Wednesday, March 21, 2012

PDR PharmEHR Summit 12 update 7


EHRs and FDA Goals: Safety and Adherence

Keynote speaker: Janet Woodcock, MD, Director for Drug Evaluation and Research, FDA

Speaker Comments

No consistent way to track if patients are taking their meds.
30% lapse in taking medications after one year.
What are the outcomes?
Effectiveness (real world) vs efficacy (artifical environment)
Patients often do not which meds they are taking or the reasons for use
FDA: No consistent way to track the diagnoses associated the with the medicaion
Epidemic of opiod abuse

Uncertainity leads to lawsuits, medicaton recalls, less favorable outcomes

Essential factors needed;
Integration of relevant drug information into work flow
Ability to access additional information is one click away
Integraton of REMs (risk elimination and medication)
Up to date medication lists for patients and prescribers
Patient education information to use the medication safely and effectively: FDA mandated single page leaflet
Abilithy to link pharmacies and providers with patients in the center: PCMH; including hosptilal discharge medications
AKA Medication Reconciliation
Abillity of provider report adverses event easily
Standarize terms to faciliate secondary use of data

Safey surveillance
Currently using min-sentinal system from Harvard Pilgrim :over 125 million patients
Based on claims
Uses common data model: no central repository, distributed model
Standardized queries are then sent out, turn around within two days


2 million lives
methods research
observational research still needs work

800,000 adverse events reported per year
500,000 serious and unexpected
no system in place for thorough analysis

Paperless medication labeling is a goal

Drug safety communicatons are standardized but often without specifics

All of the above require integration with EHRs

Hope to integrate research capability into EHRs
Research needs to be part of clinical practice
Most cancer patients are not given the option to participate in research

Working with ONC

Only 50% of practices have EHRs
Some EHRs are just electronic paper charts
Care is not consistently patient centered
Patient annotation of medication of experience is not yet available

A quick reponse for diseminating adverse events information
Better understanding and communication with patients regarding adherence
Better understaning of off-label use
Faster migration of medications to OTC
Better EHR adoption
Better EHR documentation of the medication use process

If you attended, please share your comments here. SV

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