- Email: [email protected]
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria
Public Health (2005) 119, 792–798
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria W.O. Erhuna,*, E.O. Agbanib, E.E. Bolajic a
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria b Department of Clinical and Administrative Pharmacy, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria c Comprehensive Health Centre, Sabo Ile-Ife, Nigeria Received 29 April 2004; received in revised form 12 October 2004; accepted 28 November 2004 Available online 29 June 2005
KEYWORDS Pharmacist; Hypertension; Combination diuretic; Clinical outcome; Nigeria
Summary Objective: The aim of this study was to determine whether the provision of further practice-based support by pharmacists will bring about improved outcomes for blood pressure (BP) control in middle-aged and elderly Nigerian hypertensive patients managed with combination diuretics (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) and/or methyl dopa at the primary care level. Design and setting: This was a 1-year prospective, randomized cohort study of the outpatients of a state comprehensive health centre in South-western Nigeria. Free primary health services including free drugs were provided for all patients. Patients and method: The study population comprised 51 Nigerian patients with uncomplicated hypertension aged 45 years or more, with a 0.2–3.0-year history of hypertension, registered at the Comprehensive Health Centre, Ife between October 2002 and March 2003. They were invited into the pharmacist-managed hypertension clinic and followed for the study period. Participating pharmacists counselled for current medication, personalized goals of lifestyle modification stressing weight loss and/or increased activity, increased patient awareness by providing relevant education about hypertension and associated/related diseases, adjusted drug therapy to optimize effectiveness and minimize adverse events, utilized treatment schedules that enhanced patients’ adherence to therapy, and monitored treatment outcomes between enrolment and return visits. Patient satisfaction and the number of treatment failures within 6 months post enrolment were compared with retrospective data from our earlier study involving physician-managed patients under a similar setting. Results: Uncontrolled BP reduced from 92 to 36.2% by 10.15G5.02 days after enrolment. Treatment failures were observed at 5.9% of the total return visits (nZ184) within 6 months.
* Corresponding author. Tel.: C234 803 7233 500. E-mail address: [email protected] (W.O. Erhun).
0033-3506/$ - see front matter Q 2005 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.puhe.2004.11.009
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria
793
Conclusion: Pharmacist-managed hypertension clinics can improve BP control, reduce treatment failure and increase patient satisfaction. Q 2005 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved.
Introduction A large proportion of hypertensive patients in Nigeria live with untreated or uncontrolled blood pressure (BP), although reductions in elevated BP have been shown to reduce the risk of cardiovascular mortality and morbidity.1 While there is considerable evidence for the benefit of drug treatment in reducing BP,2 published guidelines for the management of hypertensive patients recommend that strategies should be implemented at the primary care level.3,4 Pharmacy-based programmes are cost effective, can be used to determine the ideal drug and when/how it should be used, and can provide ancillary programmes to support appropriate physician prescribing and optimal patient adherence.5 A recent investigation into BP control in hypertensive Nigerian blacks managed with alpha methyldopa and combination diuretics at the primary care level6 revealed a treatment gap; only 37.5% of the studied patients had controlled BP after their first treatment, and 10.2 and 4% of the study population needed three and five treatments within 6 months, respectively, to achieve target BP levels. In nearly all cases, diuretic therapy was not individualized and lifestyle modification was not prioritized.6 A pharmacist-managed hypertension clinic was therefore set up in the facility as an intervention. We report the benefits of the provision of additional practice-based support by pharmacists at the health centre facility on BP control in this low-income population. This is the first report on this topic in Nigeria.
Methods This was a 1-year prospective, randomized cohort study of the outpatients of a state comprehensive health centre in South-western Nigeria. Free primary health services including free drugs were provided for all patients. The study population comprised 51 Nigerian patients with uncomplicated hypertension aged 45 years or more, with a 0.2–3year history of hypertension, registered at the Comprehensive Health Centre, Ife between October 2002 and March 2003. They were invited into
the pharmacist-managed hypertension clinic and followed for at least 12 months. Treatment was with methyl dopa 250 mg and/or combination diuretic (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) and/or a combination in two different regimens. Methyldopa has been evaluated most extensively, but both drugs have long-term proven efficacy and safety profiles.7–9 Resistant cases were referred to hypertension specialists within 6 weeks. The patients of this study were diagnosed and initiated on drug therapy by physicians before enrolment into the clinic. Participating pharmacists measured the patients’ BP with a validated device and recorded patients’ demographics and medical history. Exclusion criteria were: hypertension; pregnancy; aged less than 45 years; or initially prescribed with other antihypertensives besides methyl dopa 250 mg and/or combination diuretic (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) or a combination in two different regimens. Participating pharmacists counselled for current medication, personalized goals of lifestyle modification stressing weight loss and/or increased activity, increased patient awareness by providing relevant education about hypertension and associated/related diseases, adjusted drug therapy to optimize effectiveness and minimize adverse events, utilized treatment schedules that enhanced patients’ adherence to therapy, and monitored treatment outcomes between enrolment and return visits. Patient satisfaction and the number of treatment failures (TRM-F, i.e. the number of patients with uncontrolled BP) within 6 months of enrolment were compared with retrospective data from our earlier study involving physicianmanaged patients under a similar setting. Missing at least one dose between visits was defined as a missed-dose incident (M-DI). Patients were considered to have hypertension when mean systolic BP (SBP) was R140 mmHg and/or mean diastolic BP (DBP) was R90 mmHg, according to the report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure (JNC-VI).7 Midway into the study, patients were asked to grade their level of satisfaction [3 (very satisfied), 2 (satisfied), 1 (undecided yet) or 0 (dissatisfied)]
794
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and to indicate whether they preferred the clinic or a conventional visit to hospital. ‘Wait time’ before seeing the physician on enrolment days was compared with wait time for exclusive visits to the clinic. Statistical analysis was performed using SPSS version 10.0 software. Chi-squared test and paired sample Student’s t-test were used to test for statistical significance for categorical data and quantitative data, respectively. Cross-tabulation statistics and bivariate correlation were used to measure the association and investigate linear relationships between variables, respectively. Predictor4criterion modelling was by bivariate regression analysis.
