European Journal of Cardiovascular Medicine

Hypertension and its associated cardiovascular diseases have become a global health crisis. As per the NCD Risk Factor Collaboration [1], 1.13 billion individuals worldwide suffer from hypertension, with the incidence rising predominantly in low and middle-income countries [2]. According to the World Health Organization (WHO), hypertension is a leading cause of cardiovascular diseases, with significant global mortality attributed to its complications [3].

In India, hypertension affects approximately 29.8% of the population, and its prevalence is notably higher in urban areas (33%) compared to rural areas (25%) [4]. Despite the availability of effective treatments, several factors, such as lack of awareness, non-compliance with medication, and insufficient BP control, contribute to the persistence of hypertension [5-6].

This study focuses on the prescribing patterns of anti-hypertensive drugs and evaluates the adherence to WHO/INRUD drug use indicators, which provide critical insights into the rational use of medications. The study also aims to identify trends in drug prescription and evaluate the compliance with local and international treatment guidelines.

The present study is aimed to study the prescription pattern of different types of antihypertensive drug as prescribed by WHO drug use indicators among patients with hypertension attending Nandha Medical College and Hospital, Erode, Tamil Nadu, India.

Study Design:

This prospective, observational study was conducted at the Department of Pharmacology and Department of Medicine at Nandha Medical College and Hospital, Erode, Tamil Nadu, India. Institutional ethical clearance was obtained (NMCH/IEC/24/132; Date: 21.01.2023). The study included 206 hypertensive patients who attended the outpatient department (OPD) during the study period (August 2023 to October 2023).

Inclusion Criteria:

• Adults aged 18 years and above.
• Patients with a systolic blood pressure (SBP) > 140 mmHg and diastolic blood pressure (DBP) > 90 mmHg at the time of diagnosis.
• Patients who had hypertension without any co-morbid conditions.

Exclusion Criteria:

• Patients with blood pressure < 140/90 mmHg.
• Pregnant and lactating women.
• Patients with co-morbidities such as diabetes, thyroid disorders, or immune-compromised states.
• Non-cooperative patients.

Data Collection:

Prescriptions were collected from patients with hypertension, and details including the name of the prescribed drugs, fixed-dose combinations, doses, dosage forms, frequency, and duration of treatment were recorded on pre-designed case report forms (CRF). The collected data were analyzed using WHO drug use indicators.

DATA ANALYSIS:

WHO/INRUD Drug Use Indicators

The WHO/INRUD drug use indicators assess the rational use of medications. Key indicators used in this study include:

1. Prescribing Indicators:
   • Average Medicines per Encounter: Number of medications prescribed per patient visit.
   • Generic Prescriptions: Percentage of drugs prescribed by generic name.
   • Injection Prescriptions: Percentage of encounters involving injections.
   • Essential Medicines List: Percentage of drugs prescribed from the WHO’s essential list.
2. Facility Indicators:
   • Availability of Essential Medicines List/Formulary: Access to the essential medicines list for practitioners.
   • Clinical Guidelines Availability: Presence of clinical guidelines for prescribing.
   • Key Medicines Availability: Availability of key medicines at the facility.
3. Complementary Indicator:
   • Prescriptions Adhering to Guidelines: Percentage of prescriptions in line with clinical guidelines.

A total of 206 prescriptions were collected from the hypertensive patients had a systolic blood pressure of 140mmHg and diastolic blood pressure of 90mmHg attending outpatient ward in the period of three months from August 2023 to October 2023. The institutional ethical clearance was obtained (NMCH/IEC/24/132 (Date: 21.01.2023). Out of 206 patients 51% were female patients and 49% were male patients as shown in table 1. 13% of patients were in the age group between 31-40 years, 35% of patients are in the age group between 41-50 years, and 52% of patients are in the age group of 51-85 years as shown in table 2. In this study, 2 classes of antihypertensive drugs were used; they are angiotensin converting enzyme (ACE) inhibitors and calcium channel blockers.

Calcium channel blockers were the most common prescribed monotherapy drug in the study, out of 206 patients, 33 patients (16%) were prescribed for Amlodipine and 31 patients (15%) for the drug Amlodipine, followed by 10% of ACE inhibitor drugs such as Envas and Enalapril. A total of 86 patients (41%) were prescribed as monotherapy.

