Researchers estimate that 250,000 people die every year from medical errors in the U.S. alone. That is the equivalent of two jumbo jets crashing every day. Worldwide, human error is the third leading cause of death behind heart disease and cancer.
Unfortunately, society usually responds to this type of news with a 'who can we blame?' headline. In other words, the focus is on the person, not the systems. As a consequence, those believed to be at fault are often retrained, disciplined and sometimes even fired. Regardless, the underlying systems usually remain unchanged. Mistakes continue to happen and risks continue to escalate.
A real-life example about syringe drivers, which are frequently used in palliative care to deliver medicines over a fixed time period, reinforces the long-term hazards of a blame-first culture. The syringe is loaded and the injection rate set - a patient received rapid dosing because the flow rate had been incorrectly set at 15 ml/hr instead of at 1.5 ml/hr. This is a small error with a big impact.
How did it happen? When setting the flow rate, the nurse added an extra decimal point entering 1..5, which is easily done. Recognizing her mistake, she hit 'backspace' to remove the renegade decimal point. Most people would likely have done the same. Unfortunately, this action unintentionally removed both decimal points, leaving a flow rate of 15 ml/hr. In the context of the multiple distractions of a busy hospital ward, in addition to potential stress and fatigue, the nurse didn't notice the mistake.
The nurse was fired due to gross negligence, but the systems were not re-evaluated. No one considered redesigning the equipment or building in system safeguards to prevent a repeat incident. People make mistakes for a reason. Over complexity, poor process design, stress and anxiety - the list is endless. If errors are to be prevented, focus must be on the system, not the person.
Pharmaceutical regulators are getting increasingly frustrated by repeat errors and the focus on the person, not the system. This viewpoint is made crystal clear in the GMP guidelines enforced by EU regulators, illustrated specifically in this excerpt from the EU GMP's Volume 4, 1.4 xiv (redacted):
An appropriate level of root cause analysis should be applied during the investigation of deviations... in cases where the true root cause(s)... cannot be determined; consideration should be given to identifying the most likely root cause(s)... Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked.
The regulation requires that if you conclude that people are to blame for mistakes, you have the data to rule out over-complexity, poor process design, inappropriate KPIs and other causes. What the regulators are expecting to see is a comprehensive investigation and to make sure the real root cause is identified, before attributing any deviation to human error.
Reducing Error Bills and Repeat Deviations
Error reduction isn't a single project, but a matter of corporate culture. It requires a lot of effort, but is ultimately less work than continually fixing errors. One smaller pharmaceutical company estimated the cost of human error to be approximately $2.2 million per year and another large multinational company with multiple sites in excess of $150 million.
NSF Health Sciences Pharma Biotech Consulting is fortunate to work with the very best companies and organizations that have successfully reduced their error bill, repeat deviations and legacy risk. We've studied their methods and identified their top ten error practices, which include the 'error chain' and 'latent failures'. NSF's human error prevention services provide practical tools and techniques to help reduce so-called human error and repeat deviations (www.nsfhumanerrorprevention.org ), which can save significant costs and protect companies from severe regulatory action. Our public/residential courses have been attended by delegates from seven regulatory agencies and from over 350 companies.
An NSF client who attended a customized workshop reduced repeat errors by 68 percent to less than five percent in 18 months, saving $900,000 in direct labor costs which is still falling. This is a typical example of what can be achieved by using NSF's services. In summary, human error is only the symptom, never the real cause of quality problems. It is the starting point of an investigation, never the conclusion. Pharmaceutical companies need to learn the tools and techniques on how to prevent repeat incidents and get better informed about human error, causes and prevention.
For more information about NSF Health Sciences Pharma Biotech Consulting' services, please call us on + 44 (0) 1751 432 999, email firstname.lastname@example.org, or visit our website www.nsfpharmabiotech.org