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Ardavani A, Curtis F, Hopwood E, Highton P, Katapa P, Khunti K, Wilkinson TJ. Effect of pharmacist interventions in chronic kidney disease: a meta-analysis. Nephrol Dial Transplant 2025; 40:884-907. [PMID: 39384574 DOI: 10.1093/ndt/gfae221] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/05/2024] [Indexed: 10/11/2024] Open
Abstract
BACKGROUND Pharmacists are uniquely placed with their therapeutic knowledge to manage people with chronic kidney disease (CKD). Data are limited regarding the impact of pharmacist interventions on economic, clinical and humanistic outcomes (ECHO). METHODS A systematic review and meta-analysis of randomized controlled trials (RCTs) of interventions with pharmacist input was conducted, which included adults with a diagnosis of CKD, including those with and without kidney replacement therapy. Data were extracted on ECHO: economic (e.g. healthcare-associated costs), clinical (e.g. mortality) and humanistic (e.g. patient satisfaction) outcomes. Where appropriate, a random-effects model meta-analysis generated a pooled estimate of effect. A direction of effect plot was used to summarize the overall effects for clinical outcome domains. RESULTS Thirty-two RCTs reported a total of 10 economic, 211 clinical and 18 humanistic outcomes. Pharmacist interventions resulted in statistically significant improvements in systolic blood pressure and hemoglobin levels, but not in diastolic blood pressure, estimated glomerular filtration rate, creatinine and low-density lipoprotein cholesterol levels. Mixed findings were reported for clinical and economic outcomes, whilst pharmacist interventions resulted in an improvement in humanistic outcomes such as patient satisfaction and patient knowledge. CONCLUSION Findings showed pharmacist interventions had mixed results for various outcomes. Future studies should be more robustly designed and take into consideration the role of the pharmacist in prescribing and deprescribing, the findings of which will help inform research and clinical practice. TRIAL REGISTRATION The review was prospectively registered on PROSPERO (CRD42022304902).
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Affiliation(s)
- Ashkon Ardavani
- NIHR Applied Research Collaboration East Midlands (ARC-EM), Leicester Diabetes Centre, University of Leicester, Leicester, UK
| | - Ffion Curtis
- Liverpool Reviews and Implementation Group (LRIG), Institute of Population Health, University of Liverpool, Liverpool, UK
| | - Ellen Hopwood
- NIHR Applied Research Collaboration East Midlands (ARC-EM), Leicester Diabetes Centre, University of Leicester, Leicester, UK
| | - Patrick Highton
- NIHR Applied Research Collaboration East Midlands (ARC-EM), Leicester Diabetes Centre, University of Leicester, Leicester, UK
| | - Priscilla Katapa
- NIHR Applied Research Collaboration East Midlands (ARC-EM), Leicester Diabetes Centre, University of Leicester, Leicester, UK
| | - Kamlesh Khunti
- NIHR Applied Research Collaboration East Midlands (ARC-EM), Leicester Diabetes Centre, University of Leicester, Leicester, UK
| | - Thomas J Wilkinson
- NIHR Leicester Biomedical Research Centre (BRC), Leicester Diabetes Centre, University of Leicester, Leicester, UK
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Corr M, Walker A, Maxwell AP, McKay GJ. Non-adherence to immunosuppressive medications in kidney transplant recipients- a systematic scoping review. Transplant Rev (Orlando) 2025; 39:100900. [PMID: 39642406 DOI: 10.1016/j.trre.2024.100900] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2024] [Revised: 11/29/2024] [Accepted: 12/01/2024] [Indexed: 12/08/2024]
Abstract
BACKGROUND Rejection and graft failure remain common in kidney transplant recipients. Non-adherence to immunosuppressive medications is considered a major contributary factor to reduced long-term graft survival, particularly in younger people. Improvements in clinical practice based on adherence studies has been minimal. METHODS Joanna Briggs' Institute Methodology was used. MedlineALL, Embase, Web of Science Core Collection and Scopus databases were searched from January 2000 through to December 2023. Abstract and full text reviews were undertaken independently by two reviewers. Data was collated using a pre-designed extraction tool. RESULTS 359 articles met the inclusion criteria. Non-adherence was commonly defined using self-reported questionnaires or pharmacy re-fill rates. Prevalence of non-adherence varied widely. There was little correlation between method of measurement and reported rates of non-adherence. Despite younger age being identified as a risk factor for non-adherence, pooled reported prevalence did not differ significantly in studies reporting prevalence in children, adolescents, or young adults vs. older adults (36.0 % vs. 34.0 %). Interventional studies to detect or improve adherence are highly heterogenous, often report small effects and are limited by the lack of gold-standard methods to measure adherence. DISCUSSION This scoping review outlines the complexities of non-adherence to immunosuppressive medications among kidney transplant recipients, highlighting significant variability in adherence definitions, measurements, and intervention efficacy. Reported non-adherence rates vary widely (2-89 %), underscoring the need for standardisation of the definition of non-adherence in research. Findings suggest that non-adherence to immunosuppressive medication is driven by a mix of demographic, psychosocial, and transplant-specific factors. Future research should prioritise standardised definitions of adherence, validated tools to measure adherence, and focus on clinically significant outcomes in non-adherent populations to develop meaningful, impactful interventions for long-term patient benefit.
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Affiliation(s)
- Michael Corr
- Centre for Public Health- Queen's University Belfast, Belfast. UK.
| | | | | | - Gareth J McKay
- Centre for Public Health- Queen's University Belfast, Belfast. UK
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Boissiere C, Rallon T, Vigneau C, Demay E, Chatron C, Bacle A. Study of therapeutic patient education practices in French renal transplantation centres. Eur J Hosp Pharm 2024:ejhpharm-2023-004006. [PMID: 38429078 DOI: 10.1136/ejhpharm-2023-004006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2023] [Accepted: 02/20/2024] [Indexed: 03/03/2024] Open
Abstract
OBJECTIVES Therapeutic patient education (TPE) plays a critical role in the management of kidney transplant recipients. However, discrepancies exist in the guidance provided regarding the usage of immunosuppressants across different kidney transplant centres in France. METHODS To assess the current landscape of TPE practices in this patient population, an online questionnaire consisting of 51 questions was distributed to 32 French renal transplantation centres. RESULTS The participation rate in our survey was 96.9%, (31 of the 32 centres contacted). The respondents had diverse professions: they were nurses (15/31), physicians (9/31) and pharmacists (7/31). Virtually all institutions have implemented TPE initiatives, with an implementation rate of 93.5% (29/31). The topic of anti-rejection medication was consistently addressed, with only one centre not providing support at the conclusion of these sessions. However, the content of the sessions varied significantly from one centre to another, particularly regarding the proper management of anti-rejection medications. Only 19.4% (6/31) of the centres provided the correct recommendation regarding fasting when taking tacrolimus. Dietary guidance was a topic covered in 89.7% (26/29) of the centres, but significant divergences were also observed. TPE teams primarily consisted of nurses, with pharmacists present in only 51.6% (16/31) of the centres. We also observed limited involvement of patient partners, with just 9.7% (3/31) of the centres including them in their programme. CONCLUSION These findings highlight considerable variability in the approach towards TPE among kidney transplant centres. Addressing counselling variability and increasing pharmacist and patient partner involvement is an essential step to improving the quality and effectiveness of TPE. By establishing a standardised and comprehensive approach to patient education, healthcare providers can ensure that kidney transplant recipients receive information that will ultimately help them improve their health and well-being.
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Affiliation(s)
- Camille Boissiere
- Pôle Pharmacie, Service Hospitalo-Universitaire de Pharmacie, CHU Rennes, Rennes, 35000, Rennes, France
| | - Tristan Rallon
- Pôle Pharmacie, Service Hospitalo-Universitaire de Pharmacie, CHU Rennes, Rennes, 35000, Rennes, France
| | - Cécile Vigneau
- Univ Rennes, CHU Rennes, INSERM, EHESP, Irset-UMR_S 1085, IRSET, 35000, Rennes, Bretagne, France
| | - Elouan Demay
- Pôle Pharmacie, Service Hospitalo-Universitaire de Pharmacie, CHU Rennes, Rennes, 35000, Rennes, France
| | | | - Astrid Bacle
- Pôle Pharmacie, Service Hospitalo-Universitaire de Pharmacie, CHU Rennes, Rennes, 35000, Rennes, France
- Univ Rennes, CHU Rennes, INSERM, EHESP, Irset-UMR_S 1085, IRSET, 35000, Rennes, Bretagne, France
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Badri S, Dadkhah-Tehrani B, Atapour A, Shahidi S, Mortazavi M, Gholipourshahraki T. The Relationship Between Weight Indices and Blood Levels of Immunosuppressive Drugs in Renal Transplant Recipients. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH : IJPR 2024; 23:e146619. [PMID: 39830665 PMCID: PMC11742375 DOI: 10.5812/ijpr-146619] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Revised: 06/08/2024] [Accepted: 08/04/2024] [Indexed: 01/22/2025]
Abstract
Background Calcineurin inhibitors and mammalian target of rapamycin (mTOR) inhibitors are essential for maintaining transplanted organs. However, determining the appropriate dosage and predicting blood concentrations of these drugs based solely on net body weight may be inadequate. Previous studies have presented contradictory results regarding the impact of obesity on drug concentrations and transplant success. Objectives This study aims to evaluate various weight indices to identify the most reliable indicator of weight that correlates with the blood levels of drugs used in organ transplantation. Methods This retrospective descriptive study included patients from nephrology clinics affiliated with Isfahan University of Medical Sciences who were taking calcineurin and/or mTOR inhibitor drugs. Data extracted from medical records included demographic and clinical information, such as height, weight, and various weight indices (total/ideal/adjusted body weight, lean body mass (LBM), Body Mass Index, and predicted normal weight), as well as blood levels of immunosuppressive drugs at each patient's visit. The dosages of each drug (mg/kg) were analyzed to determine which weight indices best correlated with the obtained blood concentrations, using the Generalized Estimating Equation (GEE) model with logistic regression, an independent correlation matrix, and a binary distribution for data analysis. Results The study analyzed the medical records of 71 patients. Trough (C0) concentrations of drugs were evaluated in relation to each weight index, and odds ratios (OR) were calculated for statistical comparison. All weight indices increased the likelihood of achieving appropriate concentrations for cyclosporine, tacrolimus, and sirolimus. Drug dosing based on LBM (OR: 1.028), ideal body weight (OR: 1.075), and total body weight (OR: 1.041) showed the strongest correlations with achieving proper blood levels for cyclosporine, tacrolimus, and sirolimus, respectively. Conclusions Integrating various weight indices for calculating individualized doses (mg/kg) of each immunosuppressive drug increases the likelihood of achieving appropriate blood concentrations. However, the optimal weight index varies for each drug. Further studies, particularly those incorporating therapeutic drug monitoring (TDM) plans in transplant centers, are warranted to validate and generalize these findings, providing a potential avenue for improving immunosuppressive therapy and enhancing transplant outcomes.
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Affiliation(s)
- Shirinsadat Badri
- Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran
- Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | | | - Abdolamir Atapour
- Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Shahrzad Shahidi
- Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Mojgan Mortazavi
- Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Tahereh Gholipourshahraki
- Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran
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Clinical pharmacy services are reimbursed in Germany: challenges of real world implementation remain. Int J Clin Pharm 2023; 45:245-249. [PMID: 36394784 PMCID: PMC9938802 DOI: 10.1007/s11096-022-01492-7] [Citation(s) in RCA: 18] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2022] [Accepted: 09/19/2022] [Indexed: 11/18/2022]
Abstract
Over the last two decades, community pharmacy has experienced major changes as the role of pharmacists is evolving from a product to a service and a patient focus. As part of this change, new and innovative clinical pharmacy services aimed at improving medicines use and patient outcomes have been designed, both nationally and internationally. Since June 2022, five services are reimbursed by all statutory health insurance funds and private insurance companies in Germany: medication review for patients with polymedication; blood pressure control in hypertension; assuring proper inhalation techniques for patients receiving a new device or a device change; medication review including a follow-up for patients taking oral anticancer drugs or immunosuppressants post-transplantation. Beyond reimbursement, the upscaling and sustainable provision of these professional services are now the main challenges. Implementation research will provide important information for the further development of pharmaceutical care programs.
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Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev 2022; 12:CD012026. [PMID: 36472416 PMCID: PMC9724196 DOI: 10.1002/14651858.cd012026.pub2] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Low health literacy affects 25% of people with chronic kidney disease (CKD) and is associated with increased morbidity and death. Improving health literacy is a recognised priority, but effective interventions are not clear. OBJECTIVES This review looked the benefits and harms of interventions for improving health literacy in people with CKD. SEARCH METHODS We searched the Cochrane Kidney and Transplant Register of Studies up to 12 July 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. We also searched MEDLINE (OVID) and EMBASE (OVID) for non-randomised studies. SELECTION CRITERIA We included randomised controlled trials (RCTs) and non-randomised studies that assessed interventions aimed at improving health literacy in people with CKD. DATA COLLECTION AND ANALYSIS Two authors independently assessed studies for eligibility and performed risk of bias analysis. We classified studies as either interventions aimed at improving aspects of health literacy or interventions targeting a population of people with poor health literacy. The interventions were further sub-classified in terms of the type of intervention (educational, self-management training, or educational with self-management training). Results were expressed as mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CI for dichotomous outcomes. MAIN RESULTS We identified 120 studies (21,149 participants) which aimed to improve health literacy. There were 107 RCTs and 13 non-randomised studies. No studies targeted low literacy populations. For the RCTs, selection bias was low or unclear in 94% of studies, performance bias was high in 86% of studies, detection bias was high in 86% of studies reporting subjective outcomes and low in 93% of studies reporting objective outcomes. Attrition and other biases were low or unclear in 86% and 78% of studies, respectively. Compared to usual care, low certainty evidence showed educational interventions may increase kidney-related knowledge (14 RCTs, 2632 participants: SMD 0.99, 95% CI 0.69 to 1.32; I² = 94%). Data for self-care, self-efficacy, quality of life (QoL), death, estimated glomerular filtration rate (eGFR) and hospitalisations could not be pooled or was not reported. Compared to usual care, low-certainty evidence showed self-management interventions may improve self-efficacy (5 RCTs, 417 participants: SMD 0.58, 95% CI 0.13 to 1.03; I² = 74%) and QoL physical component score (3 RCTs, 131 participants: MD 4.02, 95% CI 1.09 to 6.94; I² = 0%). There was moderate-certainty evidence that self-management interventions probably did not slow the decline in eGFR after one year (3 RCTs, 855 participants: MD 1.53 mL/min/1.73 m², 95% CI -1.41 to 4.46; I² = 33%). Data for knowledge, self-care behaviour, death and hospitalisations could not be pooled or was not reported. Compared to usual care, low-certainty evidence showed educational with self-management interventions may increase knowledge (15 RCTs, 2185 participants: SMD 0.65, 95% CI 0.36 to 0.93; I² = 90%), improve self-care behaviour scores (4 RCTs, 913 participants: SMD 0.91, 95% CI 0.00 to 1.82; I² =97%), self-efficacy (8 RCTs, 687 participants: SMD 0.50, 95% CI 0.10 to 0.89; I² = 82%), improve QoL physical component score (3 RCTs, 2771 participants: MD 2.56, 95% CI 1.73 to 3.38; I² = 0%) and may make little or no difference to slowing the decline of eGFR (4 RCTs, 618 participants: MD 4.28 mL/min/1.73 m², 95% CI -0.03 to 8.85; I² = 43%). Moderate-certainty evidence shows educational with self-management interventions probably decreases the risk of death (any cause) (4 RCTs, 2801 participants: RR 0.73, 95% CI 0.53 to 1.02; I² = 0%). Data for hospitalisation could not be pooled. AUTHORS' CONCLUSIONS Interventions to improve aspects of health literacy are a very broad category, including educational interventions, self-management interventions and educational with self-management interventions. Overall, this type of health literacy intervention is probably beneficial in this cohort however, due to methodological limitations and high heterogeneity in interventions and outcomes, the evidence is of low certainty.
