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Consumers' Views on Generic Medications
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Consumers' Views on Generic Medications Caroline A. Gaither, Duane M. Kirking, Frank J. Aseione, and Lynda S. Welage
Objectives: To review the literature on consumers' knowledge, attitudes, and opinions about and use of generic medications and to ascertain the official policies of several consumer organizations regarding generic medications and therapeutic substitution . Data
Sources: Articles indexed under terms such as consumers, generic medications, generic drugs, multisource medications, or multisource drugs. These terms were used to search indexing services such as MEDLlNE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. This literature search was supplemented by a telephone survey of 12 consumer organizations. Study Selection: Performed by the authors. Data Synthesis: In general, consumers were positively inclined toward generic medications, but views differed by ethnicity, education, income, age, risk perception, knowledge, and past experience. Consultation with health care professionals and the availability of prescription drug coverage influenced consumers' use of generic medications. Few consumer organizations had official policies addressing the use of generic medications, but most of these organizations encouraged consumers to learn more about their medical conditions and to consult their physician or pharmacist about the appropriateness of prescribed medication. Conclusion: More research is needed on consumers' decision-making processes and behaviors regarding generic medications. Mass education efforts, financial incentives, and greater communication among patients and health care professionals should continue to influence the use of generic medications.
JAm Pharm Assoc. 2001;41:729-36.
In the debate over the use of brandname versus generic medications, the voice of the patient or consumer, for whom the medication is prescribed, often goes unheard. In this article we provide a chronological review of the literature on consumers' knowledge, attitudes, and opinions about, and use of, generic medications. We also offer several recommendations that pharmacists can implement in their practice settings to improve their patients' Received October 19,2000, and in revised form July 9, 2001. Accepted for publication July 20, 2001. Caroline A. Gaither, PhD, is associate professor, Department of Social and Administrative Sciences, College of Pharmacy; Duane M. Kirking, PharmD, PhD, is professor and chair, Department of Social and Administrative Sciences, College of Pharmacy, and research scientist, Health Management and Policy, School of Public Health; Frank J. Ascione, PharmD, PhD, is associate dean for academic affairs and professor, Department of Social and Administrative Sciences, College of Pharmacy; and Lynda S. Welage, PharmD, is associate professor, Department of Clinical Sciences, College of Pharmacy, and clinical pharmacist, Pharmacy Services, University Hospitals, University of Michigan, Ann Arbor. Correspondence: Caroline A. Gaither, PhD, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI48109-1065. Fax: 734-615-8171 . E-mail: [email protected]. See related articles on pages 718 and 723, as well as the introductory Viewpoint article on page 517 of the July/August 2001 JAPhA.
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medication use. In addition, to get a complete picture of consumers' views of generic drug products, we supplemented this review with a telephone survey of 12 consumer organizations thought to represent the views of their constituents regarding the use of generic medications and therapeutic substitution. This article is one of three in this issue of JAPhA that, taken together, should provide a more complete understanding of the views of generic drug use by the three major players involved-physicians, pharmacists, and consumers.
The 19708 Early studies on generic drugs examined attitudes, perceptions of risk, and knowledge of and satisfaction with generic medications, and compared the views of consumers, physicians, and pharmacists. In a study published in 1975, Nelson and Gagnonl reported that of 1,000 homemakers surveyed, 59% favored repeal of antisubstitution laws and 65% would allow or prefer the pharmacist to substitute less costly generic products. Willingness to accept generic drugs increased with higher levels of education and income and decreased with age. From December 1976 through February 1976 Lamert et al. 2
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collected data on 371 consumers in Florida regarding their predisposition toward acceptance of generic drugs. Approximately 66% of the respondents rejected lower cost generic alternatives , regardless of the amount of savings suggested. Rejecters, who were older and had lower incomes, perceived generics as less effective than did acceptors. Bearden and Mason, 3 in a study published in 1978, surveyed 105 consumers on their attitudes toward the risks involved with using generic medications. As a framework for this study, the investigators used Fishbein and Ajzen's theory of reasoned action,4 which posits that individual attitudes are the major determinants of both intention to act (in this instance, intention to use generic medication) and actual behavior (using generic medications). This theory holds that an individual's attitude toward an action is based on the summation of his or her beliefs about the consequences of the behavior and weighted by the perceived value of these consequences. Risks were represented by the probability and importance of loss across six dimensions: financial, social, drug performance, psychological, physical, and convenience. The researchers examined consumers' beliefs about and evaluations of the quality, price, safety, adverse effects, and efficacy of generic medications, as well as the reputations of generic drug manufacturers. Approximately one-third of the consumers surveyed were negatively inclined toward the use of generic drugs, one-third were positively inclined, and the remainder were neutral. Those opposed to generic substitution perceived higher risk levels for each of the six dimensions and considered those risks more important than did those favoring generic substitution practices. The latter believed that generic drug products were of high quality, safe, produced by reputable manufacturers, and would have the intended results. Further analyses indicated that consumers' preferences (negative, positive, and neutral) regarding the purchase of generic drugs were influenced by their concerns about drug performance, potential financial loss,a and safety. The authors concluded that efforts to increase the use of generic drugs should stress both the potential for consumer savings and the maintenance of quality health care. Studying the same six risk dimensions listed above, Bearden et al. 5 compared risk perceptions regarding generic drugs in two age groups (~ 54 years old versus ~ 55 years old). Overall, older subjects perceived use of generic drugs as being more risky than their younger counterparts did. Potential financial losses due to unnecessarily high prices of generics were also more important to the older group. To supplement the above findings, Bearden and colleagues 6 surveyed 118 pharmacists and 412 physicians in 1979 to compare their views with those of consumers. Consumers and pharmacists expressed higher levels of agreement than did physicians with the "The survey item was worded as follows: How likely is it that the request for and purchase of a generically prescribed drug would lead to a financial loss because it was priced higher than other brands?
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statement, "Consumers would like the opportunity to purchase generically prescribed drugs." These same groups also disagreed to a greater extent than did physicians with the statement, "Consumers are likely to face greater health risks if generic prescribing becomes common practice." Consumers agreed less than pharmacists and physicians with the statement, "Wider use of generic drugs would mean less money would be available for research to bring new drugs to the market." All three groups were in slight agreement with the statement, "Generic prescribing generally leads to use of drugs that will produce the intended therapeutic results." In addition, consumers agreed to a greater extent than did physicians and pharmacists with pricing statements (e.g., "Regulatory agencies should set 'maximum allowable costs' for drugs"). Consumers were generally supportive of practices that decrease prescription drug prices because they believed these decreases would result in potential financial savings for them. In April 1979 LaBarbara7 interviewed a convenience sample of 150 consumers in New York City to gauge their knowledge of and satisfaction with generic drugs. Only 50% of the consumers knew the definition of a generic drug. Approximately 33% got their information about generic drugs from the newspaper, while only 12% got their information from their pharmacist. Only 24% of those consumers who were incorrectly informed about generic drugs had actually used them, and, of those, 77% were very satisfied with the results. Similar to Nelson and Gagnon, I LaBarbara also showed that those individuals who intended to try generic drugs were better educated and had higher incomes. The author suggested offering pharmacists financial incentives to increase their promotion of generic drugs, and he called for the marketers of generic drugs to take steps to increase consumers' awareness of generic products and support studies aimed at resolving the controversy over the quality of generic drugs. In a telephone survey of 95 households in the Durham, N.C., area in October 1979,8 only 59% of the respondents were aware (i.e., knew about the existence of) of generic drugs. Individuals who were older, less educated, and who were taking medications for chronic conditions were less aware of generic drugs. More than 66% of the individuals who were aware of generic drugs felt they were just as safe and effective as brand products, believed they were less costly than brand products, and preferred them over brand drug products. On the basis of these results , the authors speculated that only 39% of the consumers questioned could be expected to request generic drugs from their physician or pharmacist. Approximately 7 years elapsed between this study and the next group of studies reviewed.
