The Basics

This standard reflects URAC's all-pervasive interest in consumer safety.  It requires that the organizations drug utilization management program implement systems to address consumer safety issues. 

• The first of the two required components of the consumer safety system is a method to identify drug-drug consumer safety issues through some form of communication to the requesting pharmacy and the prescriber. 
• The second required component of the consumer safety program involves the capacity to identify other situations that may compromise the safety of the consumer and escalate those safety issues as appropriate.

Management Tips

The approach you must take in developing the policy and procedures for this standard is much like that required by Pharm Core 23.  Even though the standard speaks of "a mechanism,” the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant.  Your P&Ps should address the full array of likely issues.  Brainstorm with your colleagues about all the possible emergencies that could arise for consumers, and how your staff members might come into possession of that information.

However, the tricky part of passing this standard is not so much knowing what to submit with the application, but making sure your staff members know what the basic standards of care for each of these urgent situations is.

The upshot of this is that your staff training should include appropriate responses to urgent situations.  The URAC reviewers will pose a series of hypotheticals to your staff members, and will listen carefully to their answers to detect the quality of your training.

URAC Accreditation Tips

Both elements of this standard are mandatory.

At the desktop review level, documentation submitted should include both your confidence of policy and procedure on consumer safety and any documentation of the alert system at point-of-service.  This likely will be found in a pharmacy provider manual or other documentation describing the relationship with pharmacies.

Much of the on-site review process for this standard involves interviews with both management and staff-level personnel.  In fact, it is likely that, in connection both with the standard and Pharm Core 23, the reviewer will ask virtually everybody a variety of questions around consumer safety issues, from drug recalls to suicide prevention.  In addition, your organization likely will be called upon to demonstrate the clinical information management software regarding consumer safety issues.  Finally, the reviewer will examine case files for evidence that the organization's consumer safety mechanisms are functioning properly.