Scholarly works in Clinical Pharmacy & Administration
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Item Readability of Medication Package Inserts Accompanying Prescription Drugs and Conformity of the Package Inserts Information with Regulatory Requirements.(The Association of Pharmaceutical Teachers of India (APTI), 2022) Showande, J.S.; Babalola V.O.Background: Medication package inserts (MPIs) provides patients with appropriate information on the rational use of drugs. This study evaluated the level of conformity of MPIs with the regulatory drug labelling requirements and determined the readability of selected prescription MPIs. Methods: One hundred and fifty-six MPIs of commonly used and prescribed antilipidemics, anticonvulsants, anti-diabetes, antiarthritis and antihypertensives in Nigeria were retrieved from four pharmacies. The MPIs were evaluated on the availability of 20 items drug labelling requirements for prescription drugs by the National Agency for Food and Drug Administration and Control (NAFDAC). The readability of 31 randomly selected MPIs was assessed with seven readability measures. Primary outcomes were percentage conformity with the labelling requirements and reading grade level of the MPIs. Secondary outcomes were the MPIs sentence characteristics. Results: The percentage conformity with NAFDAC drug requirements of the MPIs ranged from 82.9% to 89.6%. All the MPIs included information on active ingredient(s), adverse drug reactions, and indications. Few MPIs, 46.8% had section on product net content and 53 (34.0%) omitted information on overdose. The reading grade level for the MPIs was 14.55 ± 1.71 (undergraduate level). Most of the MPIs, 25 (80.6%), were very difficult to read. Conclusion: The percentage conformity of the MPIs with NAFDAC drug labelling requirements was high though few vital information were missing in some MPIs. Majority of the MPIs were very difficult to read. The regulatory authority may need to optimize MPIs readability and conformity of content with drug labelling requirements prior to marketing.Item Patient medication counselling in community pharmacy: evaluation of the quality and content.(Tarlor and Francis, 2022) Showande, J.S.; Laniyan M. W.Background: Patient medication counselling (PMC) is a pharmaceutical care service targeted at optimizing patient drug use, safety and improving treatment outcomes. This study assessed the content and quality of PMC from the community pharmacists’ (CPs) and pharmacy customers’ (PCs) perspectives. Methods: A cross-sectional questionnaire-guided survey was conducted in Ibadan, Nigeria, among 125 CPs and 612 PCs. The 35-counselling items validated United States Pharmacopeia Medication Counselling Behaviour Guideline scale with 10-point graded responses (1 = poor to 10 = excellent) was used. Self-reported medication counseling information content provided by CPs and received by PCs was assessed and expressed in median and interquartile ranges. The quality of PMC was evaluated and graded as poor (1–29.9%), unsatisfactory (30–59.9%), satisfactory (60–79.9%) and excellent (80–100%). Associations between demographic variables and overall quality of counseling were determined with Mann–Whitney U and Kruskal–Wallis tests at p < 0.05. Results: The response rate was 92.5% and 97.6% for PCs and CPs, respectively. The PCs’ opinions on the individual content of the PMC provided by the CPs were significantly different from the pharmacists’ self-report (p < 0.05). Some of the PMC content included how to take the medicine PC = 6.00 (2.00) vs CP = 8.00 (2.00), information on possible side effects PC = 6.00 (2.00) vs CP = 8.00 (2.00), taking history of allergies and other medications PC = 6.00 (6.00) vs CP = 7.00 (1.00), and how to incorporate drug regimen into daily routine PC = 5.00 (6.00) vs CP = 8.00 (3.00). The quality of PMC purportedly provided by CPs and received by the PCs was satisfactory (75%) and unsatisfactory (55%), respectively. The quality of communication counselling offered by CPs trained in Nigeria (Mean rank = 62.49) was higher than those trained outside Nigeria (Mean rank = 26.40), U = 228.00, p = 0.024. The PC’s age, marital status, and highest educational qualification were significantly associated with their opinion on the quality of counseling received. Conclusions: Both the community pharmacists and pharmacy customers reported the provision of patient medication counselling on side effects, drug usage, medication history and allergies among others. However, the quality of counselling provided by the pharmacists was satisfactory, but the quality of counselling received by the pharmacy customers was unsatisfactory. Pharmacists may need to engage pharmacy customers more during medication counsellingItem Pharmacists’ involvement with and pharmacy clients’ awareness of adverse drug reaction reporting in Nigeria – a mixed-methods approach.