The 1980s Researchers' interest in the study of consumers' use of generic drugs waned until the mid-1980s. A study conducted in 1986 by the American Association of Retired Persons (AARP) uncovered confusion and misinformation about generic drug products
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among a high percentage of older consumers.9 Of the respondents, 76% never asked for generic drugs from their physician or pharmacist (it was not clear whether this figure included consumers who had never received a prescription in the past). Many respondents were confused over the meaning of the term "bioequi valence." The report concluded that mass advertising was needed to inform consumers about generic drugs. AARP planned to use an educational campaign to oppose attempts by manufacturers of branded pharmaceuticals to dissuade consumers from using generic drug products. In a 1987 study involving 621 consumers in Austin and San Antonio, Tex., 33% of those interviewed had never purchased generic prescription medications.lo,11 Consumers felt that, compared with brand drugs, generic drugs were of lower quality, more risky, less effective, and less healthful. Yet, contrary to findings from previous studies, individuals older than age 55 thought generic drugs were of higher quality than did younger respondents. Using multiple regression, Shepherd II identified several factors as important predictors of reported purchase frequency of generic drugs: having purchased generic nonprescription drugs in the past (standardized ~ =.33), being asked by pharmacists if they wanted a generic drug (.27), consumers' perceptions of the quality of generic drugs (.22), being white (.12), using generic food items (.08), and having prescription benefits that encourage the use of generic medications (.07). These variables were estimated to explain 37% of the variance in consumers' reported purchase frequency of generic drugs. Another 1987 study, this one involving telephone interviews of 514 consumers in Georgia, found more than 70% agreeing that generic drugs could save them money on prescriptions. 12 In contrast to the Texas study of the same year, more than 60% of respondents indicated that generic drugs were just as safe, equivalent in quality, and just as effective as brand drugs. However, only 24% of the respondents had asked their physician or pharmacist for generic drugs when receiving a prescription. Also similar to the other 1987 study, a cluster analysis indicated that nonwhites held slightly more negative attitudes toward generics and seldom requested them. Concluding that consumers have little influence over the rate of generic drug use, Carroll et al. 12 suggested that favorable attitudes are a necessary, but not determinative, condition for increased consumer requests for generic drugs. To increase the use of generic drugs, the authors suggested, physicians and pharmacists need to prescribe these products and promote them to their patients, since patients do not actively request generic drugs. The reasons for the discrepancies between the views revealed by the two 1987 studies I 1,12 are unclear. Consumers in Texas held more negative views of the quality, safety, and effectiveness of generic drugs than did those in Georgia. The demographic profiles of the two samples were similar, except that the Texas consumers surveyed had higher education levels, were more likely to be female, and were more ethnically diverse than those surveyed in Georgia. In previous studies, those with higher education levels
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seemed more favorably disposed toward generic drug products. 1.7 It is speculated that the effects of race/ethnicity may have overridden the influence of education, accounting for the more negative views of consumers in Texas. The study conducted in Texas included a larger proportion of nonwhites, a group that held more negative views of generic medications, than did the Georgia study. A negative view of generic products is also evident in the next study reviewed. In a study done in California and Arizona, also conducted in 1987, Tootelian et al. 13 asked 389 college students about their perceptions of eight types of prescription medications and found that brand drugs were viewed as being more effective, having less potential for adverse effects, and providing greater value than their generic counterparts. The greater the perceived risk of the prescription drug, the greater the respondent's inclination to view the brand medication more favorably. The authors suggested that, in order to increase generic sales, it is important to position generics as safe and effective alternatives to brand products. Age may have influenced the views of this group, since more than 85% of individuals in the sample were 30 years old or younger. Yet, interviews with 287 Georgia consumers over 50 years of age in 1988 indicated that approximately 80% thought generic drugs were as safe and as effective as, and not lower in quality than, brand medications. 14 More than 75% of the consumers interviewed by Wolfgang and Perri were willing to ask their pharmacist about getting generic medications the next time they had a prescription filled and to recommend that a friend do the same. Previous use of a generic drug and higher family income were related to more positive attitudes. Unlike earlier studies, in this study older respondents--between 50 and 79 years of age--held positive attitudes toward generic drugs and would likely use them again in the future; their views were positively influenced by previous experience with generic drugs. In a study of 100 consumers in the Chicago area, published in 1989, more than 50% of those surveyed supported the use of generics for themselves and their families, and more than 90% felt confident in the safety and efficacy of a generic drug if a physician or pharmacist recommended it. IS Again, however, consumers' acceptance of a generic product was found to be related to the degree of risk they attached to it, the risk being dependent upon the seriousness of the disease state and not the medication itself. Although consumers in this sample knew what generic drugs were and were positively predisposed toward them, they were less likely to want to take them for chronic or serious conditions where the possibility of ineffectiveness might have serious consequences. The authors concluded that consumers' perceptions of illness, and not their beliefs regarding the equivalence of brand and generic products, was the main determinant of generic drug use. In summer 1989 U.S. Food and Drug Administration (FDA) officials were charged with taking bribes from generic drug companies and sharing proprietary information with competitors. 16,17 Numerous news reports indicated that some generic manufactur-
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ers falsified lab data and paid off FDA chemists to approve their products. I 8-21 This situation became known as the "generic drug scandal." Gallup surveyed 1,009 consumers of a broad range of ages in October 1989 to ascertain their attitudes toward generic drugs after the scanda1. 22 ,23 Most (91 %) were fairly satisfied with the generic drug products they used, and more than 70% were somewhat confident that generic drugs were just as efficacious as brand drugs. Yet, 51 % feared that generic drugs were not manufactured to the same standards as brand medications. In addition, more than 70% indicated that the scandal had affected their confidence in generic drugs to some degree. As before, only a small percentage (10%) had either asked their physician or pharmacist about generic drugs or had been switched from a brand to a generic medication. Younger individuals were more likely to obtain their information on generic drugs from television, while those over 50 years of age were more likely to obtain their information from newspapers. In a 1989 study involving 521 consumers in Georgia, Perri et 24 al. found that, after the generic drug scandal, consumers over 50 years of age were more skeptical of the safety, efficacy, and quality of generic medications and less likely to ask for a generic product when filling their next prescription than they were a year earlier. Interestingly, those consumers who were aware of the generic drug scandal (31 %) held more positive perceptions of generic drugs than did those who were unaware of it. These results suggest that the generic drug scandal affected older consumers more negatively than those younger than 50 years of age. This may explain the differences between findings from this study and the previous one. The factors that influence generic substitution, satisfaction, and intention to purchase generic drugs surfaced again in a field experiment (conducted before the generic drug scandal, but published in 1991) involving 295 patients who had obtained prescriptions for one of two brandname products at one chain pharmacy in Vancouver, British Columbia. 25 More than 80% of the patients offered a generic substitute for one of the study drugs accepted it. Patients who were older, less educated, and had prescription drug coverage were less likely to accept a substitute. Satisfaction with generic drugs was lowest for those who had no choice in their use and did not have to pay anything to receive the medication. Intention to purchase another generic drug product in the future was influenced by having recently accepted a generic substitute, perceiving that the cost savings would be high, and having to pay some or all of the cost of the medication. As did previous authors, Kendall et al.25 concluded that having pharmacists actively promote generics and having patients pay some part of the cost of the medication would increase the rate of generic substitution.
