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
(%)
105
(77)
95
(77)
10
(77)
Single
11
(8)
9
(7)
2
(15)
Widowed
10
(7)
9
(7)
1
(8)
Divorced
8
(6)
8
(6)
0
(0)
Separated
3
(2)
3
(2)
0
(0)
Married
137
Totals
124
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
The sample population had a reasonably high level of education given the rural
setting in which the population resided. Twenty-nine percent of the total sample (N 137)
had completed high school and 33% had gone beyond high school by completing
business or technical school (Table 4). In addition, 21% of the total sample had
completed college, and 9% had completed graduate school or more. Of those who
reported seeing a prescription drug ad, 2% had completed grade school or less, 3% had
completed some high school, 28% had completed high school, 35% had completed
business or technical school, 23% had completed college, and 10% had completed
graduate school or more. Interestingly, of those subjects who reported never seeing a
30
prescription drug ad, one had completed coilege, and one bad compieted graduate school
or more.
Table 4
Comparison of Total Sample by Highest Education Level: PTC Exposure
Educational level
Total
Exposed to PTC
Unexposed to PTC
n
(%)
n
(%)
n
(%)
Grade school or less
3
(2)
2
(2)
1
(8)
Some high school
7
(5)
4
(3)
3 (23)
Completed high school
40 (29)
35 (28)
5 (38)
Business or tech, school
45 (33)
43
(35)
2 (15)
Completed college
29 (21)
28 (23)
1
(8)
Graduate school or more
13
12 (10)
1
(8)
(9)
137
Totals
124
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding.
Perceived Overall Health. Question 6 asked subjects to rate their overall health
using a Likert multiple-choice scale. Within the subgroup of subjects who had seen a
prescription drug ad, only 1% of subjects (»=123) reported “poor" health (Table 5) . The
majority of subjects who had seen a prescription drug ad reported their health as being
“very good” (37%), and “good” (39%).
31
Table 5
Likert Multiple ChoiceRating of Perceived Overall Health on the Dav the Survev was
Taken and DTC Exposure
Overall health
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
Excellent
12
(9)
11
(9)
1
(8)
Very good
49
(36)
46
(37)
3
(23)
Good
53
(39)
48
(39)
5
(38)
Fair
21
(15)
17
(14)
4
(31)
1
(1)
1
(1)
0
(0)
Poor
136
Totals
123
13
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding. One survey was discounted due to multiple answers regarding health status.
Perceived Knowledge of Health and Medicines. In Question 7, subjects were
asked to rate their knowledge of health and medicines. Of the total sample (V=137), 71%
felt they were
“somewhat knowledgeable,” and 23% felt they were “very knowledgeable”
(Table 6). These percentages were mirrored in the subgroup of subjects who had seen a
prescription drug (w-124).
32
Table 6
Likert Multiple Choice Rating Self Perception of Knowled-e Atom He.HI, and
Medicines and DTC Exposure
Knowledge level
Total
Exposed to DTC
Unexposed to DTC
n
(%)
n
(%)
n
(%)
3
(2)
3
(2)
0
(0)
Very knowledgeable
31
(23)
28
(23)
3
(23)
Somewhat knowledgeable
97
(71)
88
(71)
9
(69)
Not at all knowledgeable
6
(4)
5
(4)
1
(8)
Extremely knowledgeable
137
Totals
124
13
Note. All percentages are calculated within groups.
DTC Sources
Subjects who reported seeing an ad for a prescription drug were asked to identify
the types of media responsible for the ads they had seen. Question 9 offered subjects
seven types of media from which they could choose more than one answer. Expectedly,
prescription drug ads were most frequently seen on television (98%) and in magazines
(91%) (Table 7). A considerably lower frequency of exposure via the internet (15%) was
reported.
33
Table 7
Sources of DTC PngAfagBaateltejgve, Subjects W-! M
Source
n
(%)
121
(98)
41
(33)
Magazine
113
(91)
Newspaper
35
(28)
Internet
19
(15)
Letter, flyer, or announcement you got in the mail
32
(26)
7
(6)
Television
Radio
Anywhere else
Notes. Results reported as frequencies among total responses. Subjects could select more
than one answer to this question. Therefore, percentages will not total 100.
DTC-Related Behaviors
Questions 30, 32, 33, 38, 39, and 44 dealt with subjects’ behaviors related to DTC
drug ads. When asked if a drug ad has ever caused them to ask their health care provider
about a condition or illness that they had not previously discussed, 24% (n=l 19) of
subjects replied, “Yes,” and 76% replied, "No .
Sixty-two percent (m=1 17) of respondents answered “Yes,” and 38% answered
“No” when asked if they ever read, heard, or saw something that made them think about a
question they wanted to ask their health care provider about a prescription drug. Of those
that answered, “Yes” to this question, 44% identified an ad on television or radio, and
24% identified an ad in a tnagazine or newspaper as reading to a ptesc.ip.ion drug
34
question for their health care provider (Table 8). ^ingjy, 29% reported something a
friend, relative, or netghbor said as leading to a prescription drug question for their health
care provider.
Forty-six percent of subjects (n=l 17) reported they had asked their health care
provider about a specific brand of prescription drug. When asked if they ever mentioned
a drug ad to their health care provider, or if they ever brought information about a drug
with them to a visit with their health care provider, 27% (w=l 16) had mentioned an ad,
5% had brought information with them, 7% had done both, and 61% had never
mentioned an ad nor brought drug information with them to a visit.
