Complications following COVID-19 infection or vaccination in Libyan International Medical University students and their Families

Coronavirus disease 2019 (COVID-19) caused by a novel strain of coronavirus belonging to the genus Beta coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged as a major pandemic worldwide. This contagious virus had spread in many different forms, and patients have demonstrated a wide range of symptoms, ranging from moderate to severe illness. This study aims to highlight the important associations between SARS-CoV-2 infection, vaccination, and possible complications at the Libyan International Medical University, Benghazi. This crosssectional survey was conducted among students and their families at Libyan International Medical University in Benghazi, Libya. Among the 100 participants, 72% were between the ages of 18 and 39. Up to (59%) of participants were men. As for the infection with COVID-19, 77% of participants were infected. Most of the participants had no chronic diseases (69%); however, the most common chronic disease was diabetes mellitus (13%). 82% of participants were vaccinated; the most common types of vaccines administered were Sinopharm and Sputnik V (24%). Following vaccination, 71% of participants had no COVID-19 infection, while 29% did get the infection. Regarding this study, after COVID-19 infection, 66% of participants had no complications; however, 17% had pulmonary complications, which was the most common complication among the participants. As for the complications following the vaccination, 81% of participants had none, while there were pulmonary and neurological complications in 7­6%. The results of the study showed that the most frequent complications noticed among the participants following the COVID-19 infection and vaccination were pulmonary and neurological complications.

Prise en charge anesthésiologique de l'anévrisme cérébral au Mali / Anesthesiological management of cerebral aneurysm in Mali

Objectif : Décrire la prise en charge anesthésiologique de l'anévrisme cérébral au Mali. Patients et Méthodes : étude descriptive à recueil historique de 8 ans (Novembre 2012 à Octobre 2020) au CHU « Hôpital du Mali ¼ des patients opérés pour anévrisme cérébral avec un dossier médical complet. La saisie et l'analyse ont été effectuées par SSPS version 25. Résultats : Durant la période d'étude, 32 patients répondaient à nos critères soit une prévalence de 2,1%. L'âge moyen était de 45,2 ± 12,5 ans. Le ratio femme-homme était de 2,55. Les patients résidaient à Bamako dans 71,9 %. L'HTA était l'antécédent médical le plus fréquent. Les patients étaient de grade I de WFNS dans 87,5%. La classe ASA II représentait 84,4%. Une prémédication a été faite dans 96,9%. Une anesthésie générale a été faite chez tous les patients. Une antibioprophylaxie a été faite chez tous les patients. La perte sanguine moyenne était de 737,3 ± 460,5 ml. Une transfusion per opératoire a été prescrite dans 46,8%. L'évènement indésirable per opératoire était cardiovasculaire dans 96,9 %. La durée moyenne de la chirurgie était de 267,1±77,1 minute. Celle de l'anesthésie était de 427,9 minutes. En réanimation, une complication a été observée dans 34,4%. La mortalité était de 25%. La durée moyenne de séjour était de 6,3 jours. Conclusion: Au Mali la prise en charge de l'anévrysme cérébral est en progrès malgré une mortalité encore élevée.

Objective: To Describe the anesthesiological management of cerebral aneurysm in Mali. Patients and Methods: This was an observational study, descriptive with historical collection of 8 years (November 2012 to October 2020) at the department of the university hospital "Hôpital du Mali" concerning 32 patients operated for cerebral aneurysm with a complete medical file. Input and analysis were performed by SSPS version 25. Results: During the study period, 32 patients met our criteria, a prevalence of 2.1%. The median age was 45.2 ± 12.5 years. The female-to-male ratio was 2.55. Patients resided in Bamako in 71.9%. High blood pressure was the most common medical history. Patients were grade I WFNS in 87.5o_ièvg%. ASA class II accounted for 84.4%. Premedication was done in 96.9%. General anesthesia was applied to all patients. Antibiotic prophylaxis was given to all patients. The average blood loss was 737.3 ± 460.5 ml. An intraoperative transfusion was prescribed in 46.8%. The intraoperative adverse event was cardiovascular in 96.9%. The average duration of surgery was 267.1±77.1 minutes. That of anesthesia was 427.9 minutes. In intensive care, a complication was observed in 34.4%. Mortality was 25%. The average length of stay was 6.3 days. Conclusion: In Mali, the management of cerebral aneurysm is progressing despite still high mortality.

