Familiarity, Knowledge and Practices of Healthcare Professionals Regarding the Pharmacovigilance of Biological Medicines in Lusaka, Zambia: A Multi-Facility Cross-Sectional Study.

Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines

Aphrodisiac Effects of an Ethanolic Root Extract of Ocimum fimbriatum Briq. var. fimbriatum (Kafupa) on Male Wistar Rats

Background: Ocimum fimbriatum Briq. var. fimbriatum is used traditionally in Zambia for its aphrodisiac effect, but there is no scientific evidence to support this use. Therefore, this study aimed to validate the aphrodisiac effects of the plant's root extract in rats. Study Design: This was an experimental study in which sixty Wister rats (30 males and 30 females) were separated into 5 groups of 12 rats and treated with different doses of the extract. Methods: The root extracts were administered at single oral doses of 100, 200, and 400 mg/kg to 30 male rats. Distilled water and sildenafil served as controls. Female rats were treated with 0.1 mg/kg diethylstilbesterol and paired to the male rats.Mounting frequency, intromission, ejaculation, and latency periods were monitored using recording cameras. Recordings were analyzed visually and expressed as mean ± standard error. Results: The root extract produced significant dosedependent increases in mounting, intromission, and ejaculation frequencies and latency periods, compared to negative controls. The 400 mg/kg dose produced highest number of mounts (31.33 ± 0.49, p= 0.001), intromissions (24.17 ± 0.60, p= 0.001) and ejaculations (7.67 ± 0.33, p= 0.001) compared to negative controls. At this dose, latency periods for mounting (3.00 ± 0.37min, p= 0.001) and intromission (2.1 ± 0.32 min, p= 0.001) were shortest, while the latency periods for ejaculation (6.33 ± 0.56 min, p=0.001) were longest. Conclusion: Root extract of Ocimum fimbriatum exerted significant aphrodisiac effects in rats and justifies traditional use of the plant. Further studies are required to elucidate the active principles and mechanisms involved in this effect. Keywords: Aphrodisiac effects; ejaculation; intromission; mounting frequency; Ocimum fimbriatu

Phytochemical Studies and Blood Glucose Lowering Effect of Zambian Cultivars of Piliostigma thonningii in Alloxan - Induced Diabetic Rats

Background: There is anecdotal evidence among some Zambian traditional medicine practitioners that Piliostigma thonningii possesses antidiabetic effects. This study assessed the in-vivo antidiabetic effects of ethanol extract of the plant in alloxaninduced diabetic wistar rats.Study design: A laboratory-based experimental study involving 24 rats divided into 4 groups of 6 and administered the extract,  glibenclamide and placebo.Methods: Diabetes was induced by a single intraperitoneal injection of 150mg/kg alloxan monohydrate. The in-vivo glucose lowering  effect of ethanol extract of stem bark of Piliostigma thonningii was evaluated in comparison to normal saline as negative control and glibenclamide as positive control. Standard methods for identification of alkaloids, flavonoids, saponins, tannins, glycosides, terpenoids and anthraquinones were employed in the phytochemical analysis of the extract.Results: Piliostigma thonningii ethanol stem bark extract showed presence of alkaloids, flavonoids, saponins, tannins, glycosides and terpenoids. The extract caused a 55.3% (P=0.002) reduction in blood glucose of the experimental animals over the treatment period from the initial 19.7±7.0 mmol/l to 8.8±2.5 mmol/l, compared with glibenclamide which caused 68.3 % (P=0.001) lowering blood glucose levels from 24.0±4.5 mmol/l to 7.6±5.9 mmol/l.Conclusions: Stem bark extract of Piliostigma thonningii showed a significant glucose lowering effect in diabetic rats. The study also demonstrated presence of secondary plant metabolites which could be responsible for some of the medicinal properties of the plant. Further studies are required to purify the plant and identify active fractions responsible for the anti-diabetic effect observed

Inadequate knowledge and practice of pharmacovigilance affecting adverse drug reaction reporting by health professionals in private healthcare facilities in Lusaka, Zambia

Background: There is currently insufficient information regarding the levels of knowledge and practice of Adverse Drug Reactions (ADRs) reporting among healthcare professionals in Zambia. Aim: The study examined knowledge, attitude and reporting practices among medical doctors, pharmacists and nurses in private healthcare facilities in Lusaka, Zambia. Methods: A descriptive cross-sectional study was undertaken. Data was collected using a selfadministered questionnaire assessing general knowledge, attitudes and practice of ADR reporting. A rated score was used to categorize knowledge as poor, average, or good. A Kruskal-Wallis H test followed by Bonferroni test was used to compare knowledge levels among medical doctors, pharmacists and nurses, respectively. To assess practice and attitude towards the ADR reporting, proportions were used to analyze responses to items in each of the respective domain. Results: General knowledge of ADR reporting among the medical doctors, pharmacists and nurses in the private sector was relatively low. A Kruskal-Wallis H test showed that there was a statistically significant difference in total score between the different occupations, ÷ 2 (2) = 10.839, p = 0.004, with a mean rank score of 34.08 for pharmacists (n = 18), 22.17 for doctors (n = 24) and 16.19 for nurses (n = 8). Low knowledge levels of ADR reporting were attributed to lack of pharmacovigilance training, with thirty nine (78%) of the participants indicating that they had never received any training on ADR reporting and thirty seven participants (74%) indicated that they had never reported an ADR. Factors that discouraged ADR reporting included: practitioner concern that the information reported may be wrong (46.8%); the level of clinical knowledge to decide whether an ADR had occurred (46.8%); lack of time to complete the ADR report forms (36.2%); reporting generating extra work load (25.5%); and the perceived unimportance of reporting a recognized ADR believing it would make little difference to knowledge and practice (19.1%). The major factors that encouraged ADR reporting included: seriousness of the ADR (98%); unusual reactions (77.6%); adverse reaction to a new product (83.7%); confidence in diagnosis of an ADR (73.5%), and if the reaction was well recognized for a particular drug (67.3%). The training of personnel in private practice was major indicator for improvement of ADR reporting. Conclusion: Despite the relative positive attitudes indicated, low levels of knowledge due to lack of training was the main driver of ADR underreporting practice among private health practitioners that participated in this study. Addressing the knowledge and practice gaps identified will go a long way to further improve ADR reporting rates and medication safety in private healthcare practice settings. Keywords: Pharmacovigilance, knowledge, attitude, practice, health professionals, reporting, private sector, Zambi