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Affiliation(s)
- Zoe C Campbell
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Jessica K Dawson
- Westmead Clinical School, The University of Sydney at Westmead, Westmead, Australia
- Department of Nutrition and Dietetics, St George Hospital, Kogarah, Australia
| | | | - Kirsten J McCaffery
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Jesse Jansen
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
- Department of Family Medicine, School Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, Netherlands
- Faculty of Health Medicine and Life Sciences (FHML), Maastricht University, Maastricht, Netherlands
| | - Katrina L Campbell
- Centre for Applied Health Economics, Menzies Health Institute Queensland, Griffith University, Nathan, Australia
| | - Vincent Ws Lee
- Westmead Clinical School, The University of Sydney at Westmead, Westmead, Australia
- Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Australia
| | - Angela C Webster
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
- NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
- Westmead Applied Research Centre, The University of Sydney at Westmead, Westmead, Australia
- Department of Transplant and Renal Medicine, Westmead Hospital, Westmead, Australia
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Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev 2022; 9:CD012854. [PMID: 36094829 PMCID: PMC9466987 DOI: 10.1002/14651858.cd012854.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/17/2023]
Abstract
BACKGROUND Non-adherence to immunosuppressant therapy is a significant concern following a solid organ transplant, given its association with graft failure. Adherence to immunosuppressant therapy is a modifiable patient behaviour, and different approaches to increasing adherence have emerged, including multi-component interventions. There has been limited exploration of the effectiveness of interventions to increase adherence to immunosuppressant therapy. OBJECTIVES This review aimed to look at the benefits and harms of using interventions for increasing adherence to immunosuppressant therapies in solid organ transplant recipients, including adults and children with a heart, lung, kidney, liver and pancreas transplant. SEARCH METHODS We searched the Cochrane Kidney and Transplant Register of Studies up to 14 October 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA All randomised controlled trials (RCTs), quasi-RCTs, and cluster RCTs examining interventions to increase immunosuppressant adherence following a solid organ transplant (heart, lung, kidney, liver, pancreas) were included. There were no restrictions on language or publication type. DATA COLLECTION AND ANALYSIS Two authors independently screened titles and abstracts of identified records, evaluated study quality and assessed the quality of the evidence using the GRADE approach. The risk of bias was assessed using the Cochrane tool. The ABC taxonomy for measuring medication adherence provided the analysis framework, and the primary outcomes were immunosuppressant medication initiation, implementation (taking adherence, dosing adherence, timing adherence, drug holidays) and persistence. Secondary outcomes were surrogate markers of adherence, including self-reported adherence, trough concentration levels of immunosuppressant medication, acute graft rejection, graft loss, death, hospital readmission and health-related quality of life (HRQoL). Meta-analysis was conducted where possible, and narrative synthesis was carried out for the remainder of the results. MAIN RESULTS Forty studies involving 3896 randomised participants (3718 adults and 178 adolescents) were included. Studies were heterogeneous in terms of the type of intervention and outcomes assessed. The majority of studies (80%) were conducted in kidney transplant recipients. Two studies examined paediatric solid organ transplant recipients. The risk of bias was generally high or unclear, leading to lower certainty in the results. Initiation of immunosuppression was not measured by the included studies. There is uncertain evidence of an association between immunosuppressant medication adherence interventions and the proportion of participants classified as adherent to taking immunosuppressant medication (4 studies, 445 participants: RR 1.09, 95% CI 0.95 to 1.20; I² = 78%). There was very marked heterogeneity in treatment effects between the four studies evaluating taking adherence, which may have been due to the different types of interventions used. There was evidence of increasing dosing adherence in the intervention group (8 studies, 713 participants: RR 1.14, 95% CI 1.03 to 1.26, I² = 61%). There was very marked heterogeneity in treatment effects between the eight studies evaluating dosing adherence, which may have been due to the different types of interventions used. It was uncertain if an intervention to increase immunosuppressant adherence had an effect on timing adherence or drug holidays. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on persistence. There was limited evidence that an intervention to increase immunosuppressant adherence had an effect on secondary outcomes. For self-reported adherence, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants classified as medically adherent to immunosuppressant therapy (9 studies, 755 participants: RR 1.21, 95% CI 0.99 to 1.49; I² = 74%; very low certainty evidence). Similarly, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the mean adherence score on self-reported adherence measures (5 studies, 471 participants: SMD 0.65, 95% CI -0.31 to 1.60; I² = 96%; very low certainty evidence). For immunosuppressant trough concentration levels, it is uncertain whether an intervention to increase adherence to immunosuppressant medication increases the proportion of participants who reach target immunosuppressant trough concentration levels (4 studies, 348 participants: RR 0.98, 95% CI 0.68 to 1.40; I² = 40%; very low certainty evidence). It is uncertain whether an intervention to increase adherence to immunosuppressant medication may reduce hospitalisations (5 studies, 460 participants: RR 0.67, 95% CI 0.44 to 1.02; I² = 64%; low certainty evidence). There were limited, low certainty effects on patient-reported health outcomes such as HRQoL. There was no clear evidence to determine the effect of interventions on secondary outcomes, including acute graft rejection, graft loss and death. No harms from intervention participation were reported. AUTHORS' CONCLUSIONS Interventions to increase taking and dosing adherence to immunosuppressant therapy may be effective; however, our findings suggest that current evidence in support of interventions to increase adherence to immunosuppressant therapy is overall of low methodological quality, attributable to small sample sizes, and heterogeneity identified for the types of interventions. Twenty-four studies are currently ongoing or awaiting assessment (3248 proposed participants); therefore, it is possible that findings may change with the inclusion of these large ongoing studies in future updates.
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Affiliation(s)
- Lisa Mellon
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Frank Doyle
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Anne Hickey
- Department of Health Psychology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
| | - Kenneth D Ward
- School of Public Health, University of Memphis, Memphis, Tennessee, USA
| | - Declan G de Freitas
- Department of Nephrology and Kidney Transplantation, Beaumont Hospital, Dublin, Ireland
| | - P Aiden McCormick
- Irish Liver Transplant Unit, St Vincent's University Hospital, Dublin, Ireland
| | - Oisin O'Connell
- Irish National Lung and Heart Transplant Program, Mater Misericordiae University, Dublin, Ireland
| | - Peter Conlon
- Department of Nephrology and Kidney Transplantation, Beaumont Hospital, Dublin, Ireland
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Jasińska-Stroschein M. The Effectiveness of Pharmacist Interventions in the Management of Patient with Renal Failure: A Systematic Review and Meta-Analysis. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:11170. [PMID: 36141441 PMCID: PMC9517595 DOI: 10.3390/ijerph191811170] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/28/2022] [Revised: 08/30/2022] [Accepted: 09/02/2022] [Indexed: 06/16/2023]
Abstract
The existing trials have focused on a variety of interventions to improve outcomes in renal failure; however, quantitative evidence comparing the effect of performing multidimensional interventions is scarce. The present paper reviews data from previous randomized controlled trials (RCTs), examining interventions performed for patients with chronic kidney disease (CKD) and transplants by multidisciplinary teams, including pharmacists. Methods: A systematic search with quality assessment was performed using the revised Cochrane Collaboration's 'Risk of Bias' tool. Results and Conclusion: Thirty-three RCTs were included in the review, and the data from nineteen protocols were included in further quantitative analyses. A wide range of outcomes was considered, including those associated with progression of CKD, cardiovascular risk factors, patient adherence, quality of life, prescription of relevant medications, drug-related problems (DRPs), rate of hospitalizations, and death. The heterogeneity between studies was high. Despite low-to-moderate quality of evidence and relatively short follow-up, the findings suggest that multidimensional interventions, taken by pharmacists within multidisciplinary teams, are important for improving some clinical outcomes, such as blood pressure, risk of cardiovascular diseases and renal progression, and they improve non-adherence to medication among individuals with renal failure.
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9
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Gandolfini I, Palmisano A, Fiaccadori E, Cravedi P, Maggiore U. Detecting, preventing, and treating non-adherence to immunosuppression after kidney transplantation. Clin Kidney J 2022; 15:1253-1274. [PMID: 35756738 PMCID: PMC9217626 DOI: 10.1093/ckj/sfac017] [Citation(s) in RCA: 21] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2021] [Indexed: 11/12/2022] Open
Abstract
Medication non-adherence (MNA) is a major issue in kidney transplantation and it is associated with increased risk of rejection, allograft loss, patients’ death and higher healthcare costs. Despite its crucial importance, it is still unclear what are the best strategies to diagnose, prevent and treat MNA. MNA can be intentional (deliberate refusal to take the medication as prescribed) or unintentional (non-deliberate missing the prescribed medication). Its diagnosis may rely on direct methods, aiming at measuring drug ingestions, or indirect methods that analyse the habits of patients to adhere to correct drug dose (taking adherence) and interval (time adherence). Identifying individual risk factors for MNA may provide the basis for a personalized approach to the treatment of MNA. Randomized control trials performed so far have tested a combination of strategies, such as enhancing medication adherence through the commitment of healthcare personnel involved in drug distribution, the use of electronic reminders, therapy simplification or various multidisciplinary approaches to maximize the correction of individual risk factors. Although most of these approaches reduced MNA in the short-term, the long-term effects on MNA and, more importantly, on clinical outcomes remain unclear. In this review, we provide a critical appraisal of traditional and newer methods for detecting, preventing and treating non-adherence to immunosuppression after kidney transplantation from the perspective of the practising physician.
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Affiliation(s)
- Ilaria Gandolfini
- Department of Medicine and Surgery, University of Parma, Parma, Italy
- Nephrology Unit, University Hospital of Parma, Parma, Italy
| | | | - Enrico Fiaccadori
- Department of Medicine and Surgery, University of Parma, Parma, Italy
- Nephrology Unit, University Hospital of Parma, Parma, Italy
| | - Paolo Cravedi
- Department of Medicine, Division of Nephrology and Translational Transplant Research Center, Recanati Miller Transplant Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Umberto Maggiore
- Department of Medicine and Surgery, University of Parma, Parma, Italy
- Nephrology Unit, University Hospital of Parma, Parma, Italy
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Bailey P, Vergis N, Allison M, Riddell A, Massey E. Psychosocial Evaluation of Candidates for Solid Organ Transplantation. Transplantation 2021; 105:e292-e302. [PMID: 33675318 DOI: 10.1097/tp.0000000000003732] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Transplant candidates should undergo an assessment of their mental health, social support, lifestyle, and behaviors. The primary aims of this "psychosocial evaluation" are to ensure that transplantation is of benefit to life expectancy and quality of life, and to allow optimization of the candidate and transplant outcomes. The content of psychosocial evaluations is informed by evidence regarding pretransplant psychosocial predictors of transplant outcomes. This review summarizes the current literature on pretransplant psychosocial predictors of transplant outcomes across differing solid organ transplants and discusses the limitations of existing research. Pretransplant depression, substance misuse, and nonadherence are associated with poorer posttransplant outcomes. Depression, smoking, and high levels of prescription opioid use are associated with reduced posttransplant survival. Pretransplant nonadherence is associated with posttransplant rejection, and nonadherence may mediate the effects of other psychosocial variables such as substance misuse. There is evidence to suggest that social support is associated with likelihood of substance misuse relapse after transplantation, but there is a lack of consistent evidence for an association between social support and posttransplant adherence, rejection, or survival across all organ transplant types. Psychosocial evaluations should be undertaken by a trained individual and should comprise multiple consultations with the transplant candidate, family members, and healthcare professionals. Tools exist that can be useful for guiding and standardizing assessment, but research is needed to determine how well scores predict posttransplant outcomes. Few studies have evaluated interventions designed to improve psychosocial functioning specifically pretransplant. We highlight the challenges of carrying out such research and make recommendations regarding future work.
