The document discusses the role of forensic chemistry in pharmaceutical science and practice. It argues that forensic chemistry should be an important part of pharmacy education to improve assurance of authenticity, availability, and adherence. This can be achieved through evidence-based methodologies applied in real-world settings and a focus on continual improvement. The overall goal is to meet the needs of patients and stakeholders through authentic products and an integrated systems approach.

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2. The Technical Implications
of Forensic Chemistry in
Pharmaceutical Science and
Practice
Ajaz S. Hussain, Ph.D.10/19/2018 Ajaz S. Hussain, Ph.D. 2

3. Forensic Chemistry in Pharmaceutical
Science and Practice
• Why: Authenticity, Availability, Assurance, Adherence
• How: Causal evidence-based methodologies for the real world
• What: Continual Improvement: Good Professional Practitioners
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4. Real World Assurance in 21st Century Cures
• Practice of Pharmacy evolving to provide real world assurance to meet the needs
and expectations of 21st Century Cures [Act].
• Forensic chemistry, broadly forensic science, should be a significant part of
pharmacy education to improve the global system for ensuring authenticity,
availability, assurance, adherence, ….
• Countering the challenge of counterfeits is only one aspect, ideally Forensic
Science is a part of an integrated systems approach
• Know-how of forensics science can strengthen skills pharmacists need to improve
pharmacovigilence and patient satisfaction and be an important source of
feedback for continually improving the global system
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5. Practice of Pharmacy
21st Century Cures
• Authenticity
• Affordability
• Availability
• Assurance
• Adherence
• “Value based pricing”
• “Outcome based
reimbursement”
• “Pay for performance”Hussain, A. S. How to Build and Maintain an Effective Pharmaceutical Quality
Management System. In Press, Elsievier (2018). © Ajaz S. Hussain.
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6. Practice of Pharmaceutical Forensics
AUTHENTICITY AFFORDABILITY AVAILABILITY ASSURANCE ADHERENCE
Field -Lab – Bench-side Quality, Shelf-life (extension) Validity & improvement Monitor & improve
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7. Authentic pharmaceuticals:
Proven better than placebo
• Counterfeits hide behind
the placebo effects
• The placebo effect is for
real
• The power of suggestion is
a double-edged sword
• Nocebo: Placebo’s evil
twin
• The first evidence of a
physiological basis for the
placebo effect obtained in
the late 1970s
• What, if any, are the
implications of placebo
and nocebo effects in the
real world?
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“Canary in the Coal Mine”: Need for Assurance in real world

11. Real World Evidence
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“Canary in the Coal Mine”: Need for Assurance in real world

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“Canary in the Coal Mine”: Need for Assurance

13. Risk of substandard
pharmaceuticals
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15. Shelf life extension program (SLEP)
• SLEP has been administered by the Food
and Drug Administration for the United
States Department of Defense (DOD) for
about 30 years
• Based on testing and stability assessment,
88% of the lots were extended at least
1 year beyond their original expiration
date for an average extension of
66 months, but the additional stability
period was highly variable.
• The SLEP data supports the assertion that
many drug products, if properly stored,
can be extended past the expiration date.
• Due to the lot-to-lot variability, the
stability and quality of extended drug
products can only be assured by periodic
testing and systematic evaluation of each
lot.
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Lyon, R.C., Taylor, J.S., Porter, D.A., Prasanna, H.R. and Hussain, A.S.,
2006. Stability profiles of drug products extended beyond labeled
expiration dates. Journal of Pharmaceutical Sciences, 95(7),
pp.1549-1560.

16. Building on Authenticity
Ajaz S. Hussain, Ph.D.
• Authentic generic or brand
products and evidence;
defines suitability
• Capability is in their
assurance of product,
processes and practice
quality
• An unaffordable
vulnerability; ~ 1 million
people die annually after
taking fake drugs (WHO
estimates).
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17. Forensic Science: To
prevent growing risk
• Technology
• Streamline “Rapid
Response”
• Education & reporting
• Alert networks, information
dissemination & education
• Business practices
• Rules, regulations &
enforcement
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19. Capabilities of counterfeiters evolve rapidly
No “magic bullet”
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20. No “magic
bullet”
• Know-how of forensics science
can strengthen skills pharmacists
need in 21st Century
• Improve pharmacovigilence and
patient satisfaction and be an
important source of feedback for
continually improving the global
system
• Building on Authenticity –
precision, accuracy,
reproducibility and repeatability –
the discipline of Forensic
Chemistry
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21. Investigations:
Effects to Causes
• Rapid response investigation (case by
case)
• After action review and investigations
(case by case)
• Synthesis of case-by-case to inform
policies and procedures (prevention)
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22. Research to Procedure
• US FDA’s CD3+, a counterfeit
detection tool
• Based on sample
illumination at specific
wavelengths of light
• Visual comparison to an
authentic sample
• Benchmarking to existing
screening tools; sensitivity,
specificity, and reliability
• Field testing (e.g., in Ghana)
Malar J. 2016; 15: 119. Published online 25 Feb 2016
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23. Procedure in Practice
• Quality Management System
• Management requirements
• Technical requirements
• Operations
• Training
• Change control
• Continual improvement
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24. ISO 17025 ORA
Laboratory
Procedures: Section
2 – Technical
Requirements
• General
• Personnel :Training Procedure
• Facilities and Environmental
Conditions
• Test Methods & Validation
• Methods, Method Verification
and Validation
• Estimation of Uncertainty of
Measurement
• Equipment
• Instrument and Equipment
Documentation and Records
• Measurement Traceability
• Sampling
• Sample Management
• Assuring the Quality of Test
Results
• Reporting Laboratory Data
• Operations, Applications
and Programs
• Environmental Health
and Safety
• Chain of Custody –
Sample Handling
• Recording of Results -
Analyst’s Worksheet
• Basic Statistics and
Presentation
• Analysts on Inspection
• Method Development
and Validation Program
• Private Laboratory
Guidance
• Courtroom Testimony
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25. Forensic Science
• Research (investigations),
practice, and evidence:
Science based and must
provide confidence in the
legal context
• Applied research, derivative
by nature and design, and it
emphasizes metrology and
validation
• Systems orientation and
integration of evidence
across “life cycles”
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26. Why: Authenticity, availability, assurance, adherence
How: Evidence based decisions in the real world
What: Continual Improvement: Good Professional Practitioners
Real-world evidence, maximize desired outcomes, vigilance, feedback,
and continual improvement to achieve satisfaction for all!