The 19905 A study published by Lumpkin and Strutton26 in 1992 used a
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mail questionnaire to examine the importance of information sources used by 652 elderly consumers (65 years of age or older) in helping them make the best choices when shopping for "health care advances." Defining adoption as acceptance of health care advances and using generic drug products as an example of a health care advance, they found that 59% of respondents had "adopted" generic drugs. Adopters were more likely than nonadopters to use medical experts such as physicians and pharmacists as sources of drug information. Interpersonal information sources (friends, relatives), marketing-dominated sources (salespeople, store reputation), and independent experts (magazine and newspaper reports) were also used more frequently by adopters. Since medical experts and interpersonal information sources were the resources these consumers used when making decisions regarding generic drug use, the authors concluded that gearing advertising to medical experts and opinion leaders may increase rates of generic drug adoption. A study of consumers 45 years and older conducted for AARP and published in 1994 found that the vast majority, more than 84%, were familiar with the term "generic drug."27 Contrary to findings from a study published in 1981,8 chronic/regular prescription drug users were more likely than nonchronic users to be familiar with generic drugs. The author of the later study estimated that approximately 33% of Americans aged 45 to 65 have asked their physician for a generic medication and asked their pharmacist to ftll a prescription with a generic medication. However, a slightly lower proportion (29%) of those aged 65 and older were likely to request a generic version of a drug from their physician or pharmacist. In 1994 a study by Drug Topics examined how 736 consumers across the nation viewed managed care and generic medications. 28 Approximately 40% of respondents reported that they were likely to request generic substitution. The fmdings indicated that 34% of pharmacists and 36% of physicians had initiated generic substitution on consumers ' behalf. Generic and brand products were considered "equal" in quality to brand products by 29% of consumers, and 45% indicated the two were "about the same." Lower income patients were more likely than higherincome individuals to view generic drugs as lower in qUality. A study of consumers conducted in 1995 but published in 2000 returned to the concept of risk. Similar to the study by Podulka et al. (1989),15 Ganther and Kreling29 surveyed 355 adults in central Wisconsin and found that consumers' perceptions of the risks of generic prescription drugs depended on the medical condition being treated. Study participants were asked to assess the comparative risk associated with purchasing a generic drug instead of a brand product for heart problems, high blood pressure, strep throat, pain, and cough. Respondents thought that substituting generic prescription drugs was riskiest when treating heart problems (54%) and least risky when treating strep throat (14%). Respondents also indicated the amount of savings they would require before they would accept a generic version of a drug instead of the brand product. As the risk rating for the medical
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condition decreased, more respondents were willing to take the generic product for less than a $2 cost savings. As the risk rating increased, so did the percentages who wanted a cost savings of more than $15 before they would buy the generic drug or who would not buy the generic product at any cost saving. The authors concluded that financial incentives might be important to increasing consumers' use of generic products. Similar to authors of previous studies, Ganther and Kreling designated patient education by the pharmacist as another important factor in increasing generic drug use for medical conditions perceived by patients as highrisk. In 1996 a mail survey was sent to 349 chain and independent pharmacists asking about their patients' responses to generic drugs. 29 These pharmacists indicated that only 16% of consumers hesitated to get a generic substitute when it was offered and that only 9% declined the generic substitute. Patients' major concerns were reported as quality, efficacy, potency, and consistency of generic medications as compared with brand products. Other concerns of patients reported by pharmacists included the following : "My physician does not like generics," "I've tried a generic and it doesn' t seem to work for me," and "It has too many side effects." In 1999 Merck-Medco Managed Care, L.L.c. commissioned a nationwide telephone survey of 1,000 adults 18 years of age or older to examine consumers' views of generic medications. 31 Slightly more than half of those surveyed believed they were "very knowledgeable" or "somewhat knowledgeable" about generic drugs; however, 19% were "not at all knowledgeable." In general, women were more likely than men to have some knowledge of generic drugs, but the degree of general knowledge did not vary significantly with age. As previous studies had shown, adults with an annual household income of less than $20,000 were significantly more likely than were adults in general to be not at all knowledgeable about generic drugs. In this study, consumers' overall opinion of generic drugs appeared to depend on whether they had taken a generic drug in the past. Slightly more than three-fourths of the respondents had taken a generic drug prescribed by their physician. The largest proportion (24%) of the adults who believed brand drugs were better than generics were 18 to 24 years of age or had annual incomes greater than $50,000. In addition, 20% of the adults questioned had asked their physician to write a prescription for a specific brand product. Respondents were asked to categorize several statements as a "major" or "minor" reason or "not a reason at all" for choosing a generic drug over a brand product. More than 66% indicated that a major reason for choosing a generic drug was "my pharmacist (or physician) assured me that the generic drug is a safe and effective alternative to the brandname drug." Patients whose physician or pharmacist had in fact discussed such a switch with them were more likely than those who had not had such a talk to categorize this assurance as a major reason for choosing a generic drug product. Adults 18 to 24 years of age were less likely than those in other age groups to cite such assurance as a major reason.
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Although a large number of respondents cited the recommendation of their physician or pharmacist as a reason to switch to a generic drug, 53% stated that their physician or pharmacist had never spoken with them about changing from a brand to a generic pharmaceutical. Of the 45% who said their physician or pharmacist had discussed switching, 91 % had taken generic drugs. In contrast, 65 % of those whose physician or pharmacist had not spoken with them had taken generic drugs. Approximately 66% indicated a major reason for choosing a generic drug was, ''The generic drug costs me less money than the brandname drug." Those 65 years of age and older were much more likely than those 18 to 24 years of age to consider this to be a major reason (67 % versus 54%, respectively). A smaller proportion of consumers indicated either "Choosing the generic drug saves my employer money" (31 %) or "Using the less expensive generic drug cuts down on overall health care costs to society" (52%) as a major reason for choosing generic over brand medications. Ultimately, the cost of the prescription was the motivating factor for an adult to choose a generic prescription drug over the brand equivalent. If given a choice between the brand and a generic version of the same prescription drug when each required a $10 co-pay, 61 % indicated they would choose the brand drug. If the co-pays were $20 for the brand drug and $10 for the generic drug, 79% would choose the generic drug. These findings suggest that the lower cost of generic drugs and previous positive experiences with them significantly influence one's preference for generic over brand drugs. As in other studies, respondents with lower incomes held less positive attitudes toward generic drugs. As had others before them, the authors suggested that efforts to educate consumers and health care professionals are needed to increase consumers' knowledge about and use of generic drug products. Momani et al. 32 investigated consumers' awareness of drug management strategies (formularies, drug co-payments, prior authorization, and generic substitution) in a study published in 2000. This mail survey was sent to 303 members of managed care organizations in Maryland, Pennsylvania, and West Virginia. Approximately 51 % of the respondents indicated that their health plan mandated generic substitution. Consumers agreed that "generic substitution affects my compliance with medications." Consumers were neutral in regard to the following statements: "Generic substitution makes it more convenient to get my medicines," and "Generic substitution limits my chances to get the best medicine." Consumers mildly agreed with the statements, "Generic substitution results in less effective medicines," and "Generic substitutions compromises the quality of my medicines." Although these statements reflected a slightly negative view toward generic substitution, when consumers were asked a general question regarding their overall attitude toward generic substitution, a somewhat positive response was obstained (mean =4.6 on a 7-point scale where I = negative and 7 =positive). Motivation to seek information on generic substitution did
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not differ by gender, income, education, length of enrollment in the managed care organization, or presence of a chronic illness. The authors concluded that, overall, this group of consumers held a slightly positive attitude toward generic drugs and were most aware of generic substitution and drug co-payments as means to manage drug costS.b
Consumer Organizations A research associate contacted each of the following organizations by telephone in October 1998: AARP, American Foundation for Health, American Health Decisions, Consumer Alert, Consumer Federation of America, Council on Family Health, National Association of Patient Representation, National Council on Aging, National Women's Health Network, People's Medical Society, Public Citizen's Health Research Group, and Society for Medical Consumers. A staff person at each organization was asked whether their organization had an official policy on generic and therapeutic substitution. Their comments or policy statements are described below. Only three of the organizations provided formal policies (via fax) regarding generic substitution and only two provided policies on therapeutic substitution. c
for passage of state laws that encourage access to generic drugs by eliminating prescription forms that require signatures on different lines depending upon whether generic substitution is allowed or that require physicians to specify in their own handwriting that the brand medication is medically necessary. The federation is on record urging legislators to allow drug patent holders to license other drug manufacturers to produce the product at reasonable royalties to recover research and development costs. This group opposes any attempt by drug manufacturers to extend patent or market exclusivity rights beyond the times currently specified.
The People's Medical Society The People's Medical Society generally views generic substitution positively. The organization stresses the responsibilities of the pharmacist and patient in making decisions regarding drug substitution and encourages patients to fmd out about substitution laws in their state. In their educational materials, the society provides a definition of therapeutic substitution and claims that the medical profession is staunchly opposed to therapeutic substitution because therapeutic decisions reached by physicians are based on a complex body of medical information relevant to a specific patient. The society urges consumers to check with their physician and pharmacist any time a drug is prescribed to determine whether therapeutic substitution is appropriate.
AARP AARP policy states that generic substitution laws and regulations should facilitate the substitution of generic drugs for brand equivalents. However, generic substitution should not be permitted in those cases where the prescribing physician has deemed it medically inappropriate. The policy also indicates that state governments should adopt the drugs on the federal list of therapeutically equivalent drugs (as provided in the Orange Bookl 3) as suitable generic alternatives. The association endorses Federal Trade Commission (FTC) monitoring of the practices of pharmacy benefit managers and calls on FTC to ensure that patients' prescriptions are not inappropriately switched to products manufactured by a parent company.
Consumer Federation of America The Consumer Federation of America's policy indicates that a drug's generic name should be used in licensing, prescribing, dispensing, labeling, and advertising. All government purchases should be made by generic name only, when appropriate, and FDA should maintain data on the bioequivalency of equivalent drugs to assure their interchangeability. The organization also calls bA personal communication with the author indicated that information in Table 2 of his manuscript may be misleading due to a typographical error.