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Affiliation(s)
- Pippa Bailey
- Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Renal and Transplant Service, Southmead Hospital, North Bristol NHS Trust, Bristol, UK
| | - Nikhil Vergis
- Liver Services Department, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK
- Department of Metabolism Digestion and Reproduction, Imperial College London, UK
| | - Michael Allison
- Cambridge Liver Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Amy Riddell
- Renal and Transplant Service, Southmead Hospital, North Bristol NHS Trust, Bristol, UK
- University of Exeter Medical School, Exeter, UK
| | - Emma Massey
- Department of Internal Medicine, Nephrology and Transplantation, Erasmus Medical Center, Rotterdam, The Netherlands
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11
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Villeneuve C, Rerolle JP, Couzi L, Westeel PF, Etienne I, Esposito L, Kamar N, Büchler M, Thierry A, Marquet P, Monchaud C. Therapeutic education as a tool to improve patient-reported and clinical outcomes after renal transplantation: results of the EPHEGREN multicenter retrospective cohort study. Transpl Int 2021; 34:2341-2352. [PMID: 34585793 DOI: 10.1111/tri.14127] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/07/2021] [Revised: 08/11/2021] [Accepted: 09/06/2021] [Indexed: 12/30/2022]
Abstract
Patients are not always aware of the inconveniences associated with renal transplantation, which they compare with a « rebirth », and from which they expect complete recovery. Therapeutic education is proposed to prepare patients for their life after transplantation. This study evaluated the impact of pretransplant therapeutic education on patient-reported outcomes and rejection-free survival over the first year. We collected data from 383 renal transplant patients followed-up in seven centers. Patients who benefited from therapeutic education before transplantation (N = 182) were compared with patients who did not (N = 139) for quality-of-life, adherence and adverse events using the Pearson's chi-square test, one-way ANOVA or t-test. The association between therapeutic education and time to acute rejection was investigated using Cox models. The patients who benefited from therapeutic education reported adverse events less frequently (e.g., tremor: 9% vs. 32.4%, P = 0.01) and better quality-of-life (MCS-QOL: 50.7 ± 8.1 vs. 47.7 ± 9.5, P = 0.02; PCS-QOL: 49.1 ± 7.1 vs. 46.0 ± 9.2, P = 0.013). No difference was found on adherence. Rejection-free survival was slightly better in the therapeutic education group (HR = 0.44, 95% CI = [0.19-1.01]). This multicenter retrospective cohort study suggests that integrating therapeutic education to care pathways entails clinical benefit, in terms of quality-of-life, self-reported adverse events and rejection-free survival. Randomized clinical trials are necessary to confirm this.
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Affiliation(s)
- Claire Villeneuve
- Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, CHU Limoges, Limoges, France.,UMR-1248, INSERM, Limoges, France.,FHU SUPORT, Limoges, France
| | - Jean-Phillipe Rerolle
- UMR-1248, INSERM, Limoges, France.,FHU SUPORT, Limoges, France.,Department of Nephrology, Dialysis and Transplantation, CHU Limoges, Limoges, France
| | - Lionel Couzi
- Department of Nephrology, Transplantation, Dialysis, Centre Hospitalier Universitaire (CHU) Pellegrin, Bordeaux, France.,CNRS-UMR 5164 Immuno ConcEpT, Bordeaux University, Bordeaux, France
| | - Pierre-Francois Westeel
- Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France
| | - Isabelle Etienne
- Service de Nephrologie, Rouen University Hospital, Rouen, France
| | - Laure Esposito
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France
| | - Nassim Kamar
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France.,Université Paul Sabatier, Toulouse, France.,INSERM U1043, IFR-BMT, CHU Purpan, Toulouse, France
| | - Mathias Büchler
- FHU SUPORT, Limoges, France.,University Hospital of Tours, Tours, France.,François Rabelais University, Tours, France
| | - Antoine Thierry
- FHU SUPORT, Limoges, France.,Department of Nephrology, Dialysis and Transplantation, CHU Poitiers, Poitiers, France
| | - Pierre Marquet
- Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, CHU Limoges, Limoges, France.,UMR-1248, INSERM, Limoges, France.,FHU SUPORT, Limoges, France.,Faculty of Medicine, University of Limoges, Limoges, France
| | - Caroline Monchaud
- Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, CHU Limoges, Limoges, France.,UMR-1248, INSERM, Limoges, France.,FHU SUPORT, Limoges, France
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12
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Gonzales HM, Fleming JN, Gebregziabher M, Posadas Salas MA, McGillicuddy JW, Taber DJ. A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial. Ann Pharmacother 2021; 56:685-690. [PMID: 34496669 DOI: 10.1177/10600280211044792] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
BACKGROUND Medication safety issues have detrimental implications on long-term outcomes in the high-risk kidney transplant (KTX) population. Medication errors, adverse drug events, and medication nonadherence are important and modifiable mechanisms of graft loss. OBJECTIVE To describe the frequency and types of interventions made during a pharmacist-led, mobile health-based intervention in KTX recipients and the impact on patient risk levels. METHODS This was a secondary analysis of data collected during a 12-month, parallel-arm, 1:1 randomized clinical controlled trial including 136 KTX recipients. Participants were randomized to receive either usual care or supplemental, pharmacist-driven medication therapy monitoring and management using a smartphone-enabled app integrated with telemonitoring of blood pressure and glucose (when applicable) and risk-based televisits. The primary outcome was pharmacist intervention type. Secondary outcomes included frequency of interventions and changes in risk levels. RESULTS A total of 68 patients were randomized to the intervention and included in this analysis. The mean age at baseline was 50.2 years; 51.5% of participants were male, and 58.8% were black. Primary pharmacist intervention types were medication reconciliation and patient education, followed by medication changes. Medication reconciliation remained high throughout the study period, whereas education and medication changes trended downward. From baseline to month 12, we observed an approximately 15% decrease in high-risk patients and a corresponding 15% increase in medium- or low-risk patients. CONCLUSION AND RELEVANCE A pharmacist-led mHealth intervention may enhance opportunities for pharmacological and nonpharmacological interventions and mitigate risk levels in KTX recipients.
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Affiliation(s)
| | | | | | | | | | - David J Taber
- Medical University of South Carolina, Charleston, SC, USA
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13
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No Apparent Influence of Nonadherence on Tacrolimus Intrapatient Variability in Stable Kidney Transplant Recipients. Ther Drug Monit 2021; 42:702-709. [PMID: 32941396 DOI: 10.1097/ftd.0000000000000772] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
BACKGROUND High intrapatient variability (IPV) in tacrolimus exposure has been associated with an increased risk of graft rejection and graft loss. It has been suggested that medication nonadherence has high impact on IPV. The objective of this study is to assess the relationship between tacrolimus IPV and medication nonadherence in stable kidney transplant recipients. METHODS This study was conducted within the Reducing Renal Function Deterioration trial (Netherlands Trial Register: NTR7256), which included stable kidney transplant recipients. Nonadherence was assessed quantitatively by electronic monitoring (EM) and qualitatively using the composite adherence score (CAS) consisting of patient self-reporting (Immunosuppressant Therapy Adherence Scale), a physician report, and the tacrolimus trough concentrations (C0). IPV in tacrolimus C0 and area under the concentration-time curves (AUCs) was evaluated at 5 and 3 sampling instances, respectively. RESULTS Data of 64 kidney transplant recipients (43 males, 21 females; mean age 53.6 years), mean time post-transplantation 5.4 years, were collected. Mean missed tacrolimus intake was 7% (0.3%-13.4%) based on EM, missing one intake every 2 weeks. Based on the CAS, 68.9% of the patients were categorized as nonadherent. The mean IPV was 17.9% (4.4%-65.3%) and 20.2% (2.5%-51.6%) for tacrolimus C0 and AUCs, respectively. The nonadherence data displayed a nonparametric distribution, with nonadherence scores mostly in the lower ranges. There was no significant difference in the mean IPV between adherent and nonadherent patients. There were no differences in EM, CAS, physician report, or time-in-therapeutic range, but patients with a low AUC IPV showed a slightly higher Immunosuppressant Therapy Adherence Scale score than those with a high AUC IPV (P = 0.035). CONCLUSIONS There was no apparent relationship between IPV and nonadherence in this motivated kidney transplant recipient population, with one missed tacrolimus dose every 2 weeks.
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14
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Deutsch-Link S, Weinberg EM, Bittermann T, McDougal M, Dhariwal A, Jones LS, Weinrieb RM, Banerjee AG, Addis S, Serper M. The Stanford Integrated Psychosocial Assessment for Transplant Is Associated With Outcomes Before and After Liver Transplantation. Liver Transpl 2021; 27:652-667. [PMID: 33320417 PMCID: PMC9531321 DOI: 10.1002/lt.25975] [Citation(s) in RCA: 35] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2020] [Revised: 11/27/2020] [Accepted: 12/02/2020] [Indexed: 12/07/2022]
Abstract
The Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) is a standardized psychosocial evaluation tool used in liver transplantation (LT) evaluation. We assessed the impact of the SIPAT score and subdomains on transplant waitlisting decisions and post-LT outcomes including immunosuppression (IS) nonadherence, biopsy-proven rejection, andmortality/graft failure. We conducted a single-center observational cohort study of 1430 patients evaluated for LT. Patients were divided in 2 groups based on a SIPAT cutoff score of <21 or ≥21 (higher SIPAT scores indicate higher psychosocial risk). Regression models assessed relationships between total SIPAT score and domain scores and waitlisting decisions, IS nonadherence, allograft rejection, and death/graft failure. Elevated total SIPAT and SIPAT domain scores were associated not being added to the waitlist (total SIPAT core ≥21 adjusted odds ratio [aOR], 1.78 [95% confidence interval, CI, 1.36-2.33]; readiness score ≥5 aOR, 2.01 [95% CI, 1.36-2.76]; social support score ≥4aOR, 1.50 [95% CI, 1.15-1.94]; psychopathology score ≥7 aOR, 1.45 [95% CI, 1.07-1.94]; lifestyle/substance abuse score ≥12 aOR, 1.72 [95%CI, 1.23-2.39]) and were more likely to experience IS nonadherence as measured by the tacrolimus coefficient of variation (CoV) (total SIPAT score ≥21 aOR, 2.92 [95% CI, 1.69-5.03]; readiness score ≥5 aOR, 3.26 [95% CI, 1.63-6.52]; psychopathology score ≥7 aOR, 1.88 [95% CI, 1.00-3.50]; lifestyle substance abuse score ≥12 aOR, 3.03 [95% CI, 1.56-5.86]). SIPAT readinessscore ≥5 was associated with biopsy-proven allograft rejection (aOR, 2.66; 95% CI, 1.20-5.91). The SIPAT score was independently associated with LT listing decisions and IS nonadherence, and the readiness domain was associated with the risk of allograft rejection. These findings offer insights into higher risk recipients who require additional support before and aftertransplantation.
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Affiliation(s)
- Sasha Deutsch-Link
- Department of Gastroenterology & Hepatology, University of North Carolina–Chapel Hill, Chapel Hill, NC
| | - Ethan M. Weinberg
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Therese Bittermann
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Mackenzie McDougal
- Department of Medicine, Drexel University College of Medicine, Philadelphia, PA
| | - Aniket Dhariwal
- Department of Medicine, University of Pennsylvania, Philadelphia, PA
| | - Lauren S. Jones
- Philadelphia College of Osteopathic Medicine, Philadelphia, PA
| | - Robert M. Weinrieb
- Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Arpita G. Banerjee
- Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Senayish Addis
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
| | - Marina Serper
- Division of Gastroenterology & Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA,Leonard Davis Institute of Health Economics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
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15
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Charra F, Philippe M, Herledan C, Caffin AG, Larbre V, Baudouin A, Schwiertz V, Vantard N, Labussiere-Wallet H, Ducastelle-Leprêtre S, Barraco F, Balsat M, Larcher MV, Salles G, Rioufol C, Ranchon F. Immunosuppression medication adherence after allogeneic hematopoietic stem cell transplant: Impact of a specialized clinical pharmacy program. J Oncol Pharm Pract 2021:10781552211000115. [PMID: 33683151 DOI: 10.1177/10781552211000115] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
This study aims to evaluate the impact of implementing a specialized clinical pharmacy program in patients with allogeneic hematopoietic stem cell transplant (HSCT) on their adherence to the immunosuppression treatment after discharge. A prospective open interventional design using a retrospective control group was used. The intervention was based on pharmaceutical consultations: the first was performed the day before discharge of HSCT unit and the next consultations during day-care follow-up (weeks 2 and 4 after discharge). Proactive medication reconciliation was implemented with a complete list of medications before the discharge prescription. The discharge prescription summarized on a personalized drug schedule was explained to the patient. The importance of optimal adherence and the potential problems related to self-medication were explained to the patient. Immunosuppression drug adherence was assessed by a direct method using serum levels of calcineurin inhibitors. The potential impact on acute GvHD, and infection was investigated. Twenty-six patients were included in the specialized clinical pharmacy program and 35 patients were in the control group. Seventy-nine pharmaceutical consultations were conducted in the intervention group, lasting a mean 25 min and 16 min for the first and following consultations, respectively. Serum levels in the therapeutic target range were higher in the intervention group (61.5% versus 53.0%, p = 0.07), with greater intra-individual variation (p = 0.005). There was no significant intergroup difference in acute GvHD (53.8% versus 50.3%, p = 0.85) or infection (26.9 versus 22.8%, p = 0.72). The implementation of a specialized clinical pharmacy program for patients who have received allogeneic HSCT seems to be beneficial for immunosuppression drug adherence; this now needs to be confirmed in a multicenter study involving a larger number of patients.
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Affiliation(s)
- Florent Charra
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Michael Philippe
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Chloé Herledan
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
- University Lyon 1, EA CICLY Centre pour l'innovation en cancérologie, Lyon, France
| | - Anne-Gaëlle Caffin
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Virginie Larbre
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
- University Lyon 1, EA CICLY Centre pour l'innovation en cancérologie, Lyon, France
| | - Amandine Baudouin
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Vérane Schwiertz
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Nicolas Vantard
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
| | - Hélène Labussiere-Wallet
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Sophie Ducastelle-Leprêtre
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Fiorenza Barraco
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Marie Balsat
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Marie Virginie Larcher
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Gilles Salles
- Hospices Civils de Lyon, Hematology Department, Blood and Marrow Transplantation Unit, Pierre Bénite, France
| | - Catherine Rioufol
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
- University Lyon 1, EA CICLY Centre pour l'innovation en cancérologie, Lyon, France
| | - Florence Ranchon
- Hospices Civils de Lyon, Clinical Oncology Pharmacy Department, Groupement Hospitalier Sud, Pierre Bénite, France
- University Lyon 1, EA CICLY Centre pour l'innovation en cancérologie, Lyon, France
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16
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Johnson SR, Giordano TP, Markham C, Njue-Marendes S, Dang BN. Patients' Experiences with Refilling their HIV Medicines: Facilitators and Barriers to On-Time Refills. Perm J 2020; 24:1-3. [PMID: 33482953 PMCID: PMC7849255 DOI: 10.7812/tpp/19.207] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Revised: 02/10/2020] [Accepted: 02/24/2020] [Indexed: 11/30/2022]
Abstract
BACKGROUND Adherence to antiretroviral therapy (ART) is particularly important for patients with HIV. Prior research on ART adherence has focused primarily on behavioral interventions targeting patients and providers. No study has focused on the pharmacy refill experience as a potential target for improving adherence to HIV medicines. Informed by patients' experiences, this study aimed to assess patients' experiences with refilling their HIV medicines and to explore facilitators and barriers to refilling medicines on time. METHODS We interviewed patients at three time points during their first year of care at an HIV clinic in Houston, TX. We analyzed interviews using directed and conventional content analysis. RESULTS Analyses revealed individual, interpersonal, and system-level barriers that affect patients' ability to pick up their HIV medicines on time. Many patients perceived the refill process as being difficult. For some patients, picking up their HIV medicines each month triggered anxiety. Positive interactions with pharmacists and pharmacy staff, as well as clear and consistent messaging, played a key role in augmenting patients' refill experience. Self-efficacy, social support, and workarounds to resolve issues were also key facilitators. Many patients said changing ART-dispensing protocols from 30- to 90-day refills could mitigate the anxiety experienced with picking up HIV medicines and decrease opportunities for missing a refill. CONCLUSION Offering 90-day refills for HIV medicines may decrease anxiety concerning missed doses and improve medication adherence. Providing pharmacy staff with communication skills training is another strategy that may improve the patients' refill experience.
