literature review on brand switching

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Journal of Management History

ISSN : 1751-1348

Article publication date: 13 April 2015

The aim of this paper is to explore the historical development of brands and the development of literature on brand switching to define the antecedents that cause switching behavior among consumers and the impact of switching on market share of companies.

Design/methodology/approach

The historical development of brands is tracked using different secondary sources. Then an intensive literature review is conducted on brand switching at the consumer and business levels. At each level, studies on brand switching are divided into several categories, such as household products, technological products and service providers, and the common factors behind switching for each category and between categories are determined.

An examination of the historical development of brands shows that brands appeared on products a long time ago and evolved through a number of stages based on the economic and social environment. The literature reveals that no single model can explain brand switching behavior of consumers or businesses across different industries and products. Each study uses a specific set of factors to explain brand switching. However, brand attractiveness can be counted as the most common factor behind brand switching.

Research limitations/implications

There is little understanding of the historical mutations of brand switching behavior and the influence of mutation on branding strategies. The study suggests that continuous exploration of consumer’s preferences is needed to create and sustain attractive brands.

Practical implications

Managers increasingly recognize brands as one of the most valuable assets of an organization, and, therefore, an informed knowledge of the factors underpinning brand switching may help managers build attractive brands and prevent brand switching. This condition imposes significant challenges in a highly innovative environment, where technological changes can quickly make attractive brands obsolete.

Originality/value

This paper highlights that the factors behind brand switching should be monitored constantly, even for the same brand, to define an appropriate strategy that helps sustain brand attractiveness.

• Perceived value
• Product features
• Consumer behavior
• Relationship
• Brand switching

Al-Kwifi, O.S. and Ahmed, Z.U. (2015), "An intellectual journey into the historical evolution of marketing research in brand switching behavior – past, present and future", Journal of Management History , Vol. 21 No. 2, pp. 172-193. https://doi.org/10.1108/JMH-03-2014-0076

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Copyright © 2015, Emerald Group Publishing Limited

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Factors Influencing Brand Switching Behaviour of Mobile Phone Users and the Mediating Effect of Customer Satisfaction: A Literature Review

2019, Journal of Education, Society and Behavioural Science

Mobile phone market is one of the most turbulent market environments today due to increased competition and change. Thus, it is of growing concern to look at consumer brand switching behaviour and shade light on the factors that influence the consumer switching between different brands of mobile phones. On this basis, this paper deals with consumers' brand switching behaviour of mobile phone by studying factors that influence consumers to change their mobile phones brand and the mediating effects of customer satisfaction. Using literature review, it was found that although the purchase of a mobile phone is subjective, there are some general factors that seem to influence the switching behaviour of consumers among brands. The studies further show that among other things that influence consumer switching behaviour in the purchase of mobile phones includes reference group and product quality. The study further reveals that customer satisfaction has positive effects on customer swit...

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Brand loyalty explained by concept recall: recognizing the significance of the brand concept compared to features

• Original Article
• Published: 09 June 2021
• Volume 9 , pages 185–198, ( 2021 )

Cite this article

• Takumi Kato   ORCID: orcid.org/0000-0002-1795-4754 1  

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Consumers may be attracted to superficial functionality and design, but they may easily switch brands when another company’s product/service with higher functionality and a more fashionable design appears. If consumers remain loyal to a brand, it is because they understand, sympathize with, and value the brand’s concept. However, few studies have focused on brand concept as a factor of loyalty. Therefore, this study verified the influence of the brand concept on repurchase intention. Through multiple regression analysis of Apple MacBook Pro, Dyson Big Ball, Nintendo Switch, Facebook, Starbucks, and Tokyo Disney Resort users in Japan, the first hypothesis—consumers who recall a brand concept are more likely to have repurchase intention than those who recall specific features when asked about brand attractiveness—was supported. Furthermore, Fisher’s exact test supported a second hypothesis—consumers with high loyalty maintain high-level construal, even if they use a brand frequently and recall the concept as the brand’s attractiveness, contrary to construal level theory. By introducing the viewpoint of brand loyalty, the conditions under which construal level theory does not conform were shown. The present study encourages reaffirmation of the importance of brand concept and suggests the concept recall index to effectively use management resources.

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Introduction

With technological advances, product/service functionality often exceeds the standards that consumers require, and they see little difference between brands. This means that competitiveness between brands is shifting to emotional value, such as design, rather than functional value (Noble and Kumar 2008 ). Although corporate engineers were not previously interested in subjective aesthetics (Adams 2011 ), the importance of emotional value is now recognized, and companies increasingly focus on design, as demonstrated by the growing number of companies that have chief design officers (Stuhl 2014 ).

Nevertheless, even when the design is improved, a product/service can seem similar to another from the consumer’s point of view, and it can be difficult to improve customers’ perceptions of value. One reason may be that the brand concept of the product/service is ambiguous and focuses too strongly on design/UX. Consumers may be attracted to superficial functionality and design, but they may easily switch brands when another company’s product/service with higher functionality and a more fashionable design appears. If a consumer remains loyal to a brand, it is because they understand, sympathize with, and value the brand’s concept (Aaker and Joachimsthaler 2000 ).

However, while previous brand management studies have clarified factors related to loyalty by assessing features such as product/service performance, quality, and design (Chen 2012 ; Chiu et al. 2009 ; Devaraj et al. 2001 ; Homburg et al. 2015 ; Hsu et al. 2018 ; Kumar et al. 2011 ; Lee et al. 2015 ; Shen and Yahya 2021 ; Yeh et al. 2016 ; Zehir et al. 2011 ), few studies have focused on the brand concept of a product/service (hereinafter the brand concept) as a factor of loyalty. Accordingly, the present study hypothesized that consumers who recall a brand concept are more likely to exhibit repurchase intention than consumers who recall specific features, such as attractiveness. In other words, although the importance of brand concept is recognized as a theory of business administration and marketing (Gardner and Levy 1955 ; Lafley and Martin 2013 ; Park et al. 1991 ; Simões and Dibb 2001 ; Stengel et al. 2003 ; Tilley 1999 ), to the best of my knowledge, there have been no attempts to demonstrate it as a factor that explains consumer loyalty.

Furthermore, this study also incorporated another theoretical viewpoint of consumer behavior research. According to construal level theory (CLT), when experience with using a product/service increases, the construal level decreases, and it becomes easier to focus on specific rather than essential features (Trope and Liberman 2000 ). However, previous research on CLT (Hamilton and Thompson 2007 ; Kim et al. 2008 ; Liberman et al. 2007 ; Roehm and Roehm 2011 ; Trope and Liberman 2000 ) has not included the perspective of brand loyalty. Thus, few studies have examined the present study’s second hypothesis: consumers with high loyalty maintain high-level construal, even though they use the brand frequently and can recall the brand concept as a feature of its attractiveness.

