Salt production and iodization practices among artisanal salt producers in selected districts within the Greater Accra and Central Regions of Ghana.

Background: This study was conducted to assess salt production and iodization practices by artisanal salt producers located at six districts across Greater Accra and Central regions. Methods: One Hundred and Sixty-Six (166) salt miners in Greater Accra and Central Regions were interviewed using a structured questionnaire and their production sites inspected for salt iodization practices. Results: The study revealed that salt iodization is not practiced among majority (69.28 %) of artisanal salt producers. They were conversant with salt iodization (93.98 %) and had fair knowledge on the health effects on consumers when iodine is absent in salt. Some of the producers attributed the nonadherence to the mandatory salt iodization to the unavailability of potassium iodate/iodide on the market. All artisanal salt producers interviewed utilise the solar evaporation method for salt production. The evaporation is done on tarpaulin/polyethylene lined pans and concrete pans. The tarpaulin/polyethylene lined pans were predominantly used in Greater Accra, and concrete pans in Central region. Conclusion: For Ghana to increase availability of iodized salt on the market and improve household consumption of iodized salt, regulatory authorities need to enforce the laws and regulations on salt iodization and also create the enabling environment for artisanal salt producer to have access to potassium iodate for production.

The role of constraints and information gaps in driving risky medicine purchasing practices in four African countries.

Substandard and falsified (SF) medical products pose a major threat to public health and socioeconomic development, particularly in low- and middle-income countries. In response, public education campaigns have been developed to alert consumers about the risks of SF medicines and provide guidance on 'safer' practices, along with other demand- and supply-side measures. However, little is currently known about the potential effectiveness of such campaigns while structural constraints to accessing quality-assured medicines persist. This paper analyses survey data on medicine purchasing practices, information and constraints from four African countries (Ghana, Nigeria, Sierra Leone and Uganda; n > 1000 per country). Using multivariate regression and structural equation modelling, we present what we believe to be the first attempt to tease apart, statistically, the effects of an information gap vs structural constraints in driving potential public exposure to SF medicines. The analysis confirms that less privileged groups (including, variously, those in rural settlements, with low levels of formal education, not in paid employment, often women and households with a disability or long-term sickness) are disproportionately potentially exposed to SF medicines; these same demographic groups also tend to have lower levels of awareness and experience greater levels of constraint. Despite the constraints, our models suggest that public health education may have an important role to play in modifying some (but not all) risky practices. Appropriately targeted public messaging can thus be a useful part of the toolbox in the fight against SF medicines, but it can only work effectively in combination with wider-reaching reforms to address higher-level vulnerabilities in pharmaceutical supply chains in Africa and expand access to quality-assured public-sector health services.

First results from the lessons learnt from the deployment of the Med Safety App for reporting adverse drug reactions in Ghana.

Background: The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new.The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted. Methods: This was a cross-sectional study with a purposive sampling technique. The study population was persons who had downloaded the Med Safety App launched in Ghana 18 months before the study. Results: Of the 350 participants, 121 provided answers to the questionnaire sent as a Google form, representing a response rate of 34.6%.Ninety-five (78.5%) of the participants were healthcare professionals, and the remaining were patients. Seventy-five (64.7%) of the participants were using the app after initial installation because they thought it had helpful features. However, only 33 (27.3%) participants used the app to report ADRs, and of these, seven (21.2%) participants indicated that they would continue to use the app because it was easier than the other means of reporting ADRs. Most of the respondents, 109 (94%), indicated that they would recommend the app to someone else. There were some differences between the reports received through the app and between the paper-based Council for International Organizations of Medical Sciences (CIOMS) 1 form and the app, which warrant further exploration. Conclusion: Most participants indicated that the app is a useful tool and easy to use, and they were satisfied with the features of the app. Given that only just under one-third of participants had used the app to report ADRs, more time and training may be required to fully evaluate the feasibility of the use of the app going forward. The findings will help improve introduction of the app in other countries.

Under-reporting of adverse drug reactions: Surveillance system evaluation in Ho Municipality of the Volta Region, Ghana.

