Specialty Pharmacy (4.0) 4.0

PROD 4-1: Handling and Removal

Submited by: Tom Goddard

The Basics

The pharmacy must implement policies and procedures that describe in detail how unacceptable medicines must be handled and disposed of.
"Unacceptable medications" include medicines that

  • have been recalled or discontinued,
  • have expired,
  • have been damaged, adulterated, or misbranded,
  • are counterfeit, etc.
These implemented policies and procedures must address the following issues, at a minimum:
  • How the pharmacy is to receive and process notices about unacceptable medications;
  • How the pharmacy should notify and train staff members, patients, and prescribers on an ongoing basis about unacceptable medications;
  • How staff must review and remove in-stock inventory in the event of notification about unacceptable medicines;
  • How staff must identify and remove inventory in the medication shipping process; and
  • How staff must dispose unacceptable medications.

Management Tips

This is a mandatory standard, so be sure that your policies and your staff training cover every element in detail. Leave nothing out. Imagine this policy as a user manual for unacceptable medications with sufficient detail that a new member of your staff could use it to learn what he/she/they must do.
Be sure your policy acknowledges that notifications about unacceptable medications might come from several sources, including manufacturers, the FDA, prescribers, and patients.
Not all classes of medications require notifications. Be sure your policy distinguishes those that do from those that don't.
Involve your compliance department, so that your policies are in accord with state and federal regulations on this topic.

Accreditation Tips

Desktop Review
Submit detailed policies and procedures that guide staff members on all the elements of this standard.
Validation Review
The URAC reviewer will use a combination of observation and interview to assess how well your staff members implement your unacceptable medications policies.

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