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.

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Individual case safety reports by nursing staff: a retrospective pharmacovigilance analysis

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20183919 ◽

2018 ◽

Vol 7 (10) ◽

pp. 1895

Author(s):

Padmavathi T. ◽

Rajavel Murugan P.

Keyword(s):

Healthcare Professionals ◽

Spontaneous Reporting ◽

Causality Assessment ◽

Early Stage ◽

Individual Case ◽

Staff Nurses ◽

Direct Patient Care ◽

Causality Analysis ◽

Considerable Morbidity ◽

Probable Category

Background: The burden of adverse drug reactions is high and accounts for considerable morbidity which can be prevented if healthcare professionals have proper knowledge. Early and spontaneous reporting of ADRs is the mainstay of pharmacovigilance program. Since staff nurses are closely involved in direct patient care, they can easily identify ADRs in the early stage. This study was done to assess the extent of participation of nurses in pharmacovigilance program in our institution.Methods: Retrospective observational study was conducted by analyzing the 210 Individual Case Safety Reports (ICSR) of 2years duration. Causality assessment in the ICSR was analyzed. Severity of the reactions was categorized into mild, moderate and severe according to Modified Hartwig and Siegel scale. Descriptive statistics were used.Results: There were 177 cases reported by faculties and 33 were by the staff nurses.19 nurses reported 33 adverse effects (1:1.7) whereas 41 faculties 177 events (1:4). On analyzing the severity of reactions, 188 cases were categorized as moderate (89.5%), 20 mild (9.5%) and 2 severe (1%). In moderate category of 188 reports, 82 % reporting was by faculties and 18% by staff nurses. All the 33 reports by nurses were of moderate category (100%). In the mild and severe category, 100% reporting was by faculties. Causality analysis showed that 194 were classified as probable (92%), 14 as Possible (7%) and 2as certain (1%). In probable category 85% of reporting was by faculties and 15% by nurses, in possible group 71 % by faculties and 29% by nurses and 100% by faculties in severe category.Conclusions: Training and dedicated participation of nurses can improve reporting of ICSR.

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EXPRESS: Serum biomarkers for prediction of mortality in patients with COVID-19

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/00045632211014244 ◽

2021 ◽

pp. 000456322110142

Author(s):

Rohit S Loomba ◽

Enrique G Villarreal ◽

Juan S Farias ◽

Gaurav Aggarwal ◽

Saurabh Aggarwal ◽

...

Keyword(s):

High Sensitivity ◽

Hepatic Function ◽

Pooled Analysis ◽

Cardiac Biomarkers ◽

Limited Information ◽

C Reactive Protein ◽

Acute Phase Reactants ◽

Reactive Protein ◽

Prediction Of Mortality ◽

Novel Coronavirus

Background There is limited information regarding the role of biomarker levels at predicting mortality in patients with the novel coronavirus pandemic (Covid-19). The purpose of this study is to determine the differences in serum biomarker levels in adults with Covid-19 who survived hospitalization from those who did not. Methods A comprehensive search was completed on PubMed, EMBASE, and Cochrane libraries to identify studies of interest. Endpoints of interest were blood counts, hepatic function test, acute phase reactants, cytokines and cardiac biomarkers. Results A total of 10 studies with 1,584 patients were included in the pooled analyses. Biomarkers that were noted to be significantly higher in those who died from Covid-19 (coronavirus disease 2019) included: white blood cell count, neutrophil count, C-reactive protein, high sensitivity C-reactive protein, procalcitonin, ferritin, D-dimer, interleukins 6, lactate dehydrogenase, creatine kinase, prothrombin time, aspartate aminotransferase, alanine aminotransferase, total bilirubin, and creatinine. Lymphocyte count, platelet count, and albumin were significantly lower in patients who died. Conclusion This pooled analysis of 10 studies including 1,584 patients identified significant differences in biomarkers on admission in patients who survived from those who did not. Further research is needed to develop risk stratification models to help with judicious use of limited healthcare resources.