Question 44 attempted to determine the likelihood that subjects would approach
their health care providers if they saw an ad for a drug that treats a condition that was
bothersome to them. Most subjects reported they would talk with their health care
provider about such an ad. Fifty-five percent (w~l 12) reported they would be, “very
likely,” and 32% would be, “somewhat likely” to talk with their provider about an ad for
a drug that treated a condition which was bothering them (Table 9).
Patient Attitudes
Survey questions 18 through 29 explored subjects’ attitudes regarding drug
advertisements. Subjects’ attitudes regarding statements about drug advertisements were
measured using Likert scale multiple-choice questions. Subjects’ responses about
whether they liked seeing ads for prescription drugs formed a normal distribution with
most subjects neither agreeing nor disagreeing withthe statement (Table 10).
35
Table 8
Source of Information That.CausedSubjectsto.Ask Their Health C.re Provider Abort a
Prescription Drug (7V=110)
Source
n
(%)
An ad on television or radio
48
(44)
An ad in a magazine or newspaper
26
(24)
or radio, or mention in a talk show
24
(22)
An article in a magazine or newspaper
21
(19)
6
(5)
32
(29)
provider other than your own
7
(6)
Something you saw on the internet
5
(6)
Something else
8
(7)
36
(33)
A news or educational program on TV
Something you received in the mail
Something a friend, relative, or
neighbor said
A talk you had with a health care
Never had a question about a
prescription drug
Notes. Results reported as frequencies among total responses. Subjects could seieel more
than one answer to this question, therefore, percentages »11 not total 100. Fourteen
subjects did not answer this question.
36
Table 9
Ad for.
Drug That_Jreats . Conditional Bothersome to th.
Likelihood
n
(%)
Very likely
62
(55)
Somewhat likely
36
(32)
Neither likely nor unlikely
6
(5)
Somewhat unlikely
6
(5)
Very unlikely
2
(2)
rfel 1„
112
Total
Notes. All percentages are calculated within groups. Percentages may not total 100 due to
rounding. Eleven subjects did not answer this question. One survey was discounted due
to multiple answers.
Fifty percent of subjects (n=122) agreed somewhat, and 24% agreed strongly that
prescription drug ads help make them more aware of new drugs. In contrast, only 5%
disagreed somewhat, and 2% disagreed strongly with this statement.
The majority of subjects agreed that prescription drug ads do not give enough
possible benefits and positive effects of using the drug. Forty
information about the pi
percent («=121) agreed somewhat with this statement, and 13% agreed strongly. Twenty-
;ed with this statement.
five percent neither agreed nor disagree
37
Table 10
Likert Multiple Choice RatjiJJ^^^gia&Ad^
Prescription Drugs
(Questionl8)
Rating
Total
n
(%)
Agree strongly
10
(8)
Agree somewhat
21
(17)
Neither agree nor disagree
65
(53)
Disagree somewhat
16
(13)
Disagree strongly
11
(9)
Total
123
Notes. Percentages may not total 100 due to rounding. One subject did not answer this
question.
Nearly the same percentage of subjects agreed that prescription drug ads do not
give enough information about the possible risks and negative effects of using the drug.
Regarding this statement, 15% (n=121) agreed strongly, 40% agreed somewhat, 25%
neither agreed nor disagreed, 15% disagreed somewhat, and 7% disagreed strongly.
When asked whether prescription drug ads make it seem like a health care
provider is not needed to decide if a drug is right for them, slightly more subjects
disagreed than agreed. Twenty-four percent („=120) of subjects disced somewhat with
this statement, and 2>% disagreed strongly. Converse!,, 28% agreed somewhat, and 15%
agreed strongly.
38
A high percentage of subjects agreed th,
information for them to decide whether they should diMSS the drag with their heahh
care provider. Forty-two percent of subjects („-! 18)
somewhM>
,?%
strongly with this statement, in contrast, only 10% disagreed somewhat, and 7%
disagreed strongly.
Many subjects (45%) („=119) neither agreed nor disagreed with the statement,
tc
Advertisements for prescription drugs help me make better decisions about my health”.
However, more subjects agreed with this statement than disagreed. Twenty-six percent
agreed somewhat, and 5% agreed strongly, while 13% disagreed somewhat, and 11%
disagreed strongly with this statement.
When asked whether they feel advertisements for prescription drugs help them
have better discussions about their health with their health care provider, most subjects
agreed they do. Forty-two percent (w=l 19) agreed somewhat, and 7% agreed strongly.
Only 9% disagreed somewhat, and 5% disagreed strongly with this statement.
A markedly low percentage of subjects agreed with the statement, “I would not
talk with my health care provider about an advertisement for a prescription drug, because
it would seem like I did not trust him/her.” Three percent agreed somewhat with this
statement, and 2% agreed strongly. On the other hand, 22% disagreed somewhat, and
49% disagreed strongly, while 24% neither agreed nor disagreed.
DTC’s Influence on the PatienkprovidgrRelatign^
When subjects were asked about their health care provider’s responses to their
mention of a drug advertisement, most reported fovorabie responses horn their health
39
care provider. Only 2% of subjects (n=l 09)
reported their provider seemed angry or upset
when asked about an advertised drug.
Subjects were then asked to rate their level of satisfaction with their health care
provider s response to a question about a drug. Fifty-thn*ee percent of subjects (w=109)
were satisfied (Table 11).
Subjects were asked what actions their provider took in response to their drug
questions. Subjects (n—105) reported that their providers usually recommended a
different prescription drug (28%), or prescribed the drug in question (23%). According to
survey subjects (n=98), when a health care provider did not prescribe the drug they asked
about, the provider often explained the reason (43%). The most frequent reasons cited for
not prescribing the drug in question were: (a) the drug was not right for them (23%), (b) a
less expensive drug was available (15%), and (c) the subject was unaware of the drug’s
side effects (13%).
