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Learning Objectives

After completing this chapter, the reader will be able to:

  • Differentiate between types of practice documents (e.g., policy, procedure) and approaches for managing those documents.

  • Discuss the roles and responsibilities of individuals/groups involved in the practice document development and review process (e.g., document owner, stakeholders, and consultants).

  • Identify factors that influence document development (e.g., regulations, scope, and review periods).

  • Describe the systematic methodology to develop and revise practice documents.


Key Concepts

  • image Documents should ultimately meet the need of employees who are responsible to adhere to the policy, procedure, or guideline. Thus, implementation of practice documents should result in perpetual compliance and safe medication practices.

  • image The first step to understanding the practice document development requirements is to evaluate the process for the organization.

  • image Review periods for documents vary depending on the organization (typically a biennial or triennial review) or as defined by a regulatory agency or accrediting body.

  • image The first step in developing practice documents is to identify the need for the document.

  • image It is important to gather relevant data to the practice document topic.

  • image Practice documents should be evidence based and reflect standard of care or best practice.

  • image Ensure the format, ease of use, and reading level are appropriate for the intended audience and end users.

  • image After composition, the draft document must be disseminated for review and comments.

  • image After approval, publication and education are essential to the success of any practice document.

  • image The last step in the development and maintenance of practice documents is to ensure compliance with any changes.


Health care professionals in health systems and other settings are often asked to develop practice documents (e.g., policies, procedures, and guidelines) that not only apply to their department, but also pertain to other parts of the organization or even the organization in its entirety. Given the breadth of knowledge that pharmacists possess regarding medication use, they are poised to contribute to development of practice documents affecting each aspect of the medication-use cycle (e.g., prescribing, preparation, inventory management, dispensing, and administration). These types of practice documents are appropriate for various reasons and are often created to establish best practices, ensure safe and reliable operational practices, and meet regulatory requirements. Further explanation of these various document types and justifications for document development is included throughout this chapter.

The nuances of document development are unfamiliar to many clinicians, particularly outside of clinical guidelines. Literature available to help the health care professional on document development is limited and often directed toward more general application of evidence-based medicine (EBM) and use of outcomes research in the medication-use policy development process.1–3 Selected resources are also available in the nursing literature.4 Much of what the individual is exposed to in these areas is on-the-job training. This skill set should be taught early in the educational process for pharmacists, ...

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