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Managing defective medicines

Published
Topics: Aseptic services

An overview of what defective medicines are and how they should be reported by NHS personnel.

Contents
  1. Chief Pharmacist responsibilities
  2. Assessing potentially defective medicines
  3. Reporting defective medicines
    1. Contacting Regional QA
    2. Further Information

Chief Pharmacist responsibilities

Chief Pharmacists are responsible for ensuring appropriate procedures are in place for the management and reporting of defective or suspected defective medicines. 

Historically, the SPS QA team maintained an NHS system for central logging of medicines defects called the Analytical Information Centre (AIC). This system was closed in December 2022 as the Yellow Card reporting system of the MHRA was performing the same role and led to unnecessary duplication of work. 

Assessing potentially defective medicines

When a report of a defective medicine is received, it should be investigated locally by an appropriately qualified healthcare professional.  

Firstly, preserve the sample(s) if possible, and ensure it is stored safely to protect it from further damage, and to protect staff from harm if it is a hazardous substance. If this not possible record the product details (name, form, strength batch number, expiry and manufacturer). 

Next, identify whether the medicine is actually defective.  

  • If a patient has been affected, could this be interpreted as a reaction to, or side effect of that medicine? If so, report via the Yellow Card system as a ‘suspected side effect’. 
  • Has there been inappropriate storage and handling of the medicine locally? If so, this should be managed within the local incident management system. 

Once it has been confirmed that a defect is suspected, gather as much information as possible, for example: 

  • What happened? 
  • Is more than one product affected? 
  • Is more than one batch affected? 
  • What is the appearance of the affected product? It may be helpful to take photographs or record video footage. 
  • Was the medicine administered? If so, was the patient harmed? 

Reporting defective medicines

Defective medicines should be reported via the MHRA’s Yellow Card system as a ‘suspected defective product’. The MHRA will investigate, and if necessary a medicines recall/notification may be issued. 

Defects should also be reported to the manufacturer directly to allow them to respond quickly and to replace stock. 

Contacting Regional QA

Please also contact your Regional Quality Assurance service to report defects if there is a significant concern for patient safety, or a widespread or recurrent impact on service delivery. 

Additionally, they can provide advice and support relating to investigating defective medicines and managing incidents. 

Further Information

Further information relating to reporting defective medicines may be found in the MHRA’s Guide to Defective Medicinal Products 

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