Hematological consequences of antiepileptic drug therapy among children with epilepsy

Epilepsy is a chronic neurologic disease that comes third after cerebrovascular and Alzheimer's disease. Anti-epileptic drugs may affect certain hematological parameters of epileptic patients. Few researches investigated hematological adverse effects of antiepileptic drugs in Libya. Thus, the aim was to evaluate hematological parameters in epileptic children who are on antiepileptic drugs. This retrospective study included 83 pediatric patients with epilepsy recruited from Benghazi Children Hospital, Department of Neurology, from December 2017 to April 2018. Data collected included demographic characteristics, types of epilepsy, anti-epileptic drugs and serum hematological parameters. Hematological parameters recorded included: hemoglobin, hematocrit, platelet, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration and white blood cell count. In all treated patients, regardless of the number of antiepileptic drugs therapy used, the average levels of hematological parameters were significantly lower in treated group compared to control group (11.64 gm per dl, 34.53%, 27.74 pg and 33.13 gm per dl, respectively). A significant increase (12.12109 per l) in white blood cell counts in treated group was found. Average hemoglobin, hematocrit and mean cell hemoglobin concentration levels were significantly lower in patients on poly-therapy compared to mono-therapy and control groups. Average white blood cell counts were significantly increased in patients on anti-epileptic drugs. In sodium valproate users, levels of hematological parameters were significantly decreased but significantly increased in white blood cell counts. In diazepam users, significant increases in white blood cells and platelet but no difference in other parameters observed. There were no differences in all hematological parameters among patients using carbamazepine except for platelet counts (significantly decreased). In conclusion, there is substantial effect of the anti-epileptic drugs, especially sodium valproate, on hematological parameters of children despite the effects were not critical as the changes were still in the normal range.

The current use of the artemisinin-based combination therapies in adult patients at a tertiary hospital, South-South Nigeria

Objective:The antimalarial preferences, tolerability, and cost of the Artemisinin-based combination therapies (ACTs) among adult patients and caregivers are largely understudied despite being the recommendedtreatment for Plasmodium falciparum.We, therefore, evaluated antimalarial preferences, tolerability, and cost of the ACTs among adult patients attending the University of Benin Teaching Hospital, Nigeria. Methods:This was a cross-sectional study conducted among adult patients and their caregivers atthe University of Benin Teaching Hospital, Nigeria,using a semi-structured questionnaire. Their preferred antimalarial medication, previous use of antimalarial monotherapies, current ACT use; cost considerations, and adverse effects profile were sought.Result:Six hundred respondents were recruited with a mean age of 41.4±16.3years and M/F ratio of 1.4. The majority (88.0%), reported that they had between 1-5 episodes of malaria fever in a year. Only 28.2% received doctors' prescriptions while 85.8% purchased their antimalarial medications from a pharmacy. Sixty percent of the respondents used at least one ACT; mainly Artemether-Lumefantrine (AL) 312(52.0%). Only 9.3% reported previous adverse effects with the ACTs with 4.0% of respondents discontinuing their medications. The mean (SD) cost of purchasing ACTs was 1,516.47±760.3 (3.65 USD) Naira.Conclusion: This study showed adult patients' preference for the ACTs, especially Artemether-Lumefantrine despite some inclination towards antimalarial monotherapies and parenteral route. There was also a high rate of use of malaria presumptive treatment, but only a few reported adverse effects. There is a need to make ACTs affordable because the cost is still presently high for most Nigerians.

Patient preferences and expectation for feedback on adverse drug reaction reports submitted in Ghana

Background: Personalized feedback received for spontaneous adverse drug reaction (ADR) reports serves as motivation for future reporting and the effectiveness of the feedback is dependent on the medium used in delivering the information. Objective: Explore expectation for feedback from patients on ADR reports submitted to the National Pharmacovigilance Centre (NPvC) in Ghana and the preferred medium for receiving the feedback information.Methods: Cross-sectional study using structured questionnaire administered through face-to-face interview from August to September 2016 to patients selected by convenience sampling. Pearson chi-square (Χ2) or Fisher's exact test was used to determine associations between background variables such as age, gender and level of education. Results: The response rate was 86.7% (n=442). Of the participants interviewed, 96.5% expected to receive feedback for ADR reports submitted. Age and level of education were the two variables significantly associated with patients' expectation for feedback. The preferred medium for receiving feedback in decreasing order of preference were, telephone call (60.4%), mobile phone short messaging services (23.0%), email (8.3%), face-to-face meeting (3.4%), personalized letter (3.4%) and publication in a newsletter (1.4%). Conclusion: Patients' expectation for receiving feedback for ADR reports submitted to the NPvC is in line with modern trends in communication. NPvC should explore these alternatives for providing feedback to patients. Thisstudy is limited to what patients' expectations and preferences were for receiving feedback on ADR reports submitted, additional study to further explore the type of information patients expect to be contained in the feedback will be useful to National Pharmacovigilance Centres

