TY - JOUR
AU1 - Chisholm, Marie, A.
AU2 - Spivey, Christina, A.
AU3 - Mulloy, Laura, L.
AB - Abstract Purpose. The effects of a medication assistance program with medication therapy management (MTM) on the clinical outcomes and health-related quality of life (HQOL) of renal transplant recipients were studied. Methods. All renal transplant recipients who were enrolled in the Medication Access Program at the Medical College of Georgia for at least one year were included in the study. Patients’ demographics, number of graft rejections (for one year preenrollment and one year postenrollment), and diagnoses of hypertension, diabetes, and dyslipidemia were recorded and confirmed by medical and pharmacy records. The use of antihypertensive, antidiabetic, antilipemic, and immunosuppressant agents and laboratory values for fasting blood glucose, glycosylated hemoglobin (HbA1c), blood pressure, low-density-lipoprotein (LDL) cholesterol, total cholesterol, triglycerides, and serum immunosuppressant concentrations were identified for one year preenrollment and one year postenrollment. HQOL was measured at the time of enrollment and one year postenrollment. Results. Thirty-six adult renal transplant recipients were included in the study. All patients had hypertension, 72% had dyslipidemia, and 42% had diabetes. Patients received significantly more antihypertensive agents postenrollment versus preenrollment (p < 0.001) and significantly more antidiabetic agents (p = 0.004) and antilipemics (p = 0.001). Measures of fasting blood glucose, glycosylated hemoglobin, LDL cholesterol, total cholesterol, triglycerides, blood pressure, and number of graft rejections decreased from preenrollment levels (p < 0.01). A significantly greater number of patients reached target serum cyclosporine levels postenrollment versus preenrollment (p = 0.008). HQOL was significantly increased one year postenrollment (p < 0.01). Conclusion. A medication assistance program that included MTM services improved medication access, clinical outcomes, and HQOL in renal transplant recipients. Antidiabetic agents, Antilipemic agents, Blood levels, Charity, Clinical pharmacy, Cyclosporine, Diabetes mellitus, Drug distribution, Drug use, Graft rejection, Hyperlipidemia, Hypertension, Hypotensive agents, Immunosuppressive agents, Outcomes, Pharmaceutical services, Prescriptions, Quality of life, Rational therapy, Transplantation Access to prescription medication is vital for ensuring medication adherence, and medication adherence is necessary to achieve desired health outcomes.1 For a large segment of the U.S. population, medication access is impeded by a lack of or deficits in health insurance and prescription drug coverage. Almost 44 million Americans are currently without health insurance.2 Of those with health insurance, 1 in 10 individuals age 65 years or younger and 1 in 3 individuals over age 65 do not have prescription drug coverage.3 Adding to the burden of the uninsured and underinsured, retail prescription drug prices have increased an average of 8% annually from 1994 to 2005.4 According to a 2000–01 survey, these financial barriers prevented approximately 23 million Americans from filling at least one prescription during a 12-month period.5 Thus, an important consequence of decreased medication access is decreased medication adherence. To reduce out-of-pocket costs, individuals with inadequate or no health or drug coverage are more likely to reduce medication doses, skip doses, or not fill a prescription.4,6 Renal transplant recipients have an increased risk of medication nonadherence, which occurs in approximately 20–68% of these patients.7,–10 One of the leading causes of nonadherence among renal transplant recipients is the high cost of posttransplant medications, including immunosuppressant agents and medications to treat comorbid conditions (e.g., hypertension, dyslipidemia, diabetes mellitus, infection). 8,11,–13 As of 2002, the estimated cost of immunosuppressant therapy alone exceeded $20,000 for the first year posttransplantation.14 Medication nonadherence can have devastating consequences on the health outcomes of renal transplant recipients. Nonadherence to immunosuppressant therapy is one of the leading causes of graft rejection and graft loss in this population and the leading avoidable cause of renal transplant failure.15,16 Approximately 35% of renal graft loss is attributable to nonadherence to immunosuppressant therapy, with 91% of nonadherent patients suffering graft loss or death compared with 18% of adherent patients.7,17,–19 Increasingly, programs that help improve patients’ access to medications through enrollment in pharmaceutical manufacturers’ medication assistance programs (PMAPs) and other programs or services (e.g., Medicare) are being established.20 Studies indicate that these assistance