Clinical Pharmacy & Administration
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Item Clinical and Humanistic Outcomes of Pharmaceutical Care Interventions in Diabetes Mellitus: A Systematic Review and Meta-Analysis.(West African Postgraduate College of Pharmacists, 2019) Showande, J.S.; Akande-Sholabi, W.; Fakeye, T.OBackground: Diabetes mellitus is a chronic disease for which life-long medications and care are needed. Effectiveness of care is related to good glycemic control, which is desired to forestall complications. Objective: This study evaluated the effectiveness of pharmaceutical care (PC) services provided by pharmacists in improving clinical and humanistic outcomes in diabetes mellitus patients. Method: Five databases (PubMed/Medline, Embase, Scopus, Cochrane Central Register of Control Trials and Google Scholar) were systematically searched for randomized controlled trials (RCTs) reported in English using free text and medical subject headings keywords. Studies which had PC intervention arm, a control group, type1 and type 2 diabetes mellitus patients; clinical and/or humanistic outcomes were included. For metaanalysis, standard mean difference evaluated with random effect model at P<0.05 was reported. Significant heterogeneity was further evaluated with sensitivity and subgroup analyses. Results: A total of 41 RCTs with 7,448 patients were eligible out of 1222 citations. PC intervention significantly lowered glycosylated hemoglobin, fasting blood glucose, systolic blood pressure, diastolic blood pressure, total cholesterol, and low density lipoprotein cholesterol (P < 0.05), with significant heterogeneity. PC intervention also improved self-care but medication adherence, disease knowledge and quality of life were not improved. PC services offered (patient education, identification and resolution of drug therapy problems, and pharmacotherapy evaluation) were not uniform across the studies. Conclusion: The review and meta-analysis showed that PC intervention is of great benefit to improve most clinical outcomes which may result in better disease management. A call is however made for standardized pharmaceutical care intervention.Item Clinical and Humanistic Outcomes of Pharmaceutical Care Interventions in Diabetes Mellitus: A Systematic Review and Meta-Analysis.(West African Postgraduate College of Pharmacists, 2019) Showande, J.S.; Akande-Sholabi, W.; Fakeye, T.OBackground: Diabetes mellitus is a chronic disease for which life-long medications and care are needed. Effectiveness of care is related to good glycemic control, which is desired to forestall complications. Objective: This study evaluated the effectiveness of pharmaceutical care (PC) services provided by pharmacists in improving clinical and humanistic outcomes in diabetes mellitus patients. Method: Five databases (PubMed/Medline, Embase, Scopus, Cochrane Central Register of Control Trials and Google Scholar) were systematically searched for randomized controlled trials (RCTs) reported in English using free text and medical subject headings keywords. Studies which had PC intervention arm, a control group, type1 and type 2 diabetes mellitus patients; clinical and/or humanistic outcomes were included. For metaanalysis, standard mean difference evaluated with random effect model at P<0.05 was reported. Significant heterogeneity was further evaluated with sensitivity and subgroup analyses. Results: A total of 41 RCTs with 7,448 patients were eligible out of 1222 citations. PC intervention significantly lowered glycosylated hemoglobin, fasting blood glucose, systolic blood pressure, diastolic blood pressure, total cholesterol, and low density lipoprotein cholesterol (P < 0.05), with significant heterogeneity. PC intervention also improved self-care but medication adherence, disease knowledge and quality of life were not improved. PC services offered (patient education, identification and resolution of drug therapy problems, and pharmacotherapy evaluation) were not uniform across the studies. Conclusion: The review and meta-analysis showed that PC intervention is of great benefit to improve most clinical outcomes which may result in better disease management. A call is however made for standardized pharmaceutical care intervention.Item Potential Inhibition of Major Human Cytochrome P450 Isoenzymes by Selected Tropical Medicinal Herbs—Implication for Herb–Drug Interactions.