1. Teaching of Patient Safety in
Pharmacy Curriculum
Presented at the 3rd Annual Conference of SPER at
Lovely Professional University, Punjab, India, March 8, 2014
Dr. Bhaswat S Chakraborty
Sr. Vice President & Chair – R&D Core Committee
Cadila Pharmaceuticals Ltd

2. Pharmacy Practice
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Academia, Research
Industry
Community
Hospital
Regulatory
Long term care
…
All need to be concerned with patient safety

3. Examples of Public Safety Initiatives
(USA)
• NTSB – Evolution of the Air Commerce Act of 1926
• 1938 Food Drug and Cosmetic Act
• OSHA – Occupational Safety and Health Act of 1970
• Departments of Public Safety (fire, rescue, ambulance, police
etc.)
• Homeland Security Act of 2002
All countries have such legislation

4. Context
Authors
Linda T. Kohn, Janet M. Corrigan, and Molla S.
Donaldson, Editors; Committee on Quality of
Health Care in America, Institute of Medicine
Description
•Experts estimate that as many as 98,000
people die in any given year from medical
errors that occur in hospitals.
•That's more than die from motor vehicle
accidents, breast cancer, and AIDS
•Financial cost to the human tragedy, and
medical error easily rises to the top ranks
of urgent, widespread public problems.

5. To Err is Human:
Building a Safer Health System
• This book was the first report within a larger project
(Quality of Healthcare in America)
• Developed by 38-person committee
• Rationale:
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Immense burden of harm
Preventable and shouldn’t happen
Understandable concept by Americans
Sizeable evidence base
Healthcare system is rapidly evolving
Probably this was not expected of a health care system

6. To Err is Human:
Building a Safer Health System
Major Recommendations (National Agenda):
• Center for Patient Safety within AHRQ
• Nationwide mandatory reporting system (death/serious
harm) and encourage voluntary reporting of all errors
• Peer-review protections to data
• Performance standards and expectations
• Safe use of drugs (pre and post marketing)
• Priority for organizations and professionals

7. To Err is Human:
Building a Safer Health System
“ A major force for improving patient safety is the
intrinsic motivation of healthcare providers, shaped
by professional ethics, norms and expectations”
• Definitions:
– Safety – Freedom from accidental injury
– Error – Failure of a planned action to be completed as
intended OR use of a wrong plan to achieve an aim
– Harm – any negative outcome

8. Three Reporting Categories
• Incident: Any unintended or unexpected incident which could
have, or did, lead to harm for one or more patients
• Near miss or Close call: An event or situation that did not
produce patient injury, but only because of chance
• Unsafe condition: Unsatisfactory physical condition existing in
the workplace environment immediately prior to an incident
or event
All three categories must be attended

9. High-Reliability Organizations (HROs)
• Operate in hazardous conditions and have fewer
than expected adverse events
• Examples:
– air traffic control, nuclear power plants, aircraft carriers.
• Common Key Features
– Preoccupation with failure
– Sensitivity to operations
– Culture of safety
All HROs have characteristic hazard minimization approach

10. National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP)
• Four categories of reporting
– Error
– Error, No harm
– Error, Harm
– Error, Death
Probably this was not expected of a health care system

11. National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP)

12. Components of Any Culture
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Values
Attitudes
Norms
Beliefs
• Practices
• Policies
• Behaviors
The way we do business around here

13. Culture of Safety
Key Features:
• Acknowledge high-risk nature
• Achieve consistently safe operations
• Promote blame-free environment that encourages
the reporting of errors and near misses
• Employ collaboration (ranks/disciplines) to seek
solutions to safety problems
• Organizational commitment of necessary resources

14. Measuring Safety Climate
Elements Commonly Measured:
• Easy to learn from mistakes
• Errors are handled appropriately
• Clinical leaders listen to me and care about my
concerns
• Leadership is safety-driven
• My suggestions are acted upon
• I am encouraged to report safety concerns
• I know proper administrative channels
Mistakes are not ignored rather learned from

