OUTCOMES OF COMMUNITY PHARMACIST’ CARDIOVASCULAR RISK INTERVENTION AMONG HIGH RISK RURAL DWELLERSHTML Full Text
OUTCOMES OF COMMUNITY PHARMACIST’ CARDIOVASCULAR RISK INTERVENTION AMONG HIGH RISK RURAL DWELLERS
U. D. Adje*1, C. A. Oparah 2, F. E. Williams 3 and E Akpovwovwo 4
Department of Clinical Pharmacy and Pharmacy Administration 1, Delta State University, Abraka, Nigeria.
Department of Clinical Pharmacy and Pharmacy Practice 2, University of Benin, Benin City, Nigeria.
Department of Clinical Pharmacy and Pharmacy Practice 3, University of Ilorin, Ilorin, Nigeria.
Drug Information Services 4, Delta State University Teaching Hospital, Oghara, Nigeria.
ABSTRACT: Community pharmacists are well placed to contribute to reduction of premature deaths from cardiovascular disease by implementing risk assessment and reduction strategies. The objective of this study was to assess outcomes of pharmacist's cardiovascular risk reduction intervention among high risk persons dwelling in a rural community. Cardiovascular risk reduction intervention was carried out among 45 high risk patients using a non-randomized before and after design. Blood pressure, total cholesterol, random blood sugar and BMI were measured. Intervention consisted of leaflet based patient education, referral to physician and provision of prescribed medications at no charge. Data were expressed as mean, standard deviation and 95% confidence interval. Differences between baseline and post intervention values were explored using paired t test. The primary outcome measure was change in cardiovascular risk category between baseline and end of study. The results show that there were significant differences in blood pressures at baseline vs. post-intervention, (184.74 ± 15.78 vs. 138.69 ± 13.57; P ˂ 0.001), and (102.17 ± 15.14 vs. 82.62 ± 9.45, P ˂ 0.001) for systolic and diastolic blood pressures respectively. There were no statistically significant differences in other clinical characteristics. Of the 9 males in high risk category at baseline, all were reclassified as low risk at the end of the study. At baseline 10 females in the high risk category were reclassified as low risk while 19 of the 23 in the very high risk category were reclassified as low risk (82.6%). These findings indicate that pharmacist's interventions lowered cardiovascular risk among high risk rural community dwellers.
Pharmacist’s intervention, Cardiovascular disease, Community dwellers, Risk assessment, Risk reduction
INTRODUCTION: Cardiovascular disease (CVD) is a major cause of death worldwide. The World Heart Federation projections indicate that by 2030, deaths from heart disease will reach an alarming 28.6 million annually 1-2.
Cardiovascular diseases claim more lives annually than all forms of cancers combined. Disability Adjusted Life Years (DALYs) lost due to cardiovascular disease ranks next only to HIV / AIDS. Mortality from CVD cuts across age, gender and socioeconomic status.
In fact, deaths from cardiovascular diseases among 15-35 age group in the United States of America is estimated to be 10.2 per 100,000 making it the 5th leading cause of death among this age group 3. Also, there is increasing prevalence of risk factors for cardiovascular disease in low income countries and an estimated 80% of deaths from cardiovascular disease are in these countries 4. Risk factor assessment is a critical first step in primary prevention of cardiovascular disease. There is sufficient evidence to prove that controlling risk factors reduces cardiovascular mortality5-8. Reducing cardiovascular risk requires prompt and sustained lifestyle interventions as well as drug therapy following evidence based approach. Access and availability are strong points that justify use of pharmacists in delivering preventive health services including cardiovascular risk assessment. Pharmacists have demonstrated effectiveness in the area of cardiovascular risk interventions at the level of the community pharmacy 9-13, but involvement in population based interventions is quite low. Population based risk assessment involves proactively targeting healthy persons within the population and inviting them for assessment.
Objective: The general objective of this study was to assess outcomes of the pharmacist’s interventions in cardiovascular risk reduction in the community. Specific objectives were to determine difference in blood pressure, blood glucose, and total cholesterol levels between baseline and end of study, and to evaluate pharmacotherapy components of intervention.
Setting: The setting of this study is Ezionum, a rural community in Ukwuani Local Government Area of the oil rich Delta state. Nigeria. The community has a primary health center that caters to their health needs. The general hospital located at Obiaruku, about 3 kilometres from the community serves as a referral centre for more serious cases. The community also serves as a site for Community Based Experience and Services (COBES) program for medical and nursing students of the Delta State University, Abraka. This study is a follow up to a general cardiovascular risk assessment carried out in the community.