COnly rarely can this material be found in a readily retrievable source. All policy statements can be obtained directly from the organizations.
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Other Organizations Several organizations that did not have an official policy on the use of generic medications indicated that they do favor their use. The Society for Medical Consumers favors generic drug use and therapeutic interchange if these actions are not tied to a managed care-drug manufacturer liaison. The Public Citizen Health Research Group also supports the use of quality generics. The group has no policy against therapeutic substitution, but does consider it unethical to place a burden on patients by trying to coerce them into using another class of drug. If a managed care organization or hospital has a good formulary, then this group is not opposed to therapeutic substitution. Neither the Council on Family Health nor Consumer Alert has addressed the use of generic medications. The remaining organizations contacted indicated that they did not have any official policies or comments on generic or therapeutic substitution.
Discussion Overall, based on our analysis of their responses in studies done over the past quarter-century or so, consumers seem positively inclined toward generic medications. This positive attitude seems to have remained stable across the years, with approximately 40% to 60% of consumers holding a favorable view of generic medications.
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However, a positive attitude does not always lead to increased use of generic drug products. The studies we reviewed indicated several probable reasons for this discrepancy. First, differences were found among various groups of consumers. In general, individuals with lower incomes and less education held more negative attitudes toward, and were less knowledgeable about, generic drugs than were those with higher incomes and more education. Also, whites tended to hold more positive attitudes toward generic medications than did nonwhites. The influence of age was mixed. Several studies indicated that older consumers held more negative views, but others found that younger individuals held more negative views. This may mean that there is a segment of the population (young and old) that is brand-conscious and will always view nonbranded (generic) drug products with some suspicion. Second, past experience with, knowledge of, and risks associated with generics have all been important influences on consumers' views of generic drug products. Several studies found that the use of generic products (nonprescription drugs, groceries, etc.) in the past and knowledge or awareness of generic drugs were important influences on current or future use. Also, the more serious or risky a consumer believed a medical condition was, the less likely he or she would be to choose or accept a generic drug product to treat it. Third, consultation with health care professionals regarding generic medications seems to influence their use. When consumers had talked with either their physician or pharmacist about a generic substitute, they were more likely to accept or use it. However, it is notable that very few health care professionals apparently initiated these conversations, which may explain the low incidence of patient consultation with pharmacists or physicians regarding generic drugs. These professionals may not be initiating these types of conversations due to opposition to or uncertainty about the use of generic medications. Fourth, prescription drug coverage also influenced consumers. If a third party was paying for the medication or if there were no differences in co-payments between brand and generic drugs, a brand product was preferred. Consumers tended to look more favorably on generic medications as the difference in co-payments increased. The seriousness of the illness also played a role: When consumers perceived an illness as severe, they were less accepting of a generic product at any price. Finally, few consumer organizations have official policies regarding generic drug use. Those that do are very much in favor of the use of generic medications if their use can save consumers money and does not compromise patients' health. These organizations encourage consumers to learn more about their medical conditions and to consult their physician or pharmacist regarding the appropriateness of the medication (brand or generic) prescribed. Consumer organizations also encourage their constituencies to learn more about the policies of their state governments and health care plans so they can make more informed choices about medical care.
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Conclusion The following conclusions and recommendations are provided on the basis of our analyses of the literature published over the past 3 decades related to consumers' views of generic drugs. • Researchers should consider further study of consumers' decision-making processes regarding generic medications. Positive attitudes may not be enough to lead to actual use of generic drug products. • Better communication among patients and health care professionals regarding the equivalency between most brand and generic products should increase the use of generic medications. • Mass educational efforts should be directed by consumer and health professional organizations and individual health care practitioners (pharmacists, physicians, nurses, and others) toward consumers to make them more knowledgeable about generic medications and to encourage them to take an active role in managing their medical conditions. Educational efforts should take into account the concerns of specific groups (younger or elderly, lower income, nonwhites) to overcome their fears or misconceptions about generic medications. • Managed care and other third party payers could make more extensive use of financial incentives, including differential copayments for brand and generic medications, to encourage greater use of generic drugs. Pharmacists can take active roles in implementing any or all of these recommendations. This study was supported by the Blue Cross Blue Shield of Michigan Foundation. Dr. Welage is a consultant for AstraZeneca, Wyeth-Ayerst. and Pharmacia, and has received funding from Eli Lilly, AstraZeneca, Wyeth-Ayerst (pending), Pfizer, and GlaxoWellcome (now GlaxoSmithKline). She is on the speakers bureau for Pfizer, AstraZeneca, TAP, Wyeth-Ayerst, Pharmacia, Eli Lilly, and Aventis . Dr. Ascione has received research grants from Amgen, Upjohn (now Pharmacia), and GlaxoWelicome (now GlaxoSmithKline).The other authors declare no conflicts of interests or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria .
References 1. Nelson AA, Gagnon JP. Branded substitution-the consumer's viewpoint. JAm Pharm Assoc. 1975;NS15:382-5, 391. 2. Lamert lV, Doering PL, Goldstein E, McCormick we. Predispositions toward generic drug acceptance. J Consumer Res. June 1980:14-23. 3. Bearden WO, Mason JB. Consumer-perceived risk and attitudes toward generically prescribed drugs. J Appl Psych. 1978;63:74Hl. 4. Fishbein M, Ajzen I. Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, Mass: Addison-Wesley; 1975. 5. Bearden W, Mason JB, Smith E. Perceived risk and elderly perceptions of generic drug prescribing. Gerontologist. 1979;19:191-5. 6. Mason BJ, Bearden WOo Generic drugs: Consumer, pharmacist and physician perceptions of the issues. J Consumer Affairs. 1980;14(1 ):193-206. 7. LaBarbara P. Generic groceries and generic drugs: industry and consumer reactions. Akron Bus Econ Rev. 1980;11(Spring):13-8.
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8. Carroll NV, Jang R. Consumer awareness of generic drugs. Contemp Pharm Pract. 1981;4(3):155-9.
22. Conlan MF. Confidence in generics fell among 50 and over group. Drug Topics. August 6,1990:12.
9. Brickfield CF. Pharmaceutical industry and the consumer. Vital Speeches of the Day. April 15, 1986:410-l
23. Consumer confidence in generic drug products down in wake of industry scandal, but satisfaction with products remains high, survey reveals. Am J Hosp Pharm. 1990;47:468,476.
10. Consumer drug purchases are based on perceptions of quality, survey on generics finds. Am J Hosp Pharm. 1988;45:1245.
24. Perri M III, Wolfgang AP, Janket CPo Georgia consumers' awareness and perceptions of generic drugs after the scandals. Am Pharm. 1990;NS30(10):33-6.
11. Shepherd MD. Investigation into Consumer Perceptions of Generic Drug Products As It Relates to Enhancing Generic Drug Product Marketing. Austin, Tex: Pharmacy Administration Division, University of Texas; 1988.
25. Kendall KW, Ng S, Schoner B. Consumer response to generic/chemically equivalent drugs. J Pub Pol Mark. 1991;10:182-201.
12. Carroll NV, Wolfgang AP, Kotzan JA, Perri M. Consumer attitudes and actions toward generic drugs. J Pharm Mark Manage. 1988;2(4):87-99.
26. Lumpkin JR, Strutton HD. Information sources used by elderly health care product adopters. J Ad Res. 1992;32(July/August):20-30.
13. Tootelian DH, Gaedeke RM, Schlacter J. Branded versus generic prescription drugs: perceptions of risk, efficacy, safety, and value. J Health Care Mark. 1988;8(3):26--9.
27. Rosendahl I. Consumers on generics: some clues on their views from AARP. Drug Topics [suppIJ. May 1994:54s, 56s. 29. Generic vs. brand name. Franklin Lakes, NJ: Merck-Medco L.L.C.; 1999.
14. Wolfgang AP, Perri M III. Older adults and generic drugs: an analysis of attitudes and intentions. J Pharm Mark Manage. 1991 ;5(3):97-106.
30. Muirhead G. How consumers see managed care. Drug Topics. May 24, 1994:40-54.
15. Podulka M, Krautkramer K, Amerson D, et al. Consumer attitudes toward generic drugs. J Pharm Mark Manage. 1989;4(1):93-104.
31. Cardinale V. Patients more open to generics, pharmacists find. Drug Topics [suppIJ. March 1996:8s.
16. Unger M. FDA-review tricks detailed in report. New York Newsday. August 29, 1989.
31. Ganther JM, Kreling DH. Consumer perceptions of risk and required cost savings for generic prescription drugs. J Am Pharm Assoc. 2000;40:378-83.
