Specialty Pharmacy 3.1

SDrM 3 - Treatment Recommendations Based on Clinical Decisions

Submited by: Tom Goddard

The Basics

This standard requires that your pharmacy base its recommendations for medication treatment on sound clinical information. URAC defines "appropriate" as including:

  • Evidence found in peer reviewed scientific studies, literature and journals, including standard reference compendia;
  • Evidence regarding the efficacy of the medication, including information about side effects and potential interactions with other medicines the consumer is taking; and
  • The likely impact of the medication on the patient's adherence, particularly when compared to alternatives.

Management Tips

URAC presents the following list as acceptable sources of medical or scientific evidence:

  • Peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts whare not part of the editorial staff; 
  • Peer-reviewed medical literature, including literature relating ttherapies reviewed and approved by a qualified institutional review board, biomedical compendia and other medical literature that meet the criteria of the National Institutes of Health’s Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpta Medicus (EMBASE); 
  • Medical journals recognized by the Secretary of Health and Human Services under Section 1861(t)(2) of the federal Social Security Act; 
  • The American Hospital Formulary Service–Drug Information;
  • Drug Facts and Comparisons;
  • The American Dental Association Accepted Dental Therapeutics; and 
  • The United States Pharmacopoeia–Drug Information; 
  • Findings, studies or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including:
  • The federal Agency for Healthcare Research and Quality;
  • The National Institutes of Health; 
  • The National Cancer Institute;
  • The National Academy of Sciences;
  • The Centers for Medicare & Medicaid Services;
  • The federal Food and Drug Administration;
  • Any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services; or
  • Any other medical or scientific evidence that is comparable to the above sources. 
The selection of evidence upon which organizations base their treatment recommendations is often, but not always, handled by a committee. If that is the case with your organization, be sure that your committee charter or P&P describing the committee includes this function.

Accreditation Tips

Desktop Review
You'll need to submit your P&P addressing the process for establishing your evidence-based treatment recommendations. In addition, if a committee handles this function, include formal documentation (P&P or committee charter) that describes the committee in detail and includes this as one of its functions.
Validation Review
The reviewer will interview your clinical director(s) involved in the development of treatment recommendations.
Document Review
The reviewer also will examine documentation that shows the link between treatment recommendations and the evidence underlying those recommendations. This would include committee meeting minutes, if a committee is involved in this process.