Introduction
The healthcare industry is continually engaged in the debate over generic and branded drugs, their use and effectiveness. Many nations across the world provide room for the use of generic medications over their branded counterparts, which mean that both types of drugs are just as effective (Das et al., 2017). These drugs have menial differences which are that the generic version is often twenty to ninety percent cheaper that the original and is often not manufactured by its inventor (Das et al., 2017). However, the important characteristics of these medications including their active ingredient, the quality, performance, strength, dosage and safety are similar. It is an indication that generic medicines fulfill all the important healthcare aspect of branded drugs and are cheaper.
Many countries have adopted the use of generic medication due to economic reasons. With the widespread use of these drug it would be safe for any healthcare practitioner to recommend their use to the patient he or she interacts with because the patients would get to spend less on medication and achieve the same level of well-being as they would when using branded drugs. It is necessary to study the effectiveness of generic medication and if they maintain a similar safety, quality and strength level as brand drugs. The current research aims to identify if generic medicines remain as effective on patients after they switch from branded medication.
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Literature Review
Harris (2013) points that people often believe that generic drugs are similar to and as effective as branded drugs. According to the Harris (2013), these people are right because theoretically or ideally, a generic medication should be the same and as good as branded drugs. However, the evidence available (Harris, 2013) shows that many patients who have used switched to generic medications report varied outcomes. Also, pharmacists have shown that switching to generic medications results into varied outcomes. Essentially constituents of a “Drug” can be divided into the active pharmacological ingredient and the non-active ingredients. According to Freeman & Hill (2016), a drug is initially developed by a Pharmacological Agency with a code name and such developer may create different versions of the molecule, or different isomers of the molecules that are tested (Freeman & Hill, 2016). Depending on the effects, adverse drug reaction and efficacy, a molecule is chosen. The choice depends on the best of combinations. An isomer which is a highly efficacious at killing the infection, but at the same time kills the host may not be suitable compared to a lesser efficacious one with minimal adverse reactions ( Blier, 2003) . Though tests the best attempt is made to balance them, it may not be achieved all at once.
The Impact on health outcomes and Health Utilization of switching to generic medicine
Lewek and Kardas (2014) present evidence that switching to generic medicines would result in a negative treatment outcome because of some drugs, since the body is incredibly sensitive to subtle changes. Sensitivity to Lithium is a key example. According to the Lewek and Kardas (2014), one prescribes by the brand as a change in brand could cause a massive shift in blood lithium levels; likely down to the excipients in the capsule. Glerum et al. (2018) on the other hand state that some people with certain allergies to additives may need to have branded preparations which do not have these additives. Nevertheless, Blier (2003) dismissed generic medicines because the manufacturing process for generic drugs may not be the same as that of the original molecule. He argued that the generic drugs are reverse engineered thus deny them 100% similarity to the original (though theoretically, they should) and one may not be able to isolate various isomers of the drug, and they might not also be 100% the similar to the patented molecule ( Blier, 2003) . Blier (2003) concludes that the dissimilarity fact makes switching to generic medicines less effective and reliable.
On the other hand, Greene (2014) argues that some companies may use better technological know-how and use processes that are standardized while producing some generic drugs and brand these products and sell them at a premium rate. Such a practice, according to the author might improve the outcome of treatment after switching to generic medicines. Moreover, some companies may merely choose to license the original research molecule that may include the transfer of technology for production, but these drugs might still maintain the originally researched molecules (Greene, 2014). Most people have the notion that these molecules or branded generic drugs perform better than the generic ones and they may be true to some extent. However, Glerum et al. (2018) believe that most of the generic drugs are manufactured in the developing nations and India is a huge exporter of generic drugs. According to Glerum et al. (2018) , these medicines may hardly improve any treatment outcome because time and again there have been many lawsuits and sanctions by the FDA against the poor quality of these generic medications.
Glerum et al. (2018) argue that in India itself, the generic medications and the branded generics have failed quality tests, thus rendering such drugs inappropriate. Also, there is also lack of independent testing authorities and Government regulations which may force the pharmaceutical companies to adhere to strict quality control. Therefore, the authors believe that poor mechanism to check these drugs due to corrupt authorities and lack of information to the public is a boon to the pharmaceutical agencies that are pushing sub-standard medicines in the market. As result Glerum et al. (2018) indicates that, the scenario can become worse due to the presence of spuriously manufactured products and sold in the market thus making switching to generic medications worse.
