Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

<p>Abstract</p> <p>Background</p> <p>Adverse drug reactions (ADRs) contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria.</p> <p>Methods</p> <p>Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP) and four Patent and Proprietary Medicine Stores (PPMS) in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period.</p> <p>Results and Discussion</p> <p>A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases); of this number, purchases of sulphadoxine-pyrimethamine (SP) and chloroquine (CQ) were highest (39.3 and 25.2% respectiuvely). Other anti-malarials purchased were artesunate monotherapy (AS) - 16.1%, artemether-lumefantrine (AL) 10.0%, amodiaquine (AQ) - 6.6%, quinine (QNN) - 1.9%, halofantrine (HF) - 0.2% and proguanil (PR) - 0.2%. CQ was the cheapest (USD 0.3) and halofantrine the most expensive (USD 7.7). AL was 15.6 times ($4.68) more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1) after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%).</p> <p>Conclusion</p> <p>The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource-poor setting.</p

Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial

Background Tranexamic acid reduces surgical bleeding and decreases mortality in patients with traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury (TBI) and can cause brain herniation and death. We aimed to assess the effects of tranexamic acid in patients with TBI. Methods This randomised, placebo-controlled trial was done in 175 hospitals in 29 countries. Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible. The time window for eligibility was originally 8 h but in 2016 the protocol was changed to limit recruitment to patients within 3 h of injury. This change was made blind to the trial data, in response to external evidence suggesting that delayed treatment is unlikely to be effective. We randomly assigned (1:1) patients to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Patients were assigned by selecting a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury. We prespecified a sensitivity analysis that excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline. All analyses were done by intention to treat. This trial was registered with ISRCTN (ISRCTN15088122), ClinicalTrials.gov (NCT01402882), EudraCT (2011-003669-14), and the Pan African Clinical Trial Registry (PACTR20121000441277). Results Between July 20, 2012, and Jan 31, 2019, we randomly allocated 12 737 patients with TBI to receive tranexamic acid (6406 [50·3%] or placebo [6331 [49·7%], of whom 9202 (72·2%) patients were treated within 3 h of injury. Among patients treated within 3 h of injury, the risk of head injury-related death was 18·5% in the tranexamic acid group versus 19·8% in the placebo group (855 vs 892 events; risk ratio [RR] 0·94 [95% CI 0·86-1·02]). In the prespecified sensitivity analysis that excluded patients with a GCS score of 3 or bilateral unreactive pupils at baseline, the risk of head injury-related death was 12·5% in the tranexamic acid group versus 14·0% in the placebo group (485 vs 525 events; RR 0·89 [95% CI 0·80-1·00]). The risk of head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR 0·78 [95% CI 0·64-0·95]) but not in patients with severe head injury (0·99 [95% CI 0·91-1·07]; p value for heterogeneity 0·030). Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73). The risk of vascular occlusive events was similar in the tranexamic acid and placebo groups (RR 0·98 (0·74-1·28). The risk of seizures was also similar between groups (1·09 [95% CI 0·90-1·33]). Interpretation Our results show that tranexamic acid is safe in patients with TBI and that treatment within 3 h of injury reduces head injury-related death. Patients should be treated as soon as possible after injury. Funding National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust, Department of Health and Social Care, Department for International Development, Global Challenges Research Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme)

Effect of Vernonia amygdalina Extracts and Meal on Colour, Physicochemical Properties and Microbial Load of Broiler Meat

Aims: This study was carried out to investigate the meat colour, physicochemical properties and microbial load of broiler meat fed Vernonia amygdalina extracts and meal.&#x0D; Study Design: The experiment employed a complete randomized design; all data generated were subjected to analysis of variance, P=0.05.&#x0D; Place and Duration of Study: The feeding trial of the study was carried out at the Teaching and Research Farm, University of Ibadan, Ibadan, Nigeria while meat quality attributes were evaluated at Animal Products and Processing Laboratory, Department of Animal Science of the same institution between June and September, 2016.&#x0D; Methodology: Twelve 8 weeks old broiler chickens with an average weight of 2.5±0.2 kg used in this study were obtained from an experimental unit where they were assigned to four treatments. Treatment 1 and treatment 2 were offered Vernonia amygdalina aqueous extract and ethanolic extract in drinking water respectively and leaf meal was added to the feed of treatment 3 in powdered form. Treatment 4 was offered water and feed without Vernonia amygdalina leaf meal or extracts. Meat produced from the carcass was refrigerated before being analyzed.&#x0D; Results: The result revealed that supplementation of VA extract for T1 and T2 gave better meat physicochemical parameter compared to control. However, pH ranged from 5.51-5.87 and cooking loss (29.84 -37.19) were not significantly (P&gt;0.05) different among the treatments. T2 (ethanolic extract) had the highest extract release volume. T1 (aqueous extract) had the highest meat swelling capacity (227.62) and water holding capacity (70.33). T3 (leaf meal) showed a significantly (P&lt;0.05) lower lightness (L*) and yellowness b* while T1 (Aqueous extract) had higher redness (a*). Total viable count (TVC) of treatment 2 was significantly lower compared to others.&#x0D; Conclusion: The result of these findings showed that the use of the ethanolic extract of Vernonia amygdalina in water was able to inhibit microbial load and improve physicochemical properties of fresh meat compared to aqueous extract and VA leaf meal.</jats:p