(Wiley, 2019) Showande, J.S.; Fakeye, T.O.; Kajula, M.; Hokkanen, J.; Tolonen, ABackground: Increasing use of medicinal herbs as nutritional supplements and traditional medicines for the treatment of diabetes, hypertension, hyperlipidemia, and malaria fever with conventional drugs poses possibilities of herb–drug interactions (HDIs). The potential of nine selected widely used tropical medicinal herbs in inhibiting human cytochrome P450 (CYP) isoenzymes was investigated. Materials and methods: In vitro inhibition of eight major CYP isoenzymes by aqueous extracts of Allium sativum, Gongronema latifolium, Moringa oleifera, Musa sapientum, Mangifera indica, Tetracarpidium conophorum, Alstonia boonei, Bauhinia monandra, and Picralima nitida was estimated in human liver microsomes by monitoring twelve probe metabolites of nine probe substrates with UPLC/MS-MS using validated N-in- One assay method. Results: Mangifera indica moderately inhibited CYP2C8, CYP2B6, CYP2D6, CYP1A2, and CYP2C9 with IC50 values of 37.93, 57.83, 67.39, 54.83, and 107.48 μg/ml, respectively, and Alstonia boonei inhibited CYP2D6 (IC50 = 77.19 μg/ml). Picralima nitida inhibited CYP3A4 (IC50 = 45.58 μg/ml) and CYP2C19 (IC50 = 73.06 μg/ml) moderately but strongly inhibited CYP2D6 (IC50 = 1.19 μg/ml). Other aqueous extracts of Gongronema latifolium, Bauhinia monandra, and Moringa oleifera showed weak inhibitory activities against CYP1A2. Musa sapientum, Allium sativum, and Tetracarpidium conophorum did not inhibit the CYP isoenzymes investigated. Conclusion: Potential for clinically important CYP-metabolism- Mediated HDIs is possible for Alstonia boonei, Mangifera indica, and Picralima nitida with drugs metabolized by CYP 2C8, 2B6, 2D6, 1A2, 2C9, 2C19, and 3A4. Inhibition of CYP2D6 by Picralima nitida is of particular concern and needs immediate in vivo investigations.Item Safety Evaluation of Two Nigerian Polyherbal Formulations (Fidson Bitter® and Daily Living Bitter®) in Male Wistar Rats(The Nigeria Association of Pharmacists in Academia (NAPA)., 2018) Showande, J.S.; Odukoya, O.M.; Oyalowo, G.O.Background: Herbal bitters are used for diverse diseases based on the manufacturers’ assertions. However, little is known about their toxicity profile. Objective: The safety profile of two commonly used herbal bitters in Nigeria (Fidson bitter® and Daily living bitter®)was evaluated in rats. Materials and Methods: Single oral dose, 2 g/kg, of each reconstituted bitter extract was administered to male and female rats in acute toxicity test. Animals were observed for 14 days for behavioral changes and mortality. In sub-acute oral toxicity experiment, 250 mg/kg and 500 mg/kg of each bitter was separately administered daily to different groups of male Wistar rats for 30 days. Safety profile of concurrent administration of these bitters was also assessed. Histopathological, hematological, and clinical chemistry indices were evaluated. Results: The LD50 was found to be >2 g/kg. Daily living bitter® (DLB) had no significant effect on any of the indices evaluated (P>0.05). However, Fidson bitter® caused significant reductions in white blood cells count (WBC) compared with the control. Concomitant administration of the bitters resulted in significant (P<0.05) weight gain (up to 33 %), reduction in WBC and congestion of the liver without corresponding increase in liver biomarkers. Conclusion: Daily living bitter® was safe in sub-acute administration while Fidson bitter®and combination of the two bitters reduced white blood cell count. Hence, caution should be exercised in using Fidson bitter® or combination of the two bitters in humans as findings suggest possibility of immune suppression.Item Pattern of Use of Water Beverage of Hibiscus sabdariffa Linn in a University Community in Southwest Nigeria.(West African Postgraduate College of Pharmacists (WAPCP),, 2017) Showande, J.S.; Udoh-Kalu, C.C.; Fakeye, T.OBackground:Water beverages of Hibiscus sabdariffa is widely consumed in many parts of the world. Objective: Its pattern of use in a University community in southwest Nigeria was studied. Methods: A questionnaire-guided survey was conducted among randomly selected staff (398) and students (910) of University of Ibadan on the use of water beverage of Hibiscus sabdariffa (WBHS). The questionnaire garnered information on pattern of use, side effects experienced, and drugs coadministered with WBHS. Descriptive statistics, Chi-square, and Fisher's Exact Probability tests were used to describe the association between categories of participants and indications for using and side effects experienced with WHBS. Results: Most (96.9%) respondents who had used WBHS, used it as a relaxant 382(29.2%), as an antihypertensive 318(24.3%), for weight reduction 140(10.7%), infertility 127(9.7%), to cure liver disease 87(6.7%), and for the management of diabetes 151(11.5%). Side effects experienced with its use were; diarrhea 69(5.3), dizziness 44(3.4%), insomnia 27 (2.1%), decreased libido 24(1.8%), blurred vision 16(1.2%),and headache 19(1.5%).Some of the participants 164(12.5%) coadministered WBHS with their medications such as antibiotics 51(3.9%), antihypertensives 24(1.8%), antipsychotic 18(1.4%), antilipidemic drugs 16(1.2%), and antiretroviral drugs 11(0.8%). Out of those who coadministered WBHS with their medications, 93(7.1%) were on chronic medications. Conclusion: Water beverage of Hibiscus sabdariffa is used to treat diverse diseases with attendant side effects and is sometimes coadministered with medications