programs may decrease patients’ out-of-pocket expenses21,22 and increase patients’ medication adherence.23 For example, the Central Louisiana Medication Access Program at Huey P. Long Medical Center helped more than 5000 rural indigent patients (at or below 200% of the federal poverty level) receive over 140,000 prescription drugs with cost savings to patients of greater than $2.5 million between 2001 and 2003.24 A program designed to help liver transplant recipients acquire posttransplantation medications decreased nonadherence from 25% to 10%,23 and a program to help indigent heart disease patients acquire medication increased adherence from 49% to 73%.25 While the cost benefits of medication assistance programs are wellknown, few studies have been conducted to determine whether these programs actually improve patients’ clinical outcomes and health-related quality of life (HQOL). Results of these studies have indicated increased medication use and improved health outcomes and HQOL after enrollment into a medication assistance program.1,25,26 However, the relationship between medication assistance program enrollment and clinical outcomes and HQOL in the transplant population has not been studied. The objective of this study was to determine the effects of a medication assistance program that offered medication therapy management (MTM) services on the clinical outcomes and HQOL of enrolled renal transplant recipients. Methods The mission of the Medication Access Program (MAP) at the Medical College of Georgia (MCG) is to provide medication access to solidorgan transplant recipients who reside in Georgia. Since its inception in 1999, the MAP has helped over 580 recipients receive more than $13 million in medications. MTM services are provided at least once a month for each patient enrolled in the MAP, including a review of each patient’s medication profile to ensure therapeutic outcomes and minimize adverse drug events. The MAP staff includes two clinical pharmacists who review medication regimens; identify, resolve, and prevent medication-related problems; interview patients; answer drug information questions; and make therapeutic recommendations. Moreover, one of the MAP clinical pharmacists is assigned to the MCG Renal Transplant Clinic and performs these clinical services directly with MAP patients daily. Transplant recipients are enrolled in the MAP based on a referral from the MAP pharmacist or another health care professional or transplantation team member. Patients can be referred for MAP enrollment at any time posttransplantation. Adult renal transplant recipients who received their posttransplantation care from MCG between November 1999 and September 2005 and were enrolled in the MAP for at least one year were included in the study. Only these patients were selected as participants due to feasibility issues. The study was approved by the human assurance committee at MCG and by the University of Georgia. Demographic data, including date of birth, sex, race, and date of transplantation, were collected for each patient enrolled in the study. Information regarding patients’ prescribed medication regimens (e.g., name of drug, dose, directions), number of graft rejections (one year before MAP enrollment and one year postenrollment) diagnosed according to Banff 97 criteria,27,28 and diagnoses of hypertension, diabetes, and dyslipidemia were collected and confirmed by medical and pharmacy records. The number of antihypertensive, antidiabetic, and antilipemic agents (i.e., hydroxymethylglutarase– coenzyme A reductase inhibitors, fibric acid agents, and niacin) each renal transplant recipient was taking before MAP enrollment and one year postenrollment was recorded. Costs of medications were assessed using the average wholesale price (AWP). Measurements of fasting blood glucose levels, glycosylated hemoglobin (HbA1c) values, blood pressure readings, low-density-lipoprotein (LDL) cholesterol levels, total cholesterol levels, triglyceride levels, and immunosuppressant serum concentrations (target ranges defined as 100–400 ng/mL for cyclosporine and 5–17 ng/mL for tacrolimus)29 were recorded from the most recent clinic visit before MAP enrollment and from a clinic visit at one year postenrollment using patients’ medical records. HQOL was measured at the time of MAP enrollment and one year postenrollment using the SF-12 Health Study, version 2.0 (SF-12v2). The SF-12v2 assesses functional status, well-being, and perceptions of health status across eight scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. The scores from the eight scales are used to calculate a physical component summary score and a mental component summary score. Higher scale and component summary scores are indicative of a better HQOL. See Table 11 for definitions of each scale of the SF-12v2.30,31 Table 1. SF-12 