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Affiliation(s)
- Syundai R Johnson
- Department of Medicine, Baylor College of Medicine, Houston, TX
- VA Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston, TX
- Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX
| | - Thomas P Giordano
- Department of Medicine, Baylor College of Medicine, Houston, TX
- VA Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston, TX
- Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX
| | - Christine Markham
- Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX
| | - Sarah Njue-Marendes
- Department of Medicine, Baylor College of Medicine, Houston, TX
- VA Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston, TX
- Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX
| | - Bich N Dang
- Department of Medicine, Baylor College of Medicine, Houston, TX
- VA Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Houston, TX
- Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX
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17
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Cohen EA, McKimmy D, Cerilli A, Kulkarni S. A Pharmacist-Driven Intervention Designed to Improve Medication Accuracy in the Outpatient Kidney Transplant Setting. DRUG HEALTHCARE AND PATIENT SAFETY 2020; 12:229-235. [PMID: 33269008 PMCID: PMC7701366 DOI: 10.2147/dhps.s264022] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/28/2020] [Accepted: 10/31/2020] [Indexed: 11/23/2022]
Abstract
Background Medication errors are one of the leading causes of complications and readmissions in healthcare and stem directly from inadequate medication lists. In transplantation, medication discrepancies can lead to fluctuating levels of immunosuppression, resulting in rejection, infection, or drug toxicity. Methods We implemented a pharmacist-driven intervention designed to improve the accuracy of outpatient kidney transplant patients’ medication lists in the electronic medical record (EMR). Baseline medication error rates (Phase 1) were collected, and the intervention was a dedicated pharmacist (Phase 2) who performed medication reconciliation with patients. The primary outcome was the percent of patients with inadequate medication reconciliation determined by any one error in medication reconciliation (Phase 1 vs Phase 2). Secondary outcomes included the number of medication errors, of all medications and high-risk medications, identified per patient sample using statistical process control phase analysis. Results Pharmacist-driven medication reconciliation significantly reduced medication list discrepancies from 95% to 28% (P<0.05). There were a total of 398 errors in the control group and 49 errors in the intervention group. In addition, there were 73 high-risk medication discrepancies in the control group and three in the intervention group. The total number of medication errors decreased post-intervention with a marked reduction in the variation of control limits (LCL, UCL: phase 1, −34.3, 113.9; phase 2, −7.1, 15.3) and average number of medication errors per sample (phase 1, 39.8; phase 2, 14.1). For high-risk medications, phase analysis demonstrated a marked reduction in control limit variation between phases (LCL, UCL: phase 1, −10.4, 25.0; phase 2, −0.5, 0.7) and average number of medication errors per sample (phase 1, 7.3; phase 2, 0.1). Discussion A dedicated pharmacist improved medication list accuracy over conventional practice that utilizes transplant nurses and physicians. Further studies into the cost-effectiveness of this strategy should further justify this approach.
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Affiliation(s)
- Elizabeth A Cohen
- Yale New Haven Transplant Center, Yale New Haven Hospital, New Haven, CT, USA
| | - Danielle McKimmy
- Department of Pharmacy, University of Florida Health Shands Hospital, Gainsville, FL, USA
| | - Anna Cerilli
- Heart and Vascular Center, Yale-New Haven Hospital, New Haven, CT, USA
| | - Sanjay Kulkarni
- Section of Organ Transplantation, Yale University School of Medicine, New Haven, CT, USA
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18
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Pilch NA, Park JM, Lichvar A, Kane C, Bowman L, Melaragno JI, Sobhanian M, Perez C, Trofe‐Clark J, Fleming JN. Observations from a systematic review of pharmacist‐led research in solid organ transplantation: An opinion paper of the American College of Clinical Pharmacy Immunology/Transplantation Practice and Research Network. JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY 2020. [DOI: 10.1002/jac5.1294] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Affiliation(s)
- Nicole A. Pilch
- College of Pharmacy Medical University of South Carolina Charleston South Carolina USA
| | - Jeong M. Park
- College of Pharmacy University of Michigan Ann Arbor Michigan USA
| | - Alicia Lichvar
- Department of Pharmacy Practice and Surgery University of Illinois at Chicago Chicago Illinois USA
| | - Clare Kane
- Department of Pharmacy Northwestern Memorial Hospital Chicago Illinois USA
| | - Lyndsey Bowman
- Department of Pharmacy Tampa General Hospital Tampa Florida USA
| | | | - Minoosh Sobhanian
- Department of Pharmacy Memorial Hermann‐Texas Medical Center Houston Texas USA
| | - Caroline Perez
- Department of Pharmacy Medical University of South Carolina Charleston South Carolina USA
| | - Jennifer Trofe‐Clark
- Renal Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine University of Pennsylvania Philadelphia Pennsylvania USA
- Department of Pharmacy Services Hospital of the University of Pennsylvania Philadelphia Pennsylvania USA
| | - James N. Fleming
- Department of Pharmacy Medical University of South Carolina Charleston South Carolina USA
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19
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Shi YX, Liu CX, Liu F, Zhang HM, Yu MM, Jin YH, Shang SM, Fu YX. Efficacy of Adherence-Enhancing Interventions for Immunosuppressive Therapy in Solid Organ Transplant Recipients: A Systematic Review and Meta-Analysis Based on Randomized Controlled Trials. Front Pharmacol 2020; 11:578887. [PMID: 33192520 PMCID: PMC7606769 DOI: 10.3389/fphar.2020.578887] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 09/07/2020] [Indexed: 01/06/2023] Open
Abstract
Background Immunosuppressant non-adherence is a widespread problem among solid organ recipients. With the newly published clinical trials, the randomized controlled trials (RCTs) based systematic review of adherence-enhancing interventions on immunosuppressant adherence in solid organ recipients has not been completed. In this systematic review and meta-analysis, we compared the efficacy of adherence-enhancing interventions versus routine intervention, as performed with RCTs, on immunosuppressant adherence in solid organ transplantation recipients. Methods PubMed, Embase, Cochrane Library, CINAHL full text, and PsycINFO were searched from database inception to December 2019. This review was conducted following the PRISMA’s reporting guidelines and according to the principles recommended by Cochrane Handbook for Systematic Review. Results The search yielded 10,479 articles. A total of 27 articles (26 studies) with 715 participants were included in our analysis. Results from the meta-analysis revealed that as compared with that of the routine intervention group, the rates of overall adherence, dosing adherence, and timing adherence were significantly increased within the adherence-enhancing intervention group, with the pooled risk ratio (RR) of overall adherence = 1.17, [95% confidence interval (CI): 1.07 to 1.28; p = 0.0006]; RR of dosing adherence = 1.21 (95% CI: 1.08 to 1.36, p = 0.001); RR of timing adherence = 1.16 (95% CI: 1.03 to 1.29, p = 0.01). There was a significantly increased adherence score in the adherence-enhancing intervention group; however, no statistical significance on the immunosuppressant blood concentration was found between the two study groups. Results obtained from a subgroup analysis shown interventions led by a multidisciplinary team, both the assessment time at 6 months and 12 months demonstrated a significantly increased adherence rate in the intervention group compared with the control group. Conclusions The findings of this report indicate that clinicians (doctors and nurses) should maintain a long-term intervention protocol to ensure immunosuppressant adherence within solid organ transplant recipients. To accomplish this goal, we recommend a multidisciplinary team-led, comprehensive intervention approach combined with mobile health monitoring for the administration of an effective immunosuppressive therapy regimen.
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Affiliation(s)
- Yue-Xian Shi
- School of Nursing, Peking University, Beijing, China
| | - Chun-Xia Liu
- Department of Urinary Surgery, Peking University Third Hospital, Beijing, China
| | - Fei Liu
- School of Public Health, Peking University, Beijing, China
| | - Hai-Ming Zhang
- Liver Transplantation Center, Clinical Center for Pediatric Liver Transplantation, National Clinical Research Center for Digestive Diseases, Beijing, China
| | - Ming-Ming Yu
- School of Nursing, Peking University, Beijing, China
| | - Yin-Hui Jin
- Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.,Center for Evidence-Based and Translational Medicine, Wuhan University, Wuhan, China
| | | | - Ying-Xin Fu
- Department of Kidney Transplantation, Tianjin First Center Hospital, Tianjin, China
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20
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Development of video-based educational materials for kidney-transplant patients. PLoS One 2020; 15:e0236750. [PMID: 32745145 PMCID: PMC7398512 DOI: 10.1371/journal.pone.0236750] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2020] [Accepted: 07/12/2020] [Indexed: 01/23/2023] Open
Abstract
INTRODUCTION Treatment adherence has been evaluated as a major predictor of long-term outcome, and education has been suggested to improve adherence. Considering the characteristics of adult learners, it is necessary to implement educational programs that meet the needs of transplant patients. Multimedia education may be well-suited for this. This study aims to develop video education materials in accordance with transplant patients' self-care needs. METHODS This study includes a literature review and patient interviews aimed at developing video education materials for the self-care needs of patients who underwent renal transplant surgery at a university hospital in Seoul. Ten patients were interviewed about the desired educational content, accessibility, and other preferences. After verifying the validity of the data, the video scenarios were produced and satisfaction surveys were conducted. RESULTS Eleven self-care education items were identified through interviews with 10 kidney transplant patients. The expert validation of video-based educational content result was high (mean CVI = 0.94). The mean score of the patients' satisfaction evaluation of the completed 7-minute video instructional materials was also high (4.55 on a 5-point Likert scale). CONCLUSION Findings indicate that the video education materials will meet the needs of adult learners and mitigate the limitations of the existing education programs by increasing interest and motivation and may contribute to increased treatment adherence and ultimately, positively effect self-care for new transplant patients.
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21
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Nguyen C, Dew MA, Irizarry T, McNulty M, Rennick J, Knäuper B, Descoteaux A, Grenier A, Jeannot L, Foster BJ, DeVito Dabbs AJ, TAKE-IT TOO Investigators. Promoting medication adherence from the perspective of adolescent and young adult kidney transplant recipients, parents, and health care professionals: A TAKE-IT TOO study. Pediatr Transplant 2020; 24:e13709. [PMID: 32388916 PMCID: PMC7392786 DOI: 10.1111/petr.13709] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2019] [Revised: 02/10/2020] [Accepted: 03/03/2020] [Indexed: 12/30/2022]
Abstract
Medication non-adherence is an important factor limiting allograft survival after kidney transplantation in AYA. Some interventions, including the TAKE-IT, showed some success in promoting adherence but the potential for scalability and use in routine clinical practice is limited. We applied user-centered design to gather the perspectives of recipients, parents, and health professionals concerning their needs, challenges, and potential intervention strategies to design an optimal, multi-component medication adherence intervention. The qualitative study was conducted at four Canadian and three American kidney transplant programs. Separate focus groups for recipients, parents, and health professionals were convened to explore these stakeholders' perspectives. Directed content analysis was employed to identify themes that were shared vs distinct across stakeholders. All stakeholder groups reported challenges related to taking medications on time in the midst of their busy schedules and the demands of transitioning toward independence during adolescence. The stakeholders also made suggestions for the multi-component behavioral intervention, including an expanded electronic pillbox and companion website, education materials, and customized digitized features to support shared responsibility and communication among recipients, parents, and health professionals. Several suggestions regarding the functionality and features of the potential intervention reported in this early stage will be explored in more depth as the iterative process unfolds. Our approach to actively involve all stakeholders in the process increases the likelihood of designing an adherence intervention that is truly user-informed and fit for the clinical setting.
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Affiliation(s)
- Christina Nguyen
- UH Rainbow Babies and Children’s Hospital Division of Pediatrics, Division of Pediatric Nephrology, Cleveland, OH, USA
| | - Mary Amanda Dew
- University of Pittsburgh School of Medicine, Psychiatry Pittsburgh, PA, USA
| | - Taya Irizarry
- University of Pittsburgh School of Nursing, Acute and Tertiary Care Pittsburgh, PA, USA
| | - Mary McNulty
- University of Pittsburgh School of Medicine, Psychiatry Pittsburgh, PA, USA
| | - Janet Rennick
- Research Institute of the McGill University Health Centre Montreal, QC, CAN
| | | | - Annie Descoteaux
- Centre Hospitalier Universitaire Ste. Justine, Montreal, QC, CAN
| | | | - Lovemine Jeannot
- Research Institute of the McGill University Health Centre Montreal, QC, CAN
| | - Bethany J Foster
- Research Institute of the McGill University Health Centre Montreal, QC, CAN
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22
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Lupi D, Binda B, Montali F, Natili A, Lancione L, Chiappori D, Parzanese I, Maccarone D, Pisani F. Transplant Patients' Isolation and Social Distancing Because of COVID-19: Analysis of the Resilient Capacities of the Transplant in the Management of the Coronavirus Emergency. Transplant Proc 2020; 52:2626-2630. [PMID: 32553507 PMCID: PMC7260500 DOI: 10.1016/j.transproceed.2020.05.031] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2020] [Revised: 05/23/2020] [Accepted: 05/26/2020] [Indexed: 02/02/2023]
Abstract
Background One of the peculiar aspects of the transplant patient’s life is that, in the post-surgery phase, the patient lives in an “isolation” condition, having to pay particular attention to the living environment and preferring a limited social life given that the immunosuppressive treatment entails immunodepression in the patient. With coronavirus disease 2019 (COVID)-19, as in a post-surgery situation, social isolation is being implemented. Materials and Methods The study started on March 17, 2020, and ended on April 24, 2020. Consulting/phone interviews were made. The phone questionnaire, submitted to 71 patients, consisted of a set of 15 questions that investigated structure and psychological resistance. Eight patients have been monitored exclusively for the psychological aspect through a more articulate supporting path. Results In essence, from the overall analysis of the data derived from the study of the positioning of patients based on the stage of renal function, the bands related to the development of psychopathological aspects, and the use of positive personal resources, it emerges that patients in stage V kidney failure are in the first bracket as regards the development of psychopathological aspects (absence of these experiences) and in the third bracket as regards the good use of positive resources to deal with isolation. Therefore, it can be deduced that, although with data that can be expanded, a serious or medium-serious situation from an organic point of view in this socio-health emergency situation is well addressed by the transplanted patient. Conclusion Transplant patients have faced the measure of social distancing adequately and in adherence to the treatment thanks to the phone assistance of all the medical-surgical and psychological team.
