pharma data integrity training

Data Integrity and Drug Shortages – Are You at Risk?

NSF Pharma Biotech Consulting

Last year, the European Commission announced that it was suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. The ban follows a report in 2014 by France’s medicines authority that ECG data had been manipulated in each of nine studies it investigated. Very few things take my breath away these days. This did. We, the industry, need to fix the issue of data integrity, and quickly.

Some Hints for Success: Your “Six to Fix”

Here is what you can do, right now, to make sure your data is correct.

  • Make data integrity personal. The term ‘data integrity’ doesn’t do it justice. If you want people to really ‘get it’ make sure your education programs make data integrity personal, emotional, meaningful. Then make sure your culture, systems and practices drive the right behaviors. Namely telling the truth, the whole truth and nothing but the truth. This starts with leadership.
  • Fix the ‘underlying factors'. In our experience data integrity is the tip of a very big iceberg. Beneath the surface can be a number of contributing factors, not just one. If you don’t want your business to be sunk by data integrity you have to fix what sits below the surface.
  • Educate and engage your people. As the old saying goes ‘ignorance breeds contempt’. When people don’t understand the ‘why’, the importance of what they are doing, they will just ‘tick boxes’ no matter what. Although a little knowledge can be a dangerous thing, so can a lot! Highly intelligent people can create their own rational argument and ‘bad science’ for example, rounding up a calculation to pass, rather than fail. The job of leadership (at every level) is to maintain high levels of engagement to keep the ‘tick box’ mentality at bay. If your supervisors and first line managers are not visible, approachable and connected to the patient you are in trouble.
  • Drive out FEAR. When people are punished when mistakes are made there is the chance mistakes will be hidden. After all, who likes pain, embarrassment and humiliation?
  • When you have a culture of openness and transparency you are well on the way to fewer data integrity issues, providing you use mistakes and problems as a catalyst for continuous improvement. Remember to focus on the problem and the system, not the person.
  • Make sure your KPIs drive the right behavior and your leaders, at every level, create a “see it, say it, solve it” culture. The more fear, the more data integrity issues.
  • If performance data looks too good to be true, it probably is. For example, if you have very low levels of deviations and OOS’-s, no calibration failures or perfect environmental monitoring data, start digging. Focus on the culture, leadership and measures first.
  • It is worth mentioning the impact of national culture here. It is a simple fact that in “saving face” cultures’- (notably India and China), making a mistake has negative cultural implications. Expecting anyone to celebrate their failures in front of their peers and bosses, in public? That is a big ask. You do not reverse hundreds of years of culture-driven behavior that easily. Companies that expect western ways of thinking to work in different cultures are deluding themselves. A different approach is required.
  • Drive out complexity. High levels of complexity increases the likelihood of data integrity problems. Win your war on complexity and you are a long way towards reducing this risk. Start simplifying your SOPs. In our experience most are overcomplicated, poorly designed and unworkable. So many production lines and labs rely on ‘well intentioned short cuts’- just to keep running. Adding additional check signatures is not the answer. They potentially create a false sense of security and dilute that all-important accountability.
  • Focus on the human element. Data integrity problems are a product of conscious as well as subconscious behaviors. Since 45 percent of decisions are habitual (subconscious), we really need to work hard to understand them. Remember, behaviors are a product of culture, upbringing, education, peers and leadership (at every level) that all combine to create the company culture. If you’re serious about reducing your risk of data integrity issues you must understand the behaviors first.

Your Self-Assessment Questionnaire: Are You at Risk from Data Integrity?

Just answer the following questions to see if your business is heading towards the data integrity “iceberg.” Get together with your colleagues and answer ‘yes or no’ to each of the questions below.

Have you seen performance data that is too good to be true?

Do you consider deviations, OOS’s and the like to be bad news?

Do you encourage your people to reduce deviation incidents?

Do you have a blame culture? Ask the people on the shop floor before you answer this one!

Do you train your people just to push the right buttons, without explaining why?

Do you blame your people for mistakes, rather than focusing on the systems and procedures?

Are your systems and procedures overly complex?

If you have too many yese’-s, start taking action now. You are on course for a data integrity problem.

Next Steps and Resources

  • Read an article on how to prevent data integrity problems by understanding the reasons why it occurs,
  • If you’re interested in finding out more about changing work place behaviors (habits), contact us today - call + 44 (0) 1751 432 999 or email pharmamail@nsf.org

About the Author

Martin Lush has over 30 years’ experience in the pharmaceutical and healthcare industry. He has held senior management positions in QA, manufacturing, QC and supply chain auditing and has conducted audits and education programs for many hundreds of companies in over 25 countries.

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