Although the importance of brand concept has been widely asserted in academic research on business administration and marketing, effects specifically related to brand concept have not been quantitatively evaluated. Thus, the present study encourages reaffirmation of the importance of brand concept and applies the concept of recall index to effectively use the means of design and UX for building strong brands.

Literature review

Brand concept refers to brand-unique abstract meanings that typically originate from a firm’s efforts to differentiate itself from its competitors (Park et al. 1991 ). A brand concept defines the value provided to customers and should meet consumers’ needs (Park et al. 1986 ). The framework of a brand concept comprises the target (who), value and positioning (what), and execution method (how; Lafley and Martin 2013 ; Stengel et al. 2003 ). For example, Starbucks describes its concept as the “third place” (Schultz 1997 ; Starbucks 2020 ), for which the “who” would be consumers looking for a place to relax when they go out, the “what” is a place outside of home or work where people can spend relaxing time alone or gather for a sense of community, and the “how” is by providing an atmosphere that incorporates aspects such as earth tones, comfortable music, and coffee.

Brand image refers to consumers’ cultivated perceptions of products and advertisements that are developed based on concepts devised by marketers (Zenker 2014 ). Further, consumers will develop attitudes toward a brand through their experience with its products/services and advertising, and an image will be formed as brand knowledge (Campbell and Keller 2003 ; Hoeffler and Keller 2003 ). Therefore, the brand concept is the root of a product/service, and consumers form a brand image and gain knowledge by experiencing the value created by this concept.

The brand concept is the criterion for decision-making in all corporate activities, such as planning, development, production, and sales (Simões and Dibb 2001 ; Tilley 1999 ). Product/service development involves many day-to-day decisions made by various departments, and consistent standards need to be applied throughout the process. If a concept is ambiguous, it cannot be effectively applied, and the product/service’s purpose devolves to following trends already seen in the industry. Consistent target embodiment can be thought of in three ways: zero moment of truth when viewing a website, first moment of truth when viewing a product in the store, and second moment of truth when using a product (Lecinksi 2011 ). Branding helps consumers distinguish products/services from one another; if consumers value a brand’s meaning, they will be more loyal to it. Therefore, for a product/service to become a strong brand, it is necessary to clearly define the concept before it enters the market and maintain the concept and embodiment perceived by the consumer over its life (Gardner and Levy 1955 ).

In addition, the concept plays a large role in expanding a brand or forming brand alliances. The factor that distinguishes the success or failure of a brand extension is consistency within categories and concepts (Jin and Zou 2013 ; Lanseng and Olsen 2012 ; Park et al. 1991 ; Punyatoya 2014 ; Thorbjørnsen 2005 ). Consumers who exhibit high loyalty also have high demands for consistency (Samuelsen et al. 2015 ), and the consistency of a concept is more important than its category. For instance, Breitling for Bentley, a co-brand of Swiss mechanical watchmaker Breitling and Bentley's venerable luxury car in the UK, has a low degree of product category matching but a high reputation for its expressive concept matching (Lanseng and Olsen 2012 ).

Brand loyalty factors are generally explained by product/service features, such as performance (Kumar et al. 2011 ; Yeh et al. 2016 ), quality (Devaraj et al. 2001 ; Shen and Yahya 2021 ; Zehir et al. 2011 ), design (Homburg et al. 2015 ; Hsu et al. 2018 ), and UX/usability (Chen 2012 ; Chiu et al. 2009 ; Lee et al. 2015 ). Recently, more specific emotional elements, such as brand colors (Jin et al. 2019 ) and product sounds (Kato et al. 2020 ) have been studied. Alternatively, studies incorporating factor evaluation based on brand image (Unal and Aydın 2013 ), brand reputation (Han et al. 2021 ; Selnes 1993 ), brand trust (Chaudhuri and Holbrook 2001 ; Lau and Lee 1999 ), and word of mouth (Eelen et al. 2017 ; Liang et al. 2018 ; Podoshen 2006 ) are common. Thus, although many loyalty factors have been reported in academic research on marketing, there are few examples of research where brand concept has been explored as a loyalty factor. Previous research has proposed methods for understanding brand concept from the consumer's point of view; however, brand concept has not been evaluated as a loyalty factor (John et al. 2006 ; Schnittka et al. 2012 ). In addition, some research has divided concepts into general categories (e.g., functional, symbolic, luxurious; Bhat and Reddy 1998 ; Hagtvedt and Patrick 2009 ; Park et al. 1986 ; Topaloglu and Gokalp 2018 ), making it difficult to determine if these methods pinpoint whether consumers understand brand concepts, as the general categories are too broad.

Hence, compared to product/service features, there has been little evaluation of consumer loyalty as it relates to brand concept. There are three possible reasons for this. First, researchers and corporate marketers believe it is difficult for consumers to evaluate concepts that cannot be directly experienced. Second, many brand concepts are ambiguous, and marketers can lose sight of their purpose because they cannot clearly identify how their products/services are meaningful to customers (Blount and Leinwand 2019 ). When the concept is ambiguous, products/services rely on trendy, superficial designs and advanced functions, and it is difficult to evaluate the brand concept. Consistency is the most important factor in strengthening a brand, and the meaning (or concept) of the underlying brand is necessary to maintain consistency over a long period of time (Keller 2019 ). Third, even if there is a clear concept, there may not be a consistent embodiment of the product/service, and it could come across as ambiguous in the marketplace. It takes significant effort to consistently embody a concept without compromise when each corporate department makes different claims; therefore, a thoroughly implemented product/service is a rare entity that can grow into a strong brand (Gardner and Levy 1955 ; Park et al. 1986 ). In fact, companies with strong product/service brands have development processes that enhances the degree of perfection by embodying many prototypes based on the concept and testing them many times (Keller and Kotler 2009 ).

Consumers may be attracted to superficial functionality and design, but they may easily switch brands when another company’s product/service with higher functionality and a more fashionable design appears. If a consumer remains loyal to a brand, it is because they understand, sympathize with, and value the brand’s concept (Aaker and Joachimsthaler 2000 ). Hence, whether consumers recall the brand concept when asked about the attractiveness of the brand greatly influences their loyalty. Therefore, when asked about the attractiveness of a brand, consumers should be able to recall the keywords in its concept. If the focus is on a product/service with a clear concept that builds a strong brand in the market, evaluation should be possible. Therefore, the following hypothesis was derived:

Consumers who recall the brand concept are more likely to have a repurchase intention than consumers who recall specific features, such as its attractiveness.

