Risks and benefits of direct to consumer advertising on patient - provider relationships

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1 Risks and benefits of direct to consumer advertising on patient - provider relationships Ashish Parekh, BS, MS, Candidate, Doctor of Pharmacy, Sullivan University College of Pharmacy, Louisville, KY, USA Roland Marcus, BS, Professional Research Assistant, University of Colorado Health Sciences Center, Denver, CO, USA Melissa Roberts, MS, CMA, Senior Research Associate, Lovelace Clinic Foundation, Albuquerque, NM, USA Dennis W. Raisch, PhD, MS, RPh, Professor, PEPPOR (Pharmacoeconomics, Epidemiology, Public Policy and Outcomes Research), College of Pharmacy, University of New Mexico, Albuquerque, NM, USA Direct to consumer advertising (DTCA) is a potentially powerful source of consumer health information. Currently, it is only permitted in the United States (US) and New Zealand. 1 Regulatory agencies (European Medicines Agency and Health Canada) in other countries have not allowed it due to concerns regarding the impact on public health. 2 DTCA covers both prescription and over-the-counter (OTC) products advertised through television, radio, internet and print media. The Food and Drug Administration (FDA) in the US began regulating the advertising of prescription drugs in In 1997 the FDA issued guidelines regarding the information presented within DTC advertising, which resulted in substantial increases in broadcast DTCA. 1 Total spending on pharmaceutical promotion grew 62% from $11.4 billion in 1996 to $29.9 billion in Spending on DTC advertising represented 14% of this total and grew 330% during this period to $4.4 billion. 3 DTCA spending increased to $4.8 billion in 2007 and has remained near these levels since. 4 The FDA does not review each message prior to release. Guidelines are still being developed in an effort to maximize benefits and minimize risks associated with DTCA. Since DTCA s inception, there have been a number of studies on the effects of DTCA on consumer behavior, physician behavior, health care delivery, health care utilization, risks and benefits, and health outcome in the US. 1

2 DTCA can impact multiple facets of health care including: alerting consumers to potentially beneficial treatments; increasing the number of patients taking a needed and well tolerated medicine; increasing or decreasing the number of patients taking medications without medical benefit ; reducing morbidity and mortality rates; and either increasing or reducing health care costs. 5 The overall assumption has been that DTCA directly changes, for better or worse, the patient-provider visit. 6,7 According to three FDA surveys performed from 1999 to 2002, physicians reported that DTCA had the following four beneficial effects. It improved discussions with patients, increased understanding of their disease and treatment, and increased the likelihood that patients were compliant taking their prescribed medications as directed. Finally, it enhanced the diagnosis of new conditions. 8 DTCA is also considered helpful for patient education which is likely a driver of the perceived effects listed above. In addition, it is perceived that DTCA gives patients more control over their care and well-being by prompting patient visits to providers and encouraging a more interactive clinical visit. 9,10 However, there is still a lot of controversy on the interpretation of study results and whether the overall outcome from DTCA is positive or negative. 6,8,9,11-13 Within the reviewed studies, there is a definite difference of opinion on the impact of DTCA with respect to the patient-provider relationship among both groups: patients and providers. One facet of controversy about DTCA s effects is that it could negatively affect patientprovider interactions due to DTCA increasing patient requests for unneeded or expensive medications. Some health care providers object to the resulting demands from patients for certain brand name drugs. Not only may the requested brand be inappropriate for their condition, or be less effective than advertised, it could cause side effects. Furthermore, a provider may end up prescribing the requested treatment without knowing all the risks and benefits for the patient in question or fully discussing risks and benefits with the patient. The newest drugs do not have the same long track records of effectiveness and safety that an older treatment has. DTCA may not 2

