Generic medicines have been available for many years and are routinely used to treat a wide range of acute and chronic illnesses. In order to be approved for use, a generic medicine must be bioequivalent to the originator product, and must be the same in terms of strength, safety and quality. For this reason, generic drugs have been increasingly popular as a method to reduce pressure on drug budgets, and they now make up an increasing percentage of dispensed drugs.
This study aimed to assess the patients' perception about the efficacy and similarity of generic and branded medicines by exploring the views of consumers' perception and how such beliefs can influence what kind of medication they would purchase.
A research instrument used to assess patients' perception on the efficacy and similarity of generic and branded medicine was conducted. A quantitative study design was adopted to conduct this study. The respondents of the study were randomly selected among walk-in consumers who were purchasing medicines in Evangelista Medical Specialty Hospital Pharmacy, a primary level hospital located in San Pedro, Laguna. The hospital has 50 bed capacities. The respondents' age ranges from 25 years old up to 62 years old, majority of which are female. The number of consumers who participated on the research resulted to a total of 42 respondents. The PRE-test questionnaires were distributed to consumers during their waiting time to get the medications in outpatient pharmacy department. After answering the given PRE-test questionnaire, a short compiled documentation about generic and brand medicines was given including published articles, facts about medications and excerpts from hand-outs FDA websites was shown to the consumer. After giving ample time to read, understand and be aware about the differences and similarities of generic and branded medicines, a POST-test questionnaire was finally conducted.
Medication expenses were rising throughout the years. An increase in the population, high prevalence of diseases, and major utilization of healthcare service were the main factors contributing for rising healthcare cost. Similarly, medicines expenses are one of the fast growing reasons of healthcare consumptions which is steadily increasing.
Generic medicines have been recently available for years and now becoming popularly used to treat a wide range of acute and chronic diseases. Generic drugs are identical to brand name drugs in dosage, safety, strength, method of administration, quality, performance, and intended use. Brand name drugs typically come to market after a substantial investment—including research, development, marketing, and promotion—that is protected by patents that give the developer the sole right to sell the drug.
Generic formulations provide the same therapeutic effect as branded medicines at a much economical price. For this reason, generic drugs have been increasingly popular as a method to reduce pressure on drug budgets, and they now make up an increasing percentage of dispensed drugs.
Amidst them all, the acceptance of generic medicines by patients is a fundamental element given that the patients are the end users of these medicines. Adequate knowledge and positive perceptions are essential to acceptance and use of generic medicines by patients because inadequate information and lack of understanding of generic medicines is one of the main barriers to the wide use of these medications.
The objective is to provide a high level of description of what generic medicines are and how they differ from branded medicines. In addition to the similarities, as well as the difference between generics and branded medicines, equivalents including the reasons for the cost difference seen between generic and branded medicines will be discussed.
The researcher used the theoretical framework as a guide to address the questions posed in this study.
The Theory of Buyer Behavior was developed further in 1969 by John A. Howard and Jagdish N. Sheth. It provides a sophisticated integration of the various social, psychological and marketing influences on consumer choice into a coherent sequence of information processing. Social stimuli include the influence of family and other peer and reference groups. The influence of such stimuli is internalized by the consumer before they affect the decision process.
Figure 1 Component of Theory of Buyer Behavior
The researcher used the conceptual framework as a foundation and basic structure outlining how the proposed answer to the problem will proceed.
This study was anchored on Generic Medicine Scale (GMS). The aims of this study is to assess patients' perception about generic medicines, and to investigate whether these perception differ according to demographic factors. GMS was developed by figueiras et al. (2009) to assess medicine consumers/patients beliefs about generic medicines. The Generic Medicine consists of two subscales: the efficacy and similarity of generic medicine to original brand medicine.
At both stages, the participants completed Pre-test and Post-test questionnaire measuring their perception about generic and branded medicines using Likert scale. The opportunity to assess perception about generic medicines may have implications for adherence, for the implementation of health policies and for decision making about medicines.