Summary
The results from a researcher-developed survey (Appendix B) concerning patient
experiences with DTC drug advertising were presented. The sample population consisted
of adult patients in a rural primary care practice in western state. Results were presented
as the total sample (A=137), those exposed to DTC drug ads (»-124), and those who
have never seen DTC drug ads (rt-U). Results were grouped and reported according to
research questions. Additional data are presented in Appendix C.
40
Table 11
Satisfcliw With Health CjeJMdofsteiion to „ (ju Satisfaction level
Total
n
(%)
Very satisfied
23
(21)
Satisfied
35
(32)
Neither satisfied nor unsatisfied
4
(4)
Unsatisfied
0
(0)
Very unsatisfied
0
(0)
47
(43)
Have never asked about a prescription drug
Total
109
Notes. Fourteen subjects did not answer this question. One survey was voided due to
multiple answers.
41
Chapter 5
Discussion
This study was conducted in a turn! ptim,„ care practice in western New York
state during March 2001. A msearohcr-develeped survey was admmistered to:
(a) determine the demographic make-up of those people exposed to DTC drug
advertising, (b) identify the sources of DTC drug advertising, (c) identify patient
behaviors associated with DTC drug advertisements, (d) explore patient attitudes
regarding DTC drug advertisements, and (e) reveal the influence of DTC drug advertising
on the patient-provider relationship from the patient’s perspective. Because the survey
used in this study was based on the survey used in the 1999 FDA study (FDA, 2000c)
mentioned in the literature review, this chapter focuses on comparisons between this
study and the FDA study.
PTC Exposure
To answer the first research question about who is exposed to DTC drug
advertising, the demographic information obtained from the surveys is discussed.
. Demographics, perceived overall health status, and perceived knowledge of health and
medicines are discussed.
Demographics. Of the total sample, 77% were female and 23% were male
(Table 1). Ninety-one percent of females and 88% of males reported seeing mt ad for a
prescription drug. Due to th. predominantly femaie make-up of the sampfe population,
these figures are skewed and cannot be applied to the general population. The >999
Prevention study (Prevention Maga«, 1999) found 83% of females (n=660), and 80%
of males (n-545) had seen an advertisement for a prescnptto
g
42
Thkty percent of 18 to 39 year olds had seen a prescriptio„ drag „
40 to 64 year olds. and 11% of those 65 years or older reporthtg the same (Table 2).
Within the subgroup of subjects reporting they w see„ a
percentages are approximately the same.
The sample subgroup of those who had seen a prescription drug ad can be
characterized as highly educated. Sixty-three percent had received post-secondary
education (Table 4). The FDA’s study population (FDA, 2000c) showed a somewhat
different distribution of educational levels among those who had seen a prescription drug
ad. In its study, the FDA found that only 41% had received post-secondary education. It
is important to note that the FDA study was conducted nationwide.
Perceived Overall Health. Subjects’ perceived overall health was measured using
a Likert scale multiple-choice question. Of those who had seen a prescription drug ad,
76% reported being in good health or very good health (Table 5). In comparison, the
FDA study (FDA, 2000c) found 59% of subjects reported being in good health or very
good health.
Perceived Knowledge of Health and Medicines. Among those subjects who had
seen a prescription drug advertisement, most believed they were somewhat
knowledgeable regarding health and medicines (71%) (Table 6). Twenty-three percent of
this subgroup reported being very knowledgeable about health and medicines. The FDA
study (FDA, 2000c) found 59% of subjects who had seen a prescription drug ad reported
being somewhat knowledgeable about health and medicines, and 29% reported being
.cry knowledgeable. Once again, it is important not. that the FDA study used a
nationwide sample population.
43
Sources of PTC Drug Advertising
This study found tension and magazines to
the leadi„g
0£DTC
advertisements with over 90% of subjects identifying tlKm K Mmces (Tabfc ?)
as a source of DTC ads, was reported as a distant third. The EDA study (FDA, 2000c)
found a similar ranking to these DTC sources.
Patient Behaviors
In this study, 24% of subjects who had seen a prescription drug ad have been
motivated by a drug ad to talk with their health care provider about a condition or illness
they had not previously discussed. This held true for 27% of subjects (n=688) in the FDA
study (FDA, 2000c). Sixty-two percent of subjects in this study had read, heard, or seen
something that made them think of a question for their health care provider. Only 21% of
subjects (72=960) in the FDA study (FDA, 2000c) answered “Yes” to this question. In this
study, those who answered “Yes” to this question identified an ad on television or radio
(44%), something a friend, relative, or neighbor said (29%), and an ad in a magazine or
newspaper (24%) as being the leading reasons for their question (Table 8).
Forty-six percent of subjects in this study had asked their health care provider
about a specific brand of prescription drug. In comparison, 32% of subjects (w=632) in
the FDA study (FDA, 2000c) had asked their provider about a specific brand of
prescription drug.
This study found 27% had mentioned an ad, 5% had brought information with
them, 7% had done both, and 61 % had never mentioned an ad nor broug
information with them to a visit. These percentages are much higher than the FDA
study's fttdings. Eight percent of ejects (^) h the FDA stud, (FDA. 2000c) had
44
mentioned an ad, 4% had brought infonMion
had never mentioned an ad nor brought drug information
them * *
health care provider.
Subjects in this study were asked about the iikelihood that they would talk to their
health care provider if they saw an ad for a drug that treated a condition that was
bothering them. Filly-five percent reported they would be very likely, and 32% reported
they would be somewhat likely to talk with their health care provider about such a drug
(Table 9). The FDA study (FDA, 2000c) found similar results with this question, with
54% of subjects (h=607) reporting they would be very likely, and 26% reporting they
would be somewhat likely to talk with their health care provider in this situation.