15. Why Patient Safety Education for
Pharmacists?
• Health care system is an enormous bliss to humanity and yet there
are horrific errors and system failures
• All health-care students, including Pharmacists, must prepare
themselves to practise safe care
• Patient safety knowledge applies to all areas of practice
• Pharmacists need to know and manage
– how systems impact on the quality and safety of health care
– how poor communication can lead to AEs
– More...
• Patient safety is not a traditional stand-alone discipline; rather, it is
one that integrates into all areas of health care
Pharmacist provide multi-level resistance to errors & harms

16. How were WHO Curriculum
Guide topics selected?
• The Curriculum Guide covers 11 topics
• A lot came from Australian and Canadian experiences
• Three main stages were used in the development of the Framework
content and structure
– initial review of knowledge and development of framework outline
– additional searching for content and assignment of knowledge, skills,
behaviours and attitudes
– development of performance-based format
• The Canadian approach provides an interprofessional, practical and
useful patient safety framework
– using knowledge, skills, and attitudes required by all health-care
professionals

17. The Canadian Framework
of Safety Competencies
Source: The Safety Competencies, Canadian Patient Safety Institute, 2009

18. The WHO Curriculum Guide Topics
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
What is patient safety?
Why applying human factors is important for patient safety
Understanding systems and the effect of complexity on patient care
Being an effective team player
Learning from errors to prevent harm
Understanding and managing clinical risk
Using quality-improvement methods to improve care
Engaging with patients and carers
Infection prevention and control
Patient safety and invasive procedures
Improving medication safety
The topics are taught over 4-5 curricular years

19. When and What to Teach

20. Integrating Patient Safety Education
Into Health Professional Curricula
Source: M. Walton, Sydney School of Public Health, University of Sydney, Sydney, Australia, 2010

21. Skills Training
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Communicating risk;
Asking permission;
Accepting refusal;
Being honest with patients;
Empowering patients–helping patients be active participants in
their own care;
Keeping patients and relatives informed;
Hand hygiene;
Patient-centred focus during history taking and appropriate
examinations;
Clinical reasoning–diagnostic error, consideration of risk benefit
ratio of procedures, investigations and management plans.
Skills are practiced over & over

22. Miller’s Triangle
Source: Miller GE. The assessment of clinical skills/competence/performance.AcademicMedicine,1990

23. Educational Principles
•
Main objective of any teaching is
to transfer the (classroom) learning
to workplace
•
Context is highly relevant
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Contextualize patient safety
principles
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Use examples that are realistic for
your setting
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Identify practical applications
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Use examples that are of interest
or soon will be relevant to students
Case example
While observing a surgical
operation, a nursing student
notices that the surgeon is
closing the wound and there is
still a pack inside the patient.
The student is not sure if
the surgeon is aware of the
pack and is wondering whether
to speak up.
Right teaching will teach her to
speak up in all such situations
Inspiration to do

24. Teaching Styles
• One authority identifies six important roles of
the Teacher/Professor :
– Information provider
– Role model
– Facilitator
– Assessor
– Planner
– Resource producer

25. The WHO Curriculum Guide Topics
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
What is patient safety?
Why applying human factors is important for patient safety
Understanding systems and the effect of complexity on patient care
Being an effective team player
Learning from errors to prevent harm
Understanding and managing clinical risk
Using quality-improvement methods to improve care
Engaging with patients and carers
Infection prevention and control
Patient safety and invasive procedures
Improving medication safety

26. 1. What is patient
safety?
A patient safety model of health care Emmanuel et al 2008

27. Patient Safety
• Students should:
– understand the multiple factors involved in
failures
– avoid blaming
– practise evidenced-based care
– maintain continuity of care for patients
– be aware of the importance of self-care
– act ethically everyday

28. 2. What is human factors?
• The study of all the factors that make it easier to do the
work in the right way
• Apply wherever humans work
• also sometimes known as ergonomics
• Examples
• order medications electronically
• hand off information
• move patients
If all of these tasks become easier for the health-care
provider, then patient safety can improve.

