GENERIC VS. BRANDED MEDICINES Generic versus Branded: Relationship between Socio-Economic Status, Medical Conditions, Perception and Preference on Medicines of Residents of Mojon, Malolos Gerlyn Freeda A. Agmata Nathan Cristopher A. Calayag Federico T. Camua Ace John R. Mondidu Jerico J. Roque Holy Spirit Academy of Malolos GENERIC VS. BRANDED MEDICINES March 2018 Chapter 1 The Problem and its Setting Introduction Medicines are substances used in treating and preventing the manifestation of diseases. There are two kinds of medicines - the branded and its generic counterpart. A branded/brand name medication is the first of its kind and gets to brand the name. Being first takes lots of time, effort and money. The drug is discovered, researched, tested, developed, produced and marketed - these steps start in a laboratory, then proceeds to a clinical testing facility, and go on to a Food and Drug Administration (FDA) office for approval before ever reaching a pharmacy shelf. The pharmaceutical company ensures that the drug is safe and effective by conducting a series of laboratory studies that take years to perform. Once the drug is granted FDA approval, the company can give the medication a brand name and market it. The brand is protected by a patent so other drugmanufacturers cannot copy the formula and duplicate the drug. This patent allows the innovating company a period to exclusively sell the medicine so that they can regain the money invested during drug development and generate a reasonable profit. During this time, other pharmaceutical companies are not permitted to make or sell the drug without permission from the developing company (Buzhardt, 2016). When the patent expires, other pharmaceutical companies may apply to the FDA for permission to manufacture and sell a generic version of the original compound. The generic drug manufacturer must prove that their product contains the same active GENERIC VS. BRANDED MEDICINES ingredient(s) in the same amount, and does the same job as the branded drug before it can be used as a substitute. This proves that generic and branded medicines produce the same effects. Their only difference is the pricing. Manufacturers of generic drugs do not have to repeat the years of costly laboratory and clinical trials that the developing company invested in to gain FDA approval. Generic manufacturers simply borrow a finished work and do not have to spend the time or money to do their own. Since they can produce the medication at a much lower cost, it is reasonable that they can sell it at a lower cost and still make a profit. When several companies begin to manufacture the same generic medication, competition further keeps the price down. Generic and branded drugs have the same impact in terms of treating diseases. However, some patients still have the misconception that generic drugs are inferior to brand name drugs. The Philippines already established a law (Republic Act 6675 – Generics Act of 1988) to promote require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names. This is already a support to the equivalent effects of both types of drugs yet patients still tend to deviate from their choices of the medicines they intend to buy. This quantitative research study sought to determine the relationship between socio-economic status, medical conditions, perception and the preference of the residents of Mojon, Malolos in choosing between generic and branded medicines. GENERIC VS. BRANDED MEDICINES Statement of the Problem This study sought to answer: What is the relationship between socio-economic status, medical conditions, perception and preference among the residents of Baranggay Mojon in Malolos City? Specifically, it aims to answer the following questions: 1. How can socio-economic status of the residents of Baranggay Mojon in Malolos City be described in terms of 1.1 age; 1.2 gender; 1.3 monthly family income and 1.4 occupation? 2. How can medical conditions be described? 3. How can perception of the residents of Baranggay Mojon, Malolos be described in terms of 3.1 background knowledge about the medicines and; 3.2 the relationship of price and quality? 4. What do the residents of Baranggay Mojon prefer between generic and branded medicines? 5. Is there a significant relationship between socio-economic status, medical conditions and preference of the residents of Baranggay Mojon in Malolos City? GENERIC VS. BRANDED MEDICINES Significance of the Study The results of this study will benefit the residents of Malolos City since if the government and stores will adjust to their needs and preferences, they will be sufficiently provided. Pharmaceutical stores will also benefit since they will know the common preference of residents of Baranggay Mojon regarding medicines and may adjust the supply of medicine they would sell in terms of the demands of the public. This study will also benefit the city government by knowing the preference in medicines of its residents so they could provide support programs that are anchored on the needs and preference of the people. Lastly, the future researchers will also benefit from the study by having a clearer or a more precise view of the medicine preferences of Malolos City residents and fill up the gaps that have not been studied in the paper. Scope and Delimitations This research study aims to determine the relationship between socio-economic status, medical conditions, perception and the medicine preference of the residents of Baranggay Mojon in Malolos, Bulacan