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Psychosocial, emotional and professional challenges faced by female healthcare professionals during the COVID-19 outbreak in Lahore, Pakistan: a qualitative study

BMC Women s Health ◽

10.1186/s12905-021-01344-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sumbal Shahbaz ◽

Muhammad Zeshan Ashraf ◽

Rubeena Zakar ◽

Florian Fischer

Keyword(s):

Healthcare Professionals ◽

Qualitative Interviews ◽

Working Environment ◽

Cultural Issues ◽

Self Reflection ◽

Professional Challenges ◽

Proper Training ◽

Phenomenological Methodology ◽

Novel Coronavirus ◽

And Coping

Abstract Background The novel coronavirus disease (COVID-19) is spreading rapidly, increasing the stress and challenges for healthcare professionals around the world. This study aims to discover the psychosocial, emotional and professional challenges faced by female healthcare professionals (HCPs) treating COVID-19 patients in Pakistan. Methods Using an empirical phenomenological methodology, semi-structured telephone-based qualitative interviews were conducted with 22 female HCPs who were providing their expertise for COVID-19 patients in tertiary-level hospitals in Lahore, Pakistan. Purposive sampling was used for recruitment. The interviews were conducted between 20 July and 20 August 2020. The interviews were analysed using thematic analysis. Results This study explored the psychosocial, emotional and professional challenges faced by female HCPs serving COVID-19 patients. Five themes were observed in the interviews: apprehension while treating COVID-19 patients; feelings towards COVID-19 patients; challenges as female HCPs and coping strategies; confidence in government, administration and self-reflection; and finally, future concerns and recommendations. Many of these themes have also been linked with cultural issues, making the results specific to Pakistan. Conclusions During the COVID-19 pandemic, female frontline HCPs have faced immense psychosocial pressure, ranging from unsupportive family norms to an unwelcoming working environment and insensitive hospital administrations. Moreover, rumours among the general public, lack of proper training, missing incentives and improper system surveillance have increased the anxiety and stress among HCPs. Hence, legislators are advised to take appropriate actions countrywide in order to alleviate the still ongoing challenges and support female HCPs in their working environment.

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Clinical Characteristics, Maternal and Neonatal Outcomes of COVID-19 Positive Pregnant Mothers at a Tertiary Hospital in Johannesburg, South Africa

10.21203/rs.3.rs-751147/v1 ◽

2021 ◽

Author(s):

Tanusha Devi Ramdin ◽

Rossella Marina Bandini ◽

Robin Terance Saggers ◽

Michael Radomsky ◽

Mphelekedzeni Mulaudzi ◽

...

Keyword(s):

Birth Weight ◽

Respiratory Distress ◽

Clinical Characteristics ◽

Tertiary Hospital ◽

Neonatal Outcomes ◽

Common Symptom ◽

Middle Income ◽

Symptomatic Disease ◽

Novel Coronavirus ◽

Pregnant Mothers

Abstract Background: The global spread of the novel coronavirus 2019 (COVID-19) has been sudden shock to the world and resulted in many questions that remain unanswered. Limited data has been published in low-middle-income country settings (LMICS) Objectives: To describe the clinical characteristics and outcome of mothers and neonates delivered from COVID-19 positive mothers, and to identify the incidence of COVID-19 positive neonates.Methods: A prospective, descriptive study, from 1 August 2020 to 31 March 2021 conducted at a tertiary hospital, in JohannesburgAll neonates born to mothers that were COVID-19 positive and that required admission to the neonatal unit were included. Informed consent was obtained from mothers prior to enrolment.Results: A total of 111 COVID-19 positive pregnant women delivered neonates at the tertiary hospital. In this study, only 28 of the 111 (25%) neonates born to COVID-19 positive mothers were admitted. The majority of the COVID-19 pregnant mothers were asymptomatic or had mild symptomatic disease (80%). Two (2/111 (2%) mothers required ICU admission and three (3/111 (3%) of them demised. In relation to neonatal outcomes, the majority of the neonates were delivered at a gestational age of 35 weeks with a birth weight of 2400 grams .The most common symptom was respiratory distress (89 %). The one (3%) neonate that tested positive for COVID-19 was born moderately preterm with a low birth weight and respiratory distress syndrome. Two (2/28 (7%) neonates demised, however the cause of death was not related to COVID-19. All the remaining (26/28 (93%) neonates were discharged and were well on follow up. Conclusion: Our study has shown that the risk of neonatal transmission from pregnant COVID-19 mothers is relatively low, and the majority of neonatal disease ranged from asymptomatic to mildly symptomatic disease. Further research efforts are essential to improve neonatal care in LMICS.