Assessment of adverse drug reactions in the home management of malaria cases of children under 5 years using artemisinin-based combination therapy in Mfou health district, Center region of Cameroon

health concerns in Cameroon. Its treatment is frequently initiated at home, most often with street drugs. The home management of malaria cases entails the prescription of Artemisinin-based combination (ACTs) as first-line therapy for treatment of uncomplicated malaria after having confirmed the malaria case using rapid diagnostic tests. But induced adverse reactions of this therapy are not well known in Cameroon. Thus, a prospective, observational, cohort study of adverse events associated with ACTs was conducted from January 2013 to November 2013 in the health district of Mfou. Children under 5 years receiving ACTs for malaria treatment at home were enrolled. Suspected ADRs and other clinical events were recorded. Data were managed and analysed using Epi Info version 3.5.3 and Statistical Package for Social Sciences, statistical software version 20. Of the 479 children investigated, 56.8% (n=272/479) were males, the age group 25-59 months (49.5%; n=237/479) was most represented, 27.1% (n=130/479) had experienced one form of ADRs, male children (56.2%; n=73/130) and the age group 25-59 months (50.8%; n=66/130) were most affected. No significant association was found between age, sex and incidence of adverse ACTs reactions. The main experienced ACTs reactions were tiredness (43.1%; n=56/130) followed by lack of appetite (24.6%; n=32/130). The incidence ACTs ARDs was found to be relatively low and tolerable. Home management of malaria cases using ACTs should be encouraged and community members should be trained to improve the recognizing and reporting of adverse effects

Retrospective clinical analysis of adverse drug reactions associated with antiretroviral therapy in Tlokwe district, South Africa

Background: South Africa has the highest number of patients on antiretroviral therapy (ART) globally. Various obstacles were identified that influence effective reporting of adverse drug reactions (ADRs) in resource-limited countries. This investigation aimed to identify, classify and analyse the prevalence of ART-related ADRs. Methods: This observational, quantitative and retrospective descriptive investigation utilised ADR forms completed by healthcare professionals in various healthcare facilities in the Tlokwe district, South Africa (January 2010 to December 2014). Descriptive and inferential analyses were carried out. Results: A total of 770 ART-related ADRs were included in the final analysis. The mean age was 40.1 (± 10.1%) years, with significantly higher ADRs reported in females (70.8%). In this study, 99% of the ADRs were reported by doctors. Abnormal fat distribution (58%), peripheral neuropathy (21.6%) and renal dysfunction (6.6%) were most frequently reported. Females presented with abnormal fat distribution and peripheral neuropathy at a significantly younger age (38.1 ± 4.6 vs. 43.4 ± 5.7 years, p < 0.0001 and 39.7 ± 1.1 vs. 45.1 ± 9.2 years, p < 0.001) respectively compared with males. Gender difference was practically significant (Cramer's V = 0.3) for all three of the major reported ADRs. Conclusions: Gender was highly dependent among the major reported ADR categories, and women presented with abnormal fat distribution and peripheral neuropathy at a significantly earlier age than males. This retrospective analysis can serve as aplatform for future ADR studies within this district. Sustainable and continuous efforts should be made to train and create more awareness among healthcare workers in this district

Adverse Drug Reaction Reporting by Doctors in a Developing Country: A Case Study from Ghana