MATERIALS AND METHODS:
Design: The study is a non- randomized single site before and after interventional study carried out between August 2015 and April 2016.
Patients / Population Inclusion and Exclusion Criteria: A total of 42 high CV risk category patients identified from a community wide general cardiovascular risk screening exercise using the WHO/ISH risk assessment charts were recruited for the study. All patients who met the inclusion criteria were evaluated. Inclusion criteria were: Adults 40 years to 80 years old and persons at high risk of cardiovascular events i.e. 10 year risk score of > 20 – 40%. Patients under active care of a physician, who were pregnant, below 40 years of age, unwilling to participate in the study or who were unlikely to be available for follow up were excluded from the study.
Data Collection Instruments: The main risk assessment tool was the WHO/ISH risk assessment chart for Africa D epidemiological zone 14. This was a country specific validated tool that makes use of age, gender, systolic blood pressure, smoking status, diabetes status and total non-fasting cholesterol in estimating cardiovascular risk. The point of intersection of systolic blood pressure and total serum cholesterol on the chart is colour coded to determine cardiovascular risk level. Demographic and clinical characteristics as well as risk score and risk category were entered into a data collection form designed for the study. Patients were evaluated after signing an informed consent form.
Intervention: Intervention consisted of leaflet based patient education focusing on risk factors and risk reduction strategies especially healthy lifestyle options. In addition subjects were also given a single page fact sheet relating to their specific risk factor. For subjects that were overweight a height and ideal weight chart was also made available to help them set weight targets. Referral to the physician was a critical component of the intervention. To facilitate the referral process, a cardiovascular risk assessment referral form detailing risk assessment data and reasons for referral was designed. Other measures adopted were: weekly telephone / text message reminders, and regular appointments with patients to review progress and resolve any medication related problems. Prescribed medications were also provided at no charge to indigent subjects for the duration of the study. Intervention period was 6 months.
Outcome Measures: The primary outcome measure was change in cardiovascular risk category between baseline and end of study. Secondary outcome measures were: Difference in levels of measured risk factors between baseline and end of study i.e. blood pressure, blood glucose, heart rate.
Data Analysis: Data were expressed as mean, standard deviation and 95% confidence interval. Differences between baseline and post intervention values were explored using paired t test. Predictors of high risk category were identified by performing multiple linear regression analysis. A p value of 0.05 was regarded as statistically significant.
Ethical Approval: Ethical approval was obtained from the Delta State University Health Research Ethics Committee, Oghara. Approval letter number DELSUTH/HREC/2015/038.
TABLE 1: DEMOGRAPHIC CHARACTERISTICS OF PATIENTS
|Characteristic||No % n = 42|
|I don't drink alcohol||11||18.4|
|Physical activities||0 times a week||4||9.5|
|Once a week||3||7.2|
|2 times a week||11||26.1|
|3 times a week||6||14.3|
|High blood pressure||14||33.3|
Demographic and Clinical Characteristics: A total of 45 patients at high risk of cardiovascular disease were recruited for the study. Of these, one patient had stroke before the end of the study and two patients were lost to follow up. Majority of the 42 patients that completed the study (78.6%) were females. The predominant age group was 51 to 60 years 15 (35.7%) followed by those in the above 70 age group 13 (31%). Majority 31 (81.5%) consumed alcohol and more than half 22 (53%) were engaged in moderate physical activity for at least 3 times a week. Only one third 14 (33.3%) correctly identified themselves to be hypertensive while 4 (22.8%) had diabetes. Demographic and clinical characteristics of patients at baseline are presented in Tables 1 and 2.
TABLE 2: CLINICAL CHARACTERISTICS OF PATIENTS AT BASELINE
|Characteristic No (%) n = 42|
|Blood Pressure Systolic|
|140 – 159||1 (2.3)|
|160 – 169||6 (14.3)|
|170 – 189||18 (42.9)|
|≥ 190||17 (40.5)|
|≤ 90||9 (21.4)|
|91 – 99||4(9.5)|
|100 – 109||17 (40.5)|
|110 – 119||5 (11.9)|
|≥ 120||7 (16.7)|
|Heart rate (bpm)|
|91 – 99||11(26.2)|
|Total cholesterol (mm /L)|
|1 – 4.9||26 (61.9)|
|5 – 8.0||16 (38.1)|
|Fasting blood glucose|
|≥ 7mmol/L||5 (11.9)|
|Body Mass Index|
|Less than 18.5 (Underweight)||2 (4.8)|
|18.5 – 25 (Normal)||18 (42.8)|
|˃ 25 – 29.9 (Overweight)||17 (40.5)|
|Male||N = 9|
|≤ 102 cm||5 (55.6)|
|˃ 102cm||4 (44.4)|
|Female||N = 33|
The clinical characteristics at end of study and the mean differences in values post intervention are shown in Tables 3 and 4. There were significant differences in systolic and diastolic blood pressures before and after intervention (184.74 ± 15.87 vs. 138 ± 13.57, P < 0.001 and 102.17 ± 15.14 vs. 82.62 ± 9.45 < 0.001) respectively. Though total cholesterol, heart rate, blood sugar levels, and waist circumference did not show significant differences, the upper limits of the 95% confidence interval for these variables showed moderate reductions at post intervention when compared to baseline, Table 5.
