Specialty Pharmacy 3.1

SDrM 6 - Patient Safety Process Requirements

Submited by: Tom Goddard

The Basics

This standard requires that your pharmacy maintain a robust program for addressing patient safety issues. That program needs to have the capability of:

  • Identification and reporting of adverse drug events;
  • Reporting such events to external entities (e.g., payers, MedWatch, PSO);
  • Identification and management of risk;
  • Disclosing clinically significant errors to affected patients and their caregivers;
  • Identifying potential consumer safety events in order to report them, when appropriate, to the prescriber, pharmacy, and/or patient.
  • In addition, such events need to be captured in a report that is provided no less frequently than quarterly to the quality management committee ("QMC") or equivalent committee.

Management Tips

Your policy should describe, step-by-step, how you define adverse drug events, how you document them, and what you do with that information. Be specific about the external entities to which reports of such events should be sent.
The risk-management component of this P&P should be based, at least in part, on the on the FDA Risk Evaluation and Mitigation Strategy ("REMS") programs.
When discussing in your P&P the disclosure of clinically significant errors, describe how your electronic prescribing system is involved in the identification and documentation of such events. Be clear about reporting responsibilities in your policy.
Be specific in your P&P about the level of detail you require in your report to the QMC. 
All in all, at a bare minimum, your policy should discuss:

  • FDA registries;
  • Manufacturer registries;
  • Patient, caregiver, and prescriber education;
  • What to do in the event of drug recalls;
  • Monitoring and tracking black-box warnings; and
  • Look-alike/sound-alike drugs.

Accreditation Tips

Desktop Review
At this phase, submit

  • your applicable policy and 
  • sample communications that your pharmacy has sent to patients and prescribers
Validation Review
The reviewer will interview both clinical and non-clinical staff, including customer service representatives, about what the organization's policy is regarding what they are to do in the event of an immediate threat to patient health and safety. 
Document Review
The reviewer will review systems (electronic and/or paper) by which the pharmacy identifies and reports consumer safety events.

  • 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...