Health Survey, Version 2.0, Scale and Component Summary Measure Definitions30,31 Scale Lowest Possible Score Definition Highest Possible Score Definition Physical Functioning Very limited in performing physical activities Performs all physical activities without limitations Role Physical Problems with work or other daily activities as a result of physical health No problems with work or other daily activities Bodily Pain Severe and extremely limiting pain No pain or limitations due to pain General Health Evaluates personal health as poor and believes it is likely to get worse Evaluates personal health as excellent Vitality Feels tired and worn out all the time Feels full of pep and energy all the time Social Functioning Extreme and frequent interference with normal social activities due to physical and emotional problems Performs normal social activities without interference due to physical or emotional problems Role Emotional Problems with work or other daily activities as a result of emotional problems No problems with work or other daily activities Mental Health Feelings of nervousness and depression all the time Feels peaceful, happy, and calm all the time Physical component summary Limitations in self-care, physical, social, and role activities; severe pain; frequent fatigue; health rated “poor” No physical limitations or disabilities, high energy level; health rated “excellent” Mental component summary Frequent psychological distress, social and role disability due to emotional problems; health rated “poor” Frequent positive affect, absence of psychological distress and limitations in usual social/role activities due to emotional problems; health rated “excellent” Scale Lowest Possible Score Definition Highest Possible Score Definition Physical Functioning Very limited in performing physical activities Performs all physical activities without limitations Role Physical Problems with work or other daily activities as a result of physical health No problems with work or other daily activities Bodily Pain Severe and extremely limiting pain No pain or limitations due to pain General Health Evaluates personal health as poor and believes it is likely to get worse Evaluates personal health as excellent Vitality Feels tired and worn out all the time Feels full of pep and energy all the time Social Functioning Extreme and frequent interference with normal social activities due to physical and emotional problems Performs normal social activities without interference due to physical or emotional problems Role Emotional Problems with work or other daily activities as a result of emotional problems No problems with work or other daily activities Mental Health Feelings of nervousness and depression all the time Feels peaceful, happy, and calm all the time Physical component summary Limitations in self-care, physical, social, and role activities; severe pain; frequent fatigue; health rated “poor” No physical limitations or disabilities, high energy level; health rated “excellent” Mental component summary Frequent psychological distress, social and role disability due to emotional problems; health rated “poor” Frequent positive affect, absence of psychological distress and limitations in usual social/role activities due to emotional problems; health rated “excellent” Open in new tab Table 1. SF-12 Health Survey, Version 2.0, Scale and Component Summary Measure Definitions30,31 Scale Lowest Possible Score Definition Highest Possible Score Definition Physical Functioning Very limited in performing physical activities Performs all physical activities without limitations Role Physical Problems with work or other daily activities as a result of physical health No problems with work or other daily activities Bodily Pain Severe and extremely limiting pain No pain or limitations due to pain General Health Evaluates personal health as poor and believes it is likely to get worse Evaluates personal health as excellent Vitality Feels tired and worn out all the time Feels full of pep and energy all the time Social Functioning Extreme and frequent interference with normal social activities due to physical and emotional problems Performs normal social activities without interference due to physical or emotional problems Role Emotional Problems with work or other daily activities as a result of emotional problems No problems with work or other daily activities Mental Health Feelings of nervousness and depression all the time Feels peaceful, happy, and calm all the time Physical component summary Limitations in self-care, physical, social, and role activities; severe pain; frequent fatigue; health rated “poor” No physical limitations or disabilities, high energy level; health rated “excellent” Mental component summary Frequent psychological distress, social and role disability due to emotional