Zore et al. (2013) assert that there is no difference between branded and generic drugs. They argue that for the most part branded drugs and their generic counterparts are largely indistinguishable products. Zore et al. (2013) observe that the crucial, active ingredients must be the same for the generic versions of a branded drug to meet strict FDA approval for bioequivalence. However, the only difference between the brand name drug and its counterparts according to them are the chemical composition which would be the inactive ingredients, effectively the bulking agents, color, etc. ( Zore et al., 2013). There are, generally speaking, no ‘significant’ differences; however, there are some smaller noted cases worth mentioning ( Zore et al., 2013). For example, the drug Levothyroxine used in treating thyroid hormone deficiencies whose brand name is called Synthroid and which have been found to have a slight difference between manufacturer to manufacturer in the amount of the drug that is absorbed. Therefore, the authors argue that with the effective dose the patient is getting, this could vary by 10% between manufacturers, thus making the treatment outcomes similar to the generic medicines.
In the US, generics must be equivalent to the name brand drug, i.e., the drug that was originally approved for sale ( Freeman & Hill, 2016) . For systemic drugs, equivalence is defined as having the "area under the curve" which is within the range of 80 to 120 percent. The curve to which this refers is a plot of the blood concentration against time ( Freeman & Hill, 2016) . According to the authors, this is somehow fine for most drugs; however, for drugs with a narrow therapeutic window, the 50 percent difference between the lowest and highest "equivalent" agent may be large enough to cause problems if the patient changes from one to the other ( Freeman & Hill, 2016) . The authors advise patients in such cases that it is fine for them to take a generic, but it is important to make sure that they keep on taking the same generic medicines without switching. A study of the anti-cancer drug Taxotere (docetaxel) showed large variations in both content and purity ( Freeman & Hill, 2016). To compound the problem, it is next to impossible to know where the API’s in these medications come from. However, the drug makers are required to keep a paper trail of where they are sourcing their ingredients having been noted that up to a quarter of API’s from China comes from unknown sources. The US no longer manufactures antibiotics domestically, and China now produces 90% of the world’s supply.
Theoretically generic drugs are as good as branded and patented molecules, but in a practical world, there are just too many variables in the equation to conclude that they are. Apart from the differences mentioned above, the branded and the generic drugs may also differ in dosage shape, size; fill weight and dissolution rate profile, shelf life and packing. But to maintain the patient acceptability, it is generally made to match the branded drug in terms of dimensions and color and also the dissolution rate profile to match the innovator. Generic drugs contain the same active ingredient as Branded ones, but may contain same or different Inactive ingredients as branded drugs also branded drugs have spent a lot on marketing where generic drugs have not hence branded drugs are costly as compared to generic drugs; however, several researchers are currently arguing that the quality of generic drugs is questionable.
Methodology
The researcher intends to conduct a qualitative study and use structured interviews. In the study, the researcher will interview a group of 100 patients from the Mayo Clinic in the United States and had switched to generic medicines. The interviews will be issued on a face-to-face basis where the researcher will visit the hospital and have face-to-face discussions with the research respondents. Among the questions, the researcher intends to ask his respondents include which are some of the effects they experience after switching to the generic medicine and how they generally feel health-wise after switching to generic medicine. The group of patients who were admitted in Mayo Clinic will be asked if they are willing to participate in the research to seek their consent and the ones who will accept will be given the consent form to fill before they take part in the research. Creswell (2013) argues that consent in a study is very important because it helps to improve the outcome of the study. Moreover, the researcher will ensure the confidentiality of the respondents is kept and any person interviewed is kept anonymous unless they agree to be disclosed. The study respondents used will include 60 male patients and 40 female patients. The researcher will use a slightly larger size of respondents to increase to the validity and reliability of this research. High validity and reliability of a study are very important because they would improve the quality of the research outcome (Gray & Pagram, 2017).
Furthermore, the study respondents will be enrolled by the use of a general practice list, and the researcher intends to re-interview the respondents annually based on the renewed consent and Cambridge Research Ethics Committee approval. Follow-up is very important because it will help the researcher in avoiding frail informants and under-representation of a proxy who will also take part in the study (Creswell, 2013). The face-to-face interview is essential in helping the researcher to reach all the respondents either physically or through phone calls with morality as the main source of attrition. Moreover, the validity and reliability of the qualitative study will be increased by conforming to the principles of CC75C interviewer-administered structured questionnaire. It is a scenario where the researcher conducts further interviews in the form of conversation to boost the experiences of the respondents regarding issues related to generic medicines and treatment outcomes.