TABLE 3: CLINICAL CHARACTERISTICS OF PATIENTS AT END OF STUDY
|Characteristic||No (%) n = 42|
|Blood Pressure Systolic|
|120 – 139||18 (42.9)|
|140 – 159||17 (40.50)|
|≥ 160||6 (21.4)|
|≤ 80||8 (19.1)|
|80 – 89||19 (45.2)|
|90 – 99||14 (33.3)|
|≥ 100||1 (2.4)|
|Heart rate (bpm)|
|≤ 90||30 (71.4)|
|91 – 99||11 (26.3)|
|≥ 120||1 (2.3)|
|Total cholesterol (mm /L)|
|1 – 4.9||34(81.0)|
|5 – 8.0||8 (19.0)|
|Fasting blood glucose|
|‹ 7mmol/L||28 (66.7)|
|≥ 7mmol/L||14 (33.3)|
|Body Mass Index|
|Less than 18.5 (Underweight)||1 (2.4)|
|18.5 – 25 (Normal)||18 (42.8)|
|˃ 25 – 29.9 (Overweight)||16 (38.1)|
|Male||N = 9|
|≤ 102 cm||8 (88.9)|
|Female||N = 33|
TABLE 4: CLINICAL CHARACTERISTICS AT BASELINE AND POST INTERVENTION
n = 42
n = 42
|Systolic blood pressure||184.74± 15.87||138.69±13.57||15.848||˂0.001|
|Diastolic blood pressure||102.17± 15.14||82.61± 9.45||8.768||˂0.001|
|Total Cholesterol||4.45±0.97||4.40± 0.49||0.424||0.674|
|Heart rate||85.05± 12.94||83.74 ±9.95||1.431||0.160|
|Body Mass Index||25.76 ±4.77||25.99± 4.01||-0.617||0.515|
|Fasting blood sugar||6.00 ±2.26||7.16 ±2.17||-3.461||0.001|
|Waist Circumference||91.33 ±14.31||91.40±12.34||-102||0.919|
TABLE 5: CLINICAL CHARACTERISTICS AT BASELINE AND POST
|Clinical characteristic||Mean (95% CI)|
|Baseline||Post intervention||Baseline||Post intervention|
|Systolic blood pressure||178 (162.0-193.5)||140 (127.36-152.63)||187.56 (182-192.83)||139.21 (134.59-143.84)|
|Diastolic blood pressure||98.87 (77.34-120.41)||83.18 (77.23-89.01)||99.11 (99.1-107.76)||82.96 (79.33-86.60)|
|Total cholesterol||4.83 (3.67-5.97)||4.6 (4.60-4.70)||4.36 (4.05-4.66)||4.35 (4.17-4.53)|
|Heart rate||91.5 (78.16-104.83)||88 (88.04-95.95)||84.21 (79.92-88.51)||83.15 (79.53-86.78)|
|Body Mass Index||27.7 (23.03-32.49)||27.35 (22.88-31.79)||25.08 (23.44-26.73)||25.61 (24.29-26.93)|
|Fasting blood glucose||8.1 (4.4-11.76)||7.77 (6.35-7.84)||5.54 (5.17-5.90)||7.10 (6.35-7.84)|
|waist circumference||97.75 (83.50-112)||90.06 (85.11-95.02)||97.5 (85.58-109.41)||89.93 (85.70-94.12)|
Intervention Stratified by Gender: All males enrolled in the study had favourable risk category changes while 9.5% of females were at high risk at the end of the study despite intervention, Table 6.
