Dr Adil Abd El Rahman Mahmoud Presentation outlines

Dr. Adil Abd El Rahman Mahmoud

Presentation outlines 1 Background 2 Objective 3 Method 4 5 6 Results Discussion Conclusion & Recommendation

Introduction • Hypertension accounts for 9. 4 million death worldwide every year. • In Saudi Arabia prevalence of hypertension among the population was 25. 5%. Only 44. 7% of the hypertensives were aware, 71. 8% of them received pharmacotherapy, and only 37% were controlled. • The situation emphasize the need to establishing program called (pharmaceutical care practice)to screen, and educate the pt. while the pharmacist play important role in it.

Introduction Cont. • Pharmaceutical care is defined as: Direct or indirect responsible provision of drug therapy for the purpose of achieving the elimination or reduction of a patient's symptomatology. • It is an individual face-to-face meeting with the patient which starts by assessment of the drug problems , development of a care plan and follow-up evaluation.

Introduction Cont. • The pharmaceutical care is studies are directed to: HTN, DM, and hyperlipidemia. • The role of pharmacist is to improve quality of life, increase awareness in patients about their disease and improve medication knowledge. • Many pharmaceutical care studies in China, Spain, and Egypt resulted in control of BP, improvement in adherence to medications and knowledge about nature of the disease. • In Gulf countries the concept of pharmaceutical care is not yet adopted. • In Saudi Arabia there is scarcity of studies of pharmaceutical care among hypertensive patients.

JNC 8=Joint National Comittee Important changes from the JNC 7 guidelines include the following: • In patients 60 years or older who do not have diabetes or chronic kidney disease, the goal • blood pressure level is now <150/90 mm Hg. • In patients 18 to 59 years of age without major comorbidities, and in patients 60 years or • older who have diabetes, chronic kidney disease (CKD), or both conditions, the new goal • blood pressure level is <140/90 mm Hg. • First-line and later-line treatments should now be limited to 4 classes of medications: • thiazide-type diuretics, calcium channel blockers (CCBs), ACE inhibitors, and ARBs. • Second- and third-line alternatives included higher doses or combinations of ACE

• � First-line and later-line treatments should now be limited to 4 classes of medications: • thiazide-type diuretics, calcium channel blockers (CCBs), ACE inhibitors, and ARBs. • Second- and third-line alternatives included higher doses or combinations of ACE • inhibitors, ARBs, thiazide-type diuretics, and CCBs. �

• Several medications are now • designated as later-line alternatives, including the following: beta-blockers, • alphablockers, alpha 1/beta-blockers (eg, carvedilo), vasodilating beta-blockers (eg, • nebivolol), central alpha 2/-adrenergic agonists (eg, clonidine), direct vasodilators (eg, • hydralazine), loop diruretics (eg, furosemide), aldosterone antagoinsts (eg, • spironolactone), and peripherally acting adrenergic antagonists (eg, reserpine).

• When initiating therapy, patients of African descent without CKD should use CCBs and • thiazides instead of ACE inhibitors. • �Use of ACE inhibitors and ARBs is recommended in all patients with CKD regardless of • ethnic background, either as first-line therapy or in addition to first-line therapy. • �ACE inhibitors and ARBs should not be used in the same patient simultaneously.

• CCBs and thiazide-type diuretics should be used instead of ACE inhibitors and ARBs in • patients over the age of 75 years with impaired kidney function due to the risk of • hyperkalemia, increased creatinine, and further renal impairment.

Objectives Major objective : The major objective of this study is to investigate the impact of the pharmaceutical care intervention among Saudi hypertensive patient in outpatient clinic of cardiology unit, in King Faisal Hospital. Specific objectives : The specific objectives are to investigate the outcomes of the pharmaceutical intervention on: ● control of blood pressure ● management of drug related problems ● knowledge about disease and medications ● adherence to medications

Methodology Study Design : Non randomized, uncontrolled, before-and-after study. Study Period : The study conducted during 4 month from 13 September 2015 to 28 January 2016 Setting : Cardiology unit at King Faisal Hospital in Taif, Kingdome Saudi Arabia Study population : Convenient sample of 137 patient were recruited Inclusion criteria : Adult patients (age ≥ 18 years) with controlled and uncontrolled hypertension and taking antihypertensive medications and who consent to participate in the study. Exclusion criteria : Patients who do not meet these criteria are excluded

Methodology Cont. Data collection tools : The data will be collected as follows: 1 -Dader Assessment and Pharmacotherapy follow-up forms

Methodology Cont. Data collection tools : 2 -Knowledge questionnaire: It is consisted of ten questions and uses Yes and NO type of answers. The questionnaire measures patient knowledge about: Blood pressure level, causes of the disease, ways of controlling consequences blood pressure, of untreated hypertension, drug therapy, etc.

