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Labelling and packaging of unlicensed medicines (Specials): best practice guidance for the NHS

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Topics: Policy, Commissioning and ManagerialPreparingSupplyUnlicensed medicines

National guidance from NHSE/I to reduce LASA errors and improve patient safety when considering requirements for unlicensed specials medicines

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Contents
  1. Medication errors and LASAs
    1. Best practice guidance
  2. Expectations of guidance
  3. Recommendations for pharmacy procurement teams
  4. Recommendations for NHS manufacturers
  5. Implementation
  6. Full report
  7. Update history

Medication errors and LASAs

Medication errors account for approximately 10% of all incidents reported to the National Reporting and Learning System and include many Look-Alike/Sound-Alike (LASA) errors.

LASA errors can occur during prescribing, dispensing, supply, or administration of medicines and can lead to administration of the wrong medication with potentially fatal consequences.

Best practice guidance

Following two LASA errors involving Specials reported in 2020, and the subsequent publication of a National Patient Safety Alert, NHS England and NHS Improvement committed to working with NHS and non-NHS manufacturers of Specials to agree guidance promoting best practice on the labelling and packaging of Specials.

Whilst adoption of this guidance will support staff and help to reduce errors and improve patient safety, it should be remembered that one of the underpinning principles of safe medicines use is that all staff must carefully read the label before the supply, dispensing or administration of any medicine.

Expectations of guidance

This guidance is supported by the Chief Pharmaceutical Officers of all four Home Countries:

  • Keith Ridge, CPhO NHS England
  • Andrew Evans, CPhO NHS Wales
  • Cathy Harrison, CPhO NHS Northern Ireland
  • Alison Strath, CPhO NHS Scotland

There is an expectation that:

  • NHS Manufacturing Units will adopt this guidance, to ensure that the labelling and packaging of Specials meets the requirements of the NHS
  • NHS pharmacy procurement teams will use the guidance to support risk assessment when purchasing Specials
  • Non-NHS manufacturers will consider how they can apply the principles of this guidance to further improve the labelling and packaging of their products.

Recommendations for pharmacy procurement teams

Chief Pharmacists are asked to consider the following when purchasing specials:

  • review their existing SOPs to ensure the suitability of Specials, including packaging and labelling, is assessed during sourcing
  • ensure that Specials are quarantined on receipt and checked against the specification agreed with the supplier before release for use.

Recommendations for NHS manufacturers

Chief Pharmacists are asked to ensure, where relevant, that their licensed pharmacy manufacturing unit:

  • has appropriate packaging and labelling capability, or develops a plan to buy and implement it
  • develops and implements SOPs and processes to ensure compliance with the principles described in the guidance.

Implementation

NHSE and SPS have agreed that responsibility for oversight of implementation of these recommendations and monitoring adherence to them on behalf of the Chief Pharmaceutical Officers should sit with the National Pharmaceutical Quality Assurance Committee.

Full report

Update history

  1. Minor changes to format
  1. Added "preparing" tag
  1. Published