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Affiliation(s)
- Diana Lupi
- Centro Regionale Trapianti-Regione Abruzzo-Regione Molise, L'Aquila, Italy.
| | - Barbara Binda
- U.O.C. Chirurgia Generale e dei Trapianti d'Organo, L'Aquila, Italy
| | - Filippo Montali
- Università degli Studi dell'Aquila, Dipartimento di Scienze Cliniche Applicate e Biotecnologiche, L'Aquila, Italy
| | - Andrea Natili
- U.O.C. Chirurgia Generale e dei Trapianti d'Organo, L'Aquila, Italy
| | - Laura Lancione
- U.O.C. Chirurgia Generale e dei Trapianti d'Organo, L'Aquila, Italy
| | - Davide Chiappori
- U.O.C. Chirurgia Generale e dei Trapianti d'Organo, L'Aquila, Italy
| | - Ida Parzanese
- Centro Regionale Trapianti-Regione Abruzzo-Regione Molise, L'Aquila, Italy
| | - Daniela Maccarone
- Centro Regionale Trapianti-Regione Abruzzo-Regione Molise, L'Aquila, Italy
| | - Francesco Pisani
- U.O.C. Chirurgia Generale e dei Trapianti d'Organo, L'Aquila, Italy
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23
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Analysis of Psychopathologic Elements as a Compliance Limitation: Team Work as a Therapeutic Response. Transplant Proc 2020; 52:1577-1580. [PMID: 32439333 DOI: 10.1016/j.transproceed.2020.03.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2020] [Revised: 02/24/2020] [Accepted: 03/12/2020] [Indexed: 11/23/2022]
Abstract
INTRODUCTION The psychological evaluation of the patient, carried out through psychodiagnostic tests, clinical interviews, and a joint work with the medical-surgical team, provided useful information to assess the compliance of the kidney transplant recipient. METHODOLOGY Two hundred and forty-five visits were carried out between September 2018 and May 2019 in the General Surgery and Organ Transplant Department of the San Salvatore Hospital, L'Aquila. The visits consisted of clinical interviews, targeted psychodiagnostic evaluations, graphic-projective tests, and personality and cognitive structure evaluation tests. These assessments were key not only to defining the patient's personality picture but also to offering suitable psychological support to patients on waiting lists for transplantation, during hospitalization, and during follow-up visits from transplantation phases. RESULTS From the analysis of the tests and from the clinical and support interviews, some of the patients presented forms of psycho-emotional immaturity that impaired the predisposition to compliance and ultimately the establishment of the therapeutic alliance. During 8 months, 18 compliance limit cases were observed, 5 patients were sent to mental health centers, and 13 psychological support courses were activated within the Regional Transplant Center-Abruzzo Region Molise Region. No structured psychological support courses were deemed necessary for 9 of these 13 cases, whereas 4 were sent to the mental health centers. CONCLUSIONS By assessing the complexity of each patient from a medical and a psychological point of view and by considering the high number of transplant surgeries currently occurring, it can be noted that compliance to therapy is strongly linked to the reliability of the relationships between patients and caregivers.
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24
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Chisholm-Burns MA, Spivey CA, Potukuchi PK, Streja E, Kalantar-Zadeh K, Kovesdy CP, Molnar MZ. Association between Posttransplant Opioid Use and Immunosuppressant Therapy Adherence among Renal Transplant Recipients. Nephron Clin Pract 2020; 144:321-330. [PMID: 32434210 DOI: 10.1159/000507257] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2019] [Accepted: 03/14/2020] [Indexed: 12/12/2022] Open
Abstract
INTRODUCTION Little is known about the effect of posttransplant opioid use on adherence to immunosuppressant therapy (IST) among adult renal transplant recipients (RTRs). OBJECTIVE The aim of this study was to examine the relationship between opioid use and IST adherence among adult RTRs during the first year posttransplant. METHODS Longitudinal data were analyzed from a retrospective cohort study examining US veterans undergoing renal transplant from October 1, 2007, through March 31, 2015. Data were collected from the US Renal Data System, Centers for Medicare and Medicaid Services Data (Medicare Part D), and Veterans Affairs pharmacy records. Dose of opioid prescriptions was collected and divided based on annual morphine milligram equivalent within a year of transplant. Proportion of days covered of greater than or equal to 80% indicated adherence to tacrolimus. Unadjusted and multivariable-adjusted logistic regression analyses were performed. RESULTS A study population of 1,229 RTRs included 258 with no opioid use, while 971 opioid users were identified within the first year after transplantation. Compared to RTRs without opioid usage, RTRs with opioid usage had a lower probability of being adherent to tacrolimus in unadjusted logistic regression (odds ratio [OR] (95% confidence interval [CI]): 0.22 [0.07-0.72]) and adjusted logistic regression (OR [95% CI]: 0.11 [0.03-0.44]). These patterns generally remained consistent in unadjusted and adjusted main and sensitivity analyses. CONCLUSIONS Findings indicate RTRs who use prescription opioids during the first year posttransplant, regardless of the dosage/amount, are less likely to be adherent to tacrolimus. Future studies are needed to better understand underlying causes of the association between opioid use and tacrolimus nonadherence.
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Affiliation(s)
- Marie A Chisholm-Burns
- College of Pharmacy, University of Tennessee Health Science Center, Memphis, Tennessee, USA,
| | - Christina A Spivey
- Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, Memphis, Tennessee, USA
| | - Praveen K Potukuchi
- Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.,Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, Tennessee, USA
| | - Elani Streja
- Division of Nephrology, University of California, Irvine, California, USA
| | | | - Csaba P Kovesdy
- Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.,Nephrology Section, Memphis Veterans Affairs Medical Center, Memphis, Tennessee, USA
| | - Miklos Z Molnar
- Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.,Methodist University Hospital Transplant Institute, Memphis, Tennessee, USA.,Division of Transplant Surgery, Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA
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25
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Villeneuve C, Rousseau A, Rerolle JP, Couzi L, Kamar N, Essig M, Etienne I, Westeel PF, Büchler M, Esposito L, Thierry A, Marquet P, Monchaud C. Adherence profiles in kidney transplant patients: Causes and consequences. PATIENT EDUCATION AND COUNSELING 2020; 103:189-198. [PMID: 31447197 DOI: 10.1016/j.pec.2019.08.002] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/14/2018] [Revised: 07/30/2019] [Accepted: 08/01/2019] [Indexed: 06/10/2023]
Abstract
OBJECTIVE Adherence is a dynamic phenomenon and a critical determinant of transplant patients outcome. The objective of this longitudinal study was to explore adherence in kidney transplant patients followed-up for up to three years after transplantation. METHODS Adherence was repeatedly estimated using the Morisky-Green-Levine 4-Item Medication Adherence Scale, in two successive cohorts of 345 (EPIGREN) and 367 (EPHEGREN) kidney transplant recipients. Mixed effect modeling with latent processes and latent classes was used to describe adherence time-profiles. RESULTS Two latent classes were identified. The adherent class represented 85% of the patients. Patients of the poorer-adherence class displayed a lower adherence at one month (p<10-3), which worsened over time. Good adherence was associated with age >50 years, fewer depression episodes (5% vs. 13%, p = 0.001) and a better mental health component of quality of life (MCS-SF36 47 ± 11 vs. 41 ± 13, p = 0.015). Survival without acute rejection episodes was longer in the adherent class (p = 0.004). CONCLUSIONS The risk of poor adherence in renal transplant patients can be detected as early as one month post-transplantation, using appropriate and easy tools adapted to routine monitoring. PRACTICE IMPLICATIONS An early focus on vulnerable patients should allow putting into place actions in order to reduce the risk of poor outcome related to poor adherence.
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Affiliation(s)
- Claire Villeneuve
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France.
| | - Annick Rousseau
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Univ Limoges, Faculty of Pharmacy, Department of Biophysics, F-87000 Limoges, France
| | - Jean-Phillipe Rerolle
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Department of Nephrology, Dialysis and Transplantation, F-87000, Limoges, France
| | - Lionel Couzi
- Department of Nephrology, Transplantation, Dialysis, Centre Hospitalier Universitaire (CHU) Pellegrin, Bordeaux, France; CNRS-UMR 5164 Immuno ConcEpT, Bordeaux University, Bordeaux, France
| | - Nassim Kamar
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France; Université Paul Sabatier, Toulouse, France; INSERM U1043, IFR-BMT, CHU Purpan, Toulouse, France
| | - Marie Essig
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Department of Nephrology, Dialysis and Transplantation, F-87000, Limoges, France; Univ Limoges, Faculty of Medicine, F-87000 Limoges, France
| | - Isabelle Etienne
- Service de Nephrologie, Rouen University Hospital, Rouen, France
| | - Pierre-Francois Westeel
- Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France
| | - Mathias Büchler
- FHU SUPORT, Limoges, F-87000, France; Department of Nephrology and Kidney Transplantation, University Hospital of Tours, Tours, France; François Rabelais University, EA 4245 Tours, France
| | - Laure Esposito
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France
| | - Antoine Thierry
- FHU SUPORT, Limoges, F-87000, France; CHU Poitiers, Department of Nephrology, Dialysis and Transplantation, F-86000 Poitiers, France
| | - Pierre Marquet
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Univ Limoges, Faculty of Medicine, F-87000 Limoges, France
| | - Caroline Monchaud
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France
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26
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Russell CL, Hathaway D, Remy LM, Aholt D, Clark D, Miller C, Ashbaugh C, Wakefield M, Ye S, Staggs VS, Ellis RJ, Goggin K. Improving medication adherence and outcomes in adult kidney transplant patients using a personal systems approach: SystemCHANGE™ results of the MAGIC randomized clinical trial. Am J Transplant 2020; 20:125-136. [PMID: 31291507 PMCID: PMC7179766 DOI: 10.1111/ajt.15528] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2018] [Revised: 06/27/2019] [Accepted: 07/07/2019] [Indexed: 01/25/2023]
Abstract
This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.
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Affiliation(s)
- Cynthia L. Russell
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Donna Hathaway
- College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Laura M. Remy
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Dana Aholt
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Debra Clark
- College of Nursing, University of Tennessee Health Science Center, Memphis, Tennessee
| | - Courtney Miller
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Catherine Ashbaugh
- University of Missouri Renal Transplant Program, University of Missouri Health Care, Columbia, Missouri
| | - Mark Wakefield
- University of Missouri Renal Transplant Program, University of Missouri Health Care, Columbia, Missouri
| | - Sangbeak Ye
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, Missouri
| | - Vincent S. Staggs
- Health Services & Outcomes Research, Children’s Mercy Kansas City, Kansas City, Missouri
| | - Rebecca J. Ellis
- Indiana University School of Nursing, Indiana University-Purdue University, Indianapolis, Indiana
| | - Kathy Goggin
- Health Services & Outcomes Research, Children’s Mercy Kansas City, Kansas City, Missouri
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27
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Hall CL, Fominaya CE, Gebregziabher M, Milfred-LaForest SK, Rife KM, Taber DJ. Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc 2019; 8:e13821. [PMID: 31573933 PMCID: PMC6774238 DOI: 10.2196/13821] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2019] [Revised: 05/31/2019] [Accepted: 05/31/2019] [Indexed: 12/31/2022] Open
Abstract
Background Medication errors, adverse drug events, and nonadherence lead to increased health care utilization and increased risk of adverse clinical outcomes, including graft loss, in solid organ transplant recipients. Veterans living with organ transplants represent a population that is at substantial risk for medication safety events and fragmented care coordination issues. To improve medication safety and long-term clinical outcomes in veteran transplant patients, interventions should address interorganizational system failures and provider-level and patient-level factors. Objective This study aims to measure the clinical and economic effectiveness of a pharmacist-led, technology-enabled intervention, compared with usual care, in veteran organ transplant recipients. Methods This is a 24-month prospective, parallel-arm, cluster-randomized, controlled multicenter study. The pharmacist-led intervention uses an innovative dashboard system to improve medication safety and health outcomes, compared with usual posttransplant care. Pharmacists at 10 study sites will be consented into this study before undergoing randomization, and 5 sites will then be randomized to each study arm. Approximately, 1600 veteran transplant patients will be included in the assessment of the primary outcome across the 10 sites. Results This study is ongoing. Institutional review board approval was received in October 2018 and the study opened in March 2019. To date there are no findings from this study, as the delivery of the intervention is scheduled to occur over a 24-month period. The first results are expected to be submitted for publication in August 2021. Conclusions With this report, we describe the study design, methods, and outcome measures that will be used in this ongoing clinical trial. Successful completion of the Improving Transplant Medication Safety through a Technology and Pharmacist Intervention study will provide empirical evidence of the effectiveness of a feasible and scalable technology-enabled intervention on improving medication safety and costs. Clinical Trial ClinicalTrials.gov NCT03860818; https://clinicaltrials.gov/ct2/show/NCT03860818 International Registered Report Identifier (IRRID) PRR1-10.2196/13821
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Affiliation(s)
- Casey L Hall
- Health Equity & Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States
| | - Cory E Fominaya
- Department of Pharmacy, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States
| | - Mulugeta Gebregziabher
- Health Equity & Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States.,Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States
| | | | - Kelsey M Rife
- Department of Pharmacy, VA Northeast Ohio Healthcare System, Cleveland, OH, United States
| | - David J Taber
- Health Equity & Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States.,Department of Pharmacy, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, United States.,Division of Transplant Surgery, College of Medicine, Medical University of South Carolina, Charleston, SC, United States
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28
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Elfadawy N, Flechner SM. Retransplantation after nonadherence-related kidney allograft failure - forgive or forget? Transpl Int 2019; 32:1241-1243. [PMID: 31553095 DOI: 10.1111/tri.13531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2019] [Accepted: 09/19/2019] [Indexed: 11/30/2022]
Affiliation(s)
- Nissreen Elfadawy
- Division on Nephrology, Department of Medicine, University Hospitals Cleveland Medical Center and School of Medicine, Case Western Reserve University, Cleveland, OH, USA
| | - Stuart M Flechner
- Glickman Urology and Kidney Institute, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA
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29
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Gokoel SRM, Gombert-Handoko KB, Zwart TC, van der Boog PJM, Moes DJAR, de Fijter JW. Medication non-adherence after kidney transplantation: A critical appraisal and systematic review. Transplant Rev (Orlando) 2019; 34:100511. [PMID: 31627978 DOI: 10.1016/j.trre.2019.100511] [Citation(s) in RCA: 53] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2019] [Revised: 08/27/2019] [Accepted: 08/28/2019] [Indexed: 10/26/2022]
Abstract
Medication non-adherence is one of the most important causes for shortened graft survival subsequently leading to a reduction in kidney graft survival results. Our aim was to provide an overview of its prevalence, risk factors, diagnostic methods and interventions to improve adherence in kidney transplant recipients. Therefore, we systematically searched the databases PubMed, COCHRANE Library, Web of Science and EMBASE for studies addressing "medication adherence", "compliance", "adherence", "kidney transplantation" and "life style factors". We identified 96 studies that satisfied our inclusion criteria. A problematic lack of a uniformly accepted definition for non-adherence was found, consequently leading to a wide range in non-adherence prevalence (36-55%). Using one uniformly accepted non-adherence definition should therefore be encouraged. A wide range in diagnostic methods makes it difficult to accurately detect non-adherence. Heterogeneous results of intervention studies make it difficult to select the best adherence enhancing method, challenging the battle against medication non-adherence. Literature suggests a combination of personalized interventions, based on patient-specific non-adherent behavior, to be most successful in improvement of adherence. High quality diagnostic methods and multidisciplinary, personalized interventions with focus on relevant clinical outcome are essential in overcoming medication non-adherence in kidney transplant recipients.