and the data gathering procedure was conducted during the month of November 2017 due to the limitations of time for the data gathering . Residents of Baranggay Mojon were the focus respondents of this study since based from the 2015 census; the said baranggay is the most populous in Malolos, Bulacan. Differentiation of classes in Baranggay Mojon is evident, considering that there are exclusive villages in the vicinity. Furthermore, the study will be limited due to its time constraint. GENERIC VS. BRANDED MEDICINES Chapter 2 Review of Related Literature Relevant Theory The Theory of Medical Decision Making under times of uncertainty by Karni (2009) stated that there are factors that could affect the decision making or choice of a person when diagnosed with a particular illness. These factors will affect the decision of the person on whether to opt for a particular procedure with a particular doctor under a set of circumstances that leads to the decision. The theory will be adapted because of the presence of the decision or choice making of a person and the factors that affect the decision. Relating it to our study, we are looking into the effect of the factors such as age, income, etc. to the choice of medicine of the residents of Baranggay Mojon inMalolos, Bulacan. The Theoretical Model and Theory of Pricing Strategy and Practice by Kalita, Jagpal and Lehmann (2004) stated that firms use prices to indicate quality, regardless of whether they market durable or nondurable products. Through practice and application, people tend to believe in the power of price as the dictator of quality even though they still are not knowledgeable of the specs or information about the product. The theory will be adapted because it elaborates the relationship between price and quality. In the study conducted, one of the researchers’ variables is the residents’ perception on branded and generic medicines. The researchers want to know the effect of this perception on the preference of the residents of Baranggay Mojon. This theory would greatly help the researchers because they would already have background knowledge and information on GENERIC VS. BRANDED MEDICINES what could dictate and how could the residents’ perception be described when connected to their preference, in choosing what medicine to buy. Related Literature / Studies Research about the factors associated with the preference for purchasing generic drugs done in the Households of the Municipality of Pelotas, in the State of Rio Grande do Sul, Brazil. by Guttier, Silveria,Luiza and Bertoldi (2017) showed that people with better knowledge and understanding about generic drugs have greater preference for purchasing it. Some have observed that generic drugs are cheaper, and an effective replacement for branded medicines. Doctors who prescribe generic drugs to their patients decrease the patients’ negative perception on generic drug. With the reduction of negative perception on generic drugs, doctors increase the knowledge that lay people have about generics. The study was conducted in the year 2007 in Brazil, then re-conducted the study 10 years after, having the same results and outcomes that shows people still prefer generic drugs. According to the study and analysis of various facts about branded and generic medicines of the same drugs with the literate population of Maharashtra and Rajasthan ,India conducted by Ahire, Shukla, Gattani, Singh V., and Singh M. (2013), the main reason why generic drugs were inferior to branded medicines was the lack of prescriptions received from physicians. More than half of the individuals are aware that generic drugs are cheaper but they are not aware of the effects of generic medicines; they have this perception that generics are not as safe as branded medicines.The lack of generic prescriptions received by the patients mirrors their lack of acknowledgement to these medicines – making them unaware of its efficiency. As stated by Guttier et al GENERIC VS. BRANDED MEDICINES (2017) in their recently concluded research, doctors serve as one of the most influential factor that can affect the medicine preference of the patients because they act as the source of generic medicine knowledge, and this awareness can be a factor to either increase or decrease their generic preference. Guttier et al (2017) also made mention of the low-priced generic drugs have that corresponds with the results of this study. A research study was conducted by Losifescu, Halm, Mcginn and Federman (2008) who focused on adults aged 65 years and older who were enrolled in Medicare, the federal health insurance program for elderly and disabled adults in USA, and those who lacked a diagnosis of dementia. The aforementioned study aimed to characterize seniors’ beliefs about generic drugs, and examine potential correlates of these beliefs, including socioeconomic and health status variables, health literacy, and physician communication skills that indicated in its results that individuals with low health literacy are more likely to hold negative views towards generic medications. The study has shown that an association between education level and understanding about generic medications result in greater use of these drugs. The association between health literacy and generic medications beliefs may be connected to patients’ understanding on generics. Overall, many seniors from a low-income, hospital –based, and inner city clinical practice have negative beliefs about generic drugs, and that