Specialty Pharmacy 3.1
SDrM 6 - Patient Safety Process Requirements
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.
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.
At this phase, submit
- your applicable policy and
- sample communications that your pharmacy has sent to patients and prescribers
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.
The reviewer will review systems (electronic and/or paper) by which the pharmacy identifies and reports consumer safety events.