17. Valentine PW. Former drug firm chief gets 60 days. Washington Post. September 15, 1989. 18. Gorman C. A prescription for scandal. Time. August 28, 1989:56. 19. Baker IN. Not what the doctor ordered. Newsweek. August 28, 1989:32. 20. Dentzer S. Watchdogs overdose on generic drugs. U.S. News & World Report. September 15, 1989:26.
32. Momani A, Odedina F, Rosenbluth S, Madhavan S. Drug management strategies: consumers' perspectives. J Manage Care Pharm. 2000;6: 122-6. 33. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. Rockville, Md: U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2000.
21. Gladwell M. Probe shakes generic-drug industry. Washington Post. August 14, 1989.
Consumers' Views of Pharmacists During the Generic Substitution Debates It is apparent from [this] survey that most consumers are willing to accept the pharmacist taking a larger role in selecting the brand of drug to be dispensed. The majority of the respondents favored the legislative repeal of the prohibition against substitution. Even more striking, however, was the willingness of the homemakers to allow their pharmacist to alter their physician's brand choice decision. A definitive analysis of the homemakers' rationale was not attempted; however, two possible explanations for the wide acceptance are suggested by the data-(l) homemakers do not believe that the product selection decision is critical to their family's health; and/or (2) homemakers perceive their pharmacist as being a capable and responsible health practitioner, able to be trusted with the brand selection function. Support for the first explanation can be seen in [our] data .... Most of the homemakers who favored repeal of the antisubstitution laws cited receiving a consumer price savings as their primary reason for supporting repeal. Only 2.6 percent favored repeal because they felt pharmacists have better knowledge of drug products .... Moreover, approximately one-fifth of those who would allow a substitute on their prescription stated that they did not believe that drug product selection by their pharmacist would be more beneficial to them .... Because these consumers questioned the benefits, it is doubtful they would have agreed to the substitution if they perceived pharmacists would place the patient's welfare above the pharmacist's financial gain. They perceived their pharmacist as profit-oriented rather than patient-oriented. Nelson AA Jr, Gagnon JP. Brand substitution-the consumer's viewpoint. JA m PharmAssoc. 1975;NS15:382-5, 391.
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Consumers' Views on Generic Medications Caroline A. Gaither, Duane M. Kirking, Frank J. Aseione, and Lynda S. Welage
Objectives: To review the literature on consumers' knowledge, attitudes, and opinions about and use of generic medications and to ascertain the official policies of several consumer organizations regarding generic medications and therapeutic substitution . Data
Sources: Articles indexed under terms such as consumers, generic medications, generic drugs, multisource medications, or multisource drugs. These terms were used to search indexing services such as MEDLlNE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. This literature search was supplemented by a telephone survey of 12 consumer organizations. Study Selection: Performed by the authors. Data Synthesis: In general, consumers were positively inclined toward generic medications, but views differed by ethnicity, education, income, age, risk perception, knowledge, and past experience. Consultation with health care professionals and the availability of prescription drug coverage influenced consumers' use of generic medications. Few consumer organizations had official policies addressing the use of generic medications, but most of these organizations encouraged consumers to learn more about their medical conditions and to consult their physician or pharmacist about the appropriateness of prescribed medication. Conclusion: More research is needed on consumers' decision-making processes and behaviors regarding generic medications. Mass education efforts, financial incentives, and greater communication among patients and health care professionals should continue to influence the use of generic medications.
JAm Pharm Assoc. 2001;41:729-36.
In the debate over the use of brandname versus generic medications, the voice of the patient or consumer, for whom the medication is prescribed, often goes unheard. In this article we provide a chronological review of the literature on consumers' knowledge, attitudes, and opinions about, and use of, generic medications. We also offer several recommendations that pharmacists can implement in their practice settings to improve their patients' Received October 19,2000, and in revised form July 9, 2001. Accepted for publication July 20, 2001. Caroline A. Gaither, PhD, is associate professor, Department of Social and Administrative Sciences, College of Pharmacy; Duane M. Kirking, PharmD, PhD, is professor and chair, Department of Social and Administrative Sciences, College of Pharmacy, and research scientist, Health Management and Policy, School of Public Health; Frank J. Ascione, PharmD, PhD, is associate dean for academic affairs and professor, Department of Social and Administrative Sciences, College of Pharmacy; and Lynda S. Welage, PharmD, is associate professor, Department of Clinical Sciences, College of Pharmacy, and clinical pharmacist, Pharmacy Services, University Hospitals, University of Michigan, Ann Arbor. Correspondence: Caroline A. Gaither, PhD, College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI48109-1065. Fax: 734-615-8171 . E-mail: [email protected]. See related articles on pages 718 and 723, as well as the introductory Viewpoint article on page 517 of the July/August 2001 JAPhA.
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medication use. In addition, to get a complete picture of consumers' views of generic drug products, we supplemented this review with a telephone survey of 12 consumer organizations thought to represent the views of their constituents regarding the use of generic medications and therapeutic substitution. This article is one of three in this issue of JAPhA that, taken together, should provide a more complete understanding of the views of generic drug use by the three major players involved-physicians, pharmacists, and consumers.
The 19708 Early studies on generic drugs examined attitudes, perceptions of risk, and knowledge of and satisfaction with generic medications, and compared the views of consumers, physicians, and pharmacists. In a study published in 1975, Nelson and Gagnonl reported that of 1,000 homemakers surveyed, 59% favored repeal of antisubstitution laws and 65% would allow or prefer the pharmacist to substitute less costly generic products. Willingness to accept generic drugs increased with higher levels of education and income and decreased with age. From December 1976 through February 1976 Lamert et al. 2
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collected data on 371 consumers in Florida regarding their predisposition toward acceptance of generic drugs. Approximately 66% of the respondents rejected lower cost generic alternatives , regardless of the amount of savings suggested. Rejecters, who were older and had lower incomes, perceived generics as less effective than did acceptors. Bearden and Mason, 3 in a study published in 1978, surveyed 105 consumers on their attitudes toward the risks involved with using generic medications. As a framework for this study, the investigators used Fishbein and Ajzen's theory of reasoned action,4 which posits that individual attitudes are the major determinants of both intention to act (in this instance, intention to use generic medication) and actual behavior (using generic medications). This theory holds that an individual's attitude toward an action is based on the summation of his or her beliefs about the consequences of the behavior and weighted by the perceived value of these consequences. Risks were represented by the probability and importance of loss across six dimensions: financial, social, drug performance, psychological, physical, and convenience. The researchers examined consumers' beliefs about and evaluations of the quality, price, safety, adverse effects, and efficacy of generic medications, as well as the reputations of generic drug manufacturers. Approximately one-third of the consumers surveyed were negatively inclined toward the use of generic drugs, one-third were positively inclined, and the remainder were neutral. Those opposed to generic substitution perceived higher risk levels for each of the six dimensions and considered those risks more important than did those favoring generic substitution practices. The latter believed that generic drug products were of high quality, safe, produced by reputable manufacturers, and would have the intended results. Further analyses indicated that consumers' preferences (negative, positive, and neutral) regarding the purchase of generic drugs were influenced by their concerns about drug performance, potential financial loss,a and safety. The authors concluded that efforts to increase the use of generic drugs should stress both the potential for consumer savings and the maintenance of quality health care. Studying the same six risk dimensions listed above, Bearden et al. 5 compared risk perceptions regarding generic drugs in two age groups (~ 54 years old versus ~ 55 years old). Overall, older subjects perceived use of generic drugs as being more risky than their younger counterparts did. Potential financial losses due to unnecessarily high prices of generics were also more important to the older group. To supplement the above findings, Bearden and colleagues 6 surveyed 118 pharmacists and 412 physicians in 1979 to compare their views with those of consumers. Consumers and pharmacists expressed higher levels of agreement than did physicians with the "The survey item was worded as follows: How likely is it that the request for and purchase of a generically prescribed drug would lead to a financial loss because it was priced higher than other brands?
