Guidance for the case study
In this case study you take the role of pharmacovigilance officer J. Lombard at the national regulatory authority (NRA) in the Republic of Reganda.
You are responsible for monitoring the incidence of adverse events following immunization (AEFIs) throughout the country, and reporting your findings to the Ministry of Health and to international health organizations (WHO, UNICEF). In order to respond appropriately, you must be aware of the national immunization programme and consult sources of information described in Module 5. You are also responsible for alerting vaccine manufacturers and procurement agencies if there is evidence of a vaccine-associated AEFI. Your position within the AEFI reporting system is shown in the purple box the diagram.
A non-selective mass vaccination campaign for measles is currently taking place in Reganda in response to an outbreak of measles in the north of the country, which was identified in January 2011. The programme started at the end of February and it is intended to deliver a measles vaccine to all children under school age (9 months to 5 years). Most children in Reganda have received a measles vaccination at approximately 9 months of age (MMR). The current immunization campaign is intended to enhance immunity for children who have been immunized previously and to provide some protection for children who have not been immunized previously.
At the start of the study you receive two AEFI reports from the regional health officer in the province of Karoomana and one each from Weston and Kyogo following measles vaccination.
The investigation progresses over 4 days. On each day you will be given new information and a number of options. However, your time is limited, so you must choose what options are most important. Therefore, you should prioritize your investigation, so that you gather the information efficiently from accredited sources.
At the end of each stage, you will have the opportunity to review your progress, and if necessary, rerun the investigation to find any missing information. Sometimes, you will be able to collect the information at a later stage. Keep in mind that it is essential to act quickly when AEFIs occur.
At the end of the case study you will prepare a short report for the Minister of Health (Dr Meeta Swahami, who is an immunologist herself) explaining what has happened, the results of your investigation and the actions you have taken. This report assesses how well you have collated the relevant information.
You should take written notes as you proceed.
This case scenario has been drafted to illustrate how to act in a virtual crisis situation. Be aware that these are extremely rare and that the described issues related to the vaccines usually do not occur due to a meticulous production process.