3 adequately explain treatment options and may give consumers a false sense of security regarding the safety of these advertised treatments. Furthermore, it is argued that DTCA increases utilization and health care costs by focusing primarily on the newest and most expensive drugs. This and other ongoing evaluations of the effects of DTCA on the patient-provider relationship merit further discussion and are explored in this review. The purpose of this literature review is to summarize and assess physician and patient/consumer perceptions regarding DTCA sentiment on these issues. Method: We used the ISI Web of Knowledge (Thomson Reuters) database for our search, which includes the Web of Science databases covering almost 10,000 journals. Included databases are the Science Citation Index Expanded (1899-present), Medline (1946 present), the Social Sciences Citation Index (1898-present), and the Arts & Humanities Citation Index (1975-present). We felt that while we may miss some articles in utilizing only this database, the journals represented in the database are well-regarded peerreviewed journals and should provide a substantive representative sampling of the extant literature. Our search terms were the phrase direct to consumer and advertising in combination. We included publications in English, published after 1995 that specifically included analyses of patient/consumer and physician attitudes towards DTCA. To limit our findings to research results from original data collection, we excluded letters, editorials, and news items. Meeting abstracts were also excluded due to the lower level of peer-review and lack of sufficient data. In addition we excluded articles that focused on other aspects of DTCA without describing patient and/or provider attitudes. Results: Our search was performed in September One person of the team performed the search. The search yielded 390 citations (See Figure). There were 130 letters, editorials, meeting abstracts and news items, reducing our count to 260 items. Refining 3

4 our list to only publications in English and published 1995 or later, reduced the count to 250 items. Among the 250 items, we reviewed the abstracts for 208 citations that pertained to publications from the United States. Table 1 shows a summary by publication year of the reviewed abstracts. Publications were most frequent during the years In reviewing the abstracts we looked for primary analyses of patient/consumer or physician attitudes toward DTCA, finding 65 abstracts that we further reviewed. Of the 65 articles we excluded 35 articles. The remaining 30 articles comprised 18 articles that reviewed patient attitudes, that reviewed physician attitudes, and 3 that reviewed both. 39,41,42 Overall results for articles are shown in Table 2, the details of which are discussed in the following sections. Study findings described by the papers in our review have been identified and summarized in Table 3. Positive Impact for DTCA on the patient-provider relationship Better discussion with patients A common perception in reviewed studies was that patients are more informed as a result of DTCA and that this has improved the patient-provider interaction. In a study with over 2500 patient responders, 14% of respondents disclosed health concerns as a result of DTCA and 6% requested preventive care. 29 Stratification of the responding group showed higher rates for patients with chronic conditions or who were taking 3 or more medications. Patients with chronic conditions were positively affected by DTCA because they have a better understanding of the disease in terms of prognosis and management reducing uncertainty and making them more involved in their health care. In fact, these subjects have reported improvements in their perception of health to a level equal to those who had no chronic conditions. 43 Many of these discussions are cited in studies as discussions that would not have occurred without the impetus provided by DTCA. Although data from one study revealed that DTCA is likely to increase request rates of the drug category and brand name version, these requests typically lead to some form of discussion about the disease state that would not have been present otherwise. 37 Education 4

5 Proponents of DTCA believe that the practice helps to educate patients, giving them more control over their care and improving well-being. 7,9,10 Supporters also feel that patients are more educated and feel empowered to seek help for medical conditions. 20,23 In several reports, DTCA was described as a way to bring patients into the office to talk about rarely discussed conditions. 23,33 However, patients tend to be more likely to view DTCA as educating patients than physicians. For example one study of physicians and patients found 44% of patient respondents believed DTCA helped to educate patients, while only 32% of physicians did. 41 Other separate studies show 55% of physicians and 69% of patients thought DTCA encouraged patients to seek treatment they would not have gotten otherwise. 29,36 Lastly, DTCA may benefit minority populations. In another survey of physicians, it was believed that minority populations benefited greatly from education prompted and provided by DTCA. 35 This perception was increasingly seen over a five year period. Patient more likely to take prescribed drugs DTCA has been suggested to help improve patient compliance with drug regimens in addition to increasing the likelihood of having patients get their prescriptions reordered and continuing their regimen. Two surveys found that physicians believe that DTCA exposure encourages patients to take a more active role in their health care as well as follow their prescribed regimen more accurately. 33,35 A study of over 1000 physicians found 72% saw DTCA as having a positive impact in encouraging patient compliance of treatment or advice. 36 Separately, in a study of over 2500 patients, 81% saw DTCA as having a positive impact in encouraging patient compliance of treatment or advice. 29 DTCA appears to encourage compliance with physician-prescribed treatment regimens. A study conducted by a pharmaceutical company from June 2001 found that the percentage of patients with diabetes, depression, elevated cholesterol levels, arthritis, or allergies who continued with therapy after six months was substantially higher when the patient asked for a medicine after being prompted by DTCA than when the patient was given a prescription for a medicine without such prompting. 9 In a survey, 22 percent of consumers said direct-to-consumer advertising made it more likely they would take 5