Profile of orthopaedic day-case procedures at a district general hospital (retrospective study)

Abstract Background The outcomes of orthopaedic day-case procedures have been reported widely, but there is a lack of reports from secondary health facilities such as district hospitals. Aim We aimed to perform a retrospective analysis of patient records to capture the profile of day-case procedures performed. Materials and methods We conducted a retrospective analysis of day-case procedures at the dedicated Day Surgery Unit of a moderate-sized district hospital in Saudi Arabia between January 2021 and December 2022. The medical records of all the patients who had day-case procedures by the hospital's orthopaedic unit were analyzed. Results Within the study period, 71 out of 914 elective orthopaedic procedures were carried out as day-cases, giving a day-case surgery rate of 7.8%. The mean age was 25.3 ± 12.2 (range, 4–55 years), and the male-to-female ratio was 6:1. The spectrum of the procedures was dominated by implant removal in 59 cases (83.1%). Whilst the anaesthetic technique varied, all the patients were ASA class I or II. There were minor complications in 10 patients (14.0%), with 7 of them (9.8%) needing inpatient admission. There was no cancellation of cases in our study. Conclusion We found day-case procedures to be safe and effective but with low utilisation of the Day Surgery Unit, which can be improved through the development of a detailed protocol for day surgery in the hospital

Effects of Jatropha curcas seed extract on reproductive functions in female Wistar rats

Background: Jatropha curcas is a multipurpose plant with several industrial and medicinal importance. Its seeds contain many active compounds that are used as medicines with antiinflammatory, and antioxidant activity. Objective: The objective of this study is to evaluate the effects of extract of Jatropha curcas seed which is patronized locally in some communities as agent of preventing childbirth on reproductive functions in female Wistar rats. Methods: Twenty-four animals were randomly divided into four groups of 6 rats each. Group I was administered normal saline and served as control. Groups II, III and IV were given the seed extract orally at doses of 100mg/kg, 200mg/kg and 400mg/kg body weight respectively daily for 14days orally. The animals were euthanised and blood samples collected for oestrogen, progesterone, FSH and LH assay. Statistical analysis was done using statistical package for social sciences (SPSS). Differences in means was obtained using ANOVA test. All values reported in the study were expressed as mean ± SEM. Differences in mean was taken to be significant at P&lt;0.05. Results: There was significant reduction (p&lt;0.05) in levels of progesterone, LH and FSH in moderate and high doses of the extract. But estrogen level was significantly (p&lt;0.05) decreased in both low and moderate doses, while the high dose showed significant (p&lt;0.05) increase. Conclusion: There was alteration in reproductive hormones due to arrest of development of ovarian follicles. This gives it the propensity of exhibiting contraceptive activity. J Bngladesh Soc Physiol 2021;16(1): 104-110</jats:p

Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial

Background: The CRASH-3 trial hypothesised that timely tranexamic acid (TXA) treatment might reduce deaths from intracranial bleeding after traumatic brain injury (TBI). To explore the mechanism of action of TXA in TBI, we examined the timing of its effect on death. Methods: The CRASH-3 trial randomised 9202 patients within 3 h of injury with a GCS score ≤ 12 or intracranial bleeding on CT scan and no significant extracranial bleeding to receive TXA or placebo. We conducted an exploratory analysis of the effects of TXA on all-cause mortality within 24 h of injury and within 28 days, excluding patients with a GCS score of 3 or bilateral unreactive pupils, stratified by severity and country income. We pool data from the CRASH-2 and CRASH-3 trials in a one-step fixed effects individual patient data meta-analysis. Results: There were 7637 patients for analysis after excluding patients with a GCS score of 3 or bilateral unreactive pupils. Of 1112 deaths, 23.3% were within 24 h of injury (early deaths). The risk of early death was reduced with TXA (112 (2.9%) TXA group vs 147 (3.9%) placebo group; risk ratio [RR] RR 0.74, 95% CI 0.58–0.94). There was no evidence of heterogeneity by severity (p = 0.64) or country income (p = 0.68). The risk of death beyond 24 h of injury was similar in the TXA and placebo groups (432 (11.5%) TXA group vs 421 (11.7%) placebo group; RR 0.98, 95% CI 0.69–1.12). The risk of death at 28 days was 14.0% in the TXA group versus 15.1% in the placebo group (544 vs 568 events; RR 0.93, 95% CI 0.83–1.03). When the CRASH-2 and CRASH-3 trial data were pooled, TXA reduced early death (RR 0.78, 95% CI 0.70–0.87) and death within 28 days (RR 0.88, 95% CI 0.82–0.94). Conclusions: Tranexamic acid reduces early deaths in non-moribund TBI patients regardless of TBI severity or country income. The effect of tranexamic acid in patients with isolated TBI is similar to that in polytrauma. Treatment is safe and even severely injured patients appear to benefit when treated soon after injury. Trial registration: ISRCTN15088122, registered on 19 July 2011; NCT01402882, registered on 26 July 2011