Specialty Pharmacy (4.0) 4.0

OPS 4-3: Manufacturer and FDA Requirements

Submited by: Tom Goddard

The Basics

The focus of this standard is compliance.

First, the pharmacy must have a clear process for identifying and implementing applicable regulatory and manufacturer requirements (including FDA Risk Evaluation and Mitigation Strategy - "REMS" requirements). 

Second, the pharmacy must implement mechanisms to ensure that the staff complies with those requirements.

Finally, the pharmacy must implement a mechanism to contact patients and providers of new FTA or manufacture requirements that might impact patient safety.

Management Tips

Successful compliance with this standard will involve a combination of good policies and effective training.

Your policies need to have distinct processes for the components of this standard, replete with clear identification of who is responsible for each component and how that employee will implement the processes. Be sure the policies include all of the following:

  1. Identifying existing regulatory and manufacturer requirements;
  2. Monitoring regulatory and manufacturer requirements to detect any changes;
  3. Conduct monitoring and auditing activities to ensure ongoing compliance with FDA and manufacturer requirements; and
  4. A mechanism to contact patients and prescribers about patient safety-related changes in these requirements.

Accreditation Tips

Desktop Review

Submit policies that address all the components described above.

Validation Review

Interviews

The reviewer will both interview staff members involved in tracking and monitoring compliance with regulatory and manufacturer requirements and observe implementation of those requirements.

  • Core 3.4 / 06.29.2020

    CORE 40 - Health Literacy

    This standard, a new, experimental standard, suggests that your organization should have policies and procedures that address health literacy. In this context, the meaning of health literacy is, "The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate decisions regarding their health." The three suggested...

    READ FULL POST
  • Core 3.4 / 06.29.2020

    CORE 39 - Consumer Satisfaction

    This short standard requires that your organization have a mechanism to collect information about your consumers' satisfaction.This often is done in the form of customer satisfaction surveys, consumer complaints, and sometimes even focus groups. Find out what your organization does -- it's likely more than one mechanism.

    READ FULL POST
  • Core 3.4 / 06.29.2020

    CORE 38 - Consumer Safety Mechanism

    One of the most important of the URAC standards is this one, which requires that the organization have processes to respond quickly to urgent situations that threaten consumers' well-being.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. You can see th...

    READ FULL POST
Top