TABLE 6: RISK CATEGORY AT THE END OF STUDY
Pharmacotherapy Component: All the subjects were on prescribed medications at the end of the study. Majority were on 2 or 3 drug combination therapy for hypertension at the end of study. There were more patients on ACEI followed by potassium sparing low dose diuretic and methyl dopa. Low dose aspirin was the sole anti-platelet agent which was prescribed for more than a quarter of the patients. All medications provided were generic brands and monthly cost of drug therapy ranged from N280 ($ 0.7) to N2360 ($ 5.9), Table 7 and 8.
TABLE 7: SUMMARY OF PRESCRIBED MEDICATIONS AT THE END OF STUDY
|Drug||No of patients
|No of tablets
|No of tablets per day||Cost per tab
|Cost of daily dose Naira|
|Amlodipine 10 mg||16(38.10)||1||1||14.29||14.29|
|Lisinopril 10 mg||22(52.38)||1||1||14.29||14.29|
|Nifedipine 20 mg||5(11.90)||1||2||15||30.000|
|Low dose aspirin||11(26.20)||1||1||4||4|
|2 drug s|
TABLE 8: COST OF DRUG THERAPY FOR PATIENTS AT END OF STUDY
|Drug combination||Cost per week / patient N*||Cost per month / patient N*|
|Amlodipine/ lisinopril / co amiloride||270||1080|
|Methyldopa, Lisinopril, Amlodipine / Co amiloride||590||2360|
|Atenolol/ Lisinopril / Amlodipine||410||1640|
|Nifedipine/ Lisinopril / Co amiloride||380||1520|
*N= Naira, 1 US $ = N400.00
DISCUSSION: The gender, alcohol consumption, tobacco use and physical activity pattern of high risk community dwellers was similar to that of the source population. The predominance of the 51-60 years age group followed by the above 70 age group can be explained by the fact that blood pressure rises with increasing age 15 and that risk charts employed for this study classifies most persons above 70 years as in the high risk category.
Clinical Characteristics of Subjects: The clinical characteristics evaluated were systolic and diastolic blood pressures, total non- fasting cholesterol, heart rate, body mass index, random blood sugar, waist circumference and cardiovascular risk category. Of these, only systolic and diastolic blood pressures showed significant reductions at the end of study. There was a significant reduction in mean fasting blood sugar level although this was not clinically significant as both values were within normal limits. Overall, other clinical variables did not show any significant differences between baseline and end of study. This profile suggests that the main determinants of cardiovascular risk in this community were age and blood pressure levels. Systolic blood pressure has been shown to be significantly associated with high risk category in both males and females in the general population 16-17 and in the elderly 18. Future interventions in this community should therefore focus more on blood pressure control.
Although there were subjects with high values of all the other variables measured both at the baseline and end of study, the proportion was small and did not contribute significantly to the overall mean. The fact that there were appreciable differences in the upper limits of the 95% confidence intervals for total cholesterol, heart rate and waist circumference at end of study compared to baseline may suggest that extending the duration of intervention might have produced statistically significant differences.
All the subjects received their prescribed medications at the end of the study. Majority were on 2 or 3 drug combination therapy for hypertension at the end of study. For patients at high risk of cardiovascular events, combination therapy with at least 3 drugs has been shown to effectively reduce blood pressure and ensure positive cardiovascular outcomes 19 - 20.
CONCLUSION: Pharmacist’s intervention resulted in significant improvements in some clinical characteristics and lowered cardiovascular risk among rural community dwellers. This might suggest that community pharmacists could play a more significant role in cardiovascular risk reduction. The limitations of this study include the fact that the WHO / ISH risk assessment charts may underestimate risk in specified population groups including very obese patients, elderly female population and persons already on antihypertensive medications. Also a longer duration of intervention might have impacted better on measured clinical characteristics.
AKNOWLEDGEMENT: The authors are grateful the Nigerian government Tertiary Education Trust Fund (TETFUND) grant for supporting this work.
CONFLICT OF INTEREST: The authors confirm that there is no conflict of interest associated with this work.
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How to cite this article:
Adje UD, Oparah CA, Williams FE and Akpovwovwo E: Outcomes of community pharmacist’ cardiovascular risk intervention among high risk rural dwellers. Int J Pharm Sci Res 2017; 8(12): 5353-59.doi: 10.13040/IJPSR.0975-8232.8(12).5353-59.
All © 2013 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.
U. D. Adje*, C. A. Oparah, F. E. Williams and E. Akpovwovwo
Department of Clinical Pharmacy and Pharmacy Administration, Delta State University, Abraka, Nigeria.
17 April, 2017
12 June, 2017
29 June, 2017
01 December, 2017