However, this hypothesis is contrary to CLT. Psychological distance includes temporal, spatial, social, and empirical distance (Liberman et al. 2007 ). When there is great psychological distance between the consumer and object, the construal level is high, and the consumer grasps the essential attributes of the object. In contrast, when there is a small psychological distance between the consumer and the object, the construal level is low, and the consumer concretely grasps the object (Trope and Liberman 2000 ). A study of hotel review sites reported that essential attributes were more important when temporal and social distances were great (Kim et al. 2008 ). In a study of banks, fit with personal values was effective for long-term campaigns, and a specific amount of money was effective for short-term campaigns (Roehm and Roehm 2011 ). As experience with using a product/service increases, the psychological distance decreases, and the construal level becomes lower. In experiments on music player devices, consumers had a lower construal level when directly touching the product, and emphasis was placed on ease of use rather than product desirability (Hamilton and Thompson 2007 ). However, this study lacked a perspective on brand loyalty. There is a clear difference between consumers who use a product/service due to inertia and those who use it because of an attachment, even if both groups use it with the same frequency (Dick and Basu 1994 ). Therefore, as shown in Fig.  1 , two hypotheses were derived:

Visual depiction of H2 (left side: construal-level theory, right side: hypothesis in this study)

Consumers with low loyalty have low-level construal when they use a brand frequently, and recall specific features, such as function and design, as the attractiveness of the brand (consistent with CLT).

Consumers with high loyalty maintain high-level construal, even if they use a brand frequently, and recall the concept as the attractiveness of the brand (contrary to CLT).

Research method

Survey method.

This study verified the three hypotheses with the target product brands of Apple MacBook Pro (hereafter, Apple), Dyson Big Ball (canister vacuum cleaner, hereafter, Dyson), and Nintendo Switch (hereafter, Nintendo), and target service brands Facebook, Starbucks, and Tokyo Disney Resort (hereafter, Disney). These brands were selected for two reasons: confirmation of the concept on the corporate website and covering diverse B2C industries. An online survey was conducted in Japan from November 5 to 10 2020. Inclusion criteria for respondents were that they (a) were aged between 20 and 59 years; (b) had purchased new products from three of the target brands; and (c) used the target brand at least once a month (for Disney, at least once every three years).

The survey was randomly distributed through a survey panel owned by a major Japanese research company, Cross Marketing, Inc. The survey consisted of a screening survey and a main survey, both conducted online. The screening survey identified respondents who met criteria (a)–(c). Those who met these criteria were immediately routed to the main survey. The screening survey comprised eight questions: (1) gender, (2) age, (3) area of residence, (4) occupation, (5) annual household income, (6) ownership of each product brand, (7) how the product brand was purchased, and (8) frequency of use of the brand. When the criteria were met for multiple brands in (6)–(8), the respondent was randomly assigned to one brand and directed to the main survey. The results of the survey collection were as follows: of 41,077 screening survey respondents, 40,139 completed it; of these, 2953 responded to the main survey, and 2897 completed it. Next, 400 respondents for each brand were randomly sampled for a total of 2400 respondents. The sample sizes were evenly distributed for each brand for two reasons: first, to ensure bias-free evaluation; and second to ensure that the number of concepts recalled could be easily compared. The distribution is shown in Table 1 .

In the main survey, respondents were asked about one assigned brand. The questionnaire items were as follows: (9) satisfaction, (10) recommendation intention, (11) repurchase intention (product)/reuse intention (service; hereinafter, repurchase intention), (12) reason for repurchase intention. Items (9)–(11) were rated on a 7-point Likert scale (1 = very unsatisfied to 7 = very satisfied). The mean values (satisfaction, recommendation intention, repurchase intention) for the brands were as follows: Apple (5.688, 5.523, 5.713), Dyson (4.895, 4.743, 4.535), Nintendo (5.640, 5.445, 4.313), Facebook (4.490, 4.298, 4.810), Starbucks (5.458, 5.415, 5.858), and Disney (5.580, 5.650, 5.888). Item (12) was a pure recall question, in which an answer was freely requested without presenting options to the respondent. This was because aided recall, which presents options, introduces bias, and the options may then be overestimated (Kardes et al. 2002 ). There was concern that the concept of interest in this study would encourage consumers who were not normally aware of it to recognize it. By using pure recall, respondents could provide answers about a brand concept only if they really understood it.

Verification method

It should be noted that, to date, there is no established brand concept framework or evaluation method. In this study, the focus was on whether consumers could recall the concept when asked about the attractiveness of a brand. Furthermore, to avoid introducing bias, no options were presented and the answer was to be provided by pure recall. Therefore, consumer responses were evaluated based on whether they included keywords from the concepts published by each brand.

The concepts for each brand as extracted from their official websites were as follows: Apple, “the ultimate work tool for professionals who innovate in the world” (Apple 2020 ); Dyson, “the cleaner that doesn’t lose suction” (Dyson 2000 ); Nintendo, “transforming from home console to portable system in a snap” and “controllers give you total gameplay flexibility” (Nintendo 2020 ); Facebook, “give people the power to build community and bring the world closer together” (Facebook 2020 ); Starbucks, “third place” (Schultz 1997 ; Starbucks 2020 ); and Disney, “the kingdom of dreams and magic” (Oriental Land Co. 2020 ). Note that Oriental Land Co. operates Tokyo Disney Resort under a license agreement with the Walt Disney Company.

The present study used natural language processing to determine whether respondents provided keywords used in the brand concepts as their stated reasons for repurchase intention. Words (nouns and adjectives) of interest were extracted from the sentences freely written by the respondents, and when they were used in a positive sense, an appearance flag called a “tag” was added. As shown in Table 2 , the concept tags for each brand were set, and the keywords were registered in the database. To eliminate subjectivity, the keywords for each brand were set to three (nouns and adjectives). For instance, Disney’s concept C6_Disney includes the words “dream,” “magic,” and “magical;” however, differences in notations with exactly the same meaning were taken into consideration. In the Japanese language, there are four ways to express an idea: kanji, hiragana, katakana, and English. For example, the word cute, “可愛い,” “かわいい,” “カワイイ,” [kawaii] and “キュート” [kjúːt] have the same meaning. In addition, it is necessary to understand specific features, such as function and design, as comparison targets. In natural language processing, there are no established standard tags; thus, the researchers defined the tags, and as the words contained in data differ, it was necessary to define the tags that matched the data. In this study, features that appeared more than 20 times in total were extracted and used as tags. Therefore, four tags were set as emotional values: design, convenience, fun, and delicious. Functional values were set as: function, quality, information, and lineup. Direct negative expressions, such as failure, heavy, expensive, coronavirus, “I already have it (hence, no repurchase intention),” and “nothing special,” were also set.

