Evidence-Based

Clinical Decision Support (CDS)

Part 2

Terry Seaton, Pharm.D., FCCP, BCPS

Professor of Pharmacy Practice
 Clinical Decision
Support Systems (CDSS)
Common approaches:
• Alerts
• Reminders
• Drug-dosage calculators
• Care summary dashboards
• Order Sets
 KM Worksheet Follow-Up
Other considerations:
• Dosage form, route of administration, or salt
form—are there clinical differences?
– IV incompatibility vs. pharmacokinetic or
pharmacodynamic DDI
– Absorption DDI for oral but not parenteral
– Systemic bioavailability of topical drugs
– Immediate-release vs. controlled-release
 KM Worksheet Follow-Up
Other considerations:
• Administration issues
– Adverse events influenced by rate of
administration (usually IV)
– Restrictions on timing of doses
– Optimal monitoring of serum drug
concentrations
 KM Worksheet Follow-Up
Overall recommendations:
• Message
– Clear
– Concise—fewest words possible
– Tailored to target clinician
– Unambiguous intent—informational vs.
directive aimed at behavior
 Homework
1. Choose ANY other drug pair with a known
drug-drug interaction (each pair must be
different from your teammates’ pairs)
2. Complete a KM Worksheet on that pair
3. Bring your worksheet to next week’s class
because you will be sharing your
worksheet with the team
 Drug Interaction CDS Alerts
• Drug-Drug
• Drug-Allergy
• Drug-Disease
• Drug-Genomics (next frontier…)
 Recommendations for
Drug-Drug Interaction Evidence
• 2009 multistakeholder conference (AHRQ)
• Participants included:
o Consumers
o Health care providers
o Those responsible for relevant policies
and guidelines
o Vendors

Hines LE, Malone D, et al. Pharmacotherapy 2012;32:304-13.

 Recommendations for
Drug-Drug Interaction Evidence
1. Conduct well-designed studies to determine
the incidence, outcomes, and patient-level
risk factors for DDIs
2. Use a systematic and transparent process
for evaluating the DDI evidence
3. Improve the integration of DDI evidence into
electronic CDS

Hines LE, Malone D, et al. Pharmacotherapy 2012;32:304-13.

 Recommendations for
Drug-Drug Interaction Evidence
Proposed classification system:
• Four classes (A-D, from minor/no relevance
to clinically relevant) for clinical relevance
• Five classes (0-4, from extrapolation of data
from similar drugs to controlled studies) for
level of documentation
• Five categories (0-4, from animal studies to
clinical trials) for quality of evidence

Hines LE, Malone D, et al. Pharmacotherapy 2012;32:304-13.

 Drug-Allergy Alerts
Challenges in CDS:
• Coded data vs. text fields
• Data entry by nurses, physicians, or
pharmacists
• Inclusion of “intolerances” (e.g. GI upset)
• Inclusion of non-drug allergies (animal,
gluten, dyes)
• Inclusion of other “warnings” (e.g. blood
products for Jehovah's Witnesses)
 Clinical Prediction Rules
• Mathematical tool to guide clinicians in
decision-making
• Four phases:
o Development
o Validation (suitably powered cohort study
or controlled trial
o Impact analysis
o Implementation
• Popularity greater now than ever before

Adams ST, Leveson SH. BMJ 2012;344:d8312.

 Clinical Prediction Rules
Use data available electronically:
• Patient demographics (e.g. age, weight, etc.),
from administrative database
• Medications, from pharmacy system, CPOE,
or eMAR
• Laboratory, from lab system
• Radiology, from radiology system
• Other
 Clinical Prediction Rules
Use data available electronically:
• Patient demographics (e.g. age, weight, etc.),
from administrative database
• Medications, from pharmacy system, CPOE,
or eMAR
• Laboratory, from lab system
• Radiology, from radiology system
• Other
 Prediction Rules: Example Evidence

Conducted similar studies in:

• Diabetes mellitus (statin prescribing)
• Other CHD risk-equivalents (statin
prescribing)
• Heart failure (ACEI prescribing)
• Care transitions, using Medicaid data and
Direct Care Pro pharmacist system within
CyberAccess EHR (medication adherence)
 Drug-Disease CDS Alerts
• Often used in prospective and retrospective
drug utilization review (DUR) programs in
managed care
• Use clinical prediction rules
• May be used for auto-adjudication for prior
authorization
 Drug-Genomic CDS Alerts (GCDS)

• Newest frontier in CDS

• Development is parallel with advances in field
(many questions about utility of genomics)
• Many technical challenges
• Lack of clinician expertise
• Standards need to be developed
• Vendors need to incorporate functionality and
interfaces
• Economic environment constantly changing
 Drug-Genomic CDS Alerts (GCDS)

Existing applications:
• Oncology – genetic testing of cancer cells
and tailoring effective treatments
• Infectious diseases - genetic testing of
viruses and tailoring effective treatments
• Anticoagulation – warfarin dosing
• Cardiovascular – antiplatelet DDIs with PPIs
• DDIs – CYP450 and drug metabolism
• Patient education, via PHR portal

Overby CL, et al. Genet Med 2013; doi:10.1038/gim.2013.128.

 Drug Dosing CDS Alerts
• Common CDS approach in CPOE (ordering)
and pharmacy system (verification)
• Highly susceptible to alert fatigue
Examples:
• Single dose (minimum and maximum)
• Total daily dose (minimum and maximum)
• Total course (usually maximum)
• Patient-specific—e.g. consider renal function
 Drug Dosing: Example Evidence
Implementing a commercial rule base:
• Observational study, 3 sites
• Baseline
• Modifications:
– CLcr buffer
– Weight buffer
– Duplicate order suppression
– Frequency multiplier
• Decreased overall rate from 7.8% to 1.2%

Reichley R, Seaton TL, et al. JAMIA 2005;12:383-9.

 CDS Reminders
• Second-most often used approach in CDS
• Reminds clinicians of periodic interventions
Examples:
• Immunizations (tracked in all settings)
• Diabetes example – foot exams, eye exams,
A1c monitoring, microalbumin monitoring
• Smoking cessation
• Colonoscopies and other screenings
• Challenge is where in workflow and target
 Activity
Scenario: The ACIP of the CDC recently
revised their recommended immunizations for
older adults. Persons aged 65 years and older
should now receive Prevnar-13 (Pneumococcal
13-valent conjugate vaccine) in addition to the
standard pneumococcal vaccine (Pneumovax).

Task: Design a CDSS (trigger, time in workflow

and message), within a community pharmacy
system, that will remind the pharmacist to
facilitate the adherence to the new ACIP
guideline.
Dashboards in CDS
 Order Sets
• Ubiquitous in hospital setting (CPOE)
• Long history of beneficial effects on safety
and effectiveness with paper order sets
• Use for specific diseases (e.g. pneumonia,
VTE prophylaxis) OR drugs (e.g. heparin
drip)
• Develop using multidisciplinary approach
• Customize vendor templates
• Perform quality analyses
• Large potential for causing medication errors
Muddiest Points?