4. Discussion
The Polish study on patients’ opinions about generic medicines was conducted in 2011 among 500 patients [
13], and in 2013 among a population of 1000 patients [
14], while the discussed study was conducted in January 2022–June 2023, and 1220 patients took part in it.
Among the respondents in our own study, most of the respondents had already heard about generic medicines. Worse than this, it was noted in Auckland, New Zealand, that only 51% of their respondents had heard of the term “generic medicines” [
15], and in Malaysia, it was noted that 85.8% did not know the term “generic medicines” [
16]. However, this aspect was noted to be better in studies conducted in Brazil. In the study by Lira et al., almost all respondents had already heard about generic medicine [
17], and similarly in the study by da Rocha et al. [
18].
Almost half of the respondents to the current survey declared that they had some knowledge of reconstructive drugs. Findings similar to those presented in this study were described in a study conducted in Malaysia of 216 people, 32.5% of whom stated that they knew what generic drugs were [
19].
A generic drug is defined as a drug, the production of which is possible at the time of expiry of the patent protection of the original drug [
20]. In this study, only half of the respondents knew about that. More than half of the respondents said that generic medicines were comprised of the same substances as the reference medicines. Likewise, in the study by Lira et al. more than half of the respondents defined generics as medications with the same active ingredient(s) as the original medicines [
17]. A generic medicine is a product that is launched with no intellectual property or other protection after the protection expires on the originator medicine. The original and generic medicine may differ in name, manufacturer, and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount, will always be the same [
21].
Generic medicines were considered “same in quality” to brand-name products by 52.5% of the respondents. In 1994, in the study by Muirhead, generic products were considered “equal in quality” to brand-name products by 29% of consumers, and 45% indicated that the two were “about the same” [
22]. However, 14.4% of the respondents in the study by Lira et al. thought that generic drugs were inferior to the original drugs [
17]. Fortunately, in this study, the knowledge of the respondents was better than that noted in other countries, and only 10.7% of the respondents thought that generic drugs were of poorer quality than the reference drugs. Similarly, the difference in quality between generic and original drugs is not seen by 11.6% of the study group analyzed by Grzywinska [
13]. Among the respondents, 640 (52.5%) thought that the replacement drugs were as safe as the reference drugs, however, in the study by Lira et al., it was 75.2% [
17]. Generic medicines have the same level of effectiveness and quality as brand-name drugs [
21].
Generic medications, typically, cost less. When asked about price, almost 3/4 of the respondents stated that generic medications cost less than the branded medicines. In the study by Naing et al., the vast majority of the respondents were unaware of price differences between generic and reference medicines [
16], however, in the study by Lira et al., 88.8% stated that generic drugs are less expensive than the reference drugs [
17]. While asking the respondents about the reasons for generic substitution, as many as 660 per 1220 respondents (which is 54.1%) mentioned that they thought it was because the generics were cheaper. Generic alternatives are often cheaper than brand-name medicines because the manufacturers have not spent money on research and development of the medicine or buying the rights to sell it [
23]. In Poland, most patients are directed by price in choice of medicines [
24,
25].
The question “Have you already taken generic medicines?” was aimed at verification of the number of patients who reach for these medicines. This question also qualified the respondents for answering the subsequent questions. Analysis of responses indicated that 61% patients admitted that they used generic medicines but 38.52% of respondents claimed that they had never used or do not know about the cheaper generic substitutes for original drugs. This result is similar to that obtained in the other study conducted in Poland in 2015 [
14]. Among patients who took generic medications, as many as 360 respondents, i.e., 29.5%, sometimes bought generic drugs. In Poland, the use of generics is high. According to 2017 data, among the reimbursed prescription medicines, the share of generics was 27% by value and 89% by volume in hospitals and, respectively, 66% and 76% in outpatient pharmacies [
26].
In Poland, physicians are able to make individual choices for prescribing drugs, and these choices are largely based on brand. In Poland, it is the doctor who decides which medicine he will prescribe to a patient. In our own study, almost ¼ of patients declared that their doctor never offered them a generic drug during the visit. On the other hand, in another study conducted in Poland, of a group of 119 doctors, the results showed that almost 70% of the surveyed doctors (n = 83) admitted that they prescribed mostly generic drugs to their patients [
13]. In Greece, overall, 75% of physicians claimed that they were not influenced by the sales representatives from drug companies and that Greek patients do not interfere with their prescribing, but they often complain about the drug costs [
27].
In Poland, there is no obligation to replace original drugs with generics; nevertheless, the pharmacists have the right to switch from branded to generic medicines unless the prescriber has specified otherwise [
28,
29]. In the present study, the pharmacists sometimes recommended generics for 42.6% of the respondents. Whereas, Grzywinska evaluated community pharmacists’ practices on generic medicines in Poland [
13], and of the pharmacists surveyed, 65% recommended generics over original brands. It was found that 66% of pharmacists recommended the substitution of a prescribed branded drug by a different form of the same active substance often, or very often, but only 25.41 per cent of respondents replied that their doctors talked to them about generic medications and sometimes prescribed these medicines. A study conducted in Poland, “Factors affecting the opinions of family physicians regarding generic drugs—a questionnaire-based study”, by Lewek et al., showed that 73.0% of physicians were considering prescribing generics and 71.1% regularly informed patients of this possibility. The physicians who considered generics when prescribing a drug tended to report doing so either often or always (in 50–100% of cases;
p < 0.001) and were more ready to inform patients about generic substitution (
p < 0.001) [
30]. It should be noted that generic substitution of branded products has played an important role in limiting the cost of medicines.
