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

Munsour EE, Awaisu A, Ahmad Hassali MA, Dabbous Z, Zahran N, Abdoun E

Res Social Adm Pharm, 2020 Jun;16(6):793-799.
PMID: 31542446 DOI: 10.1016/j.sapharm.2019.08.038

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

Munsour EE, Awaisu A, Hassali MAA, Abdoun E, Dabbous Z, Zahran N, et al.

Int J Clin Pract, 2020 Aug;74(8):e13527.
PMID: 32386077 DOI: 10.1111/ijcp.13527

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.
Fulltext Readability and Comprehensibility of Patient Information Leaflets for Antidiabetic Medications in Qatar

Munsour EE, Awaisu A, Hassali MAA, Darwish S, Abdoun E

J Pharm Technol, 2017 Aug;33(4):128-136.
PMID: 34860991 DOI: 10.1177/8755122517706978

Background:The readability and comprehensibility of the patient information leaflets (PILs) provided with antidiabetic medications are of questionable standards; this issue negatively affects adherence to drug therapy, especially in patients with limited literacy skills. Objective: To evaluate the readability and comprehensibility of PILs supplied with medications used for the treatment of type 2 diabetes mellitus in Qatar. Methods: All PILs of the antidiabetic medications in Qatar were evaluated using the Flesch Reading Ease (FRE) score for readability. The Flesch-Kincaid Grade Level, Gunning-Fog Index, and SMOG Grading were used to estimate the comprehensibility of PILs in terms of school grade levels. Results: A total of 45 PILs were evaluated: 32 (71.1%) PILs of brand-name products and 13 (28.9%) for generics. Nine (20%) of the PILs were in English only; 8 (17.8%) were in English, Arabic, and French; and 28 (62.2%) were in English and Arabic. The mean FRE score was 37.71 (±15.85), and the most readable PIL had FRE score of 62. The mean scores for the comprehensibility evaluations were 10.96 (±2.67), 15.02 (±2.52), and 11.41 (±1.6) for the Flesch-Kincaid Grade Level, Gunning-Fog Index, and SMOG Grading, respectively. The most commonly used antidiabetic medication was metformin with 1372.9 (±552.9) as PILs' mean number of words. Conclusion: Only 2.2% of PILs had acceptable readability scores. All PILs could be comprehended by at least an 11th grade student, which exceeds the recommended grade level for health-related materials. Approximately 20% of these PILs were in English only and were not readable by most patients.

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