problems; health rated “poor” Frequent positive affect, absence of psychological distress and limitations in usual social/role activities due to emotional problems; health rated “excellent” Scale Lowest Possible Score Definition Highest Possible Score Definition Physical Functioning Very limited in performing physical activities Performs all physical activities without limitations Role Physical Problems with work or other daily activities as a result of physical health No problems with work or other daily activities Bodily Pain Severe and extremely limiting pain No pain or limitations due to pain General Health Evaluates personal health as poor and believes it is likely to get worse Evaluates personal health as excellent Vitality Feels tired and worn out all the time Feels full of pep and energy all the time Social Functioning Extreme and frequent interference with normal social activities due to physical and emotional problems Performs normal social activities without interference due to physical or emotional problems Role Emotional Problems with work or other daily activities as a result of emotional problems No problems with work or other daily activities Mental Health Feelings of nervousness and depression all the time Feels peaceful, happy, and calm all the time Physical component summary Limitations in self-care, physical, social, and role activities; severe pain; frequent fatigue; health rated “poor” No physical limitations or disabilities, high energy level; health rated “excellent” Mental component summary Frequent psychological distress, social and role disability due to emotional problems; health rated “poor” Frequent positive affect, absence of psychological distress and limitations in usual social/role activities due to emotional problems; health rated “excellent” Open in new tab Statistical analyses were performed using SPSS software, version 14.0 (SPSS Inc., Chicago, IL). Paired t tests and McNemar tests (nonparametric tests used to analyze variables with two categories) were conducted. Analyses of clinical indicators were conducted according to the relevant disease state subsample. For example, changes in systolic and diastolic blood pressures were analyzed only for patients with hypertension. Because of the number of analyses conducted, statistical significance was set at the relatively stringent level of p < 0.01 to reduce the possibility of committing a Type I error. Each patient’s baseline values (preenrollment in the MAP) served as his or her own control values. Results A total of 66 adult renal transplant recipients (9.7% of the 684 adults who underwent renal transplantation at MCG between 1995 and 2005) received posttransplantation care from MCG, but only 36 of these patients were enrolled in the MAP for at least one year and were enrolled in the study. The majority of patients (61.1%) enrolled in the study were male and had a mean ± S.D. age of 52.78 ± 13.37 years (Table 22). Approximately half of the patients in the sample were Caucasian. Comorbid conditions were common: all patients had hypertension, 72.2% had dyslipidemia, and 41.7% had diabetes (Table 2 2). Approximately 81% of the sample received Medicare benefits. A total of $331,289 worth of medications (based on AWP) was provided to the patients through the MAP for one year postenrollment (mean ± S.D. amount for each patient, $9,202.47 ± $1,786.48). Table 2. Characteristics of Renal Transplant Recipients Enrolled in the Medication Access Program (MAP) (n = 36) Characteristic Value Male, no. (%) pts 22 (61.1) Race, no. (%) pts     Caucasian 18 (50)     African American 16 (44)     Hispanic 1 (3)     Asian 1 (3) Mean ±S.D. age, yr 52.78 ±13.37 Medicare recipients, no. (%) pts 29 (80.6) Years posttransplantation, mean ±S.D. (range) 10.89 ±6.22 (1–23) Years between transplantation and MAP enrollment, mean ±S.D. (range) 6.19 ±5.50 (0–22) Diagnoses, no. (%) pts     Hypertension 36 (100)     Diabetes 15 (42)     Dyslipidemia 26 (72) No. (%) pts receiving drugs through MAP     Antihypertensives 27 (75)     Antidiabetics 9 (25)     Antilipemics 23 (64)     Immunosuppressants 33 (92)         Tacrolimus 6 (17)         Cyclosporine 30 (83)         Azathioprine 3 (8)         Prednisone 23 (64)         Mycophenolate mofetil 20 (56)         Sirolimus 1 (3) Mean ±S.D. no. immunosuppressants prescribed 2.31 ± 0.71 Characteristic Value Male, no. (%) pts 22 (61.1) Race, no. (%) pts     Caucasian 18 (50)     African American 16 (44)     Hispanic 1 (3)     Asian 1 (3) Mean ±S.D. age, yr 52.78 ±13.37 Medicare recipients, no. (%) pts 29 (80.6) Years posttransplantation, mean ±S.D. (range) 10.89 ±6.22 (1–23) Years between transplantation and MAP enrollment, mean ±S.D. (range) 6.19 ±5.50 (0–22) Diagnoses, no. (%) pts     Hypertension 36 (100)     Diabetes 15 (42)     Dyslipidemia 26 (72) No. (%) pts receiving drugs through