Nouns and adjectives were extracted by morphological analysis; when registered words were detected, parsing defined whether a word was stated positively. If it was positive, the corresponding tag was added. If a word belonging to the same tag was detected multiple times in one text, the corresponding tag was only added once. Japanese open-source software MeCab was used for morphological analysis and CaboCha was used for parsing. There were 1988 tags from the 2400 respondents, and 729 respondents were not tagged. The distribution of tags is shown in Table 2 . For example, for the C1_Apple tag, 34 out of 400 people mention the concept. The percentage of people who mentioned the concept (concept recall rate) was highest for Disney, at 28.5%, and lowest for Nintendo, at 6.75%. Note that some texts mentioned words registered as Apple’s concept in other brands, but this study dealt only with the concept of specific brands. Then, as shown in Table 3 , the respondent attributes and tags were made into dummy variables, and the subsequent analysis was conducted.

H1 was verified by multiple regression analysis in which the objective variable was repurchase intention (No. 1 in Table 3 ), the control variables were the attribute dummies obtained in the screening survey (No. 4–33), and the explanatory variables were the tag dummies (No. 34–48). Note that when 2400 (number of respondents) is multiplied by the mean of the tag dummies in Table 3 , this equals the total number in Table 2 . The concept was that only tags that match each brand are handled; thus, the total is 428. Since there were many variables, the stepwise method was adopted: estimate the regression equation that incorporates all the variables and remove the variables to improve Akaike's information criterion (AIC). Then, when the AIC ceases to improve, the model is finalized. H1 was tested by a model for all brands to reach generalized conclusions. In addition, models for each brand were built for consideration.

H2-1 and H2-2 were verified by propensity score matching (Rosenbaum and Rubin 1983 ), a typical method for estimating causal effects when random allocation designs for treatment are difficult. Consumer attribute variables were aggregated into one variable called the propensity score, and variables other than the presence or absence of treatment were homogenized. Here, as shown in Table 1 , 756 people who selected the highest frequency, “five to seven times a week” (for Disney, once a week), for question (8) were defined as the treatment group (frequent users) and 1644 others were defined as the control group (non-frequent users). Since the characteristics of consumers with high frequency of use and those with low frequency of use differed, the causal effect was estimated by matching subjects with close propensity scores and homogenizing both groups. When the true value of the propensity score of each subject is unknown, estimating from the data by a logistic regression model is common.

First, loyalty was extracted by factor analysis from the three variables of satisfaction, recommendation intention, and repurchase intention (No. 1–3 in Table 3 ), and the factor scores of each respondent were calculated. The factor scores ranged from − 3.3 to 1.4, and 539 respondents with 0.7 or higher, who corresponded to approximately the top 20%, were defined as high loyalty and 1861 as low loyalty. From the concept (No. 34) and the specific feature (No. 35–42) in the answers to question (12), respondents were categorized into one of the recall categories: neither (None), only the specific feature (Feature), only the concept (Concept), or both (Both).

Next, as shown Table 4 , each respondent’s propensity score was estimated by a logistic regression model in which the treatment group dummy (No. 33 in Table 3 ) was used as the objective variable and the respondent attributes and brand dummy variables (No. 4–32) were used as the explanatory variables. The stepwise method was applied to variable selection. Then, the respondents with similar propensity scores were matched. Extraction was found to be non-restoring. As a result, out of 539 high-loyalty respondents (treatment group: 192; control group: 347), a total of 192 (96 in each group) were extracted. As shown in Table 5 , the respondent attributes of both groups are homogenized. Similarly, of the 1,861 low-loyalty respondents (treatment group: 564, control group: 1,297), a total of 964 (i.e., 482 in each group) were extracted.

Finally, a matrix of group × recall category was created for both high- and low-loyalty respondents, and the presence or absence of a significant difference was verified by Fisher’s exact test. The analysis environment was R, and the step AIC function from the MASS package for multiple regression analysis and the Match function from the Matching package for propensity score matching were used.

Results and discussion

As shown in Table 6 , when examining the results of the whole model estimated by multiple regression analysis, the tag E1_Design, at 0.681, was the highest among specific features. This finding was in line with previous studies that have reported the importance of emotional value as represented by design is increasing (Adams 2011 ; Noble and Kumar 2008 ; Sweeney and Soutar 2001 ). However, Concept at 0.710 contributed more than the specific characteristics of emotional value and functional value among the regression coefficients that were significant at the 5% level. Hence, H1 was supported.

In reviewing the results of each brand, Apple had the highest Concept at 0.934, followed by E1_Design at 0.889 and F2_Quality at 0.745. Negative effects extracted for Apple included N2_Heavy, which was very large at − 3.207, N3_Expensive − 0.756, and N6_None − 0.858. In terms of respondent attributes, the characteristics of high frequency of use, profession (e.g., designer), and male gender tended to be associated with high repurchase intention. The following four brands showed the same tendencies as Apple. Dyson: F1_Function 0.925, E1_Design 0.804 < Concept 1.013; Nintendo: E3_Fun 1.012 < Concept 1.755; Starbucks: F4_Lineup 0.313, E4_Delicious 0.295 < Concept 0.472; and Disney: E3_Fun 0.104, E4_Delicious − 0.233 < Concept 0.563. Five out of six brands were suitable, which was considered significant for the usefulness of concept recall. Only Facebook exhibited factors that were more effective than the concept confirmed; Concept 0.458 < E2_Convenience 0.770. This was likely because, as Facebook was the only brand in the study that can be used free of charge, the psychological barrier to reuse was low; thus, the factor that can be experienced more directly is prioritized. The business model of services provided free of charge is more peculiar than that of paid services (Hamari et al. 2020 ).

From another perspective, it was confirmed that individual brands have unique characteristics. Since E4_Delicious had a negative effect on Disney, this indicates that consumers seeking delicious food are less likely to have high repurchase intention. The tag N4_Corona was extracted for Disney as a negative effect. The COVID-19 pandemic has made it difficult for consumers who are concerned about infection to visit crowded places, such as theme parks. Consumers have been shown to behave in a risk-averse manner in a pandemic situation, especially in the tourism industry (Schiopu et al. 2021 ), which has been reportedly the most affected by business closures (Gursoy and Chi 2020 ). This was in line with the results obtained in this study. Since N5_Enough was extracted for Dyson and Nintendo, this indicated that a certain number of consumers have difficulty answering when asked about their next purchase intention, as they already have the product. As a job, Job_06_Freelancer in Starbucks became significant. As shown in the concept of the “third place” (Schultz 1997 ; Starbucks 2020 ), the place (in-store space) is vital. Therefore, with the growth of the gig economy, space at Starbucks is often also used as a workplace. In addition to the physical elements of WiFi and comfortable chairs, seeing other people working is reported to be stimulating, and moderate noise can enhance creativity (Mehta et al. 2012 ). This tendency was further strengthened by the increase in working remotely during the COVID-19 pandemic. In fact, in 2020, a Starbucks store designed as a “teleworking branch” for businesspeople opened in Ginza, Tokyo (Baseel 2020 ). However, Job_09_Student had a negative effect on Starbucks. Students find Starbucks to be expensive, and it is presumed that freelancers use the store as a workspace.