BACKGROUND: Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018. ADR Surveillance System (ADRSS) also known as pharmacovigilance has been put in place by the Ghana Food and Drugs Authority (FDA) to collect and manage suspected ADR reports and communicate safety issues to healthcare professionals and the general public. The ADRSS in Ho Municipality was evaluated to assess the extent of reporting of ADRs and the system's attributes; determine its usefulness, and assess if the ADRSS is achieving its objectives. METHODS: We evaluated the ADRSS of the Ho Municipality from January 2015 to December 2019. Quantitative data were collected through interviews and review of records. We adapted the updated CDC guidelines to develop interview guides and a checklist for data collection. Attributes reviewed included simplicity, data quality, acceptability, representativeness, timeliness, sensitivity, predictive value positive and stability. RESULTS: We found a total of 1,237 suspected ADR during the period, of which only 36 (3%) were reported by healthcare professionals in the Ho Municipality to the National Pharmacovigilance Centre (NPC). Only 43.9% of health staff interviewed were familiar with the ADRSS and its reporting channel. Staff who could mention at least one objective of the ADRSS were 34.2%, and 12.2% knew the timelines for reporting ADR. Reports took a median time of 41 (IQR = 25, 81) days from reporter to NPC. Reports sent on time constituted 37.5%. Fully completed case forms constituted 77.1% and the predictive value positive (PVP) was 20%. About 53% of ADRs were reported for female patients. Up to 88.9% of ADRs were classified as drug related. Anti-tuberculosis agents and other antibiotics constituted (40.6%) and (18.8%) of all reports. The ADRSS was not integrated into the disease surveillance and response system of Ghana's Health Service and so was not flexible to changes. A dedicated ADR surveillance officer in regions helped with the system's stability. Data from Ghana feeds into a WHO database for global decision making. CONCLUSIONS: There was under-reporting of ADRs in the Ho Municipality from January 2015 to December 2019. The ADR surveillance system was simple, stable, acceptable, representative, had a strong PVP but was not flexible or timely. The ADRSS was found useful and partially met its objectives.

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry.

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current status of the initiative's operating model by the pharmaceutical industry users. This study examined the challenges being encountered and identified strategies that would strengthen the ECOWAS-MRH initiative moving forward. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from manufacturers who have submitted applications to the joint assessment procedure and had identified recommendations for improving the performance of the ECOWAS-MRH initiative. Results: Ten pharmaceutical manufacturer participants (innovator, generic foreign, generic local) all reported that harmonisation of registration requirements was a major benefit, allowing submission of the same dossier to multiple countries, reducing the application burden and saving time and resources. Additionally, receipt of the same list of questions from several countries enables the compilation of a single response package, resulting in shorter timelines for approvals compared to the individualised country responses. Another benefit of a harmonised registration process was the simultaneous accessibility of medicines in various markets. Key challenges included a lack of centralised submission and tracking, differences in regulatory performance of the national medical regulatory authorities, a lack of detailed information for applicants and a low motivation to use the ECOWAS-MRH route with a preference for other regulatory pathways in the ECOWAS member states. Conclusion: This study identified several approaches to increase the effectiveness of this initiative: the implementation of risk-based approaches such as use of reliance pathways; establishment of a robust information technology systems, building assessor capacity to facilitate processing and monitoring applications; and priority review of ECOWAS-MRH products.

Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities.

PURPOSE: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making practices and evaluating the overall regulatory performance from 2019 to 2021, as well as the challenges and opportunities for improvement. METHODS: The FDA Ghana representatives completed the optimising efficiencies in regulatory agencies (OpERA) questionnaire, including data identifying the milestones and overall approval times for all products registered by the FDA Ghana from 2019 to 2021. RESULTS: Of the new active substances approved from 2019 to 2021, 91% were biologicals processed by full or abridged reviews pathways. Timelines for these reviews were within authority targets but were longer compared with generics. Of generics approved from 2019 to 2021, 97% were pharmaceuticals processed by the full review pathway, with timelines within authority targets and shorter compared with new active substances. Regardless of the review model used, approval times for new active substances increased from 84 to 355 calendar days 2019-2021 due to the impact of the pandemic. Guidelines, standard operating procedures and review templates were in place and the majority of indicators for good review practices were implemented. Several quality decision-making practices were implemented, although currently there is not a systematic structured approach. CONCLUSION: The FDA Ghana monitors regulatory performance and currently meets its target timelines. To achieve World Health Organization Maturity Level 4 status, an electronic tracking system, benefit-risk assessment framework and template and the publication of assessment reports are recommended.

Evaluation of surveillance system for post market activities on pre-packaged foods in Greater Accra Region, Ghana, 2021.