MAP     Antihypertensives 27 (75)     Antidiabetics 9 (25)     Antilipemics 23 (64)     Immunosuppressants 33 (92)         Tacrolimus 6 (17)         Cyclosporine 30 (83)         Azathioprine 3 (8)         Prednisone 23 (64)         Mycophenolate mofetil 20 (56)         Sirolimus 1 (3) Mean ±S.D. no. immunosuppressants prescribed 2.31 ± 0.71 Open in new tab Table 2. Characteristics of Renal Transplant Recipients Enrolled in the Medication Access Program (MAP) (n = 36) Characteristic Value Male, no. (%) pts 22 (61.1) Race, no. (%) pts     Caucasian 18 (50)     African American 16 (44)     Hispanic 1 (3)     Asian 1 (3) Mean ±S.D. age, yr 52.78 ±13.37 Medicare recipients, no. (%) pts 29 (80.6) Years posttransplantation, mean ±S.D. (range) 10.89 ±6.22 (1–23) Years between transplantation and MAP enrollment, mean ±S.D. (range) 6.19 ±5.50 (0–22) Diagnoses, no. (%) pts     Hypertension 36 (100)     Diabetes 15 (42)     Dyslipidemia 26 (72) No. (%) pts receiving drugs through MAP     Antihypertensives 27 (75)     Antidiabetics 9 (25)     Antilipemics 23 (64)     Immunosuppressants 33 (92)         Tacrolimus 6 (17)         Cyclosporine 30 (83)         Azathioprine 3 (8)         Prednisone 23 (64)         Mycophenolate mofetil 20 (56)         Sirolimus 1 (3) Mean ±S.D. no. immunosuppressants prescribed 2.31 ± 0.71 Characteristic Value Male, no. (%) pts 22 (61.1) Race, no. (%) pts     Caucasian 18 (50)     African American 16 (44)     Hispanic 1 (3)     Asian 1 (3) Mean ±S.D. age, yr 52.78 ±13.37 Medicare recipients, no. (%) pts 29 (80.6) Years posttransplantation, mean ±S.D. (range) 10.89 ±6.22 (1–23) Years between transplantation and MAP enrollment, mean ±S.D. (range) 6.19 ±5.50 (0–22) Diagnoses, no. (%) pts     Hypertension 36 (100)     Diabetes 15 (42)     Dyslipidemia 26 (72) No. (%) pts receiving drugs through MAP     Antihypertensives 27 (75)     Antidiabetics 9 (25)     Antilipemics 23 (64)     Immunosuppressants 33 (92)         Tacrolimus 6 (17)         Cyclosporine 30 (83)         Azathioprine 3 (8)         Prednisone 23 (64)         Mycophenolate mofetil 20 (56)         Sirolimus 1 (3) Mean ±S.D. no. immunosuppressants prescribed 2.31 ± 0.71 Open in new tab To determine if patients’ number of medications changed after MAP enrollment, paired t tests were conducted. Patients received a greater number of antihypertensive, antidiabetic, and antilipemic agents after enrollment in the MAP versus preenrollment (Table 33). Table 3. Medication Use Before and After Enrollment in the Medication Access Program (MAP)a Mean ± S.D. No. Medications Medication Type Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving specific medications through the MAP. Antidiabetic 1.00 ±0.00 1.67 ±0.50 0.004 Antihypertensive 2.33 ±0.55 3.04 ±0.59 <0.001 Antilipemic 1.04 ± 0.21 1.43 ±0.51 0.001 Mean ± S.D. No. Medications Medication Type Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving specific medications through the MAP. Antidiabetic 1.00 ±0.00 1.67 ±0.50 0.004 Antihypertensive 2.33 ±0.55 3.04 ±0.59 <0.001 Antilipemic 1.04 ± 0.21 1.43 ±0.51 0.001 Open in new tab Table 3. Medication Use Before and After Enrollment in the Medication Access Program (MAP)a Mean ± S.D. No. Medications Medication Type Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving specific medications through the MAP. Antidiabetic 1.00 ±0.00 1.67 ±0.50 0.004 Antihypertensive 2.33 ±0.55 3.04 ±0.59 <0.001 Antilipemic 1.04 ± 0.21 1.43 ±0.51 0.001 Mean ± S.D. No. Medications Medication Type Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving specific medications through the MAP. Antidiabetic 1.00 ±0.00 1.67 ±0.50 0.004 Antihypertensive 2.33 ±0.55 3.04 ±0.59 <0.001 Antilipemic 1.04 ± 0.21 1.43 ±0.51 0.001 Open in new tab Patients who received antidiabetic agents through the MAP (n = 9) had decreased fasting blood glucose concentrations and decreased HbA1c values after MAP enrollment (Table 44). Patients who received antihypertensive medication through the MAP (n = 27) had decreased systolic and diastolic blood pressure values after enrollment in the MAP. Similarly, patients who received antilipemic medication through the MAP (n = 23) had decreased LDL cholesterol, total cholesterol, and triglyceride concentrations postenrollment in the MAP (Table 4 4). Postenrollment fasting blood glucose and HbA1c values did not significantly differ from preenrollment values, nor did the number of antidiabetic agents taken, in those patients who did not receive antidiabetic medication through the MAP (n = 6). Similarly, no significant differences were found between the preenrollment and postenrollment periods in LDL cholesterol, total cholesterol, or triglyceride levels or in the number of antilipemic agents of patients with dyslipidemia who did not receive antilipemic medication through the MAP (n = 3). No significant differences were found