This document discusses opportunities for medication safety research. It defines medication errors and outlines the National Coordinating Council for Medication Error Reporting and Prevention's classifications of medication errors. Research on medication safety is important to understand error causes and reduce errors. Key areas for research include outcomes, target populations, factors that cause errors, and intervention studies. Quantitative research using large databases can study prescribing patterns and adverse drug events while qualitative research explores human, process, and system factors contributing to errors. The document provides examples of potential medication safety studies.

1. Medication Safety Research: Types
and Opportunities
Monira Alwhaibi, Assistant Professor
Clinical Pharmacy Department, College of Pharmacy
Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia
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2. Medication Errors
 Any preventable event that may cause or lead to inappropriate medication use
or patient harm
 These errors may be related to professional practice, health care products,
procedures, and systems, including prescribing; order communication; product
labelling, packaging, and nomenclature; compounding; dispensing;
distribution; administration; education; monitoring; and use
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The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP)

3. – an adverse event if a patient is harmed
– a near miss if a patient is nearly harmed or
– neither harm nor potential for harm
A medication error may result in (Patient Outcome
Categories)–…
Medication errors are preventable
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4. Why do we need Research on Medication Safety
• Understand the factors that cause Medication Errors
• A step to reduce Medication Errors
• It is difficult to reduce or eliminate medication errors when information on
their prevalence is absent, inaccurate, or contradictory
• One of the Institute of Medicine (IOM) priority area for transforming health
care
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Raebel, M. A., Chester, E. A., Brand, D. W., & Magid, D. J. (2008). Imbedding Research in Practice to Improve Medication Safety.

5. Conducting Research on Medication Safety
Outcome
Target
Population
Research Area
Causative
factors
OR
Intervention
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6. Epidemiological Formula--
Mathematical Consideration
Y = α + βX1 + βX2 + βX3 + βX4+…..+ε
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Causative
factors/Intervention
Outcome

7. Conducting Research on Medication Safety
Outcome
• Preventable adverse drug events (pADEs)
• Hospital Admission due to Medication Errors
• Emergency Department Visit
• Death
• Prescribing pattern
 Codispensing of interacting drugs
 Dispensing of contraindicated drugs (Pregnancy)
 Prescribing of drugs to be avoided (elderly)
 Dosage adjustment (Kidney disease)
• INR monitoring (warfarin)
• laboratory monitoring for High-Risk Drug
Outcome Outcome
Target
Population
Research Area
Causative
factors
Raebel, M. A., Chester, E. A., Brand, D. W., & Magid, D. J. (2008). Imbedding Research in Practice to Improve Medication Safety.
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8. Conducting Research on Medication Safety
Research Area
Three drug categories were responsible for 86.5% of pADEs:
• cardiovascular drugs,
• analgesics, and
• hypoglycaemic agents.
Research Area Outcome
Study
Population
Research Area
Causative
factors
Thomsen, L. A., Winterstein, A. G., S ndergaard, B., Haugb lle, L. S., & Melander, A. (2007). Systematic review of the incidence and characteristics of
preventable adverse drug events in ambulatory care. Annals of Pharmacotherapy, 41(9), 1411-1426.
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9. Conducting Research on Medication Safety
Research Area
• Cardiovascular
• Genetic
• Infectious
• Oncology
• Psychiatric
Research Area Outcome
Study
Population
Research Area
Causative
factors
Thomsen, L. A., Winterstein, A. G., S ndergaard, B., Haugb lle, L. S., & Melander, A. (2007). Systematic review of the incidence and characteristics of
preventable adverse drug events in ambulatory care. Annals of Pharmacotherapy, 41(9), 1411-1426.
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10. Conducting Research on Medication Safety
Study population
• Patients
• Healthcare providers
(Physicians, Pharmacists, or Nurses)
Target population Outcome
Target
Population
Research Area
Causative
factors
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11. Data indicated
5,366 medication
error reports
68.2% resulted in
serious patient
outcomes
9.8% were fatal
48.6% occurred in
patients over 60
years
Improper dose
(40.9%)
Wrong drug (16%)
Wrong route of
administration
(9.5%)
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Phillips, J., Beam, S., Brinker, A., Holquist, C., Honig, P., Lee, L. Y., & Pamer, C. (2001). Retrospective analysis of mortalities associated with medication
errors. American Journal of Health-System Pharmacy, 58(19), 1835-1841.

12. Factors related to safety Issues in Clinical Practice
• Human Factors
• Process Factors
• System Factors
The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) , NCC MERP Taxonomy of Medication Errors
Outcome
Target
Population
Research Area
Causative
factors
Causative Factors
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13. Factors related to safety Issues in Clinical Practice
• Individual characteristics
• Skill/education/ experience
• Knowledge of medications
• Fatigue/Lack of Sleep
• Miscalculation of Dosage or Infusion Rate
• Inadequate screening for allergies, interactions, etc.
Human Factors
The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) , NCC MERP Taxonomy of Medication Errors
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14. Factors related to safety Issues in Clinical Practice
• Documentation of medication
• Supervision
• Medication management and patient monitoring
• Adhering to protocols for medication administration
• Lack of double checking
• Failure to follow policies and procedures
• Unclear orders
• Implementation of medication safety practices
Process Factors
The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) , NCC MERP Taxonomy of Medication Errors
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15. Factors related to safety Issues in Clinical Practice
• Workload and staffing
• Organizational climate (Lighting, Noise Level , etc.)
• Length of work shift
• Frequent Interruptions and distractions
• Communication systems between health care practitioners
• Patient counselling
System Factors
The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) , NCC MERP Taxonomy of Medication Errors
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16. Research Types to Assess Medication Safety?
• Quantitative Research
– Patient Reported Outcomes
– Big Data Analysis
– Meta-anlaysis, Systematic Review
– Cost analysis
• Qualitative Research
Research Types
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17. Quantitative Research -- Big Data Analysis
 What Outcomes could be identified from EHR?
• Prescribing pattern:
 Codispensing of interacting drugs
 Dispensing of contraindicated drugs (Pregnancy)
 Prescribing of drugs to be avoided (elderly)
 INR monitoring (warfarin)
 Dosage adjustment (Kidney disease)
 laboratory monitoring for High-Risk Drug
 What Information could be identified from FDA reports?
 Preventable adverse drug events (pADEs) -- (Harmful, Not harmful)
 Population
 Causes
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18. Conclusions – Connect the dots
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Outcome
Target
Population
Research Area
Causative
factors
Preventable Adverse Drug Events
Elderly Patients with
cardiovascular disease
Cardiovascular
• Pharmacist
counseling
• Age
• Comorbid
conditions
• Prescriber
• Encounter type
• Polypharmacy
Use

19. Conclusions – Connect the dots
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Outcome
Target
Population
Research Area
Causative
factors
Dispensing of contraindicated drugs
(Pregnancy)
Pregnant Women
Women Health
• Age
• Comorbid
conditions
• Prescriber

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