Patient Attitudes
Subjects’ attitudes regarding prescription drug advertisements were explored
using a series of Likert scale multiple-choice questions. This study found most subjects
(53%) neither agreed nor disagreed with the statement, “I like seeing advertisements for
prescription drugs” (Table 10). Those subjects that agreed, and those that disagreed with
this statement were evenly distributed on either side of the curve. Responses to this
statement were quite different in the FDA study (FDA, 2000c). That study («=711) found
52% of subjects agreed with this statement.
Fifty percent of subjects in this study agreed somewhat, and 24% agreed strongly
tat prescription drug ads help make them more aware of new drugs. The FDA study
(FDA, 2000c) found slightly higher percentages for this statement. The FDA study foun
39% (n=711) of subjects agreed somewhat, and 47% agreed strongly that preset,p.i.n
drug advertisements help make them aware of ne
45
Forty percent of subjects fit this stud, agreed somewhat with the statemen,
-Advertisements for prescription drugs do not give enough
possible benefits and positive effects of using the
abM the
wUe n%
These results differed somewhat from the FDA study's (FDA 2000c) findings th., 28%
of subjects (tt-711) agreed somewhat, and 21% agreed slmugjy. Th., study
f„md
23% of subjects disagreed somewhat, and 16% disagreed strongly wdththia statement.
Subjects were also asked about their attitude regarding the statement,
“Advertisements for prescription drugs do not give enough information about the
possible risks and negative effects of using the drug.” Regarding this statement, 15% of
subjects in this study agreed strongly, and 40% agreed somewhat. Twenty-six percent of
subjects (n=711) agreed strongly, and 32% agreed somewhat in the FDA study (FDA,
2000c).
Slightly more subjects in this study disagreed than agreed with the statement,
“Advertisements for prescription drugs make it seem like a health care provider is not
needed to decide whether a drug is right for me.” Twenty-four percent of subjects
disagreed somewhat with this statement, and 21% disagreed strongly. Conversely, 28/o
agreed somewhat, and 15% agreed strongly. This finding is in contrast
study's (FDA, 2000c) findings. That study («=711) found a greater percentage of subjects
disagreed with this statement, with 21% of subjects disagreeing somewhat, and 49%
disagreeing strongly.
Forty-two percent of subjects in this study agreed — and 17% agreed
strongly with the statement, ‘Advertisements for prescription dnrgs give enough
information for me to decide whether I should discuss the drug with a health care
46
provider.” Only 10% disagreed somewhat, «d 7% dtagreed 9rong|y
More subjects m the FDA study (FDA, 2000c) agreed * this statement
that study revealed 42% of subjects
„ agreed
with this statement.
Forty-five percent of subjects in this study
statement, “Advertisements for prescription drugs help me make better decisions about
my health.” However, this study found more subjects agreed with this statement than
disagreed. Twenty-six percent agreed somewhat, and 5% agreed strongly, while 13%
disagreed somewhat, and 11% disagreed strongly with this statement. Twenty-nine
percent of subjects (n=711) in the FDA study (FDA, 2000c), agreed somewhat with this
statement. However, that study found 21% disagreed strongly.
Most subjects in this study agreed with the statement, “Advertisements for
prescription drugs help me have better discussions with my health care provider about my
health.” Forty-two percent agreed somewhat, and 7% agreed strongly. This was also
found to be true in the FDA study (FDA, 2000c). Thirty-six percent of subjects (n=711)
in the FDA study agreed somewhat with this statement, while 26% agreed strongly.
A very low percentage of subjects in this study agreed with the statement, "1
would not talk with my health care provider about an advertisement lor a prescription
drug, because it would seem like I did not trust him/her.” Three percent agreed somewhat
with this statement, and 2% agreed strongly. In sharp contrast, 22% disagreed somewhat,
and 49% disagreed strong^, while 24% neither agreed nor disagreed. While subjects in
the FDA study (FDA, 2000c) echoed the findings in this study, an
47
percentage disagreed with this stati
ement. That study found 15% of subjects (n=711)
disagreed somewhat with this statement,
and 72% disagreed strongly.
The Patient-Provider Relationship
Subjects in this study were asked about their health care provider’s responses to
their mention of a drug advertisement. Most subjects reported fevorable responses Sum
their health care provider. Two percent of subjects reported their provider seeming angry
or upset when asked about an advertised drug. A comparable 2% of subjects (n=220) in
the FDA study (FDA, 2000c) reported their health care provider seemed to get angry or
upset.
Subjects were then asked to rate their level of satisfaction with their health care
provider’s response to a question about a drug. The majority of subjects were satisfied
(32%), or very satisfied (21%) (Table 11). Thirty-seven percent of subjects (w=220) in the
FDA study (FDA, 2000c) were satisfied with their provider’s response, and 48% were
very satisfied.
When asked what actions their provider took in response to their drug questions,
subjects reported that their providers usually recommended a different prescription drug
(28%), or prescribed the drug in question (23%). Subjects in the FDA study (FDA,
,viders most frequently prescribed the drug in question
2000c) (n=220) reported that pro
’ ion drug (32%), and recommended changes m
(50%), recommended a different prescription
behavior or lifestyle (29%).
