|Year : 2022 | Volume
| Issue : 2 | Page : 195-200
Real-world effectiveness of generic antihypertensive drugs of pradhan mantri bhartiya janaushadhi kendra
Chandani Sheikh, Nikita Donage, Bhavana Donga, Stephen Benny, Kiran Majjigeri, Sowmya Spoorthi, Ramesh Bhandari, MS Ganachari
Department of Pharmacy Practice, KLE College of Pharmacy Belagavi, A constituent unit of KLE Academy of Higher Education and Research, Belagavi, Karnataka, India
|Date of Submission||26-Jan-2022|
|Date of Acceptance||23-May-2022|
|Date of Web Publication||23-Aug-2022|
Department of Pharmacy Practice, KLE College of Pharmacy Belagavi, KLE Academy of Higher Education and Research, Belagavi, Karnataka
Source of Support: None, Conflict of Interest: None
Background: The Government of India started the Janaushadhi Scheme in 2008 to control individuals' expenditure by providing low-cost generic medicines for health benefits. Hence, this study aims to study the real-world effectiveness of Jan Aushadhi generic antihypertensive medicines at a Pradhan Mantri Bhartiya Janaushadhi Kendra and also to assess knowledge and attitude toward generic drugs. Methods: This study was done in Pradhan Mantri Bhartiya Janaushadhi Kendra. Participants who were hypertensive and on at least one antihypertensive drug from Pradhan Mantri Bhartiya Janaushadhi Kendra were enrolled in the study. All the participants received three blood pressure (BP) measurements, i.e., two manual readings and an average of two taken. One digital reading is followed by questionnaires, which help assess patients' knowledge and attitude using Pradhan Mantri Bhartiya Janaushadhi Kendra medicines. All the participants were evaluated for baseline, 1st-month, 2nd-month, and 3rd-month follow-up visits. The baseline, 1st-month, 2nd-month, and 3rd-month data were compared using paired t-test and Cochran's q-test. Results: The important findings were a considerable reduction in BP compared to the baseline, 1st-month, 2nd-month, and 3rd-month follow-up. Approximately half of the patients (53.36%) know the difference between generic and brand medicines. A significant proportion of the participants believe that taking Janaushadhi medication reduces the cost. Hence, considerable improvement was evidenced in all outcome measures. Conclusion: A significant reduction in systolic and diastolic BP was achieved for all the hypertension stages, providing the authentication that most hypertensive patients may benefit from low-cost generic Jan Aushadhi medicines.
Keywords: Antihypertensive, effectiveness, generic medicines, Jan Aushadhi medicines
|How to cite this article:|
Sheikh C, Donage N, Donga B, Benny S, Majjigeri K, Spoorthi S, Bhandari R, Ganachari M S. Real-world effectiveness of generic antihypertensive drugs of pradhan mantri bhartiya janaushadhi kendra. J Sci Soc 2022;49:195-200
|How to cite this URL:|
Sheikh C, Donage N, Donga B, Benny S, Majjigeri K, Spoorthi S, Bhandari R, Ganachari M S. Real-world effectiveness of generic antihypertensive drugs of pradhan mantri bhartiya janaushadhi kendra. J Sci Soc [serial online] 2022 [cited 2022 Oct 3];49:195-200. Available from: https://www.jscisociety.com/text.asp?2022/49/2/195/354257
| Introduction|| |
Generic drugs (GDs) can be elucidated similarly to brand drugs' inactive ingredients, dosage with exact pharmacological effects, and approval by the food and drug administration (FDA). Different studies stated that GDs are approved only when their bioavailability and bioequivalence are within the normal range of principle drugs, as illustrated by the FDA.
On November 25, 2008, one of the famous schemes was initiated by the Government of India named “Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK).” The main aim of this program was to increase the accessibility of GDs in rural and nonrural areas at an affordable price so that every people can afford them.
Janaushadhi GDs are produced by the manufacturer authorized by the Bureau of Pharma PSUs of India, a government authority for managing the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) scheme, and confirmed to be tested at the National Accreditation Board for Testing and Calibration Laboratories approved laboratory. Other GDs are sold with brand names at more discounts and assert to the public that these drugs are generic.
Since the PMBJP generic medicines scheme was introduced in India, many efforts have been made by the government and National Government Organizations to promote generic medicines through televisions, newspapers, and other social media. However, more efforts are needed to reach the people, building trust in health-care providers, and the general population.
According to a few studies, physician-reported different criteria for prescribing the drugs and some of them are listed below:
- Subject's socioeconomic status
- Bonus provided by the manufacturers
- The name of the drug should be easy to remember
- Some physicians also said that medical representatives from the brand drug companies visit regularly compared to GD representatives.
Some studies show that they usually prefer to prescribe the brand drug to the geriatrics age group because they generally have more negative thoughts concerning the GDs.
Due to widespread myths, lack of confidence, acceptance, and doctor's recommendation, the general population is not ready to accept that generic medicines are safer and more effective than brand medicines.