Rationale
The health effects associated with switching to a generic medicine and research in local perspectives would be necessary when studied because the study outcomes would add to the existing knowledge about the use of generic medicines across the world. Therefore, the main objective of conducting this study among the Mayo Clinic patients in the United States of America will be to determine the experiences of patients after switching to generic medicines. The main aim that is targeted to get accomplished after the end of this study will be to extract the specific ideas from switching to generic medicines thus adding more knowledge to the existing ones concerning the impacts on the health outcomes and the health utilization of switching to generic medicines. This research intends to solve the issues related to generic medicines with the objective of integrating the generic and brand medicines, while achieving the same quality standards (Greene, 2014). By integrating both the generic and brand name medicines to achieve similar quality standards, the patients across the world will have the opportunity to get quality healthcare services thus improving their treatment outcomes. Ideally or theoretically this integration will ensure that the generic medication can do everything that a patent licensed medication does. If there is in an acceptable range, which may not be same as the original molecule, but a generic replicated molecule falls in that range (which is no significant statistical difference) (Greene, 2014), the generic molecule will still be able to get a license for production.
The research findings will be given to the Local Medicine Manufacturers of the United States who have attempted to integrate the two medications to achieve a similar quality standard. The outcomes of the research interviews will be given to the Local Healthcare Centers to help them understand the perspectives of switching to generic medicines and how they can improve treatment outcomes of patients that switch to the use of generic medicines. Moreover, the study will seek to have an in-depth examination of issues related to the impacts on health outcomes and health utilization of switching to generic medicines and raise awareness to improve treatment using generic medications. While many studies exist, how the generic drugs are manufactured using materials and methods that are not controlled by patent or are manufactured in countries that do not enforce the applicable patents, the study will attempt to bridge the gaps that exist in the formulation that makes the patients given to vary widely. The research outcomes might encourage the manufacturers to spend less on manufacturing them, possibly by using cheaper ingredients. The impact of the change is different not only for every drug, but also for every manufacturer. In a few cases, the performance of a generic drug may be much poorer than that of the branded equivalent; however, there is no way of knowing without seeing the manufacturers’ data.
Conclusion
It is undeniable that there exists a raging debate on the effectiveness of generic medicines compared to their branded counterparts. Different regions have authorized the use of these generic versions and they seem to be working. However, there are various doubts concerning how effective these drugs and evidence towards substantiating the claim is limited thus establishing a gap. It is necessary to identify how effective generic drugs are and the current study looks to analyze their effectiveness after patients have switched from using branded drugs to the generic version. The conclusion that will be made by the study will help cement the effectiveness of generic drugs when compared to brand drugs and provide a rich source of information on generic and branded drugs.
References
Blier P. (2003). Brand versus generic medications: the money, the patient and the research. J Psychiatry Neurosci ; 28:167-168
Creswell, J. W. (2013). Research design: Qualitative, quantitative, and mixed methods approaches. Sage publications.
Das, M., Choudhury, S., Maity, S., Hazra, A., Pradhan, T., Pal, A., & Roy, R. K. (2017). Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department. Journal of natural science, biology, and medicine , 8 (1), 26.
Freeman, J. A., & Hill, A. (2016). The use of generic medications for hepatitis C. Liver International , 36 (7), 929-932.
Glerum, P. J., Yu, Y., Yamada, W. M., Neely, M. N., Maliepaard, M., Burger, D. M., & Neef, C. (2018). Interchangeability of generic drugs: a nonparametric pharmacokinetic model of gabapentin generic drugs. Clinical Pharmacology & Therapeutics , 104 (5), 966-973.
Gray, J., & Pagram, J. (2017). Research Preparation: Methods of Research. Edith Cowan University (ECU).
Greene, J. A. (2014). Generic: The unbranding of modern medicine . Baltimore: Johns Hopkins University Press.
Greene, J. A. (2014). Generic: The unbranding of modern medicine . Baltimore: Johns Hopkins University Press.
Harris, A. (2013). Generic medications in ophthalmology . Amsterdam: Kugler Publications.
Lewek P & Kardas P. (2014). Generic drugs: the benefits and risk of making the switch. J Fam Pract. 2010 (59), 634-640
Zore, M., Harris, A., Tobe, L. A., Siesky, B., Januleviciene, I., Behzadi, J., ... & Wirostko, B. (2013). Generic medications in ophthalmology. British Journal of Ophthalmology , 97 (3), 253-257.
