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Suitability & Capability of Pharmaceutical Measurement Systems

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The 21st century ushered in the Experience Economy in which Assurance is a critical patient experience that links directly to safety and efficacy of pharmaceuticals. To the only state that Assurance, in and of itself, is critical to quality, safety and efficacy would fail to emphasize its importance. Reduction of errors and external failures (e.g., Product Withdrawals, Recalls, Warning Letters, and Import Alerts) is an urgent need, and it is the need to ensure effective corrective actions and preventive actions and to improve continually. Continuous Improvement means reducing variability in a process. One can only improve a (manufacturing) process that is stable, capable and in a state of (statistical) control. In the pharmaceutical sector, we often talk about continual improvement, but we cannot objectively achieve it for many reasons that span from how we set specifications, use compendial standards, and how we “validated” our measurement systems and “control” manufacturing processes. The goals and aspirations of the FDA initiatives of Process Analytical Technology and Pharmaceutical CGMP’s for the 21st Century should have been realized with the accumulated guidance under ICH and the FDA Guidance on Process Validation (2011). This talk will discuss what it will take to realize these goals and to practice continuous improvement indeed.

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Suitability & Capability of Pharmaceutical Measurement Systems

  1. 1. 21st Century Pharmaceutical Quality Assurance: Suitability & Capability of Measurement Systems Ajaz S. Hussain, Ph.D. President, The National Institute of Pharmaceutical Technology & Education Insight, Advice & Solutions LLC 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 1
  2. 2. ExpectedP1 – ObservationP1 = ∆P1 ExpectationP2 – ObservationP2 = ∆P2 Objective is to reduce the ∆ ∆P1 - ∆P2 = 0 (Satisfaction) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 2
  3. 3. [ExpectedP1]– ObservationP1 = ∆P1 [ExpectationP2]– ObservationP2 = ∆P2 Remove expectancy-effects ∆P1 - ∆P2 ≠ 0 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 3
  4. 4. ObservationP0– ObservationP1 = ∆P1 ObservationP0– ObservationP2 = ∆P2 Double-blinding & Placebo-arm ∆P1 - ∆P2 = 0; 95% CI α =0.05; or ∆𝑃𝑃𝑃 ∆𝑃𝑃𝑃 = 1 (0.8 to 1.25) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 4
  5. 5. Chang, R.S. and Lotti, V.J., 1986. Biochemical and pharmacological characterization of an extremely potent and selective nonpeptide cholecystokinin antagonist. Proceedings of the National Academy of Sciences, 83(13), pp.4923-4926. Colloca, L. and Benedetti, F., 2005. Placebos and painkillers: is mind as real as matter?. Nature Reviews Neuroscience, 6(7), p.545.. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 5
  6. 6. Is mind as real as matter? When words are painful: Unraveling the mechanisms of the nocebo effect. Neuroscience, 147(2), pp.260-271 (2007) Nocebo hyperalgesia: How anxiety is turned into pain. Current Opinion in Anesthesiology, 20(5), pp.435-439 (2007) Getting the pain you expect: Mechanisms of placebo, nocebo and reappraisal effects in humans. Nature medicine, 16(11), p.1277 (2010). The pharmacodynamics of placebo: Expectation effects of price as a proxy for efficacy. Editorial. American Academy of Neurology. February 2015. Interactions between brain and spinal cord mediate value effects in nocebo hyperalgesia. Science, 358(6359), pp.105-108 (2017) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 6
  7. 7. Is mind as real as matter? Nature Reviews Neuroscience (2005) • When words are painful: Unraveling the mechanisms of the nocebo effect. Neuroscience, 147(2), pp.260-271 (2007) • Nocebo hyperalgesia: How anxiety is turned into pain. Current Opinion in Anesthesiology, 20(5), pp.435-439 (2007) • Getting the pain you expect: Mechanisms of placebo, nocebo and reappraisal effects in humans. Nature medicine, 16(11), p.1277 (2010). • The pharmacodynamics of placebo: Expectation effects of price as a proxy for efficacy. Editorial. American Academy of Neurology. February 2015. • Interactions between brain and spinal cord mediate value effects in nocebo hyperalgesia. Science, 358(6359), pp.105-108 (2017) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 7
  8. 8. Pharmaceuticals in the Experience Economy: illustrative examples of changing business models and the rising need for Assurance 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 8
  9. 9. We are experiencing pain and inequality in ways that are unprecedented! 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 9 Data is dated!
  10. 10. Experiencing Automatic Substitution Annals of internal medicine. 161(2), pp.96-103 2014 Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction. The Washington Post. 14 July 2014. If Color or Shape of Generic Pills Changes, Patients May Stop Taking Them. Final Guidance. June 2015 Guidance for Industry. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. Pharmaceutical Quality/CMC. Generics for Me, but a Brand for You! #@* Research in Social and Administrative Pharmacy, 8(6), pp.574-578 (2012)
  11. 11. Levothyroxine Experience in France Aug. 24 2017 Levothyrox: The controversy over one of France's most commonly prescribed drug explained (The Local) Sep. 11 2017 No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe (in-Pharma Technologist.com) Sep. 16 2017 France to bring back old thyroid drug after complaints (RFI) Oct. 4 2017 Police raid Merck pharmaceutical plant amid mysterious drug crisis. Is something wrong with hormone therapy or are patients over-reacting? (arsTECHNICA) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 11