The operational framework of the study denotes the effectiveness on conducting assessment on patients' perception on the efficacy and similarity of generic and branded medicines. Same set of questionnaires were provided for Pre-test and Post-test respectively.
A research instrument used to assess patients' perception on the efficacy and similarity of generic and branded medicine was conducted.
The PRE-test questionnaires were distributed to consumers during their waiting time to get the medications in outpatient pharmacy department. After answering the given PRE-test questionnaire, a short compiled documentation including published articles, facts about medications and excerpts from hand-outs FDA websites was shown to the consumer. After giving ample time to read, understand and be aware about the differences and similarities of generic and branded medicines, a POST-test questionnaire was finally conducted.
Statement of the Problem
This study aimed to assess the patients' perception on generic and branded medicine by exploring the views of consumers' beliefs and how such beliefs can influence what kind of medication they would purchase.
Specifically, the research will attempt to answer the following questions;
1.) What is the efficacy of generic and branded medicines as perceived by walk-in consumers of EMSH Pharmacy before and after listening to information campaign?
2.) What is the similarity of generic and branded medicines as perceived by walk-in consumers of EMSH Pharmacy before and after listening to information campaign?
3.) Is there a significant difference in the efficacy of generic and branded medicines as perceived by walk-in consumers of EMSH Pharmacy before and after listening to information campaign?
4.) Is there a significant difference in the similarity of generic and branded medicines as perceived by walk-in consumers of EMSH Pharmacy before and after listening to information campaign?
5.) What information campaign maybe developed for the efficacy of generic medicines?
Statement of Hypotheses
This study revolved around the following assumptions which were given to the problem;
1. Patients' knowledge regarding the differences of generic medicine and branded medicine is insufficient and lack of understanding.
2. Generic medicines is not being supported and represented well by majority of medical health allied.
Scope and Delimitation
Patients/Consumers. This would provide enough knowledge to determine the right definition of branded and generic medication. Also, helps in guiding them to choosing the kind of medicine to purchase.
Healthcare Institution. They would have competent and reliable professional that could deliver accurate information regarding medicines and can bring satisfaction to their clients.
Other Researchers. This pilot study of “The efficacy and similarity of generic and branded medicines as perceived by walk-in consumers of Evangelista Medical Specialty Hospital Pharmacy” may be used as future reference of other researchers, or could also be used and improved for further studies.
Definition of Terms
For the purpose of this study, the following terms were defined operationally;
Generic Medicine Scale (GMS) – was developed by Figueiras et al (2009) to assess medicine consumers/ patients' beliefs about generic medicines. The GMS consists
of two subscales: efficacy and similarity of generic and original brand medicines.
Theory of Buyer Behavior – was developed further in 1969 by John A. Howard and Jagdish N. Sheth. It provides a sophisticated integration of the various social, psychological and marketing influences on consumer choice into a coherent sequence of information processing.
Branded medicine – a drug that has a trade name and is protected by a patent (can be produced and sold only by the company holding the patent). Prescription drugs marketed with a specific brand name by the company that manufactures it, usually the company which develops and patents it. When patents run out, generic version of many popular drugs are marketed at lower cost by other companies.
Generic medicine – is bioequivalent to the branded product, meaning there is either no significant difference between the two drugs in terms of the rate and extent of absorption or if there is a difference, it is either intended or not medically significant.
Efficacy – the ability of a drug to produce the desired therapeutic effect. In the context of evidence-based medicine, the capacity of a drug or therapy to positively influence the course or duration of a disease at the dose tested in the patient population for which it is designed and has been tested.
Similarity – the state of being similar, likeness or resemblance. In medicine, chemical similarity refers to the similarity of chemical elements, or its chemical compound with respect to either structural qualities or functional qualities.
Patients' Perception – as calls are made for a more patient- centered healthcare system, it is critically based on reports directly from patients on how they define quantity; provide an overview of how health plans, hospital physicians and health care in general are currently viewed by patients, assess whether and how patients health status and demographic characteristics relate to perception of health care quality.