Methodology Cont. Data collection tools : 3 -Patient 'adherence to medications using Morisky scale: which is consisted of four items assessing patients forgetfulness about taking medications, carelessness about taking medications, stopping medication when feeling better and when feeling worse. The questions are of yes and No types.

Methodology Cont. Data collection tools : 4 -Patient consent form: Which documents the consent of the patient to participate in the study, and gives a brief about the objectives of the study. Mobile number was taken if the patient gave his/her consent.

Methodology Cont. Data collection tools : 5 -Physician communication Form: Which conveys the pharmacist recommendations regarding drug problems if discovered.

Methodology Cont. Pharmaceutical care intervention: 1 ) The study was pre-piloted in 10 hypertensive patients in the clinic. 2 ) Every patient was interviewed by the intern student before entering to the consultant or the specialist clinic in a separate care room. 3 ) A nurse prepare patient's file and introduce the patient to the pharmaceutical care room. 4 ) Each interview took about 15 -20 minutes. 5 ) Consent of patients was obtained before the baseline intervention.

Methodology Cont. Pharmaceutical care intervention: 6 ) The data was collected by face-to-face interview at the baseline of the study and after 4 months by three female pharmacy intern students. 7 ) At the baseline the following information were taken from the patient and patient file: Demographic information, medication review, blood pressure (BP), and body mass index (BMI).

Methodology Cont. Pharmaceutical care intervention: 8 ) After 4 months, the patients and while they were in their usual appointment in the clinic, they were interviewed about their knowledge and adherence using the same questionnaires used at the baseline. Blood pressure was checked and recorded. Any new drug problem was recorded and new recommendation were conveyed directly to the physician.

Methodology Cont. Data analysis : -Data were recorded in Microsoft Excel and after revision they were transferred to statistical package for social sciences (SPSS) version 20. Descriptive statistics was used (frequency, percentage, Means & Standard deviation). For inferential statistics: t-test, one Way Anova was used Significance was taken as P-value < 0. 05. .

Results Table 1 : Demographic profile and general information about the patients.

Sex Male Female Age 26 – 35 36 – 45 46 – 55 56 – 60 + 60 Education No education Primary education Secondary education Post-secondary education BMI 20 or <20 underweight 21 – 25 normal 26 – 30 overweight > 30 obese Allergy Yes No Smoking Yes No Number of drugs used 1 – 4 drugs 5 or > 5 drugs " polypharmacy" Associated disease Diabetes Mellitus Dyslipidemia Atrial fibrillation Hypothyroidism Diabetes Mellitus & Ischemic heart disease Diabetes Mellitus & Atrial fibrillation Diabetes Mellitus & dyslipidemia Diabetes Mellitus & hypothyroidism Others Frequency Percent % 55 82 40. 1 59. 9 2 2 8 37 31 57 70 38 17 12 4 1. 5 5. 8 27 22. 6 41. 6 0 0 0 0 17 120 12. 4 87. 6 24 113 17. 5 82. 5 95 42 69. 3 30. 7 57 17 5 3 21 5 4 2 23 41. 6 12. 4 3. 6 2. 2 15. 3 3. 6 2. 9 1. 5 16. 8 51. 1 27. 7 12. 4 8. 8

Results Cont. Table 2 : Blood pressure measurement ( Mean & SD ) The blood pressure values at the end of the study showed a significant improvement in the systolic and the diastolic blood pressure measurements (P = 0. 017 and 0. 009) At baseline : Mean ± SD End of the Study : Mean ± SD Systolic 145, 56± 23. 885 140. 13± 22. 42527 Diastolic 78. 35± 13. 57034 75. 62± 19. 68727