Fig:1The antihypertensive drugs prescribed, were Amlodipine, Enalapril and Telmisartan. Amlodipine 10 mg was the most commonly prescribed anti-hypertensive agent (52%). Amlodipine 5mg (20%), Enalapril 2.5 mg  (14%).  Amlodipine 10 mg + Atorvastatin 20 mg + Enalapril 2.5 mg (12%). Amlodipine 10 mg +Telmisartan (2%).

Fig-1: Antihypertensive drugs prescribed

A total of 3 antihypertensive drugs and 2 combinations were prescribed, they are  Amlodipine, Enalapril (Angiotensin-converting enzyme(ACE) inhibitors) and one Angiotensin II receptor blocker Telmisartan. The very frequently prescribed drug in combination was Amlodipine and Enalapril followed by Amlodipine and Telmisartan combination. Atorvastatin is given in a three-drug combination with two other drugs.  3 patients with very high BP of 180/92 were prescribed 2 drugs at combination per encounter which was Amlodipine and Enalapril.

Table 1: Gender distribution

Table 2; Age group of study participants

Table 3: Mean Blood pressure recording

Table 3 shows blood pressure recoeding of study participants. MeanSystolic blood pressure 148.7±11 (134 - 180) mmHg , and mean diastolic blood pressure  92.4±4.6 (80 – 100)mmHg

Table4: prescribing indicators

Table 5: Generic prescribed

Table 6: The WHO prescribing indicators

The prescribing indicators (Table 4,5 & 6) showed that 50% of patients were prescribed 1 drug per encounter, 45% of patients were prescribed 2 drugs per encounter and only 5% of patients were prescribed 3 drugs per encounter. 88% of medicines were prescribed by generic name. 88% of medications were prescribed under their generic names. 0% of encounters involved a prescription injection. It was discovered that 100% of the medications prescribed came from the formulary or list of essential medications.

Facility Indicators: The availability of a formulary or list of necessary medications to practitioners. There are clinical guidelines available. Key medications are 100% available. Complementary Drug Use Indicators: 100% of prescriptions were written in compliance with clinical recommendations.

In the present study, patients with blood pressure (BP) greater than 140/90 mmHg at the time of diagnosis were included in the study. Previous studies have shown that an increase in systolic blood pressure of 20/10 mmHg more than normal, increases the risk of cardiovascular disease. Hypertension is a major reason, directly involving itself in 57% of all stroke deaths and 24% of all coronary heart disease deaths in India. Every 10 mmHg increase in systolic BP increases, hemorrhagic stroke by 74% and ischemic stroke by 43%. For every 19 mmHg elevation in systolic BP, the risk of renal damage can increase by more than 80% [7-8]. As a result, careful monitoring of blood pressure by a physician in a hypertensive patient is critical for antihypertensive management.

In this study, it was observed that female patients were higher than male patients, it was also observed that the patients above 50 years of age attended for the treatment of hypertension. Hypertension is more dominant in older peoples due to higher arterial and arteriolar wall stiffness, decreased baroreceptor sensitivity, altered renal and sodium metabolism accompanying with aging[9-12]. The reports were well correlated with the observation made by Elanchezhiyan et al., 2019 conducted from a tertiary care centre at Vizianagaram, Andhra. The patients visited outpatient department with high systolic blood pressure of 180mmHg and diastolic blood pressure of 100mmHg[13]. Majority of the patients who receive anti-hypertension drugs were at the age group was above 40 years. The similar results were found with the study conducted by Adejumo et al., 2017 from Nigeria who studied the prescription pattern among hypertension patients[14]. In this study, the calcium channel blockers were the majority prescribed drug as monotherapy, specifically Amlodipine was used for about 16% of patients, followed by Amlodipine (15%), the results were found similar with the previous study in patients of South Korea by Kim et al., 2019[15].