Walk-in consumer – the person or patients who randomly purchased any medication bringing a valid prescription or simply purchases over-the-counter medication at no specific time or any day.
Generic Drugs: An Overview
Brand name pills are sold by pharmaceutical makers under a trademark-protected name. These medicines must be delivered and sold only by the creator that holds the patent for the medication. Interestingly, generic medicines are not protected and can be created and sold by any maker that has acquired U.S. Food and Drug Administration (FDA) approval.
Generic medicines are identical to brand name medicines in quality, safety, strength, dosage, method of administration, performance, and intentional use. Branded medicines normally come to market after a substantial deal—including research, development, promotion and marketing —that is protected by patents that grant the developer the sole right to sell the medicines. While the product is under patent protection, maker can set prices without facing competition, even though some branded products do facade competition among alike products. As these patents close to expiration, other drug makers can apply to the FDA to sell generic versions. Because generic drug makers generally do not spend the same development costs, their products are usually sold at significant discounts.
6 months after the first generic for a brand name medicine is affirmed, other generic manufacturers can be approved by the FDA to sell their products, additionally lowering the generic (and brand name) drug's market price through competition. Until about quarter of a century ago, the access of generic drugs was slow in the United States. About 150 off-patent branded drugs had no generic equivalents on the market when Congress enacted the Drug Price Competition and Patent Term Restoration Act in 1984. This legislation, also known as the Hatch-Waxman Act, formed a shorter and less costly approval method for generic drugs and they quickly gained popularity among generic makers and doctors. Before Hatch-Waxman Act, only 35 percent of branded drugs had generic competition after their patents ended. At present, almost all branded drugs face such competition. Generic prescribed drugs now account for two-thirds of the prescribed medicines dispensed in the United States.
At the moment, the highest percentage of prescriptions that can be filled using a generic drug is 80 percent. The left behind 20 percent of prescriptions represents branded drugs that do not have a generic counterpart. The level of generic drug utilization in the United States, now at 67 percent, is elevated than other countries of the world. Case in point, the generic supply rate is 48 percent in Canada, and approximately 30 percent in Australia. Other countries have even lesser levels of generic utilization. In Japan, only 17 percent of prescriptions are for generic drugs and some European countries have generic sale shares of less than 10 percent. This occurrence is due to a number of factors, including difference in pricing and refund approval that inhibit competition and payment systems that provide a financial disincentive to dispense generic drugs.
On the other hand, researchers have found that patients who initiate therapy with lower-cost generic medications have higher rates of observance, making them appealing to prescribers who want to ensure treatment compliance and avoid uncalled for spending. Another factor driving generic utilization is an unprecedented and prolonged wave of patent expirations. These patent expirations can be expected to have an pressing impact, as branded drugs lean to quickly lose market share once generic versions are available on the market. But, it should be well-known that generic entry can be delayed for months or even years by legal action and administrative issues such as citizen petitions. Thus far, there has not been any scientific proof that the increase in generic drug consumption in the United States has resulted in adverse patient outcomes.
State of the Art
The US Food and Drug Administration (FDA), which regulates the pharmaceutical market in the United States defines generic medicines as:
- A drug product that is comparable to brand/ reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.
- Copies of branded drugs are the same as those brand name drugs in dosage form, safety, and strength, route of administration, quality, performance distinctiveness and intended use.
The 1984 Drug Price Competition and Patent Term Restoration Act (more commonly known as the Hatch Waxman Act) in the US allowed for an reduced system for approval of generic copies of all drugs approved after 1962, meaning that pre-clinical and clinical testing did not have to be repeated for generics. The anticipated result of this legislation was to ensure that generic medicines would be less pricey than the originator of the medicine because it was not obligatory for generic medicine manufacturers to repeat discovery, pre-clinical and clinical studies.
To gain FDA approval, a generic medicine must:
- have the same active ingredient as the originator drugs
- Be matching in strength, dosage form, and route of administration
- Have the similar use indications
- Be bioequivalent
- Meet the same batch requirements from identity, quality, purity, and, strength
- Be manufactured under the same firm standards of FDA's good manufacturing practice regulations required for originator products.