for chronic diseases. This may predispose users to herb-drug interactions. Thus there is a need to investigate some of the drugs co-administered with the beverage for possible herb-drug interaction.Item In vivo Pharmacodynamic and Pharmacokinetic Interactions of Hibiscus sabdariffa Calyces Extracts with Simvastatin(Wiley, 2017) Showande, J.S.; Adegbolagun, O.M.; Igbinoba S.I.; Fakeye T.O.What is known and objectives: Increasing number of patients use herbs with their medications. Such practice may result in beneficial or harmful herb-drug interactions. A recent survey reported that some participants co-administered Hibiscus sabdariffa, a widely used beverage, or tea, with their antihyperlipidaemic medications. This study therefore evaluated the effect of concomitant administration of Hibiscus sabdariffa calyces’ extracts with simvastatin on hyperlipidaemia and pharmacokinetics of the drug in vivo. Methods: Factorial experimental designs were used to evaluate the comparative effectiveness and interactions between simvastatin and aqueous extract of Hibiscus sabdariffa (AEHS) on lipid profile parameters in hyperlipidaemia-induced Wistar rats. Different combinations of low (AEHS 250 mg/kg; simvastatin 10 mg/kg) and high doses (AEHS 500 mg/kg; simvastatin 20 mg/kg) were administered individually and concurrently daily for 2 and 4 weeks. Lipid profile parameters were assessed at these treatment periods. Subsequently, the effect of aqueous beverage of Hibiscus sabdariffa (ABHS) on the pharmacokinetics of single-dose 40 mg simvastatin was also evaluated in six healthy human volunteers using two-period randomized crossover design. Blood samples were collected at predetermined times for 24 hours. The plasma obtained was analysed for simvastatin using RP-HPLC/ UV method. Results: Aqueous extract of Hibiscus sabdariffa reduced total cholesterol (Tc) better than simvastatin (P = .031). Low-dose AEHS and low-dose simvastatin used concomitantly caused 38.3% and 57.4% reductions in Tc and triglyceride levels, respectively, compared with low-dose simvastatin (P < .05). Also, ABHS increased clearance and reduced peak concentration of simvastatin by 44.6% and 18.0%, respectively (P < .05). The geometric mean ratio of simvastatin AUC0-∞ with or without ABHS was 0.646 with the 90% confidence interval (0.564, 0.758) falling outside the bioequivalent range. What is new and conclusion: Aqueous extract of Hibiscus sabdariffa lowered Tc better than simvastatin and enhanced the antihyperlipidaemic activity of the drug when co-administered at low doses in an animal model. However, aqueous beverage of Hibiscus sabdariffa caused a significant herb-drug interaction resulting in overall reduction in exposure to simvastatin in humans. Caution should thus be placed on clinical judgement or recommendations based on the animal results. Nevertheless, co-administration of the beverage with simvastatin should be discouraged until more clinical data are available.Item Remedies for Glucose Intolerance – Are Traditional Herbal Concoctions for Diabetes Effective?(Nigeria Association of Pharmacists in Academia (NAPA), 2015) Showande, J.S.; Bello, J.J.Background:Preventing or delaying the onset of diabetes in prediabetes has the potential to reduce the disease prevalence. Objective:The effectiveness of traditional herbal concoctions for diabetes in ameliorating glucose intolerance was investigated. Material and Methods:Oral glucose tolerance test (OGTT) was carried out by giving 500 mg/kg and 1000 mg/kg of individual plant extract and their aqueous herbal concoctions made from Musa sapientum + Allium sativum + Tetracarpidium conophorum; Gongronema latifolia + Bauhinia monandra; and Alstonia boonei + Mangifera indica to groups of rats, 30 and 60 minutes respectively prior to 3 g/kg of glucose load. Blood glucose levels were determined at 0, 10, 20, 30, 45, 60, 90, and 120 minutes post administration. Area under the curve (AUC) for OGTT and glycemic index were calculated and compared with the vehicle control and metformin (100 mg/kg). Level of significance was set at P<0.05. Results:Oral glucose tolerance test AUCs of individual plants were significantly lower than that of the vehicle control (P<0.05) but comparable with that of metformin (P>0.05) when given 30 minutes prior to glucose load. The OGTT curve AUCs of the three herbal concoctions were significantly higher than the two controls (P>0.05). Glycemic index of the concoctions were significantly higher than that of metformin (P>0.05) Conclusion:The herbal concoctions were not effective in ameliorating glucose intolerance. Individual plants were more effective when administered 30 minutes prior to glucose load. The individual herbs showed potentials to delay the onset of diabetes. Further investigations should be conducted on the numerous herbal concoctions used for diabetes.Item Evaluation of the Extent and Pattern of Use of Herbal Bitters among Students in a Tertiary Institution in