Brand versus generic medications: A disease state approach to identify patients’ perceptions and concerns

Abstract

Background

Medication cost does not solely dictate patient preference of brand name or generic medications. However, few studies have been completed to assess the influence of other factors, such as demographics and chronic diseases.

Methods

Responses were collected from 347 English speaking adults in the United States, age 18 and older, pertaining to demographics, diagnosed conditions, preference and knowledge of brand and generic medications.

Results

Participants with COPD, epilepsy, and high cholesterol felt that their condition influenced their preference of brand or generic medication more as compared with participants diagnosed with other conditions. If cost was not an issue, then 46% of respondents would prefer the brand name product, while 18% of participants felt their preference depended on the condition that the medication was intended to treat. Roughly one-third of the participants did not fully understand why there are both brand name and generic medications, and education level did not impact comprehension significantly.

Conclusion

The incentive for generic preference over brand name is primarily due to cost differences. However, improvement of education pertaining to brand/generic equivalency is needed, as some patients still believe brand name medications are superior to generic alternatives for certain disease states.

Keywords

Brand generic health literacy cost disease state preference

Introduction

Generic medications are becoming a major part of our healthcare system. According to the 2014 Generic Pharmaceutical Association annual report, 9.5 million generic prescriptions are filled every day, which contributes to nearly $4.6 billion saved every week.¹ In addition, it is estimated that generic medications have saved the United States health system nearly $1.5 trillion over the past 10 years, including $239 billion in savings during the year 2013 alone.¹ This savings represent a 14% increase over cost savings achieved in 2012.¹ United States consumers now have access to more than 12,000 affordable generic medicines, which further contributes to the savings increase.¹ Based on this financial data, it could be inferred that generic medications accounted for roughly three quarters of all the medications dispensed during the year 2014. These large expenditures and savings demonstrate the importance of generic medications to healthcare.

The FDA defines a generic medication as a drug that is “identical – or bioequivalent – to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use”.² Only slight variations between brand and generic drugs are allowed. This definition was tested in 2009 when Buehler et al.³ retrospectively evaluated 2070 human studies conducted from 1996 to 2007 to examine the bioequivalence of generic and brand name products. This analysis was based on the theory that the amount of drug absorbed is equivalent to its efficacy. The study showed that an average of 4.35% difference in C_max and 3.56% difference in AUC existed between the generic medications and their corresponding brand name product. In 98% of the studies, the generic drug’s AUC differed from the brand name product’s AUC by less than 10%.³ The results of this study indicated that generic medications approved by the FDA are nearly identical to brand name products, and therefore patient outcomes should not differ based on the type of product used.

Nevertheless, some patients still have concerns. Several studies have examined patients’ attitudes and apprehensions towards generic drugs. For example, Berg et al.⁴ completed an online survey regarding patients’ perspectives of generic substitution of antiepileptic medications. They found that 70% of the participants thought that a substitution for their seizure medication would lead to negative treatment outcomes and 34% believed it could lead to breakthrough seizures. A weakness of Berg et al.’s⁴ study was that the response rate was only 31%. This could have been due to the fact that the subjects only had a week to complete the online survey after receiving the email or postal mail invitation. Also, the survey was strictly online which could have caused older epileptic patients to be unresponsive.⁴ In addition, this study only evaluated one disease state, and therefore its results cannot be extrapolated to the population without epilepsy.

An additional study completed in 2009 evaluated national views on generic medications and patient’s comfort level with using generic products over their brand name counterparts. They found that patients who had positive perceptions towards generic drugs were more likely to use them. One of the major limitations of this study is that it excluded adults enrolled in Medicaid, and the responders were mostly older than non-respondents. As a result, the findings from this study may not be applicable to young adult patients of lower socioeconomic status.⁵

Ultimately, medications, whether they be for an infection, chronic disease state, or to alleviate the symptoms of a common cold, are widely used in the United States and across the globe. Between 2009 and 2012, 48.7% of the population in the United States had used at least one prescription drug in the past 30 days when questioned.⁶ According to the FDA, nearly 8 out of 10 prescriptions in the U.S. are for generic drugs.² Therefore, almost half of the country’s population use a prescription medication in a month’s time period, and the vast majority of those prescriptions are automatically substituted for a cheaper generic medication. This brings up an important underlying question often asked by many patients, “Which is better, brand or generic?” Due to many factors including marketing, word of mouth, prior utilization and individual research, patients develop personal preferences. The purpose of this study was to evaluate and interpret those preferences with hope of better understanding patient partiality and the reasoning behind it. Thereby more educational programs could be implemented to increase patient comfort with generic substitution which in turn would further reduce prescription drug expenditures.

