Ghana Case Study  A From Vertical Activity to Nationwide System Ghana’s Pharmacovigilance Experience Huihui Wang Delese Mimi Darko Albert Figueras Patricio V. Marquez James K. Kumwenda Korea–World Bank Partnership Facility China–World Bank Partnership Facility B Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System © 2022 International Bank for Reconstruction and Development / The World Bank 1818 H Street NW Washington DC 20433 Telephone: 202-473-1000 Internet: www.worldbank.org This work is a product of the staff of The World Bank with external contributions. The findings, interpretations, and conclusions expressed in this work do not necessarily reflect the views of The World Bank, its Board of Executive Directors, or the governments they represent. 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From Vertical Program Activity to Nationwide System Ghana’s Pharmacovigilance Experience ii Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Table of Contents Acknowledgements.............................................................................................................. iv Reports in the Pharmacovigilance and Essential Public Health Services Series........................................................................... v Abbreviations and Acronyms............................................................................................ vi Introduction...............................................................................................................................2 Ghana’s Health System: Organizational Structure and Governance......................3 Ministry of Health........................................................................................................................................3 Ghana Health Service.................................................................................................................................3 Health Sector Funding................................................................................................................................3 Origins of FDA Ghana.................................................................................................................................4 Legislative mandate of FDA Ghana....................................................................................7 Mission...............................................................................................................................................................7 Provisions on Drugs, Herbal Medicinal Products, Cosmetics, and Medical Devices..........................................................................................................8 Funding of the FDA Ghana and for PV.............................................................................. 9 Reporting in the Ghana PV System..................................................................................10 Addressing Underreporting................................................................................................................... 12 Toward the Digitalization of Reporting........................................................................................... 13 Pharmacovigilance in Public Health Programs........................................................... 14 COVID-19 Vaccine Surveillance: Organization and Challenges.............................. 15 The Value of Safety Monitoring during a Pandemic and in Normal Times..................15 Response to COVID-19 Vaccination Rollout.................................................................................. 16 The Safety Monitoring Potential of FDA Ghana............................................................ 17 Opportunities to Improve PV in Ghana.......................................................................................... 18 Potential Areas of International Support....................................................................................... 18 Lessons Learned.....................................................................................................................19 References...............................................................................................................................20 Table of Contents iii Box Box 1  Description of the Safety Monitoring of Medicines and Medicinal Products, Ghana.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....................................................... 8 Figures Figure 1  FDA Ghana Revenue and Expenditure Performance, 2020–2022........... 9 Figure 2  Ghana Pharmacovigilance System........................................................................11 Figure 3  Individual Case Safety Reports, by Number and Year, 2016–22. . ........... 12 Figure 4  Share of AEFIs Reported by 306 Health Care Workers Surveyed.............. 14 Map Map 1  Pharmacovigilance in African Countries................................................................. 6 Tables Table 1  Development Milestones: The Pharmacovigilance System, Ghana............ 5 Table 2  Funding for Pharmacovigilance in Ghana from 2018–2022......................... 10 iv Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Acknowledgements This report was prepared by a team led by Huihui Wang (Senior Health Economist, Health, Nutrition, and Population Global Unit, World Bank), including Delese Mimi Darko, CEO, Food and Drugs Authority (FDA), Ghana; Albert Figueras (Consultant, World Bank); Patricio V. Marquez (Consultant, World Bank); and James K. Kumwenda (Consultant, World Bank). Kseniya Bieliaieva (ET Consultant, World Bank) supported the work of the team. Information and data for this report were also drawn from a 2023 background technical note “Infectious Disease Surveillance, Prevention, and Control Capacity: Ghana Case Study” commissioned to Erasmus Emmanuel Akurugu Agongo and Prince Asumadu Adu (Consultants, World Bank). The authors would like to thank George Tsey Sabblah (Head, Safety Monitoring Department, FDA Ghana), Adela Ashie (Head, Vigilance Unit, FDA Ghana), and Abena Asamoa-Amoakohene (Head; Risk Management Unit, FDA Ghana) for their review, comments, and contributions. Robert Zimmermann (Consultant, WBG) kindly reviewed and edited the draft report. Juan Pablo Uribe, Global Director, Health, Nutrition, and Population, World Bank, and Director, Global Financing Facility (GFF), and Monique Vledder, Practice Manager, HHNGE, World Bank, provided strategic guidance during the preparation of the reports on pharmacovigilance and essential public health services that form this collection. Design and layout for the report was created by Spaeth Hill. The preparation of this report was carried out with the support provided by the Korea-World Bank Partnership Trust Fund (KWPF) and the China–World Bank Partnership Facility (CWPF). Washington, DC, September 15, 2023 Reports in the Pharmacovigilance and Essential Public Health Services Series v Reports in the Pharmacovigilance and Essential Public Health Services Series Global Synthesis Report on Pharmacovigilance: Why is the Safety of Medicines Important for Resilient Health Systems? Positioning Report on Pharmacovigilance: The Value of Pharmacovigilance in Building Resilient Health Systems Post-COVID Pharmacovigilance Situation Analysis Report: Safety Monitoring of Medicines and Vaccines Regional Realizing a Regional Approach to Pharmacovigilance: A Review of the European Union Approach The Caribbean Regulatory System: A Subregional Approach for Efficient Medicine Registration and Vigilance Financing of Essential Public Health Services in the Caribbean Region Country Scope Learning from the Republic of Korea: Building