When a heahh care pt^der does not prescribe the drug a subject asked about, the
according to 43% of subjects in this study. Subjects
provider often explained the reason,
in this study most frequently cited the following
their health care provider’s reasons
48
for not prescribing die drug they *datout; (i)fc
(b) a less expensive drug was available (15%) and
u>
(c) the subject was unaware of the
drug’s side effects (13%). The FDA study (FDA. 2000c) fomd 59% „f
w)
reporting they received an exp1Mio„ for not prescribmg a
provider. The most frequent reasons revealed in that stud
ly were: (a) the drug was not
right for the them (48%), (b) the doctor wanted th<
------ lem to take a different drug (35%), and
(c) the drug had side effects they were not aware of (29%).
Conclusions
Overall, the results of this study met the goal of answering the research questions.
The study met its goal of identifying the demographics of patients who have been
exposed to DTC drug advertising. It also met its goals of identifying the types of media
used for DTC drug advertising, patient behaviors related to DTC drug advertising, patient
attitudes regarding prescription drug advertisements, and the influence of DTC drug
advertising on the patient-provider relationship from the patient’s perspective.
The amount of money spent on DTC drug advertising is reflected in the
percentage of subjects in this study who had seen a prescription drug advertisement. DTC
drug advertisements were most frequently seen on television or in magazines. Subjects
were likely to talk with their health care provider about a prescription drag ad they had
seen. While most subjects in this study Mt DTC drug advertisements do not give enough
information about risks and benefits, they did agree these advertisements provide enough
information for them to decide if they should discuss the drug with their
• +u- ctndv DTC drug advertising has not damaged the
provider. Based on the findings in this study, D1 <- arug
patient-provider relationship.
49
Subjects in this study reported to DTC prescript™ drug ads
them
of new drugs, as weil as providing them with
discuss the drug with their health care provider. This study
found tta subjects
likely to discuss an advertised drug with their health care provider. These Mings
suggest that patients are likely to initiate a conversation about an advertised drug with
their health care provider. The patient who approaches their health care provider with a
question about an advertised drug is engaging in self-care agency and acting as the selfcare agent. The nurse practitioner, as health care provider, can assist this patient by using
the supportive-educative nursing system. This can be achieved by educating the patient
about the information they received in a DTC prescription drug ad. This study’s findings
suggest that the probability that patients will discuss advertised drugs with nurse
practitioners and other health care providers is high. This presents the opportunity for
health care providers, particularly nurse practitioners, to assist the patient, as self-care
agent, through use of the supportive-educative nursing system
Limitations of the Study
The size of this sample in this study was relatively small, and the results can only
be generalized to patients in the same geographic area. The ethnicity of the sample was
predominantly “White,” with only 2 subjects reporting their ethnicity as
Indian or Alaska Native.” In addition, a majority of the sample
<73%)'
,
“Too long” written on them by the subject. The
Two surveys had the comment 1
&
been the reason several surveys were not My
lengthiness of the survey may have
a„ examination room before completing the survey
completed. Subjects being called into
may be another explanation for incomplete surv y
50
The seffing in which the survey was administered ma
,
u.
influenced the
responses of some subjects. This may have „
...
subject was a patient at the
survey. An attempt to dispe! this concern was made by pra*8 „
in the cover letter to the questionnaire.
Recommendations for Further Study
To test its effectiveness as a tool for identifying attitudes and behaviors related to
DTC drug advertising, this survey should be tested on larger and more representative
populations. In its current state, the survey is lengthy and may be viewed by some
respondents as inconvenient to complete. Future studies may attempt to simplify and
condense the survey. However, doing so may compromise the comprehensiveness of the
survey as it is currently written. It would also be helpful to apply the McLaughlin SMOG
formula to the survey to test the grade-level difficulty of its readability.
51
References
Allen, M. C. (1997). Medicine goes Madison Avenue: An evaluation of the effect
of direct-to-consumer pharmaceutical advertising on the learned intermediary doctrine.
Campbell Law Review. 20, 113.
The Board of Trustees of the American Medical Association (1999). Direct-to-
consumer advertising of prescription drugs (B of T Report 38 - A-99) [Online],
Available:
http://www.ama-assn.org/meetmgs/public/aimual99/reports/oasite/bot/rtf7bot38.rtf [2000,
September 29].
Borzo, G. (1997, September 8). New FDA rules for advertising drugs on
television raises questions. American Medical News, 3.
Changing the doctor-patient relationship. (1997, May 14). Scott-Levin Press
Release. [Online]. Available:
http://www.scottlevin.com/news/view release.cfin?rid-5 1 [2000, December 2].
Colford, P. D. (1997, October 20). DTC ads: Just what the doctor ordered.
Mediaweek, 7, 46.
Commerce and Trade, 15 U.S.C. 52-55 (1994).
Dickinson, J. G. (1994). 16 do’s and don'ts from FDA. Medical Marketin&&
Media, 29(6), 40-41.
DTC advertising effective catalyst for consumer prescription choice. (1999,
July 19). Drug Store News, CP6.
Everett, S. E. (1991)- Lay audience response to prescription drug advertising.
Journal of Advertising Researching), 43 49.
52
Food
o and
an Drug
rug Administrate
Administration (2000a). Debate brewing on consumer ads for
prescription drugs. [Online]. Available:
http7/www.fda.gov/cder/about/histor y/page52.htm [2000, November 11].
Food and Drug Administration (2000b). Guidance for industry: Consumer-
directed broadcast advertisements. [Online]. Available:
http://www.fda.gov/cder/guidance/index.htm. [2000, November 15].
Food and Drug Administration (2000c). Attitudes and behaviors associated with
direct-to-consumer (DTC) promotion of prescription drugs: Main survey results.
[Online]. Available:
http://www.fda.gov/cder/ddmac/dtcindex.htm. [2000, October 17].
Food and Drugs, 21 U.S.C. 352 (1999a).
Food and Drugs, 21 U.S.C. 352(n) (1999b).