Bioequivalence is demonstrated when the rate and range of absorption do not show a significant difference from the originator drug, or where the amount of absorption does not show a major difference and any difference in rate is calculated or not medically noteworthy. The FDA's formal meaning of bioequivalence is: the absence of a significant dissimilarity in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes accessible at the site of drug action when administered at the same molar dose under similar conditions in an aptly designed study.
See Figure 1: Originator (New Drug Application - NDA) versus Generic (Abbreviated New Drug Application - ANDA) Review Process Requirements  for a comparison of the originator versus generic medicine review process.
For that reason, bioequivalent drugs are pharmaceutical equivalents whose speed and extent of adsorption are not statistically different when administered to patients or subjects as the same molar dose under similar experimental conditions.
The bioequivalence limits may suggest that a difference of 25% between an originator brand and a generic product is possible. Nevertheless, this may not actually be the case. A study was performed which investigated 12 years of bioequivalence data submitted to the FDA, comparing the generic and patented drug trial from 2070 single-dose clinical bioequivalence studies of orally administered generic medicine products approved by the Food and Drug Administration (FDA) from 1996 to 2007.
This research showed that the average distinction in absorption into the body between the generic and the patented drug was 3.5% and is comparable to differences between two different batches of a patented drug. However, it should be noted that variations with in batches of patented drugs may themselves threaten patient safety. In 2012, Patel et al. reported that (in 2010) patients given Lamotrigrine (LTG, an anti-epileptic medication) experienced unexplained toxicity. When investigated, the maker (GlaxoSmithKline) accepted responsibility for an altered formulation due to changes made to the manufacturing procedure.
The latest incarnation of off-patent medicines are “biosimilar” medicines, also known as “follow-on biologics”. Biosimilar medicines have been an actuality in the European Union for several years and the necessary legal framework was adopted in the EU on 31 March 2004 with the first biosimilar medicines accepted by the European Commission in April 2006.
A biological medicine is a drug whose active substance is made by or derived from a living organism. For example, insulin can be produced by a living organism (such as a bacterium or yeast) which has been genetically manipulated to generate insulin. A “biosimilar” medicine is one that is alike to a medicine of biological origin that has already been approved (known as the biological reference medicine). Biological products are primarily different from standard chemical products in terms of their complexity, and it is not likely that the biosimilar product will have an equal structure to that of the reference product, by this means requiring evidence of safety and efficacy before approval. In this regard, biosimilars are dissimilar to the (to date) more familiar generic products.
As with other generic medicines, a biosimilar medicine undergoes testing to make sure that it is as safe and effective as the reference product. But, due to the complex method of production, the active substance may be different slightly between the two drugs and so, additional safety and efficacy studies may be mandatory on a case-by-case basis.
Naming of New Drugs
During the R&D process, a new pharmaceutical substance is given an International Non-proprietary Name [INN] or generic name, in addition to the name that may in time become its proprietary, or brand, name. Each INN is unique, globally recognized and is public property.
Non-proprietary names are planned for use in pharmacopoeias, labeling, product information, advertising and other promotional material, drug guideline and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by countrywide or, as in the case of the EU, by international legislation. As a result of ongoing collaboration, national names such as Dénominations Communes Françaises (DCF), British Approved Names (BAN), Japanese Adopted Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INN. Names which are given the status of an INN are selected by the World Health Organization on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. An imperative feature of the INN naming system is the use of a common “stem” which indicates the action of the substance and the pharmacological group to which it belongs. The stem is generally placed at the end of the name, but in some cases it may be placed at the beginning or in the middle of the name. For example:–mab indicates a monoclonal antibody (e.g. infliximab); -substances having –adol/-adol- as the stem indicate an analgesic (e.g. tramadol); -azepam indicates a diazepam derivative (e.g. temazepam) and –vir indicates antiviral agents (e.g. acyclovir). All of the stems recommended by the WHO are contained in the “stem book” alongside with guidance for their use. The INN, containing the common stem, provides a solitary, unique name which enables healthcare professionals to distinguish the substance and the family of similar pharmacological substances to which it belongs. The INN is generally the name under which the generic form of a drug is marketed.