Health System Resilience Learning from Best Practices: An Overview of the Republic of Korea Pharmacovigilance System Pharmacovigilance in Brazil: Creating an Effective System in a Diverse Country Starting and Strengthening a National Pharmacovigilance System: The Case of Catalan Regional Activities that Propelled the Spanish Pharmacovigilance System Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System vi Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Abbreviations and Acronyms ADR Adverse drug reaction AEFI Adverse event following immunization FDA Food and Drugs Authority GHS Ghana Health Service MOH Ministry of Health PV Pharmacovigilance WHO World Health Organization PIDM Program for International Drug Monitoring (WHO) 1 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Abstract Establishing and consolidating a pharmacovigilance (PV) system in a country requires political opportunity, the involvement of well- trained health professionals, and the activity of engaged individuals who submit the reports. However, the initial spark is produced according to the characteristics of the country, the interests of mindful professionals, and awareness of the opportunity. This case study analyzes the evolution of this process in Ghana. This experience shows that one way to promote the development of PV capacity in a country is to take advantage of public health programs that are centered on the administration and use of vaccines and medicines for disease control, such as the immunization program or the TB, HIV, or malaria programs. In Ghana, the routine reporting on adverse events began with the monitoring of adverse effects following immunization (AEFIs) under the Expanded Program on Immunization, that was launched in 1978. Similar efforts followed under other public health programs for disease control, such as the National Malaria Eradication Program, the National Tuberculosis Control Program, the National AIDS Control Program, and the Neglected Tropical Diseases Control Program. The experience generated under these disease control programs served to expand the reporting of adverse drug reactions from other medicines after the establishment of and development of a mature medicine regulatory authority—the Food and Drugs Authority (FDA), Ghana—and a solid PV system that, in 2001, became part of the World Health Organization (WHO) Program for International Drug Monitoring (PIDM). Ghana was among the early adopter countries in Africa, and the lessons from its experience are relevant to other low- and middle-income countries for developing PV as a core public health function in the health system. Introduction 2 Safe and effective medicines, vaccines, and medical devices are a key component of health care systems Introduction efficacy of human and veterinary medicines, food, biological products, cosmetics, medical devices, household chemical substances, clinical trials, and the control of tobacco products through the enforce- ment of relevant standards to protect public health.1 The objective of this report is to examine the development of pharmacovigilance (PV) in Ghana, Safe and effective medicines, vaccines, and medical and illustrate the role it plays in the health system, devices are a key component of health care systems, and more recently, during the COVID-19 emergency and their regulation is a core public health function response. It concludes by offering some relevant (Nwokike and Eghan 2010; Owusu-Asante et al. 2023). lessons for building PV capacity in other low-and In Ghana, the Food and Drugs Authority (FDA) is the middle-income countries. agency mandated to ensure the safety, quality, and 1   ee Corporate Profile (web page), Food and Drugs Authority, Accra, S Ghana, https://fdaghana.gov.gh/about-us.php. 3 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Ghana’s Ghana Health Service Health System: The Ghana Health Service (GHS) is an MOH public service agency outside the civil service. The GHS Organizational governing council is mandated by Act 525 to imple- ment approved national policies on health service Structure and delivery in the country, expand access to improved health services, and manage resources. The GHS is Governance the lead service delivery agency in the Secretariat of the Cabinet in the Office of the President. It handles about 60 percent of health service delivery. It supervised a health workforce of 68,132 in 2020 (Awoonor-Williams 2020). The GHS sets technical guidelines, establishes effective mechanisms for the Secretariat of the Cabinet, and collaborates with other recognized health care providers.2 The GHS has 11 divisions and operates at five Ministry of Health levels: community, subdistrict, district, region, and The Ministry of Health (MOH) is responsible for nationwide. Under a director-general and a deputy providing policy direction, resource mobilization, and director-general, these divisions are organized into overall stewardship of the health sector, including programs, units, and departments. The 16 regional infectious disease surveillance, prevention and and 260 district health directorates are the subna- control, decision-making, coordination of health-­ tional structures of the GHS that are responsible for related programs, and monitoring progress of the planning and coordinating the delivery of compre- health sector in achieving national goals. Ultimately, hensive primary and secondary health services in policy making resides with the executive presidential their respective jurisdictions in collaboration with system through the submission of a cabinet other service providers and stakeholders. memorandum for approval. If legislation is required, the cabinet approval memorandum is drafted into a bill with the assistance of the Attorney-General’s Health Sector Funding Department and submitted for parliamentary The health sector in Ghana is financed by public deliberation and passage. The bill becomes law if the funds (government revenues), private funds from president gives assent. companies and from households through prepaid In policy implementation, the MOH mobilizes and voluntary premiums and out-of-pocket payments, allocates resources and oversees the agencies under and international funds from donors and develop- its umbrella in the discharge of their respective core ment partners.3 Government revenues are subdivided mandates (MOH 2021). The MOH also collaborates into general revenue for the health budget, targeted with other ministries, departments, and agencies, revenues for the National Health Insurance Scheme, development partners, private sector institutions and local government revenue.4 The National Health and organizations, and nongovernmental and civil Insurance Authority under the MOH manages the society organizations in the discharge of its functions through common management arrangement 2  S  ee Ghana Health Service (web page), Ministry of Health, Accra, structures, such as the Inter-Agency Leadership Ghana, https://www.moh.gov.gh/ghana-health-service/. Committee, the Health Sector Working Group, 3   020 Budget Estimates of Ministry of Health (dashboard), Ministry 2 business meetings, and annual health summits of Finance, Accra, Ghana, https://mofep.gov.gh/publications/budget- (MOH 2014). estimates/moh/2020. 