Methods

This study was conducted from June 2015 to September 2015, after receiving approval by the institutional review board (IRB) at Florida Agricultural and Mechanical University. Information was collected from adults in the United States, who were age 18 years and older, pertaining to preference and knowledge of brand and generic medications. Data was gathered by both online surveys and paper surveys, which were completed at various locations in North Florida over a three-month period (July 2015–September 2015). Utilizing an online survey conducted via SurveyMonkey provided an alternative method of participation for those who did not desire to complete a paper version. Access to the online survey was distributed randomly via email and social media (Facebook). The aforementioned distribution methods provided potential online participants with information documenting weblink, password, and instructions. Respondents who were non-English speaking required exclusion. Participants who took part in the paper survey provided verbal consent, while those taking part in the online survey provided implied consent.

Each participant received a confidential survey that provided questions related to demographics, disease state history, medication history, cost of medications, and preferences regarding such factors. Information gathered by paper survey was re-entered into the online survey format. All data was documented using SurveyMonkey and Microsoft Excel software. Data included complete counts of the number of respondents, number of respondents relating to demographic data, and number of respondents with each listed disease state. SurveyMonkey was also utilized to show trends related to specific questions. Respondents who had specific disease states were pooled and their responses to other questions were summarized. Microsoft Excel was utilized to improve display quality and functionality as compared to SurveyMonkey. Microsoft Excel was also utilized to provide additional comparisons, sums, percentages, and probabilities by correlating demographic and disease state information with specific questions. In addition, data was extrapolated on an individual survey by survey basis allowing us to correlate connections between demographics, disease states, and participant opinions.

Results

A total of 347 participants were surveyed across the United States. Data from all participants was able to be utilized without any respondents requiring exclusion. As shown in Table 1, demographics showed that the majority of participants self-identified themselves as Caucasian (84%). In addition, female respondents encompassed 78% of the entire surveyed population. The age of participants was diverse, with the largest age group being the 18–24 years old group at approximately 25% of participants. The other age groups were relatively equal in participant number (44 to 60 participants per each age group), except for the elderly age group, which only made up about 8% of participants. The average age range of participants was 35–44 years old. Although this survey was available online, the vast majority of participants (96%) were from the South, which was defined in the survey as inclusive of the following states: Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, and Texas.

Table 1.

Participant demographics

Age	Number of participants	Percentage of participants
18–24	86	25.20
25–34	60	17.80
35–44	44	13.06
45–54	62	18.40
55–64	58	17.21
≥65	26	7.72
Prefer not to answer	1	0.30
Gender
Female	263	78.00
Male	73	21.66
Prefer not to answer	1	0.30
Race
Caucasian	281	84.38
Hispanic or Latino	5	1.50
African American	33	9.91
American Indian	3	0.90
Asian/Pacific Islander	8	2.40
Prefer not to answer	3	0.90

Influence of gender

Demographics did not greatly influence preference of brand or generic medications. More than half of both groups did not have a preference (females: 53%; males: 55%). In addition, approximately 20% of males and females preferred brand name products and 20% preferred generic medications. The remaining percentage of each gender skipped the question regarding preference.

Influence of education

The majority of participants (85%) had some amount of formal education after high school. The remaining percentage of respondents (15%) had completed high school, achieved a GED (General Education Development), or preferred not to answer. A comparison of the education level of each participant and comprehension of differences between brand and generic medications was completed. Most respondents answered yes to fully understanding the difference as shown in Chart 1 (between 55% and 83% of participants in each education level). Nearly all of the population surveyed who had a professional/doctorate degree answered that they fully understood the difference (83%), whereas only 42% of people who preferred not to answer the education level question documented that they fully understood the difference.

Chart 1.

Comprehension of differences between brand and generic medications. The chart illustrates the relationship between brand and generic medication preference and education level. A “yes” response indicated that the participant felt that he or she fully understood the differences between brand and generic medications. A “no” response indicated that the participant did not fully understand the differences.