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Childhood Sexual Violence in Indonesia: A Systematic Review

Trauma Violence & Abuse ◽

10.1177/1524838018767932 ◽

2018 ◽

Vol 21 (2) ◽

pp. 284-299 ◽

Cited By ~ 4

Author(s):

Lauren Rumble ◽

Ryan Fajar Febrianto ◽

Melania Niken Larasati ◽

Carolyn Hamilton ◽

Ben Mathews ◽

...

Keyword(s):

Protective Factors ◽

Sexual Violence ◽

Survey Methods ◽

Significant Risk ◽

Evidence Base ◽

Limited Information ◽

Childhood Experiences ◽

Middle Income ◽

Prevalence Studies ◽

Nationally Representative

There has been relatively little research into the prevalence of childhood sexual violence (CSV) as well as the risk and protective factors for CSV in low- and middle-income countries including Indonesia. Systematic searches conducted in English and Bahasa Indonesia in this review identified 594 records published between 2006 and 2016 in peer-reviewed journals and other literature including 299 Indonesian records. Fifteen studies, including nine prevalence studies, met the quality appraisal criteria developed for this review. The review found that CSV research is scarce: Only one study included nationally representative prevalence estimates. Varying definitions for CSV, survey methods, and sample characteristics limited the generalizability of the data. The available evidence points to significant risk of sexual violence affecting both girls and boys across many geographical and institutional settings. Married adolescent girls are vulnerable to sexual violence by partners in their homes. Children in schools are vulnerable to CSV by peers and adults. Victims seldom disclose incidents and rarely seek support. In addition, early childhood experiences of trauma were strongly associated with later perpetration of sexual violence and revictimization. Limited information is available about protective factors. This review synthesizes evidence about what is currently known about CSV in Indonesia and identifies the strengths and weaknesses of the existing research. A more robust evidence base regarding CSV is required to better inform policy and justify investment into prevention programs.

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Knowledge, Attitude, and Practices of Healthcare Professionals on COVID-19 and Risk Assessment to Prevent the Epidemic Spread: A Multicenter Cross-Sectional Study from Punjab, Pakistan

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17176395 ◽

2020 ◽

Vol 17 (17) ◽

pp. 6395 ◽

Cited By ~ 1

Author(s):

Usman Rashid Malik ◽

Naveel Atif ◽

Furqan Khurshid Hashmi ◽

Fahad Saleem ◽

Hamid Saeed ◽

...

Keyword(s):