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statement, "Consumers would like the opportunity to purchase generically prescribed drugs." These same groups also disagreed to a greater extent than did physicians with the statement, "Consumers are likely to face greater health risks if generic prescribing becomes common practice." Consumers agreed less than pharmacists and physicians with the statement, "Wider use of generic drugs would mean less money would be available for research to bring new drugs to the market." All three groups were in slight agreement with the statement, "Generic prescribing generally leads to use of drugs that will produce the intended therapeutic results." In addition, consumers agreed to a greater extent than did physicians and pharmacists with pricing statements (e.g., "Regulatory agencies should set 'maximum allowable costs' for drugs"). Consumers were generally supportive of practices that decrease prescription drug prices because they believed these decreases would result in potential financial savings for them. In April 1979 LaBarbara7 interviewed a convenience sample of 150 consumers in New York City to gauge their knowledge of and satisfaction with generic drugs. Only 50% of the consumers knew the definition of a generic drug. Approximately 33% got their information about generic drugs from the newspaper, while only 12% got their information from their pharmacist. Only 24% of those consumers who were incorrectly informed about generic drugs had actually used them, and, of those, 77% were very satisfied with the results. Similar to Nelson and Gagnon, I LaBarbara also showed that those individuals who intended to try generic drugs were better educated and had higher incomes. The author suggested offering pharmacists financial incentives to increase their promotion of generic drugs, and he called for the marketers of generic drugs to take steps to increase consumers' awareness of generic products and support studies aimed at resolving the controversy over the quality of generic drugs. In a telephone survey of 95 households in the Durham, N.C., area in October 1979,8 only 59% of the respondents were aware (i.e., knew about the existence of) of generic drugs. Individuals who were older, less educated, and who were taking medications for chronic conditions were less aware of generic drugs. More than 66% of the individuals who were aware of generic drugs felt they were just as safe and effective as brand products, believed they were less costly than brand products, and preferred them over brand drug products. On the basis of these results , the authors speculated that only 39% of the consumers questioned could be expected to request generic drugs from their physician or pharmacist. Approximately 7 years elapsed between this study and the next group of studies reviewed.
The 1980s Researchers' interest in the study of consumers' use of generic drugs waned until the mid-1980s. A study conducted in 1986 by the American Association of Retired Persons (AARP) uncovered confusion and misinformation about generic drug products
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among a high percentage of older consumers.9 Of the respondents, 76% never asked for generic drugs from their physician or pharmacist (it was not clear whether this figure included consumers who had never received a prescription in the past). Many respondents were confused over the meaning of the term "bioequi valence." The report concluded that mass advertising was needed to inform consumers about generic drugs. AARP planned to use an educational campaign to oppose attempts by manufacturers of branded pharmaceuticals to dissuade consumers from using generic drug products. In a 1987 study involving 621 consumers in Austin and San Antonio, Tex., 33% of those interviewed had never purchased generic prescription medications.lo,11 Consumers felt that, compared with brand drugs, generic drugs were of lower quality, more risky, less effective, and less healthful. Yet, contrary to findings from previous studies, individuals older than age 55 thought generic drugs were of higher quality than did younger respondents. Using multiple regression, Shepherd II identified several factors as important predictors of reported purchase frequency of generic drugs: having purchased generic nonprescription drugs in the past (standardized ~ =.33), being asked by pharmacists if they wanted a generic drug (.27), consumers' perceptions of the quality of generic drugs (.22), being white (.12), using generic food items (.08), and having prescription benefits that encourage the use of generic medications (.07). These variables were estimated to explain 37% of the variance in consumers' reported purchase frequency of generic drugs. Another 1987 study, this one involving telephone interviews of 514 consumers in Georgia, found more than 70% agreeing that generic drugs could save them money on prescriptions. 12 In contrast to the Texas study of the same year, more than 60% of respondents indicated that generic drugs were just as safe, equivalent in quality, and just as effective as brand drugs. However, only 24% of the respondents had asked their physician or pharmacist for generic drugs when receiving a prescription. Also similar to the other 1987 study, a cluster analysis indicated that nonwhites held slightly more negative attitudes toward generics and seldom requested them. Concluding that consumers have little influence over the rate of generic drug use, Carroll et al. 12 suggested that favorable attitudes are a necessary, but not determinative, condition for increased consumer requests for generic drugs. To increase the use of generic drugs, the authors suggested, physicians and pharmacists need to prescribe these products and promote them to their patients, since patients do not actively request generic drugs. The reasons for the discrepancies between the views revealed by the two 1987 studies I 1,12 are unclear. Consumers in Texas held more negative views of the quality, safety, and effectiveness of generic drugs than did those in Georgia. The demographic profiles of the two samples were similar, except that the Texas consumers surveyed had higher education levels, were more likely to be female, and were more ethnically diverse than those surveyed in Georgia. In previous studies, those with higher education levels
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seemed more favorably disposed toward generic drug products. 1.7 It is speculated that the effects of race/ethnicity may have overridden the influence of education, accounting for the more negative views of consumers in Texas. The study conducted in Texas included a larger proportion of nonwhites, a group that held more negative views of generic medications, than did the Georgia study. A negative view of generic products is also evident in the next study reviewed. In a study done in California and Arizona, also conducted in 1987, Tootelian et al. 13 asked 389 college students about their perceptions of eight types of prescription medications and found that brand drugs were viewed as being more effective, having less potential for adverse effects, and providing greater value than their generic counterparts. The greater the perceived risk of the prescription drug, the greater the respondent's inclination to view the brand medication more favorably. The authors suggested that, in order to increase generic sales, it is important to position generics as safe and effective alternatives to brand products. Age may have influenced the views of this group, since more than 85% of individuals in the sample were 30 years old or younger. Yet, interviews with 287 Georgia consumers over 50 years of age in 1988 indicated that approximately 80% thought generic drugs were as safe and as effective as, and not lower in quality than, brand medications. 14 More than 75% of the consumers interviewed by Wolfgang and Perri were willing to ask their pharmacist about getting generic medications the next time they had a prescription filled and to recommend that a friend do the same. Previous use of a generic drug and higher family income were related to more positive attitudes. Unlike earlier studies, in this study older respondents--between 50 and 79 years of age--held positive attitudes toward generic drugs and would likely use them again in the future; their views were positively influenced by previous experience with generic drugs. In a study of 100 consumers in the Chicago area, published in 1989, more than 50% of those surveyed supported the use of generics for themselves and their families, and more than 90% felt confident in the safety and efficacy of a generic drug if a physician or pharmacist recommended it. IS Again, however, consumers' acceptance of a generic product was found to be related to the degree of risk they attached to it, the risk being dependent upon the seriousness of the disease state and not the medication itself. Although consumers in this sample knew what generic drugs were and were positively predisposed toward them, they were less likely to want to take them for chronic or serious conditions where the possibility of ineffectiveness might have serious consequences. The authors concluded that consumers' perceptions of illness, and not their beliefs regarding the equivalence of brand and generic products, was the main determinant of generic drug use. In summer 1989 U.S. Food and Drug Administration (FDA) officials were charged with taking bribes from generic drug companies and sharing proprietary information with competitors. 16,17 Numerous news reports indicated that some generic manufactur-
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ers falsified lab data and paid off FDA chemists to approve their products. I 8-21 This situation became known as the "generic drug scandal." Gallup surveyed 1,009 consumers of a broad range of ages in October 1989 to ascertain their attitudes toward generic drugs after the scanda1. 22 ,23 Most (91 %) were fairly satisfied with the generic drug products they used, and more than 70% were somewhat confident that generic drugs were just as efficacious as brand drugs. Yet, 51 % feared that generic drugs were not manufactured to the same standards as brand medications. In addition, more than 70% indicated that the scandal had affected their confidence in generic drugs to some degree. As before, only a small percentage (10%) had either asked their physician or pharmacist about generic drugs or had been switched from a brand to a generic medication. Younger individuals were more likely to obtain their information on generic drugs from television, while those over 50 years of age were more likely to obtain their information from newspapers. In a 1989 study involving 521 consumers in Georgia, Perri et 24 al. found that, after the generic drug scandal, consumers over 50 years of age were more skeptical of the safety, efficacy, and quality of generic medications and less likely to ask for a generic product when filling their next prescription than they were a year earlier. Interestingly, those consumers who were aware of the generic drug scandal (31 %) held more positive perceptions of generic drugs than did those who were unaware of it. These results suggest that the generic drug scandal affected older consumers more negatively than those younger than 50 years of age. This may explain the differences between findings from this study and the previous one. The factors that influence generic substitution, satisfaction, and intention to purchase generic drugs surfaced again in a field experiment (conducted before the generic drug scandal, but published in 1991) involving 295 patients who had obtained prescriptions for one of two brandname products at one chain pharmacy in Vancouver, British Columbia. 25 More than 80% of the patients offered a generic substitute for one of the study drugs accepted it. Patients who were older, less educated, and had prescription drug coverage were less likely to accept a substitute. Satisfaction with generic drugs was lowest for those who had no choice in their use and did not have to pay anything to receive the medication. Intention to purchase another generic drug product in the future was influenced by having recently accepted a generic substitute, perceiving that the cost savings would be high, and having to pay some or all of the cost of the medication. As did previous authors, Kendall et al.25 concluded that having pharmacists actively promote generics and having patients pay some part of the cost of the medication would increase the rate of generic substitution.
