الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Hemodialysis is a renal replacement therapy that is essential to maintain the lives of ESRD patients. Hemodialysis imposes a financial burden on patients and the country due to the high cost of dialysis, medications, and the lost productivity, in addition to the humanistic burden in the form of impaired quality of life. HD patients are more prone to DRPs due to multiple co-morbidities, complex drug regimens, the change in drug pharmacokinetics and pharmacodynamics induced by kidney disease, and polypharmacy (Almodóvar & Nahata, 2019; Stemer & Lemmens-Gruber, 2011).
Medication therapy management (MTM) plays an essential role in resolving problems such as polypharmacy, adherence, and other DRPs. Medication therapy management can be achieved by performing a medication review, selecting, modifying, or administering medication therapy, evaluating the patient response to therapy, identifying and resolving any DRPs, and providing patient education to enhance the patient understanding and adherence to the treatment plan. These pharmaceutical services have shown a positive impact on dialysis patients regarding the economic, humanistic, and clinical aspects. (Pai, Boyd, Chavez, et al., 2009; Pai, Boyd, Depczynski, et al., 2009).
The patient reported outcomes measure of pharmaceutical therapy (PROMPT) scale is a new tool, designed to identify the effect of medication burden on HRQoL. The availability of new tools designed to measure the impact of pharmacy interventions on HRQoL demonstrates the need for an interventional study that evaluates different outcomes of MTM application in HD patients and assesses HRQoL using one of these novel tools. This work aimed to evaluate medication therapy management application in a hemodialysis unit in Alexandria. The specific objectives were:
• To assess baseline characteristics of hemodialysis patients including drug related problems, hospital admission rate, hemoglobin levels, and medication burden quality of life.
• To implement a medication therapy management program in the hemodialysis unit.
• To evaluate the effect of the medication therapy management program on
- Medication burden quality of life
- Hemoglobin levels, drug related problems, number of medications, hospital admission rate, and adherence.
Both the validation study and the interventional study were conducted among HD patients in Alexandria. First, the PROMPT questionnaire was validated, after being translated, and culturally adapted. Eighty patients on regular HD were interviewed for validation, after one week, forty of them were re-interviewed for reliability testing.
To assess the impact of MTM application in a HD unit, an intervention study (one group pretest-posttest) design was used. Medication burden quality of life change was considered the primary outcome, all patients in El-Moassat university hospital who were 18 years or older and were receiving HD for at least three months were included in the study.
A predesigned structured interview questionnaire was used to collect the baseline data such as personal data (age, gender, marital status, smoking), HD related data (HD vintage, HD access, responsible physician), hospital admission for the past three months, medications, DRPs and adherence, adverse effects, medication burden quality of life, and laboratory parameters (serum calcium, serum phosphorus, and hemoglobin levels).
Medication therapy management was applied for three months. This included medication therapy review to detect any drug related problems, developing personal medication records, participating in the medication-related action plan, and patient education sessions.
After three months, participants were reassessed for hospital admission within the past three months, laboratory parameters, DRPs, adherence, adverse effects, and medication burden quality of life.
Results showed that the sample used for validation was similar to the study sample. The factor structure of the questionnaire revealed five domains, items were significantly correlated to their domains. Most of the domains were not significantly correlated to each other which indicated convergent and divergent validity.
Internal consistency for all items showed Cronbach’s alpha of 0.759. The results for individual domains ranged from 0.713 to 0.844 for most of the domains. In test-retest reliability, the ICC was statistically significant for the total score as well as the individual domains indicating the reliability of the PROMPT questionnaire.
After MTM application, the total PROMPT score has significantly increased from (50.74±9.68) to (59.3± 9.86), (p<0.001). The individual domains scores were significantly increased, (p-value ranged from 0.004 to <0.001), except for the medicine effectiveness domain.
The total number of DRPs per patient has decreased significantly from (11.97±4.65) per patient to (7.63±3.85) after MTM application, (p<0.001). The most prevalent DRPs were adverse effects, followed by untreated indication, and drug overdose.
The mean number of administered medications per patient was (8.10±2.78) pre and (8.29±2.57) post MTM application, with no statistically significant difference (p > 0.05). The proportion of adherent patients was increased from (44.1%) pre MTM application to (55.9%) post MTM application, however, the increase was not statistically significant.
There was a statistically significant reduction in the proportion of some adverse effects after MTM application such as dry mouth, change of appetite, nausea and vomiting, stomach pain and dyspepsia, diarrhea, constipation, and flatulence, palpitations, muscle and joint pain, headache, dizziness and vertigo, and skin complaints, p-value ranged from (0.011) to (<0.001).
While serum calcium level has decreased significantly (p=0.001), no statistically significant difference was detected in the hemoglobin level, or serum phosphorus level after the application of MTM. Hospital admissions were decreased after MTM application, but the decrease was not statistically significant.
A multiple linear regression model was used to identify the independent predictors of the PROMPT total score after MTM application. The model explains 47% of the variation in PROMPT score by the variation in educational level, and the total number of DRPs after MTM. In this model, being a university graduate increased the score by (7.64) folds (p=0.004), and the presence of any DRPs decreased the score by (1.49) folds, (p<0.001).
6.2 Conclusion
• The PROMPT questionnaire is a valid and reliable tool that can be used for the assessment of MBQoL among HD patients.
• The application of MTM in a dialysis unit decreased the presence of DRPs and improved MBQoL.
• Adverse effects, untreated indications, and drug overdose were the most common DRPs in HD patients.
• Adverse effects and subtherapeutic doses were significantly correlated to MBQoL among HD patients.
• The incorporation of the patient and pharmacist in the management plan improved patient outcomes.
• The level of education affects the patient understanding of his treatment plan, medications, and precautions which was reflected on his MBQoL.
• Dialysability of drugs should be taken into consideration when prescribing medications for HD patients.
6.3 Recommendations
6.3.1 Recommendations to the Ministry of Health and Population
• Each HD unit should include a clinical pharmacist as part of the health care team.
• Continuous medical education is important for all the health care team members to ensure correct responses to patients’ concerns.
• Erythropoietin stimulating agents and other expensive drugs should be made available according to patients’ needs, as well as required laboratory tests.
• Educational programs are needed for the HD patients.
• The Ministry of Health and Population should encourage the digital transformation of MTM services.
6.3.2 Recommendations to clinical pharmacists
• Using the PROMPT questionnaire regularly not only as a tool to assess MBQoL, but also to identify knowledge gaps and patient’s worries from medications.
• Adherence should be assessed periodically, barriers to adherence should be identified and resolved.
• Adverse effects should be assessed regularly, adaptive measures should be taken.
• Educational leaflets regarding HD, nutrition, care of HD access, precautions, possible adverse events should be distributed to patients and updated on regular basis (appendix III).
6.3.3 Recommendations to the patients
• Patients should be encouraged to enhance their knowledge regarding their disease and their medications.
• Chronic patients should be encouraged to carry a detailed list of their medications, and to show it whenever necessary.
6.3.4 Recommendations to researchers
Further studies are needed to:
• Assess patterns of prescribing vitamin D analogs among HD patients.
• The Arabic version of the PROMPT questionnaire was validated among HD patients. If it is to be used with different comorbidities it should be validated first.