Objectives: This evaluation was to assess the usefulness and attributes of the surveillance system for post market activities on pre-packaged foods in the Greater Accra Region of Ghana and also to determine if the systems objectives are being met. Methods: A descriptive cross-sectional design was used for the evaluation. Data/records on Food Market Surveillance collected between 2018 and 2020 was reviewed and key stakeholders involved in the Food Market Surveillance interviewed using a semi-structured questionnaire. Surveillance operations were also observed. Quantitative data was analyzed using descriptive summary statistics. Information gathered from interviews were put under themes. Result: Some policy decision taken were based on analysis of data from the surveillance system. The system is useful in detecting trends signaling changes on label of registered prepackage food products. The system can permit assessment of the compliance of levels of importers/manufacturers; however, such analysis was not done. The system involves single step notification and processing steps and can incorporate data from other systems. Some retailers perceived the system as a hindrance to business. Completion of notification forms takes 2-5 min and 1-5 working days to process and take regulatory action. The surveillance system had a data accuracy and completeness of 94.6% (194/205) and 94.1% (193/205) respectively with less than 0.1% (3/95) double entries. The system did not have any data validation process or team in place. Conclusion: The system was partially meeting its intended objectives and found useful despite some gaps and challenges observed. The system is simple, flexible, accepted by most of the stakeholders and covers almost the entire districts in the Greater Accra Region. We recommend that data validation process or team be instituted to ensure reliability of data generated for policy and regulatory decisions.

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries.

Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and effective medicines and vaccines by the 15 countries in the Economic Community of West African States region. Although this project has made significant progress towards the realisation of its goals, challenges still remain. The aims of this study were to evaluate the effectiveness and efficiency of the WA-MRH, examine what challenges are being encountered and identify strategies that would strengthen the process for realising the initiative's goals. Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire was used to collect data from assessors representing the seven active NMRAs in the joint assessment procedure that identified the benefits, challenges and recommendations for improving the performance of the WA-MRH project. Results: The benefits of the joint assessment procedure include time savings to manufacturers resulting from submitting one dossier and the same response package to multiple countries resulting in access to the multiple African markets within the same timeframe. Additionally, some of the NMRAs have been able to strengthen their technical capacity as a result of this initiative. Key challenges to the project include the lack of a robust information technology system that would enable dossier tracking and constraints in human resources needed to support dossier submissions and the assessment process. Conclusion: This study identified the strengths of the WA-MRH initiative as well as strategies for improvement and achievement of its objectives. The centralised submission of a dossier and its tracking is key to the regulatory assessment process. This research has demonstrated that amongst other considerations, a robust information technology system, coupled with the necessary human resource capacity would greatly enhance the effectiveness and efficiency of the WA-MRH initiative.

Needs-driven talent and competency development for the next generation of regulatory scientists in Africa.

Capacity building programmes for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gaps, reports on regulatory assessment pathways used in Ghana, South Africa and Zimbabwe and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.

Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers.

WHO convened an Advisory Group (AG) to consider the feasibility, potential value, and limitations of establishing a closely-monitored challenge model of experimental severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in healthy adult volunteers. The AG included experts in design, establishment, and performance of challenges. This report summarizes issues that render a COVID-19 model daunting to establish (the potential of SARS-CoV-2 to cause severe/fatal illness, its high transmissibility, and lack of a "rescue treatment" to prevent progression from mild/moderate to severe clinical illness) and it proffers prudent strategies for stepwise model development, challenge virus selection, guidelines for manufacturing challenge doses, and ways to contain SARS-CoV-2 and prevent transmission to household/community contacts. A COVID-19 model could demonstrate protection against virus shedding and/or illness induced by prior SARS-CoV-2 challenge or vaccination. A limitation of the model is that vaccine efficacy in experimentally challenged healthy young adults cannot per se be extrapolated to predict efficacy in elderly/high-risk adults.

Clinical characteristics, treatment regimen and duration of hospitalization among COVID-19 patients in Ghana: a retrospective cohort study.

INTRODUCTION: COVID-19 is a global pandemic seen in modern times. The clinical characteristics, treatment regimen and duration of hospitalization of COVID-19 patients remain unclear in Ghana. METHODS: we retrospectively reviewed the secondary data of 307 discharged COVID-19 patients to characterize their demographics, clinical symptoms, treatment regimen given and duration of hospitalization. RESULTS: the mean age and temperature of the patients were 37.9 years and 36.3°C, respectively. The majority (85.7%) of the cases reviewed were asymptomatic; for those presenting with symptoms, the main ones were cough (50%), fever (29.6%), headache (27.3%), and sore throat (22.7%). Comorbidities were present in 25.1% of the patients; the popularly reported comorbidities were hypertension (71.4%), asthma (7.8%) and diabetes (6.5%). The average duration of hospitalization was 13.8 days, and the duration of hospitalization for patients managed with azithromycin + chloroquine (AZ+CQ) was 10.4 days, followed closely by those managed with hydroxychloroquine (HCQ) only, 11.0 days. There was longer duration of hospitalization among patients who received AZ only compared to patients receiving AZ + CQ (3.24 ± 1.10 days, p=0.037; 95% CI 0.11, 6.37). Linear regression analysis showed that the duration of hospitalization for patients who received AZ only was 2.7 days, which was higher than that of patients who received AZ+CQ and HCQ only (95% CI 0.44, 4.93; p=0.019). CONCLUSION: in this cohort of COVID-19 patients, the common symptoms were cough, fever, headache, and sore throat. The use of AZ+CQ or HCQ only as a therapy for managing COVID-19 patients shortened the duration of hospitalization.