Risk Assessment ◽

Online Survey ◽

Healthcare Professionals ◽

Assessment Tool ◽

Cross Sectional Study ◽

World Health ◽

Primary Role ◽

Cross Sectional ◽

Attitudes And Practices ◽

Novel Coronavirus

In the current outbreak of novel coronavirus (COVID-19), healthcare professionals (HCPs) have a primary role in combating the epidemic threat. HCPs are at high risk of not only contracting the infection but also spreading it unknowingly. It is of utmost importance to evaluate their knowledge, attitudes, and practices (KAP) and the ability to assess the risks associated with the outbreak. A cross-sectional online survey involving physicians, pharmacists, and nurses was conducted. A 39-itemed questionnaire based on the World Health Organization (WHO)COVID-19 risk assessment tool was shared with healthcare professionals in three purposively selected key divisions of Punjab province. Out of 500 healthcare professionals, 385 responded to the survey. The majority (70%) were aged 22–29 years; 144 (37.4%) physicians, 113 (29.4%) nurses, and 128 (33.2%) pharmacists completed the survey. Overall, 94.8% of healthcare professionals scored adequately (>14) for COVID-19-related knowledge; 97.9% displayed an optimistic attitude (>42) and 94.5% had an adequate practice score (>28). Kruskal–Wallis and Jonckheere–Terpstra tests showed significant differences (p < 0.05) in KAP and risk assessment scores among groups; physicians and nurses scored higher as compared to pharmacists. Further research and follow-up investigations on disaster management and risk assessment can help policy-makers better tackle future epidemics.

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Prevalence and factors associated with poor mental health among healthcare professionals in low- and lower-middle-income countries: a systematic review protocol

Systematic Reviews ◽

10.1186/s13643-019-1201-7 ◽

2019 ◽

Vol 8 (1) ◽

Author(s):

Julia Lohmann ◽

Denny John ◽

Aso Dzay

Keyword(s):

Mental Health ◽

Healthcare Professionals ◽

Health Workers ◽

Poor Mental Health ◽

Psychological Wellbeing ◽

Health Issues ◽

Middle Income ◽

Factors Associated ◽

Middle Income Countries ◽

Mental Health Issues

Abstract Background A healthy and productive health workforce is central to a well-functioning health system. However, health workers are at high risk of poor psychological wellbeing due to their particularly strenuous work demands. While mental health of health workers is a well-researched issue in high-income countries, research from low- and lower-middle-income countries (LLMIC) has begun to emerge only recently. The review aims to synthesize this body of research, specifically to assess the prevalence of mental health issues among health workers in LLMIC, to identify factors associated with good or poor mental health, and to highlight gaps in knowledge. Methods We will perform a systematic search of the published English and French language literature (from inception onwards) in MEDLINE, EMBASE, and PsycINFO. Eligible for inclusion are observational studies (e.g., cross-sectional, case-control, or cohort) and control arms of randomized controlled trials reporting investigations on the nature, prevalence, and factors associated with mental health or psychological wellbeing among formally trained health professionals and health associate professionals delivering health services in formal healthcare facilities in LLMIC. The primary outcomes will be burnout, depression, and general psychological wellbeing. Secondary outcomes include other specific mental health diagnoses, as well as general psychological stress, distress and/or trauma if work-related and explicitly framed as a mental health issue. Two authors will independently examine the studies against the eligibility criteria in the stages of title, abstract, and full-text study selection, as well as assess the risk of bias in included studies using standard checklists depending on study design. Disagreements will be resolved in discussion with the third author. Data will be extracted from included studies using a predefined and piloted coding framework. Given the anticipated heterogeneity of studies, we do not expect to be able to conduct meta-analysis and plan to summarize the extracted data in narrative form. The framework method will be used to organize narrative data by subthemes and explore patterns. Discussion In assessing the prevalence of mental health issues among healthcare professionals in LLMIC and identifying factors associated with positive or poor mental health, the review aims to synthesize all possible available information for policy makers and health system managers on a potentially highly important but not yet much-discussed issue and to highlight gaps in currently available knowledge. Systematic review registration International Prospective Register of Systematic Reviews PROSPERO (registration number CRD42019140036)

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Negative pressure rooms and COVID-19

Journal of Perioperative Practice ◽

10.1177/1750458920949453 ◽

2020 ◽

Vol 31 (1-2) ◽

pp. 18-23

Author(s):

Sammy Al-Benna

Keyword(s):

Negative Pressure ◽

Health Care Professionals ◽

Healthcare Professionals ◽

Clinical Care ◽

Public Health Emergency ◽

Positive Pressure ◽

Global Pandemic ◽

Operating Theatres ◽

Novel Coronavirus ◽

Surrounding Areas

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes 2019 novel coronavirus disease (COVID-19), has rapidly developed into a global pandemic and public health emergency. The transmission and virulence of this new pathogen have raised concern for how best to protect healthcare professionals while effectively providing care to the infected patient requiring surgery. Although negative pressure rooms are ideal for aerosol-generating procedures, such as intubation and extubation, most operating theatres are generally maintained at a positive pressure when compared with the surrounding areas. This article compares negative and positive pressure rooms and the advantages of a negative pressure environment in optimising clinical care and minimising the exposure of patients and health care professionals to SARS-CoV-2.