negative beliefs are also common to those with lower health literacy and physicians who have poor communication skills. The health literacy of people that affected their preference on generic medicines is connected to the study of Guttier et. al. (2017) that knowledge of people is a factor to their preference along with the prescriptions of physicians. GENERIC VS. BRANDED MEDICINES According to Choudhury et. al. (2017), over 90% of the patients believed that generic drugs were as effective as branded medicines. Poor people are forced to settle for generics due to low therapeutic costs. Patients attending the public hospital were socioeconomically and educationally constrained, but they still believed that generic drugs available in their vicinity were effective. The study made by Igbinovia (2007) showed that males are less likely to use generic drugs compared to females. People who are more concerned about the quality and safety of medicine tend to purchase branded medicines. People who are more concerned about the price are more likely to use generics than branded because of its cheap cost. The study also found that the higher the educational level of a person is, the more likely a person will use generic drugs. The findings of this study correspond to the paper made by Tavares et al (2016) wherein females are more likely to prefer generic medicine over branded medicine. The study of Wong (2015) about the prevalence of Philippine prescribing, dispensing and use behavior in relation to generic drugs states that the factors that affect the generics prescribing behavior are patients’ welfare, compliance, socio-economic status and their fear of punishment. For the consumers, there is actually a preference for branded medicines over generics. Consumers only purchase generic medicines because of influence of family and friends, public facility, and it is a requirement by the law to state the generic names of medicine in the prescriptions that doctors give out. Results from the study done by Kesselheim et al (2016)showed that a vast majority of patients prefer asking their physicians to write prescriptions for generic drugs if available. Patients consider generic drugs to be interchangeable with brand-name drugs. GENERIC VS. BRANDED MEDICINES Nearly all respondents reported that generic drugs were less expensive than brand-name drugs. This study had found a major shift in patients’ positive perception on generic drugs. This study can be correlated to the involvement of doctors and their prescriptions according to previous literatures of Guttier et al (2017) and Ahire et al (2013). According to Mehta and Chouldhry (2009) 94% of the respondents believed that generics are less expensive than brand-name drugs, and less than 10% of the respondents believed that generics cause more side effects than branded drugs. Overall, the respondents agreed that generic drugs are a better value than branded drugs. Patients also reported that they prefer to use generic medications for the treatment of high cholesterol, a chronic asymptomatic condition, and back pain. Patients with less education were significantly more likely to rate generics as greater value. Women were more likely to value generic drugs than men. The findings of this study correspond to the results of studies by Guttier et al. (2017) that stated that knowledge plays a key role in one’s preference in medicine and also the study of Tavares et al (2016) that had results showing that female has more chances of preferring generic drugs than men. A research paper done by Bertoldi et. al.(2016) states that half of the respondents were reported as generic medicine users. There was no difference considering education level. The prevalence was higher in females. Generic medicines were widely used by those who belong in the middle class. Many of the respondents prefer purchasing generic drugs thanks to the availability of these medicines in the market. Omojasola, Hernandez, Sansgiry and Jones (2012) conducted a study that stated in the results that race and ethnicity have no impact in the utilization of generic drug discount programs. When it comes to analyzing their perception, the participants had a GENERIC VS. BRANDED MEDICINES positive perception on the safety, quality, and effectiveness of generic prescription drugs. The education level of a patient directly affects the acceptability of generic drugs. According to Nardi, Ferraz, Pinhiero, Kowalski and Sato (2015), higher use of generic drugs was observed in the female and elderly populations. The higher use of generic drugs among the elderly population may also be related to their lower spending power, which may cause a preference for cheaper products like generic drugs. Regarding the participants’ perceptions of the attributes of generic drugs, it was observed that almost a third believed generic were less effective than branded drugs, and the most negative opinions were observed in the lower income group and elderly. Although most of participants had a positive perception regarding the effectiveness of generic drugs, more than half said that if there was no price difference, they would prefer branded. This findings reinforce the idea that price has a strong influence on the decision to purchase a generic drug. Skipper and Vejlin (2015) stated in their study that the choice of using branded drugs were mainly determined by the complementary relationship of price and quality. But the findings showed that socio-economic characteristics of both