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 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 „ (ju999 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 71 O H Q o +-> Os so 'O JJ o & Xi Os s ^r cn a OO c .2 tn o o O S' w o O H a o -t—* co CM £ 'O o O Xi & X so os oo CM CM O H Q oh I is 1?0) .■tf £ T5 CM ob o Z 73 ’O H £ co (D 00 03 C a nJ (D £ & a o 75 s £ 75 CM in ■4—1 o H m OK CM O co co Iw 1 H g o O cn cn O o 75 73 a .2 o 'O -So co g o O CO 0£) 2 (D so GO I (D 00 45 00 T? O aj I o U o o JD co co (D .sco 3 CQ e £ □ o 1 o O (D O, 3 (D o (33 O (D CO O Z 75 O » ■^r oo ^r m ok a o 43 4=5 a3 o <4-H o £ 73 o H OK KO cn I m CM o £ > o g 43 73 43 7> x W TS O O 00 (D > o H 7 co S3 t3 tn 43 -—^ C3 CD 43 00 .8 g00 cd o Z 1 o H 3. Z 77 cn 3 +-* CD s oo C .3 .2 -g tn ex cn 00 X5 2 o a ,o .2 .& c ZJ o ’U Q CO o <2 cn 2 O G> s nJ c3 45 o -♦-» JD £ s x: cn ^r tn CM tn KO ^r ■4—' o c 43 CM oo < bl .S cn CM •1 1 ’TJ g O co on e Q a .2 75 O TO £ o xt o o O o o IS 75 o ■w •^> cu Q * > 'O o oo cn on cn .8 OO ? on c o u< to .S I 1s o <7i » o g 8 c3 ■+-' o c >> co ZJ (Z) § 2 (D ’£ < x: oo cn o 75 75 o 4-» W 01 2 aG .2 -4-» ’S' o < 'O 01 .S(D Q 1o O co *£ 3 o ob .S Os cn X1 G co ■+-» § CZ) O £ o x: o o o O O o CM O s o o PL( CM X •1 c f o •I o Q 15 ■+-> o H £ OO x: o CO uo CM 01 CD t5 so CO CM (D (D CD 3> CO (D 00 Cd 15 J O o 2? 00 .2 H 73 ? oo c o .a a co +5 o H w O z d .2 to CD =J & 81 % < St (N O C4 KO o bl .8 < W o o IT) CM "4- cn oo cn KO -o- *3o £ Os s: o bl 04 .8 I ja H l I 04 Os 'O tn 04 Ol KO 83 6 .2 ft (D o 00 .8 I g(D I 1 >> Tb c o H to > & o a o iR co §co >* (70 (D o KO u ie § £ co a> Q co co o Z E < I o § 4-» o a :2 ’O nj -w 01 (D .S (D cd oo o H £ oo CO ITS (D x: o sn SO so CO CM »