Debunking the Top 5 Taboos of Automation in Pharmacovigilance

The volume and type of safety data that needs to be collected, analysed and reported continues to rise annually.

These heavily manual processes rely on people to have not only received initial training, in order to process reports, but continued training to ensure up to date activities are being performed globally. This places strains on Pharma and any outsource Partner to ensure high quality and costly training to ensure data accuracy and timeline compliance.

In the world of drug safety, the topic of innovation and implementing automated solutions is often met with great scepticism, underpinned by long-standing myths that can be found across numerous industries governed by strict legislation, where unforeseen problems have resulted in more failures than successes.

For Global Pharma to truly evolve and enhance global patient safety within the modern era, it is therefore essential to demystify these taboos in order to leverage the benefits that automation offers.

Common Taboos:

Cost: Perceived high initial investments deter companies, ignoring long-term savings and efficiency gains and implementations do not have to be expensive.

Time: Concerns about lengthy setup and onboarding periods often overlook the eventual optimisation and streamlining of processes. Setting up an automated system does not need to be lengthy or require large numbers of internal staff to move into production.

Effort: The perceived complexity of integration and training can seem daunting, but this is more fear of the unknown than the actual.

Benefit-Risk: Apprehension towards potential risks that automation may introduce instead of focusing on the tangible benefits, with no consideration for risk mitigation strategies. Utilising performance statistics to compare the rewards of automation versus the previous manual process not only demonstrates the decision to automate but demonstrates to higher management enhanced compliance, data accuracy and cost-savings.

Culture: Resistance to change and adopting new technologies can hinder progress. Fundamentally, in any Organisation is the insight to evolve in order to improve and not become extinct.

Nevertheless, these barriers stem from misconceptions and can be overcome by strategic planning and a focus on both short and long-term advantages. By addressing these misconceptions head-on, the following strategies for success can help your Company move towards a more effective, streamlined approach that enhances patient safety.

Strategies for Success:

Clear Implementation Roadmap: Creating a clear implementation roadmap involves drafting a comprehensive plan that outlines each step of the automation integration process. This roadmap should detail the objectives, timelines, and responsible parties for each milestone, as well as setting realistic, achievable goals that can be adjusted in line with progress reviews. This may also involve a phased introduction so that the implementation matches the specific Company needs – rather than a more generic application.

Stakeholder Engagement: Stakeholder engagement is vital in overcoming barriers to implementing automation. This involves fostering an environment of open dialogue and collaboration amongst all parties impacted by the automation process to ensure the implementation is personalised to the type of products the Company has (e.g. Drugs, Devices, vaccines etc…). This includes employees, management, regulatory bodies, and technology providers.

Phased Approach: Adopting a phased approach to implementing automation enables organisations to manage change more effectively, allowing for each stage of the process to be optimised before moving to the next. This facilitates continuous learning, adjustment, and improvement, whilst also reducing the risk of disruption and enabling more precise tailoring of the system to meet specific drug safety needs.

Comprehensive Training: Prioritising comprehensive training programs is crucial for ensuring employees are well-equipped to effectively utilise any new automated system. This involves designing robust training that covers both the technical aspects of the new tools and the operational changes made to existing processes so that all staff are aware of the system flexibilities to match specifically the Company requirements.

Performance Monitoring: Performance Monitoring involves establishing key performance indicators (KPIs) to assess the efficiency and effectiveness of an automated system within pharmacovigilance, this would include all of the goals that were hoped to be achieved in implementing such a system. This approach facilitates continuous oversight of system performance, whilst also ensuring the automated solution meets or exceeds the outlined objectives for safety data management (accuracy; compliance; ease of use; cost-saving).

Risk Assessment and Mitigation: Risk assessment and mitigation in the context of implementing automation within drug safety involves the identification of potential challenges and barriers that could have a detrimental impact on patient safety. It is the early identification of these risks that will enable Companies to develop comprehensive contingency plans that are tailored to their specific concerns. This includes evaluating technical, operational, and regulatory risks, as well as mitigation plans that address issues such as system compatibility, data security, compliance adherence, and user adoption. For example, will the automation tool be adaptable to fit onto any safety database or just one database, because then the risk is heightened that the Company is not tied to one database but two.

Change Management: Implementing change management involves strategic planning and communication that fosters a culture that embraces innovation – especially within the transition phase. This process requires engaging with stakeholders at all levels to understand and address potential concerns and provide clear information on the benefits and impacts of the automated solution.

Regular ROI Assessment: The implementation of regular ROI (Return on Investment) assessments is critical when validating the financial and operational value provided by automated solutions. By periodically measuring the ROI, Companies can ensure the automated solution aligns with both commercial and safety objectives – facilitating informed decision-making and helping to identify areas of success and opportunities for improvement.

Overall, overcoming the taboos associated with implementing automation within pharmacovigilance is essential for achieving the objectives and goals being set by governing bodies worldwide.

As an innovative provider of global clinical and post marketing drug safety services, our team is well versed in the benefits of automation – we even have our very own automated solution: R.A.P.T.A.R® Reporting! Naturally, R.A.P.T.A.R® encompasses all of the aspects discussed above to ensure that any implementation is quick, comprehensive, simple and cost-effective.

Contact us today for an introductory meeting.