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Standards for medicines safety

Contents

  1. Aim
  2. Link to overarching policy
  3. Medicines safety
  4. Adverse drug reactions
  5. Medicine defect reporting
  6. Drug alerts, recalls and safety notices

1 Aim

The aim of this document is to set down the standards medicines safety.

2 Link to overarching policy

This document links to the overarching safe and secure handling of medicines manual

3 Medicines safety

The Medicines and Healthcare Products Regulatory Agency (MHRA) issue a regular drug safety alert monthly electronic bulletin bringing information and clinical advice about the safe use of medicines. These Alerts are reviewed by the Medicines Management Committee (MMC) and appropriate recommendation made; they are then circulated to all prescribers for information. It is intended for all healthcare professionals who work in the UK, doctors, pharmacists, nurses, dentists, allied health professionals, and coroners. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

All staff (including self-employed staff contracted to work within trust provided services) should follow best practice detailed in MHRA alerts and reports.

CAS alerts are assessed by pharmacy for relevance and circulated to the relevant teams for action; this is reported on by regular audit.

4 Adverse drug reactions

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Prescribers, pharmacist and nurses are urged to help by reporting adverse reactions to the medicines and Healthcare Products Regulatory Agency (MHRA) on pre-paid yellow forms, which are available in the British National Formulary (BNF) or on the BNF website (opens in new window).

The BNF also provides further detail on the type of medicines and type of reactions, which should be reported (staff can also refer to appendix E of the safe and secure handling of medicines manual for further details). If the reporter of the adverse effect is not the lead clinician, they must be made aware of the problem and the clinical record updated accordingly.

5 Medicine defect reporting

Medicines may be considered defective for two principal reasons:

  • physical defects caused by damage or contamination noted by an individual handling the medicine at any point in the medicines trail
  • efficacy defects caused by reactions that in the judgment of a professional caring for the patient(s) concerned indicate an unexpected response

Within the trust the following procedure applies when a defect is found or is suspected in any medicine:

  • inform the supplying pharmacy who will advise on all reporting, recording and investigating on the defect
  • retain any remaining product and any associated products or equipment (for example, administration sets, infusion devices and so on.) and clearly mark it “Defective: not for use”
  • notify the chief pharmacist who is responsible for formally reporting all defective medicines to the authorities, the manufacturer concerned, and other wards and departments as necessary. In addition to this the chief pharmacist is also responsible for:
    • the retention of suspected defective medicines for analysis, return or impounding.
    • recall to the pharmacy department of all potentially defective medicines.
    • the dissemination of information relating to potentially defective medicines within the trust
  • complete an electronic IR1 report, recording details of the product and defect
  • if the product has been administered to a patient, inform the doctor responsible for them and record the defects in the patient’s clinical record
  • report the incident to the appointed practitioner in charge

Suspected defective medicinal products are notifiable by doctors and pharmacists to:

The Adverse Incident Centre
MHRA
2 or 2G Market Towers
1 Nine Elms Lane
London SW8 5NQ

6 Drug alerts, recalls and safety notices

The Medicines Health Care Regulatory Authority (MHRA) is responsible for informing trusts and primary care providers of product defects, which may have implications on a wider, sometimes national, scale. Such notification will then be circulated to trust units by their supplying pharmacy.

All such notifications received must be immediately brought to the attention of the assigned practitioner in charge, or member of healthcare staff in charge of the unit.

The staff member in charge must follow the instructions received regarding the identification and withdrawal of the defective product and bring any withdrawn medicines to the attention of the ward or unit pharmacist or other authorised pharmacy staff.

A record of the action taken must be made in the ward or unit 24-hour report.

Document control

  • Version: 2.
  • Unique reference number: 559.
  • Approved by: Clinical policy review and approval group.
  • Date approved: 3 October 2023.
  • Name of originator or author: Senior pharmacist.
  • Name of responsible individual: Executive medical director or Medicines Management Committee.
  • Date issued: 26 October 2023.
  • Review date: 31 October 2026.
  • Target audience: Trust wide.
  • Description of change: Review of document.

Page last reviewed: December 16, 2024
Next review due: December 16, 2025

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