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Year : 2018  |  Volume : 7  |  Issue : 1  |  Page : 5-10

A Cross-sectional study to look at the determinants of poor adherence to secondary penicillin prophylaxis for rheumatic heart disease at a tertiary care center in South India

1 Department of Cardiology, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India
2 Department of Cardiology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India

Date of Web Publication11-Jan-2018

Correspondence Address:
Dr. Lalita Nemani
Nizam's Institute of Medical Sciences, Hyderabad - 500 082, Telangana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JCPC.JCPC_25_17

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Background: Rheumatic heart disease (RHD) continues to create havoc in the developing countries even decades after its discovery. It is entirely preventable through primordial, primary, and secondary level intervention. Secondary prevention is a reasonable treatment option in patients in India, but it suffers due to poor adherence which remains the main impediment to its implementation. The aim is to study the compliance with benzathine penicillin as secondary prophylaxis in RHD patients and to establish the patient-related factors for adherence and reasons for missing of doses. Materials and Methods: This is a cross-sectional study of RHD patients presenting to our institute. The demographic data, clinical history, and details of penicillin prophylaxis were noted. The patient was labeled as compliant or noncompliant depending on frequency and duration of prophylaxis as prescribed. Potential factors between the two groups have been analyzed by univariate and binary logistic regression. Results: The study cohort of 500 patients consisted of 261 compliant and 239 noncompliant patients. Average age of presentation was 29 ± 13 years with females outnumbering the males. Noncompliance with secondary prophylaxis was more prevalent among male (P = 0.003), low socioeconomic class (P = 0.0009), uneducated (P = 0.000018), and the rural population (P = 0.025) while those with previous history of rheumatic fever (RF) were found to be more compliant (P = 0.04). Recurrences of RF were more common in those not on regular prophylaxis (P = 0.011). The most common reason cited for noncompliance was the absence of proper counseling followed by a sense of well-being, injection site pain and financial constraints. Conclusion: Compliance with secondary penicillin prophylaxis is essential to ensure eradication of RHD. Education about the importance and necessity of prophylaxis would improve compliance. A close patient and health personnel relationship is important in improving adherence to secondary prophylaxis.

Keywords: Acute rheumatic fever, compliance, eradication, rheumatic heart disease, secondary penicillin prophylaxis

How to cite this article:
Nemani L, Maddury J, Barik R, Arigondam AK. A Cross-sectional study to look at the determinants of poor adherence to secondary penicillin prophylaxis for rheumatic heart disease at a tertiary care center in South India. J Clin Prev Cardiol 2018;7:5-10

How to cite this URL:
Nemani L, Maddury J, Barik R, Arigondam AK. A Cross-sectional study to look at the determinants of poor adherence to secondary penicillin prophylaxis for rheumatic heart disease at a tertiary care center in South India. J Clin Prev Cardiol [serial online] 2018 [cited 2023 Jun 9];7:5-10. Available from: https://www.jcpconline.org/text.asp?2018/7/1/5/222923

  Introduction Top

Rheumatic heart disease (RHD) has a decreasing trend worldwide. However, there is a significant gap in the prevalence of the same between the developed and developing nations.[1] It continues to create havoc in the developing countries with its high morbidity and mortality.[2],[3] Decades after the discovery of the disease, its true prevalence still remains underreported worldwide. It is an entirely preventable disease, especially if the primordial prevention is strengthened[4] which may not be feasible in a developing country. Primary prevention is difficult owing to significant subclinical nature of the disease. Thus, secondary prevention remains the most effective strategy to reduce mortality and morbidity due to RHD. It is proven beyond doubt that intramuscular (IM) long-acting benzathine penicillin G (BPG) is effective in reducing the rates of streptococcal pharyngitis, recurrences of acute rheumatic fever (ARF), and progression of RHD. It might even lead to regression of mild-to-moderate valvular lesions.[5],[6],[7] Improvement in RHD severity has been confirmed by echocardiography[8],[9] follow-up. Early diagnosis is very helpful for initiating secondary penicillin prophylaxis (SSP), and the 2012 World Heart Federation echocardiographic criteria facilitate this.[10]

SSP is the only RHD control strategy that is simple, cheap, and cost effective. In our country, IM BPG is advised for all diagnosed cases of ARF/RHD every 21 days (3 weeks) for at least 40 years and lifelong if possible. However, poor adherence to SPP is the main impediment to its implementation. In this cross-sectional study, we looked at the challenges encountered in adherence and reinforcement of SSP for patients presenting to our hospital which is a tertiary care center in South India. This information is crucial to plan strategies for control of ARF and RHD.