Next, the results for H2-1 and H2-2 were evaluated. As shown at the top of Table 7 , at low loyalty, there was no significant difference in distribution between the low-frequency-use control group and the high-frequency-use treatment group. The results of Fisher’s exact test found the p -value = 0.180, and no significant differences were confirmed. Meanwhile, in high loyalty, the ratio of the control group recalling brand concept was 13.5%, while that of the treatment group was 29.2%, and the feature decreased from 31.3 to 21.9%. The results of Fisher’s exact test found the p -value = 0.032, and it a significant difference was confirmed. From the above, although H2-1 was not supported, H2-2 was supported. Therefore, it can be concluded that, contrary to CLT, consumers with high loyalty maintain high-level construal, even if they use a brand frequently, and recall the concept as the attractiveness of products/services. In this way, it is the contribution of this study to introduce consumer loyalty as a new perspective to the concept of CLT and clarify the conditions of consumer behavior that do not match CLT. Furthermore, this study showed different results from CLT even in consumers with low loyalty. According to previous research on CLT (Hamilton and Thompson 2007 ; Kim et al. 2008 ; Roehm and Roehm 2011 ), the closer the psychological distance, the more the consumer’s interest shifts to specific rather than essential features. However, in this study, for consumers with low loyalty, there was no difference in the factors recalled as the attractiveness of the brand depending on the psychological distance measured by frequency of use. The reason was assumed that the definition of essential features was different. In previous studies, the core functions of the target products/services were defined as essential features. Thus, CLT did not address brand concept, unlike the present study. The verification of CLT from the viewpoint of brand concept is a novel feature of this study, and since there is limited knowledge in this area, further research is required.

Regarding implications for practice, first, companies should reaffirm the importance of brand concept. In this study, the effect of the concept was quantitatively shown in comparison with concrete features such as design. This makes it possible to more clearly understand the importance of concepts that were previously recognized as a theory of business administration and marketing (Gardner and Levy 1955 ; Lafley and Martin 2013 ; Park et al. 1991 ; Simões and Dibb 2001 ; Stengel et al. 2003 ; Tilley 1999 ). In a company, many departments and professionals are involved in developing and delivering products and services. If each department passes a judgment for varying purposes simultaneously, the focus will be blurred and products similar to that of other companies will be produced. The brand concept plays a major role here. In order for the concept to take root in the organization, it is important to present the basis for quantitatively showing its superiority as in this study. Second, the index of concept recall—a unique index proposed by this study—should be emphasized in brand management. In general, after measuring loyalty based on aspects such as recommendation intention and repurchase intention, efforts are made to understand the factors that contribute to loyalty by evaluating each specific feature of a product/service brand. While this study’s results certainly showed positive effects regarding design and performance, consumers who are attracted to superficial functionality and design may easily switch brands when a different company’s product offers higher functionality and a more fashionable design. In contrast, consumers who understand, sympathize with, and value a brand’s concept display stronger brand loyalty. Therefore, companies should evaluate whether consumers recall the concept as their reason for remaining loyal to a brand. It is hoped that the index of concept recall will be adopted not only in the industrial world but also in the academic world in research on consumer behavior and brand management.

In this study, hypotheses regarding concept recall were tested to identify the factors related to brand loyalty. The hypothesis that consumers who recall a brand concept are more likely to have repurchase intention than those who recall specific features (e.g., design) when asked about the attractiveness of a brand was supported. In addition, CLT argues that the more experience a consumer has with a product, the lower the construal level, and consumer interest shifts to specific rather than essential features. However, CLT does not include loyalty. Therefore, the present study supported its hypothesis contrary to CLT, that consumers with high loyalty maintain high-level construal, even if they use the brand frequently and recall the concept as the attractiveness of the product/service. Thus, when consumers are asked about the attractiveness of the brand, ability to recall the concept strongly influences loyalty.

There are three main limitations to the present study. First, generalization is limited, as only six target products/services were examined. In the future, it will be necessary to expand the target industries and number of brands. Second, the results may vary depending on the concept evaluation method. In this study, arbitrariness was eliminated as much as possible by extracting and using three keywords (nouns and adjectives) from the concept texts published by each company. However, results may vary slightly depending on the number of keywords and survey method (e.g., pure recall vs. aided recall). Third, since pure recall was applied, features that consumers usually have difficulty recalling are unlikely to appear in the evaluation (e.g., corporate social responsibility). Therefore, only typical features, such as design, convenience, function, and quality, were compared in this study. Thus, further research is required on these issues.

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Kato, T. Brand loyalty explained by concept recall: recognizing the significance of the brand concept compared to features. J Market Anal 9 , 185–198 (2021). https://doi.org/10.1057/s41270-021-00115-w

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Potential Clinical and Economic Impact of Switching Branded Medications to Generics

Robert j. straka.

1 University of Minnesota, Department of Experimental and Clinical Pharmacology, College of Pharmacy, Minneapolis, MN;

Denis J. Keohane

2 Pfizer Inc, New York, NY; and

Larry Z. Liu

3 Weill Medical College of Cornell University, New York, NY.

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

INTRODUCTION

An increase in medical expenditures has led health care providers and authorities to implement measures to minimize costs and maximize cost savings. Brand-name medications are typically 30%–60% more expensive than their generic counterparts. 1 , 2 As a result, an increased use of cheaper generic prescription drugs as alternatives to more expensive branded products is encouraged by health authorities worldwide. In contrast to innovator drugs, comprehensive clinical trial evidence is not mandatory for approval of generic drugs by national authorities. 2 However, generic drugs approved by national regulatory authorities must be bioequivalent to the brand-name version. In essence, the bioequivalence of 2 products is determined by their relative comparability in terms of pharmacokinetic and pharmaceutical equivalence. Specifically, products are bioequivalent if the pharmacokinetic properties of the comparator compound fall within prescribed limits relative to the reference compound. For example, the US Food and Drug Administration (FDA) and European regulations consider the products to be bioequivalent if the mean maximum concentration achieved, the time at which that concentration is achieved, and the area under the concentration–time curve for the generic product falls within 80%–125% of the innovator or branded product, when administered under a fed or fasting state. 3 , 4

To conduct such tests, the 2 products must be pharmaceutically equivalent in that they contain the same amount of active ingredients, are of the same dosage form, and are given by the same route of administration, 5 meaning they are comparable in quality, intended use, and clinical efficacy. The FDA found no significant difference between branded and generic drugs in a review of bioequivalence data from 2070 single-dose clinical pharmacokinetic trials of orally administered generics that they had approved over a period of 12 years (1996–2007). 6 However, certain limitations apply to the FDA-stipulated bioequivalence requirements for generic drugs. First, these studies are conducted in healthy adult volunteers rather than in patients within the therapeutic indication for which the drug is used. Therefore, the data generated are not reflective of any variations associated with disease, gender, and age. 7 – 10 Second, these studies do not measure the ratios of the active compound/metabolite; this may be very important for those drugs where the metabolite is as active as the parent compound (as is the case with venlafaxine and its metabolite O-desmethylvenlafaxine).