Scientific considerations for global drug development.

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

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. FUNDING: None declared.

Barriers to healthcare workers reporting adverse events following immunization in four regions of Ghana.

Despite didactic training on adverse events following immunization (AEFI) in Ghana, the reporting ratio of AEFI was 1.56 per 100,000 surviving infants in 2015, below the minimum reporting ratio of 10. We aimed to estimate the proportion of health care workers (HCWs) reporting AEFI and to identify barriers to reporting. We conducted a cross-sectional survey of HCWs in four regions in Ghana. A simple random sample of 176 health facilities was selected and up to two HCWs were randomly selected per facility. We used the Rao-Scott Chi-squared test to compare factors associated with reporting of AEFI in the last year. We used an open-ended question to identify reasons for low reporting. One supervisor from each facility, responsible for overall reporting and management of AEFI, was also interviewed. A total of 306 HCWs from 169 facilities were interviewed. Of these, 176 (57.5%) reported they had ever encountered an AEFI. Of the 120 who had encountered an AEFI in the last year, 66 (55.0%) indicated they had reported the AEFI, and 38 (31.7%) completed a reporting form. HCWs (n = 120) reported multiple barriers to reporting of AEFI; the most common barriers were fear of personal consequences (44.1%), lack of knowledge or training (25.2%), and not believing an AEFI was serious enough to report (22.2%). Discussion of AEFI during the last supervisory visit was significantly associated with reporting in the past year (OR 7.39; p < .001). Of 172 supervisors interviewed, 65 (37.8%) mentioned their facilties had ever encountered an AEFI; over 90% of facilities had reporting forms. We identified low reporting of AEFI and multiple barriers to reporting among HCWs in the four selected regions of Ghana. Discussing AEFI during supervisory visits with HCWs might improve reporting. Additionally, strategies to address fear of personal consequences as a barrier to reporting of AEFI are needed.

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 (§2) 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. This study 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. FUNDING: None declared.

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

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios.

BACKGROUND: Timely reporting of safety information post vaccination is pivotal for the success of any vaccination program. Reports of adverse events following immunization (AEFI) of 6 different vaccinations from Ghana were analysed for signals. METHODS: De-identified data from active surveillance for AEFIs after 2009 AH1N1 influenza, yellow fever, meningitis, measles-rubella, pneumococcal-rotavirus and human papilloma virus vaccinations were used. All vaccinations occurred between January 2010 and December 2013. The ten most occurring events for each vaccination were captured and arranged using Medical Dictionary for Regulatory Authorities (MedDRA) Preferred Term (PT) and System Organ Classification (SOC) codes. Adverse event incidence rates were calculated for each vaccine type, and signals were generated using proportional reporting ratios (PRR). RESULTS: A total number of 5,141 reports were analysed ranging from 33 (human papilloma virus) to 1958 (measles-rubella). Between 22% and 55% of all AEFIs per vaccine type were collected on the day of vaccination. For each vaccine type, at least 87% of all reported AEFIs occurred in the first 7 days post-vaccination. Multiple reports were received per vaccine type. For the MR vaccine, urticarial recorded the highest attack rate of 6.6 (95% CI 6.2, 7.1) per 100,000 vaccines. The AEFI with the highest PRR for both human papilloma and measles-rubella vaccines was abdominal pain, recording a PRR of 8.15 (95% CI 3.46, 19.23) and 43.75 (95% CI 17.81, 107.45) respectively. CONCLUSION: These results underscore the competency of public health systems in sub-Saharan African countries (like Ghana) to identify most frequently occurring and important vaccine related safety issues.

Patients' Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana.

INTRODUCTION: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. OBJECTIVE: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. METHODS: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. RESULTS: Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting. CONCLUSION: Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.

Adverse drug reactions in Ghanaian children: review of reports from 2000 to 2012 in VigiBase.

OBJECTIVE: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana. METHODS: Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs. RESULTS: A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases. CONCLUSIONS: Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports.

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