In our study, monotherapy drugs such as amlodipine and enalapril were predominantly used for the hypertensive patients. Elenchezhiyan et al. (2019) reported that, a monotherapy drug Amlodipine was highly used (28%) followed by telmisartan (33%) for the patients[16]. Fares H et al. (2016) reported that amlodipine was frequently prescribed as a monotherapy drug for hypertension patients, which is similar to our study findings and given the better outcome of the results [17-19]. Amlodipine was a potent antioxidant; its mode of action was cardioprotection by reducing oxidative stress induced in myocardial infarction by stopping free radical-mediated catecholamine assault[20].

Enalapril is a second most drug used in our study. Similar to our study, Salman et al., (2019) reported that, Enalapril is a common anti – hypertension drug and widely used (38%) of hypertension treatment[21-22]. It was lowering blood pressure by suppressing the renin-angiotensin-aldosterone pathway, which is how a non-sulphydryl antihypertensive drug works[23-24].

According to the overall findings of the current study, using a monotherapy medicine for the treatment of hypertension patients with blood pressure of 140/90 mmHg is a good first step to control the severe hypertension-related life-threatening disorders.

The prescribing patterns of anti-hypertensive drugs in the tertiary care center were in accordance with standard treatment guidelines. The most commonly prescribed drugs were Amlodipine and Enalapril, either as monotherapy or in combination. The study highlighted rational drug use with a preference for generic prescriptions and adherence to essential medicine lists, ensuring cost-effective care for hypertensive patients. Minimal prescription errors were observed, suggesting effective drug utilization practices at the center.

Acknowledgement:

We sincerely thank each and every one of the participants for taking the time to complete our survey. The authors thank the Department of Medicine & Pharmacology, Nandha Medical College and Hospital, Erode, Tamil Nadu, for providing the necessary facilities.

Ethical approval:

This study was conducted in accordance with the Declaration of Helsinki‑Ethical principle for medical research involving human subjects. Accordingly, the ethical clearance was obtained from a joint ethical review committee intuitional ethical committee (IEC), Nandha Medical College and Hospital, Erode No: (NMCH/IEC/24/132 (Date: 21.01.2023).

Financial support and sponsorship:

Nil

Conflicts of interest:

There are no conflicts of interest.

Author’s contribution:

Dr.Paramasivan: Conceptualization, Formal analysis, Project administration, Writing‑original draft, Validation, Investigation. Dr. Dr.Arul Mohan: Conceptualization, Writing‑review and editing, Formal analysis, Validation, Investigation, Visualization. Dr. Dr.S.Nagarajan: Conceptualization, Methodology, Writing‑review and editing, Validation, Resources. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. All authors have read and agreed to the published version of the manuscript.

DATA AVAILABILITY:

All datasets generated or analyzed during this study are included in the manuscript.

INFORMED CONSENT:

Written informed consent was obtained from the participants before enrolling in the study