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Affiliation(s)
- Sumit R M Gokoel
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands.
| | - Kim B Gombert-Handoko
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Tom C Zwart
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Paul J M van der Boog
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands
| | - Dirk Jan A R Moes
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Johan W de Fijter
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands
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Hawley CE, Triantafylidis LK, Paik JM. The missing piece: Clinical pharmacists enhancing the interprofessional nephrology clinic model. J Am Pharm Assoc (2003) 2019; 59:727-735. [PMID: 31231002 PMCID: PMC8150925 DOI: 10.1016/j.japh.2019.05.010] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2019] [Revised: 05/13/2019] [Accepted: 05/14/2019] [Indexed: 12/24/2022]
Abstract
OBJECTIVES To embed pharmacy residents in an interprofessional nephrology clinic to conduct medication reconciliation in targeted high-risk patients with nondialysis kidney disease. SETTING This pilot was a prospective quality improvement initiative conducted in an interprofessional outpatient nephrology clinic. PRACTICE DESCRIPTION The nephrology clinic team includes nephrology providers, a social worker, and a geriatrician. The team is responsible for the management of conditions such as nondialysis kidney disease, resistant hypertension, acute kidney injury, proteinuria, and nephropathy. EVALUATION Primary outcomes included the number and type of medication discrepancies and drug therapy problems identified. Secondary outcomes included the changes in care process directly resulting from the pharmacy residents' recommendations. The perceived value of the pharmacy residents to the interprofessional team was assessed through postintervention anonymous surveys and semistructured interviews. RESULTS The pharmacy residents conducted 118 visits for 87 unique patients (mean age 73 years, 97% male) with nondialysis kidney disease (89% stages III-V), polypharmacy (87% of patients taking > 10 medications), and a heavy comorbidity burden (85% hypertension, 80% dyslipidemia, 59% diabetes mellitus type II) from January to October 2017. Pharmacists identified 344 medication discrepancies and 301 drug therapy problems, resulting in 398 changes in care process. The most frequently identified discrepancies and drug therapy problems were the omission of an active medication from the medication list (86 of 344 discrepancies, 25%) and potentially inappropriate medications (106 of 301 drug therapy problems, 35%). Pharmacists recommended 228 medication changes, provided 76 adherence devices, facilitated 24 consults or referrals, and communicated with the primary care team on 70 occasions. The interprofessional team members all strongly agreed that patients and the team benefited from the pharmacists' involvement. CONCLUSION Pharmacy resident-led medication reconciliation resulted in the identification and resolution of medication discrepancies and drug therapy problems, leading to changes in the care process.
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Affiliation(s)
- Chelsea E. Hawley
- New England Geriatric Research, Education, and Clinical Center
- Department of Pharmacy, VA Boston Healthcare System, Boston, MA
| | | | - Julie M. Paik
- New England Geriatric Research, Education, and Clinical Center
- Renal Section, VA Boston Healthcare System
- Brigham and Women’s Hospital
- Department of Medicine, Harvard Medical School, Boston, MA
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Al Raiisi F, Stewart D, Fernandez-Llimos F, Salgado TM, Mohamed MF, Cunningham S. Clinical pharmacy practice in the care of Chronic Kidney Disease patients: a systematic review. Int J Clin Pharm 2019; 41:630-666. [PMID: 30963447 PMCID: PMC6554252 DOI: 10.1007/s11096-019-00816-4] [Citation(s) in RCA: 65] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2018] [Accepted: 03/27/2019] [Indexed: 11/24/2022]
Abstract
Background Clinical pharmacy services have potential to contribute significantly to the multidisciplinary team providing safe, effective and economic care for patients. Given recent practice developments (e.g. polypharmacy reviews and pharmacist prescribing) there is a need to provide a current synthesis of the evidence base for characteristics and outcomes of clinical pharmacy practice in chronic kidney disease patients. Aim of the review To critically appraise, synthesise and present the available evidence of the characteristics (structures and processes) and outcomes of clinical pharmacy practice as part of the multidisciplinary care of patients with chronic kidney disease. Method PubMed, International Pharmaceutical Abstracts (IPA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline and Scopus were searched for peer reviewed papers using improved search strategy. Included studies were quality assessed using Downs and Black tool for controlled studies and the mixed methods appraisal tool for all controlled and non-controlled studies. Data were extracted and synthesised using a narrative approach. Screening, quality assessment and data extraction were performed by two independent researchers. Ethics approval was not required. Results Forty-seven studies were identified from a variety of countries, with 31 based in a hospital setting. Controlled study designs were employed in 20, with only ten of these using randomisation. Resources available for service provision were poorly reported in all papers. Positive impact on clinical outcomes included significant improvement in parathyroid hormone, blood pressure, haemoglobin and creatinine clearance. Pharmacists identified 5302 drug related problems in 2933 patients and made 3160 recommendations with acceptance rates up to 95%. Impact on humanistic outcomes was shown through improvement in health related quality of life and patient satisfaction. Economic benefits arose from significant cost savings through pharmaceutical care provision. Conclusion While there is some evidence of positive impact on clinical, humanistic and economic outcomes, this evidence is generally of low quality and insufficient volume. While the existing evidence is in favour of pharmacists' involvement in the multidisciplinary team providing care to patients with chronic kidney disease, more high-quality research is warranted.
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Affiliation(s)
- Fatma Al Raiisi
- School of Pharmacy & Life Sciences, Robert Gordon University, Aberdeen, Scotland, UK
| | - Derek Stewart
- School of Pharmacy & Life Sciences, Robert Gordon University, Aberdeen, Scotland, UK
| | - Fernando Fernandez-Llimos
- Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
| | - Teresa M Salgado
- Department of Pharmacotherapy & Outcomes Science, Center for Pharmacy Practice Innovation, Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA
| | | | - Scott Cunningham
- School of Pharmacy & Life Sciences, Robert Gordon University, Aberdeen, Scotland, UK.
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Shneider C, Dunphy C, Shemesh E, Annunziato RA. Assessment and Treatment of Nonadherence in Transplant Recipients. Gastroenterol Clin North Am 2018; 47:939-948. [PMID: 30337042 DOI: 10.1016/j.gtc.2018.07.015] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
Stable intake of an immunosuppressant medication regimen is essential for posttransplant survival in the vast majority of cases. And yet, many patients are nonadherent (do not take their medications as prescribed), and suffer consequences ranging from rejection to morbidity and mortality. We review the evidence related to monitoring of adherence to medications, and intervention strategies. Our aim is to provide a baseline from which readers may approach behavioral aspects of posttransplant care. This review may also help readers in designing clinical programs for routine monitoring of adherence, and inform the choice of intervention when adherence falls below a certain threshold.
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Affiliation(s)
- Caitlin Shneider
- Center for Translational Science, Children's National Medical Center, 111 Michigan Avenue Northwest, 5th Floor Main, Suite 5500, Office 5533, Washington, DC 20010, USA
| | - Claire Dunphy
- Clinical Psychology, Department of Psychology, Fordham University, 441 East Fordham Road, Dealy Hall, Bronx, NY 10458, USA
| | - Eyal Shemesh
- Division of Behavioral and Developmental Health, The Department of Pediatrics, Kravis Children's Hospital, Icahn School of Medicine at Mount Sinai, Box 1198, 1 Gustave L Levy Place, New York, NY 10029, USA.
| | - Rachel A Annunziato
- Psychology, Fordham College at Rose Hill, Fordham University, 441 East Fordham Road, Dealy Hall, Bronx, NY 10458, USA
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Sam S, Guérin A, Rieutord A, Belaiche S, Bussières JF. Roles and Impacts of the Transplant Pharmacist: A Systematic Review. Can J Hosp Pharm 2018; 71:324-337. [PMID: 30401999 PMCID: PMC6209508] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
BACKGROUND Pharmacists have been involved in the care of transplant recipients for several decades, and a growing body of literature shows the beneficial effects of clinical pharmacist care on important outcomes for these patients. OBJECTIVES The primary objective was to describe the roles and impacts of pharmacists in a solid organ transplant setting. The secondary objective was to describe and rate the pharmacists' interventions. DATA SOURCES Three databases-PubMed, Embase, and Evidence-Based Medicine Reviews-were searched from January 1, 1990, to June 16, 2015. STUDY SELECTION AND DATA EXTRACTION All studies addressing the roles of pharmacists and the impacts of clinical pharmacy services on the care of solid organ transplant recipients were considered. Only studies providing a statistical analysis were included. Design, setting, sample size, patient characteristics, pharmacists' interventions, study bias, and outcomes were extracted for analysis. DATA SYNTHESIS Four randomized controlled trials, 4 cohort studies, 3 pre-post studies, and 1 quasi-randomized controlled trial were included in the review, representing a total of 1837 patients. Of the 12 studies included, 8 specifically focused on renal transplant, and 1 each focused on liver, lung, abdominal organ, and general solid organ transplant. The pivotal pharmacist activities leading to the main patient outcomes were medication counselling (n = 8 studies), medication reconciliation (n = 5), and reviewing and optimizing drug therapy (n = 3). Improvements to medication adherence (n = 6 studies), morbidity (n = 4), costs (n = 2), and medication errors (n = 2) were reported. CONCLUSION Currently available evidence suggests that pharmacists can improve patient outcomes in the solid organ transplant setting. Adherence, morbidity, costs, and medication errors were identified as the main outcomes that were improved by pharmaceutical interventions. Transplant programs need to invest more in this resource.
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Affiliation(s)
- Sébastien Sam
- , PharmD, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec
| | - Aurélie Guérin
- , PharmD, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, Montréal, Quebec
| | - André Rieutord
- , PharmD, PhD, is with the Pharmacy Department, Hôpital Antoine-Bédère, Clamart, France
| | - Stéphanie Belaiche
- , PharmD, is with the Pharmacy Department, Centre hospitalier universitaire Lille, Lille, France
| | - Jean-François Bussières
- , BPharm, MSc, MBA, FCSHP, is with the Pharmacy Practice Research Unit, Pharmacy Department, Centre hospitalier universitaire Sainte-Justine, and the Faculty of Pharmacy, Université de Montréal, Montréal, Quebec
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Ettenger R, Albrecht R, Alloway R, Belen O, Cavaillé-Coll MW, Chisholm-Burns MA, Dew MA, Fitzsimmons WE, Nickerson P, Thompson G, Vaidya P. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant 2018; 18:564-573. [PMID: 29288623 DOI: 10.1111/ajt.14635] [Citation(s) in RCA: 41] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2017] [Revised: 11/16/2017] [Accepted: 12/18/2017] [Indexed: 01/25/2023]
Abstract
The Food and Drug Administration (FDA) held a public meeting and scientific workshop in September 2016 to obtain perspectives from solid organ transplant recipients, family caregivers, and other patient representatives. The morning sessions focused on the impact of organ transplantation on patients' daily lives and the spectrum of activities undertaken to maintain grafts. Participants described the physical, emotional, and social impacts of their transplant on daily life. They also discussed their posttransplant treatment regimens, including the most burdensome side effects and their hopes for future treatment. The afternoon scientific session consisted of presentations on prevalence and risk factors for medication nonadherence after transplantation in adults and children, and interventions to manage it. As new modalities of Immunosuppressive Drug Therapy are being developed, the patient perceptions and input must play larger roles if organ transplantation is to be truly successful.