The earliest stage of development of a new medicine begins with the synthesis and purification of the new chemical moiety, or the selection of existing compounds for potential use as drugs. The aim of pre-clinical study is to determine whether the drug is rationally safe for potential use in humans, and sufficiently effective against a disease target in chemical tests or animal models. During pre-clinical studies, the pharmacology of the new drug in addition to its pharmacokinetics: metabolism, absorption, distribution, pharmacodynamics and excretion & half-life; mechanism of action and estimates of therapeutic effects, are assessed. Initial studies relating to toxicology including carcinogenicity, mutagenicity, and teratogenicity are also carried out, as are efficacy studies on animals.
Once authorization has been received from the appropriate regulator to administer a new drug to humans, clinical studies may begin.
Clinical studies required to bring a new drug to market generally take place over three phases as follows:
• · Phase 1: Safety studies on healthy volunteers. Typically involve 20–80 healthy volunteers (women of childbearing potential are not included). The highlight is on drug safety and on the building of a safety profile for the drug in humans.
• · Phase 2: Clinical studies on a scale limited to determine efficacy of the drug. Typically involve 100–300 voluteers who have the target illness. Patients receiving the drug are compared to similar patients getting a placebo or another drug, and safety evaluations continue.
• · Phase 3: Comparative studies on a big number of patients. Usually involve 1000–3000 patients. The emphasis is on safety and effectiveness and studies investigate diverse populations and different dosages as well as evaluating the new drug in mixture with other drugs. Data gathered in a phase 3 trial are used to verify the risk versus benefit profile of the drug.
Following successful completion of clinical trials, the sum of the information about the drug is compiled into an application and submitted to the pertinent competent authority. The competent authority reviews this application, and additional information may be wanted from, or discussions held with, the applicant before the regulator makes its assessment. The regulator will, after assessing the scientific data pertaining to the new drug, either allow it to be marketed, or reject approval to the applicant.
In Spain, a potential randomized multicentre studies was carried out over a 12-month period in which patients taking drug treatments for continual problems obtained an educational intervention on generic drugs at the time they attended exceptional preferred practices inside the metropolis of Barcelona where the implementation of drug patent regulation turned into late 1997 and generic drug shared 0.15% of the Spanish drug marketplace, Valles et al. assessed patients' recognition of the substitution of branded medicines for generic medicines for chronic situations in fitness care practices. 27 public primary care centres had been randomized to the intervention institution (8 centres) or the manipulate group (19 centres). Of 4620 patients inside the intervention institution who received verbal facts and handout substances on the benefits and downsides of generic equivalents and brand medicines, 98.9% agreed to acquire a generic formula. The primary care centre and the class of drug had been associated with statistically sizable differences in the share reputation of generic drugs. In the typical population, widespread prescribing within the intervention practices increased to 5.9% compared with 2.8% in controls. Personal academic intervention in patients with repeat prescribing led to a high charge of time-honored acceptability.