Results Fifty-one patients were enrolled in the study; 15 males and 36 females. Of these, 33.3, 43.1 and 19.6% were normal weight, overweight and obese, respectively, and only 3.9% suffered from extreme obesity at enrolment according to ‘Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report’.8 The patients were either nonalcohol drinkers or did so at a frequency and volume that was considered to be inconsequential.10 About 63% (62.7) of the patients had a primary education and only 5.9% had post secondary education; the rest of the population were either educated to secondary level (19.6%) or had no formal education (11.8%). The majority (80.4%) of the study
population were farmers or traders, and 19.6% were civil servants. Most (88.2%) of the study population claimed to be married, and 11.8% stated that they were either divorced or separated. All the patients were found to eat high calorie foods on a regular basis, 62.7% majorly on carbohydrates and protein on a daily basis. About half (47.1%) of the patients agreed that the disease had affected their life notably, while 52.9% claimed that their work or social life had not really changed since they were diagnosed. Table 1 gives further details of the patients’ demographics and medical records at study enrolment. The second visit was made 10.15G5.02 days after enrolment, and only 54.9% of these were scheduled. Similarly, the third and fifth visits were made 39.33G16.13 and 159.93G32.62 days after enrolment, with 42.1 and 60.4% being scheduled visits, respectively. BP control within the population at the second, third, fourth and fifth visits is shown in Fig. 1 and Table 2. In total, the 51 patients made about 235 visits to the clinic within the first 6 months, and the treatment plan was observed to be failing on 11 occasions (Fig. 1). Patients’ BPs responded well to treatment in 173 of the total return visits made during this period. Patients classified as overweight at enrolment constituted 64.7, 57.1, 75 and 100% of the TRM-F observed for the second, third, fourth and fifth visit, respectively. Similarly, TRM-F values for other BMI groups were as follows: obese, 17.6, 14.3, 0 and 0%; extremely obese, 0, 0, 0 and 0%; normal weight, 17.6, 28.6, 25.0 and 0%.
Table 1 Selected patients’ medical records and demographics in the prospective study of hypertensive patients at primary care level.
Mean SD Median Mode Variance Skewness SE of skewness Minimum Maximum a
Patients’ PCV (%)
Patients’ weight (kg)
Patients’ height (inches)
Reduction in patient weight (kg/week)
No. of days for which a reduction was observed
Patients’ age
Patients’ protein level from urine analysis (mg/dl)
Patients’ glucose level from urine analysis (mg/dl)
67.48 11.96 69.00 69.00a 142.96 0.13 0.33
62.71 2.76 64.00 65.00 7.61 K0.53 0.33
0.48 0.82 0.50 1.10 0.67 K1.83 0.45
22.78 5.87 20.00 19.00 34.49 1.21 0.45
60.86 8.31 60.00 67.00a 69.00 K0.13 0.33
2.44 8.23 0.00 0.00 67.69 3.15 0.39
50.1667 36.71 141.8687 10.11 0.0000 40.00 0.00 36.00a 20,126.7143 102.21 2.873 K03.34 0.393 0.42
49.00 92.00
58.00 66.00
K1.80 1.10
18.00 34.00
45.00 73.00
0.00 30.00
Multiple modes exist. The smallest value is shown. PCV-Packed cell volume
0.00 500.00
0.00 45.00
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria
795
Figure 1 Control of blood pressure (BP) at enrolment and return visits in hypertensive patients for which ‘preceding visit’ treatment dose/regimen was sustained [TRM (M)], decreased [TRM (R)] or increased [TRM (F)] in a pharmacistmanaged hypertension clinic. **Significant reduction in systolic (P!0.01) and diastolic (P!0.05) BP relative to baseline. Reproduce 12 cm wide, mono. Do not include title within figure.
Cross-tabulation of the number of M-DIs and the patient’s baseline BMI group showed that 35.6, 35.3 and 66.7% of the M-DI cases for the second, third and fourth visits, respectively, were by normalweight patients. Similarly, M-DI values in other patients’ BMI groups were as follows: overweight, 378, 23.5 and 33.3%; obese, 2.2, 29.4 and 0%; extremely obese, 4.4, 11.8 and 0% for the second, third and fourth visits, respectively. Paired sample t-test revealed a significant decrease in SBP (P!0.01) and DBP (P!0.05) of returning patients at successive visits relative to enrolment values (Table 2). Patient satisfaction determined by interview and questionnaire showed that 97.5% of the patients were ‘very satisfied’ with treatment, 2.5% were ‘satisfied’, none were ‘dissatisfied’ and over 78% preferred the clinic to conventional ‘time-consuming visits’ to hospital. The time spent with physicians before enrolment into the clinic ranged from 5 to 15 min, and the time spent with pharmacists on visits after enrolment ranged from 17 to 29 min.