patients and doctors to have very low explanatory power on the choice of medicines. This would mean that whatever income class they are in, their preference is not affected. Physicians’ prescribing decision also does not affect the variation of the patients’ preferences. GENERIC VS. BRANDED MEDICINES Conceptual Framework Hypotheses H01: Gender has no significant relationship with the respondents’ preference of medicine. H02: Medical conditions have no significant relationship with the respondents’ preference of medicine. H03: Age has no significant relationship with the respondents’ preference of medicine. H04: Income has no significant relationship with the respondents’ preference of medicine. H05: Occupation has no significant relationship with the respondents’ preference of medicine. H06: Perception has no significant relationship with the respondents’ preference of medicine. H07: Price and quality have no significant relationship with the respondents’ preference of medicine. GENERIC VS. BRANDED MEDICINES Definition of Terms Branded medicines. Virtual Medical Center (2011) defined branded medicines as the original products that have been developed by a pharmaceutical company. Furthermore, these are drugs containing the same dosage of active ingredient as the generic medicine but does not have inactive ingredients that may contribute to its taste, texture and color. In this research study, branded medicines are drugs people consider as expensive and effective. Generic medicines. Cadth (2015) stated that these medicines are a copy of the original product; medicines that are equivalent to a branded drug in terms of strength, dosage, route of administration, quality, performance and intended use. Generic medicines are generally less expensive that branded medicines. This research study focuses on generic medicines being less expensive than branded medicines, but is as effective as its branded counterparts. Medical conditions. are defined by WebMD as an injury, disease or disorder in the human body. In this research study, medical conditions are anything that would require one to take medicine in order to cure it, compelling the people to make use of either of the two kinds of medicine, generic and branded Income. In this research study, monthly family income was used wherein it measures the income of all people in a household. Occupation. In this research study, occupation refers to the profession of a person that provides and supports the needs of a family. Perception. As defined by Williams of College Psychology and Ethics Isthe Process, it is where we take in sensory information from our environment and use that GENERIC VS. BRANDED MEDICINES information in order to interact with our environment and also includes how we respond to the information. In this research study, perception refers to how the residents of a certain baranggay apprehend medicines. GENERIC VS. BRANDED MEDICINES Chapter 3 Research Methodology Research Design In order to assess the degree of relationship between variables — socio-economic status, medical conditions, perception and preference on the choice of medicines of the residents of Mojon, Malolos, a descriptive correlational research design was used. According to Burns and Grove (2013), a descriptive study defines an opinion, attitude, or behavior held by a group of people on a given subject. It is also used to justify current practices, make judgments and develop theories. The study was descriptive in nature since it aims to describe the variables socio-economic status in terms of age, gender, monthly family income and occupation; people’s varying perceptions in terms of the complementary relationship of price and quality with respect to the overall preference of the respondents in choosing which type of medicine to buy. A correlational study aims to assess the relationships between and among two or more variables and the making of predictions (Strangor, 2011). The correlational nature of the research design was to determine if there is a significant relationship between the variables of the study. It was also used to test if the formulated hypotheses on the relationships would be accepted or not accepted. Population and Sampling Technique The focus population of the study was the whole residents of Barangay Mojon. This barangay is the most populous in Malolos according to the 2015 census conducted by the National Statistics Office (NSO), having a population size of 18,239. Since this is GENERIC VS. BRANDED MEDICINES too big to handle, the study would use a sample (n) to represent the population (N). Using the standard formula, the sample size computed and used was 377 (5% margin of error, 95% confidence interval and 50% standard of deviation). The sampling technique used in the study was cluster convenience sampling. The researchers divided the population into clusters (subdivisions and villages within Mojon – Felicissima, San Felipe, Maunlad, Menzyland, San Jose, Golden Grain).The questionnaires prepared were given to respondents who were available at the time the researchers are conducting the data gathering in Mojon. Research Instrument The questionnaire used in this study was divided into three sections: the socioeconomic status, perception of the respondents and their preference on the choice of medicine. The socio-economic status section consisted of the respondents’ age, gender, monthly family income, and occupation. The middle section, composed of questions that measure the respondents’ perception, was