between the preenrollment and postenrollment periods in number of antihypertensive agents or systolic blood pressure measurements among renal transplant recipients with hypertension who did not receive their antihypertensive medication through the MAP (n = 9). However, these patients’ mean ± S.D. diastolic blood pressure levels increased significantly postenrollment versus preenrollment (80.22 ± 4.18 mm Hg versus 77.78 ± 3.93 mm Hg, p = 0.002). Table 4. Clinical Indicators Before and After Enrollment in the Medication Mean ±S.D. Value Clinical Indicator Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving medications specific to each indicator through the MAP. LDL = low-density-lipoprotein. Fasting blood glucose, mg/dL 129.22 ±18.25 112.22 ±17.43 0.001 Glycosylated hemoglobin, % 8.07 ±0.81 7.42 ±0.61 0.002 LDL cholesterol, mg/dL 305.48 ±66.20 191.78 ±27.39 <0.001 Total cholesterol, mg/dL 345.83 ±108.33 239.91 ±47.24 <0.001 Triglycerides, mg/dL 290.78 ±90.74 223.13 ±36.93 <0.001 Systolic blood pressure, mm Hg 140.52 ± 7.81 134.30 ±7.54 <0.001 Diastolic blood pressure, mm Hg 79.19 ±3.97 77.04 ±4.24 <0.001 Serum tacrolimus conc., ng/mL 8.67 ±3.5 10.17 ±1.17 0.343 Serum cyclosporine conc., ng/mL 178.77 ±61.4 214.7 ±44.14 0.007 Graft rejection 0.50 ±0.51 0.22 ±0.42 0.008 Mean ±S.D. Value Clinical Indicator Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving medications specific to each indicator through the MAP. LDL = low-density-lipoprotein. Fasting blood glucose, mg/dL 129.22 ±18.25 112.22 ±17.43 0.001 Glycosylated hemoglobin, % 8.07 ±0.81 7.42 ±0.61 0.002 LDL cholesterol, mg/dL 305.48 ±66.20 191.78 ±27.39 <0.001 Total cholesterol, mg/dL 345.83 ±108.33 239.91 ±47.24 <0.001 Triglycerides, mg/dL 290.78 ±90.74 223.13 ±36.93 <0.001 Systolic blood pressure, mm Hg 140.52 ± 7.81 134.30 ±7.54 <0.001 Diastolic blood pressure, mm Hg 79.19 ±3.97 77.04 ±4.24 <0.001 Serum tacrolimus conc., ng/mL 8.67 ±3.5 10.17 ±1.17 0.343 Serum cyclosporine conc., ng/mL 178.77 ±61.4 214.7 ±44.14 0.007 Graft rejection 0.50 ±0.51 0.22 ±0.42 0.008 Open in new tab Table 4. Clinical Indicators Before and After Enrollment in the Medication Mean ±S.D. Value Clinical Indicator Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving medications specific to each indicator through the MAP. LDL = low-density-lipoprotein. Fasting blood glucose, mg/dL 129.22 ±18.25 112.22 ±17.43 0.001 Glycosylated hemoglobin, % 8.07 ±0.81 7.42 ±0.61 0.002 LDL cholesterol, mg/dL 305.48 ±66.20 191.78 ±27.39 <0.001 Total cholesterol, mg/dL 345.83 ±108.33 239.91 ±47.24 <0.001 Triglycerides, mg/dL 290.78 ±90.74 223.13 ±36.93 <0.001 Systolic blood pressure, mm Hg 140.52 ± 7.81 134.30 ±7.54 <0.001 Diastolic blood pressure, mm Hg 79.19 ±3.97 77.04 ±4.24 <0.001 Serum tacrolimus conc., ng/mL 8.67 ±3.5 10.17 ±1.17 0.343 Serum cyclosporine conc., ng/mL 178.77 ±61.4 214.7 ±44.14 0.007 Graft rejection 0.50 ±0.51 0.22 ±0.42 0.008 Mean ±S.D. Value Clinical Indicator Before Enrollment After Enrollment p aData presented only for those renal transplant recipients receiving medications specific to each indicator through the MAP. LDL = low-density-lipoprotein. Fasting blood glucose, mg/dL 129.22 ±18.25 112.22 ±17.43 0.001 Glycosylated hemoglobin, % 8.07 ±0.81 7.42 ±0.61 0.002 LDL cholesterol, mg/dL 305.48 ±66.20 191.78 ±27.39 <0.001 Total cholesterol, mg/dL 345.83 ±108.33 239.91 ±47.24 <0.001 Triglycerides, mg/dL 290.78 ±90.74 223.13 ±36.93 <0.001 Systolic blood pressure, mm Hg 140.52 ± 7.81 134.30 ±7.54 <0.001 Diastolic blood pressure, mm Hg 79.19 ±3.97 77.04 ±4.24 <0.001 Serum tacrolimus conc., ng/mL 8.67 ±3.5 10.17 ±1.17 0.343 Serum cyclosporine conc., ng/mL 178.77 ±61.4 214.7 ±44.14 0.007 Graft rejection 0.50 ±0.51 0.22 ±0.42 0.008 Open in new tab Serum cyclosporine concentrations increased significantly postenrollment (p = 0.007); however, serum tacrolimus concentrations did not differ significantly after enrollment in the MAP (Table 44). Of the 30 patients who were prescribed cyclosporine, more reached target serum concentrations postenrollment than during preenrollment (p = 0.008). Of the 6 patients who were prescribed tacrolimus, there was no difference between the numbers of those who reached target serum tacrolimus concentrations postenrollment versus preenrollment. Significant differences were found between preenrollment and postenrollment HQOL scores on all but four of the SF-12v2 scales (Physical Functioning, Role Physical, Bodily Pain, and Vitality) (Table 55). HQOL scores increased significantly postenrollment for General Health, Social Functioning, Role Emotional, and Mental Health scales (p < 0.001 for each comparison) and on the physical component summary (p = 0.006) and mental component summary (p < 0.001). Table 5. Health-Related Quality-of-Life Scores Before and After Enrollment in the Medication Access Program (n = 36) Mean ±S.D. Score Scale Before Enrollment After Enrollment p Physical Functioning 45.51 ±7.3 47.18 ±7.23 0.280 Role Physical 43.36 ±4.67 45.05 ±4.71 0.042 Bodily Pain 41.31 ±10.72 42.44 ±8.95 0.457 General Health 38.57 ±13.86 49.47 ±8.88 <0.001 Vitality 46.63 ±4.01 48.03 ±1.68 0.058 Social Functioning 40.02 ±12.11 50.4 ±6.05 <0.001 Role Emotional 38.79 ±6.18 41.59 ±6.32 <0.001 Mental Health 41.81 ±5.13 46.72 ±5.23 <0.001 Physical component summary 43.79 ±7.74 46.72 ±6.27 0.008 Mental component summary 40.61 ±6.42 46.14 ±4.62 <0.001 Mean ±S.D. Score Scale Before Enrollment After Enrollment p Physical Functioning 45.51 ±7.3 47.18 ±7.23 0.280 Role Physical 43.36 ±4.67 45.05 ±4.71 0.042 Bodily Pain 41.31 ±10.72 42.44 ±8.95 0.457 General Health 38.57 ±13.86 49.47 ±8.88 <0.001 Vitality 46.63 ±4.01 48.03 ±1.68 0.058 Social Functioning 40.02 ±12.11 50.4 ±6.05 <0.001 Role Emotional 38.79 ±6.18 41.59 ±6.32 <0.001 Mental Health 41.81 ±5.13 46.72 ±5.23 <0.001 Physical component summary 43.79 ±7.74 46.72 ±6.27 0.008 Mental component summary 40.61 ±6.42 46.14 ±4.62 <0.001 Open in new tab Table 5. Health-Related Quality-of-Life Scores Before and After Enrollment in the Medication Access Program (n = 36) Mean ±S.D. Score Scale Before Enrollment After Enrollment p Physical Functioning 45.51 ±7.3 47.18 ±7.23 0.280 Role Physical 43.36 ±4.67 45.05 ±4.71 0.042 Bodily Pain 41.31 ±10.72 42.44 ±8.95 0.457 General Health 38.57 ±13.86 49.47 ±8.88 <0.001 Vitality 46.63 ±4.01 48.03 ±1.68 0.058 Social Functioning 40.02 ±12.11 50.4 ±6.05 <0.001 Role Emotional 38.79 ±6.18 41.59 ±6.32 <0.001 Mental Health 41.81 ±5.13 46.72 ±5.23 <0.001 Physical component summary 43.79 ±7.74 46.72 ±6.27 0.008 Mental component summary 40.61 ±6.42 46.14 ±4.62 <0.001 Mean ±S.D. Score Scale Before Enrollment After Enrollment p Physical Functioning 45.51 ±7.3 47.18 ±7.23 0.280 Role Physical 43.36 ±4.67 45.05 ±4.71 0.042 Bodily Pain 41.31 ±10.72 42.44 ±8.95 0.457 General Health 38.57 ±13.86 49.47 ±8.88 <0.001 Vitality 46.63 ±4.01 48.03 ±1.68 0.058 Social Functioning 40.02 ±12.11 50.4 ±6.05 <0.001 Role Emotional 38.79 ±6.18 41.59 ±6.32 <0.001 Mental Health 41.81 ±5.13 46.72 ±5.23 <0.001 Physical component summary 43.79 ±7.74 46.72 ±6.27 0.008 Mental component summary 40.61 ±6.42 46.14 ±4.62 <0.001 Open in new tab Discussion The objective of this study was to determine the effects of enrollment into a MAP that included MTM services on clinical and quality-of-life outcomes in renal transplant recipients. While several studies have examined the financial implications of medication assistance programs, only a few have addressed their effects on clinical outcomes. Strum et al.1 and Schoen et al.25 attributed improvement in patients’ medication adherence and clinical outcomes to reductions in financial barriers to medication access. In this study, increased medication access through MAP enrollment appeared to increase renal transplant recipients’ number of prescription medications. The majority of patients enrolled in this study (91.7%) received their immunosuppressant therapy through the MAP. They also received a greater number of antidiabetic, antihypertensive, and antilipemic agents postenrollment. Furthermore, patients’ clinical outcomes and HQOL appeared to improve as a result of MAP enrollment, which may be attributed to both increased access to medications and the provision of MTM services. For example, of the 30 patients who were prescribed cyclosporine, the percentage of those within the target serum concentration range increased from approximately 77% before MAP enrollment to 100% after enrollment. Patients also had a decreased number of graft rejections postenrollment. Dyslipidemia, hypertension, and diabetes—comorbid conditions common in renal transplant recipients— have been associated with increased cardiovascular events in the renal transplant population and are risk factors for reducing graft and patient survival.32,–39 Thus, ongoing, aggressive treatment of hypertension, dyslipidemia, and diabetes is vital to graft and patient survival. For example, lipid-lowering therapy has been shown to have a beneficial effect on long-term outcomes of renal transplant recipients.40,41 Although postenrollment levels in our sample remained above the National Cholesterol Education Program Adult Treatment Panel III’s optimal concentrations for LDL cholesterol (<100 mg/dL), total cholesterol (<200 mg/dL), and triglycerides (<150 mg/dL),42 the significant improvements for each indicator demonstrate the positive effect of MAP services. Similarly, though systolic blood pressure levels decreased post-enrollment, the average reading for patients in the study remained slightly above the recommended target level (<130 mm Hg).43,44 However, an analysis of the Collaborative Transplant Study results found that patients with a systolic blood pressure of <140 