Influence of disease states

Participants were also probed regarding their diagnosis of 10 disease states. As shown in Table 2, 70% of respondents had been diagnosed with a chronic disease state. The most commonly reported conditions were high cholesterol (13%) and high blood pressure (17%). When asked if participants thought that their diagnosis of one or more of the previous conditions influenced whether or not they would prefer a brand name medication over a generic medication, 82% of participants responded by choosing “no” on the survey. When characterized by disease state, participants diagnosed with COPD, epilepsy, and/or high cholesterol were more likely to feel that their condition influenced their brand name or generic medication preference (40% vs. 29% vs. 22%, respectively). Participants diagnosed with gout, heart problems, and/or high blood pressure were more likely to feel that their disease state did not influence their preference (100% vs. 96% vs. 85%). The percentages of respondents diagnosed with each disease state who answered yes or no to such question can be found in Chart 2. For each disease state more participants did not believe their condition influenced their preference as compared with the number of participants who felt their diagnosed condition influenced their brand name or generic partiality.

Chart 2.

Response to whether or not the following condition influences brand name versus generic medication preference. The chart illustrates the relationship between brand and generic medication preference and diagnosed conditions. A “yes” response indicated that the participant felt that his or her diagnosed condition influenced preference. A “no” response indicated that the participant did not feel his or her condition influenced preference.

Table 2.

Diagnosed conditions

Diagnosed condition	Number of participants	Percentage of participants
Epilepsy	6	1.00
Asthma	32	7.00
COPD	5	1.00
Depression	50	10.00
Heart problems	24	5.00
Diabetes	17	4.00
Gastrointestinal diseases	50	10.00
High cholesterol	63	13.00
High blood pressure	85	17.00
Gout	8	2.00
Not applicable	148	30.00

Influence of efficacy beliefs and costs

Participants were asked if they believed brand name medications work better than generic drugs to treat a chronic disease. Sixty-one percent of participants responded that they believed brand name drugs and generic drugs are equally efficacious and 25% were unsure. However, when asked about their preference if cost was no longer an issue, 46% of respondents would still prefer the brand name product, while 18% of participants stated that their preference depended on the condition that the medication was intended to treat. The other 36% would prefer the generic product or had no preference. This data is illustrated in Charts 3 and 4.

Chart 3.

Participant preference.

Chart 4.

Preference if cost was equivalent.

Discussion

Throughout the duration of this study the investigators were able to evaluate the opinions and misconceptions of the public with regard to brand and generic medications. Overall, the majority of individuals surveyed felt that brand name medications are equally as effective as a generic alternative. Additionally, chronic medical conditions did not seem to greatly influence brand or generic preference. This is in contrast to Berg et al.’s⁴ study, as discussed in the introduction, where 65% of patients were concerned about the efficacy of generic medications for seizure control. However, through data collection and conversing with participants, 59 (17%) of them felt that their brand name medication offered more benefit depending on the particular condition the drug is currently treating. Brand name preference for certain conditions may be partially due to the influence of advertisements and editorials which express favoritism for or subtly try to indicate superiority of brand name products. This statement is supported by the results of a meta-analysis completed Kesselheim et al.⁷ which analyzed 47 articles, including 38 randomized controlled trials, focused on cardiovascular medications. Clinical equivalence was reported among the majority of the trials, indicating that brand name products are not superior to generic. However, more than half of the editorials that included remarks on these trials expressed negative views towards generic medication substitution.⁷

Another interesting point discovered through this study was that although 61% of participants felt there would be no difference in brand or generic medications, almost half of the study population would still choose a brand name product over a generic if cost was not a factor. This finding is consistent with the results from a national survey of commercially insured adults in 2009. It was revealed that although 56% of respondents felt that Americans should use more generic medications, only 37.6% actually preferred generic drugs for their personal use.⁸ Americans may claim to understand the equivalence of brand name and generic medications; however, their preferences do not always correlate with this assumption.