4   rief Introduction to the NHIS (web page), National Health B Insurance Authority, Accra, Ghana, https://www.nhis.gov.gh/about. Ghana’s Health System: Organizational Structure and Governance 4 National Health Insurance Fund, which relies on on a scale of 1 to 4.6 Level 3 represents the minimum six main sources of funding to operate the health target for most regulatory authorities: a stable, insurance scheme: well-functioning, and integrated regulatory system. Level 4 exceeds this required standard and represents • The national health insurance levy, which largely a regulatory system operating at an advanced level funds the scheme, is a 2.5 percent levy on goods of performance and continuous improvement and services collected under the value added tax (Khadem Broojerdi et al. 2020). • A 2.5 percent social security deduction among formal sector workers managed by the Social The FDA serves as the National Pharmacovigilance Security and National Insurance Trust Center and coordinates pharmacovigilance activities • Premiums and contributions paid by scheme in Ghana. It is also the repository of adverse reaction subscribers reports from patients, health care professionals, and • Annual government budgetary allocations the pharmaceutical industry.7 Table 1 lists the key ­ proposed and approved by Parliament for the milestones in the development of the pharmacovigi- health insurance fund lance system in Ghana. • Accruals from National Health Insurance Council The WHO Program for International Drug Monitoring investments of surplus funds in the health (PIDM) is a global collaboration that seeks to ensure ­insurance fund the timely detection of safety issues in medicinal • Grants, gifts, and donations for the health products. The Safety Monitoring Department of FDA ­insurance fund Ghana, which hosts the National Pharmacovigilance Center, joined the WHO-PIDM in November 2001, the 65th member of the program. Membership by Origins of FDA Ghana African countries may be classified by year according FDA Ghana is an agency under the MOH with an to four waves (Map 1). South Africa and Morocco eleven member Governing Board inclusive of the (1992) and Tanzania and Tunisia (1993) were the Chief Executive Officer who is responsible for its day innovators, while Zimbabwe (1998) and Ghana (2001) to day administration. started the second wave of early adopters, together FDA Ghana was initially established as the Food with Egypt (2001), Nigeria (2004), and Mozambique and Drugs Board in 1997 by the Food and Drugs (2005). Most countries joined WHO-PIDM during the Act of 1992, as amended by the Food and Drugs third early majority wave between 2006 and 2010. Act of 1996. The food and drugs legislation was Ghana, however, was the first West African country to revised in 2012 and integrated into the new Public undertake PV activities. Public health programs, such Health ACT, 2012 (Act 851), which created the FDA as the immunization program and the malaria, HIV, (Assembly Press 2012).5 and tuberculosis programs, contributed to instituting and scaling up pharmacovigilance. In West Africa, FDA Ghana is considered a pioneer among national medicines regulatory authorities. Ghana has been actively involved in various PV It is respected because of its regulatory standing. activities during these two decades. It is a dynamic It was adjudged maturity level 4 Regulatory Function partner in the WHO-PIDM and a PV model in western through the World Health Organization (WHO) 6   o ensure structural consistency across regulatory functions and T global benchmarking tool in 2020 (Owusu-Asante to assist benchmarking on one or more specific themes across et al. 2023). The tool is used to assess the maturity of the functions, the tool indicators are classed into nine categories: (a) legal provisions, regulations, and guidelines; (b) organization national regulatory authorities by classifying them and governance; (c) policy and strategic planning; (d) leadership and crisis management; (e) transparency, accountability, and communication; (f) quality and risk management system; (g) regulatory process; (h) resources (human, financial, infrastructure, equipment, and information management system), 5  S  ee Corporate Profile (web page), Food and Drugs Authority, and (i) progress monitoring and impact assessment. Accra, Ghana, https://fdaghana.gov.gh/about-us.php; Food and Drugs Authority (web page), Ministry of Health, Accra, Ghana, 7  C  onsumer Reporting Form (web page), Food and Drugs Authority, https://www.moh.gov.gh/foods-and-drug-authority/. Accra, Ghana, http://adr.fdaghana.gov.gh/patient.php. 5 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Sub-Saharan Africa. Additionally, to strengthen PV in the safety surveillance of priority medicinal products Ghana, Ghana also collaborates with and is mentored across the African continent through efficiencies, by other international organizations, such as the such as technological innovation, resource pooling, UK Medicines and Healthcare Products Regulatory and work sharing. Agency and the Netherlands Pharmacovigilance Research results of the PV system in Ghana have Center, in addition to the WHO and the WHO-PIDM. been shared with colleagues at the interna- Ghana is also one of the five countries piloting the tional level, such as at International Society of African Union Smart Safety Surveillance Program. Pharmacovigilance meetings and publications in This program is funded by the Bill and Melinda Gates peer-reviewed journals. Foundation and has a long-term goal to strengthen Table 1  Development Milestones: The Pharmacovigilance System, Ghana 1999 Formal collation of individual case safety reports 2001 Ghana joined the WHO Program for International Drug Monitoring (PIDM) First collaboration with the Expanded Program on Immunization pentavalent vaccine introduction 2005 Formation of the technical advisory committee on safety of medicines 2012 The Food and Drugs Law was revised and renamed the Food and Drugs Act; provisions for pharmacovigilance are now included 2013 New guidelines developed to align with the new act First edition of the drug safety newsletter (DrugLens Newsletter) 2015 First training of qualified persons for pharmacovigilance Designation as regional center of regulatory excellence for pharmacovigilance 2016 Launch of direct patient reporting Formation of the technical advisory committee on safety of vaccines and biological products to focus on the review of safety information from vaccines and biological products 2019 Launch of the MedSafety App 2020 Attainment of WHO maturity level 4 Ghana’s Health System: Organizational Structure and Governance 6 Map 1  Pharmacovigilance in African Countries TUNISIA MOROCCO ALGERIA ARAB REP. LIBYA OF EGYPT CABO MAURITANIA VERDE MALI NIGER ERITREA SENEGAL CHAD SUDAN THE GAMBIA BURKINA FASO GUINEA GUINEA NIGERIA BISSAU CÔTE BENIN CENTRAL SOUTH ETHIOPIA SIERRA D’IVOIRE AFRICAN REP. SUDAN LEONE LIBERIA SOMALIA GHANA CAMEROON TOGO UGANDA EQUATORIAL GUINEA REP. OF RWANDA KENYA CONGO SÃO TOMÉ DEM. REP. AND PRÍNCIPE OF CONGO BURUNDI SEYCHELLES PIDM African GABON TANZANIA Full Member Countries COMOROS ANGOLA Innovators 1992–1993 MALAWI ZAMBIA MAURITIUS Early Adopters 1998–2005 MOZAMBIQUE ZIMBABWE MADAGASCAR Early Majority 2006–2010 NAMIBIA BOTSWANA Late Majority 2011–2023 ESWATINI Associate Members SOUTH AFRICA LESOTHO Not PIDM Members Sources: Adapted from Africa (dashboard), MapChart, mapchart.net, https://www.mapchart.net/africa.html; WHO PIDM (Programme for International Drug Monitoring), Uppsala Monitoring Center, Uppsala, Sweden, https://who-umc.org/ about-the-who-programme-for-international-drug-monitoring/. 