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Affiliation(s)
- Robert Ettenger
- Department of Pediatrics, UCLA Mattel Children's Hospital, Los Angeles, CA, USA
| | - Renata Albrecht
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Rita Alloway
- Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Ozlem Belen
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Marc W Cavaillé-Coll
- Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Marie A Chisholm-Burns
- Colleges of Pharmacy and Medicine, University of Tennessee Health Science Center, Memphis, TN, USA
| | - Mary Amanda Dew
- Departments of Psychiatry, Psychology, Epidemiology, Biostatistics, and Clinical and Translational Science, University of Pittsburgh, Pittsburgh, PA, USA
| | | | - Peter Nickerson
- Department of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Graham Thompson
- Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
| | - Pujita Vaidya
- Office of Program and Strategic Analysis, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA
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Flamme-Obry F, Belaiche S, Hazzan M, Ramdan N, Noël C, Odou P, Décaudin B. [Clinical pharmacist and medication reconciliation in kidney transplantation]. Nephrol Ther 2018; 14:91-98. [PMID: 29477279 DOI: 10.1016/j.nephro.2017.04.004] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2017] [Revised: 03/30/2017] [Accepted: 04/04/2017] [Indexed: 11/29/2022]
Abstract
INTRODUCTION Drug related problems (DRP) can lead to severe consequences in kidney recipients. The aim of the study was to assess the impact of the clinical pharmacist interventions on the incidence of DRP. METHOD The number of DRP were evaluated according to 3periods: Without intervention, with medication reconciliation at admission, and with medication reconciliation at admission associated with an interview with the clinical pharmacist at discharge. RESULTS Patients concerned were mainly men, 55years old (median age), stage3 of CKD, transplanted for less than 3months or more than 1year, with cardiovascular risk factors and receiving an average of 9drugs/day. Among the DRP, 20% were avoidable and severe in most cases. In period1, 27.7% patients had at least 1DRP, in period2, 21.3% patients had at least 1DRP, and in period3, 17.4% of patients had at least 1DRP (P=0.03). One hundred and ten patients had medication reconciliation at admission with a mean of 0.6unintentional discrepancies per patient (omission in 81% of cases). The main drugs involved concerned the digestive-metabolic (24.5%), cardiovascular (23%), and nervous (23%) system. Sixty-eight interviews at discharge were realized and revealed self-medication habits. CONCLUSION Our study shows that medication reconciliation at admission associated with an interview with the clinical pharmacist at discharge can help to reduce DRP in kidney recipients. Further studies are needed to confirm our results.
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Affiliation(s)
| | - Stéphanie Belaiche
- Institut de pharmacie, CHRU de Lille, rue Philippe-Marache, 59000 Lille, France; EA 7365, GRITA, groupe de recherche sur les formes injectables et les technologies associées, University Lille, 59000 Lille, France.
| | - Marc Hazzan
- Service de néphrologie, CHRU de Lille, 59000 Lille, France; Inserm U995, Lille Inflammation Research International Center (LIRIC), University Lille, 59000 Lille, France
| | - Nassima Ramdan
- EA 2694, santé publique : épidémiologie et qualité des soins, CHRU de Lille, University Lille, 59000 Lille, France
| | - Christian Noël
- Service de néphrologie, CHRU de Lille, 59000 Lille, France; Inserm U995, Lille Inflammation Research International Center (LIRIC), University Lille, 59000 Lille, France
| | - Pascal Odou
- Institut de pharmacie, CHRU de Lille, rue Philippe-Marache, 59000 Lille, France; EA 7365, GRITA, groupe de recherche sur les formes injectables et les technologies associées, University Lille, 59000 Lille, France
| | - Bertrand Décaudin
- Institut de pharmacie, CHRU de Lille, rue Philippe-Marache, 59000 Lille, France; EA 7365, GRITA, groupe de recherche sur les formes injectables et les technologies associées, University Lille, 59000 Lille, France
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Duncan S, Annunziato RA, Dunphy C, LaPointe Rudow D, Shneider BL, Shemesh E. A systematic review of immunosuppressant adherence interventions in transplant recipients: Decoding the streetlight effect. Pediatr Transplant 2018; 22:10.1111/petr.13086. [PMID: 29218760 PMCID: PMC5811374 DOI: 10.1111/petr.13086] [Citation(s) in RCA: 43] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/23/2017] [Indexed: 12/23/2022]
Abstract
Non-adherence to immunosuppressant medications is an important risk factor for graft dysfunction. To evaluate the effectiveness of adherence-enhancing interventions, we reviewed adherence intervention studies in solid organ transplant recipients (all ages). Using the following databases: PsycINFO, PubMed, Scopus, and ScienceDirect, we identified 41 eligible studies. Only three non-randomized trials showed a possible positive effect on objective indicators of transplant outcomes (such as rejection, liver enzyme levels, kidney function). None of the 21 RCTs showed an improvement in transplant outcomes. Three studies showed a higher rate of adverse events in the intervention group as compared with controls, although this may be related to ascertainment bias. Improvement in adherence as measured indirectly (eg, with electronic monitoring devices) was not aligned with effects on transplant outcomes. We conclude that adherence interventions, to date, have largely been ineffective in improving transplant outcomes. To improve this track record, intervention efforts may wish to concentrate on non-adherent patients (rather than use convenience sampling, which excludes many of the patients who need the intervention), use direct measures of adherence to guide the interventions, and employ strategies that are intensive and yet engaging enough to ensure that non-adherent patients are able to participate.
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Affiliation(s)
- S Duncan
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - R A Annunziato
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - C Dunphy
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
- Department of Psychology, Fordham University, Bronx, NY, USA
| | - D LaPointe Rudow
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
| | - B L Shneider
- Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA
| | - E Shemesh
- Department of Pediatrics, Icahn School of Medicine at Mount Sinai, Kravis Children's Hospital, New York, NY, USA
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West LM, Vetter-Kerkhoff C, Miljkovic N, Frontini R. Is there a need for a hospital pharmacy common training framework? Review of the literature on the impact of educational interventions on health outcome. Eur J Hosp Pharm 2018; 25:6-9. [PMID: 31156978 PMCID: PMC6452398 DOI: 10.1136/ejhpharm-2016-001185] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2016] [Revised: 02/01/2017] [Accepted: 02/06/2017] [Indexed: 11/04/2022] Open
Abstract
BACKGROUND With the update of the directive 2005/36/EU on the recognition of professional qualifications (2013/55/EU), the European Union (EU) legislation opened also to pharmacists the possibility to define specialisations via a common training framework (CTF). OBJECTIVE The aim of this study was to review, synthesise and present published evidence on the impact of health educational interventions targeting healthcare professionals on patients' health outcomes that support a hospital pharmacy CTF in EU. METHOD The search was carried out in Medline and Cumulative Index to Nursing & Allied Health Literature and was limited to English language full review articles or primary research published since 2000. Data were extracted independently and compared by three of the researchers. RESULTS Ten papers (9 primary research studies and one literature review) were identified. Almost one-third of the studies (30%, n=3) targeted pharmacists in their research. The majority of studies (80%, n=8) have shown that higher education levels among healthcare professionals improved patient outcomes. No study discussed the importance of a CTF. CONCLUSION The review of the literature has demonstrated the need for education and training of health personnel to improve patient outcome. Controlled studies about pharmacist education and training in European countries showed that the benefit of a CTF is lacking.
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Affiliation(s)
- Lorna Marie West
- Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
| | | | - Nenad Miljkovic
- Department of Pharmacy, Institute of Orthopaedic Surgery "Banjica", University Hospital of Belgrade, Belgrade, Serbia
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Clemmons AB, Alexander M, DeGregory K, Kennedy L. The Hematopoietic Cell Transplant Pharmacist: Roles, Responsibilities, and Recommendations from the ASBMT Pharmacy Special Interest Group. Biol Blood Marrow Transplant 2017; 24:914-922. [PMID: 29292057 DOI: 10.1016/j.bbmt.2017.12.803] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2017] [Accepted: 12/26/2017] [Indexed: 12/14/2022]
Abstract
Pharmacists are increasingly recognized as an essential member of the multidisciplinary team for hematopoietic cell transplant (HCT) patients. However, until recently, their educational background, required training, and potential roles have not been well described. Therefore, the purpose of this manuscript is to provide supporting evidence for the HCT Clinical Pharmacist Role Description, which has been endorsed by several organizations including the American Society for Blood and Marrow Transplantation. This document provides justification for the various roles pharmacists fulfill with respect to medication management, transitions of care, patient and provider education, policy development, quality improvement, and research. Furthermore, evidence supporting the value, financially and otherwise, HCT pharmacists provide is reviewed. Pharmacists in the HCT setting are encouraged to report on novel practice models and potential impact of their services to increase awareness and utilization of HCT pharmacists.
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Affiliation(s)
- Amber B Clemmons
- Department of Clinical and Administrative Pharmacy, University of Georgia College of Pharmacy, Augusta, Georgia; Department of Pharmacy, Augusta University (AU) Medical Center, Augusta, Georgia.
| | - Maurice Alexander
- Department of Pharmacy, University of North Carolina Medical Center, Chapel Hill, North Carolina
| | - Kathlene DeGregory
- Department of Pharmacy, University of Virginia Health System, Charlottesville, Virginia
| | - LeAnne Kennedy
- Department of Pharmacy, Wake Forest Baptist Health, Winston Salem, North Carolina
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Mathes T, Großpietsch K, Neugebauer EAM, Pieper D. Interventions to increase adherence in patients taking immunosuppressive drugs after kidney transplantation: a systematic review of controlled trials. Syst Rev 2017; 6:236. [PMID: 29187249 PMCID: PMC5707897 DOI: 10.1186/s13643-017-0633-1] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2016] [Accepted: 11/21/2017] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND Immunosuppressive drugs have to be taken through the whole duration of kidney transplant survival to avoid rejection. Low adherence can increase the risk of allograft rejection. The objective was to evaluate the effectiveness of adherence-enhancing interventions (AEI) in kidney transplantation recipients taking immunosuppressive drugs. METHODS A search was performed in Medline, Embase, CINAHL, and PsycINFO. The search was performed in May 2016. We included comparative studies on AEI for kidney transplant recipients taking immunosuppressive drugs. The primary outcome was medication adherence. All identified articles were screened according to the predefined inclusion criteria. The risk of bias was assessed with the Cochrane risk of bias tool. Study selection and risk of bias assessment were performed by two reviewers independently. Data were extracted in standardized tables. Data extraction was verified by a second reviewer. All discrepancies were resolved through discussion. Data were synthesized in a structured narrative way. There is no registered or published protocol for this systematic review. RESULTS We identified 12 studies. The number of participants ranged from 24 to 1830. Nine studies included adults, two children, and one adults and children. Risk of bias was high. The main reasons for high risk of bias were inadequate allocation sequence (confounding) and that studies were not blinded. Eleven studies evaluated AEI consisting of educational and/or behavioral components. All these studies showed an effect direction in favor of the intervention. Intervention effect was only moderate. Most adherence measures in studies on educational and behavioral interventions showed statistically significant differences. Studies that combined educational and behavioral intervention components showed larger effects. All studies that were statistically significant were multimodal. Studies that included an individualized component and more intensive interventions showed larger effects. One study evaluated a reminder system. Effect size was not reported. This study showed no statistical significant difference (p > 0.05). CONCLUSION Educational and behavioral AEI can increase adherence. In particular, multimodal and individualized interventions seem promising. However, because of the small effect, the high risk of bias, and the invalidity of adherence measures, the actual benefit of adherence interventions for an unselected patient population (i.e., including also adherent patients) seems limited. No conclusion is possible for interventions combining adherence-enhancing components that address intentional (behavioral) as well as unintentional adherence (reminder).
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Affiliation(s)
- Tim Mathes
- Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109 Cologne, Germany
| | - Kirsten Großpietsch
- Institute for Health Economics and Clinical Epidemiology of the University of Cologne, Gleueler Str. 176-178, 50935 Cologne, Germany
| | - Edmund A. M. Neugebauer
- Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109 Cologne, Germany
- Brandenburg Medical School Theodor Fontane, Neuruppin, Germany
| | - Dawid Pieper
- Institute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, Building 38, 51109 Cologne, Germany
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Hucker A, Bunn F, Carpenter L, Lawrence C, Farrington K, Sharma S. Non-adherence to immunosuppressants following renal transplantation: a protocol for a systematic review. BMJ Open 2017; 7:e015411. [PMID: 28963283 PMCID: PMC5640118 DOI: 10.1136/bmjopen-2016-015411] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
INTRODUCTION Adherence to immunosuppressant medication is essential for renal transplant recipients. This review aims to summarise what is known about non-adherence, with a view to providing comprehensive evidence to inform strategies aimed at advancing adherent behaviour. METHODS AND ANALYSIS A systematic review of quantitative studies that report adherence to immunosuppressants in adult (over 18 years) renal transplant recipients. The review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines; study quality will be assessed using the Downs and Black checklist. Systematic searches will be completed across relevant databases. Two reviewers will independently extract data using a predefined data extraction form. We will summarise the operationalisation of adherence across studies and use narrative synthesis to identify factors associated with non-adherence. A meta-analysis will be conducted if there is sufficient homogeneity, and available data, across studies to estimate the prevalence of non-adherence in renal transplant recipients. Heterogeneity will be assessed using the I2 test. Survival analysis will be conducted to estimate hazard ratios to explore the impact of non-adherence on graft survival, graft failure and patient survival. ETHICS AND DISSEMINATION Findings will be published in a peer-reviewed journal and disseminated at conferences for professionals and researchers. Review outcomes will help support clinical practice by highlighting the extent of non-adherence among adults, and in doing so, signpost the need for suitable intervention. TRIAL REGISTRATION NUMBER PROSPERO registration number (CRD42016038751).