Despite this, there can be differences in formulation between the innovator brand-name drug and a generic counterpart. It is not a regulatory requirement that the “inactive” ingredients in a generic version be identical to those in the innovator formulation. 11 , 12 However, small changes or impurities in the excipients used in a formulation can alter the properties of a medication and lead to unexpected adverse effects on drug absorption, bioavailability, efficacy, and safety. 13 , 14 Certain excipients are not tolerated by some patients, including lactose and gluten, and certain dyes. 7 Furthermore, the appearance, taste, allergenicity, and shelf life may differ between generic and branded medications because of variations in the salt or ester of the active ingredient in the formulations. 15 , 16

In the majority of patients and for the majority of medications, generic switching is a means to obtain similar therapeutic benefit at considerably lower costs, without any problems. Indeed, generic prescribing already accounts for 83% of prescriptions in the United Kingdom. 17 , 18 In the United States, generic medicines account for over 70% of prescriptions dispensed. 19 However, several researchers have reported patient concerns related to generic medicines. 20 – 24 Many investigations center on the impact of the relative cheapness of generic medications on attitudes toward effectiveness, 25 , 26 with some reports showing that patients did not perceive a generic drug to be as effective, or work at all, in comparison with original branded drugs. 27 , 28 Generic switching has the potential to interfere with a patient's usual medication regimen and impact adherence, 29 , 30 which can affect clinical and safety outcomes and the total costs of care. 31 – 34 One of the main problems is that generic medicines often have different names, sizes, shapes, colors, tastes, smells, and packaging to one another, and to their branded medicine, which can cause anxiety, insecurity, and confusion among certain patient populations and lead to reduced adherence. 33 , 35

Branded to generic switching for classes of drugs with narrow therapeutic indices, 36 such as antiepileptic, antiarrhythmic, thyroid medications, and anticoagulants, is particularly problematic and may result in adverse clinical outcomes. 5 , 37 – 39 Generic switching could result in subtherapeutic levels or increased toxicity after small changes in dosage level. 39 When treating epilepsy, a slight change in dosing because of substitution can result in a whole spectrum of serious adverse events, including hospitalization or even death. 37 , 39 – 41 Generic drugs in modified- and sustained-release formulations may not exhibit the same pharmacokinetic profiles as the branded drugs, 2 biologicals, and biosimilars. 7 Subgroups of people who have been well controlled on a branded drug for a long period, those being treated for a serious or chronic illness, those with symptom-free conditions (such as hypertension), patients being treated for psychological disorders, those taking multiple medications, and the elderly have less favorable attitudes toward generic substitution. 38 , 42 – 45

Based on these observations, we conducted a comprehensive review to summarize the available evidence from the published literature to assess the potential negative clinical and economic consequences of switching from branded to generic medications on patient outcomes. Our objective was to highlight the importance of considering patient, global, economic, and outcome-related consequences beyond the obvious drug acquisition costs when undertaking brand to generic switching.

MATERIALS AND METHODS

A literature search of peer-reviewed articles published in English between January 1, 2003, and March 31, 2013, was conducted using PubMed, OvidSP, and ScienceDirect databases with the purpose of identifying all relevant original research articles on generic substitution. The search terms used were a combination of words related to “brand to generic switching,” “generic substitution,” “poor adherence,” and “poor clinical outcome.” Based on title and abstract, articles were identified for further analysis. In addition, a manual screen of the reference lists of any identified articles was conducted.

A total of 127 relevant articles were screened based on our search terms, among which 30 articles discussed the therapeutic equivalence of generic medications and their brand-name versions. An overview of the articles included in this review is presented in Table ​ Table1, 1 , listed alphabetically according to first author, year of publication, country where the study was conducted, the research methodology, number of participating subjects, and drug classification. The results were grouped according to theme and are described in detail in the main text. Of the articles identified and reviewed, most were related to diseases of the central nervous system, in particular, epilepsy. Overall, the potential impact of switching fell into 3 broad categories: patient attitudes and medication adherence, clinical and safety outcomes, and cost and resource utilization; these are discussed in the Results section.

Articles included in the literature review.

Patients' attitudes and medication adherence

Several questionnaire-based surveys have suggested that switching from branded to generic medications could negatively impact adherence because of concerns and confusion among patients otherwise stable on branded medications. The Aston Medication Adherence Study (AMAS) surveyed participants in the United Kingdom to establish the extent of nonadherence to prescribed generic medication within 4 treatment areas (dyslipidemia, type 2 diabetes, hypothyroidism, and prophylaxis of thrombosis). 35 Almost all patients reported changes to their medication including changes in the color of tablets received, changes in the shape of tablets, changes in the taste of medicines, and changes in packaging. Patients reported that this led to confusion and distress. Their low price was equated to poor quality. A number of patients believed that it was important for pharmacists to inform patients of changes to their generic medicines.

Another study surveyed primary care patients with hypertension (n = 804) about their thoughts on generic drug use. 27 Nearly 30% were not satisfied with the information given by their doctor and 37% of patients expressed general skepticism toward generic drugs because they were cheaper. Patients younger than 60 years, those who were chronically ill, and/or without higher education more frequently expressed this opinion. About 30% of patients had become accustomed to the color or shape of their substituted drug. Twelve percent claimed a diminished effect of their medication after the switch and 13% reported the occurrence of new adverse events. More than half of the individuals who were aware that their medications had been substituted (30% of the overall sample) were reported to be skeptical about the switching.

Two surveys were conducted in Finland after the substitution reform that became effective in 2003. In the first survey, 28% of customers accepted and 72% of customers refused generic substitution. 26 The main reason for this was lower costs and the fact that the generic medication was recommended by the pharmacist. The most common reasons for refusing substitution were positive experiences with drugs used previously and a wish to discuss the substitution with their physician first. In the second survey, 81% of the participants considered cheaper generics to be as effective as branded medications and 85% did not consider generic substitution as a risk to drug safety. 25 In both surveys, males and patients younger than 60 years were identified as those individuals most likely to feel positive toward generic switching.

In a Norwegian survey conducted by Kjønniksen et al, 47 36% of the participants (n = 281) reported 1 or more negative experiences with generic substitution, for example, more adverse events or a reduced therapeutic effect, and 21% of the participants claimed an overall negative experience with switching. The negative experiences did not seem to be associated with the age or gender of survey participants or the number of drugs. Participants who had received information from their general physician or the pharmacy about generic substitution were more likely to have switched ( P < 0.001). In total, 41% preferred not to change their medication without financial savings.