Results Cont. Table 3 : Knowledge of patient at baseline and end of the study Question Baseline of study Frequency (%) Yes No End of study Frequency (%) Yes No Q 1 : Do you Know your Blood pressure level ? 47 (34. 3%) 90 (65. 7%) 91 (66. 4%) 46 (33. 6%) Q 2 : Do you know normal blood pressure ? 38 (27. 7%) 99 (72. 3%) 90 (65. 7%) 47(34. 3%) 74 (54%) 87 (63. 5%) 50(36. 5%) 62 (45. 3%) 75 (54. 7%) Q 3 : Do you know your weight ? 63(46%) Q 4 : Do you know your Height ? 29(21. 2%) 108 (78. 8%) Q 5 : How often should blood pressure be checked ? 99 (72. 3%) 38 (27. 7%) 82 (59. 9%) 55(40. 1%) 119(86. 9%) 18 (13. 1%) 70 (51. 1%) 67(48. 9%) 119(86. 9%) 18(13. 1%) 52 (38%) 77 (56. 2%) 60(43. 8%) 95(69. 3%) 42(30. 7%) 114(83. 2%) 23(16. 8%) Q 9 : Do you know the complications of untreated 44 (32. 1%) 93 (67. 9%) 62 (45. 3%) 75(54. 7%) hypertension ? 71 (50. 8%) 66(48. 2%) 120(87. 6%) 17(12. 4%) 96 (70. 1%) 41(29. 9%) 111(81%) 126(92%) 11(8%) Q 6 : Do you know the causes of high blood pressure ? Q 7 : Do you know the ways of controlling hypertension? Q 8 : Nature of disease a ) Hypertension has no drug therapy ? b ) Therapy is lifelong ? c ) Blood pressure can rise without feeling it ? 85(62%) Q 10: Do you know about drug therapy of hypertension ? 26(19. 0%)

Results Cont. Table 4 : Adherence of patient to their hypertensive medications Question Q 1 : Do you ever forget to take your Baseline pf study Frequency (%) Yes No End of study Frequency (%) Yes No 50 (36. 5%) 87 (63. 5%) 35 (25. 5%) 102 (74. 5%) 40(29. 2%) 97 (70. 8%) 24 (17. 5%) 113 (82. 5%) 30 (21. 9%) 107 (78. 1%) 19 (13. 9%) 118(86. 1%) 39 (28. 5%) 98 (71. 5%) 28 (20. 4%) 109 (79. 6%) medicine ? Q 2 : Are you careless at times about taking your medicine? Q 3 : When you feel better , Do you sometimes stop taking your medicine? Q 4 : Sometimes if you feel worse when you take the medicine , Do you stop taking it?

Table 5: Antihypertensive medications used

Discussion • The results of this study showed that pharmacists intervention improved the blood pressure control in Saudi hypertensive patients. Blood pressure represented as systolic and diastolic pressure, were reduced at the end of the study by 5. 4 and 2. 7 mm. Hg, respectively. The blood pressure of 45. 3%(62 patients) of the patients was controlled at baseline, compared to 59. 1%(80 patients) after the pharmaceutical care intervention. • Knowledge of the patients improved at the end of the study and this could be explained by the following: The verbal education at the end of the first interview, leaflets of information given to the patients or caregivers, and the continuous monthly telephone contacts. Patients became more knowledgeable about the importance of weight and height measurement, frequency of checking BP, causes of high blood pressure, lifestyle measures and complications of untreated BP.

Discussion Cont. • The current study resulted in improvement in adherence to medications, but still slight percentage of patient were noncompliant to medications and has affected the level of the control of blood pressure obtained (54. 7%). The rate improved from 46% to 54. 7% This necessitates a well-planned pharmaceutical care program with strict follow-up system, since adherence needs continuous coaching. • Most of the drug related problems were discovered at baseline. The drug related problems were either due to non-compliance mostly, additional drug used and high doses and other. • It is one of the first studies in Saudi Arabia which targeted hypertensive patients and the results of this study is expected to start the road for the implementation of pharmaceutical care in Saudi Hospitals.

Discussion Cont. • Robinson et. al (17) in their study in nine chain pharmacies in which pharmaceutical care intervention was compared to usual care group, showed that in 50% of the patient blood pressure was controlled compared to 22% in usual care. The average reduction in systolic BP (SBP) was 9. 9 mm. Hg in the pharmaceutical care group compared to 2. 9 mm. Hg in the usual care group. • Zhao et. al (11) in their randomized controlled study, showed that pharmaceutical care intervention among hypertensive patients (controlled or uncontrolled), improved hypertension education, medication adherence and blood pressure control. With low mean SBP and DBP at baseline (142. 5 / 85. 2 mm. Hg), a 8. 5 / 4. 7 mm. Hg reduction was gained in the intervention group at the end of the study (6 months).