One limitation that was encountered several times throughout this study was the lack of a thyroid disorder option in the survey question asking about patient conditions. According to the American Thyroid Association, women are five to eight times more likely to have thyroid problems than men.⁹ With 78% of the survey respondents being female, the lack of thyroid disorder as an answer choice potentially contributed to the 30% response rate of “not applicable” concerning the disease state condition question. Also, three quarters of the participants were female and 84% were Caucasian, which could have skewed some of the results. However, according to the 2014 United States Census Bureau, 78.36% of the American population is Caucasian.¹⁰ This suggests that the population surveyed is an adequate representation of the total United States population regarding ethnicity. In addition, the southern United States has a very similar demographic background regarding other ethnic groups as compared to the overall United States population. Therefore, we feel that the study adequately represented each ethnic group correctly and the results were not biased based on ethnicity.

With regard to method limitations, the survey was primarily completed through the utilization of an online survey system (SurveyMonkey) with the link being shared through Facebook, email, and a Florida-based school system. Only a small percentage of surveys were distributed in person. Another limitation was that questions in both the online and paper surveys were allowed to be skipped. However, less than 10% of survey participants skipped one or more questions. The addition of answer choices conveying uncertainty would combat the occurrence of unanswered questions and allow additional information to be inferred.

Despite certain limitations to the study, much knowledge was still able to be extrapolated to further evaluate the opinions and misconceptions the public has with regard to brand and generic medications. While it is obvious that the majority of the population believes that generic medications are cheaper and equal in effectiveness to brand name medications, there is still a disconnect regarding their usage. This could be the result of advertisements, articles, physician recommendations, comprehension, and familiarity with brand name medications.^11,12 Another possibility is that although patients reported understanding generic medications, the depth of their understanding may not be adequate enough to make an informed decision regarding generic substitution.¹³ This is congruent with data from a national survey in 2009 in which the use of generic medications was most associated with communication with providers and patient comfortability with generic substitution.⁵

Although disease state did not significantly impact patient preference in this study, more studies should be conducted in order to further examine the influence of secondary factors on participant preference. Studies examining the influence of disease states should seek to focus on only a few disease states in order to gather an adequate population from which to draw conclusions. For example, this study examined the influence of 10 disease states, which left conditions, such as epilepsy, with less representation in comparison with core disease states like hypertension and hyperlipidemia. If a study focuses on multiple disease states, then a larger population should be surveyed in order to provide more applicable condition responses. Furthermore, a study needs to be completed that objectively tests participant understanding of the differences between brand name and generic medications. For this study, participants had to gauge their own comprehension, which could have led to over- or underestimation of brand name and generic knowledge. In summary, this study provides a basis for additional investigation.

Conclusion

Cost may be the most important factor in determining a patient’s preference. This statement was supported by the findings of this study that a large percentage of participants would prefer brand name products instead of generic alternatives if cost was no longer an issue. However, cost is not always the deciding factor. Some patients truly believe that brand name drug products work better than generic alternatives for certain disease states or conditions. Many simply do not understand why there are brand and generic medications even though the majority of patients take both brand name drugs and generic alternatives for their conditions. However, an overwhelming number of participants recognized the cost differences. Overall, the surveyed group was primarily focused on medication cost and was mostly unable to distinguish other differences between the two groups of drugs. With the development of future studies focused on the depth and adequacy of the population's understanding of generic medications, it will then be possible to fully correlate patients’ perceptions and concerns with the variables that affect their decisions.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Author biographies

Lillian Smith is an Assistant Professor of Pharmacy Practice at Florida A & M University College of Pharmacy and Pharmaceutical Sciences, in Crestview, FL. She specializes in medication therapy management within the primary care setting.

Juan Mosley is an Assistant Professor of Pharmacy Practice at Florida A & M University College of Pharmacy and Pharmaceutical Sciences, in Crestview, FL. He specializes in medication therapy management in the areas of primary care and HIV/AIDS management.

Megan Ford is a fourth year pharmacy student from Florida A & M University College of Pharmacy and Pharmaceutical Sciences. Her main research interests include geriatric medicine and patient education.

Jonathan Courtney is a fourth year pharmacy student from Florida A & M University College of Pharmacy and Pharmaceutical Sciences. His main research interests are medication adherence and pharmacoeconomics.

Chase Stefanelli is a fourth year pharmacy student from Florida A & M University College of Pharmacy and Pharmaceutical Sciences. He plans to pursue a career in the community setting upon graduation.

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