Msrc types research

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
1

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
2
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
3

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
4
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
5

6. Epidemiological Formula--
Mathematical Consideration
Y = α + βX1 + βX2 + βX3 + βX4+…..+ε
6
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.
7

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.
8

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.
9

10. Conducting Research on Medication Safety
Study population
• Patients
• Healthcare providers
(Physicians, Pharmacists, or Nurses)
Target population Outcome
Target
Population
Research Area
Causative
factors
10

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%)
11
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
12

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
13

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
14

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
15

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
16

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
17

18. Conclusions – Connect the dots
18
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
19
Outcome
Target
Population
Research Area
Causative
factors
Dispensing of contraindicated drugs
(Pregnancy)
Pregnant Women
Women Health
• Age
• Comorbid
conditions
• Prescriber

20. 20