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Item Utility of information in package inserts by pharmacists and pharmacy clients in a metropolitan city in Southwest Nigeria(Oxford University Press, 2021) Showande S.J; Babalola O.VObjective Package inserts provide relevant information to patients and health care professionals on the safety and rational use of drugs. This study evaluated the utility of package inserts by pharmacy clients for information, and by pharmacists during consultation and counselling with patients. Methods This cross-sectional self-administered questionnaire-based study was conducted in Ibadan, Nigeria among 705 pharmacy clients and 344 community and hospital pharmacists. The questionnaire had a 12-item and a 14-item package insert utility scale for pharmacists and pharmacy clients, respectively. The level of utility and association between demographic variables and package insert utility scores were determined with Mann–Whitney U and Kruskal–Wallis tests at P < 0.05. Key findings The response rate was 88.2% for pharmacy clients and 67.2% for pharmacists. Most of the pharmacy clients, 459 (73.8%), check for package inserts in drug packs. The most assessed information in package inserts was dose 432 (69.5%). Some of the pharmacy clients, 276 (44.4%), considered information from health professionals more reliable than that in package inserts. The pharmacy clients’ level of education was associated with package insert utility score (P = 0.001). Most of the pharmacists, 137 (59.3%), read package inserts but only 36 (15.6%) consulted package inserts during counselling with patients. The pharmacists’ age and the number of years spent in practice were significantly associated with package insert utility scores (P < 0.05). The level of utility of the information in package inserts by the pharmacy clients and the pharmacists was moderate – 66.8 and 60.0%, respectively. Conclusion Both pharmacists and pharmacy clients use package insert content moderately. Pharmacy clients rely more on information provided by health professionals than the information in package inserts but pharmacists seldom consult package inserts during counselling process.Item Readability of medication package inserts accompanying prescription drugs and conformity of the package inserts information with regulatory requirements(2022) Showande S.J; 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 Impact of pharmacists’ training on oral anticoagulant counseling: a randomized controlled trial(2019) Showande S.J; 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 counselingItem Management of uncomplicated gastric ulcer in community pharmacy: a pseudo‑patient study(2019) Showande S.J; Adenike R.A.Background Increasing role of community pharmacists sometimes demands the diagnoses of minor ailments using appropriate questioning skills and recommendation of over-the-counter medications to patients seeking self-care. Objective To evaluate community pharmacists’ questioning and diagnostic skills of minor ailment complaints, and the appropriateness of medication(s) recommendations made. Setting One hundred and thirty-one community pharmacies in Ibadan, Nigeria. Method A cross-sectional survey employing pseudo-patient study method. The pseudo-patient visited 131 community pharmacies from June 2017 to January 2018 and complained of stomach ache. The conversation between the pharmacists and pseudopatient were audio-taped and transcribed verbatim. Two criteria were used to evaluate the questioning skill of the community pharmacists. One of the criteria was developed by a six-membered panel and had 13 questions while the other contained five questions:—Who is it for? What are the symptoms? How long have the symptoms been present? Action taken? and Medication used.? Questioning skill of the community pharmacists was classified based on the median scores of these two criteria as: poor, moderate and optimal. The diagnoses made by the community pharmacists from the pseudo-patients complaints were compared with the expected diagnosis of uncomplicated gastric ulcer caused by the use of ibuprofen. Recommendations for the pseudo-patients minor ailment were also compared with the Nigeria standard treatment guideline. Main outcome measure Pharmacists’ questioning skill, types of diagnosis made and appropriateness of medications recommended. Results The median scores for the questioning skill criterion containing 5 and 13 questions were 2 and 4, respectively; showing poor questioning skill. Differential diagnoses of gastric ulcer, dyspepsia, gastroesophageal reflux, and hyperacidity were made by 92 (67.4%) pharmacists but 3 (2.3%) correctly diagnosed the pseudo-patients’ minor ailment as uncomplicated gastric ulcer caused by short-term use of ibuprofen. Antacids were recommended in line with the standard treatment guideline by 46 (35.7%) pharmacists while proton pump inhibitors were recommended by 6 (4.7%) pharmacists. None advised the withdrawal of the provocative factor according to the treatment guideline. Conclusion The questioning skill of the community pharmacists in this setting was poor. Few community pharmacists diagnosed the pseudo-patients’ minor ailment correctly. Also, recommendations were mostly inappropriate compared with the standard treatment guideline.Item In Vitro Modulation Of Cytochrome P450 Isozymes And Pharmacokinetics Of Caffeine By Extracts Of Hibiscus Sabdariffa Linn Calyx(2019) Showande S.J; Igbinoba S.I.; Kajula M.; Hokkanen J.; Tolonen A.; |Adegbolagun O.M.; Fakeye T.O.Background: Hibiscus sabdariffa beverage (HSB) is widely consumed as a medicinal herb and sometimes used concomitantly with drugs. This study evaluated the in vitro inhibitory potential of the aqueous extract of H. sabdariffa calyces (AEHS) on selected cytochrome P450 (CYP) isozymes and the effect of HSB on the pharmacokineticsofcaffeineinvivo. Methods:InvitroinhibitionsofeightmajorCYPisozymesbyAEHSwereestimatedbymonitoringCYP-specific modelreactionsof10CYPprobesubstratesusingN-in-oneassaymethod.Subsequently,anopen,randomized, two-periodcrossoverdesignwasusedtoevaluatetheeffectofHSBonthepharmacokineticsofsingle-dose200 mg caffeine in six healthy human volunteers. Blood samples were obtained at specific times over a 24 h period. Probe drugs and metabolites were analyzed in their respective matrices with ultra-performance liquid chromatography/mass spectrometer/mass spectrometer and reversed-phase high-performance liquid chromatography/ultravioletdetection. Results:TheH.sabdariffaaqueousextractweaklyinhibitedtheselectedCYPisozymesinvitro,withIC50of >100 μgmL-1 intheorderofCYP1A2>CYP2C8>CYP2B6»CYP2D6>CYP2C19>CYP3A4>CYP2A6>CYP2C9. HSBdecreasedterminalt1/2andTmaxofcaffeineby13.6%and13.0%,respectively,andincreasedCmaxby10.3%. Pointestimatesofprimarypharmacokineticendpoints,Cmax=1.142(90%confidenceinterval(CI)=0.882,1.480) andAUC0–∞=0.992(90%CI=0.745,1.320),wereoutsidethe90%CIof0.8–1.25bioequivalencelimits. Conclusion:TheaqueousextractofH.sabdariffaweaklyinhibitedeightCYPisozymesinvitro,butHSBmodified theexposuretocaffeineinhuman.CautionshouldbeexercisedinadministeringHSBwithcaffeineorsimilar substratesofCYP1A2untilmoreclinicaldataareavailable.Item Evaluation of the extent and pattern of use of herbal(2014) Showande S.J; Amokeodo O.S.Purpose: 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 programme.