Lean six sigma approach in Pharmacovigilance

Pharmacovigilance is proactive detection, assessment, understanding and prevention of any drug related problems and it is a complex science characterised by many processes and outputs. The quality and precision of safety data processing is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which directly impact safety of the patients and safe use of drug. As per regulators along with the quality, compliance is also important factor in the process. Compliance in pharmacovigilance refers to legal and regulatory guidance, internal (e.g. standard operating procedures) and external (industry codices) policies.

Five Key Performance Indicators (KPIs) have been predetermined for PV; these have to be continuously monitored:

• timeliness of 15-day and 90-day reporting,
• quality of submitted reports to competent authorities,
• timeliness of Periodic Safety Update Reports (PSURs),
• timeliness of safety variation submissions,
• adherence to risk management plan (RMP) commitments.

Many pharmaceutical companies has been highly reactive in nature resulting in implementing pharmacovigilance processes that in some cases increase the risk for compliance failure. 

The implementation of lean six sigma method in pharmacovigilance helps to reduce quality costs and improve compliance performance by streamlining drug safety protocols – resulting in safer medications, sustainable operational improvements and increased profit margins.

Lean six sigma approach is a methodology to improve the capability of business process by reducing variability and eliminating defects in any process from transactional to product to service. The basic component of this lean system is waste and rework elimination, improving process efficiency and effectiveness by streamlining processes, improve process efficiency and effectiveness by streamlining processes, and reducing the time to produce the outputs.

The process begins by analysing the process and systems where root cause analysis is performed, by defining the problem (which is Critical To Quality (CTQ)), then measures performance of those CTQs. The “5 Whys” is a brilliantly simple method of getting to the root cause of a problem. By asking and answering the question, “why?” the basis of a problem can usually be found in five iterations. The gaps between actual and planned output will be analysed to find root causes of problem and determine which problems have the most impact.

Value stream mapping (VSM) is an essential tool to understand the situation at hand and identify the complicating factors. VSM provides visual picture of the processes, with metrics, staffing levels, regulatory timelines, case volumes, customer demands and input variations. These maps are essential in moving towards a process cure and an organisational understanding of ‘where the organisation is today’.

Next step includes simplifying the process, where non value added activity (waste) is removed.Then integrating the process across the organisation where the new process is reviewed for resulting or downstream affects to other sites and automating the process.

Benefits of Lean Six Sigma approach in pharmacovigilance:

• Increase in productivity by 2 to 3 times with existing staff
• Improved quality and ontime case submission
• Compliance improvement
• Minimized risk associated with non-compliant operations
• Immeasurable value to the public, the organization, and the shareholders in meeting regulatory requirements.

Examples of Lean and six sigma tools:

• Statistical Process Control
• Design of Experiments
• Process Analysis
• Organizational Development
• Project Management
• FMEA – Failure Mode and effects analysis

Lean six sigma approach in Pharmacovigilance occurs when an organization delivers performance excellence within its’ regulated environments, where effective processes are both compliant and cost efficient. Service, responsiveness, efficiency, information capture and compliance performance can be improved together through the application of Lean techniques.  

The result is a perfect balance between improved service levels, quality and cost performance in parallel with improved compliance performance. Lean Pharmacovigilance builds on the principles of Lean thinking to realize the benefits of aligned and effective processes. Creating efficient cost effective processes adds value to the organization, resulting in rapid response to marketplace and regulatory requirements.