Risk-Informed Interventions in Community Risk-Informed Interventions in Community Pharmacy: Implementation and Evaluation Pharmacy: Implementation and Evaluation Michael R. Cohen (Principal Investigator) Judy L. Smetzer (Project Manager) Institute for Safe Medication Practices September 14, 2009
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Risk-Informed Interventions in Community Pharmacy: Implementation and Evaluation Michael R. Cohen (Principal Investigator) Judy L. Smetzer (Project Manager)
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Risk-Informed Interventions in Community Pharmacy: Risk-Informed Interventions in Community Pharmacy: Implementation and Evaluation Implementation and Evaluation
Michael R. Cohen (Principal Investigator)
Judy L. Smetzer (Project Manager)
Institute for Safe Medication Practices
September 14, 2009
ISMP 2009 Institute for Safe Medication Practices 2
Current Research Project
Risk-informed Interventions in Community Pharmacy: Implementation and Evaluation
Three interventions
1) Scripted mandatory patient counseling for targeted high-alert medications
2) Readiness assessment for bar-coding technology
3) Risk assessment/intervention scorecard
ISMP 2009 Institute for Safe Medication Practices 3
Prior Study Aims
Using Risk Models to Identify and Prioritize Outpatient
High-Alert Medications
• Identify a list of high-alert medications dispensed from community pharmacies– Available error data, ISMP surveys, review of literature, litigation
data,
• Develop comprehensive risk models for four high-alert medications (ST-PRA) using model building teams with facilitators– Warfarin, fentanyl transdermal, insulin analogs, methotrexate oral
• Identify error pathways that have the highest probability of causing harm (fault trees)
• Identify and determine the impact of approaches for eliminating or reducing the risk of harm
ISMP 2009 Institute for Safe Medication Practices 4
High-Alert Medications
Drug Class/CategoryDrug Class/Category
• Antiretroviral agents
• Chemotherapy, oral
• Hypoglycemic agents, oral
• Immunosuppressant agents
• Insulin
• Opioids, all formulations
• Pregnancy category X drugs
• Pediatric liquid medications that require measurement
Individual DrugsIndividual Drugs
• carbamazepine
• chloral hydrate liquid – sedation of children
• heparin– unfractionated/low-molecular weight
• methotrexate– non-oncologic use
• midazolam liquid– sedation of children
• propylthiouracil
• warfarin
ISMP 2009 Institute for Safe Medication Practices 5
– Socio-technical aspects • At-risk behaviors and procedural deviations
• Mechanical/technology failures
• Some data readily available in community pharmacies
– Rx volume, exposure rates, technologies and percent of use, computer alerts followed, presence of certain steps or processes like use of drive through window, availability of 24 hr pharmacy, opening bag at P.O.S.
ISMP 2009 Institute for Safe Medication Practices 7
• ST-PRA models translated into practical assessment tool and scorecard
• Tool Kit will include:– Introduction – Key learning from risk models (prior study)– User instructions– HAMERS tool
• Scorecard with qualitative (distribution of risk) and quantitative (PADE rates) information
• Tool calculations driven by reports from original risk models
ISMP 2009 Institute for Safe Medication Practices 20
Intervention 3: HAMERS
Inputs
• Set-up questions– Relevance: Would the step provide capture opportunity?– System attributes: Require data entry verification for pharmacists?– Availability: Use bar-coding technology? Specific computer alerts?– Prescription volumes?
• Exposure rates– Frequency of pharmacists/technicians entering prescriptions?
• Capture opportunities– What percent of errors will be caught during this step?
• At-risk behaviors– Frequency of choosing not to ask patient for second identifier?
• Human errors– Frequency of forgetting to read back an oral prescription?
ISMP 2009 Institute for Safe Medication Practices 21
Intervention 3: HAMERS
Outputs
• Scorecard that quantifies the risk of specific PADEs
• Bar-graph that shows distribution of risk– Which elements contribute most to the PADE?
• Menu of interventions to reduce risk – Pharmacy chooses from the menu of interventions
– Pharmacy makes changes to inputs based on the planned interventions
– Pharmacy receives a revised scorecard that quantifies improvements based on planned interventions
– “If (intervention) is implemented, then risk that the PADE will reach the patient is ___%.”
– If risk factor is (increased/decreased) by __%, risk that the PADE will reach the customer is reduced to __%.”
ISMP 2009 Institute for Safe Medication Practices 22
Intervention 3: HAMERS
• Tool can be used to measure risk within dispensing system for any medication or most types of errors/ PADEs– Focus on high-alert medications– Can measure risk of not capturing prescribing errors– Cannot measure risk of patient self-administration
• Limited menu of interventions– General in nature– Specific to high-alert medications– Include all tested interventions from prior study and
others
ISMP 2009 Institute for Safe Medication Practices 23
Intervention 1: Patient Counseling
• Pre-intervention observation in pharmacies– 50 observations completed
– 4 states• 2 states with mandatory counseling
• 2 states with mandatory offer to counsel
– Preliminary findings• No counseling in states with “offer” to counsel
– Counseling for OTCs more common than for prescription drugs
• More frequent counseling in states with mandatory counseling
– Differences between state enforcement of counseling
– Not covering information linked to PADEs
ISMP 2009 Institute for Safe Medication Practices 24
Intervention 1: Patient Counseling
• Implementation Tool Kit– Scripted counseling materials, checklists, health questions
– Consumer handouts about targeted drugs
• Specifically targets known causes of PADEs
– Consumer outreach materials to promote counseling
• Availability on http://www.consumermedsafety.org
– Model state regulations for requiring/limiting mandatory counseling for high-alert drugs