Hypertension (HTN) is a condition with a persistent elevation of blood pressure (BP). There are different causes for increased BP and can differ from individual to individual. BP must be under control because it can lead to comorbidities such as stroke and other cardiac complications.
The worldwide prevalence of HTN is lowest in rural India (3.4% in men and 6.8% in women) and the highest in Poland (68.9% in men and 72.5% in women)., According to the age, the prevalence of HTN in the rural population increased in males from 8% to 17% and in females from 7% to 12%, whereas in urban people, males from 20% to 27% and females from 17% to 22%.
The drug selection depends on the patient's socioeconomic background, advertising, easy-to-memorize drugs, and the bonuses provided by pharmaceutical companies, stated the physician. Another study revealed that young physicians had been found to recommend generic medicines to their health-care providers. Simultaneously, clinicians over 55 years of age prescribe brand medicines and have opposing views on generic medications. They also reported that the brand drug is prescribed more often as the brand pharmaceutical companies' representatives visit them routinely than that generic pharma companies. They also stated that changing the course of the treatment from generic medicines to a brand leads to the treatment's failure. A minimal study on Janaushadhi GDs explained their merits over brand and other GDs.
Hence, this study proposed providing real-world evidence of antihypertensive Janaushadhi GD effects and assessing knowledge, attitude, and practices regarding Janaushadhi drugs among the patients.
| Methods|| |
Ethical approval from KLE College of Pharmacy Belagavi Institutional Ethics Committee was obtained prior initiating the study. The written informed consent was taken prior enrolling the patient in the study.
Study design, setting, and materials
The prospective observational study was conducted at PMBJK at KLE's Dr. Prabhakar Kore Charitable Hospital for 6 months (November 2018‒April 2019).
The materials used were the informed consent form, prevalidated data collection form, and the data source were the patient's case notes, treatment charts, laboratory reports, and patient interviews.
The total sample size calculated was 90 hypertensive patients recruited to achieve 95% power. Hypertensive patients of either gender were enrolled at the generic medicines store (PMBJK) with their self-decision to start with Janaushadhi generic medicines and 18–70 years of age. Patients taking brand antihypertensive and Janaushadhi GDs, special populations such as pregnant and lactating women, end-stage renal disease, human immune deficiency virus/acquired immunodeficiency syndrome, or any other life-threatening condition patients who were not willing to come for follow-ups were excluded from the study.
Preparation of knowledge and perception assessment questionnaire
Thorough literature search was done on similar studies for questionnaire. The questions related to our studies were selected or rephrased and validated by a group of experts (supervisor and two academic pharmacists) using the physical validation technique.
The data obtained were entered into MS-Excel and were analyzed using the IBM SPSS (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.). The continuous variable was assessed at different time points using a dependent t-test. The association between the proportions of variables was assessed using the Chi-square test.
The outcome variables were reduction of systolic blood pressure & diastolic blood pressure at 1st month, 2nd month and 3rd month.
Study procedure involved in the study is depicted in the [Figure 1].
| Results|| |
A total of 143 patients were screened for the study and out of which 50 patients did not meet inclusion criteria. Of the 93 patients, 67.7% were male and 32.3% were female. The patients' mean age was 52.02 ± 10.22 years, with a mean body mass index of 24.81 ± 3.05, as shown in [Table 1].
Most of the patients were newly diagnosed with HTN. About 75.3% of patients had a positive family history of HTN, and 19.4% relied on over-the-counter medications to manage HTN [Table 2].
|Table 2: Distribution of patients by duration of hypertension, family history, and Use of any over-the-counter drug medications|
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Amlodipine was the most commonly used drug, and enalapril was the least used drug among all prescriptions.
A paired sample t-test was conducted to compare the baseline systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 1-month, 2-month, and 3-month intervals. The mean SBP in baseline was 141.88 ± 9.59 mmHg by the manual method and 142.71 ± 9.28 mmHg by the digital method. There was a significant difference (both manual and digital) between the baseline SBP and all three-time intervals SBP as shown in [Table 3].
|Table 3: Comparison of baseline, 1-month, 2-month, and 3-month time points with systolic blood pressure and diastolic blood pressure using manual and the digital method by dependent t-test|
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The baseline means DBP by the manual and the digital method were 91.26 ± 9.36 mmHg and 91.89 ± 8.54 mmHg, respectively. There was a significant difference (both manual and digital) between the baseline DBP and all three-time intervals DBP, as shown in [Table 3]. There was no statistically significant difference (both manual and digital) between the baseline pulse rate and different time interval point pulse rates. The BP was measured by both methods, i.e., manually and digitally. There was no statistically significant difference between manual and digital method of measuring systolic blood pressure and diastolic blood pressure at different time interval points as shown in [Table 4].
|Table 4: Comparison of the manual and digital method with systolic blood pressure and diastolic blood pressure at baseline, 1-month, 2-month, and 3-month time points by dependent t-test|
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The questionnaire was administered to assess the participants' knowledge, and the responses are represented in [Table 5]. Most of the participants (70.97%) had heard the term Janausadhi and 53.76% knew the difference between generic and brand medicines.