adapted from an existing questionnaire of a recent study conducted by Ahire et al (2013). The existing questionnaire was designed to check the awareness, and knowledge of the respondents’ regarding generic and branded medicines. Considering the similarity on the objectives, the researchers decided to adapt the questionnaire and modifications were made to answer the research questions and objectives of the study. The last section contains a dichotomous close-ended question that determines what type of medicine – branded or generic, they prefer. The first and last sections of the questionnaire were improvised by the researchers. After designing the questionnaire, the validity and reliability were established. Validity of a questionnaire assures that the content accurately measures the study’s GENERIC VS. BRANDED MEDICINES objectives, and what needs to be measured. Reliability, on the other hand, refers to the ability of the questionnaire to reproduce results (Pineda, 2017). In pursuance of achieving validity and reliability, the research instrument was assessed by professionals – professors and doctors from the faculty of the Senior High School Department of Holy Spirit Academy of Malolos based on construct and face validity. The suggestions and feedback of the validators were all taken into consideration while reconstructing the final research instrument. After the improvement of the questionnaire in terms of validity, it was then subjected to a pilot test to establish reliability. Printed questionnaires were distributed to 30 random Grade 12 students of HSAM and their responses were tabulated and recorded using Microsoft Excel. Cronbach’s Alpha was not used in the pilot testing procedure, since there were no Likert-scale questions in the research instrument. After all, a questionnaire can be reliable but invalid, but a valid questionnaire is always reliable (Pineda, 2017). Data Gathering Procedure Printed questionnaires in form of pen and paper were handed out to residents of Barangay Mojon, Malolos, Bulacan. The contents of the questionnaires were explained to each respondent in detail before and during the answering process, then the questionnaires were collected after the respondents have completed answering all questions. Deviation from the original random cluster sampling was necessary since the data gathering was done during weekdays that limited the presence of available respondents in every household leading the researchers to use convenience sampling with approximately 63 respondents spread evenly through all six subdivisions of Barangay GENERIC VS. BRANDED MEDICINES Mojon. The data gathering proper was conducted during the weeks of October 29 to November 4 and November 19 to 25, 2017. Data Analysis Procedure The responses of the respondents were tabulated and summarized in Microsoft Excel, which served as the basis for the development of the study’s charts, graphs and tables. Charts and graphs are classified under descriptive statistics –the statistics concerned with describing the population under study (Surbhi, 2016). For the purpose of describing properties, descriptive statistics uses the measures of central tendency (mean, median, and mode), and measures of dispersion (range, standard deviation, and variance) wherein in this study, only the variable age has numerical attributes that allowed the calculation of the measures of central tendency and dispersion. To further represent the data in a visually meaningful way, charts and graphs were used. Majority of the questions were dichotomous close-ended questions, which allowed the utilization of pie charts to represent the data. Bar graphs were also present in representing data that do not sum up to a meaningful whole (100%). Along with these graphs are the percentages that represent all tabulated and counted responses. Charts and graphs were applied to all questions in the research instrument, to organize and represent the dataset. Inferential statistics was also used in the study. Taylor (2016) stated that inferential statistics is used to determine the probability of properties of the sample. The chi-square test of independence was used as the statistical model of the study which determines if there is a significant relationship between two nominal variables (Fisher et. al, 2015). The Chi-square test always tests the null hypothesis, which states that there is no significant difference between the expected and observed result (Fisher et al, 2015). GENERIC VS. BRANDED MEDICINES The software Statistical Package for the Social Science (SPSS) was used to compute for the Chi-square statistical test. An association between two variables is statistically significant if the asymptotic significance (2-sided) is equal or less than the designated alpha value, which in this study’s case is 0.05. Phi and Cramer’s V are both tests of the strength of the association. Phi is used to measure the strength of the association between two variables, each of which has only two categories. Cramer’s V is used to measure the strength of the association between one nominal variable with another nominal or ordinal variable (Lab Manual, n.d.) The table below shows the value of the level of association Level of Association Verbal Description 0.00 No Relationship .00 to .15 Very Weak .15 to .20 Weak .20 to .25 Moderate .25 to .30 Moderately Strong .30 to .35 Strong .35 to .40 Very Strong .40 to .50 Worrisomely Strong .50 to .99 Redundant 1.00 Perfect Relationship GENERIC VS. BRANDED MEDICINES