The 19905 A study published by Lumpkin and Strutton26 in 1992 used a
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mail questionnaire to examine the importance of information sources used by 652 elderly consumers (65 years of age or older) in helping them make the best choices when shopping for "health care advances." Defining adoption as acceptance of health care advances and using generic drug products as an example of a health care advance, they found that 59% of respondents had "adopted" generic drugs. Adopters were more likely than nonadopters to use medical experts such as physicians and pharmacists as sources of drug information. Interpersonal information sources (friends, relatives), marketing-dominated sources (salespeople, store reputation), and independent experts (magazine and newspaper reports) were also used more frequently by adopters. Since medical experts and interpersonal information sources were the resources these consumers used when making decisions regarding generic drug use, the authors concluded that gearing advertising to medical experts and opinion leaders may increase rates of generic drug adoption. A study of consumers 45 years and older conducted for AARP and published in 1994 found that the vast majority, more than 84%, were familiar with the term "generic drug."27 Contrary to findings from a study published in 1981,8 chronic/regular prescription drug users were more likely than nonchronic users to be familiar with generic drugs. The author of the later study estimated that approximately 33% of Americans aged 45 to 65 have asked their physician for a generic medication and asked their pharmacist to ftll a prescription with a generic medication. However, a slightly lower proportion (29%) of those aged 65 and older were likely to request a generic version of a drug from their physician or pharmacist. In 1994 a study by Drug Topics examined how 736 consumers across the nation viewed managed care and generic medications. 28 Approximately 40% of respondents reported that they were likely to request generic substitution. The fmdings indicated that 34% of pharmacists and 36% of physicians had initiated generic substitution on consumers ' behalf. Generic and brand products were considered "equal" in quality to brand products by 29% of consumers, and 45% indicated the two were "about the same." Lower income patients were more likely than higherincome individuals to view generic drugs as lower in qUality. A study of consumers conducted in 1995 but published in 2000 returned to the concept of risk. Similar to the study by Podulka et al. (1989),15 Ganther and Kreling29 surveyed 355 adults in central Wisconsin and found that consumers' perceptions of the risks of generic prescription drugs depended on the medical condition being treated. Study participants were asked to assess the comparative risk associated with purchasing a generic drug instead of a brand product for heart problems, high blood pressure, strep throat, pain, and cough. Respondents thought that substituting generic prescription drugs was riskiest when treating heart problems (54%) and least risky when treating strep throat (14%). Respondents also indicated the amount of savings they would require before they would accept a generic version of a drug instead of the brand product. As the risk rating for the medical
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condition decreased, more respondents were willing to take the generic product for less than a $2 cost savings. As the risk rating increased, so did the percentages who wanted a cost savings of more than $15 before they would buy the generic drug or who would not buy the generic product at any cost saving. The authors concluded that financial incentives might be important to increasing consumers' use of generic products. Similar to authors of previous studies, Ganther and Kreling designated patient education by the pharmacist as another important factor in increasing generic drug use for medical conditions perceived by patients as highrisk. In 1996 a mail survey was sent to 349 chain and independent pharmacists asking about their patients' responses to generic drugs. 29 These pharmacists indicated that only 16% of consumers hesitated to get a generic substitute when it was offered and that only 9% declined the generic substitute. Patients' major concerns were reported as quality, efficacy, potency, and consistency of generic medications as compared with brand products. Other concerns of patients reported by pharmacists included the following : "My physician does not like generics," "I've tried a generic and it doesn' t seem to work for me," and "It has too many side effects." In 1999 Merck-Medco Managed Care, L.L.c. commissioned a nationwide telephone survey of 1,000 adults 18 years of age or older to examine consumers' views of generic medications. 31 Slightly more than half of those surveyed believed they were "very knowledgeable" or "somewhat knowledgeable" about generic drugs; however, 19% were "not at all knowledgeable." In general, women were more likely than men to have some knowledge of generic drugs, but the degree of general knowledge did not vary significantly with age. As previous studies had shown, adults with an annual household income of less than $20,000 were significantly more likely than were adults in general to be not at all knowledgeable about generic drugs. In this study, consumers' overall opinion of generic drugs appeared to depend on whether they had taken a generic drug in the past. Slightly more than three-fourths of the respondents had taken a generic drug prescribed by their physician. The largest proportion (24%) of the adults who believed brand drugs were better than generics were 18 to 24 years of age or had annual incomes greater than $50,000. In addition, 20% of the adults questioned had asked their physician to write a prescription for a specific brand product. Respondents were asked to categorize several statements as a "major" or "minor" reason or "not a reason at all" for choosing a generic drug over a brand product. More than 66% indicated that a major reason for choosing a generic drug was "my pharmacist (or physician) assured me that the generic drug is a safe and effective alternative to the brandname drug." Patients whose physician or pharmacist had in fact discussed such a switch with them were more likely than those who had not had such a talk to categorize this assurance as a major reason for choosing a generic drug product. Adults 18 to 24 years of age were less likely than those in other age groups to cite such assurance as a major reason.
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Although a large number of respondents cited the recommendation of their physician or pharmacist as a reason to switch to a generic drug, 53% stated that their physician or pharmacist had never spoken with them about changing from a brand to a generic pharmaceutical. Of the 45% who said their physician or pharmacist had discussed switching, 91 % had taken generic drugs. In contrast, 65 % of those whose physician or pharmacist had not spoken with them had taken generic drugs. Approximately 66% indicated a major reason for choosing a generic drug was, ''The generic drug costs me less money than the brandname drug." Those 65 years of age and older were much more likely than those 18 to 24 years of age to consider this to be a major reason (67 % versus 54%, respectively). A smaller proportion of consumers indicated either "Choosing the generic drug saves my employer money" (31 %) or "Using the less expensive generic drug cuts down on overall health care costs to society" (52%) as a major reason for choosing generic over brand medications. Ultimately, the cost of the prescription was the motivating factor for an adult to choose a generic prescription drug over the brand equivalent. If given a choice between the brand and a generic version of the same prescription drug when each required a $10 co-pay, 61 % indicated they would choose the brand drug. If the co-pays were $20 for the brand drug and $10 for the generic drug, 79% would choose the generic drug. These findings suggest that the lower cost of generic drugs and previous positive experiences with them significantly influence one's preference for generic over brand drugs. As in other studies, respondents with lower incomes held less positive attitudes toward generic drugs. As had others before them, the authors suggested that efforts to educate consumers and health care professionals are needed to increase consumers' knowledge about and use of generic drug products. Momani et al. 32 investigated consumers' awareness of drug management strategies (formularies, drug co-payments, prior authorization, and generic substitution) in a study published in 2000. This mail survey was sent to 303 members of managed care organizations in Maryland, Pennsylvania, and West Virginia. Approximately 51 % of the respondents indicated that their health plan mandated generic substitution. Consumers agreed that "generic substitution affects my compliance with medications." Consumers were neutral in regard to the following statements: "Generic substitution makes it more convenient to get my medicines," and "Generic substitution limits my chances to get the best medicine." Consumers mildly agreed with the statements, "Generic substitution results in less effective medicines," and "Generic substitutions compromises the quality of my medicines." Although these statements reflected a slightly negative view toward generic substitution, when consumers were asked a general question regarding their overall attitude toward generic substitution, a somewhat positive response was obstained (mean =4.6 on a 7-point scale where I = negative and 7 =positive). Motivation to seek information on generic substitution did
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not differ by gender, income, education, length of enrollment in the managed care organization, or presence of a chronic illness. The authors concluded that, overall, this group of consumers held a slightly positive attitude toward generic drugs and were most aware of generic substitution and drug co-payments as means to manage drug costS.b
Consumer Organizations A research associate contacted each of the following organizations by telephone in October 1998: AARP, American Foundation for Health, American Health Decisions, Consumer Alert, Consumer Federation of America, Council on Family Health, National Association of Patient Representation, National Council on Aging, National Women's Health Network, People's Medical Society, Public Citizen's Health Research Group, and Society for Medical Consumers. A staff person at each organization was asked whether their organization had an official policy on generic and therapeutic substitution. Their comments or policy statements are described below. Only three of the organizations provided formal policies (via fax) regarding generic substitution and only two provided policies on therapeutic substitution. c
for passage of state laws that encourage access to generic drugs by eliminating prescription forms that require signatures on different lines depending upon whether generic substitution is allowed or that require physicians to specify in their own handwriting that the brand medication is medically necessary. The federation is on record urging legislators to allow drug patent holders to license other drug manufacturers to produce the product at reasonable royalties to recover research and development costs. This group opposes any attempt by drug manufacturers to extend patent or market exclusivity rights beyond the times currently specified.