Southwestern Nigeria(Pharmacotherapy Group, University of Benin., 2014) Showande, J.S.; Amokeodo, O.SPurpose: To evaluate the extent and pattern of use of herbal bitters among students. Methods: This was a cross-sectional study where pre-tested structured questionnaires were administered to 1000 students. The questionnaire elicited information on the extent and pattern of use, self-reported indications, side effects experienced and possible drugs that were concomitantly coadministered with herbal bitters. Pearson Chi square, Fisher exact test and Relative risk ratio were used to detect association between gender and self-reported indications and side effects experienced with herbal bitters at a level of significance of p < 0.05. Results: The response rate and extent of use were 96 % and 40.9 % respectively. Herbal bitters were used for claims such as cleansers 88 (40.2 %), anti-infectives 48 (21.1 %), for rejuvenation 32 (14.0 %), and for weight loss 14 (6.1 %). Self-reported side effects included dizziness 49 (22.0 %), loss of taste 46 (20.6 %) and nausea and vomiting 22 (9.7 %). Herbal bitters were also co-administered with antimalarials 22 (6.3 %); analgesics 16 (4.5 %) and herbal supplements 13 (3.7 %). Reports of students using two different types of herbal bitter concurrently 15 (3.9 %) were also garnered. Male students experienced more side effects than females (p < 0.05). Conclusion: The co-administration of herbal bitters with allopathic medicines and the use of more than one herbal bitter at a time reported in this study can be addressed by the appropriate health authorities through proper educational program.Item Use of Antibiotics among Non-Medical Undergraduate Students in a Nigerian University.(Makerere University, Faculty of Medicine.Kampala, Uganda., 2013) Sanya, E.; Fakeye, T.O.; Adisa, R.; Showande, J.S.Background: Antibiotic misuse is a major contributory factor to treatment failure, antibiotic resistance and high healthcare costs. Objectives: To evaluate level of self-reported antibiotic misuse among non-medical undergraduate students of a Nigerian university. Methods: Respondents’ knowledge of antibiotics and disposal system for left-over antibiotics were explored using a structured questionnaire. Data were summarized with descriptive statistics. Chi square was used to evaluate relationship between specific categorical variables and respondents’ opinions with p<0.05. Results: More than half the respondents obtained their antibiotics through doctor’s prescriptions (273;68.3%). The study revealed gross antibiotic misuse with majority, (298;74.5%) either by keeping left-over antibiotics for future use or throwing it away with refuse. Respondents (289; 72.3%) sometimes forgot to take the antibiotics. Financial constraints (73; 18.3%), long duration of treatment (70; 17.5%), side effects experienced (60;15.0%), polypharmacy (56;14.0%), tablet size (45;11.3%), and perceived low level of confidence in the prescriber (11; 2.8%) were major reasons for non-adherence. Course of study of respondents had no significant effect on respondents’ knowledge or adherence (p>0.05). Conclusion: Misuse of antibiotics among non-medical undergraduate students in a Nigerian university setting is pervasive suggesting an urgent need for enlightenment on rational use and disposal of antibiotics.Item The Concept of Adverse Drug Reaction Reporting: Awareness among Pharmacy Students in a Nigerian University(AKS Publications., 2007) Showande, J.S.; Fakeye, T.OAdverse drug reaction (ADR) is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students’ knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0%) had heard about pharmacovigilance at symposiums, 7(10.1%) during clinical clerkship program and 18(26.1%) from media jingles. Twenty nine (42.0%) agreed that pharmacovigilance was in their curriculum, however only 16(23.2%) could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had personally experienced in detail, however, they did not know the channel of reporting it. Only 3% reported incidences of personal experience of ADR to the physician while another 3% reported cases of such to the pharmacist. There was a significant difference comparing students’ year of study in the pharmacy program with their opinion scores on the National Pharmacovigilance Centre (NPC) guidelines on ADR reporting (p <0.05). The lack of pharmacovigilance and adverse drug reaction reporting courses in the pharmacy school curriculum result in the poor knowledge of the students on the concept of adverse drug reaction reporting, nonetheless the view and knowledge they had garnered from different sources helped the students in identifying and describing ADR but this is not enough in properly documenting cases of ADRs. Thus, the poor knowledge on ADR reporting among the students requires speedy implementation of new curriculum incorporating pharmacovigilance to enhance the involvement of pharmacists in ADR reporting in Nigeria.
