Summary
OBJECTIVE: The aim of the present study is to investigate (1) what is the patients' attitude towards and (2) preferences to use generic medicines in Bulgaria and (3) which are the main factors influencing their opinion.METHODS: Using pseudo-randomization we select a sample of 225 participants, men and women from general population, patients in community pharmacies. For our survey we used a standardized self-questionnaire of ten points. The influence of age, education, medical history, knowledge of generic drugs and experience with generic substitution and medicines was examined through Chi-square tests.
RESULTS: The results show that 74% of the participants seemed not to be informed on generic drugs and 26% received valuable and relevant information from their general practitioner or pharmacist. 94% believed that generic medicines are inferior to brand medicines on quality, safety and efficacy.
CONCLUSIONS: The main reason for almost all the participants (94%) to prefer original medicines, over generics is the insufficient information, they have. The core factors forming patients' opinion and expectations for generic drugs are medical professionals' recommendation and previous experience. The main advantages of the generics according to the participants in the study are the lower price and better accessibility. The results raise the issue of the awareness and level knowledge about generic medicines and the rational drug use in the general population.
Introduction
In an era of ageing population and rising healthcare costs, generic medicines allow patients to access safe, effective and high quality medicines at 20 to 80% of the price of branded originator medicines[1]. Competition from generic medicines also incites originator companies to develop innovative medicines and reduce prices after patent expiree, thus generating additional savings for patients, healthcare budgets and insurance funds.The issue of patients' attitude and experience towards generic drugs use is crucial in the frame of reducing the cost of medicines and therapy. A few studies show that patients do not have enough knowledge, but still have their opinion on generic drugs[2-5].
Generic medicines save patients' and insurance funds significant costs. The main reason for their lower price is the different business model of the generic companies – low investments in R&D, lower sales and marketing expenses, lower margins and benefiting from an already established market by the originator company.
Generic medicines play a key role in healthcare provision in the new EU Member States. They are crucial to making medicines accessible to patients, who cannot afford high co-payments for essential treatment. This is even more important considering that:
• Average GDP per capita for 2009, in the new Member States is more than 2 times lower than in the old member countries (GDP of Bulgaria is 9,362 EUR vs. 23,600 EUR average in EU 27)[6].
• Real spending per capita on healthcare in the new Member States is €400 on average compared to over €1,600 in the EU[7].
• Several new Member States are already experiencing healthcare budget deficits due to rising pharmaceutical costs.
• Many patients do not buy their prescriptions, because they cannot afford the high out-of-pocket co-payments[7].
Generics represent nearly half of the volume of medicines dispensed to European citizens, but correspond to only 18% of the value of the total pharmaceutical market[7]. However, volume share changes at country level.
Generic market for 2010 in Bulgaria is estimated to be over €460 million, which is only 10% more than the originator market. Meanwhile 5 times more generic medicines (in volume) were sold for the same period[8].
European citizens are more familiar with generic medicines in the self-medication where payment is made directly out-ofpocket. However it is chronic and terminal diseases, that account for most of the healthcare costs paid indirectly, through insurance funds and taxes contributions. This is also the area where generic medicines play the more significant role. The medicinal product must comply with the maximum degree of medical and financial interests of the patient[7].
The decision of prescribing a medicine is defined by the physician's perception of the illness, which is influenced by its seriousness and the interpretation of the symptoms. Previous studies show that the more serious illness is perceived less likely is the patient to agree with prescription of generic medicine[9].
Our study investigates patients' attitude and understanding of the generic medicinal products in Bulgaria. We focused on the main factors that influence their perception in relation to efficacy, safety and confidence in the therapy.
Methods
All the participants were interviewed in ten community pharmacies in five big cities in Bulgaria – Sofia, Burgas, Varna, Pleven, Plovdiv, during the period of May/July 2010. In order to participate in the study, each patient should respond to some inclusion criteria – literacy, availability of personal prescription from general practitioner, previous experience to visited community pharmacy. A self-questionnaire with ten questions was distributed among the patients. The questionnaire included socio-demographic data, measure of understanding the difference between brand and generic medicines and patients’ preferences for treatment.All the source population (n=458) were Bulgarian, men and women aged over 18 years old. A sample of 225 (49%) participants or every second (pseudo-randomization) was made. After validation in the analysis were included 216 (96%).