6 their medicine regularly. The authors concluded well informed patients comply better with long term treatment than those who are not. 6 All of the above studies demonstrate that both physicians and patients firmly believe that exposure to DTCA has improved this aspect of the clinical relationship. New conditions diagnosed DTCA can help improve public health by encouraging more people to talk with health care professionals about health problems, particularly under-treated conditions such as high blood pressure and high cholesterol. Also, DTCA can help to remove the shame that accompanies diseases that in the past were rarely discussed, such as erectile dysfunction or depression. 7 A study that evaluated diagnosis as a result of DTCA found 25% of patients that initiated a clinical visit due to DTCA exposure, received a new diagnosis of which almost half were considered high priority. 30 These conditions included reflux disease, arthritis, diabetes, and high cholesterol. For chronic diseases, especially those with high prevalence that can be treated with prescription drugs, the consequences of not seeking appropriate treatment can affect not only the patient, but also the family and society. For example, untreated diabetes can lead to blindness or chronic kidney disease. Non treated high cholesterol can lead to heart attack or stroke, while cholesterol-lowering drugs can reduce risk by 30% approximately. 9 DTCA encourages members of the public, particularly those of low socioeconomic status, who may not receive regular medical check-ups, to seek medical care. It encourages people to disclose health concerns to their doctor, and enhances some patients sense of confidence and control during a visit. 9,14,17 A patient survey found that 14% of respondents were driven to discuss conditions with their physician and that the effect was larger for patients with lower socioeconomic status. 29 DTCA may also help consumers to recognize symptoms and encourage them to seek appropriate care. 44 6

7 Negative Impact for DTCA on the patient-provider relationship Unnecessary increased utilization It is also suggested that DTCA could increase utilization and health care costs by focusing on only the newest and most expensive drugs, could potentially result in adverse health outcomes, and give consumers a false sense of security regarding the safety of advertised drugs. Some health care providers object to the resulting demands from patients for certain brand name drugs that may be inappropriate for their condition, are more expensive than other options, have side effects of which the patient is unaware, or are less effective than advertised. One study tried to quantify the increased utilization due to DTCA with a survey of patients. 29 Results show that 5% made requests for a test, medication change or referral and 3% received the requested intervention. Although this is not a large percentage, it merits consideration based on the overall number of patients it implies. A real-time, point of care survey, similarly found 3.5% of patients requesting utilization based on DTCA exposure. 38 Segregated to private practices, this rate was 7.5%. Compared to a previous real-time point of care survey, this rate was half what it was 5 years prior, indicating a potential decreasing trend of requests related to DTCA. To explore increased utilization further, a study used COX-2 inhibitors to describe utilization of requests due to DTCA exposure. 45 In this study, 78% of patients who experienced some form of DTCA asked for and were prescribed COX-2 inhibitors as compared to 43% of all other patients. People who saw specialists were twice as likely to receive prescriptions. A maximum of 67% of those prescribed were deemed appropriate given many factors including risk of gastrointestinal bleeding. A separate study of physician opinions corroborates this finding, as 49% of respondents deemed prescription requests as inappropriate with a stunning 69% fulfilling these requests. 36 That translates to 1/3 of all requests being fulfilled by physicians even though deemed inappropriate. Propagated throughout the health care system, costs directly related to increased utilization associated with DTCA could be significant. Diminished time evaluating a patient 7

8 Providers are under pressure to limit the time devoted to office visits and to increase their productivity in terms of numbers of patients seen, but many health care providers would prefer to spend more time on diagnosis and treatment and less time convincing patients they do not need advertised drugs. 46 Multiple studies in this survey support this argument. One study of over 700 physician perceptions found that DTCA increases patient requests for specific medications and therefore changes the patient expectations of prescribing. 39 This same group of physicians believe that DTCA is lacking in information regarding cost, alternative treatments and adverse effects, which they must address during clinical visits. Two additional studies report 39% of physicians and 38% of patients view requests deriving from DTCA as damaging to the efficiency of the visit. 29,36 Impede doctors effectiveness Some health providers consider that with exposure to DTCA, patients may withhold information from their doctors or even attempt to self-treat themselves with over-thecounter and alternative medicines, both of which lead to non-optimal outcomes. Aiming prescription drug ads at consumers can affect the "dynamics of the patient-provider relationship," and ultimately, the patient's quality of care. It has also been seen that DTCA can motivate consumers to seek more information about a product or disease, however physicians need to help patients evaluate health-related information they obtain from DTCA. 8 An in depth study evaluating physician responses to patient requests for information as a result of DTCA, showed a statistically significant negative impact on physician willingness to answer 145 questions and provide additional information which clearly can impact the effectiveness of the clinical visit. 47 Misinformation The design and implementation of DTCA has been perceived as misleading, affecting negatively the relationship between patient and physician. 37 DTCA has been accused of lacking educational value, misleading consumers into thinking that they have conditions that can be cured with the advertised medications. 39,48 As a result, doctors may have to 8