7 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Legislative mandate the Center for Import and Export Control, and the Center for Laboratory Services and Research. of FDA Ghana FDA Ghana is structured in four divisions, as follows:8 • Food • Health Products and Technologies • Technical Operations • Corporate Services The Center for Laboratory Services and Research manages six testing laboratories and a quality assurance unit that is responsible for the quality man- ­ Mission agement system of the center. The six laboratories Public Health Act, 2012 (Act 851) provides a legal basis are specialized in (1) drug physicochemical properties, for preventing, promoting, safeguarding, maintaining, (2) food physicochemical properties, (3) pharmaceuti- and protecting human and animal health and allied cal microbiology, (4) food microbiology, (5) cosmetics matters in Ghana (Assembly Press 2012). Public and household chemical substances, and (6) medical Health Act, Part 7, Section 81 defines the mission of devices. The laboratories hold accreditation according the FDA. According to Section 82, the functions of the to the International Organization for Standardization– authority are as follows: International Electrotechnical Commission ISO/IEC • Ensure adequate and effective standards for food, 17025:2017 standard. The quality assurance unit is medicines, cosmetics, household chemicals, and accredited by both the ISO/IEC 17025:2017 standard medical devices and the WHO good practices for pharmaceutical • Through district assemblies and any other public quality control laboratories. agency, monitor compliance with the provisions of The FDA is assisted by five technical advisory com- Parts 6, 7, and 8 of the Public Health Act mittees made up of experts with diverse scientific • Advise the minister on measures for the protection backgrounds. The technical advisory committees of the health of consumers cover (1) the safety of medicines, (2) the safety of • Advise the minister on the preparation of effective vaccines and biological products, (3) medical devices, regulations for the implementation of Parts 6, 7, and (4) clinical trials, and (5) nutrition. The FDA also 8 of the Public Health Act sets up ad hoc technical advisory committees for • Approve the launch and implementation of clinical specific purposes as needed, for instance, the joint trials in the country malaria vaccine committee and the joint COVID-19 • Perform any other functions that are ancillary to vaccine safety review committee. These committees attaining the objectives of the authority are responsible for reviewing safety data from the Section 83 of the Public Health Act provides for the Malaria Vaccine Implementation Program and establishment of the Governing Board with the COVID-19 vaccines, respectively. responsibility of ensuring the effective realization of The role of the FDA in the fight against infectious the functions of the FDA. The FDA Governing Board diseases is enshrined in Public Health Act, 2012, Part 7. currently has 10 members. FDA Ghana is headed The divisions, laboratories, and technical advisory by a chief executive officer, who reports directly to committees apply separate approaches in the fight the Governing Board and takes responsibility for against infectious diseases, including ensuring daily operational management, service delivery, and the safety, efficacy, and quality of medicines, food, strategic issues. herbal medicinal products, vaccines, and other The office of the chief executive officer consists medical products through testing, regulation, and of departments on internal audit, finance, business development, international partnerships, 8   ee Corporate Profile (web page), Food and Drugs Authority, Accra, S Ghana, https://fdaghana.gov.gh/about-us.php. Legislative mandate of FDA Ghana 8 standard setting. After approval for the manufacture the African region. The FDA has a critical part in and use of a product, the FDA conducts market COVID-19 vaccine production in Ghana and in other surveillance and pharmacovigilance activities African countries, such as Rwanda (RBC 2022). continuously to ensure that product quality and The FDA has established risk communication safety are maintained. The FDA is also mandated to arrangements to guide communication to avert crisis authorize the launch and implementation of clinical escalation in case of adverse drug events based trials, examine the efficacy of vaccines and drugs on country safety data and data of collaborating in the context of infectious disease control and agencies. prevention, and evaluate adverse events following immunization (AEFIs) (Assembly Press 2012). It issues clinical trial certificates to researchers, monitors clinical trials, and may stop a trial if the trial infringes Provisions on Drugs, Herbal on the trial subjects or public safety or if it does not Medicinal Products, Cosmetics, meet required standards. and Medical Devices The functions of the clinical trial technical advisory Public Health Act, 2012 includes provisions on drugs, committee include providing the FDA with the herbal remedies, medicinal products, cosmetics, and technical support required to conduct investigations medical devices. It defines standards, what con- to authenticate the safety, efficacy, purity, and quality stitutes misleading consumers, who can sell these of drugs, herbal medicinal products, and medical substances and products, advertisement, and the devices. The FDA currently has at least 86 national control of manufacturing processes. It also describes and 2 international collaborators, including the Food applications, the registration process, conditions and Agriculture Organization of the United Nations, for the cancellation of the registration, and import the US Food and Drug Administration, and the WHO. restrictions. Section 125 covers drug safety monitoring It therefore plays a key role in quality laboratory (Box 1). These activities are the responsibility of the testing and assurance not only in Ghana, but in Safety Monitoring Department. Box 1 Description of the Safety Monitoring of Medicines and Medicinal Products, Ghana • A local representative for a regulated product shall be appointed by the relevant body. • The local representative – Shall monitor the safety of the product granted marketing approval – Shall report an adverse effect or event to the authority during the period during which the product is registered • The authority shall continually monitor the safety of the products regulated under this act through analysis of adverse effects or event reports and any other means and take appropriate regulatory action if necessary Source: Assembly Press 2012. 9 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Funding of the FDA manufacturing practice audit and licensing of manufacturing facilities, clinical trial authorization Ghana and for PV and monitoring, and laboratory testing services. In terms of medicines, application fees are charged based on the type of marketing authori- zation application for new active substance and generic medicines. As shown in Figure 1, FDA Ghana exceeded its revenue target by 13 percent in 2022 and increased As stipulated in Public Health Act, 2012 (Act 851), revenue collection by 30 percent compared the funds of the FDA Ghana include: with 2021 figures. The total revenue generated in • moneys approved by Parliament, 2022 amounted to 141.3 million Ghanaian Cedis • donations, gifts and grants, (USD 12. Million).9 However, the institution exceeded • loans contracted and guaranteed by the its expenditure by 12 percent and performed Government of Ghana (GoG), subject to article 181 126 ­percent over 2021 expenditure figures due to the of the Constitution, and general increase in the prices of goods and services, • any other moneys that are approved by the Minister increase in exchange rates and upward review of of Finance contracts (FDA 2022). FDA Ghana is mandated to retain a percentage The funding for PV is obtained from GoG/Internal of money that accrues to the Authority in the Generated