Weissenfeld et al 28 pooled data from 8 studies (n = 12,463). Generic substitution was generally accepted by over two-thirds of the study population. However, among the patients being treated for psychological diseases who had had their medication substituted to a generic version, 34% experienced additional adverse events because of their poor perceptions of the generic drug. This is termed the nocebo effect.

In a further survey, the attitude of participants (n = 441) toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist, and their type of illness. Patients were more inclined to change to generics for minor problems, such as hay fever, cold, or flu (78%) rather than for major issues, such as heart problems, diabetes, or asthma (59%). The switch in medication was more likely to be accepted by patients who were younger, educated, and had sufficient knowledge about generic drugs for both minor and major problems. 23 In a study of elderly patients (n = 107), participants showed considerable misgivings regarding the use of generic medicines, 20 highlighting their doubts about the extent of the pharmaceutical industry's influence on health care professionals, their suspicions of foreign generic drug manufacturers, skepticism that the generics would achieve the same therapeutic effect, and concerns over changes in packaging. The participants also thought that general physicians need to discuss more actively a switch to a generic medication with their patients as this plays an important role in their decision to accept the substitution.

Personal interviews, using a semistructured questionnaire, were conducted with 174 Norwegian patients (50–80 years) who had had their branded antihypertensive drug substituted with a nonbranded counterpart. Overall, 29% of the patients reported feeling anxious when they first started using the generic medication. 29 , 49 Two of the 3 survey participants noticed that the generically substituted product had a different size, color, or shape compared with their original brand-name medication. One in 3 participants claimed that generic switching made keeping track of their medications increasingly demanding. Some thought it was easier to recognize and identify the brand-name drug because the different nonbranded products frequently feature similarities in the appearance of packaging and tablets. Others had experienced the nonbranded product as harder to swallow because of a lack of coating or a greater size. With respect to medical outcome and effectiveness, 8% of the patients believed that the effect of the substituted drug differed, and all of these, except 1, thought the effect was poorer after generic substitution. Fifteen percent of patients claimed they experienced new or more side effects.

The effect of change in the external appearance of generic antiepileptic medications on adherence was studied in a nested case–control study of 11,472 patients with epilepsy compared with >50,000 controls. 38 Seven different antiepileptic drugs studied were produced in a total of 37 colors; 4 drugs were produced in a single shape, and the remaining 3 were produced in 2 different shapes. A change in pill color will significantly increase the odds of nonpersistence; odds of color discordance were 53% higher for those who were nonadherent than for those who were adherent {adjusted odds ratio, 1.53 [95% confidence interval (CI): 1.07–2.18]}. The odds of shape discordance were also greater in patients than in controls, but the difference was not statistically significant.

A US national survey evaluated patients' perceptions about generic medications. Patients surveyed (n = 1047) agreed that generic drugs were less costly and better value than innovator branded drugs, with similar safety. However, although 56% believed that in general US patients ought to use more generically substituted medications, only 37.6% would opt for generics themselves. 48

In a survey of psychoses/schizophrenia patients (n = 106), 73% of the respondents stated that they would be unlikely to take a generic antipsychotic medication. Among these, 50% attributed this decision to a difference in packaging, whereas 28% claimed that they had no faith in the efficacy of the generic drug as it was not prescribed by their psychiatrist. 44 They also thought that generic substitution should take place only with the knowledge and agreement of the psychiatrist and the patient.

One study has investigated the effects of providing information to patients. In a multicenter study, the effect of patient education on the use of generically substituted medications in general practice, including verbal information and providing hand outs, helped 99% of participants to accept their generic substitution. However, patient acceptance of substitution was once again less for drugs acting on the central nervous system compared with drugs used for other conditions. 50

Impact on clinical and safety outcomes

Kesselheim et al 5 conducted a meta-analysis of 47 studies (38 were randomized controlled trials) involving 9 different classes of cardiovascular drugs (α-blockers, angiotensin-converting enzyme inhibitors, antiplatelet agents, β-blockers, calcium channel blockers, diuretics, and statins). No evidence of superiority was found for original branded medications versus generically substituted medications.

In a further meta-analysis of 9 randomized controlled trials, Kesselheim et al 19 found no difference in the odds ratio (1.0; 95% CI: 0.7–1.4), of uncontrolled seizures for patients receiving generic drugs versus those receiving branded drugs. However, some retrospective case–control studies with antiepileptic drugs have yielded data suggestive of therapeutic inequivalence with higher adverse events and higher use of medical resources from loss of efficacy. Table ​ Table2 2 lists different adverse consequences reported in patients administered generic psychotropic drugs including antiepileptics.

Summary of reported issues associated with generic formulations of psychotropic drugs.

Crawford et al 13 conducted a systematic literature search of 70 articles of antiepileptic drugs after generic substitution. They found therapeutic failure associated with increased seizure frequency in 25% of study subjects after a brand-to-generic switch. Another large survey was conducted in 974 patients and 435 physicians from Canada, the United Kingdom, Germany, France, and Spain in patients with epilepsy. 46 In total, 58% of participants declared that they had concerns about the safety and efficacy of generic antiepileptic drugs; of these, 23% believed that substitution was linked to breakthrough seizures, whereas 58% felt uncomfortable taking a generically substituted drug.

In a retrospective review of 760 epileptic patients, a significant proportion of patients taking generic levetiracetam needed a switch back to the original brand-name drug because of an increase in seizure frequency and adverse events, including blurred vision, headache, depression, memory loss, aggression, and mood swings. 52 Similarly, substitution to generic phenytoin was associated with decreased seizure control compared with the branded version. Switching from branded to generic phenytoin also resulted in 22%–31% lower plasma drug levels with generic drug compared with the brand-name drug. 54

A questionnaire conducted by the FDA among 196 neurologists reported decreased clinical efficacy and increased seizure frequency and adverse events among their patients after generic substitution of antiepileptic drugs. Approximately two-thirds reported increased seizure frequency and 56% reported increased adverse events. 57

In another survey, cases of loss of seizure control followed by generic substitution were reviewed among physicians. 37 In total, 50 patients who were well controlled on a branded antiepileptic drug experienced a breakthrough seizure or had an increase in seizure frequency after generic switching. Almost half of the patients on the generic drug had lower drug serum levels at the time of the breakthrough seizure. Clearly, the studies referred to above underscore a clear theme of citing safety, toxicity, or efficacy concerns where brand-to-generic switching is concerned in the area of antiepileptic medications. However, as noted below, outcomes for this particular condition can also translate into cost-based concerns that are not favorable to brand-to-generic switching.

In a further survey of 1354 epileptic patients, high switch-back rates from generics to brand-name antiepileptic drugs (12.9%–20%) were reported compared with antihypertensive agents and antidepressants (1.5%–2.9%). 51 Again, this was because of increased toxicity and/or loss of seizure control associated with the use of generic antiepileptic drugs.