Discussion Supposition from the retrospective study of Erhun et al.6 showed that hypertensive Nigerian blacks ignore routine check ups and seldom go to clinic except when highly inconvenienced by the disease. This may explain the high level of unchecked BP in
patients managed by physicians at the health centre during the years covered by the retrospective study,6 and it perhaps explains why a number of the patients enrolled into this study did not attend again after at least one normal BP reading (Fig. 1) despite the education provided on the chronic nature of the disease and the need for continuity in management. Low-income patients in Nigeria rely heavily on primary health centres, which are assisted by government funds to varying degrees. These centres are often congested, making hospital visits ‘a whole day task’ for many patients. Our study found that this was a major reason (65%) why patients did not attend routine check ups. The intervention (pharmacist-managed hypertension clinic) enhanced patient satisfaction. The decreased waiting time, relevant counselling and more time spent with the patients created a good impact and impression that may account for the improved BP control (Fig. 1 and Table 2) and the increasing number of patients returning for scheduled check ups. These observations are supported by the outcome data of similar studies.11–15 Time is an important factor in providing the level of education, drug counselling and follow-up care required by hypertensive patients to ensure that their drug regimen is providing adequate BP control without adverse effects. When patients’ waits for medical attention are prolonged, the impact is often negative16,17 and may inhibit patients’ responses and compliance with treatment schedules.
126.20G 06.20 119.00 K0.32 116.00 134.00 80.60G 04.66 78.00a K0.63 74.00 88.00 0.00G 0.00 0.00 0.00 0.00 0.00 127.94G 07.37 130.00a K1.10 110.00 137.00 82.42G 06.83 81.00 0.56 68.00 102.00 11.44G 19.61 0.00 01.77 0.00 52.00 140.71G 22.42 119.00 0.72 110.00 185.00 86.62G 11.81 81.00 01.13 68.00 118.00 a
Multiple modes exist. The smallest value is shown.
01.31G 02.17 0.00 01.49 0.00 7.00 144.66G 17.65 88.00 1.42 121.00 209.00 91.02G 12.45 139.00 0.93 62.00 195.00 167.90G 30.32 156.00 0.17 97.00 230.00 103.09G 32.09 78.00 01.34 62.00 195.00 MeanG SD Mode Skewness Minimum Maximum
Systolic BP Diastolic BP Diastolic BP Systolic BP Diastolic BP
Systolic BP
Missed doses
Diastolic BP
Systolic BP
Missed doses
Diastolic BP
Systolic BP
Missed doses
Fifth visit Fourth visit Third visit Second visit Enrolment point
Efficacy index: variation in blood pressure with clinic visit in patients managed by the pharmacist-led hypertension clinic. Table 2
0.00G 0.00 0.00 0.00 0.00 0.00
W.O. Erhun et al. Missed doses
796
Hypertensive patients often avoid physical exertion, perhaps because they are afraid that it will do them harm.18 However, daily engagements in mild exercise have been shown to produce modest falls in BP in these patients.19 This study provided a variety of schedules for patients to get active and shed excess weight, such as performing home chores often left to children and going for a morning/evening walk. The result showed a mild correlation between weight reduction and decreasing SBP that was significant only at the second [rZK0.298, sig. (two-tailed)Z0.042] and fourth [rZ0.487, sig. (two-tailed)Z0.047] visits within the first 6 months. Some patients actually gained weight during the study period; a cross-tabulation of the control of hypertension at return visits with patients’ BMI showed that 70% of the obese and 100% of the extremely obese patients had their BP under control by the second visit, while by the third visit, 80% of the obese and 100% of the extremely obese had controlled BP. Weight loss in obese, hypertensive patients may reduce BP by about 1.6/1.3 mmHg per kg loss and, in addition, may also improve lipid profile and insulin resistance.20 The reduction in dietary sodium, abstinence from alcohol, kola nuts and cigarettes, individualized, monitored weight reduction programme involving caloric restriction and increased physical activity, and personalized drug therapy emphasized in the study were factors in the positive benefits produced in these patients. The results of this study appear to show that BMI is a significant singular predictor of treatment outcomes in hypertension management. Although the normal-weight patients reported the highest occurrence of M-DI within the first 6 months, we observed low TRM-F values in this group. This is worthy of note because high M-DIs did not invoke high TRM-F values. Contrarily, we found the highest TRM-F values in the overweight patients who constituted 23.5–37.8% of the patients missing doses between successive appointments; total compliance with non-pharmacological management schedules may thus have produced improved results in this group, similar to obese and extremely obese patients. Predictor influences of the sharp increase in the number of missed doses recorded for the third visit (Table 2) investigated by bivariate regression analysis revealed that about half (47.3%) of the variances observed in BP values at the third visit were associated with doses missed [rZ0.688, r2Z0.473, F(2,42)Z18.87, P!0.01, standard error of estimateZ1.61]. Failure to follow a prescribed drug dose/regimen have previously been implicated in about 50% of patients with non-responding high