Gelles, J. (1997, September 6). Prescription-drug advertisements prompt cheers,
fears: Onslaught of television commercials may nudge people to go see their doctors, or it
might lead to abuse. The Seattle Times, p. A2.
Gilgore, L. S. (1991). A consideration of direct-to-consumer advertising of
prescription drugs and potential legal problems with the brief summary requirement. Is
the FDA’s regulatory authority illusory? Food, Drug, Cosmetic Law Journal, 46, 849,
855.
Goetzl, D. (2000a). DTC execs quick to learn upfront value. Advertising Age,
71(21), 58.
Goetzl D (2000b). New venture aims to measure effectiveness of DTC drug
work. Advertising Age, 71(23), 16-17.
53
Goetzl, D. (2000c). Pill chill. Advertising Age, 71(36) 1-2.
Gorov, L. (1997, October 13). AIDS drug makers aim pitch right at patients.
Boston Globe, p. Cl.
Hartweg, D. L. (1991). Dorothea Orem: Self-care deficit theory. Newbury Park,
CA: Sage Publications, Inc.
Horton, L. R., & Hastings, K. E. (1998). A plan that establishes a framework for
achieving mutual recognition of good manufacturing practice inspections. Food and Drug
Law Journal, 53, 527.
Kessler, D. A., & Pines, W. L. (1990). The federal regulation of prescription drug
advertising and promotion. Journal of the American Medical Association, 264, 2409-
2415.
Lau, G. (1998, May 18). Doc’s just an employee now. Forbes, 161(10), 162.
Marriner, A. (1986). Nursing theorists and their work. St. Louis: The
C.V. Mosby Company.
Marx, W. (1996). Shrinking the drug pipeline. Management Review, 85(4),
56-59.
Meyer, H. (1998, February 5). The pills that ate your profits. Hospital and Health
Networks, 19, 21.
Morgan, C., & Levy, D. (1998, January 19). To their health: Pharmaceutical firms
are increasing their use of direct-to-consumer advertising. Brandweek, 30.
Orem, D. E. (2001). Nursing: Concepts of practice (6th ed.). St. Louis. MO:
Mosby-Year Book.
54
Pines, W. L. (1997). New challenges for medical product promotion and its
regulation. Food and Drug Law Journal. 52.61 -67
Pinsi, A. (1999). Patient-directed drug advertising puts pressure on U.S. doctors.
The Lancet, 354, 1887.
Prevention Magazine (1998). National survey of consumer reactions to direct-toconsumer advertising. Emmaus, PA: Rodale Press.
Prevention Magazine (1999). Year two: A national survey of consumer reactions
to direct-to-consumer advertising. Emmaus, PA: Rodale Press.
Rosenberg, J. (2000). DTC ramps up for onslaught. Advertising Age, 71(29), 4.
Sherr, M. K., & Hoffman, D. C. (1997). Physicians—Gatekeepers to DTC
success. Pharmaceutical Executive, 17(10), 56.
Sibley, C. E. (2000). Research report: DTC advertising studies. [Online].
Available:
http://www.cohealthcom.org/pages/dtcadstudies.html . [2000, October 15].
Tanouye, E. (1997, December 22). Drug ads spur patients to demand more
prescriptions. Wall Street Journal, p. Bl.
Tyler, B. J., & Cooper, R. A. (1997). Blinded by the hype: Shifting the burden
when manufacturers engage in direct-to-consumer advertising of prescription drugs.
Vermont Law Review, 1073, 1099.
Wechsler, J. (1997, December 6). Direct-to-marketers: FDA talks to the industry.
Pharmaceutical Executive, 52.
Withdrawal of moratorium, 50 Fed. Reg.36,677 (1985).
55
Woodward, D. (1996). The new drug marketing: A consumer protection
perspective. Food and Drug Law Journal. 51. 637.
56
Appendix A
Policy Statements on Product-Specific Direct-to-Consumer
Advertising of Prescription Drugs
1. That the AMA support those product-specific DTC advertisements that follow
the guidelines for such advertisements that were developed by the AMA, in consultation
with the FDA, in 1993. The guidelines are as follows:
a) The advertisement should be disease-specific and enhance consumer
education;
b) The ad should convey a clear, accurate and responsible health education
message (i.e., information on the prevention or treatment of a disease,
disorder, or condition);
c) In all cases, the ad should refer patients to their physicians for more
information;
d) The ad should not encourage self-diagnosis and self-treatment, but
should identify the consumer population risk:
e) Discussion of the use of the drug product for the disease, disorder, or
condition should exhibit fair balance;
f) Warnings, precautions, and potential adverse reactions associated with
the drug product should be clearly explained so as to facilitate
communication between physician and patient;
g) No comparative claims can be made for the product. In the interest of
fair balance, alternative non-drug management options for the disease,
disorder, or condition can be included;
57
h) The brief summary information should be presented in language that
can be understood by the consumer;
i) The advertisement must comply with applicable FDA rules, regulations,
policies and guidelines as provided by their Division of Drug Marketing,
Advertising and Communications;
j) The ad should be part of a manufacturer’s education program that would
include collateral materials to educate both physician and consumer; and
k) The manufacturer should not run concurrent incentive programs for
physician prescribing and pharmacist dispensing.
2. That the AMA encourage the pharmaceutical industry to develop product
specific DTC advertisements, regardless of medium, that follow the above AMA
guidelines.
3. That the AMA encourage the FDA, other appropriate federal agencies, and the
pharmaceutical industry to conduct or fund research on the effect of DTCA, focusing on
its impact on the patient-physician relationship as well as overall health outcomes;
research results should be available to the public.