29. Are the lines crooked or straight?
Optillusions.com

30. What is an error?
• The failure of a planned action to achieve its intended
outcome
• A deviation between what was actually done and what should
have been done
• Easier: “Doing the wrong thing when meaning to do the right
thing.”

31. Situations associated with an
increased risk of error
• unfamiliarity with the task*
• inexperience*
• shortage of time
• inadequate checking
• poor procedures
• poor human equipment interface
Vincent
* Especially if combined with lack of supervision

32. Performance level
Stress and Performance
Area of
“optimum”
stress
High stress
Anxiety, panic
Low stress
Boredom
Stress level
Yerkes, R. M., & Dodson, J. D. (1908) The relation of strength of stimulus to rapidity of habit-formation.
Journal of Comparative Neurology and Psychology, 18, 459-482

33. 2. Systems and Effect of Complexity
on Patient Care
• The study of all the factors that make it easier to do the work
in the right way
• Apply wherever humans work
• also sometimes known as ergonomics
• Examples
• order medications electronically
• hand off information
• move patients
If all of these tasks become easier for the health-care
provider, then patient safety can improve.

34. 5. Learning from Errors to Prevent Harm
• Error: Doing the wrong thing when meaning to do the right
thing
• Violation: A deliberate deviation from an accepted protocol or
standard of care
• Incident monitoring: collecting and analysing information
about any events that could have harmed or did harm anyone
in the organization
• Incident monitoring: a fundamental component of an
organization’s ability to learn from error
Error management is removing error traps by monitoring

35. Performance
Am I safe to work today?

36. Root Cause Analysis
• A rigorous, confidential approach to answering:
– What happened?
– Why did it happen?
– What are we going to do to prevent it from happening
again?
– How will we know that our actions improved patient
safety?

37. 11. Improving Medication Safety
• Prescribing involves choosing an appropriate medication for a
given clinical situation taking individual patient factors into
account such as allergies
• selecting the administration route, dose, time and regimen
• communicating details of the plan with:
– whoever will administer the medication (written-transcribing and/or
verbal)
– and the patient
• documentation

38. How can Prescribing Go Wrong?
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Inadequate knowledge about drug
indications and contraindications
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Ignoring individual patient factors e.g.
allergies, pregnancy, co-morbidities,
other medications
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Wrong patient, wrong dose, wrong
time, wrong drug, wrong route
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Inadequate communication (written,
verbal)
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Documentation - illegible, incomplete,
ambiguous
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Mathematical error when calculating
dosage
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Incorrect data entry when using
computerized prescribing e.g.
duplication, omission, wrong number

39. Look-a-like and Sound-a-like Medications
• Celebrex (an anti-inflammatory)
• Cerebryx (an anticonvulsant)
• Celexa (an antidepressant)
• Avoiding such confusion
– know accepted local terminology
– write neatly, print if necessary
– avoid trailing zeros
• e.g. write 1 not 1.0
– use leading zeros
• e.g. write 0.1 not .1

40. Finally, Pharmacovigilance
• Any curriculum in patient safety would be incomplete without
teaching pharmacovigilance (PV)
• PV has emerged as a standalone course and a well practiced
domain of patient safety all over the world
• PV involves
– Monitoring, evaluation and implementation of drug safety
– Detection and quantitation
• of adverse drug reactions (ADRs)
• novel or partially known
– previously unknown
– known hazard ↑frequency or ↑severity
• in their Clinical nature, Severity or Frequency

41. Conclusions
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A huge body of evidence exists indicating that patients are not always
safe in the modern health care system
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Harm mainly comes from therapeutic failures, medication errors,
neglect of patients, wrong dispensing, inadequate supply and also lack
of education and good practices of care givers
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Teaching patients safety to health care students like doctors and
pharmacists is one of the best approaches to mitigate some of the
safety problems
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WHO curriculum guide for multi professionals is a very rich resource to
address teaching and learning of patient safety
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Patient safety and Pharmacovigilance must be taught and integrated at
both undergraduate and graduate levels of pharmacy educations
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All highly reliable organizations make sure that safety of the people that
they serve comes first

42. Acknowledgement: Ms. Raji Nair
Thank you Very Much
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