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Affiliation(s)
- Abigail Hucker
- Department of Psychology and Sport Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK
| | - Frances Bunn
- Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK
| | - Lewis Carpenter
- Department of Psychology and Sport Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK
| | | | - Ken Farrington
- Renal Unit, Lister Hospital, Stevenage, Hertfordshire, UK
| | - Shivani Sharma
- Department of Psychology and Sport Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK
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Thrall SA, Fominaya CE, Chiasson JM, Castle S, Taber DJ. Improvement in immunosuppression therapy monitoring in organ transplant recipients. Am J Health Syst Pharm 2017; 74:S67-S74. [PMID: 28842520 DOI: 10.2146/ajhp160872] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE The results of a study to determine whether a technology-enabled pharmacist intervention improved immunosuppression monitoring in organ transplant recipients are presented. METHODS This was a retrospective, longitudinal cohort study. Eligible patients included veteran solid organ transplant recipients receiving immunosuppression therapy from a Veterans Affairs Medical Center (VAMC) between July 1, 2013, and July 1, 2015. A clinical pharmacist used an electronic surveillance system to determine need for laboratory monitoring and engaged the recipients to obtain regular laboratory monitoring at the VAMC or an outside facility. The primary aim was to determine whether the intervention improved immunosuppression monitoring using an interrupted time series inquiry with segmented regression analysis. The secondary aim was to assess care coordination using descriptive statistics. RESULTS A total of 110 veteran transplant recipients were included; 96% were male, 50% received kidney transplants, 36% received liver transplants, and 14% received thoracic transplants. During the 6-month initial intervention period, the rate of patients meeting minimum immunosuppression monitoring criteria increased by 4.7% per month (p < 0.001). The monthly rate of patients meeting immunosuppressant monitoring for tacrolimus, cyclosporine, and antimetabolites increased by 4.1% (p = 0.0013), 9.5% (p = 0.0442), and 1.5% (p = 0.0077), respectively. The clinical pharmacist performed 126 medication reconciliations, documented 259 outside laboratory values, and referred 9 patients to other providers. CONCLUSION Clinical pharmacist intervention resulted in an increased number of patients with solid organ transplant meeting minimum immunosuppressant monitoring recommendations.
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Affiliation(s)
- Stephanie A Thrall
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC, and College of Pharmacy, Medical University of South Carolina, Charleston, SC.
| | - Cory E Fominaya
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC
| | - Jordan M Chiasson
- College of Pharmacy, Medical University of South Carolina, Charleston, SC
| | - Sharon Castle
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC
| | - David J Taber
- Department of Pharmacy, Ralph H. Johnson VAMC, Charleston, SC, and Division of Transplant Surgery and College of Medicine, Medical University of South Carolina, Charleston, SC
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Nevins TE, Nickerson PW, Dew MA. Understanding Medication Nonadherence after Kidney Transplant. J Am Soc Nephrol 2017; 28:2290-2301. [PMID: 28630231 PMCID: PMC5533244 DOI: 10.1681/asn.2017020216] [Citation(s) in RCA: 100] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
Alloimmunity remains a barrier to long-term graft survival that necessitates lifelong immunosuppressive therapy after renal transplant. Medication nonadherence has been increasingly recognized as a major impediment to achieving effective immunosuppression. Electronic medication monitoring further reveals that nonadherence manifests early after transplant, although the effect is delayed. The etiology of nonadherence is multifactorial, with the strongest risk factors including past nonadherence and being an adolescent or young adult. Other risk factors with smaller but consistently important effects include minority race/ethnicity, poor social supports, and poor perceived health. In children, risk factors related to parental and child psychologic and behavioral functioning and parental distress and burden are also important. Qualitative systematic reviews highlight the need to tailor interventions to each transplant recipient's unique needs, motivations, and barriers rather than offer a one size fits all approach. To date, relatively few interventions have been studied, and most studies conducted were underpowered to allow definitive conclusions. If the kidney transplant community's goal of "one transplant for life" is to become a reality, then solutions for medication nonadherence must be found and implemented.
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Affiliation(s)
- Thomas E. Nevins
- Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota
| | - Peter W. Nickerson
- Department of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; and
| | - Mary Amanda Dew
- Department of Psychiatry, University of Pittsburgh School of Medicine and Medical Center, Pittsburgh, Pennsylvania
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Hayward KL, Martin JH, Cottrell WN, Karmakar A, Horsfall LU, Patel PJ, Smith DD, Irvine KM, Powell EE, Valery PC. Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial. Trials 2017; 18:339. [PMID: 28728560 PMCID: PMC5520368 DOI: 10.1186/s13063-017-2075-4] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/16/2016] [Accepted: 07/01/2017] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death. METHODS/DESIGN A patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients' knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks. DISCUSSION The intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients. TRIAL REGISTRATION Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459 . Registered on 15 June 2016.
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Affiliation(s)
- Kelly L. Hayward
- School of Medicine, The University of Queensland, Brisbane, QLD Australia
- Pharmacy Department, Princess Alexandra Hospital, Brisbane, QLD Australia
| | - Jennifer H. Martin
- School of Medicine and Public Health, The University of Newcastle, Newcastle, NSW Australia
| | - W. Neil Cottrell
- School of Pharmacy, The University of Queensland, Brisbane, QLD Australia
| | - Antara Karmakar
- School of Medicine, The University of Queensland, Brisbane, QLD Australia
| | - Leigh U. Horsfall
- The Centre for Liver Disease Research, Translational Research Institute, The University of Queensland, Brisbane, QLD Australia
- Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD Australia
| | - Preya J. Patel
- The Centre for Liver Disease Research, Translational Research Institute, The University of Queensland, Brisbane, QLD Australia
- Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD Australia
| | - David D. Smith
- Statistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, QLD Australia
| | - Katharine M. Irvine
- The Centre for Liver Disease Research, Translational Research Institute, The University of Queensland, Brisbane, QLD Australia
| | - Elizabeth E. Powell
- The Centre for Liver Disease Research, Translational Research Institute, The University of Queensland, Brisbane, QLD Australia
- Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD Australia
| | - Patricia C. Valery
- Cancer and Chronic Disease Research Group, Level 4, Central, QIMR Berghofer Medical Research Institute, 300 Herston Rd, Brisbane, QLD 4006 Australia
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Lima LF, Martins BCC, Oliveira FRPD, Cavalcante RMDA, Magalhães VP, Firmino PYM, Adriano LS, Silva AMD, Flor MJN, Néri EDR. Pharmaceutical orientation at hospital discharge of transplant patients: strategy for patient safety. EINSTEIN-SAO PAULO 2017; 14:359-365. [PMID: 27759824 PMCID: PMC5234747 DOI: 10.1590/s1679-45082016ao3481] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2015] [Accepted: 06/30/2016] [Indexed: 11/22/2022] Open
Abstract
Objective: To describe and analyze the pharmaceutical orientation given at hospital discharge of transplant patients. Methods: This was a cross-sectional, descriptive and retrospective study that used records of orientation given by the clinical pharmacist in the inpatients unit of the Kidney and Liver Transplant Department, at Hospital Universitário Walter Cantídio, in the city of Fortaleza (CE), Brazil, from January to July, 2014. The following variables recorded at the Clinical Pharmacy Database were analyzed according to their significance and clinical outcomes: pharmaceutical orientation at hospital discharge, drug-related problems and negative outcomes associated with medication, and pharmaceutical interventions performed. Results: The first post-transplant hospital discharge involved the entire multidisciplinary team and the pharmacist was responsible for orienting about drug therapy. The mean hospital discharges/month with pharmaceutical orientation during the study period was 10.6±1.3, totaling 74 orientations. The prescribed drug therapy had a mean of 9.1±2.7 medications per patient. Fifty-nine drug-related problems were identified, in which 67.8% were related to non-prescription of medication needed, resulting in 89.8% of risk of negative outcomes associated with medications due to untreated health problems. The request for inclusion of drugs (66.1%) was the main intervention, and 49.2% of the medications had some action in the digestive tract or metabolism. All interventions were classified as appropriate, and 86.4% of them we able to prevent negative outcomes. Conclusion: Upon discharge of a transplanted patient, the orientation given by the clinical pharmacist together with the multidisciplinary team is important to avoid negative outcomes associated with drug therapy, assuring medication reconciliation and patient safety.
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Affiliation(s)
- Lívia Falcão Lima
- Hospital Universitário Walter Cantídio, Universidade Federal do Ceará, Fortaleza, CE, Brazil
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Sin JH, Li H, Jandovitz N, King M, Tsapepas DS. Dynamic Interplay of Pharmacy Learners During a Solid Organ Transplantation Learning Experience. J Pharm Pract 2017. [DOI: 10.1177/0897190017715392] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Institutions with established clinical pharmacy services have the ability to offer focused patient care learning experiences, often led by a clinical specialist, for pharmacy residents and pharmacy students. Since all parties are continually involved in professional development and lifelong learning, the aforementioned groups can all be considered “pharmacy learners.” By utilizing the dynamic interplay and collaboration between pharmacy learners through direct and nondirect patient care activities, experiential and educational opportunities may be improved and enhanced for each learner. A tiered learning approach engages individuals in areas such as direct patient care, patient education, presentations, research projects, career development, and the feedback process. We describe our experience during a solid organ transplantation learning experience using a layered learning practice model that included a clinical pharmacy specialist, a postgraduate year 2 specialty pharmacy resident, a postgraduate year 1 pharmacy resident, and a pharmacy student.
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Affiliation(s)
- Jonathan H. Sin
- Department of Pharmacy, Massachusetts General Hospital, Boston, MA, USA
| | - Hanlin Li
- Department of Pharmacy, NewYork–Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA
| | - Nicholas Jandovitz
- Department of Pharmacy, NewYork–Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA
| | - Madeline King
- Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA, USA
| | - Demetra S. Tsapepas
- Department of Pharmacy, NewYork–Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA
- Division of Abdominal Transplantation, Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, NY, USA
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Zhu Y, Zhou Y, Zhang L, Zhang J, Lin J. Efficacy of interventions for adherence to the immunosuppressive therapy in kidney transplant recipients: a meta-analysis and systematic review. J Investig Med 2017; 65:1049-1056. [PMID: 28483983 PMCID: PMC5847104 DOI: 10.1136/jim-2016-000265] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/13/2017] [Indexed: 01/23/2023]
Abstract
Immunosuppressive treatment regimens are complex and require ongoing self-management. Medication adherence can be difficult to achieve for several reasons. The current meta-analysis and systematic review investigated whether adherence interventions improved immunosuppressive treatment adherence in kidney transplant recipients. Medline, Cochrane, EMBASE, and Google Scholar were searched until October 17, 2016 using the following search terms: kidney transplantation, compliance, adherence, and immunosuppressive therapy. Randomized controlled trials and two-arm prospective, retrospective, and cohort studies were included. The primary outcomes were adherence rate and adherence score. Eight studies were included with a total for 546 patients. Among participants receiving intervention, the adherence rate was significantly higher than the control group (pooled OR=2.366, 95% CI 1.222 to 4.578, p=0.011). Participants in the intervention group had greater adherence scores than those in the control group (pooled standardized difference in means =1.706, 95% CI 0.346 to 3.065, p=0.014). Sensitivity analysis indicated that findings for adherence rate were robust. However, for adherence score, the significance of the association disappeared after removing one of the studies indicating the findings may have been overly influenced by this one study. Intervention programs designed to increase immunosuppressive adherence in patients with kidney transplant improve treatment adherence.
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Affiliation(s)
- Yichen Zhu
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Yifan Zhou
- National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA
| | - Lei Zhang
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Jian Zhang
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Jun Lin
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
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Dobbels F, De Bleser L, Berben L, Kristanto P, Dupont L, Nevens F, Vanhaecke J, Verleden G, De Geest S. Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. J Heart Lung Transplant 2017; 36:499-508. [PMID: 28162931 DOI: 10.1016/j.healun.2017.01.007] [Citation(s) in RCA: 83] [Impact Index Per Article: 10.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2016] [Revised: 12/22/2016] [Accepted: 01/04/2017] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND Well-designed randomized controlled trials (RCTs) testing efficacy of post-transplant medication adherence enhancing interventions and clinical outcomes are scarce. METHODS This randomized controlled trial enrolled adult heart, liver, and lung transplant recipients who were >1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3-month run-in period, patients were randomly assigned 1:1 to intervention group (IG) or control group (CG) (visit 2), followed by a 6-month intervention (visits 2-4) and a 6-month adherence follow-up period (visit 5). All patients used electronic monitoring for 15 months for adherence measurement, generating a daily binary adherence score per patient. Post-intervention 5-year clinical event-free survival (mortality or retransplantation) was evaluated. The IG received staged multicomponent tailored behavioral interventions (visits 2-4) building on social cognitive theory and trans-theoretical model (e.g., electronic monitoring feedback, motivational interviewing). The CG received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan-Meier survival analysis. RESULTS Of 247 patients, 205 were randomly assigned (103 IG, 102 CG). At baseline, average daily proportions of patients with correct dosing (82.6% IG, 78.4% CG) and timing adherence (75.8% IG, 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG, 79.1% CG; p < 0.001), resulting in odds of adherence being 5 times higher in the IG than in the CG (odds ratio 5.17, 95% confidence interval 2.86-9.38). This effect was sustained at end of follow-up (similar results for timing adherence). In the IG, 5-year clinical event-free survival was 82.5% vs 72.5% in the CG (p = 0.18). CONCLUSION Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability.
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Affiliation(s)
- Fabienne Dobbels
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland.
| | - Leentje De Bleser
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium
| | - Lut Berben
- Institute of Nursing Science, University of Basel, Basel, Switzerland
| | | | - Lieven Dupont
- Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Frederik Nevens
- Liver Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Johan Vanhaecke
- Heart Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Geert Verleden
- Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium
| | - Sabina De Geest
- Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland
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Affiliation(s)
- Gilbert J Burckart
- Department of Pharmacy, University of Southern California, 1540 Alcazar St., CHP-217E, Los Angeles, CA 90033, USA.
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Alshammari TM. Patient's medicinal knowledge in Saudi Arabia: Are we doing well? Saudi Pharm J 2016; 24:560-562. [PMID: 27752228 PMCID: PMC5059822 DOI: 10.1016/j.jsps.2015.03.014] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2015] [Accepted: 03/15/2015] [Indexed: 12/02/2022] Open
Abstract
Patient education is one of the main factors of patient therapeutic plan and without it, the patient may not benefit from his/her medications. Several studies showed the effectiveness of educating patients about their disease(s) and their medication(s) which ultimately enhance their quality of life especially in chronic diseases such as diabetes mellitus and hypertension. Concept of patient education is well known and understood in the Western countries while in the Kingdom of Saudi Arabia it is not well established despite some efforts made by few big hospitals. In Saudi Arabia, different stakeholders such as hospitals, pharmaceutical companies, healthcare professionals, health societies and association and governmental agencies do not do their job as patient education. Aim of this paper was to throw some light about the current situation in Saudi Arabia.
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Ohler L, Lo A. Transplant Pharmacists: Key to a Successful Transplant Program. Prog Transplant 2016; 14:80-1. [PMID: 15264451 DOI: 10.1177/152692480401400201] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
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