“To err is human.. but to persist is diabolical”. Indeed, human error is a long-standing problem which may have a critical impact on heavily regulated environments such as GMP, GCP and GVP.
In pharmacovigilance, case management is the area in which human errors are the most frequent due to the large amount of data that has to be processed manually and due to stringent regulations. Other processes where human errors can occur include PSUR and DSUR preparation, literature screening, and many others.
On the 18th of November we conducted a webinar titled “Pharmacovigilance Processes: Minimising the Risk of Human Error”.
During this webinar we expolored the main causes of human errors, discussed the ways to minimise their risk in pharmacovigilance processes and share practical examples.
During the Q&A session of the webinar we received so many questions, that we decided to turn them into a blog. We how you enjoy the read!
Do you think an artificial intelligence tool may help to avoid human errors?
Potential of A.I. to reduce the possibility of human error is one of the drivers of growing interest in it. However, we need to consider that A.I. applications may be subjected to error. Generally, the cause of A.I. error is human – it can come either from the data or from the code.
If human error is not a root cause, then what is? Lack of training or lack of resources or unclear process?
This is exactly what we need to investigate in order to apply the correct actions. As discussed in the webinar there are different factors that can potentially be a real root cause.
What indications come from inspections or audits regarding avoiding Human Errors?
Quality control steps executed by a different person are recommended especially for case processing and for processes aimed to identify ICSRs such as triage of L2A reports downloaded from EudraVigilance and literature screening.
Could you please provide an example when a human error is not root of cause for CAPA?
For example, a member of the team is appointed to check inbound messages in the Drug Safety Department mailbox. However, he/she forgets to control it on Friday afternoon since he/she was engaged in another task. As a consequence, the ICSRs were distributed to Partners with a delay. This situation happens due to a human error, but indeed the problem is the process. A company should always identify a backup for critical processes. What is more, the person in charge for the task must alert her/his backup in case of need.
Why do you think retraining is not so efficient?
Trainings and refresher trainings are extremely useful in reducing human errors due to poor understanding of a process or to forgetting steps of complex processes. However, they are not so useful in reducing human errors when it comes to errors occurring due to different factors such as environmental or personal factors.
How frequent should training on procedures be performed?
It depends on the procedure. We recommend to perform a refresher training every time when poor understanding of a process or laps of some steps are identified as the root causes of a deviation.
Can we take the risk of making mistakes to zero percent or is there always a risk margin?
This question has statistical implications and there are ways to calculate the % of risk in a process. Generally speaking, we can say it is really hard to ensure 0 errors, but a process should strive to bring it to 0 by putting in place all necessary measures.