Funds and donor funding as shown in performance of its functions as provided by law. Table 2. The conservative estimated total funding for Approved fees and charges include registration PV in Ghana over the past 5 years was 17.18 million application fees, facility inspection fees, good Ghanaian Cedis (USD 1.56 million). Figure 1  FDA Ghana Revenue and Expenditure Performance, 2020–2022 30% 126% Revenue Generated Expenditure 2020 85,287,479.49 56,835,717.48 2021 108,667,195.69 52,758,521.86 2022 141,078,363.64 118,995,054.06 % Difference 30% 126% 2022 & 2021 2020 2021 2022 % Difference 2022 & 2021 Source: Adapted from FDA Financial Report (2022) 9   xchange rate: 1 USD = 11.0207 Ghanaian Cedis (Source: https:// E www.bog.gov.gh/treasury-and-the-markets/daily-interbank-fx- rates/ [Accessed 5 Sept. 2023]) Reporting in the Ghana PV System 10 Table 2  Funding for Pharmacovigilance in Ghana from 2018–2022 2018 2019 2020 2021 2022 Revenues from Government (or Internally Generated Funds) 0.95 1.47 1.54 2.32 1.91 Ghanaian Cedis, million Non-Government Revenue (Donor funds) 1.37 0.45 1.24 4.00 1.93 Ghanaian Cedis, million Total Ghanaian Cedis, million 2.32 1.92 2.78 6.32 3.87 Source: Elaboration by FDA Ghana team, September 5, 2023. Reporting in the reactions by health care professionals and patients using a mobile app.10 If a patient experiences an ADR, Ghana PV System the FDA Blue Form is filled out through institutional contact persons or any health professional at the facility and submitted to the regional offices of the Ghana FDA (Asiamah et al. 2022). FDA Ghana also collaborates with public health programs to ensure that the medicines used in these programs are safe, efficacious, and good in quality.11 At the regional Initially, PV activities in Ghana were centralized. offices, designated regional PV officers receive the Reporting occurred through a few hospitals in the submitted reports, assess the validity of the reports, Greater Accra Region. However, there has been and submit the reports to the national FDA Central significant decentralization of PV in recent years. Database (SPS 2009). Adverse drug events and reaction reports are received FDA Ghana manages an online database, Safety from 15 FDA regional offices nationwide. FDA Watch System, for registering and sharing reports regional pharmacovigilance officers are responsible on adverse drug events.12 The system is compliant for collecting the reports submitted by patients and with the International Council for Harmonisation health care professionals. There are also institutional of Technical Requirements for Pharmaceuticals contact persons in almost all health care facilities for Human Use, which aims to achieve greater who serve as links between the FDA and other health harmonization worldwide to ensure that safe, care staff in the institutions. effective, and high-quality medicines are developed Figure 2 describes the operation of the Ghana PV and registered in the most resource efficient manner. system. The reporting system for ADRs uses the FDA adverse reaction reporting form, but there are 10  S  ee What Is Regional Centres of Regulatory Excellence (RCOREs) additional forms, including the tuberculosis form and (web page), African Union Development Agency, Midrand, South the AEFI form (Amedome and Dadson 2017). In 2016, Africa, https://www.nepad.org/publication/what-regional-centres- of-regulatory-excellence-rcores. the FDA launched direct patient reporting, a program 11  S  ee Corporate Profile (web page), Food and Drugs Authority, Accra that allows patients to report adverse drug reactions Ghana, https://fdaghana.gov.gh/about-us.php. (ADRs) directly to the FDA. The Med Safety App was 12  S  WS (Safety Watch System) (log-in page), Food and Drugs launched in 2019 to encourage reporting on adverse Authority, Accra, Ghana, https://adr.fdaghana.gov.gh/. 11 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Figure 2  Ghana Pharmacovigilance System Patients + General Public Primary Reporters Doctors, Pharmacists, Nurses, etc ICPS RPOs SMD of FDA Technical Advisory FDA Safety Database (SWS) WHO Database Committee Signal Generation Possible Regulatory Action Source: Adapted from Darko 2023. The council has issued efficacy guidelines. E2B is one regulatory recommendations to the FDA. These of the PV guidelines. It deals with data elements for recommendations may encompass label updates, the transmission of individual case safety reports.13 communication with health care professionals, and In addition, spontaneous reports that are received other appropriate measures. Figure 3 shows the are sent to VigiBase, the ADR database for the WHO volume of individual case safety reports received by PIDM through an application programming interface the FDA in 2016–22. (FDA 2016). The higher number of reports received in 2021 Signal detection is typically carried out using relative to previous years was primarily attributed qualitative and quantitative methods. The FDA ­ to the influx of adverse event reports following the receives assistance from the UK Medicines deployment of COVID-19 vaccines. and Healthcare Products Regulatory Agency in quantitative signal detection. Potential signals While patients and health professionals report detected are presented to the relevant technical ADRs voluntarily, reporting is compulsory for advisory committee for review and confirmation. ­ manufacturers. Pharmaceutical companies report If a signal is confirmed, the committee provides ADRs associated with their products to FDA Ghana through qualified persons for pharma- covigilance, trained individuals responsible for 13   ee E2B(R3) Individual Case Safety Report (ICSR) Specification and S ­ monitoring the safety of all medicinal products Related Files (dashboard), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, granted authorization for marketing in Ghana Geneva, https://www.ich.org/page/e2br3-individual-case-safety- (Asiamah et al. 2022). report-icsr-specification-and-related-files. Reporting in the Ghana PV System 12 Figure 3  Individual Case Safety Reports, by Number and Year, 2016–22 10,214 3,729 3,663 3,366 2,963 2,821 1,607 0 2016 2017 2018 2019 2020 2021 2022 Source: Data of FDA Ghana. Two technical advisory committees—the technical Efforts to understand why health care professionals advisory committee on safety of medicines and tech- identify ADRs, but do not report them, or do not nical advisory committee on safety of vaccines and identify ADRs are crucial for a PV system. In 2019, biological products—provide expertise to assist FDA a cross-sectional survey was conducted among Ghana in making appropriate benefit-risk assessments 306 health care workers in 176 health facilities in based on the reports received by the Authority. Ghana to understand the factors associated with reporting AEFIs (Gidudu et al. 2020). Of these, 58 percent reported that they had encountered an Addressing Underreporting AEFI; of the 42 percent who had encountered an Spontaneous ADR reporting is the most widely used AEFI in the previous year, only 55 percent indicated and cost-effective method of monitoring the safety of they had reported the AEFI (Figure 4). The most drugs. However, the method is heavily affected by the common barriers to reporting were fear of personal underreporting of ADRs by health care professionals. consequences (44.1 percent), lack of knowledge or This is also a problem in Ghana, acknowledged by percent), and not believing an AEFI training (25.2 ­ the program coordinators in the country. In 2015, the was sufficiently serious to report (22.2 percent). FDA received a total of 697 spontaneous reports. The authors conclude that discussing AEFI during The ­population of Ghana was 27.4 million at that supervisory visits with health care workers might time. The number of reports thus represented improve reporting. 