In a learning performed within Brazil, A consultant household pattern was selected, constructing an ultimate sample of 3182 individuals. Data have been accrued the use of an organized interview. The authors projected the percentage regarding generic medicine uses beside the aggregation of drugs used, assessed the population\'s attention of frequent cure characteristics and studied the nearly recognized standards aged with the aid of consumers for buying medicines. Interviewees have been requested in regard to the utilization concerning medication among the preceding 15 days and requested to demonstrate the packaging and prescription, or in accordance in conformity with it applications drugs which can be categorized as branded and generic. Population dissemination about widely used cure traits have been assessed by means of asking the following questions: (a) Does the generic drug cost more, the identical yet much less than the branded drug? (b) Is the quality about generic medicines better, the identical and worse than so much concerning branded drugs? (c) What does the generic medicine incorporate so much differentiates from brand drugs? Strategies in selecting preparations when buying a prescription have been investigated for the duration of 15 days, and the recurring method because interviewees whosoever had not bought medicines for the duration of up to expectation period. Interviewees have been requested whether he (a) buy (or always buy) precisely the prescribed drug, (b) exchange (or normally replace) the true medicine with the corresponding well-known one, (c) substitute (or typically replace) the true remedy along a formulated production then (d) exchange (or generally replace) the prescribed medicine with a lower-priced alternative, regardless regarding whether or not it was once a generic, formulated then similar medicine. Results showed so much the percentage on generics within quantity capsules was once 3.9%. While 86% knew up to expectation prevalent medicinal drug virtue less yet 70% knew that the virtue is comparable in conformity with branded medicines, solely 57% knew anybody packaging characteristics so much differentiate everyday medicines beside ignoble ones. The authors concluded so the near large determinants into selecting medicines are price and the medical prescription, as majority concerning individuals were buying exactly what used to be prescribed.
In a contemporary Australian study, the researchers interviewed 16 consumers aged 22–80 years, residing into the metropolitan area in Melbourne, Australia. The use of thematic investigated has recognized four subject matters associated in imitation of wide-spread cure utilization. The researchers back a qualitative strategy in conformity with explore consumers' perceptions or opinions concerning generic medicine and identifying its barrier after their use of generic drugs. These were: Information about generics, acceptance about generic medicines, non-acceptance over generic medicine and enhancing knowledge pertaining to the use of generics medicine. In that study, it determine that most patients had been not acquainted together with the term widespread medication however it was extra acquainted with the time period cheaper brand regarding medicine. The foremost reason for acceptance was cost, and main barriers according to acceptance are from prescribing medical practitioners, To finish, the authors justified that customers normally had tremendous attitude towards the use on medicines for some treatments and recommended to advocate more regarding generic medicines for the public to be familiar.
Pharmacists among Norway are obliged in conformity to notify the patient in regarding the availability of the cheapest accessible generic medicine in accordance to a listing produced by Norwegian Medicines Agency. In Norway, current pharmacy law applied into March 2001 gave Norwegian pharmacies the right to switch medication into generic medicine at the start of prescription. The patient and/or the physician may decline generic substitution; however the patient needs also to understand the use of affordable medication.
A recent learning among Malaysia explored client perceptions and understanding regarding the use of generic medicines. This survey confirmed a gap in client understanding and perception about generic medicines. Academic propagation by health care providers can result to a solution in rising generic uptake. Survey forms were provided to 400 respondents on a university which lasted for 5 sequent days. Analysis about the 396 usable varieties revealed as solely 28.3% respondents have been conscious over the term generic medicine. 70% concerning respondents have been strange on the advertising of wide-spread generic medicines, yet 34% concerning respondents pointed out that information regarding generic medicines was provided by the community pharmacist. Most of the buyers 64% showed their interest regarding the use of generic medicines which are high-priced than their branded counterparts yet 32% perceived generics to cause more bad side effects.
Heikkila et al. carried out a descriptive research to discover the reviews, attitudes and experiences that physicians and customers had of this legislative reform. Customers' perspectives had explored the use of questionnaires: the first questionnaires have been handed out in 15 pharmacies in 5 geographical areas of Finland to clients (n = 544) who had refused generic substitution and the second in 18 pharmacies in six geographical areas to customers (n = 214) who had accepted substituted drug treatments. They discovered that most customers thought customary substitution was a good reform measure, and the physicians embraced the idea. Generic substitution became notion to be a great reform measures in particular among customers who had experience it. Clients who had refused substitution would possibly have a bad prejudice or they had been careful with this reform. The financial savings in scientific prices and the recommendation given via the pharmacists have been the principle reasons for accepting substitutes. The maximum important purpose for refusing substitution was delight with drug treatments used formerly. Most of them thought inexpensive drugs have been as powerful and safe as extra high priced ones. The authors concluded that standard substitution had been a hit reform degree, but that a few customers had been stressed and careful, at least within the early stage, because the scenario become new to them.