1. Abera, H. and Woldemichael, M., 2016. Pattern of antihypertensive therapy among diabetic HYPERTEN-SIVE patients in ZEWDITU Memorial Hospital, Addis ABABA. diabetes, 1, p.2.
2. Adejumo, O., Okaka, E. and Iyawe, I., 2017. Prescription pattern of antihypertensive medications and blood pressure control among hypertensive outpatients at the University of Benin Teaching Hospital in Benin City, Nigeria. Malawi Medical Journal, 29(2), pp.113-117.
3. Alkaabi, M.S., Rabbani, S.A., Rao, P.G. and Ali, S.R., 2019. Prescription pattern of antihypertensive drugs: an experience from a secondary care hospital in the United Arab Emirates. Journal of research in pharmacy practice, 8(2), p.92.
4. Anchala, R., Kannuri, N.K., Pant, H., Khan, H., Franco, O.H., Di Angelantonio, E. and Prabhakaran, D., 2014. Hypertension in India: a systematic review and meta-analysis of prevalence, awareness, and control of hypertension. Journal of hypertension, 32(6), p.1170.
5. Armstrong, C., 2014. JNC8 guidelines for the management of hypertension in adults. American family physician, 90(7), pp.503-504.
6. Begum, S. and Akhter, N., 2007. Cardioprotective effect of amlodipine in oxidative stress induced by experimental myocardial infarction in rats. ||| Bangladesh Journal of Pharmacology|||, 2(2), pp.55-60.
7. Casas, J.P., Chua, W., Loukogeorgakis, S., Vallance, P., Smeeth, L., Hingorani, A.D. and MacAllister, R.J., 2005. Effect of inhibitors of the renin-angiotensin system and other antihypertensive drugs on renal outcomes: systematic review and meta-analysis. The lancet, 366(9502), pp.2026-2033.
8. Elenchezhiyan, V., Moorthy, S., MK, S., Mattam, B.N. and Sayana, S.B., 2019. Study of prescribing pattern of antihypertensive drugs in diabetic patients in a tertiary care centre, Vizianagaram, India.
9. Hoshide, S., Kario, K., Tomitani, N., Kabutoya, T., Chia, Y.C., Park, S., Shin, J., Turana, Y., Tay, J.C., Buranakitjaroen, P. and Chen, C.H., 2020. Highlights of the 2019 Japanese Society of Hypertension Guidelines and perspectives on the management of Asian hypertensive patients. The Journal of Clinical Hypertension, 22(3), pp.369-377.
10. Hussain, Z., Sana, A., Mohammed, S.A.L.A.H.U.D.D.I.N. and Razzaq, M.A., 2014. Patterns of drug therapy among diabetic hypertensive patients with other complications. Int J Pharm PharmSci, 6(6), pp.270-7.
11. Jain, S., Upadhyaya, P., Goyal, J., Kumar, A., Jain, P., Seth, V. and Moghe, V.V., 2015. A systematic review of prescription pattern monitoring studies and their effectiveness in promoting rational use of medicines. Perspectives in clinical research, 6(2), p.86.
12. Kim, S.H., Shin, D.W., Kim, S., Han, K., Park, S.H., Kim, Y.H., Jeon, S. and Kwon, Y.C., 2019. Prescribing patterns of antihypertensives for treatment-naïve patients in South Korea: from Korean NHISS claim data. International Journal of Hypertension, 2019.
13. Komolafe, M.A., Ogunlade, O. and Komolafe, E.O., 2006. Stroke mortality in a teaching hospital in south-west of Nigeria. African Journal of Neurological sciences, 25(2), pp.75-77.
14. Mason, R.P., Mak, I.T., Trumbore, M.W. and Mason, P.E., 1999. Antioxidant properties of calcium antagonists related to membrane biophysical interactions. The American journal of cardiology, 84(4), pp.16-22.
15. Mathers, C.D. and Loncar, D., 2006. Projections of global mortality and burden of disease from 2002 to 2030. PLoS medicine, 3(11), p.e442.
16. Okeahialam, B.N., 2004. The burden of arrhythmia in hypertension: an electrocardiographic study. Nig J Cardiol, 1, pp.53-56.
17. Pinto, E., 2007. Blood pressure and ageing. Postgraduate medical journal, 83(976), pp.109-114.
18. Salman, J., Salman, A., Kumar, S., Gjeka, R., Tegeltija, V., Peterson, D., Chams, N. and Ross, I., 2019. Improving the use of intravenous antihypertensive medications in the hospital setting: a quality improvement initiative for patient safety. BMJ open quality, 8(4), p.e000626.
19. Swami, S.S., Swami, S.C., Patil, V.W. and Kanhere, A.M., 2015. Hypertension and diabetes in India: a review. Int J ClinBiochem Res, 2(1), pp.54-58.
20. Wang, T.D., 2018. Our stance towards the 2017 ACC/AHA high blood pressure clinical practice guideline: has the pendulum swung too far?.ActaCardiologicaSinica, 34(1), p.1.
21. Weber, M.A., Neutel, J.M. and Cheung, D.G., 1989. Hypertension in the aged: a pathophysiologic basis for treatment. The American journal of cardiology, 63(16), pp.25-32.
22. WHO, Global health observatory data 2008. Available from http://www.who.int/gho/ncd/risk_factors/blood_pressure_mean_text/en/
23. World Health Organization, Projections of mortality and causes of death, 2015 and 2030. Health statistics and information systems. 2013.
24. Zhou, B., Bentham, J., Di Cesare, M., Bixby, H., Danaei, G., Cowan, M.J., Paciorek, C.J., Singh, G., Hajifathalian, K., Bennett, J.E. and Taddei, C., 2017. Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19· 1 million participants. The Lancet, 389(10064), pp.37-55.