24.4 reports per million inhabitants, far from the A study among doctors in Ghana that assessed WHO–Uppsala Monitoring Center recommendation ADR reporting rates, knowledge about the reporting of 200 reports per million per year (UMC 2000). In system, and attitudes to spontaneous reporting in 2017, the situation improved as the PV center received Greater Accra showed that only 27.4 percent of doc- 2,715 spontaneous ADR reports, which represented tors participating in the study had received training 90 reports per million inhabitants. And, in 2018, the on drug safety monitoring and ADR reporting. Among report volume rose again to 3,729 (121 reports per the respondents, 59.5 percent had seen a patient with million). Based on the reports received, several timely suspected ADRs in the previous year, although only safety-related regulatory decisions have been taken, 20 percent of these respondents had reported the including the withdrawal of substandard and unreg- ADR by completing the spontaneous ADR reporting istered medicines from the Ghanaian market, notices form (Sabblah et al. 2014). The most prominent sent to health care professionals, and alerts issued to reasons given by the doctors for not reporting were protect public health and safety. unavailability of the reporting form (43.1 percent) 13 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System and lack of knowledge of the reporting procedures Toward the Digitalization of (28.5 percent). Because most of the doctors who participated in the study had not previously received Reporting training on ADR reporting, the findings suggest that Computer technology, which allows multiple reporting forms should be made readily available to databases to be linked, is helping in investigating the doctors, training and refresher courses should drug safety issues. The widespread use of electronic be organized, and each report submitted by a doctor medical record databases enhances patient safety should be acknowledged and prompt feedback given through the automation of signal ADR detections, on the actions taken. thereby improving the quality of medical services. The major strategy for promoting spontaneous Besides reducing printing costs and the use of paper, reporting in Ghana has been the implementation of electronic reporting centralized on a web page allows awareness creation and training programs for health the receipt of reports without any delay, which is care professionals (FDA 2016). Since 2015, the FDA highly relevant in case of serious ADRs or clusters of has also launched initiatives to increase the ADR ADRs that suggest a possible signal. reporting rate and improve signal generation. One In 2016, FDA Ghana embarked on an initiative to initiative has involved the identification of qualified empower the public to report safety issues involving persons for pharmacovigilance who are able to regulated products to the FDA (FDA 2016). The effort ensure mandatory industry reporting. Others are the led, in 2019, to the launch of the mobile application Patient Reporting Program and the launch of the Med Safety App to enable patients, consumers, and Patient Safety Center, which has been undertaken health care professionals to report ADRs associated in collaboration with community pharmacies. There with medicines, herbal medicines, vaccines, and is also a program in collaboration with the GHS to other health products. The app adds an electronic peer review the pharmacovigilance performance platform to existing reporting tools to enable consum- of health facilities using the pharmacovigilance ers, patients, and health care professionals to report assessment tool adapted from the indicator-based safety issues concerning their medicines and other pharmacovigilance assessment tool developed health products to the FDA in real time. through the Strengthening Pharmaceutical Systems The Med Safety App has been developed with Program (SPS 2009). This is to ensure that pharma- support from the Access and Delivery Partnership, covigilance issues are promoted within these health the WEB–Recognizing Adverse Drug Reactions care facilities by measuring the PV performance Project, and the UK Medicines and Healthcare of the facilities using established indicators. The Products Regulatory Agency. It is downloadable National Pharmacovigilance Center has successfully from the App Store or Google Play Store and is a collaborated with the Nursing and Midwifery Council ­ convenient alternative to paper or online reporting of Ghana to incorporate PV into the curriculum tools (FDA 2019). The intended benefits for users among nurses and midwives in training institutions are as follows: in Ghana. The center makes presentations to students at pharmacy training schools in Ghana and • Facilitates the submission of reports on adverse is working with these institutions to make PV an reactions while offline integral part of the training curriculum. Additional • Permits the viewing or submission of updates to strategies are needed to address the fear of personal previously submitted reports consequences as a barrier to reporting AEFIs • Allows previous ADR reports submitted through the (Gidudu et al. 2020). app to be examined • Permits the immediate acknowledgment that a PV should not be seen as a job for a select few; all report has been received health care workers must be involved. Moreover, if • The associated medication watchlist may be the public comes to see their role as a stakeholder, accompanied by personalized news and alerts this can lead to improvements in reporting rates. Pharmacovigilance in Public Health Programs 14 Figure 4  Share of AEFIs Reported by 306 Health Care Workers Surveyed 100% 90% 80% 120 54 70% 60% 50% 40% 30% 176 66 20% 10% 0% AEFI Reporting No AEFI identified AEFI identified Reported Not reported Source: Gidudu et al. 2020. Pharmacovigilance Eradication Program, which involves the monitoring of adverse events and administration of seasonal in Public Health malaria chemoprevention, such as antimalaria drugs or intermittent preventive treatments Programs against malaria aimed at reducing the burden of malaria among certain high-risk groups, namely, pregnant women and children. Other examples are the National Tuberculosis Control Program, the National AIDS Control Program, and the Neglected Tropical Diseases Control Program for monitoring adverse events among patients receiving therapy Monitoring medicine safety is an important under- for neglected tropical diseases, such as lymphatic taking for public health programs on disease control ­ nchocerciasis, trachoma, schistosomiasis, filariasis, o within countries. Vaccination programs and other soil-­transmitted helminthiasis, Buruli ulcer, yaws, vertical public health programs offer opportunities to leprosy, and Guinea worm. enhance reporting and strengthen national pharma- In the case of the Expanded Program on covigilance systems. Immunization, PV developed in association with the This has been the case of PV in Ghana, where the overall aim of promptly detecting and managing routine reporting of AEFIs began with the launch of AEFIs, real or perceived, and contributing to the the Expanded Program on Immunization in 1978 and credibility of immunization programs by preventing was continued by the FDA beginning in 2001 through inappropriate responses to reports of AEFI that the establishment of the National Pharmacovigilance could lead to crises or vaccine-hesitancy among the Centre. Similar efforts have been undertaken through population in the absence of a surveillance system other programs. An example is the National Malaria (Laryea et al. 2022). 