The questionnaire took place in two phases: May/June 2010 and June/July 2010 for twenty workdays. Each community pharmacy from the preliminary chosen ones was visited twice between 9 am – 2 pm and the questionnaire was distributed. The filled in and given back questionnaires were validated and analysed.
ANALYSIS
SPSS (Statistical Package for Social Sciences v.17) was used to
investigate factors influencing patients’ attitude towards generic
medicines. The independent values were age, gender,
education, previous experience with generic drugs, whether
they have been informed by their general practitioners and
pharmacists about generic substitution.
Results
29.6% of the respondents were men and 70.4% were women. Women are the main patients in the community pharmacies and they should be the target group of the generic industry. Half of the respondents (50%) had a university degree. These results are explained with the inclusion criteria “literacy” and the fact that the questionnaire was distributed only in major cities. Even with a possible selection bias, these patients are educated enough to acquire knowledge of generic medicines through educational campaigns and trust the pharmacist when he/she recommends them a generic medicine.The majority of the respondents were aged over 46 years old. 25.5% were chronically ill. Most of the patients were diagnosed with hypertension (52.7%), alone or in combination with diabetes, heart failure or ischemic heart disease, diabetes (5.5%), asthma (12.7 %), etc. (Table 1).
TABLE 1: Patients distribution according to chronic diseases prevalence
Information and knowledge about generic medicines
About ¾ of the respondents with chronic disease, replied that
they do not have enough information about generic medicines
and the difference between original (branded) and generic
drugs (fig.1). Those who feel most informed are aged over 35
year, but are not necessary chronically ill. Only 1/3 of the patients
with chronic diseases know the difference between original
and generic medicines. They are either not aware of the
different alternatives for their treatment or they haven’t had
the right of informed choice.
Click Here to Zoom |
FIGURE 1: Responders’ opinion on the difference between original and generic medicines (total number of participants – 216) |
Factors influencing patients’ attitude and expectation
towards generic medicines
Physicians are the main factor influencing the patients in Bulgaria.
Under the local regulations generic substitution is not allowed.
Pharmacists are not authorized to replace prescribed medicinal
product to its generic alternative. The alternative is for physician
to prescribe the medicine under international non-proprietary
name (INN) and then the pharmacist is choosing between the generic
and the branded drugs. In the real practice this option is rarely used by the medical doctors and this makes them the most
influential side in the triangle Doctor-Pharmacist-Patient (Tables
2a, 2b). Both relations are significant (p<0.001).
TABLE 2A: Influence of the factor “generic substitution”
TABLE 2B: Influence of the factor “generic substitution”
In table 3 we present summary data and preferences in the choice of medication by the respondents. We believe that insufficient information on generic medicinal products is the main reason nearly all patients (94%) prefer the original to generic products. This rate remains among the chronically ill, who are better informed and generally more inclined to substitution. The relation between the choice and presence or absence of chronically disease is not significant (p>0.05)
TABLE 3: Influence of the factor “chronic disease”.
When respondents were asked about the most often prescribed drugs to them – 79.6% responded that these were the original medicines. Only 6.5% definitively stated that their physician had suggested replacing the therapy with generic one.
One of the main objectives of this study was to ascertain the attitudes among patients to generic drugs. The results show that 26.4% of the respondents believe that the generics have more or less advantages over the original medicines. This is roughly equal to the percentage of respondents who consider themselves familiar with the difference between innovative and generic medicines.
Main advantages of generic medicines
Among the main benefits of generic medicines, the respondents
placed the lower price (54.2%) and the fact that they are
available and more easily affordable in pharmacies (16.2%)
(Figure 2). Almost one fifth of the participants believe that generics
do not have any advantages in terms of price, quality or
availability compared to branded medicines. This coincides
with previous studies showing that between 20-30% of
consumers believe that generics are less safe and effective, as
well as inferior or different from theoriginal product[3].
Click Here to Zoom |
FIGURE 2: The main advantages of the generic medicines |
Price is the leading factor for the people aged over 55 years and for the chronically ill patients, while availability in pharmacies is of upmost importance for younger people between 18 and 25 years old. These relations remained unproved (p>0.05).
Conclusion
The main reason for almost all the participants (94%) to prefer original medicines, over generics is the lack of availability or insufficient information. The core factors forming patients’ opinion and expectations for generic drugs are medical professionals’ recommendation and previous experience. The main advantages of the generics according to the participants in the study are the lower price and better accessibility. The results raise the issue of the awareness and level knowledge about generic medicines and the rational drug use in the general population.
Conflicts of interest
None
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