  Materials and Methods Top

This is a cross-sectional observational study of patients diagnosed with RHD presenting to our hospital either to the outpatient department or inpatient department. All patients diagnosed for more than an year are included. De novo diagnosed cases of RHD and those aged 40 and above at diagnosis were excluded. Data were collected from patient's medical records and direct questionnaire. We collected the demographic and socioeconomic details of the patient, clinical details regarding the rheumatic fever (RF)/RHD including past admissions and interventions for the same. The details of the penicillin prophylaxis such as its duration, frequency, mode of administration, and alternates in case of hypersensitivity were noted. The reason for noncompliance was noted. Information was collected from the patient and the nearest reliable attendant preferably the parent. In this study, the rate of adherence to penicillin prophylaxis was calculated by dividing the number of injections of BPG administered by the number of expected injections in a year which is about 17 per year considering a frequency of 3 weeks as recommended by the World Health Organization (WHO). Patients were classified as compliant if the rate of adherence was ≥80% and noncompliant if adherence was <80%. Furthermore, only those who had been on prophylaxis from the beginning, i.e., since the time of diagnosis, were considered as compliant.

Statistical analysis

Minitab 17 software (Minitab Inc., Pennsylvania) is used. Continuous variables are mentioned as mean ± standard deviation. Potential factors between compliant and noncompliant are compared by Chi-square test, and a P < 0.05 was considered statistically significant. Odds ratios and 95% confidence intervals were used to quantify the strength of these associations. Binary logistic regression was used to test the significance of multiple significant variables at 0.05 levels. The deviance and Hosmer–Lemeshow goodness-of-fit test was used to evaluate the final regression model.

  Results Top

The study cohort consists of 500 patients of RHD. Females outnumbered males (54% vs. 46%). Average age at diagnosis of RHD was 29 ± 13 years. Baseline demographic characteristics of the study population are mentioned in [Table 1]. Dyspnea was the most common symptom, and the disease was detected for the first time during pregnancy in ten patients. Baseline clinical and disease-related characteristics of the study population are mention in [Table 2]. Nearly 89% required valvular intervention. Surgical intervention in the form of valve repair or replacement was done in 296 patients (59%) and percutaneous balloon valvotomy in 184 patients (37%).
Table 1: Baseline social and demographic characteristics of study population

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Table 2: Baseline clinical and disease-related characteristics

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Two hundred and sixty-one patients were considered compliant and 239 were noncompliant as per the adherence rates. Univariate analysis comparing the compliant and noncompliant groups is summarized in [Table 3]. Noncompliance with secondary prophylaxis was more prevalent among male (P = 0.003), low socioeconomic class (P = 0.0009), uneducated (P = 0.000018), and the rural population (P = 0.025). Those with a history of RF were more compliant with secondary prophylaxis (P = 0.04). Recurrences of RF were more common in those not on regular prophylaxis (P = 0.011).
Table 3: Univariate analysis comparing compliant and noncompliant group

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Among the 239 noncompliant patients, 54 (10.8%) had adherence rate 50%–80% and 185 (37%) had adherent rates <50%. The reason for noncompliance was analyzed and is presented in [Table 4]. Nearly 59% said that they were never advised regarding the secondary prophylaxis. A countable few among them (28 patients) had taken the first injection but were never counseled properly to continue prophylaxis. Five patients had discontinued prophylaxis after surgery as they were not told to continue. Thirty-nine percent patients were advised but not on prophylaxis due to their own negligence. Among the reasons cited for noncompliance were a sense of well-being, pain at the site of injection, financial constraints, distance to travel, unavailability of medicine and health-care professional, and allergy.
Table 4: Reason for noncompliance

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When the multiple confounding factors were tested for their significance by binary logistic regression model [Figure 1] and [Figure 2], noncompliance to secondary prophylaxis was associated with male gender, uneducation, and low socioeconomic status. Noncompliance significantly contributed to recurrences of RF. The final regression model was confirmed by the deviance goodness-of-fit test.
Figure 1: Probability plot for factors determining noncompliance to penicillin prophylaxis

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Figure 2: Binary logistic regression and deviance tables for multiple confounding factors for noncompliance to secondary penicillin prophylaxis

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  Discussion Top

RHD affects 15.6 million patients worldwide every year.[11] The annual incidence of ARF is between 100 and 200 per 1,00,000 children of school age and that of RHD is around 600,000 children in India.[12] The disease mainly affects the children and the youth and is a major cause of economic drain for the country. Unfortunately, the government resources are scarce to treat and prevent the disease. Secondary prevention is the most cost-effective strategy to reduce mortality and morbidity and forms the cornerstone of all the WHO control programs for RF/RHD in our country. Secondary prevention of ARF is defined as the continuous administration of specific antibiotics to patients with a previous attack of RF, or well-documented RHD, to prevent colonization of the upper respiratory tract with group A beta-hemolytic streptococci and the recurrence of ARF.[13] The appropriate duration of secondary prophylaxis is determined by age and time since the last episode of RF and potential harm from recurrent ARF. The WHO recommendations for secondary prevention in RHD are shown in [Figure 3] and are practised in our country.[23]
Figure 3: WHO recommendation for secondary prophyaxis in Rheumatic Heart Disease

