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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
Pharmacy Practice
•
•
•
•
•
•
•

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

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
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
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
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
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
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
National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP)
Components of Any Culture
•
•
•
•

Values
Attitudes
Norms
Beliefs

• Practices
• Policies
• Behaviors

The way we do business around here
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
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
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
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
The Canadian Framework
of Safety Competencies

Source: The Safety Competencies, Canadian Patient Safety Institute, 2009
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
When and What to Teach
Integrating Patient Safety Education
Into Health Professional Curricula

Source: M. Walton, Sydney School of Public Health, University of Sydney, Sydney, Australia, 2010
Skills Training
•
•
•
•
•
•
•
•
•

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
Miller’s Triangle

Source: Miller GE. The assessment of clinical skills/competence/performance.AcademicMedicine,1990
Educational Principles
•

Main objective of any teaching is
to transfer the (classroom) learning
to workplace

•

Context is highly relevant

•

Contextualize patient safety
principles

•

Use examples that are realistic for
your setting

•

Identify practical applications

•

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
Teaching Styles
• One authority identifies six important roles of
the Teacher/Professor :
– Information provider
– Role model
– Facilitator
– Assessor
– Planner
– Resource producer
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
1. What is patient
safety?

A patient safety model of health care Emmanuel et al 2008
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
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.
Are the lines crooked or straight?
Optillusions.com
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.”
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
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
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.
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
Performance

Am I safe to work today?
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?
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
How can Prescribing Go Wrong?
•

Inadequate knowledge about drug
indications and contraindications

•

Ignoring individual patient factors e.g.
allergies, pregnancy, co-morbidities,
other medications

•

Wrong patient, wrong dose, wrong
time, wrong drug, wrong route

•

Inadequate communication (written,
verbal)

•

Documentation - illegible, incomplete,
ambiguous

•

Mathematical error when calculating
dosage

•

Incorrect data entry when using
computerized prescribing e.g.
duplication, omission, wrong number
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
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
Conclusions
•

A huge body of evidence exists indicating that patients are not always
safe in the modern health care system

•

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

•

Teaching patients safety to health care students like doctors and
pharmacists is one of the best approaches to mitigate some of the
safety problems

•

WHO curriculum guide for multi professionals is a very rich resource to
address teaching and learning of patient safety

•

Patient safety and Pharmacovigilance must be taught and integrated at
both undergraduate and graduate levels of pharmacy educations

•

All highly reliable organizations make sure that safety of the people that
they serve comes first
Acknowledgement: Ms. Raji Nair

Thank you Very Much

42

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Teaching of Patient Safety in Pharmacy Curriculum

  • 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
  • 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: – – – – – 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 • • • • 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 • • • • • • • • • 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 • Contextualize patient safety principles • Use examples that are realistic for your setting • Identify practical applications • 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? • Inadequate knowledge about drug indications and contraindications • Ignoring individual patient factors e.g. allergies, pregnancy, co-morbidities, other medications • Wrong patient, wrong dose, wrong time, wrong drug, wrong route • Inadequate communication (written, verbal) • Documentation - illegible, incomplete, ambiguous • Mathematical error when calculating dosage • 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 • A huge body of evidence exists indicating that patients are not always safe in the modern health care system • 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 • Teaching patients safety to health care students like doctors and pharmacists is one of the best approaches to mitigate some of the safety problems • WHO curriculum guide for multi professionals is a very rich resource to address teaching and learning of patient safety • Patient safety and Pharmacovigilance must be taught and integrated at both undergraduate and graduate levels of pharmacy educations • 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 42

Notas del editor

  1. Agency for Healthcare Research & Quality (AHRQ)
  2. Having contributed and worked in a culture of patient safety, manage safety risks. Optimize human and environmental factors and finally identify and disclose AEs.
  3. This blueprint integrates the patients safety course together with other professional courses in health sciences.
  4. The lines are perfectly straight and parallel. Why don’t they look straight? Our brain is playing a trick on us - the way we perceive things isn’t always what’s going on (reality).
  5. All common situations for inexperienced staff.
  6. All common situations for inexperienced staff.
  7. The optimum level of performance is reached when the level of arousal is neither too high or too low. Boredom is a problem if we are doing a highly automated and repetitive task, e.g. transcribing medication charts: may be easy to commit a transcribing error