(Oxford, 2022) Showande, J.S.; Ikuomola F.I.Objectives Adverse drug reactions are one of the leading causes of death, yet they are under-reported. This study assessed the involvement of community pharmacists in the identification, documentation, and reporting of adverse drug reactions and pharmacy clients’ awareness of the adverse drug reaction reporting system. Methods A cross-sectional questionnaire-guided survey was conducted among 780 pharmacy clients in six selected community pharmacies, and seven mystery clients visited 125 community pharmacies in Ibadan, Nigeria. Information on pharmacy clients’ experience of adverse drug reactions, to whom and how they were reported, was obtained. Female and male mystery clients’ performed two scripted scenarios, complaining of black patches on their thighs and blood in their faeces, respectively. The proportion of pharmacists who identified the complaints as adverse drug reactions, documented and reported them, was described. Key findings The response rate for the pharmacy clients’ survey was 98.5%. Some pharmacy clients, 385 (50.1%), had experienced adverse drug reactions; 49 (12.7%) of these pharmacy clients were hospitalised and 73 (19.0%) of them reported the adverse drug reactions to physicians or pharmacists. Most of the pharmacy clients, 706 (91.9%), did not use the available reporting system. A total of 218 mystery client visits were made. The proportion of pharmacists who recognised the mystery client complaints as adverse drug reactions was 4.9–60.3% depending on the scenario presented and up to two pharmacists documented and supposedly reported the adverse drug reactions. Conclusions Some of the pharmacy clients reported experiencing adverse drug reactions to healthcare professionals, but most did not report through the existing reporting scheme. Community pharmacists could identify adverse drug reactions but most failed to document or report them.Item Safety Evaluation of Hibiscus sabdariffa Tea and its Effect on Blood Pressure, Blood Glucose and Lipid Profile: A Randomised Controlled Trial.(EManuscript Services, 2021) Showande, J.S.; Dede, A.I; Fakeye T.O.Background: Hibiscus sabdariffa lowers blood pressure, blood glucose and total cholesterol in patients yet healthy individuals widely consume the tea. This study evaluated the effect of Hibiscus sabdariffa tea (HS-tea) on clinical, biochemical and haematological parameters in healthy human volunteers. Materials and Methods: Thirty-two healthy human volunteers were randomized in a two-arm open-labelled parallel study into HS-tea (n=17) and Water group (n=15). Three hundred millilitre of either HS-tea or Water was taken daily for 28 days by the participant and clinical (Systolic blood pressure SBP, fasting blood glucose FBG, total cholesterol TC, etc.), biochemical (alanine aminotransferase ALT, albumin ALB, aspartate aminotransferase AST, Serum creatinine SCr, etc.) and haematological (haematocrit HCT, white blood cells count WBC, total protein TPro, etc.) parameters were measured at baseline and on the 14th and 28th day. Results: Daily intake of HS-tea reduced SBP (9.1%, p=0.008), FBG (8.0%, p=0.006) and TPro (5.8%) but increased WBC (34.3%) on the 28th day compared with baseline values. No change was observed with Water. HS-tea lowered SBP, FBG, TC and ALB significantly on the 28th day compared with Water. No significant difference between HS-tea and Water with liver and kidney function markers (AST, ALT, SCr) and haematological parameters (HCT, WBC, TPro). Conclusion: Daily intake of Hibiscus sabdariffa tea for 28 days is safe and reduced SBP, FBG, TC and ALB in healthy human volunteers. It may be considered as a potential nutraceutical candidate for people at risk of developing hypertension, diabetes and hypercholesterolemia.Item Safety Evaluation of Hibiscus sabdariffa Tea and its Effect on Blood Pressure, Blood Glucose and Lipid Profile: A Randomised Controlled Trial.(EManuscript Services, 2021) Showande, J.S.; Dede, A.I; Fakeye T.O.Background: Hibiscus sabdariffa lowers blood pressure, blood glucose and total cholesterol in patients yet healthy individuals widely consume the tea. This study evaluated the effect of Hibiscus sabdariffa tea (HS-tea) on clinical, biochemical and haematological parameters in healthy human volunteers. Materials and Methods: Thirty-two healthy human volunteers were randomized in a two-arm open-labelled parallel study into HS-tea (n=17) and Water group (n=15). Three hundred millilitre of either HS-tea or Water was taken daily for 28 days by the participant and clinical (Systolic blood pressure SBP, fasting blood glucose FBG, total cholesterol TC, etc.), biochemical (alanine aminotransferase ALT, albumin ALB, aspartate aminotransferase AST, Serum creatinine SCr, etc.) and haematological (haematocrit HCT, white blood cells count WBC, total protein TPro, etc.) parameters were measured at baseline and on the 14th and 28th day. Results: Daily intake of HS-tea reduced SBP (9.1%, p=0.008), FBG (8.0%, p=0.006) and TPro (5.8%) but increased WBC (34.3%) on the 28th day compared with baseline values. No change was observed with Water. HS-tea lowered SBP, FBG, TC and ALB significantly on the 28th day compared with Water. No significant difference between HS-tea and Water with liver and kidney function markers (AST, ALT, SCr) and haematological parameters (HCT, WBC, TPro). Conclusion: Daily intake of Hibiscus sabdariffa tea for 28 days is safe and reduced SBP, FBG, TC and ALB in healthy human volunteers. It may be considered as a potential nutraceutical candidate for people at risk of developing hypertension, diabetes and hypercholesterolemiaItem Impact of pharmacists’ training on oral anticoagulant counseling: A randomized controlled trial.