Background: Spontaneous adverse drug reaction reporting is the most widely used and cost effective method of monitoring the safety of drugs. This method is heavily afflicted by underreporting by healthcare professionals. The study aims at assessing adverse drug reaction (ADR) reporting rate by doctors; knowledge of the reporting system and attitudes to SADR in the Greater Accra region. Methods: This was a cross sectional survey of 259 doctors randomly selected from 23 hospitals classified as government 199 (76.8); quasi-governmental 43(16.6) and private 17 (6.6) hospitals in the Greater Accra Region of Ghana. Data collection was by self-administered questionnaire from May 5; 2012- July 6; 2012. Descriptive statistics was used to describe the background characteristics of the doctors and the outcome measures like training and reasons for ADR reporting were summarized as frequencies and percentages. Results: One-third (27.4) of doctors surveyed had received previous training on drug safety monitoring and ADR reporting; training and knowledge of the reporting system was found to improve reporting. More than half 154 (59.5) of the doctors had seen a patient with suspected ADR in the past one year although only 31 (20) had reported it by completing the SADR reporting form. Doctors working in government hospitals were about 5 times more likely to report than those in private hospitals [OR=4.94; 95CI (1.55-15.69)]. Conclusion: Training and knowledge of the ADR reporting system were found to be associated with the likelihood of reporting an ADR. Most of the doctors had not previously received training on ADR reporting

Attitude and practice of doctors toward adverse drug reactions (adrs) reporting in a Nigerian tertiary health facility

Background : Adverse drug reactions; (ADRs); constitute an important cause of morbidity and mortality worldwide. Spontaneous adverse drug reaction (ADR) reporting is the bedrock of post-marketing surveillance but under-reporting remains its major drawback. Objectives : This study aimed at evaluating the attitude and practice of ADR among doctors in a tertiary health facility in Oyo State; Nigeria; with a view to improving ADRs reporting. Methods : This was a cross-sectional questionnaire based study involving medical doctors working at the Ladoke Akintola University of Technology (LAUTECH) Teaching Hospital; Ogbomoso. Consenting doctors were evaluated on their attitude and practice of ADRs through self-administered questionnaire. Data obtained were entered and analyzed using SPSS version 17. Results : A total of 35 doctors responded to the questionnaires. Only about 57.1 considered ADR before prescribing; all of whom were also aware of the procedure for reporting. Awareness of the existence of National Pharmacovigilance Center (NPC) was 71.4. Thirty (85.7) of the respondents have encountered ADR; but only 2.9 have ever reported it with yellow form. Majority (85.7) of the respondents did not consider ADR reporting as a useful tool in the prevention of drug related morbidities and mortalities. Other factors that may hinder ADR reporting include: lack of awareness of the existence of yellow forms for reporting (68.6) and poor knowledge of procedure for reporting (48.6). Conclusion : ADR reporting rate was very low among the participants in this small study; large studies aimed at evaluating the determinants of ADR reporting should be considered. Should these findings be confirmed; training and re-retraining through Continuing Medical Education (CME); and establishment of pharmacovigilance committee would be required to ensure a national pharmaovigilance system

Incidence of Adverse Drug Reactions in Patients on Antiretroviral Therapy: A study of Pharmaceutical Care in HIV Interventions in Nigeria

Background: Over 415;000 HIV-infected patients are receiving antiretroviral therapy (ART) in Nigeria but studies documenting their adverse reactions are limited. Objectives: This study determined the incidence and type of ADRs of severity grades II to IV in ART patients following pharmaceutical care directed active ADR surveillance program in Nigeria. Methods: This was a longitudinal study. A study-specific pharmaceutical care daily work sheet and national ADR reporting form were used for ADR screening and reporting respectively. Study population included 73;589 ART patients who were screened for ADR from April 2009 to December 2010 in 69 HIV treatment centres. All individual case safety reports (ICSRs) of severity grades II to IV in these patients were collated and analyzed. Chi-square was used to test the association between groups of variables at 95 Confidence Interval. Results: A total of 4600 ICSRs of severity grades II to IV reported were analyzed. Mean age of patients was 35.5(95CI; 35.2-35.9) years; 68.1 were females; and 7002 ADRs were reported; an average of 1.5 ADR perpatient. ADR incidences were 18.2 for d4T/3TC/EFV; 13.9 for d4T/3TC/NVP; and 4.4 for AZT/3TC/NV Pregimens; however overall incidence was 6.3. Major reported ADRs included skin rash (16.5); peripheral neuropathy (12.7); and headache (9.4). ADR occurrence was associated with specific ART regimens; concomitant medicines and age groups (p0.05); unlike gender. Lipodystrophy was associated withd4T/3TC/NVP [OR