In a large retrospective study of medical and pharmacy claims, LeLorier et al 39 measured the percentage of patients who switched from a generic drug to a brand-name drug among users of antiepileptic drugs compared with other therapeutic drug classes. Antiepileptic drug users were more inclined to switch back to branded medications (20.8%–44.1%) compared with patients taking generic antihypertensive agents or statins, where fewer patients switched back to their branded drugs (7.7%–9.1%).

In contrast to antiepileptic drugs, antipsychotics, antidepressants, and benzodiazepines are generally believed to have a somewhat broader therapeutic window, and dosing is adjusted based on clinical efficacy or rate-limiting adverse events. Desmarais et al 33 conducted a thorough literature search to evaluate the effectiveness, tolerability, adherence, and economics of generic psychotropic medications. Table ​ Table2 2 lists different adverse consequences and adherence issues reported in patients administered generic psychotropic drugs. Relative to the widespread use of generics in these psychotropic medication classes, only a few case reports exist on clinical inequalities, such as switch-related increases in adverse events or re-emergence of symptoms. For example, re-emerging or worsening symptoms were observed in 20 patients after a brand-to-generic switching of citalopram. Emerging symptoms included suicidal ideation, increase in anxiety, obsessive thoughts, compulsions, irritability, and depressive thoughts. Although the previous treatment response was restored after switching back to the innovator brand-name drug, the time required for restoration was greater than the time taken for the re-emergence (0.7–12 weeks vs. 0.58 weeks, respectively). 56

Impact on cost and resource use

Helmers et al 58 reported the outcome of a large study (n = 33,625) where generic antiepileptic drug treatment was associated with higher total medical service and direct health care costs than with branded drug use, despite the generic drugs being less expensive. After adjustment for confounding factors, the overall annual health care costs for patients receiving therapy with generics were 25.8% higher [adjusted cost differences (95% CI): $3254 ($2403–$4105), P < 0.05] than for patients treated with brand-name products, because of higher health care costs. In another study, compared with the use of the brand-name product, use of topiramate multiple-generic products was correlated with a higher utilization of other prescription drugs, higher hospitalization rates, and longer hospital stays. Also, the risk of head injury and the overall annual health care cost per patient were higher with multiple-generics use than with brand-name use. 51

Treur et al 55 also estimated the health–economic consequences after the generic substitution of risperidone in schizophrenic patients. In Germany, substituting risperidone with generic products in patients with schizophrenia was found to be not cost-effective if it involved a reduction in adherence rates. Patients who become nonadherent after generic substitution had poorer symptom control, increasing the probability of requiring treatment in a more intensive and expensive facility (eg, hospital). Keeping a patient with schizophrenia on the brand-name risperidone product rather than switching to a generic version was found to be cost-effective (assuming a 40% reduction in medication costs), providing the incremental probability for nonadherence after generic substitution was greater than 5.2%.

Johnston et al 11 reviewed a large number of studies in the treatment of hypertension. They found that the treatment of hypertension was often associated with cost-containment measures, and switching to generics was commonly observed to reduce the drug acquisition costs. However, in certain cases, switching antihypertensive caused extra clinic visits, additional laboratory tests, and potential hospitalization because of cardiovascular events from uncontrolled hypertension.

Each of the above highlights the complexities involved when evaluating the economic benefits of switching to generics. Total cost of care and, in some cases, potential indirect costs are among the more comprehensive measures of the true cost of switching to generics. Indeed, each case, condition, or therapeutic entity may represent a unique circumstance requiring careful study before considering its true impact.

Brand-to-generic switching is a common practice across all therapeutic areas with the main aim of cost savings. According to the FDA, the cost of a generic drug can be 80%–85% lower than the innovator's branded product; hence generic drugs can be rapidly substituted after patent expiration with estimated cost savings to consumers of $8 to $10 billion a year. 40

Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences. The present review highlights that generic substitution may lead to concerns among patients, which can lead to challenges in drug adherence. The studies reviewed highlight the existence of negative attitudes toward generic products in a sizeable minority (∼33%) of the patients. Some patients believed that lower prices translated into poorer quality, whereas others believe that economic savings were the reason that they had accepted the generic product. Changes in physical attributes of their medicine added to their uncertainty. Some patients reported a different effect or new or more adverse events. In the case of chronic illnesses, patients who were familiar with their drugs by appearance were less prepared to accept the switch.

Many patients who were surveyed believed that general physicians and pharmacists should discuss generic substitution more actively with them and wished to receive further information, as this would impact their decision to accept the substitution. Furthermore, the research implied that patients would generally prefer the medications to be prescribed by their physician.

Clearly, there are differences in the success rates, either measured by switch-back rates or overall costs of care, prevalence of side effects, toxicity, and/or efficacy based on the therapeutic class of agents undergoing the switch. This is particularly relevant to agents that have narrower therapeutic indices compared with other classes of drugs. For example, in the treatment of epilepsy, significant issues have been documented after generic switching, including breakthrough seizures, more adverse events, and increased cost of care because of extra physician visits or hospitalizations.

Given these observations, the significance of considering the overall impact of generic substitution on medication adherence should be carefully considered for each indication and circumstance relative to their presumed economic benefit. Adherence to treatment should be focused on several levels, including the patient, the health care provider, and the health care scheme. Patients require the knowledge, attitudes, and skills to adhere to an appropriately prescribed treatment regimen. Similarly, health care providers are required to follow established treatment guidelines, make certain that patients are aware and understand the reason for their prescribed medications (branded or generic), any potential adverse effects, interactions with other drugs, and how their medicine should be taken, as well as make certain that the suggested treatment regimen is the simplest possible. If the health care system insurer or the patient cannot afford the branded medication, then the justification and support for generic switching should be explained to the patient, so as not to adversely affect adherence. With a thoughtful approach, the true cost of the medications and consequences of generic switching may be more appropriately considered.

To the best of our ability, we have attempted to include examples of what has been published on the impact of generic substitution. Although we did note a publication bias toward the reporting of negative findings, we do believe that our review is of value as it heightens awareness of the issues surrounding generic substitution.

In summary, caution and careful consideration should be given when implementing a generic switching policy. Based on our review, in certain therapeutic areas, physicians and patients should retain the right to request the branded product when medically justifiable. Generic switching should be assessed on an individual basis, and with disclosure of possible consequences to the patient and a plan to implement the change and assess its ultimate impact through education and monitoring. 53

Supported by Pfizer Inc. Editorial support was provided by Sarah Knott of Engage Scientific Solutions and funded by Pfizer Inc. Additional support, composed of copyediting a late draft of the manuscript, was provided by Anne Jakobsen, MSc, and Abegale Templar, PhD, of Engage Scientific and funded by Pfizer Inc.

R. J. Straka was a paid consultant to Pfizer Inc in connection with this study and development of this manuscript. D. J. Keohane and L. Z. Liu are employees of Pfizer Inc.