15 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System The operation of the AEFI surveillance system is a spontaneous reporting during nationwide yellow collaborative effort between the Expanded Program fever and measles-rubella campaigns. The FDA and on Immunization of the GHS and the FDA Ghana that other stakeholders involved in PV promote reporting involves the collection and collation of routine data in these situations as part of immunization cam- using the health structures of the GHS (Laryea et al. paigns that convene thousands of citizens in a short 2022). Case reporting is passive, that is, caregivers and period or other, vertical public health programs. This vaccinees report adverse events to health facilities. practice has led to good results in Ghana, contributing The health facilities then record the reported events to the evolution and strengthening of PV nationwide. using a standard case reporting form to submit Overall, Ghana’s experience shows that involving the report to the district health directorate, where vertical public health programs that monitor the the data forms are entered into the district health safety of the medicines administered may represent a information management system II and transmitted quick way to start receiving reports and consolidating to the national level through an intervening regional PV activities, but also to increase the effectiveness of focal point. Data are aggregated at the regional and these programs by understanding the adverse effects national levels. Some notifications are sent directly of the medicines used and increase patient adher- from the community or the health facility to FDA ence. The latter also helps reduce drug resistance to Ghana through an electronic reporting system. medicines administered in such programs as well. In 2018, almost one-third of the spontaneous ADR reports (1,132) were AEFI reports involving stimulated COVID-19 Vaccine is the only African country that included volunteers in the initial COVID-19 vaccine trials. According Surveillance: to the African Academy of Sciences Clinical Trials Community, only 2 percent of clinical trials globally Organization and for any type of vaccine take place in African nations and the WHO Africa Region (Makoni 2020). Some Challenges clinical data from trials are thus not representative of the Ghanaian population. For this reason, safety monitoring within the country is important to obtain relevant information. In Ghana, pharmacovigilance is a well-known and long-standing activity that had to be adapted to respond to the rollout of the COVID-19 vaccines. In both routine and emergency situations, informa- tion on vaccines, which represent a control measure in these situations, is always limited, especially safety The Value of Safety Monitoring data, because of the accelerated product development process and the product reviews carried out on during a Pandemic and in the basis of incomplete information. Yet, safety is Normal Times key in emergencies and pandemics and cannot be In Ghana, it is said that the response improves compromised. with each pandemic. Because of Ebola, FDA Most African countries participate only irregularly Ghana upgraded the clinical trial system in 2014 in clinical trials, including vaccine trials. South Africa (FDA 2015). Because of the COVID-19 pandemic, COVID-19 Vaccine Surveillance: Organization and Challenges 16 PV has been greatly enhanced. The FDA realized The committee reviewed the 9,584 AEFI reports and that PV helps ensure that risk minimization carried out causality assessments on 63 serious measures are ­implemented and that the vaccines AEFI reports. Based on the extensive data collected administered and the vaccination process are as in Ghana, it concluded that AEFIs associated with safe as possible. COVID-19 vaccinations are rare and that the vaccines are well tolerated. Statistically, the AEFIs reported in According to 2021 data, the National association with COVID-19 vaccines occur at about Pharmacovigilance Center received 1,359 ADR reports 36 events for every 100, 000 doses administered. Most and 8,325 AEFI reports (FDA 2022). This important of these reported AEFIs were also identified during increase in the reporting rate paralleled the COVID-19 clinical trials of the vaccines and were thus not vaccination campaigns and was the consequence of unexpected. the resilience of the PV system, which had become well consolidated in the country and was able to After each meeting, clear and effective information adapt to the new situation. was distributed to the public to build trust in the immunization process and AEFIs, thus reducing The availability of safety data on Africa also tended vaccine hesitancy. Additionally, a dedicated telephone to boost confidence and trust in immunization. line was opened to facilitate the reporting of The results could be used to counteract the fake suspected AEFIs by the public. An app was prepared news on the vaccine that was favoring vaccine for the PV system to ease the process and as a hesitancy. PV, which monitors safety, can contrib- complement to the web page that was available for ute to the attainment of global herd immunity and health professionals and patients (FDA 2021). more rapid control over COVID-19. In addition to contributing to VigiBase, the global safety database, national safety monitoring programs help inform the public.14 Response to COVID-19 Vaccination Rollout In response to the COVID-19 vaccination rollout, the government instituted the Joint COVID-19 Vaccine Safety Review Committee, an independent committee with expertise in diverse fields and broad competence to review safety data and make recommendations on safety monitoring of vaccines. The committee met every two weeks and reviewed the reports describing AEFIs. A total of 26,513,553 doses of the five vaccines—Covishield/Vaxzevria, COVID-19 vaccine Janssen, Moderna COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine, and ­ Sputnik V) that had received emergency use authorization were distributed in Ghana from March 2021 to July 2023. 14   bout VigiBase (web page), Uppsala Monitoring Centre, Uppsala, A Sweden, https://who-umc.org/vigibase/. 17 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System The Safety although the reliance approval process can be used in some cases. As of June 2021, FDA Ghana had Monitoring Potential given emergency use authorization for two COVID-19 vaccines. As of December 2022, six COVID-19 of FDA Ghana vaccines had received emergency use authorization (Comirnaty, Covishield, Jcovden, Spikevax, Sputnik V, and Vaxzevria). Health authorities also have a safety monitoring strategy. This has been a key element because it is a prerequisite for emergency authorization. An enhanced vaccination system relies on vaccination National medicines regulatory authorities are reports, which are appropriately followed up on the gatekeepers of the supply chain of medical and assessed. Furthermore, health authorities products. They are mandated to ensure the quality, conduct cohort event-monitoring studies to collect safety, and efficacy of medicines, vaccines, blood information on any rare event occurring at a higher and blood products, and medical devices, including frequency than expected in the target population of diagnostics and traditional or herbal medicines. 