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria BP,21,22 and may be attributable to a number of factors of which cost, complex drug regimen and inadequate education were controlled during our study. Some patients (9%) could not tolerate the diuretic effect of the therapy. They complained of frequent urination ranging from two to seven times at night. Responsive counselling and a regimen adjustment for these patients had a noticeable impact as none of them reported missing a dose at the fourth and fifth visits (Table 2). Comparison of the results of this study with our retrospective study6 on physician-managed patients under the same setting (reported previously) shows a marked decrease in treatment failures and a finely tuned rise in patient compliance and satisfaction. Over 60% of the return visits were earlier than or as scheduled. This may indicate patients’ confidence in the clinic/pharmacists, as over 52% of these patients claimed to be functionally unaffected by the disease. The authors also considered patients’ comments such as ‘I feel considerably better these days’, ‘Thank you for the attention’ and ‘Why have you not started this before now?’ as evidence of patient satisfaction and the positive benefit of the clinic. Although considered poor, the patients were often willing to give money or offer gifts unsolicited as a sign of their appreciation for the intervention. In the cultural setting of this study, this is a common way of showing appreciation. Although studies indicating the apathy of general practitioners have been reported,23 pharmacistmanaged disease state management clinics are meeting with huge success worldwide. Positive patient outcomes are commonplace, for example, within the Indian Health System (IHS) pharmacybased disease management clinics.24 Pharmacists at individual IHS facilities develop and implement many types of chronic disease management clinics. Organized at local level, these clinics usually have low ‘start-up’ costs, thus helping to promote pharmacy initiatives as cost-conscious programmes.24–26 One example of a pharmacistinitiated and-operated disease state management clinic is the Seizure Clinic at the Northern Navajo Medical Center in Shiprock, New Mexico. Established in 1998, the clinic manages about 150 patients and has documented reduced numbers of adverse events with these patients. Likewise, the pharmacy-based Tohatchi Health Center Hypertension Management Clinic (HMC), serving the Navajo community north of Gallup, New Mexico, has been able to control BP at twice the national average. Approximately 50 patients/year are actively followed in the HMC after being diagnosed by a staff physician.24–26 However, in a related study, Flobbe
797
et al. showed that pharmacists need to be provided with specific training in the application and interpretation of screening procedures, and in the implementation of quality control measures to reduce the number of false referrals or nonreferrals and quality of the service.27 The expanding role of the pharmacist can be beneficial to physicians, pharmacists and patients. The training of Nigerian pharmacists would need to be further tailored to gain physicians’ confidence while meeting these extended responsibilities.
Conclusion The pharmaceutical service provided by a pharmacist-managed hypertension clinic improved BP control, reduced treatment failures and recorded remarkable patient satisfaction. The impact of this intervention on clinical outcomes such as mortality and morbidity will be the focus of further studies.
Acknowledgements The authors acknowledge the support of the Medical Officer and clinic staff of the Comprehensive Health Centre, Sabo, Ile-Ife as well as the support of the Hospital Management Board, Osogbo, Osun State, Nigeria.
References 1. Collins R, Peto R, MacMahon S, Hebert P, Fiebach NH, Eberlein KA, Godwin J, Qizilbash N, Taylor JO, Hennekens CH. Blood pressure, stroke and coronary heart disease. Part 2. Short-term reductions in blood pressure: overview of randomised drug trials in epidemiological context. Lancet 1990;335:827–38. 2. Ramsay LE, Williams B, Johnston GD, MacGregor GA, Poston L, Potter JF, Poulter NR, Russell G. British hypertension society guidelines for hypertension management : summary. BMJ 1999;319:630–5. 3. Department of Health. Health Survey for England. London: Department of Health; 1998. 4. Scottish Health Statistics 2000. Web resource. Edinburgh. http://www.show.scot.nhs.uk/isd/scotish_health_statistics/SHS2000/home.htm. 5. Sclar DA. Disease state management: an overview for the managed care pharmacist. Drug Benefit Trends 1996;7: 10–11. 6. Erhun WO, Agbani EO, Bolaji EE. Managing hypertension with combination diuretics and methyldopa in Nigerian blacks at the primary care level. Clin Drug Invest 2003;23:583–90. 7. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Arch Intern Med 1997;157:2413–2446.
