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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).

  • Assess various document management philosophies.

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

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

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

Key Concepts

  • 1 Documents should ultimately meet the need of employees who are responsible to adhere to the policy, procedure, or guideline that is intended to result in perpetual compliance and safe medication practices.

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

  • 3 Review periods for documents can vary depending on the organization (typically a biennial or triennial review) or defined by a regulatory agency.

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

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

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

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

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

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

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


Health care professionals in health systems are often asked to develop policies, procedures, and guidelines that not only apply to their department, but pertain to other parts of the health system or even the system 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, administration). These types of practice documents are appropriate for various reasons and are often created to establish a clinical best practice, ensure safe and reliable operational practices, and meet regulatory requirements. Further explanation of these various types and justifications for document development is included throughout this chapter.

Document development is unfamiliar to many clinicians. Literature available to help the health care professional on document development is limited and often directed toward more general application of evidence-based medicine 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, with a specific recommendation from the Center for the Advancement of Pharmacy Education to engage pharmacy students in the development ...

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