4. That the AMA encourage physicians to be familiar with the above AMA
guidelines for product-specific DTCA and with the recommendations of the Council on
Ethical and Judicial Affairs (CEJA) Report, “Direct-to-Consumer Advertisements of
Prescription Drugs,”
and to adhere to the ethical guidance provided in the CEJA report.
5. That the AMA continue to monitor DTCA, including new research findings,
and work with the FDA and the pharmaceutical industry to make policy changes
regarding DTCA, as necessary.
58
6. That the following AMA policies be rescinded: H-105.989; H-105.990; H-
105.991; H-105.994; H-105.998; and H-105.999. Policy H-105.993 is modified to delete
any reference to “prescription drugs.” (Board of Trustees, 1999).
59
Appendix B
Direct-to-Consumer Drug Advertising Survey
I would like to introduce myself. My name is Jeffrey R. Larson, RN, SRNP.
This survey is part of a research project I am completing for an
advanced nursing degree at Edinboro University of Pennsylvania. It will
provide information about the effect of drug advertisements on patient
attitudes and behaviors.
*********************$*****
This survey should take about 10 minutes to complete.
Please do not place your name on the survey.
All surveys will be kept strictly anonymous.
All information will be reported as group information.
Your care here will in no way be affected by your decision to participate or
your refusal to participate in this survey.
***************************
For your information, the results of this survey will be posted at the
reception desk in April of 2001.
If you have any questions regarding this research project, please call
Judith Schilling, CRNP, PhD at 814-732-2900.
Thank you very much for your participation.
60
Direct-to-Consumer Drug Advertising Survey
Please answer all questions to the best ofyour ability. Indicate your answer by circling
the number that corresponds with your answer. Depending on your answers, you may
be instructed to skip some questions. You may give more than one answer to some
questions. When you have completed the survey, please return it to the receptionist or
the nurse.
1. What is your gender?
1. Male
2. Female
2. What is your age?
1. 18-39
2. 40-64
3. 65+
3. What is your marital status?
1.
2.
3.
4.
5.
Married
Single
Widowed
Divorced
Separated
4. What is the last grade of school you completed?
1. Grade school or less
2. Some high school
3. Completed
high
--------—
o school
Beyond
high
school (business, technical, etc.)
4. ]
5. Completed college
6. Graduate school or more
5. Which of these best represents your ethnic group?
1. American Indian or Alaska Native
2.
3.
4.
5.
Asian
Black or African-American
Hispanic or Latino
Native Hawaiian or other Pacific Islander
6. White
61
6. Overall, would you say your health is:
1.
2.
3.
4.
5.
Excellent
Very good
Good
Fair
Poor
7. How knowledgeable would you say you are about health and medicines? Would
you say you are:
1.
2.
3.
4.
Extremely knowledgeable
Very knowledgeable
Somewhat knowledgeable
Not at all knowledgeable
8. Do you recall ever seeing or hearing an advertisement for a prescription drug?
1. Yes
2. No*
*If you answered ‘No’ to this question, you are finished with the survey.
Please return the survey to the receptionist. You may keep the pen in return
for your participation. Thank you very much for your participation.
9. Did you see or hear an advertisement for a prescription drug in any of the
following ways (You may circle more than one answer):
On television
On the radio
In a magazine
In a newspaper
On the internet
In
6. ] a letter, flyer, or announcement you got in the mail
7. Anywhere else
1.
2.
3.
4.
5.
10. How many different prescription drugs do you recall seeing advertised?
1.
2.
3.
4.
5.
None
1-3
4-6
7-9
10+
62
11' more
2.
3.
4.
5.
6.
7.
8.
9.
C°ntained
ab<>ut (*>« ™y circle
The benefits of the drug
Directions for use of the drug
Who should take the drug
Questions to ask the health care provider about the drug
What to do in case of an overdose
The risks or side effects of the drug
Who should not take the drug
Have never seen television ads for prescription drugs
12. How easy or difficult is it for you to tell whether an advertisement on television is
for a prescription drug? Would you say it is:
1.
2.
3.
4.
5.
6.
Very easy
Somewhat easy
Neither easy nor difficult
Somewhat difficult
Very difficult
Have never seen television ads for prescription drugs
13. How easy or difficult is it for you to tell whether an advertisement in a magazine
or newspaper is a prescription drug? Would you say it is:
1.
2.
3.
4.
5.
6.
Very easy
Somewhat easy
Neither easy nor difficult
Somewhat difficult
Very difficult
Have never seen magazine or newspaper ads for prescription drugs
14. Advertisements for prescription drugs in magazines and newspapers usually have
small print information that gives more details about the drug. How much, if any,
of the small print information in magazine or newspaper prescription drug
advertisements would you say you usually read? Would you say you.
1.
2.
3.
4.
5.
6.
7.
Read all of the information
Read almost all of the information
Read about half of the information
Read only a little of the information
Read none of the information
Didn’t even notice the information was there
Have never seen magazine/newspaper ads for prescription drugs
63
15. If you were especially interested in the advertised drug for some reason, how
much, if any, of the small print information would you read? Would you say you
would:
1.
2.
3.
4.
5.
6.
Read all of the information
Read almost all of the information
Read about half of the information
Read only a little of the information
Read none of the information
Have never seen magazine or newspaper ads for prescription drugs
16. Has an advertisement for a prescription drug ever caused you to look for more
information, for example, about the drug or about your health?
1. Yes
2. No
17. Did you look for further information (You may circle more than one answer)'.
1.
2.
3.
4.
5.
6.
7.
8.