798 8. National Heart Lung and Blood Institute (NHLBI) obesity education imitative: Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report, NIH Publication No. 98-4083, National Institutes of Health; 1998. 9. MRC Working Party. Medical Research Council trial of treatment of hypertension in older adults: principal results. BMJ 1992;304:405–41. 10. Klatsky AL, Friedman GD, Siegelaub AB, Gerard MJ. Alcohol consumption and blood pressure. N Engl J Med 1977;296: 1194. 11. Okamoto MP, Nakahiro RK. Pharmacoeconomic evaluation of a pharmacist-managed hypertension clinic. Pharmacotherapy 2001;21:1337–44. 12. McKenney JM, Slining JM, Henderson HR, Devins D, Barr M. The effect of clinical pharmacy services on patients with essential hypertension. Circulation 1973;48:1104–11. 13. Schneider PJ, Larrimer JN, Visconti JA, Miller WA. Role effectiveness of a pharmacist in the maintenance of patients with hypertension and congestive heart failure. Contemp Pharm Pract 1982;5:74–9. 14. Carter BL, Barnette DJ, Chrischilles E, Mazzotti GJ, Asali ZJ. Evaluation of hypertensive patients after care provided by community pharmacists in a rural setting. Pharmacotherapy 1997;17:1274–85. 15. Reinders TP, Rush DR, Baumgartner Jr RP, Graham AW. Pharmacist’s role in management of hypertensive patients in an ambulatory care clinic. Am J Hosp Pharm 1975;32:590–4. 16. Afolabi MO, Erhun WO. Patients response to waiting time in an outpatients pharmacy in Nigeria. Trop J Pharm Res; Dec. 2003;2(2):207–14. 17. Kiyohara LY, Kayano LK, Kobayashi KL, Alessi MS, Yamamoto MU, Yunes-Filho PR, Pessoa RR, Mandelbaum R,
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Okubo ST, Watanuki T, Vieira JE. The patient-physician interactions as seen by undergraduate medical students. Sao Paulo Med 2001;119:97–100. Spencer C, Lip G. Management of the hypertensive patient. Pharm J; Sept. 1999;263:383–386. Shaper AG, Wannamethee G, Walker M. Physical activity hypertension and risk of heart attack in men without evidence of ischaemic heart disease. J Hum Hypertens 1994;8:3. Staessen J, Faggard R, Linjen P, Amery A. Body weight, sodium intake and blood pressure. Ibid 1989;7(Suppl. 1):19. Setaro JF, Black HR. Refractory hypertension. N Engl J Med 1992;327:543–7. Miller NH, Hill M, Kottke T, Ockene IS. The multilevel compliance challenge: recommendations for a call to action. A statement for healthcare professionals, AHA special report. Circulation 1997;95:1085–90. Hampton A, Wilson A, Hussain M. Measuring blood pressure in an inner city pharmacy: an attempt at coordination with general practice. Fam Pract 1990;7:52–5. Giberson S, Cox T. Indian Health Service: Leader in Pharmaceutical Services. www.hhs.gov/pharmacy/pdf/ giberson.pdf Paavola FG, Dermanoski KR, Pittman RE. Pharmaceutical service in the United States Public Health Service. Am J Health Syst Pharm 1997;54:766–72. Church RM, Dermanoski KR, Pukas TB. Pharmacy practice roles in the US Public Health Service: a portrait of diversity. J Pharm Pract 1990;3:389–97. Flobbe K, IJsselmuiden CB, Rheeder P, Gerber JJ, Lubbe M. The pharmacy screening project-an evaluation of pharmacybased screening programmes. S Afr Med J 1999;89:980–6.
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria W.O. Erhuna,*, E.O. Agbanib, E.E. Bolajic a
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Nigeria b Department of Clinical and Administrative Pharmacy, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria c Comprehensive Health Centre, Sabo Ile-Ife, Nigeria Received 29 April 2004; received in revised form 12 October 2004; accepted 28 November 2004 Available online 29 June 2005
KEYWORDS Pharmacist; Hypertension; Combination diuretic; Clinical outcome; Nigeria
Summary Objective: The aim of this study was to determine whether the provision of further practice-based support by pharmacists will bring about improved outcomes for blood pressure (BP) control in middle-aged and elderly Nigerian hypertensive patients managed with combination diuretics (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) and/or methyl dopa at the primary care level. Design and setting: This was a 1-year prospective, randomized cohort study of the outpatients of a state comprehensive health centre in South-western Nigeria. Free primary health services including free drugs were provided for all patients. Patients and method: The study population comprised 51 Nigerian patients with uncomplicated hypertension aged 45 years or more, with a 0.2–3.0-year history of hypertension, registered at the Comprehensive Health Centre, Ife between October 2002 and March 2003. They were invited into the pharmacist-managed hypertension clinic and followed for the study period. Participating pharmacists counselled for current medication, personalized goals of lifestyle modification stressing weight loss and/or increased activity, increased patient awareness by providing relevant education about hypertension and associated/related diseases, adjusted drug therapy to optimize effectiveness and minimize adverse events, utilized treatment schedules that enhanced patients’ adherence to therapy, and monitored treatment outcomes between enrolment and return visits. Patient satisfaction and the number of treatment failures within 6 months post enrolment were compared with retrospective data from our earlier study involving physician-managed patients under a similar setting. Results: Uncontrolled BP reduced from 92 to 36.2% by 10.15G5.02 days after enrolment. Treatment failures were observed at 5.9% of the total return visits (nZ184) within 6 months.
* Corresponding author. Tel.: C234 803 7233 500. E-mail address: [email protected] (W.O. Erhun).
0033-3506/$ - see front matter Q 2005 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.puhe.2004.11.009
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria
793
Conclusion: Pharmacist-managed hypertension clinics can improve BP control, reduce treatment failure and increase patient satisfaction. Q 2005 The Royal Institute of Public Health. Published by Elsevier Ltd. All rights reserved.
Introduction A large proportion of hypertensive patients in Nigeria live with untreated or uncontrolled blood pressure (BP), although reductions in elevated BP have been shown to reduce the risk of cardiovascular mortality and morbidity.1 While there is considerable evidence for the benefit of drug treatment in reducing BP,2 published guidelines for the management of hypertensive patients recommend that strategies should be implemented at the primary care level.3,4 Pharmacy-based programmes are cost effective, can be used to determine the ideal drug and when/how it should be used, and can provide ancillary programmes to support appropriate physician prescribing and optimal patient adherence.5 A recent investigation into BP control in hypertensive Nigerian blacks managed with alpha methyldopa and combination diuretics at the primary care level6 revealed a treatment gap; only 37.5% of the studied patients had controlled BP after their first treatment, and 10.2 and 4% of the study population needed three and five treatments within 6 months, respectively, to achieve target BP levels. In nearly all cases, diuretic therapy was not individualized and lifestyle modification was not prioritized.6 A pharmacist-managed hypertension clinic was therefore set up in the facility as an intervention. We report the benefits of the provision of additional practice-based support by pharmacists at the health centre facility on BP control in this low-income population. This is the first report on this topic in Nigeria.