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Delivery of secondary prophylaxis is one of the greatest challenges faced by health systems dealing with RHD. Compliance to BPG injections is of utmost importance. In our study, 52% were compliant with SPP. This is quite low compared to that reported previously from India (89%–92%) and New Zealand (80%–100%), though higher than Australia, Egypt, Taiwan, Brazil, Uganda, and South Africa (30%) and in par with Uganda and Africa.[14],[15],[16] The difference in the rate of compliance could be attributed to difference in the enrolment of patients. High adherence with ARF prophylaxis in India in the previous studies[17] was credited to the training of health workers, school teachers, and pupils to recognize the signs of ARF and refer suspected persons to a health center. Our study is a representation of the real world scenario and highlights the fact that the ARF/RHD prophylaxis is not uniform in India.

Factors related to the lack of adherence in other studies were lower education of the parents, living in rural or semi-urban areas, low parental knowledge about the disease, and dissatisfaction of the family with care. This has been proven so in the present study where 79% of patients in the noncompliant group were of low socioeconomic status, 45% were uneducated, and 74% resided in the rural areas. These values were significantly different from those on regular prophylaxis. Seventy-three percent were educated in the group on regular prophylaxis with 24% being graduates suggesting high levels of awareness about the disease and its prevention in the educated class. The fact that patients who resided in a town/city tended to have better adherence could be explained by the fact that these patients have easier access to health-care facilities compared to those from rural areas.[18] Male sex has been associated with nonadherence in the previous studies and even in this present study.[18],[19] Multivariate analysis by Ehmke et al.[19] identified three independent factors of poor adherence: ≥6 individuals in the household; inadequate health-care coverage; and previous history of symptomatic ARF. In our study, past history of ARF correlated positively with good compliance to SSP.

Poor adherence to SPP was observed in the face of poor knowledge. According to Eissa et al.,[20] many of the RHD patients or their caretakers were unable to retain initial information provided at the time of diagnosis and emphasized the need for effectiveness in the communication of knowledge to clients. This is well reflected in our study where 62% of patients stated that they have never been counselled properly. Out of these, nearly 77% denied having ever been advised prophylaxis. About 39% of patients had been advised but were not on regular prophylaxis due to their own negligence. This is quite low compared to the Jamaican population studied,[21] where 74% of defaulters had stated that they had been educated about the disease and the need for SSP. The most common reason cited for missing monthly injections was patients' feeling of well-being (59%), followed by painful nature of the injection (15%) and lack of money (13%) which was seen in the previous studies also.[22] These factors have also been described by the WHO expert consultation[23] in Geneva. Five patients stopped prophylaxis after surgery as they were not properly counselled regarding continuation of secondary prophylaxis postsurgery. The analysis of factors responsible for nonadherence to SPP highlights the fact that compliance can be greatly improved by better communication between the patients and treating health professionals.[24] Thompson et al.[25] had stated that encouragement by a nurse or doctor entrust in care would improve compliance with injection. Fear of receiving injections owing to pain is another barrier to adherence to penicillin. Painful nature of the BPG injection can be reduced by administration of BPG with lidocaine.[26] Using a 23-gauge needle, warm syringe, allowing alcohol from swab to dry before inserting the needle, the use of ethyl chloride spray before injection can reduce the pain associated with these injections significantly.[27] Dissolving the injection in 6 ml of distilled water and giving 3 ml each on both glutei areas, slowly over 2–3 min, good rapport and conversation with the patient during administration of injections also benefits in reducing the pain. Administration of the injection on a holiday such as Saturday to the child would be beneficial as the child can go to school from Monday, thus improving the adherence to the injection. Financial constraints should not be a cause for noncompliance in our country as the penicillin injection is given free of cost in government hospitals.


This is a cross-sectional nature of study. Lack of detailed profile of morbidity and mortality pattern in the recruited patients is the major limitations of this study. There is a lack of follow-up of the patients.

  Conclusion Top

Compliance to IM BPG injections is of utmost importance in ensuring secondary prevention in RHD. The expected probability of noncompliance can be calculated from various demographic factors, and appropriate counseling can be given. SSP counseling should be an integral part of each health visit. Education and ensuring entrust in the importance and necessity of prophylaxis would improve compliance. A close nurse–doctor/patient relationship is important in improving adherence in clients with ARF/RHD. There is a dire need for registries of RHD or ARF to work toward its eradication. The findings of these studies could be useful in planning health promotion and disease control programs for ARF/RHD.

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Conflicts of interest

There are no conflicts of interest.

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  [Figure 1], [Figure 2], [Figure 3]

  [Table 1], [Table 2], [Table 3], [Table 4]

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