Information Management Systems
There are 15 members of the Economic Community of West African States (ECOWAS) are Benin, Burkina Faso, Cabo Verde, Cote d’Ivoire, The Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone, and Togo. The main goal of ECOWAS is to promote economic cooperation among member states in order to raise living standards and promote economic development.
Existing R-IMS Across ECOWAS.
The R-IMS systems existing across ECOWAS include SIAMED, Vigiflow/Vigibase, Pharmadex and MedNet. Some countries have customized systems or are in the process of acquiring customized systems, others use software provided by WHO, and others use Microsoft Word and Excel to produce, manage and store information. This section details the various systems that have been identified.
The WHO developed the Model System for Computer-assisted Drug Registration (SIAMED) to improve the efficiency of drug regulatory authorities by enabling them to ensure that market authorizations are in line with the national drug policies. Country experiences with the system are as follows
- BoMRA used SIAMED for a while but experienced technical challenges that caused usage of the system to be stopped. SIAMED was not user-friendly, uploading information was challenging, and it did not make communication with MA applicants any easier.
- SAHPRA implemented SIAMED but the system is currently not in use. The NMRA is building a new R-IMS that will support all their regulatory functions. Most of the systems used in the NMRA are standalone and not integrated.
- Cote D’Ivoire installed SIAMED in 2016, with the help of an expert from Tunisia but it is not used.
- The NMRA in Tunisia is currently working on adapting SIAMED to its laboratory activities.
MedNet is a collaborative platform provided by the WHO for sharing and exchange of scientific information. Several communities exist in MedNet such as Global Cooperation on Assistive Health Technology and International Non-proprietary Names. MedNet has restricted access and each community is managed by the scientific community leader.
Vigiflow and Vigibase
Vigiflow is a web-based Individual Case Safety Report (ICSR) Management System. Vigiflow can be used by national authorities and companies for management of their own reports. It allows for data entry, assessment, storage, and retrieval of information and communication with other parties. Vigiflow is E2B compatible. E2B is an international standard for transmitting medicine adverse event reports specified by the ICH (Walberg, 2009).
Manual data entry from ADR paper forms can be done with support from WHO Drug and MedDRA which are integrated international terminologies. eReporting is an optional module for Vigiflow. It allows national pharmacovigilance centers to capture ICSRs from healthcare professionals and patients into Vigiflow. eReporting reduces the workload of manual data entry from ADR paper forms.
- ICSR data can be shared and exchanged in ICH E2B XML format with external stakeholders such as pharmaceutical companies and the WHO global database of ICSRs, VigiBase. Vigiflow also has a search and statistics module that allows for advanced searches and statistics of finalized or committed reports.It also allows the management of committed reports
- Cabo Verde also uses Vigiflow to document Adverse Drug Reaction Reports. The ERIS website has an e-reporting form for adverse drug reactions. The information is received and analyzed and uploaded to Vigiflow. Over the past two years, ERIS has shared safety reports and pharmacovigilance information with Angola, Ethiopia, Ghana and Sao Tome and Principle.
- Sierra Leone’s Pharmacovigilance department uses Vigibase to upload ADR reports. Each department has its own database for storing information. The Registration department’s database was built in-house. The Enforcement department does not have a specific system for managing information, but they use Excel files to store their information.
- Niger’s NMRA uses VIGIFLOW with the database, which is VIGIBASE, for notifications or alerts that need quick processing. VIGIFLOW is a data collection software that allows us to have data from all countries and centralize them in order to analyze them at the global level. There was a new version of VIGIFLOW in 2019 which is easier to use. The NMRA is collaborating with some countries including Morocco which is a WHO collaborating center for pharmacovigilance and also with ECOWAS countries including Togo, Burkina Faso, and Ivory Coast. They also use an Open Data Kit (ODK) form for the collection of adverse vaccine reactions, which is an online form that can be adapted with geolocation, so that pharmacovigilance officers can fill in the reports from the health districts. It works offline and downloads when there is internet access.
- NAFDAC has a more mature system for Pharmacovigilance. The NMRA also uses Vigiflow. They have an electronic ADR reporting form, but they still receive hard copy reports that have to be inputted into Vigiflow manually.
National Regulatory Information Management System
The NMRA has a computerized information management system to store and retrieve information on the various procedures, registrations, inspections, and other regulatory functions (World Health Organization, 2011).
None mentioned in relation to drug regulation on the website. The ERIS website. However, Cabo Verde’s National Pharmacovigilance Centre collaborates with other National Pharmacovigilance centres in other countries.
Cabo Verde has a system called Integrated Pharmaceutical Market Monitoring System (SIMFAR) which is an integrated approach to the technical and economic aspects of drugs, namely by monitoring access, price and stock and also by assessing the quality, safety, efficacy and effectiveness. The aim of SIMFAR is to:
- Collect, process, and make available information on the market for medicines and pharmaceutical products for the purpose of monitoring and supporting the preparation of studies and opinions on accessibility and consumption of medicines.
- Provide information capable of contributing to the execution of inspection and inspection actions.
- Support policy formulation, decision-making and impact assessment.
- Integrate the support instruments needed to implement systems to prove the quality, safety and efficacy of medicines and pharmaceutical products.
DPML has a web portal that allows applicants to register their products through. There is also a portal for people to make pharmacy sites allocation requests. This can be access via: http://pharma.dpmlci.net/. The user should already have an account.
According to the WHO Pharmaceutical Sector Country Profile, Mali’s DPM has its own website: www.dirpharma.org. However, no website can be found upon following this link. DPM uses paper-based systems and Microsoft Office to perform its regulatory functions. The electronic system for medicine registration, SIAMED, which was installed two years ago, is no longer functional (Kikule, Diarra, Sangare, & Thumm, 2017).
According to the responses of Niger in the WHO Pharmaceutical Sector Country Profile, the DPHL/MT has a computerized information management system but only marketing authorization information is computerized.
The Food and Drugs Authority has an information management system that is used for inspections, product registration and other regulatory procedures (World Health Organization, 2012).
NAFDAC allows users to apply for product registration and register details of current NAFDAC approved products on the NAPAMS portal. There is also the e-license application that allows NAFDAC clients to digitize their already issued certificates and permits.
The Division of Pharmacy and Medicine has a website where applicants can download application forms, access guidelines, and get general information about medicines. The DPL answered in the WHO Pharmaceutical Sector Questionnaire that it has an IMS that supports its regulatory processes.
According to the WHO Pharmaceutical Country Profile, the NMRA uses a computerized information management system to store and retrieve information on the various regulatory procedures, however further information is not provided on this information system is not provided. The NMRA does not have a website (World Health Organization, 2011).
The Pharmacy Board had a computerized information management system but only importation and registration information are computerized.