“The great majority of reported defective medicinal products has resulted from human error or carelessness, not from the failure of technology” 

Source: MHRA, Orange Guide 2002

As stated by Orange Guide 2002, human error is responsible for the majority of defective medicinal products that impact the patient’s health badly so keeping this in view, it is necessary to identify and control the possibility of human error in the pharmaceutical environment.

Studies tell that during an investigation, all responsible person commits their error and blame the system & procedure and it was evident that people do not address the system or procedure deficiencies before making the error.

“Human behavior explain human error” 

There is a number of the incident which had happened due to human error and poor quality of the products affected the patient health badly. Summary of one such poor quality product incident are given below ;

Contaminated Isosorbide tablets supplied by Major cardiac care clinic in the year 2012 at Lahore resulted in the death of more than 100 patients and several patients hospitalized by consuming this contaminated Isosorbide tablets. 

Root cause behind this incident was a simple mix of an excipient and an API during manufacture.

In this incident, on every consumption patient consumed a chronic overdose of Pyrimethamine which cause bone marrow suppression in the patient and lead to death.

On testing, this product was complying with the specification but due to the presence of a chronic overdose of Pyrimethamine, it was lethal to the patient.

Apart from the above mention incident, there are so many other incidents where the patient dies by consuming contaminated poor quality medicine and most of the case happened due to human error so now you can understand that how much is necessary to eliminate of chances of human error in critical activities like drug substance and drug products manufacturing which directly affect the patient health i.e. adversely affect health or sometimes even cause death.

We all know human error can not be eliminate 100% without automation and the sometimes chance of human error is also remains in the automation process if the system/ program did not design properly. Here are some tips to reduce human error in the pharmaceutical and healthcare environment.

Five ways to reduce human error are given below;

1. Analyze Each Human Error Deeply & Trending

Analysis of each human error is very much essential as there are some reasons behind each human error like Inadvertent error & Deliberate Error or Non-Compliance.

Inadvertent Error can further subcategorize into (i) Action Error &  (ii) Thinking Error and similarly, Deliberate Error can be categorized as (i) Exceptional Error (ii) Situational Error (iii) Routine Error.

All these errors can be further categorized. You can read Human Error categorization in our previous articles.

Trending of each human error cause is required to identify any opportunity to fix the problem and control the human error in the future. 

We all know that human error can not be eliminated permanently but these can be reduced.

2. Identify critical step/ area of drug substance and drug product manufacturing & packing

The manufacturing process of any drug substance/ drug product should be mapped for all critical manufacturing & packing steps and in all these critical processes/steps minimize the human intervention so in nut-shell all these critical steps should be governed by automatic process/recipe based operation wherever possible. All such processes and associated software should comply with 21 CFR part 11 / GAMP 5 requirements with privilege access control so that unauthorized modification can be avoided.

3. Simplify the procedure

In most cases, it has been seen that the procedure written by us is responsible for human error which is not easy to understand, and as a result people make mistakes. Most of the time, we make the procedure to please the regulatory authority and not to the operator.   The procedure should be written step by step and in easy to understand language and if possible it should be written in regional language also so that operator can easily understand the requirement of the procedure and follow the same.

It is better if the procedure has a flow chart of all key points or aid memories which are easy to understand.

4. Right People at Right Place

Deploy only right trained people at the right place or task as a trained person can do the task better. It is better to develop subject matter experts for each of the critical operations which can directly affect the product quality and all these activities should be performed by subject matter expert or under his/ her supervision.

5. Develop Healthy Quality Culture

Avoid blame game culture and develop a healthy, fearless quality culture where people can report any failure to the senior management and accept the mistake without any fear in his/ her mind.

This type of healthy and fearless quality culture will make the people comfortable and they will provide the right information behind any failure which will make it easy to take right corrective and preventive action to avoid the failure in the future.

Conclusion

It is concluded that to understand each and every human error, the right categorization of human error is very much required to understand the cause behind human error so that the right action can be taken. Apart from that procedure, it should be easy to understand (Preferably include Aid-Memories/ flow chart) and it is better if it is available in the local regional language so that people can understand it easily and do the task rightly.

Automation to handle all critical steps makes the process error-free unless automation failed. Automation can also fail if it not designed correctly so take care during the design of any automation and use the risk-based approach to handle/control each and every critical manufacturing step. Data-Integrity assessment of each GxP automation facility is required so that during any manufacturing/packing operation breach of data integrity can be avoided.

All these techniques and things are useless if there is no healthy quality culture so it is essential to develop a healthy environment and culture where people feel fearless and provide correct information during failure investigation and right corrective and preventive action can be proposed.

 

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