Kjoenniksen et al. conducted a research in 2006 to assess patients' attitudes and reviews generic substitution for 3 years after frequent substitution of prescription medicines was authorized. A mailed questionnaire was provided to 404 patients receiving eight or extra distinctive drugs on the fifth level inside the Anatomical healing Chemical (ATC) system, which yielded 386 usable responses. The research showed that a high percent of patients (41%) did now not allow their drugs to be substituted, two-thirds of the patients who had used prevalent drug treatments were glad, and approximately one-third of patients who switched had negative experiences. This confirms that generic drug substitution for a number of patients is not perceived as an equal opportunity to branded drugs and those patients may also need additional facts and support. Records approximately generic substitution strongly affected whether or not patients had switched or not, in which a blended effort from docs and pharmacy staff regarded to be the only, and this confirms that efforts to increase generic substitutions need to be targeted first and most important at health care practitioners.
In 2007, Figueiras et al. conducted a cross-sectional metering within Portugal according to study, they have an effect on some common illnesses like influenza, bronchial asthma and angina pectoris over the stage concerning agreement with the instruction on generic medicines as like properly imitation of look at the union of socio-demographic factors concerning burden beliefs about generic medicines. The opportunistic pattern (n = 1278) was recruited out of the overall populace over Portugal on a 4-week period. A total over a hundred and one questionnaires had been partial or 52 people declined in conformity with participate, hence the remaining pattern used to be 1125 Portuguese (61% females; mean age 33 years), giving a report quantity of 88%. Participants seemed in conformity with have had well-defined beliefs in relation to time-honored pills regarding theirs efficacy yet symphony together with manufacturer medicines. Beliefs as regards the ability on customary drug treatments differed notably in accordance after youth group or level about education. Although contributors exhibited a moderate level on settlement with the instruction about generic drugs for influenza, bronchial asthma and angina pectoris, their settlement decreased significantly so the illness was once perceived extra serious. The universal effects indicated participants normally believed on generic drug treatments that had been advantageous and comparable to theirs manufacturer equivalents. The strongest beliefs within the faculty on everyday drugs were last by the greater skilled yet youthful participants, as the strongest beliefs within the similarity concerning generics after theirs branded equivalents were held with the aid of older participants.
Iosifescu et al. published a research in 2008 approximately the ideas of older adults regarding generic drugs and assessed potential correlations to those ideas, which includes socioeconomic and fitness variables, fitness literacy and doctor verbal exchange skills. Adults with higher than sixty five years of age (n = 311) had been interviewed in number one care practices of a tertiary care sanatorium. Ideas regarding generic drugs have been measured using a scale that as compared generic and brand tablets throughout 4 domain names. Bad feedbacks about generics had been generated on non-white race and lower educational attainment respondents. Individuals with low health literacy and who reported that their physicians had terrible conversation capabilities have been more likely to keep terrible views.
Synthesis of the State of the Art
It has been clearly shown that, at least at a physiological level, generic medicines behave very similarly to their originator counterparts. As described earlier, an assessment of 12 years of bioequivalence data submitted to the FDA, comparing 2070 single-dose clinical bioequivalence studies of orally administered generic medicine products approved by the Food and Drug Administration (FDA) from 1996 to 2007, demonstrated that the products did not differ significantly. Similarly, referring to clinical efficacy, Kesselheim et al. (2008) published an extensive systematic review and meta-analysis that were favorable towards use of generic drugs in treating cardiovascular disease.
Researchers have, however, also reported patient concerns related to generic medicines. These studies range from qualitative assessment of perceptions in specific patient cohorts to general lay/consumer knowledge versus knowledge of professionals. Many of these studies focus on the influence of relative cheapness on perceptions and use of generic medicines. Some publications have shown that consumers felt that a generic medicine did not work either as effectively, or at all, in comparison to when they were taking the originator medicine.
