Ther Adv Drug Saf

Background: Our aim in this study was to evaluate the effect of a combined educational intervention and year-long monthly text message reinforcements via the Short Messaging System (SMS) on the knowledge, attitude and practice (KAP) of healthcare professionals (HCPs) towards pharmacovigilance. Methods: Six randomly selected teaching hospitals in the South-South zone of Nigeria were randomized in 1:1 ratio into intervention and control groups. The educational intervention consisted of delivering a seminar followed by sending monthly texts message reinforcements via SMS over 12 months. Then a semi-structured questionnaire regarding the KAP of pharmacovigilance was completed by HCPs working in the hospitals after the intervention. Data was analysed descriptively and inferentially. Results: A total of 931 HCPs participated in the post intervention study (596 in the intervention and 335 in the control). The M:F ratio was 1:1.5. According to the KAP questionnaire, a significant difference was observed between the intervention and control groups, regarding knowledge of the types of adverse drug reactions (ADRs). ADR resulting from pharmacological action of the drug (85.6% versus 77%, p = 0.001), the fact that ADRs can persist for a long time; (60.1% versus 53.4%, p = 0.024) and a higher awareness of the ADR reporting form (48.7% versus 18.8%, p < 0.001). Most respondents in the intervention group (68.5% versus 60.6%, p = 0.001) believed they should report ADRs even if they were unsure an ADR has occurred, a greater proportion of HCPs from the intervention group had significantly observed an ADR (82% versus 73.4%, p = 0.001). Furthermore, of the 188 who had ever reported an ADR, 41% from the intervention group used the national ADR reporting form compared with 19.8% from the controls (p < 0.001). Conclusion: This educational intervention and the use of SMS as a reinforcement tool appeared to have positively impacted on the knowledge and practice of pharmacovigilance in South-South Nigeria with a less-than-impressive change in attitude. Continuous medical education may be required to effect long-lasting changes

Global overview of the management of acute cholecystitis during the COVID-19 pandemic (CHOLECOVID study)

Background: This study provides a global overview of the management of patients with acute cholecystitis during the initial phase of the COVID-19 pandemic. Methods: CHOLECOVID is an international, multicentre, observational comparative study of patients admitted to hospital with acute cholecystitis during the COVID-19 pandemic. Data on management were collected for a 2-month study interval coincident with the WHO declaration of the SARS-CoV-2 pandemic and compared with an equivalent pre-pandemic time interval. Mediation analysis examined the influence of SARS-COV-2 infection on 30-day mortality. Results: This study collected data on 9783 patients with acute cholecystitis admitted to 247 hospitals across the world. The pandemic was associated with reduced availability of surgical workforce and operating facilities globally, a significant shift to worse severity of disease, and increased use of conservative management. There was a reduction (both absolute and proportionate) in the number of patients undergoing cholecystectomy from 3095 patients (56.2 per cent) pre-pandemic to 1998 patients (46.2 per cent) during the pandemic but there was no difference in 30-day all-cause mortality after cholecystectomy comparing the pre-pandemic interval with the pandemic (13 patients (0.4 per cent) pre-pandemic to 13 patients (0.6 per cent) pandemic; P = 0.355). In mediation analysis, an admission with acute cholecystitis during the pandemic was associated with a non-significant increased risk of death (OR 1.29, 95 per cent c.i. 0.93 to 1.79, P = 0.121). Conclusion: CHOLECOVID provides a unique overview of the treatment of patients with cholecystitis across the globe during the first months of the SARS-CoV-2 pandemic. The study highlights the need for system resilience in retention of elective surgical activity. Cholecystectomy was associated with a low risk of mortality and deferral of treatment results in an increase in avoidable morbidity that represents the non-COVID cost of this pandemic

Impact of an Educational Intervention on Adverse Drug Reaction reporting in Tertiary Hospitals in South-South Nigeria

BACKGROUND: Nigeria is yet to achieve the internationally recommended number of Adverse Drug Reactions (ADRs) reports. OBJECTIVE: This study evaluated the impact of an educational lecture followed by repeated text messages via the Short Messaging System (SMS) on ADR reporting. METHODS: Six teaching hospitals in the South-South zone of Nigeria were randomized in 1:1 ratio into intervention and non-intervention hospitals. The intervention hospitals received an educational lecture followed by monthly SMS reinforcements over 12 months. The number and quality of ADR reports from the local pharmacovigilance centers of each teaching hospital over the 12 months before and after the intervention were described. RESULTS: A total of 4912 healthcare professionals were working in the 6 hospitals at the time of the study (3099 in the intervention and 1813 in the control) and the educational intervention was conducted between January and March 2016. In the intervention hospitals, the number of ADR reports increased from 57 in the pre-intervention period (from January 1st 2015) to 75 in the post- intervention period. However, the proportion of serious ADRs decreased slightly from 26(45.6%) to 33(44%). Post-intervention, the report of suspected drug details in the ADR report form also improved. CONCLUSION: There was a trend to increased absolute number and quality of reports following educational intervention and SMS reminders