Methods This was a 1-year prospective, randomized cohort study of the outpatients of a state comprehensive health centre in South-western Nigeria. Free primary health services including free drugs were provided for all patients. The study population comprised 51 Nigerian patients with uncomplicated hypertension aged 45 years or more, with a 0.2–3year history of hypertension, registered at the Comprehensive Health Centre, Ife between October 2002 and March 2003. They were invited into
the pharmacist-managed hypertension clinic and followed for at least 12 months. Treatment was with methyl dopa 250 mg and/or combination diuretic (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) and/or a combination in two different regimens. Methyldopa has been evaluated most extensively, but both drugs have long-term proven efficacy and safety profiles.7–9 Resistant cases were referred to hypertension specialists within 6 weeks. The patients of this study were diagnosed and initiated on drug therapy by physicians before enrolment into the clinic. Participating pharmacists measured the patients’ BP with a validated device and recorded patients’ demographics and medical history. Exclusion criteria were: hypertension; pregnancy; aged less than 45 years; or initially prescribed with other antihypertensives besides methyl dopa 250 mg and/or combination diuretic (amiloride hydrochloride 5 mgChydrochlorothiazide 50 mg) or a combination in two different regimens. Participating pharmacists counselled for current medication, personalized goals of lifestyle modification stressing weight loss and/or increased activity, increased patient awareness by providing relevant education about hypertension and associated/related diseases, adjusted drug therapy to optimize effectiveness and minimize adverse events, utilized treatment schedules that enhanced patients’ adherence to therapy, and monitored treatment outcomes between enrolment and return visits. Patient satisfaction and the number of treatment failures (TRM-F, i.e. the number of patients with uncontrolled BP) within 6 months of enrolment were compared with retrospective data from our earlier study involving physicianmanaged patients under a similar setting. Missing at least one dose between visits was defined as a missed-dose incident (M-DI). Patients were considered to have hypertension when mean systolic BP (SBP) was R140 mmHg and/or mean diastolic BP (DBP) was R90 mmHg, according to the report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure (JNC-VI).7 Midway into the study, patients were asked to grade their level of satisfaction [3 (very satisfied), 2 (satisfied), 1 (undecided yet) or 0 (dissatisfied)]
794
W.O. Erhun et al.
and to indicate whether they preferred the clinic or a conventional visit to hospital. ‘Wait time’ before seeing the physician on enrolment days was compared with wait time for exclusive visits to the clinic. Statistical analysis was performed using SPSS version 10.0 software. Chi-squared test and paired sample Student’s t-test were used to test for statistical significance for categorical data and quantitative data, respectively. Cross-tabulation statistics and bivariate correlation were used to measure the association and investigate linear relationships between variables, respectively. Predictor4criterion modelling was by bivariate regression analysis.
Results Fifty-one patients were enrolled in the study; 15 males and 36 females. Of these, 33.3, 43.1 and 19.6% were normal weight, overweight and obese, respectively, and only 3.9% suffered from extreme obesity at enrolment according to ‘Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: the Evidence Report’.8 The patients were either nonalcohol drinkers or did so at a frequency and volume that was considered to be inconsequential.10 About 63% (62.7) of the patients had a primary education and only 5.9% had post secondary education; the rest of the population were either educated to secondary level (19.6%) or had no formal education (11.8%). The majority (80.4%) of the study
population were farmers or traders, and 19.6% were civil servants. Most (88.2%) of the study population claimed to be married, and 11.8% stated that they were either divorced or separated. All the patients were found to eat high calorie foods on a regular basis, 62.7% majorly on carbohydrates and protein on a daily basis. About half (47.1%) of the patients agreed that the disease had affected their life notably, while 52.9% claimed that their work or social life had not really changed since they were diagnosed. Table 1 gives further details of the patients’ demographics and medical records at study enrolment. The second visit was made 10.15G5.02 days after enrolment, and only 54.9% of these were scheduled. Similarly, the third and fifth visits were made 39.33G16.13 and 159.93G32.62 days after enrolment, with 42.1 and 60.4% being scheduled visits, respectively. BP control within the population at the second, third, fourth and fifth visits is shown in Fig. 1 and Table 2. In total, the 51 patients made about 235 visits to the clinic within the first 6 months, and the treatment plan was observed to be failing on 11 occasions (Fig. 1). Patients’ BPs responded well to treatment in 173 of the total return visits made during this period. Patients classified as overweight at enrolment constituted 64.7, 57.1, 75 and 100% of the TRM-F observed for the second, third, fourth and fifth visit, respectively. Similarly, TRM-F values for other BMI groups were as follows: obese, 17.6, 14.3, 0 and 0%; extremely obese, 0, 0, 0 and 0%; normal weight, 17.6, 28.6, 25.0 and 0%.
Table 1 Selected patients’ medical records and demographics in the prospective study of hypertensive patients at primary care level.
