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*Due to abuse, sample regulations were implemented in 1987 (PDMA)
* Applies to manufacturers
* Manufacturers must keep records of sample distribution
* Requires signed requests by prescribers
* Requires appropriate storage conditions
JCAHO Sample Requirements
* Applies to hospitals and health-systems
* Same standards as non-sample medications
* Written policies and procedures
* Proper, secure storage, regular inspections
* Labeled and dispensed like other meds
* Documentation same as other orders
* An effective recall mechanism
Strategies to Improve Sample Use
* Apply JCAHO requirements
* Develop sample formulary
o Consider use of generic samples
* Clinics can ban samples
o No Free Lunch has developed a patient education leaflet entitled “Why we don’t have free samples”
o It is available for download free of charge at www.nofreelunch.org
o Helps to support clinics that choose not to accept samples
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