Test yourself with this checklist: Depending on the purpose of a campaign, social media could be the most helpful marketing channel for companies to reach their target audiences. Unfortunately, due to strict laws and regulations, pharmaceutical companies cannot simply decide to use these channels. Issues such as side effects must be reported on time. This article explains why a protocol is indispensable and what things you should pay attention to. We also included a checklist to check whether everything is included in your AE protocol.
Roles and responsibilities
A critical element within AE events monitoring is the proper definition and application of roles and responsibilities. It starts with establishing clear, framed descriptions and processes. For example, how do you deal with unavailable employees for a certain time? And do all employees have the right access? It is best to centralise the activities as much as possible to ensure consistency. This applies to your employees but also to agencies or other parties you collaborate with.
Checklist – Roles and Responsibilities
- Are roles defined and delineated?
- Are responsibilities defined and delineated?
- Does everyone have access to the proper channels (and no unnecessary access)?
- Is everyone involved in social media aware of which colleagues are monitoring AEs? Is there a replacement in case of illness or leave?
- Is the way of working (in the current situation) still as efficient and centralised as possible?
- Is it specified which channels/accounts are monitored? And for how long? Is there a specification per channel on how the monitoring takes place?
Laws and regulations
If you use social media, you should remember that your reach continues beyond national borders. We recommend documenting current laws and regulations and including country- and region-specific regulations. All employees who use or monitor social media on behalf of the organisation should be trained. As a result, they are aware of the applicable laws and regulations of the markets in which they operate.
Checklist – Laws and regulations
- Are all laws and regulations documented and up to date?
- Is the potential reach of the channels deployed considered?
- Is there a training program? Has this been completed by all the involved employees?
All processes need to be mapped out and described correctly. Are there examples of when an adverse event does or does not occur? Who should report an adverse event, where and in what way? Are there templates for responses to patients? Are there processes arranged to manage and track all social media channels, campaigns, pages, and advertisements? Appropriate monitoring is of great importance here.
Tools can help, but they are not foolproof. People responsible for monitoring AEs should not be lacking in their tasks. Even on weekends, AE monitoring should go on.
Checklist – Processes
- Are all possible processes clearly defined and established? Does all involved staff have access to the protocols?
- Are there relevant and current examples of when an AE does or does not occur? Is it clear who, where, and how to report an adverse event?
- Are there templates for responses to patients?
- Are there processes arranged to manage and track all (future) social media channels, campaigns, pages, and advertisements in sight?
- Is personal 24/7 monitoring in place?
Community management and AE monitoring are closely linked. Therefore, it should always be described in the AE protocol. Different people responsible for community management and AE monitoring should be aware of each other’s work. This way, you can turn threats into opportunities for AE monitoring and more general questions.
Checklist – Community
- Is there a community management protocol, or is it included in the AE protocol? Are AE managers and community managers aware of each other’s work?
- Is there contact/synergy between AE managers and community managers?
When reporting AE notifications, you have to process personal data. Therefore, the privacy of the reporter must be protected. To do so, you must comply with the WBP and GDPR. If personal data is no longer needed, it must be deleted. Shared data should always be encrypted.
Checklist – Privacy
- Is the privacy of the AE reporter ensured in accordance with the WBP and GDPR? Is personal data that is no longer required deleted?
- When data is shared, does it follow protocols (for example, encrypted by email)?