Analytical Profile of Coleus Forskohlii | Forskolin .pptx
Msrc types research (1)
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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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
In order to do a research on Medication Safety, we need to formulate our Research Question
Causative factors
Target Population
Area of Research
Outcome
he basic require-
ments for epidemiological study include: a clear study
design; and an operational definition for the numerator,
the condition to be evaluated; and for the denominator,
the population in which it is to be evaluated.These require-
ments pose problems when the object of study is error
Defining Medication Error?
Using knowledge gained from the epidemiologic studies, we designed, implemented, and evaluated a series of projects for patients who: (1) are prescribed critically interacting drugs (Critical Drug Interactions); (2) receive anticoagulation treatment and are prescribed drugs that interact with warfarin (Warfarin-Drug Interactions); (3) receive high-risk drugs requiring laboratory monitoring (High-Risk Drug Lab Monitoring); (4) have chronic kidney disease and are prescribed drugs requiring dosage adjustment based on renal function (Renal Dosing); (5) are 1 pregnant and are prescribed drugs that are contraindicated during pregnancy (Prescribing during Pregnancy); or (6) are elderly and are prescribed drugs considered inappropriate in that age group (Prescribing in the Elderly).
Nursing staff do employ the traditional 'five right' principles - right patient, right medication, right dose, right route and right time - for safe administration.
The data indicated 5,366 medication error reports.
Fifty-nine reports were excluded and classified as duplicate reports or intentional overdoses. Of the remaining medication error reports, 68.2% resulted in serious patient outcomes and 9.8% were fatal. Of the 469 fatal medication error reports, 48.6% occurred in patients over 60 years. The most common types of errors resulting in patient death involved administering an improper dose (40.9%), administering the wrong drug (16%), and using the wrong route of administration (9.5%). The most common causes of errors were performance and knowledge deficits (44%) and communication errors (15.8%). Fatal medication errors accounted for approximately 10% of medication errors reported to FDA and were most frequently the result of improper dosing of the intended drug and administration of an incorrect drug. A review of case reports of medication errors from 1993 to 1998 yielded information on the most frequent causes of and contributing factors involved in fatal medication errors.