Cochran's q-test was applied to examine whether the satisfaction level improved over 3 months. Cochran's q-test did not show any differences among the 1st-month, 2nd-month, and 3rd-month proportions among the first six questions, as shown in [Table 6], but there was a statistically significant difference in question no. 7 (X2 = 7.684, P = 0.021). This means the proportion of responding to question no. 7 has significantly improved.
|Table 6: Comparison of satisfaction of participants at a different time intervals (1 month, 2 months, and 3 months)|
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Participants were asked how they came to know about Janaushadhi. Most people heard from friends and relatives (33.33%), followed by pharmacists (21.51%), and complete responses are tabulated in [Table 7].
Most of the patients (90.32%) agree that the pharmacist at Janaushadhi Kendra provides sufficient information regarding Janaushadhi medicines [Table 8].
|Table 8: Responses on does the pharmacist at Jan Aushadhi Kendra provide you with sufficient information regarding Jan Aushadhi medicine?|
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| Discussion|| |
The present study aimed at the effectiveness of PMBJK medicines, and PMBJK medicines are equal to that of brand medicines, thereby helping reduce the economic burden of the real-world population. Hence, the availability of PMBJK medicines is affordable at reasonable prices in the rural and urban areas.
In this study, the number of the male population was higher than that of females. HTN is more prone in older adults, which is evident in our research, i.e., the population age groups between 41 and 50 years were found to be high. In our study, the ratio between obese (n = 47) is slightly more than the nonobese (n = 46). In our research, most of the newly diagnosed HTN patients were enrolled due to which patient's having HTN <1 year was found to be maximum, i.e., 32.3%, and the patients having a history of HTN of more than 7 years were found to be 23.7%.
The Janaushadhi generic medicines are effective if the mean SBP is below 140 mmHg or the mean DBP found to be below 90 mmHg. The reduction in the mean SBP and mean DBP was observed by analyzing baseline, 1st-month, 2nd-month, and 3rd-month follow-up visits, after taking PMBJK medicines continuously for 3 months. It is statistically significant at P < 0.05.
It's been 12 years since the Janaushadhi GDs were started. Most participants have good knowledge about Janaushadhi generic medicines and are completely satisfied with the Janaushadhi GDs in our study. Similar results were observed in the survey conducted by Jadhav et al. on generic medicines.
There was no change in the SBP and DBP readings using manual and digital methods. Hence, both approaches are reliable for assessing the control in the BP readings.
The statistical analysis of questionnaires was carried out using Cochran's Q test to assess the participants' satisfaction level, and the significant difference can be observed in Q 7 [Table 6].
The patient switches to the PMBJK medicines either by their self-decision or the doctor's recommendation. The drug is substituted and the dose is recommended by the physician in a few patients. The physician also made the appropriate substitution of the drug and the change in the salt form of the medicine.
In this study, participants were satisfied with the Janaushadhi GDs after 3 months. Whereas in Sadiq et al. study, they illustrated that some physicians were still not satisfied with the safety and effectiveness of the Janaushadhi GDs. Hence, they focused on motivating physicians with the Janaushadhi GDs' effectiveness, which is equivalent to the brand drugs.
In this study, physicians recommended Janaushadhi GDs to 37.50% of the population. However, according to Gupta et al. results in 2015, 63% of physicians prescribed Janaushadhi GDs. During prescribing, physician-prescribed Janaushadhi GDs are based on the socioeconomic status of the patients. They have also counseled regarding the advantages of Janaushadhi GDs to needy people.
Cameron et al. evaluated that changing from brand drugs to the lowest price GDs in different developing countries can give 60% of cost savings. Similarly, in our study, the proportion agreeing with the statement of reducing cost by Janaushadhi GDs is more.
The study was carried out only in hypertensive patients to assess the safety and effectiveness of Janaushadhi generic medicines.
| Conclusion|| |
The study's significant findings were a considerable reduction in the BP compared to the baseline, 1st month, 2nd month, and 3rd month. Hence, PMBJK medicines were found to be as effective as brand medicines. Therefore, people recommended them to their family, friends, and relatives, reducing the real-world population's economic burden. However, no change was found in SBP and DBP values using the manual and digital methods since the significant improvement was evidenced in all outcome measures.
The government should take the initiative to promote Janaushadhi generic drugs and clear the myths among patients and physicians by highlighting the benefits of choosing Janaushadhi generic medicines to reduce out-of-pocket health-care expenses without compromising the quality. Further studies should focus on Janaushadhi GDs' pharmacoeconomic impact and eventually effectiveness on actual clinical outcomes.
We heartily thank KLE's PMBJK for allowing us to collect the data.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]