The People's Medical Society The People's Medical Society generally views generic substitution positively. The organization stresses the responsibilities of the pharmacist and patient in making decisions regarding drug substitution and encourages patients to fmd out about substitution laws in their state. In their educational materials, the society provides a definition of therapeutic substitution and claims that the medical profession is staunchly opposed to therapeutic substitution because therapeutic decisions reached by physicians are based on a complex body of medical information relevant to a specific patient. The society urges consumers to check with their physician and pharmacist any time a drug is prescribed to determine whether therapeutic substitution is appropriate.
AARP AARP policy states that generic substitution laws and regulations should facilitate the substitution of generic drugs for brand equivalents. However, generic substitution should not be permitted in those cases where the prescribing physician has deemed it medically inappropriate. The policy also indicates that state governments should adopt the drugs on the federal list of therapeutically equivalent drugs (as provided in the Orange Bookl 3) as suitable generic alternatives. The association endorses Federal Trade Commission (FTC) monitoring of the practices of pharmacy benefit managers and calls on FTC to ensure that patients' prescriptions are not inappropriately switched to products manufactured by a parent company.
Consumer Federation of America The Consumer Federation of America's policy indicates that a drug's generic name should be used in licensing, prescribing, dispensing, labeling, and advertising. All government purchases should be made by generic name only, when appropriate, and FDA should maintain data on the bioequivalency of equivalent drugs to assure their interchangeability. The organization also calls bA personal communication with the author indicated that information in Table 2 of his manuscript may be misleading due to a typographical error.
COnly rarely can this material be found in a readily retrievable source. All policy statements can be obtained directly from the organizations.
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Other Organizations Several organizations that did not have an official policy on the use of generic medications indicated that they do favor their use. The Society for Medical Consumers favors generic drug use and therapeutic interchange if these actions are not tied to a managed care-drug manufacturer liaison. The Public Citizen Health Research Group also supports the use of quality generics. The group has no policy against therapeutic substitution, but does consider it unethical to place a burden on patients by trying to coerce them into using another class of drug. If a managed care organization or hospital has a good formulary, then this group is not opposed to therapeutic substitution. Neither the Council on Family Health nor Consumer Alert has addressed the use of generic medications. The remaining organizations contacted indicated that they did not have any official policies or comments on generic or therapeutic substitution.
Discussion Overall, based on our analysis of their responses in studies done over the past quarter-century or so, consumers seem positively inclined toward generic medications. This positive attitude seems to have remained stable across the years, with approximately 40% to 60% of consumers holding a favorable view of generic medications.
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However, a positive attitude does not always lead to increased use of generic drug products. The studies we reviewed indicated several probable reasons for this discrepancy. First, differences were found among various groups of consumers. In general, individuals with lower incomes and less education held more negative attitudes toward, and were less knowledgeable about, generic drugs than were those with higher incomes and more education. Also, whites tended to hold more positive attitudes toward generic medications than did nonwhites. The influence of age was mixed. Several studies indicated that older consumers held more negative views, but others found that younger individuals held more negative views. This may mean that there is a segment of the population (young and old) that is brand-conscious and will always view nonbranded (generic) drug products with some suspicion. Second, past experience with, knowledge of, and risks associated with generics have all been important influences on consumers' views of generic drug products. Several studies found that the use of generic products (nonprescription drugs, groceries, etc.) in the past and knowledge or awareness of generic drugs were important influences on current or future use. Also, the more serious or risky a consumer believed a medical condition was, the less likely he or she would be to choose or accept a generic drug product to treat it. Third, consultation with health care professionals regarding generic medications seems to influence their use. When consumers had talked with either their physician or pharmacist about a generic substitute, they were more likely to accept or use it. However, it is notable that very few health care professionals apparently initiated these conversations, which may explain the low incidence of patient consultation with pharmacists or physicians regarding generic drugs. These professionals may not be initiating these types of conversations due to opposition to or uncertainty about the use of generic medications. Fourth, prescription drug coverage also influenced consumers. If a third party was paying for the medication or if there were no differences in co-payments between brand and generic drugs, a brand product was preferred. Consumers tended to look more favorably on generic medications as the difference in co-payments increased. The seriousness of the illness also played a role: When consumers perceived an illness as severe, they were less accepting of a generic product at any price. Finally, few consumer organizations have official policies regarding generic drug use. Those that do are very much in favor of the use of generic medications if their use can save consumers money and does not compromise patients' health. These organizations encourage consumers to learn more about their medical conditions and to consult their physician or pharmacist regarding the appropriateness of the medication (brand or generic) prescribed. Consumer organizations also encourage their constituencies to learn more about the policies of their state governments and health care plans so they can make more informed choices about medical care.
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Conclusion The following conclusions and recommendations are provided on the basis of our analyses of the literature published over the past 3 decades related to consumers' views of generic drugs. • Researchers should consider further study of consumers' decision-making processes regarding generic medications. Positive attitudes may not be enough to lead to actual use of generic drug products. • Better communication among patients and health care professionals regarding the equivalency between most brand and generic products should increase the use of generic medications. • Mass educational efforts should be directed by consumer and health professional organizations and individual health care practitioners (pharmacists, physicians, nurses, and others) toward consumers to make them more knowledgeable about generic medications and to encourage them to take an active role in managing their medical conditions. Educational efforts should take into account the concerns of specific groups (younger or elderly, lower income, nonwhites) to overcome their fears or misconceptions about generic medications. • Managed care and other third party payers could make more extensive use of financial incentives, including differential copayments for brand and generic medications, to encourage greater use of generic drugs. Pharmacists can take active roles in implementing any or all of these recommendations. This study was supported by the Blue Cross Blue Shield of Michigan Foundation. Dr. Welage is a consultant for AstraZeneca, Wyeth-Ayerst. and Pharmacia, and has received funding from Eli Lilly, AstraZeneca, Wyeth-Ayerst (pending), Pfizer, and GlaxoWellcome (now GlaxoSmithKline). She is on the speakers bureau for Pfizer, AstraZeneca, TAP, Wyeth-Ayerst, Pharmacia, Eli Lilly, and Aventis . Dr. Ascione has received research grants from Amgen, Upjohn (now Pharmacia), and GlaxoWelicome (now GlaxoSmithKline).The other authors declare no conflicts of interests or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria .
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Consumers' Views of Pharmacists During the Generic Substitution Debates It is apparent from [this] survey that most consumers are willing to accept the pharmacist taking a larger role in selecting the brand of drug to be dispensed. The majority of the respondents favored the legislative repeal of the prohibition against substitution. Even more striking, however, was the willingness of the homemakers to allow their pharmacist to alter their physician's brand choice decision. A definitive analysis of the homemakers' rationale was not attempted; however, two possible explanations for the wide acceptance are suggested by the data-(l) homemakers do not believe that the product selection decision is critical to their family's health; and/or (2) homemakers perceive their pharmacist as being a capable and responsible health practitioner, able to be trusted with the brand selection function. Support for the first explanation can be seen in [our] data .... Most of the homemakers who favored repeal of the antisubstitution laws cited receiving a consumer price savings as their primary reason for supporting repeal. Only 2.6 percent favored repeal because they felt pharmacists have better knowledge of drug products .... Moreover, approximately one-fifth of those who would allow a substitute on their prescription stated that they did not believe that drug product selection by their pharmacist would be more beneficial to them .... Because these consumers questioned the benefits, it is doubtful they would have agreed to the substitution if they perceived pharmacists would place the patient's welfare above the pharmacist's financial gain. They perceived their pharmacist as profit-oriented rather than patient-oriented. Nelson AA Jr, Gagnon JP. Brand substitution-the consumer's viewpoint. JA m PharmAssoc. 1975;NS15:382-5, 391.
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