9 spend more of the clinical visit addressing misunderstandings of drug and treatment options. 35,41 Some providers consider that DTCA rarely includes additional alternative information on lifestyle changes that could be as important as the taking of medication. 49 For some patients, weight loss, exercise, and healthy diets can be as beneficial to maintaining health as taking cardiac medication. Thus, opponents of DTCA believe that lifestyle changes should be addressed by the physician, rather than depending solely on the action of advertised specific medications. 5,7 For many of the reasons described above, DTCA is seen to have both positive and negative effects with multiple studies describing in different ways which facets of the relationship are affected. As an example, one study summarized physician perceptions of the effect of DTCA on the clinical experience. Physicians saw 24% of visits as positive, 66% neutral and 10% as negative. 38 Table1 highlights the differences between Patient and Physician view while also indicating the total number of articles which contained the Beneficial and Detrimental aspects of DTCA. The three most beneficial aspects of Direct to Consumer Advertisement were found to be: Education of Disease/Awareness of Drugs, Discussion, and Disease Detection. Patients have a slight positive view and physicians have a slight negative view. The benefits of DTCA to the patient- physician relationship in the order most often cited are education of disease and awareness, discussion, disease detection and compliance. Detrimental effects in the order most often cited are misinformation, specific drug requests, unnecessary utilization, negative impact on clinical visit, inappropriate medication use and diminished evaluation time. Overall, the effect of DTCA on the patient provider relationship is viewed as a positive one. Reasons for the mixed view can be used to provide the framework to determine modifications to DTCA for maximum benefit and minimum negative impact. Future directions for DTCA to improve the patient-provider relationship 9

10 Direct-to-consumer advertising does not supersede the physician patient relationship; its effect is rather to encourage an informed discussion between patient and physician. As has been discussed in FDA hearings since the introduction of DTCA, and with the advent of the Bad Ad program, DTCA could be monitored and evaluated closely to ensure a balanced message was being delivered. These investigations will allow changes to DTCA that limit the negative impact as well as enhance the patient-provider relationship. A recent study showed that only 18% of print ads evaluated in a one month period were compliant with FDA guidelines with over 50% of the ads showing serious risks of the medication. 50 Currently the FDA sponsors a website that was created in collaboration with EthicAd containing materials for consumers to educate them on drug advertising. 51,52 Although utility of the internet to locate health information is rising rapidly, a website alone may not be the sole suitable medium for many individuals. For example, highly targeted, practice-specific posters and pamphlets placed in doctor waiting rooms or pharmacies combined with digital media placement may expand the FDA's outreach to a broader audience. In order to minimize negative effects of DTCA, information must be accurate, not misleading and should reflect the balance between risks and benefits. Information should be designed to educate consumers and to refer patients to health professionals for further discussion as to whether the drug is appropriate, after their condition has been evaluated. DTCA should also be designed to clearly explain potential risks and side-effects, discourage self-diagnosis and self-treatment, as well as promote healthy lifestyle practices. The consumer should be strongly encouraged to discuss medications with health care practitioners as the health care provider is often a better source of information and less biased than DTCA regarding the most suitable medicines. Health care providers should also know that patients are increasingly seeking information through multiple channels regarding new therapies and be prepared to discuss these therapies as a part of the consultation. 10

11 Limitations Our article is a review of the extant published studies concerning patient and practitioner attitudes about DTCA and its impact on the patient provider relationship, based upon the search methodology described. A more thorough search of unpublished literature would undoubtedly generate more information than we have presented here, but the information would not have been subjected to peer review. We believe that our search resulted in a comprehensive set of the published articles on this topic. The articles encompassed surveys of both primary and specialist physicians and a wide range of patient demographics. REFERENCES 1. Silver LS, Stevens RE, Loudon D. Direct-to-consumer advertising of pharmaceuticals: concepts, issues, and research. Health Mark Q 2009;26: Barbara M. Health Council of Canada. What are the public health implications? Direct-to-consumer advertising of prescription drugs in Canada. In. Toronto; Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. New England Journal of Medicine 2007;357: Frosch DL, Grande D, Tarn DM, Kravitz RL. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. Am J Public Health 2010;100: Findlay SD. Direct-to-consumer promotion of prescription drugs - economic implications for patients, payers and providers. Pharmacoeconomics 2001;19: Bonaccorso SN, Sturchio JL. Direct to consumer advertising is medicalising normal human experience. British Medical Journal 2002;324: Viale PH. What nurse practitioners should know about direct-to-consumer advertising of prescription medications. Journal of the American Academy of Nurse Practitioners 2003;15: Rados C. TRUTH in advertising: Rx drug ads come of age. (Cover story). FDA Consumer 2004;38:

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16 Table 1 Publication Year for Reviewed DTCA Abstracts Publication Year Record Count % of % % % % % % % % % % % % % % Table 2 Reviewed Articles: Summary Overall Impact Beneficial Aspects Detrimental Aspects Mixed Overall Summary Positive Negative Total Impression Physician View Patient View # # Aspect Total Articles Articles Discussion Education of Disease/Awareness of Drugs Compliance Disease Detection Other Unnecessary increased utilization Leads to patients specifically requesting drug Inappropriate use Misinformation / Not enough information Diminished patient evaluation time / increased visit time Impede doctors effectiveness / negatively impact doctor/patient relationship

17 Table 3 Reviewed Articles: Detail Author, Pub Year Overall Impact Benefits Risks Respondents Physician View Patient View Discussion Disease / Drug Treatment Education Compliance Disease Detection Other Unnecessary increased utilization Leads to patients specifically requesting drug Inappropriate use Misinformation / Not enough information Diminished time for patient evaluation / increased visit time Impede doctors effectiveness/negatively impact doctor/patient relationship Physician: Specialist (S) Primary Care (P) or Mixed (M) Patients: Young (Y) Older (o) or Mixed (M) Abel, 2009 Neg Y Y Y Y Y Y Y M An, 2008 Pos Y Y Y Y M Bell, 1999 Pos Y Y Y Y Y M Bell, 1999 Mix Y Y Y Y Y Y Y Y M Bozic, 2007 Mix Pos Y Y Y Y Y Y Y Y S M Burak, 2000 Mix Y Y Y Y Y Y Y Choi, 2007 Mix Y Y Y Y Y Y Y M Datti, 2006 Mix Y Y Y Y Y Y M DeLorme, 2006 Mix Y Y Y Y Y Y Y Y Y M DeLorme, 2007 Mix Y Y Y Y Y O DeLorme, 2009 Mix Y Y Y Y Y Y Y O Deshpande, 2004 Pos Y Y Y Y Y Y Y O Fortuna, 2008 Neg N Y Y Y M Herzenstein, 2005 Mix Y Y Y Y Y M Huh, 2004 Mix Y Y Y Y Y Y M Huh, 2007 Neg Y Y Y Y Y Y M Kon, 2008 Mix Mix Y Y M M Lee, 2007 Mix Y Y Y Y Y M Lipsky, 1997 Neg Y Y N Y Y Y P Marinac, 2004 Mix Y Y Y Y Y O Menon, 2003 Mix Y Y Y Y Y Y M Mintzes, 2003 Neg Y Y Y Y Y Y Y P Morris, 2007 Pos Y Y Y Y Y Y M Murray, 2003 Mix Y Y Y Y N M Murray, 2004 Pos Y Y Y N N M Parker, 2003 Mix Y Y Y Y Y Y Y Y Y M Parnes, 2009 Pos Y Y Y N P Robinson, 2004 Neg Neg Y Y Y Y Y Y M M Weissman, 2003 Pos Y Y Y N M 17

18 Weissman, 2004 Pos Y Y N Y Y Y N P Figure. DTCA Literature Review Flow Diagram Assessed for eligibility (n= 390) Excluded (n= 130) Letters, editorials, meeting abstracts, news items (n=130) Non-English, earlier than 1995 (n=10) Non-U.S. studies (n=42 ) Abstracts Reviewed (n= 208) Excluded (n= 143) Review articles Studies not of patient/practitioner attitudes toward DTCA Articles Reviewed (n= 65) Excluded (n= 35) Aspects other than patient/practitioner attitudes (n=15) Impact of advertising expenditures (n=7) Physician training (n=4) Hypothetical situation studies (n=4) Duplicate study summaries (n=2) Article not obtainable (n=2) Literature review (n=1) Articles Included (n= 30) 18