10,000 people enrolled in these cohorts. Additionally, The associated evaluation and assessment those responsible for marketing authorization process is based on verification of the indicators conduct formal epidemiological studies (which included in a data collection tool conforming to the is also a requirement for authorization). Research recommendations of the WHO for strengthening centers are performing complementary studies that regulatory bodies.15 If a national regulatory system is advance the authorization process, such as gene independent, efficient, science-based, transparent, sequencing to identify available SARS-CoV2 variants and well-managed, it supports robust and effective in the country. medical product regulation. As a result, medicines and other health technologies entering the market In Ghana, there are legal mandates regarding PV are more likely safe, efficacious, and assured in that apply to anyone marketing a product, and the quality. This protects the population from harm public and private sectors must monitor the product’s arising from unregulated supplies, including safety. So, there are guidelines for the surveillance substandard and falsified medical products, and of vaccines at various levels, including the unit thus fosters confidence in the health care delivery responsible for marketing authorization, the health system (Khadem Broojerdi et al. 2020). care provider, and the public. The COVID-19 pandemic has served as a demonstra- Within this framework, the support of several tion of the safety monitoring potential of FDA Ghana actors and stakeholders should be highlighted. First as a national regulatory authority. is the Ghana MOH, which carries out the required PV activities. Second is the strong collaboration First, a national regulatory authority must be prepared with the WHO, the African Vaccines Regulatory to review the documentation submitted on COVID-19 Forum, and the Africa Centers for Disease Control vaccine applications, even though some of them may and Prevention. The Vaccine Safety Surveillance have already been approved by the WHO. According System available through the Africa Union Smart to national policy, all the applications submitted Safety Surveillance provides a continental view, to the regulatory authority must be reviewed, even though reports are also uploaded to the WHO VigiBase global database. 15  S  ee System for Evaluation of the National Regulatory Authorities for Medicines (web page), Pan American Health Organization, Washington, DC, https://www3.paho.org/hq/index. php?option=com_content&view=article&id=1615:2009-sistema- evaluacion-autoridades-reguladoras-nacionales-medicamentos&It emid=0&lang=en#gsc.tab=0. The Safety Monitoring Potential of FDA Ghana 18 Opportunities to Improve PV Potential Areas of International in Ghana Support Three main opportunities have been identified for In PV, many planned activities require funding improving PV in Ghana: support that is appropriately allocated. These activities, which are important in ensuring complete • The attainment in 2020 of WHO maturity level 4 surveillance of the COVID-19 vaccination deployment, for PV in Ghana indicating a regulatory system include the following: operating at an advanced level of performance challenges the government to support • The scaling of cohort event monitoring to COVID-19 ­ continuous improvement (WHO 2021), including vaccines the funding required to expand and carry out • Training programs for health care workers and the PV activities across the different regions awareness of the importance of AEFI reporting in the country. • Improvement of the dedicated telephone line • The introduction of medicines that will be to a call center that is able to handle many calls used mainly in Africa and for which the safety simultaneously monitoring responsibility resides solely with • Support for the engagement of short-term the national regulatory authority provides ­ employees across various regions opportunities for improvement of the PV system, Additionally, the FDA could benefit from the develop- for example, malaria vaccine, COVID-19 thera- ment of its technical capacity and the strengthening peutics (generic), and monoclonal antibodies of its expert committees to assist in reviewing vaccine for prevention. safety data and publishing the resulting information to • Because it is a Regional Center of Regulatory increase the trust of health professionals and the public. Excellence, FDA Ghana is provided with the opportunity to share expertise and knowledge International technical cooperation agencies could within and beyond the subregion. The designation also supply assistance. For example, the WHO sup- means that FDA Ghana is in a partnership ports member states in strengthening their regulatory with other institutions with specific regulatory systems for medical products by setting norms and expertise and training capabilities that has standards, promoting smart regulation, identifying been established by the African Union’s African strengths and gaps, providing specialized technical Medicines Regulatory Harmonization program assistance and capacity-building opportunities, and to fill a gap and address the regulatory capacity advising on issues related to the quality assurance challenges experienced by national medicines of medicines for national and international markets. regulatory authorities and the pharmaceutical Also, as part of its regulatory system strengthening industry in Africa. program, WHO could support in benchmarking and regulatory systems by, for instance, using a set of indicators designed to evaluate regulatory oversight for vaccines (Khadem Broojerdi et al. 2020). 19 Ghana’s Pharmacovigilance Experience: From Vertical Program Activity to Nationwide System Lessons Learned health programs that are centered on the admin- istration and use of vaccines and medicines for disease control, such as the immunization program or the TB, HIV, or malaria programs. • Sharing safety information on specific public health programs is important to ensure continued collaboration. Ghana’s PV experience offers some lessons that may • Having the right staff strength in terms of be of relevance to other countries, as follows: knowledge and numbers is important for effective ­ safety monitoring. • A strong national medicines regulatory authority, • Communication arrangements are crucial to such as FDA Ghana, is crucial to defining clear minimizing crisis escalation in the case of adverse objectives for medicines safety monitoring and drug events based on country safety data and from to informing key legislation that facilitates the abroad. emergence and growth of a national pharmacovig- • Good international relations help in remaining ilance system. up to date on good international practices and in • Both local and external stakeholders are needed to facilitating early engagement with interesting and build a strong PV system. useful projects. • Clearly defined funding arrangements are critical • Preparing international publications explaining the for ensuring the sustainability of PV activities. results of PV activities requires expertise and time, The judicious use and accountability of donor but the potential impact on becoming a reference funds are important to ensuring continuous support. center will repay all the effort. • One way to promote the development of PV capacity in a country is to take advantage of public References 20 References Gidudu, Jane F., Anna Shaum, Alex Dodoo, Samuel Bosomprah, George Bonsu, Kwame Amponsa-Achiano, ­ Healthcare Delese Mimi Darko, et al. 2020. “Barriers to ­ Workers Reporting Adverse Events Following Immunization in Four Regions of Ghana.” Vaccine 38 (5): ­ 1009–14. https://doi.org/10.1016/j.vaccine.2019.11.050. 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