Bridging the Gap on the Present Study
The assumption that branded drugs are superior when compared to generic medicines has been the subject of debate since the early 1990's. Understanding the differences with supported studies and testimonials can literary uplift the generic uptake and can suppress the stigma incorporated in the use of generic which was less efficacious to the knowledge of majority of consumers that leads in a stale growth of sales and reputation.
Therefore, bioequivalence between an originator medicine and a generic equivalent have already been proven, as required by the current regulatory guidelines, given the differences in other ingredients it is incumbent on prescribing physicians to remain vigilant to the potential risks, and exercise caution in the substitution of a medication with an equivalent. This is applicable to both substitution of a branded medication with a generic equivalent and to switching between different, equivalent, preparations of generic medications.
A quantitative study design was adopted to conduct this study. The study was conducted in Evangelista Medical Specialty Hospital Pharmacy, a primary level hospital located in San Pedro, Laguna. The hospital has 50 bed capacities.
The PRE-test questionnaires were distributed to consumers during their waiting time to get the medications in outpatient pharmacy department. After answering the given PRE-test questionnaire, a short compiled documentation about generic and brand medicines was given including published articles, facts about medications and excerpts from hand-outs FDA websites was shown to the consumer. After giving ample time to read, understand and be aware about the differences and similarities of generic and branded medicines, a POST-test questionnaire was finally conducted.
This finding correlates the study conducted in Malaysia by Al-Gedadi NA et al (2008) which explored consumer perception and knowledge about the issues of generic medicines. The survey showed a gap in consumers' knowledge and understanding about generic medicines, thus educational outreach by healthcare providers can be a key to increase generic uptake.
This finding corresponds to the study conducted in Finland by Heikkila et al (2007). The researcher conducted a descriptive study to explore the opinions, attitudes and experiences that physicians and customers regarding generic substitution. They found that the majority of customers thought generic substitution was a good reform measure, and the physicians had accepted it. Generic substitution was thought to be a good reform measure especially among customers who had accepted it and had experience with it. Customers who had refused substitution might have a negative prejudice or they were careful with this reform. The savings in medical expenses and the advice given by the pharmacists were the main reasons for accepting substitutes.
This finding affirms the study conducted by kjoenniksen et al (2006). The study showed that almost half of the patients did not allow generic medicines to be substituted. This confirms that generic drug substitution for a number of patients is not perceived as an equal alternative to branded medicines, and these patients may need additional information and support. A combined effort from the doctor and pharmacist seemed to be most effective way for giving information about generic medicines which strongly affects patients' decision.
This study confirms the reseach conducted in Brazil. The researcher, Bertoldi AD et al (2005) estimated the proportion of generic drug use from the total of medicines used, assessed the population\'s knowledge of generic drug characteristics and studied the most common criteria used by consumers for purchasing medicines. Data were collected using a structured interview. Interviewees were asked about the utilization of any medicine in the previous 15 days and requested to show the packaging and prescription, and according to these packages drugs were classified as branded or generic. The authors concluded that the most important determinants in choosing medicines are price and the medical prescription, as the majority of individuals reported buying exactly what was prescribed.
This finding confirms the study in Australia by Hassali MA et al (2005). The researchers used a qualitative approach to explore consumers' perceptions and opinions of generic medicines and to identify barriers to their use of generic medicines. In this study, it was found that most patients were not familiar with the term generic medicine but they were more familiar with the term cheaper brand of medicine. Finally, the authors concluded that consumers generally had positive attitudes towards the use of generic medicines and suggested that direct patient education by the health care providers on issues relating to safety and efficacy of generic medicines could further enhance their uptake.
This study correlate with the study conducted in Spain by Valles et al (2003). The study assessed patients' acceptance of the substitution of brand-name drugs for generic drugs for chronic conditions in primary health care practices. A prospective randomized multicentre study was conducted over a 12-month period in which patients taking medications for chronic disorders received an educational intervention on generic drugs at the time they attended different general practices in the city of Barcelona for repeat prescribing. The primary care centre and the class of drug were associated with statistically significant differences in the percentage acceptance of generic drugs. Individual educational intervention in patients with repeat prescribing resulted in a high rate of generic acceptability.
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