The patients themselves may also request generic versions of prescribed medications when they are either with the doctor, or when they visit the pharmacy to collect their prescription, or when they buy over-the-counter drugs. In our own study, only 4.1% (n = 50) of patients always request a switch from an original drug to the generic drug from their doctor or pharmacist.
The results in the previously mentioned study are different; about ¼ of patients asked their doctor for a cheaper drug often or very often, while 15.2% of patients never asked a doctor for a generic drug [
13]. In the same study, doctors and pharmacists were also asked how often patients themselves ask for a generic substitution. It turned out that, according to physicians, patients ask them to replace the drug with a cheaper equivalent often or very often in almost half of the cases, i.e., in 47.9% of cases, while ¼ of the surveyed pharmacists (25%) stated that patients themselves rarely ask them to change an innovative drug to generic [
13]. Another Polish survey conducted among 22 pharmacists showed that 59% of pharmacy employees stated that patients “never” on their own initiative sought information about the possibility of replacing the drug with its cheaper equivalent [
31].
Most of the respondents in this study (n = 420; 34.4%) obtained information on generic medicines from medical practitioners. In the study conducted by Kjoenniksen et al., 24% of participants indicated that their physicians had given them information about generic substitution, while a larger proportion (53%) indicated that the pharmacist had done so [
32]. Grzywinska has shown that 30% of pharmacists declared that patients ask them often or very often about the difference between generics and branded medicines [
13]. Firstly, the healthcare professionals are a reliable source of information of generic substitution. Secondly, studies conducted in Poland show that the pharmacists have a position of public trust and are fully competent to provide information on medications in patients’ opinions [
24]. Similarly, most of the patients trust their doctors [
33].
Among patients with previous experience with generic switching, only 1.6% of respondents felt the impact of changing brands of medicines and only 4.9% felt side effects. From the manuscript “A review of patient perspectives on generics substitution: what are the challenges for optimal drug use”, it follows that between 8–34% of patients reported poorer effects and/or new side effects after a change—except for antiepileptic drug users of which the number of reports was even higher [
34].
Out of various factors that may affect knowledge of generic drugs and their use, high education, medical education, place of residence (city > 500 thousand residents), and net income per household (up to PLN 2000 = about 500 USD) were statistically significant. The results were consistent with a study conducted by Iosifescu et al., where it was observed that negative beliefs about generic medications were associated with lower education and low income [
35]. Similarly, a meta-analysis by Dunne and Dunne evaluating perceptions of physicians, pharmacists, and patients found that patients with less education were more skeptical of generic medications [
36].
In this study, there was no statistically significant relationship between the sex of respondents and responses of participants about generic medicines. Other studies were in line with our findings [
13,
34,
35,
37].
Additionally, in our own study, there were no statistically significant differences between responses of respondents in terms of age, marital status, chronic illness other than epilepsy, long-term use of medication other than antiepileptic drugs, and healthcare facility where respondents receive outpatient care.
Generic substitution is a common practice in most healthcare systems [
38]. It is vital to remember that generic substitution has its pros and cons. On the one hand, the usage of generic medications is economically justified, but, on the other hand, there appear to be concerns about the safety and effectiveness of treatment. However, many opinions on this issue are ambiguous or even contradictory. According to Krauss and Privitera’s study, generic substitution appears to be safe for antiepileptic drugs [
39]. However, Wilner’s study [
40] showed that after switching from the original drug to a generic, as many as 81.4% of neurologists reported an increase in seizures (67.8%) or toxic symptoms (56%) in their epilepsy patients. In addition, when switching from one generic drug to another, the proportion was 32.5% and 26.6%, respectively. In this case, not only the health of patients deteriorated, but also the cost of their therapy increased. Thus, generic substitution is not always effective and cost-effective. For levothyroxine, a thyroid medicine, the use of its substitutes was associated with a risk of side effects [
41]. In conclusion, thinking about switching from an original drug to a generic drug should take into account, among other factors: the patient’s age; pharmacogenetic factors; co-existing diseases; underlying disease; bioequivalence studies; or the use of other drugs [
10]. In Poland, studies have been conducted on opinions on generic drugs among medical staff, however, not many studies have been conducted among patients in Poland.
This study has some limitations. The study involved a large group of people with higher education, including medical education, which may not reflect the opinion of the general public about generic drugs. It is very similar when it comes to a place of living. The questions in the survey concerned generic medicines in general, not generic anti-epileptic drugs. However, it can provide useful data for doctors, pharmacists, and health policy makers to further improve the use of generic medicines by considering the patients’ perspectives. However, the fact that this is the first, and, so far, the only, study on epilepsy patients’ knowledge on generic medications conducted in Poland is worth a mention. Hence, it should constitute a foundation for further detailed research. This study has limitations due to its being confined to a single group—patients with epilepsy—and lack of a control group. Further research should be performed to compare the results of substitution of generics for brand-name drugs in the treatment of patients with epilepsy.