Specialty Pharmacy 3.1

SDrM 4 – Prospective, Concurrent, and Retrospective Drug Management

Submited by: Tom Goddard

The Basics

If your pharmacy is contracted to conduct prospective, concurrent, and retrospective reviews, it must implement policies that such reviews involve a consideration of, where appropriate, the following issues:

  • Therapeutic appropriateness; 
  • Over and underutilization;
  • Generic use;
  • Therapeutic interchange;
  • Duplication;
  • Drug-disease contraindications;
  • Drug-drug or drug-allergy interactions; 
  • Drug dosage;
  • Duration of treatment;
  • Clinical abuse or misuse;
  • Drug-age precautions;
  • Drug-gender precautions;
  • Drug-pregnancy precautions; and
  • Regulatory limitations.
Most of these issues are addressed by modern pharmacy dispensing software programs. 

Management Tips

If your organization is required by contract, or is likely to be required by contract, to do any of these types of reviews, your P&P needs to address all 14 types of review, even those types not in your current contractual requirements. Make sure your policies describe both the technological and human resource aspects of these requirements, i.e., who is doing what and with what tools, computer and otherwise, should be explicitly stated.

Accreditation Tips

Desktop Review
At this stage of the process, submit both your P&P and examples of the capabilities of your drug utilization management system. Screen shots are an excellent way to let the reviewer see how things work with your software, particularly if you provide an explanation in the "Notes" section of the citation accompanying the screen shots.
If your pharmacy is not in the business of conducting drug utilization management, submit an attestation to that effect.
Validation Review
The reviewer will interview your clinical staff involved with drug utilization management to assess compliance with your P&Ps. 
Document Review
The reviewer will review how your drug utilization management process works by examining randomly selective files from a log of requests for prospective, concurrent, and retrospective review requests.

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020


    Focus area

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 7-1: Compounding Requirements

    If the pharmacy engages in compounding, it must implement policies and procedures that ensure that the compounding activities meet both USP guidelines and applicable laws and regulations, whether state or federal. Those policies need to identify who is responsible for ensuring such compliance and how he/she/they are to do that. 

  • Specialty Pharmacy (4.0) 4.0 / 05.19.2020

    PROD 6-1: Machine and Equipment Maintenance

    The pharmacy must implement written policies and procedures that:ensure that all machines and equipment in the pharmacy are maintained according to both the guidelines provided by the manufacturers and any applicable regulations, andprovide for the documentation of the implementation of the processes dealing with cleaning, calibrating, and auditing of the machinery and equipment.The machinery and...