Reducing Risk: Human Error Prevention in Health Care and Pharma

Did you know the third leading cause of death in U.S. hospitals is human error? Researchers estimate that 250,000 people die every year from medical errors in the United States alone. Worldwide, human error is also the third leading cause of death, behind heart disease and cancer.

Unfortunately, society usually responds to this news with a “whom can we blame?” headline. In other words, the focus is often on the person responsible, not the systems that failed. People get retrained, often disciplined and sometimes fired. The underlying systems, however, typically remain unchanged, mistakes continue to happen and risks continue to escalate.

Consider this real-life example about syringe drivers, which are frequently used in palliative care to deliver medicines over a fixed period. The syringe is loaded, and the injection/flow rate is set.

• When setting the flow rate, a nurse added an extra decimal point, entering 1..5 rather than 1.5, which is easily done. Recognizing her mistake, she hit the backspace key 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. Due to the multiple distractions of a busy hospital ward, stress and fatigue, the nurse didn’t notice the mistake.
• As a result, the patient received rapid dosing, because the flow rate had been incorrectly set at 15 ml/hr instead of 1.5 ml/hr. A small error with a big impact.

This nurse was fired due to gross negligence, but the systems were not reevaluated. No one considered redesigning the equipment or building in system safeguards to prevent a repeat incident. However, not all errors occur on the patient side. Human errors in manufacturing can also increase risk and cost for pharmaceutical companies.

Despite errors being common, it’s possible to reduce human error and associated costs. An NSF client who attended our error reduction course reduced repeat errors by 67% in six months and saved over $1.2 million. To better understand human error risk reduction, we must understand how these errors occur. To start, remember the following:

• Human error is the consequence, but rarely the cause, of mistakes.
• Human error must be the investigation starting point, not its automatic conclusion.
• There is no such thing as one single root cause for any error or mistake.
• If you want to prevent errors from happening, focus on the system, not the person.

Focus on latent, not active, failures (preventive versus corrective controls).

Pharma regulators are growing increasingly frustrated by repeat errors and the focus being placed on the person responsible rather than the system. This is made crystal clear in the GMP guidelines enforced by EU regulators. Look at 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 unnecessary complexity, poor process design, inappropriate KPIs and other causes.

Error reduction isn’t a single project, but a matter of corporate culture. It requires a lot of effort but is ultimately less work — and less expensive — than continually fixing the same errors. One pharma company estimated the cost of human error to be approximately $2.2 million per year, and another put the figure in excess of $150 million. Can your company really afford your “error bill”?

At NSF, we’re fortunate to work with the best companies and organizations that have successfully reduced their error bills and legacy risks. We’ve studied their methods and identified their top error-prevention practices, which include the “error chain” and “latent failures.”

Leverage the Error Chain

To prevent repeat incidents, focus on identifying the error chain rather than looking for one or two “root causes.” Remember:

• Every error results from multiple causes or contributing factors.
• Errors occur when multiple causes come together to form an error chain.
• The focus of any problem solver (deviation investigator) must be to find and fix as many contributing factors as possible, which includes fixing the underlying (latent) failures.

Regulatory Pressure to Reduce Human Error

Active failures are mistakes made by people in the workplace, like a nurse in a busy, chaotic ward. Conversely, latent failures lurk beneath the surface, representing systemic weaknesses and problems. For example:

• Poor workplace design
• Overly complex procedures
• Lack of adequate education
• Absent supervision to support, guide and mentor the less experienced
• A rampant blame culture triggered by poor KPIs

If you want to reduce your error bill and legacy risk:

• Focus on looking for the error chain. The term “root cause(s)” programs busy people to stop at the surface of the problem and focus on the person, not the system. The incident report gets closed quickly, but the error eventually returns and risk increases.
• Uncover latent system-related errors and weaknesses and fix as many as possible.
• Use FMEA and similar techniques as they were intended: to prevent risk, not to respond to it. During the design phase, ask, “What can go wrong?” and engineer it out.
• Move from CAPA to PACA. Make “PA” your priority. Eighty percent of your actions should be preventive, and 20 percent corrective. The other way around is firefighting.