The effect of tailored consumer medicine information on patients with type 2 diabetes mellitus: A randomised controlled interventional study.

INTRODUCTION: In patients with diabetes, better health communication is associated with better health outcomes including medication adherence and glycaemic control. The conventional patient information leaflet does not consider the cultural and behavioral perspectives of diverse patient populations. Consumer medicine information (CMI) is a written information about the prescription drugs developed by organisations or individuals other than a drug manufacturer that is intended for distribution to consumers at the time of medication dispensing. OBJECTIVE: This study aimed to evaluate the impact of CMI on medication adherence and glycaemic control among patients with type 2 diabetes in Qatar. METHODS: We developed and customised CMI for all the anti-diabetic medications used in Qatar. A randomised controlled trial in which the intervention group patients (n = 66) received the customised CMI with usual care, while the control group patients (n = 74) received usual care only, was conducted. Self-reported medication adherence and haemoglobin A1c (HbA1c ) were the primary outcome measures. Glycaemic control and medication adherence parameters were measured at baseline, 3 months, and 6 months in both groups. Medication adherence was measured using the 8-item Morisky Medication Adherence Scale (MMAS-8). RESULTS: Although the addition of CMI resulted in better glycaemic control, this did not reach statistical significance, possibly because of the short-term follow-up. The median MMAS-8 score improved from baseline (6.6 [IQR = 1.5]) to 6-month follow-up (7.0 [IQR = 1.00]) in the intervention group. In addition, there was a statistically significant difference between the intervention and the control groups in terms of MMAS-8 score at the third visit (7.0 [IQR = 1.0]) vs 6.5 (IQR = 1.25; P-value = .010). CONCLUSION: CMI for anti-diabetic medications when added to usual care has the potential to improve medication adherence and glycaemic control among patients with type 2 diabetes. Therefore, providing better health communication and CMI to patients with diabetes is recommended.

Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus.

BACKGROUND: The importance of providing accurate medication information that can be easily comprehended by patients to subsequently best use their medication(s) has been widely reported in the literature. Patient information leaflet (PIL) is a supporting tool aiding patients to make decisions about their treatment plan and improve patient-clinician communication and thus medication adherence. PIL is the written document produced by the pharmaceutical manufacturers and packed with the medicine. The available PILs do not consider cultural and behavioral perspectives of diverse populations residing in a country like Qatar. Consumer medication information (CMI) is written information about prescription drugs developed by organizations or individuals other than a drug's manufacturer that is intended for distribution to consumers at the time of drug dispensing. OBJECTIVE: To investigate the impact of customized CMI (C-CMI) on health-related quality of life (HRQoL) among type 2 diabetes mellitus (T2DM) patients in Qatar. METHODS: This was a randomized controlled intervention study, in which the intervention group patients received C-CMI and the control group patients received usual care. HRQoL was measured using the EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS) at three intervals [i.e. baseline, after 3 months and 6 months]. RESULTS: The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit. There was a statistically significant difference between groups in the HRQoL utility value (represented as EQ index) at 6 months (0.939 vs. 0.796; p = 0.019). Similarly, the intervention group compared with the control group had significantly greater EQ-VAS at 6 months (90% vs. 80%; p = 0.003). CONCLUSIONS: The impact of C-CMI on health outcomes of T2DM patients in Qatar reported improvement in HRQoL indicators among the intervention patients. The study built a platform for health policymakers and regulatory agencies to consider the provision of C-CMI in multiple languages.

Population Pharmacokinetics of Intravenous Methotrexate in Patients with Hematological Malignancies: Utilization of Routine Clinical Monitoring Parameters.

BACKGROUND AND OBJECTIVE: Clinical response to methotrexate in cancer is variable and depends on several factors including serum drug exposure. This study aimed to develop a population pharmacokinetic model describing methotrexate disposition in cancer patients using retrospective chart review data available from routine clinical practice. METHODS: A retrospective review of medical records was conducted for cancer patients in Qatar. Relevant data (methotrexate dosing/concentrations from multiple occasions, patient history, and laboratory values) were extracted and analyzed using NONMEM VII®. A population pharmacokinetic model was developed and used to estimate inter-individual and inter-occasion variability terms on methotrexate pharmacokinetic parameters, as well as patient factors affecting methotrexate pharmacokinetics. RESULTS: Methotrexate disposition was described by a two-compartment model with clearance (CL) of 15.7 L/h and central volume of distribution (V c) of 79.2 L. Patient weight and hematocrit levels were significant covariates on methotrexate V c and CL, respectively. Methotrexate CL changed by 50 % with changes in hematocrit levels from 23 to 50 %. Inter-occasion variability in methotrexate CL was estimated for patients administered the drug on multiple occasions (48 and 31 % for 2nd and 3rd visits, respectively). CONCLUSION: Therapeutic drug monitoring data collected during routine clinical practice can provide a useful tool for understanding factors affecting methotrexate pharmacokinetics. Patient weight and hematocrit levels may play a clinically important role in determining methotrexate serum exposure and dosing requirements. Future prospective studies are needed to validate results of the developed model and evaluate its usefulness to predict methotrexate exposure and optimize dosing regimens.