mm Hg (our sample had a mean post-enrollment systolic blood pressure of 134.30 mm Hg) at three years post-transplantation had significantly better graft survival and a lower risk of cardiovascular death than patients with uncontrolled systolic blood pressure.45 Tighter control of blood glucose levels can also decrease morbidity rates and improve patient and graft survival in renal transplant recipients.46,47 We found that diabetic renal transplant recipients’ fasting blood glucose levels and HbA1c values decreased one year after MAP enrollment, indicating that MAP services that included MTM services improved clinical indicators in this population, which may prove beneficial to long-term health outcomes. Since Grady et al.48 found that less financial stress is predictive of better HQOL in heart transplant recipients, we hypothesized that decreasing the financial burdens related to post-transplantation medication regimens through MAP enrollment would increase HQOL scores among our study population. Indeed, HQOL scores improved post-enrollment, with significant differences from pre-enrollment in General Health, Social Functioning, Role Emotional, Mental Health, and physical and mental component summaries one year after MAP enrollment. Given these findings, the improved HQOL scores may be the result of both improved clinical outcomes, such as decreased blood glucose and LDL cholesterol levels, and decreased financial stress related to post-transplantation medications. We suspect that a combination of factors related to MAP enrollment, rather than a single factor, such as increased medication access, played a role in patients’ improved clinical outcomes and HQOL scores. Services provided to MAP patients included both medication access and MTM with a clinical pharmacist. Further, physicians were aware of which patients were enrolled in the MAP and may have prescribed more aggressive therapy because of the patients’ increased access to medication and MTM services, which may explain the increased number of prescribed antihypertensive, antilipemic, and antidiabetic agents postenrollment. Thus, we hypothesized that the combination of increased medication access (with prescriptions filled on a more regular basis), more aggressive therapy, and the involvement of a clinical pharmacist contributed to better achievement of target clinical indicators. This combination of factors may also have influenced HQOL scores. This study had several limitations. Because it was retrospective in nature, control groups did not exist to assess for confounding variables (e.g., changes in diet or exercise). However, patients’ clinical indicators and HQOL scores were documented at baseline (preenrollment to the MAP) and served as each patient’s own control values. The instrument used to measure HQOL, the SF-12v2, was chosen because it is a widely used instrument with proven validity and reliability and is shorter than most other HQOL instruments, thus decreasing the burden on participants. Generic HQOL measures, such as the SF-12v2, may not be sensitive enough to capture differences among certain types of patients.49,50 Despite the SF-12v2 being a generic HQOL measure, we were able to capture differences in HQOL using the survey. The small sample size (n = 36) limits the generalizability of the study’s results. However, significant differences were found, demonstrating the positive effects of MAP services on renal transplant recipients’ clinical outcomes and HQOL. Similar studies should be conducted in the future using larger samples to further substantiate and provide greater insight into this study’s findings. Conclusion A medication assistance program that included MTM services improved medication access, clinical outcomes, and HQOL scores of renal transplant recipients. References 1 Strum MW, Hopkins R, West DS et al. Effects of a medication assistance program on health outcomes in patients with type 2 diabetes mellitus. Am J Health-Syst Pharm . 2005 ; 62 : 1048 –52. Crossref Search ADS PubMed 2 Hadley J, Holahan J. The cost of care for the uninsured: what do we spend, who pays, and what would full coverage add to medical spending? www.kff.org/uninsured/7084.cfm (accessed 2007 Mar 29). 3 Schur CL, Doty MM, Berk ML. Lack of prescription coverage among the under 65: a symptom of underinsurance. Issue Brief . 2004 ; 716 : 1 –8. 4 The Henry J. Kaiser Family Foundation. 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TI - Effects of a medication assistance program with medication therapy management on the health of renal transplant recipients
JF - American Journal of Health-System Pharmacy
DO - 10.2146/ajhp060634
DA - 2007-07-15
UR - https://www.deepdyve.com/lp/oxford-university-press/effects-of-a-medication-assistance-program-with-medication-therapy-OR0I4Q65ko
SP - 1506
VL - 64
IS - 14
DP - DeepDyve
ER -