Mean SD Median Mode Variance Skewness SE of skewness Minimum Maximum a
Patients’ PCV (%)
Patients’ weight (kg)
Patients’ height (inches)
Reduction in patient weight (kg/week)
No. of days for which a reduction was observed
Patients’ age
Patients’ protein level from urine analysis (mg/dl)
Patients’ glucose level from urine analysis (mg/dl)
67.48 11.96 69.00 69.00a 142.96 0.13 0.33
62.71 2.76 64.00 65.00 7.61 K0.53 0.33
0.48 0.82 0.50 1.10 0.67 K1.83 0.45
22.78 5.87 20.00 19.00 34.49 1.21 0.45
60.86 8.31 60.00 67.00a 69.00 K0.13 0.33
2.44 8.23 0.00 0.00 67.69 3.15 0.39
50.1667 36.71 141.8687 10.11 0.0000 40.00 0.00 36.00a 20,126.7143 102.21 2.873 K03.34 0.393 0.42
49.00 92.00
58.00 66.00
K1.80 1.10
18.00 34.00
45.00 73.00
0.00 30.00
Multiple modes exist. The smallest value is shown. PCV-Packed cell volume
0.00 500.00
0.00 45.00
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria
795
Figure 1 Control of blood pressure (BP) at enrolment and return visits in hypertensive patients for which ‘preceding visit’ treatment dose/regimen was sustained [TRM (M)], decreased [TRM (R)] or increased [TRM (F)] in a pharmacistmanaged hypertension clinic. **Significant reduction in systolic (P!0.01) and diastolic (P!0.05) BP relative to baseline. Reproduce 12 cm wide, mono. Do not include title within figure.
Cross-tabulation of the number of M-DIs and the patient’s baseline BMI group showed that 35.6, 35.3 and 66.7% of the M-DI cases for the second, third and fourth visits, respectively, were by normalweight patients. Similarly, M-DI values in other patients’ BMI groups were as follows: overweight, 378, 23.5 and 33.3%; obese, 2.2, 29.4 and 0%; extremely obese, 4.4, 11.8 and 0% for the second, third and fourth visits, respectively. Paired sample t-test revealed a significant decrease in SBP (P!0.01) and DBP (P!0.05) of returning patients at successive visits relative to enrolment values (Table 2). Patient satisfaction determined by interview and questionnaire showed that 97.5% of the patients were ‘very satisfied’ with treatment, 2.5% were ‘satisfied’, none were ‘dissatisfied’ and over 78% preferred the clinic to conventional ‘time-consuming visits’ to hospital. The time spent with physicians before enrolment into the clinic ranged from 5 to 15 min, and the time spent with pharmacists on visits after enrolment ranged from 17 to 29 min.
Discussion Supposition from the retrospective study of Erhun et al.6 showed that hypertensive Nigerian blacks ignore routine check ups and seldom go to clinic except when highly inconvenienced by the disease. This may explain the high level of unchecked BP in
patients managed by physicians at the health centre during the years covered by the retrospective study,6 and it perhaps explains why a number of the patients enrolled into this study did not attend again after at least one normal BP reading (Fig. 1) despite the education provided on the chronic nature of the disease and the need for continuity in management. Low-income patients in Nigeria rely heavily on primary health centres, which are assisted by government funds to varying degrees. These centres are often congested, making hospital visits ‘a whole day task’ for many patients. Our study found that this was a major reason (65%) why patients did not attend routine check ups. The intervention (pharmacist-managed hypertension clinic) enhanced patient satisfaction. The decreased waiting time, relevant counselling and more time spent with the patients created a good impact and impression that may account for the improved BP control (Fig. 1 and Table 2) and the increasing number of patients returning for scheduled check ups. These observations are supported by the outcome data of similar studies.11–15 Time is an important factor in providing the level of education, drug counselling and follow-up care required by hypertensive patients to ensure that their drug regimen is providing adequate BP control without adverse effects. When patients’ waits for medical attention are prolonged, the impact is often negative16,17 and may inhibit patients’ responses and compliance with treatment schedules.
126.20G 06.20 119.00 K0.32 116.00 134.00 80.60G 04.66 78.00a K0.63 74.00 88.00 0.00G 0.00 0.00 0.00 0.00 0.00 127.94G 07.37 130.00a K1.10 110.00 137.00 82.42G 06.83 81.00 0.56 68.00 102.00 11.44G 19.61 0.00 01.77 0.00 52.00 140.71G 22.42 119.00 0.72 110.00 185.00 86.62G 11.81 81.00 01.13 68.00 118.00 a
Multiple modes exist. The smallest value is shown.