Drug-related events in an emergency department of a tertiary health care facility in South- South Nigeria

Background: Drug-related adverse events refer to any injury from a medical intervention relating to a drug. This study identified suspected drug-related events presenting to the accident and emergency (A&amp;E) unit of a teaching hospital. Methods: The adult admission registers of the A&amp;E unit of the University of Benin Teaching Hospital, Benin-City, Nigeria were retrospectively reviewed over a four-year period (January 2015 –December 2018). Patients with diagnosis that may indicate a drug-related event were included in the study. Results: A total of 24510 new patients were seen over the 4- year period, with 648(2.6%) presenting with a drug-related event (DRE). There were 353 (54.5%) males, and the mean age (SD) was 48.9(20.4) years. Main DRE identified were adverse drug reactions (n=465, 71.8%) and of these, Non-steroidal antiinflammatory drugs (NSAIDs)-induced upper gastrointestinal bleeding (n=145, 31.2%), drug-induced hypoglycaemia (n=79, 21.5%), herbal medicines related events(n=27, 4.2%), were the commonest. Other DREs were substance abuse/misuse (n=105, 16.2 %), causing substance (notably cannabis) - induced mental and behavioural disorders (n=60, 9.3%), andlastly poisoning (n=78, 12%) which were mostly intentional poisoning (notably organophosphates) (n=43, 6.6%). Conclusions: Drug-related events constitute a significant burden on the emergency system. Upper gastrointestinal bleeding following use of NSAIDs, drug induced hypoglycaemia, organophosphate poisoning were found to be notable life threatening causes of emergency admissions. require multifaceted public health interventional strategies to mitigate the burden. Keywords: drug-related medical emergencies; adverse drug reactions; poisoning; anti-inflammatory agents non-steroidal; Nigeri

Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries

Background: An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. Objectives: The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa. Methods/processes: The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out. Results: The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions. Conclusion: In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa

Statement of Commitments from Humanitarian Scholars at World Humanitarian Summit

In the wake of the World Humanitarian Summit (WHS), held in Istanbul on 22 and 23 May, researchers have signed and endorsed the Statement of Commitments from Humanitarian Scholars at World Humanitarian Summit. The statement is the main scholarly outcome of the WHS and has been drafted by experts in the humanitarian field and the International Humanitarian Studies Association (IHSA). Aiming at giving a positive turn to humanitarian scholarship, the statement has signaled that the Summit will contribute to spur all kinds of research activities, explore mechanisms to effectively communicate and collaborate around the unfolding humanitarian research agenda, as well as following up on the core responsibilities of the WHS agenda. The statement has also provided a normative frame that can underpin and inspire numerous initiatives focusing on the commitments, with regards to advancing evidence-based approaches; localising research and education; promoting transdisciplinary work; and developing and upholding of research ethics. Given the vast possibilities and the large community of scholars that work on these issues within their own programmes and networks, the statement aspires to enhance the communication and exchange about this

Global overview of the management of acute cholecystitis during the COVID-19 pandemic (CHOLECOVID study)

Background: This study provides a global overview of the management of patients with acute cholecystitis during the initial phase of the COVID-19 pandemic. Methods: CHOLECOVID is an international, multicentre, observational comparative study of patients admitted to hospital with acute cholecystitis during the COVID-19 pandemic. Data on management were collected for a 2-month study interval coincident with the WHO declaration of the SARS-CoV-2 pandemic and compared with an equivalent pre-pandemic time interval. Mediation analysis examined the influence of SARS-COV-2 infection on 30-day mortality. Results: This study collected data on 9783 patients with acute cholecystitis admitted to 247 hospitals across the world. The pandemic was associated with reduced availability of surgical workforce and operating facilities globally, a significant shift to worse severity of disease, and increased use of conservative management. There was a reduction (both absolute and proportionate) in the number of patients undergoing cholecystectomy from 3095 patients (56.2 per cent) pre-pandemic to 1998 patients (46.2 per cent) during the pandemic but there was no difference in 30-day all-cause mortality after cholecystectomy comparing the pre-pandemic interval with the pandemic (13 patients (0.4 per cent) pre-pandemic to 13 patients (0.6 per cent) pandemic; P = 0.355). In mediation analysis, an admission with acute cholecystitis during the pandemic was associated with a non-significant increased risk of death (OR 1.29, 95 per cent c.i. 0.93 to 1.79, P = 0.121). Conclusion: CHOLECOVID provides a unique overview of the treatment of patients with cholecystitis across the globe during the first months of the SARS-CoV-2 pandemic. The study highlights the need for system resilience in retention of elective surgical activity. Cholecystectomy was associated with a low risk of mortality and deferral of treatment results in an increase in avoidable morbidity that represents the non-COVID cost of this pandemic