  12. 12. Experience New & Improved Formulation! Assuring the Quality of the Most Prescribed Drug New formulation launched in France, March 2017 Within a few weeks, the social media started buzzing. The backlash intensified; the media storm posed political problem for the French government! Just wondering if anyone else is taking the new Levo formula from XYZ. I've been on it about 2 or 3 weeks and so far gained three kilos. 😩😩! “France brings back a phased-out drug after patients rebel against its replacement” - Science Magazine. 27 September 2017 Germany, New Zealand,….
  13. 13. A hurricane: BAD-I • Widespread breaches in the assurance of data integrity • Pharmaceuticals • Automobile • All over • Companies Everywhere Copied Japanese Manufacturing. Now the Model is Cracking: Concepts celebrated in business publications worldwide have been tarnished by a sting of scandals. The Wall Street Journal, 4 February 2018. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 13
  14. 14. Illusions of Quality (Gold Sheet 2014) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 14
  15. 15. Hurricane in our mind matters! 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 15
  16. 16. Without the burden of BAD-I: It took Amgen About 10 years to 6 σ * *Ajaz Hussain. How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen). Pharmaceutical Online. September 2017. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 16
  17. 17. A short history of Pharma’s key process quality methodology by Ron Snee! • First is the fact that major changes — so-called paradigm shifts — take a long time — sometimes a generation or more before a new idea becomes standard practice. The adoption of a new idea moves forward most rapidly when a major need has been clearly identified and agreed upon, a usable solution has been developed, and clearly and continuously articulated by the adopters. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 17
  18. 18. To Err is Human & Pharmaceutical Quality for the 21st Century 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 18
  19. 19. Healthcare sectors • Electronic Medical Records • Quality improvement programs • Example – fractal-based quality management infrastructure, lean six sigma, at Johns Hopkins • Patient satisfaction, outcome and sustainability metrics • Professional Development • Need to change the current culture of continuing education to focus on Continuous Professional Development (IOM, 2010) 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 19
  20. 20. Goodbye Gauss, hello Pareto: Welcome to the Experience Economy! • Welcome to the Experience Economy (Harvard Business Review, 1998) • The End of Rational Economics (Harvard Business Review, 2009) • Average Is Over: Powering America Beyond the Age of the Great Stagnation. Tyler Cowen, Publisher - Penguin Group, 2013. • If color or shape of generic pills changes, patients may stop taking them. Washington Post. 14 July 2014. • Why is the Placebo Effect Exploding in the U.S. But Nowhere Else? Forbes. 7 October 2015. • Side Effects Skyrocket in France With Levothyroxine Reformulation. Medscape. 11 October 2017. Andriani, P. and McKelvey, B., Perspective—From Gaussian to Paretian thinking: Causes and implications of power laws in organizations. Organization Science, 20(6), pp.1053-1071. (2009). 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 20
  21. 21. 4 A grades we must achieve! 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 21
  22. 22. Order of Consciousness 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 22
  23. 23. Standing on shoulder of giants…. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 23
  24. 24. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 24
  25. 25. To Cause the Desired Effect: From Gaussian to Paretian thinking: Design thinking, to Systems thinking,… the Power Law ISO to ICH Q10 Deming's Theory of Profound Knowledge 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 25
  26. 26. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 26
  27. 27. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 27
  28. 28. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 28
  29. 29. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 29
  30. 30. 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 30
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  32. 32. Let us recognize our expectancy effects in the real world! 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 32
  33. 33. We can choose to keep our blindfolds, or we can agree to see an elephant in the dark. • Our development is reflected at times of challenge and controversy. The mounting challenges and controversies today are a reflection of our current order of consciousness. We will never solve the problems tomorrow with the same order of consciousness we are using to create the problems of today. We must be the change. To do so, we must pay attention to a canary which is already in the coals of our mind. We must agree to see the elephant in the dark. Only by our commitment to hold high our knowledge candles, and to be together strong, we genuinely are suitable and capable of confronting risks lurking in our collective darkness. We are in the dark, our candles held high, no one but us know how secure or insecure we feel inside. It doesn’t matter as long as we remain committed to illuminating the darkness. In doing so, we raise our order of consciousness! 3/20/2018 ©Copyright 2017-2018 Ajaz S. Hussain, Ph.D. 33

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