In a reference book
In a magazine or newspaper
On the internet
By asking a friend, relative, or neighbor
By calling the 1-800 number in the ad
By talking to a pharmacist
By talking to your health care provider
By talking to a health care provider other than your own health care
provider
18.1 like seeing advertisements for prescription drugs.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
19. Advertisements for prescriptions drugs help make me aware of new drugs.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
64
20. Advertisements for prescription drugs do not give enough information about the
possible benefits and positive effects of using the drug.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
21. Advertisements for prescription drugs make the drugs seem better than they really
are.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
22. Advertisements for prescription drugs make the drugs seem more dangerous than
they really are.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
23. Advertisements for prescription drugs do not give enough information about the
possible risks and negative effects of using the drug.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
24. Advertisements for prescription drugs make it seem like a health care provider is
not needed to decide whether a drug is right for me.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
65
25. Advertisements for prescription drugs give enough information for me to decide
whether I should discuss the drug with a health care provider.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
26. Advertisements for prescription drugs help me make better decisions about my
health.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
27. Advertisements for prescription drugs help me have better discussions with my
health care provider about my health.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
28. Only the safest prescription drugs are allowed to be advertised to the public.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
29.1 would not talk with my health care provider about an advertisement for a
prescription drug, because it would seem like I did not trust him/her.
1.
2.
3.
4.
5.
Agree strongly
Agree somewhat
Neither agree nor disagree
Disagree somewhat
Disagree strongly
66
30. Has an advertisement for a prescription drug ever caused you to ask a health care
provider about a medical condition or illness of your own that you had not talked
about to a health care provider before?
1. Yes
2. No
31. At any of the visits to your health care provider, was there any conversation about
a prescription drug?
1. Yes
2. No
32. Did you ever read, hear, or see anything that made you think about a question you
wanted to ask your health care provider about a prescription drug?
1. Yes
2. No
33. Think about what it was that you read, heard, or saw that made you think about
that question. Was it because of (You may circle more than one answer)'.
1. An advertisement on television or radio
2. An advertisement in a magazine or newspaper
3. A news or educational program on TV or radio, or mention in a talk show
4. An article in a magazine or newspaper
5. Something you received in the mail
6. Something a friend, relative, or neighbor said
7. A talk you had with a health care provider other than your own
8. Something you saw on the internet
9. Something else
10. Never had a question about a prescription drug
34. Are you currently taking one or more prescription drugs?
1. Yes
2. No
35. Before any visits to your health care provider, did you ever think he/she might:
1.
2.
3.
4.
Switch your current drug to a new drug
Keep you on your current drug
Start you on a new drug for a different condition
I’m not taking any prescription drugs
36. Think about what it was that made you think your health care provider might put
you on a new prescription drug. Was it because of (Tom may circle more than
one answer):
1. An advertisement on television or radio
2. An advertisement in a magazine
3. A news or educational program on TV or radio, or mention in a talk show
4. An article in a magazine or newspaper
5. A previous prescription for the same condition
6. Something you received in the mail
7. Something a friend, relative, or neighbor said
8. A talk you had with a health care provider other than your own
9. Something you saw on the internet
10. Something else
11. Have never thought my provider would put me on a new drug
37. Have you ever asked your health care provider whether there is a prescription
drug to treat your condition?
1. Yes
2. No
38. Have you ever asked your health care provider about a specific brand of
prescription drug?
1. Yes
2. No
39. Have you ever mentioned an advertisement you saw or heard for a drug, or did
you bring any information about a drug with you?
1.
2.
3.
4.
Yes, I mentioned an ad I saw or heard
Yes, I brought something about the drug with me
Yes, both
No
40. Which, if any, of these possible reactions did your health care provider have when
you asked about the drug? {You may circle more than one answer)-.
1.
2.
3.
4.
5.
He/she seemed to get angry or upset
He/she seemed to react like it was an ordinary part of the visit
He/she seemed to welcome my question
He/she discussed the drug with me
Have never asked about a prescription drug
68
41. How did you feel about your health care provider’s reactions when you asked
about the drug? Were you:
1.
2.
3.
4.
5.
6.
Very satisfied
Satisfied
Neither satisfied nor unsatisfied
Unsatisfied
Very unsatisfied
Have never asked about a prescription drug
42. Did your health care provider do one or more of the following (You may circle
more than one answer)'.
1.
2.
3.
4.
5.
6.
Give you the prescription drug you asked about
Recommend a different prescription drug
Recommend an over-the-counter drug
Recommend no drug
Recommend that you make changes in your behavior or lifestyle
Have never asked about a prescription drug
43. Did your health care provider tell you why he/she didn’t prescribe the drug you
asked about?
1. Yes. Was it because (You may circle more than one answer)'.
• The drug was not right for you
• The provider wanted you to take a different drug
• The drug had side effects you were not aware of
• You did not have the condition the drug is used to treat
• A less expensive drug was available
• The provider said you didn’t need a prescription drug
• The provider said you could use an over-the-counter drug
• Some other reason
2. No
3. Have never asked about a prescription drug
44. If you saw an advertisement for a drug that treats a condition that was bothering
you, how likely would you be to talk to your health care provider about the drug?
1.
2.
3.
4.
5.
Very likely
Somewhat likely
Neither likely nor unlikely
Somewhat unlikely
Very unlikely
69
45. Which, if any, of these possible reactions do you think your health care provider
would have if you asked about a prescription drug you had seen advertised? (You
may circle more than one answer) ’.
1.
2.
3.
4.
5.
He/she would get angry or upset
He/she would react like it was an ordinary part of the visit
He/she would welcome my question
He/she would discuss the drug with me
None of the above
Thank you for completing this survey. You may keep the pen in return for your
participation. Please return the survey to the receptionist or the nurse.
70
Appendix C
Additional Data
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