The Impact of Herbal Remedies on Adverse Effects and Quality of Life in HIV-Infected Individuals on Antiretroviral Therapy

Introduction: Use of herbal remedies among HIV-infected individuals in Africa increased in the past decade; mainly due to traditional beliefs and at times inconsistent access to antiretroviral drugs. In Zimbabwe; accessibility and availability of antiretroviral drugs has increased in recent years; however; the use of herbal remedies remains high. This study was conducted to determine the impact of concomitant use of herbal remedies with antiretroviral drugs on adverse events and on quality of life. Methodology: A convenient sample of HIV positive patients at Parirenyatwa group of hospitals' Family Care Clinic (Harare; Zimbabwe) was enrolled. A questionnaire was used to collect data on the adverse event experiences of the patients using herbal remedies for their HIV; as well as the types of herbal remedy used. Quality of life index was measured using an HIV/AIDS targeted quality of life (HAT-QOL) tool developed by the World Health Organization. Results: Abdominal pain (odds ratio = 2.7; p-value = 0.01) and rash (odds ratio = 2.5; p-value = 0.02) had significant associations with using herbal remedies during antiretroviral therapy. Improved quality of life index was not significantly associated with herbal remedy use during antiretroviral therapy. Conclusions: There is evidence to suggest that some traditional herbal remedies used in Zimbabwe may increase incidence of certain types of adverse events when used in combination with antiretroviral drugs. Use of herbal drugs in combination with antiretroviral therapy does not significantly improve quality of life index in comparison to antiretroviral drug use only

La vectorisation des antibiotiques : developpement et applications therapeutiques

La vectorisation des medicaments s'est beaucoup developee ces dernieres annees grace a l'apparition de nouvelles formes galenique issues de la nanotechnologies .Ces formes d'administrastions submicroniques permettent un ciblage des antibiotiques au niveau intracelluraire ainsi que le controle de leur distribution dans le temps et dans l'espace. Nous essayons d'exposer l'evolution dans ces vecteurs ainsi que leurs application dans le traitement de certaines maladies infectieuses

Immune activation; allergic drug toxicity and mortality in HIV-positive tuberculosis

This study was conducted to correlate serum levels of markers of immune activation with mortality and drug toxicity in HIV+TB. Design: Substudy of a randomised clinical trial of streptomycin-thiacetazone-isoniazid (STH) vs. rifampin-isiniazid-pyrazinamide (RHZ) in HIV + TB. Design: Substudy of a randomized clinical trial of streptomycin-thiacetazone-isoniazid (STH) vs. rifampin-isoniazid-pyrazinamide (RHZ) in HIV + TB. Results: Neopterinor =14 ng/mg; TNF-alpha receptorsor = 6.5 ng/ml; and negative skin test were independently associated with increased mortality (P0.01). Among STH-treated subjects; dermatologic toxicity and mortality (P0.05); although these two adverse events occurred independently. Activation markers increased from baseline after 2 months of therapy with the less rapidly bactericidal STH regimen; whereas they declined in those treated with RHZ; suggesting a relationship with continued mycobacterial replication. Conclusions: Immune activation in HIV+TB is associated with shortened survival and increased risk of drug toxicity. HIV+TB patients with elevated serum neopterin should be treated with a rapidly-bactericidal drug regimen which does not include thiacetazone

Preliminary findings from stimulated spontaneous reporting of adverse drug reactions during COVID-19 pandemic: an experience from Ghana

Background: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There is limited information on the safety of drugs used for the treatment of COVID-19. Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries. Methods: This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1st April 2020 to 31st July 2020 in SARS-CoV-2 positive patients in Ghana. The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Preferred Term. Results: Information was received from 40 COVID-19 Treatment Centres across the country with 9 centres submitting a total of 53 ICSRs containing 101 ADRs; approximately two ADRs per ICSR. Females accounted for 29(54.7%) of the ICSRs and males 24(45.3%). Newly reported ADRs of interest were one report each of tremor for doxycycline; scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine; and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine. A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic. Conclusion: This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana. The profile of most of the ADRs reported appears consistent with what is expected from the summary of product characteristics. A study with a larger sample size with well-defined denominator in future studies is paramount in determining the relative risk of these medications in SARS-CoV-2 positive patients