Reducing the Risk in Risk Management - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Reducing the Risk in Risk Management
A firm grasp of probability and ongoing re-evaluation are key.


Pharmaceutical Technology
Volume 35, Issue 8, pp. 36, 39


Lynn D. Torbeck
Has risk management gone mainstream? One might think so given the June 13, 2011 article in the Chicago Tribune on using the game of poker to train stockbrokers in the nature of risk (1).

In the pharmaceutical industry, the reception of International Conference on Harmonization Guidelines Q8, Q9, and Q10 has led to widespread discussion, if not implementation, of the Quality Trio guidelines, with ICH Q9 specifically addressing risk management.

While it is perhaps too early to say that risk management has gone mainstream, it has certainly had its fair share of news coverage of late. Due to a rare 9.0 magnitude earthquake and an unprecedented 45-ft tsunami that washed over the nuclear power plant in Fukushima, three out of six reactor cores melted down—the worst possible outcome. It will take decades and billions of yen to clean up.

The world was stunned by that event. If a highly-regulated industry run by a detail-oriented and meticulous culture such as Japan made this mistake, what chance do the rest of us have at risk management? Which raises the questions, what are the risks in risk management and can we reduce them? First it is important to define terms.

In ICH Q9, risk to a patient equals probability times severity. What is probability? We can do little better than this observation from Bernoulli in 1713:

"For it should be presumed that a particular thing will occur or not occur in the future as many times as it has been observed, in similar circumstances, to have occurred or not occurred in the past." —D. Bernouilli

This definition has been refined since then. Here are the three common definitions given:

  • An undefined subjective measure of belief from personal estimate, gut feeling or intuition
  • The observed frequency of outcomes, as a fraction, percentage or a proportion
  • A theoretical characteristic of the situation as determined by the limiting frequency of an infinite random series.

I note with concern and dismay that ICH Q9 does not include probability in the list of definitions. Perhaps the authors assume that everyone has the same universal understanding of this complex topic, so a definition is not needed.

Severity is the second component of risk and is defined in ICH Q9 as "a measure of the possible consequences of a hazard" (i.e., a meltdown). Now, let's turn to key steps for mitigating the risk in risk management.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
30%
Breakthrough designations
10%
Protecting the supply chain
40%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here