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SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR NEONATES AND INFANTS IN THE UK 2001–2010

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.48 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.43-e1

Author(s):

Dan Hawcutt ◽

Hannah Maqsood ◽

Simon Gomberg ◽

Andrew Riordan ◽

Mark Turner

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Gestational Age ◽

Spontaneous Reporting ◽

Swine Flu ◽

Yellow Card ◽

Neisseria Meningitides ◽

Spontaneous Adverse Drug Reaction ◽

The Uk ◽

Neonates And Infants

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme [YCS]) to collect ‘suspected' adverse drug reaction (ADR) data. We aim to describe the Yellow card reports received for patients aged ≤1 year for a 10 year period and assess their utility.MethodsData on all ADRs reported via the YCS in Infants aged ≤1 years from the years 2001–10 were supplied by the MHRA.ResultsIn total, 3217 suspected ADRs were reported to the YCS between 2001–10 for infants age ≤1 year (Neonates n=97, vaccinations n=2673, infant [neither neonate nor vaccine] n=477). Overall only 0.88 YC per day were received by the MHRA with a male preponderance (Male 50.3%, Female 45.7%); only 25 (0.8%) YC reports stated a gestational age for the affected infant. The medications most frequently reported as suspected of causing an ADR were Swine Flu Vaccine (neonates n=8), Neisseria meningitides (vaccinations n=693) and oseltamivir (infants n=37). Reports associated with vaccinations followed the expected trends. ADRs highlighted by regulators for neonatal and infant populations are not represented in the YCs received by the regulator.Conclusions The frequency of YCS reports for those ≤1 year is low, with less than 1 per day overall. Neonates are poorly represented, and recording of gestational age is very limited. The YCS appears to be more effective for spontaneous reporting of vaccination-related ADRs in infants than for other medications. Action is required to improve reporting of suspected ADRs that affect neonates and infants.

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Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future

Therapeutic Advances in Drug Safety ◽

10.1177/2042098620938595 ◽

2020 ◽

Vol 11 ◽

pp. 204209862093859 ◽

Cited By ~ 2

Author(s):

Muaed Alomar ◽

Ali M Tawfiq ◽

Nageeb Hassan ◽

Subish Palaian

Keyword(s):

Adverse Effects ◽

Health Professionals ◽

Healthcare Professionals ◽

Spontaneous Reporting ◽

Future Prospects ◽

Innovative Strategies ◽

Post Marketing Surveillance ◽

The Future ◽

Post Marketing ◽

Reporting Programs

Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance. Plain language summary Monitoring adverse effects of marketed medicines through reporting by healthcare professionals and its challenges and way forward Introduction: This article highlights the importance of safety monitoring of medicines after they are launched in the market, mainly through reporting by healthcare professionals. We also highlight the strengths and weaknesses, and provide an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to the topic were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. Health professionals’ awareness regarding existing programs on reporting safety of medicines is highlighted. Results: Though beneficial, reporting of adverse effects by healthcare professionals who deal with patient lacks clarity in diagnosing the adverse effects. Under-reporting and bias are the major challenges. Online software is needed to strengthen reporting by healthcare professionals. We list the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance. Conclusion: To strengthen medicine safety monitoring and reporting by healthcare professionals, more awareness among health professionals and innovative strategies are needed. Integrating the genetic data of patients can be beneficial in predicting adverse effects, therefore avoiding them and enhancing safe prescribing and dispensing by healthcare professionals.

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