Limitations ü The study used a convenient sample. ü The pharmacy intern students trained for short period, and are not experienced in detecting therapeutic problems. ü Most of the patients were reluctant to the monthly meeting in the clinic and are not familiar with this new type of practice. ü Controlled and uncontrolled patients were chosen for this study ü The study was done at single site in Al-Taif city and cannot be generalized for the situation in all Saudi Arabia hospitals.

Conclusion v Pharmacists intervention provided to Saudi hypertensive patients resulted in improvement in blood pressure control, knowledge and adherence to medications. v Policies should be made to facilitate implementation of pharmaceutical care in hospital setting.

Recommendations Ø Patients and health professionals should be oriented about pharmaceutical care practice. Ø Pharmacy colleges should establish pharmaceutical care skills laboratories in which students will be trained in pharmaceutical care practice properly. Ø More stress should be made for teaching pharmacotherapy of chronic diseases in pharmacy colleges.

Recommendations Cont. Ø Pharmaceutical care practice should be as a routine practice in Saudi hospitals, and it should be part of the system of patient care. Ø Students clerkship clinical rotations should involve real training of pharmaceutical care interventions. Ø Pharmacy associations and industry in Saudi Arabia should not only declare their acceptance of pharmaceutical care as a philosophy but should fund projects related to its implementation, and competently follow its widespread in all hospitals.

DRAFT PROPOSAL FOR POLICY MAKERS 1 -Introduction of clinical pharmacy and pharmacy practice in the undergraduate programs. 2 -Change in regulations to permit community pharmacists to: -Practice pharmaceutical care and other clinical pharmacy practices as: Drug review for chronic disease patients (with proper facilities as: consultation room, patient medication records. . . Etc. ). -Undergo screening tests e. g. blood pressure, blood glucose. . etc. 3 -Joint work of community pharmacists with health promotion unit in the Pharmacy Administration in the Ministry of Health to fulfill certain health targets: e. g. prevention of Malaria, AIDS, kidney problems, Diabetes and Cardiovascular diseases, with proper incentives where possible.

4 - Government should enter in contracted form of relationship with community pharmacies, to do some services starting with dispensing and ending with some Drug reviews for certain chronic patients and pharmaceutical care. In the start this can be piloted in pharmacies related to the Health Insurance System.

5 -Private pharmacies can be piloted for these practices also e. g. to choose 5 -10 or more pharmacies in Khartoum state which has proper facilities i. e. spacious with consultation rooms and area for screening tests. 6 -Policy for minor disease management in community pharmacies should be adopted: -Detailing the type of diseases. -Detailing procedure of consultation. -Detailing the limit after which referral is required. -Proper documentation. -National format for community pharmacists’ referral.

References 1. Pei-Xi Zhao, Chao Wang, Li Qin, Ming Yuan, Qian Xiao, Ying-Hua Guo and Ai-Dong Wen. Effect of clinical pharmacist's pharmaceutical care intervention to control hypertensive outpatients in China. African Journal of Pharmacy and Pharmacology 2012 ; 6(1): 48 -56. 2. Pedro A, Daniel S, Emilio G. , Miguel A. , Rosa P. , Francisco M. , Jose A. , Jose J. and Maria. J. Effectiveness of Dader method for pharmaceutical care on control of blood pressure and total cholesterol in outpatients with cardiovascular disease or cardiovascular risk: EMDADER-CV Randomized controlled trial. Journal of Managed Care Pharmacy 2012; 18(4): 311 -323. 3. Abdel –Hameed I. M. Ebid, Zina T. Ali and Mohamed A. F. Ghobary. Blood pressure control in hypertensive patients: impact of an Egyptian pharmaceutical care model. Journal of Applied Pharmaceutical Sciences 2014; 4(09): 93 -101. 4. Pharmaceutical Care Researh Group. Pharmacotherapy follow-up: The Dader method (3 rd revision: 2005). Pharmacy Practice 2006; 4(1): 44 -53. 5. Azuka C Oparah, David U Adje and Ehijie FO Enato. Outcomes of pharmaceutical care intervention to hypertensive patients in a Nigerian Community pharmacy. The International Journal of Pharmacy Practice 2006; 14: 115 -12.

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