01.31G 02.17 0.00 01.49 0.00 7.00 144.66G 17.65 88.00 1.42 121.00 209.00 91.02G 12.45 139.00 0.93 62.00 195.00 167.90G 30.32 156.00 0.17 97.00 230.00 103.09G 32.09 78.00 01.34 62.00 195.00 MeanG SD Mode Skewness Minimum Maximum
Systolic BP Diastolic BP Diastolic BP Systolic BP Diastolic BP
Systolic BP
Missed doses
Diastolic BP
Systolic BP
Missed doses
Diastolic BP
Systolic BP
Missed doses
Fifth visit Fourth visit Third visit Second visit Enrolment point
Efficacy index: variation in blood pressure with clinic visit in patients managed by the pharmacist-led hypertension clinic. Table 2
0.00G 0.00 0.00 0.00 0.00 0.00
W.O. Erhun et al. Missed doses
796
Hypertensive patients often avoid physical exertion, perhaps because they are afraid that it will do them harm.18 However, daily engagements in mild exercise have been shown to produce modest falls in BP in these patients.19 This study provided a variety of schedules for patients to get active and shed excess weight, such as performing home chores often left to children and going for a morning/evening walk. The result showed a mild correlation between weight reduction and decreasing SBP that was significant only at the second [rZK0.298, sig. (two-tailed)Z0.042] and fourth [rZ0.487, sig. (two-tailed)Z0.047] visits within the first 6 months. Some patients actually gained weight during the study period; a cross-tabulation of the control of hypertension at return visits with patients’ BMI showed that 70% of the obese and 100% of the extremely obese patients had their BP under control by the second visit, while by the third visit, 80% of the obese and 100% of the extremely obese had controlled BP. Weight loss in obese, hypertensive patients may reduce BP by about 1.6/1.3 mmHg per kg loss and, in addition, may also improve lipid profile and insulin resistance.20 The reduction in dietary sodium, abstinence from alcohol, kola nuts and cigarettes, individualized, monitored weight reduction programme involving caloric restriction and increased physical activity, and personalized drug therapy emphasized in the study were factors in the positive benefits produced in these patients. The results of this study appear to show that BMI is a significant singular predictor of treatment outcomes in hypertension management. Although the normal-weight patients reported the highest occurrence of M-DI within the first 6 months, we observed low TRM-F values in this group. This is worthy of note because high M-DIs did not invoke high TRM-F values. Contrarily, we found the highest TRM-F values in the overweight patients who constituted 23.5–37.8% of the patients missing doses between successive appointments; total compliance with non-pharmacological management schedules may thus have produced improved results in this group, similar to obese and extremely obese patients. Predictor influences of the sharp increase in the number of missed doses recorded for the third visit (Table 2) investigated by bivariate regression analysis revealed that about half (47.3%) of the variances observed in BP values at the third visit were associated with doses missed [rZ0.688, r2Z0.473, F(2,42)Z18.87, P!0.01, standard error of estimateZ1.61]. Failure to follow a prescribed drug dose/regimen have previously been implicated in about 50% of patients with non-responding high
Positive benefits of a pharmacist-managed hypertension clinic in Nigeria BP,21,22 and may be attributable to a number of factors of which cost, complex drug regimen and inadequate education were controlled during our study. Some patients (9%) could not tolerate the diuretic effect of the therapy. They complained of frequent urination ranging from two to seven times at night. Responsive counselling and a regimen adjustment for these patients had a noticeable impact as none of them reported missing a dose at the fourth and fifth visits (Table 2). Comparison of the results of this study with our retrospective study6 on physician-managed patients under the same setting (reported previously) shows a marked decrease in treatment failures and a finely tuned rise in patient compliance and satisfaction. Over 60% of the return visits were earlier than or as scheduled. This may indicate patients’ confidence in the clinic/pharmacists, as over 52% of these patients claimed to be functionally unaffected by the disease. The authors also considered patients’ comments such as ‘I feel considerably better these days’, ‘Thank you for the attention’ and ‘Why have you not started this before now?’ as evidence of patient satisfaction and the positive benefit of the clinic. Although considered poor, the patients were often willing to give money or offer gifts unsolicited as a sign of their appreciation for the intervention. In the cultural setting of this study, this is a common way of showing appreciation. Although studies indicating the apathy of general practitioners have been reported,23 pharmacistmanaged disease state management clinics are meeting with huge success worldwide. Positive patient outcomes are commonplace, for example, within the Indian Health System (IHS) pharmacybased disease management clinics.24 Pharmacists at individual IHS facilities develop and implement many types of chronic disease management clinics. Organized at local level, these clinics usually have low ‘start-up’ costs, thus helping to promote pharmacy initiatives as cost-conscious programmes.24–26 One example of a pharmacistinitiated and-operated disease state management clinic is the Seizure Clinic at the Northern Navajo Medical Center in Shiprock, New Mexico. Established in 1998, the clinic manages about 150 patients and has documented reduced numbers of adverse events with these patients. Likewise, the pharmacy-based Tohatchi Health Center Hypertension Management Clinic (HMC), serving the Navajo community north of Gallup, New Mexico, has been able to control BP at twice the national average. Approximately 50 patients/year are actively followed in the HMC after being diagnosed by a staff physician.24–26 However, in a related study, Flobbe
797
et al. showed that pharmacists need to be provided with specific training in the application and interpretation of screening procedures, and in the implementation of quality control measures to reduce the number of false referrals or nonreferrals and quality of the service.27 The expanding role of the pharmacist can be beneficial to physicians, pharmacists and patients. The training of Nigerian pharmacists would need to be further tailored to gain physicians’ confidence while meeting these extended responsibilities.
Conclusion The pharmaceutical service provided by a pharmacist-managed hypertension clinic improved BP control, reduced treatment failures and recorded remarkable patient satisfaction. The impact of this intervention on clinical outcomes such as mortality and morbidity will be the focus of further studies.
Acknowledgements The authors acknowledge the support of the Medical Officer and clinic staff of the Comprehensive Health Centre, Sabo, Ile-Ife as well as the support of the Hospital Management Board, Osogbo, Osun State, Nigeria.
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