(Elsevier, 2021) Showande, J.S.; Edidiong, N.O.Objective: The study evaluated the impact of oral anticoagulant counseling training on the quality of counseling provided by pharmacists. Methods: A prospective RCT was conducted among 33 pharmacists from 23 pharmacies in Ibadan, Nigeria. Six mystery patients (MPs) who were either warfarin-naïve, experienced adverse drug reaction (ADR), or drug interaction (DI) to warfarin were used to assess pharmacists’ oral anticoagulant counseling quality at pre- and post-intervention. A 2-week online oral anticoagulant counseling training was given to the intervention group pharmacists. Quality of counseling was categorized as poor (0–20 %), fair (21–50 %), moderate (51–80 %), and optimal (81–100 %). Results: At pre-intervention, the quality of oral anticoagulant counseling provided to the MPs was poor. Post-intervention, the quality improved among pharmacists in the intervention group, from poor to fair for both warfarin-naïve MP and MP who experienced DI, and from fair to moderate for MP with ADR. Conclusion: Short-term online oral anticoagulant counseling training improved the quality of counseling provided by community pharmacists to mystery patients on warfarin. Practice implication: Online oral anticoagulant counseling training may be employed by pharmacists’ professional bodies intermittently to improve oral anticoagulant counseling.Item Potential inappropriate prescribing among ambulatory elderly patients in a geriatric centre in southwestern Nigeria: Beers criteria versus STOPP/START criteria.(Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria, 2020) Akande-Sholabi, W.; Ajilore, O.C.; Showande, J.S.; Adebusoye. L.A.Purpose: To identify potentially inappropriate prescribing in ambulatory elderly patients and compare the appropriateness of guidelines; Beers' and Screening Tool of Older Person’s Prescription (STOPP)/ Screening Tool to Alert Right Treatment (START) criteria to detect potentially inappropriate prescribing among the elderly. Methods: A retrospective study was conducted using case files of 335 elderly patients aged ≥ 60 years between 1st January and 31st December 2016, using a data extraction sheet. The 2015 American Geriatrics Society (AGS)-Beers Criteria, and version 2 of the STOPP and START were subsequently used to identify the Potentially Inappropriate Prescribing (PIP) and Potential Prescribing Omissions (PPOs). Results: Mean age of patients was 69 ± 0.4 years (range 60 - 85 years) and 219 (65.4 %) were females. An average of 4.2 medications per patient prescription was found. The Beers criteria identified 26.5 % PIP, while STOPP criteria identified 57.1 % PIP. START detected 29 PPOs in 15 (4.4 %) of the patient’s prescription. The most prevalent disease conditions were hypertension 235 (70.1 %) and osteoarthritis 64 (19.3 %). Polypharmacy was significantly associated with PIP in both Beers (p = 0.002) and STOPP (p = 0.001) criteria. Conclusion: The prevalence of PIP is high among elderly patients. The STOPP/START criteria identified a higher proportion of PIP among elderly patients compared with Beers criteria. The frequency of PIP should stimulate efforts to curtail potentially inappropriate prescribing and may require the need for advocating for a national criterion to be adopted by health care professionals in Nigeria.Item Potential inappropriate prescribing among ambulatory elderly patients in a geriatric centre in southwestern Nigeria: Beers criteria versus STOPP/START criteria.(Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria, 2020) Akande-Sholabi, W.; Ajilore, O.C.; Showande, J.S.; Adebusoye. L.A.Purpose: To identify potentially inappropriate prescribing in ambulatory elderly patients and compare the appropriateness of guidelines; Beers' and Screening Tool of Older Person’s Prescription (STOPP)/ Screening Tool to Alert Right Treatment (START) criteria to detect potentially inappropriate prescribing among the elderly. Methods: A retrospective study was conducted using case files of 335 elderly patients aged ≥ 60 years between 1st January and 31st December 2016, using a data extraction sheet. The 2015 American Geriatrics Society (AGS)-Beers Criteria, and version 2 of the STOPP and START were subsequently used to identify the Potentially Inappropriate Prescribing (PIP) and Potential Prescribing Omissions (PPOs). Results: Mean age of patients was 69 ± 0.4 years (range 60 - 85 years) and 219 (65.4 %) were females. An average of 4.2 medications per patient prescription was found. The Beers criteria identified 26.5 % PIP, while STOPP criteria identified 57.1 % PIP. START detected 29 PPOs in 15 (4.4 %) of the patient’s prescription. The most prevalent disease conditions were hypertension 235 (70.1 %) and osteoarthritis 64 (19.3 %). Polypharmacy was significantly associated with PIP in both Beers (p = 0.002) and STOPP (p = 0.001) criteria. Conclusion: The prevalence of PIP is high among elderly patients. The STOPP/START criteria identified a higher proportion of PIP among elderly patients compared with Beers criteria. The frequency of PIP should stimulate efforts to curtail potentially inappropriate prescribing and may require the need for advocating for a national criterion to be adopted by health care professionals in Nigeria.