DR BRUCE WARNER
Associate Director of Patient Safety
National Patient Safety Agency
As Associate Director of Patient Safety at the NPSA, Bruce is responsible for strategic and operational management, particularly focused on delivering large-scale sustainable change in patient safety improvement within the NHS in England and Wales. Prior to his current post, Bruce was Head of Primary Care, Ambulance and Specialist Programmes. Bruce has also worked as a senior pharmacist in the Safe Medication Practice team at the NPSA, developing and implementing safety solutions relating to medicines. Bruce has extensive experience in community pharmacy, as well as working in a PCT and an acute trust as a prescribing adviser. Prior to joining the NPSA, he worked in academia and undertook research in medication error
In June 2009, a primary care trust (PCT) contacted the National Patient Safety Agency (NPSA) regarding a clinical audit of vaccine storage it had carried out in GP practices within the PCT. The results of that audit were very concerning.
A routine infection control audit showed that childhood vaccines had been stored incorrectly in a single GP practice.(1) Advice was sought from the Health Protection Agency (HPA), and it was determined that vaccines that had been inadvertently frozen were the ones most likely to be rendered ineffective. This perhaps goes against most people’s perception of where the real risk lies in relation to vaccine storage, as we tend to concentrate on making sure vaccines are not kept too warm.
Subsequently, similar findings were reported from other GP practices. The PCT then decided to undertake a two-year retrospective audit (where records existed for that length of time) of 96 GP practices, which revealed that more than 40% of vaccines had been stored outside of the recommended temperature range.(1) Patients were recalled from two practices within the PCT, which involved approximately 560 patients and required a fulltime person for one month, with administrative assistance and help from a data-quality team to help track patients.
The cost of this programme to both the practices and the PCT, plus the anxiety and potential risk that the patients were exposed to, not to mention the potential wider public health issues, served as a salutary reminder that we sometimes take the storage of medicines, and vaccines in particular, for granted.
Once alerted to the situation by the PCT concerned, the NPSA searched its database of patient safety incident reports and discovered a further 260 reports of incidents related to vaccination cold storage. Table 1 describes the type of incident reported to the NPSA.
This situation perhaps illustrates how dependent the NPSA is on being alerted to issues at a local level, and using them as a trigger to search its database (which currently holds more than four million reported incidents) and eventually issue guidance to the whole NHS. Practice managers have a large role to play in encouraging their practice teams to report patient safety incidents.
Rapid Response Report guidance
Following a series of consultations, the NPSA issued a Rapid Response Report (RRR) in January 2010, prompting anybody who stored vaccines to take action to make sure the vaccines remained both safe and effective.(2) The RRR consists of three key action points for NHS organisations to implement (a “must do” requirement for PCTs). These are stated in Box 1, along with suggested actions for practice managers.
While product use following a break in the cold chain may be appropriate in certain circumstances for individual products, it will usually be outside the terms of the product licence, and use remains at the discretion of individual practitioners.
For practical day-to-day guidance on the use of UK-licensed medicines and vaccines when the cold chain has been broken, UK Medicines Information (UKMi) maintains a database that collates published and unpublished information from manufacturers. This is known as The Fridge Database (see Resources). It recommends action designed to prevent wastage for 237 medicines and 50 vaccines. Access can be obtained by contacting regional medicines information centres (contact details are provided in the RRR supporting information on the NPSA website,(1) and at the front of the British National Formulary).
Further comprehensive advice regarding the principles, practices and procedures relating to immunisation programmes in the UK, as well as information on the diseases, vaccinations and vaccines, can be found in the Department of Health (DH) publication Immunisation against infectious disease – The Green Book.(3)
Vaccination programmes in the UK are well developed and have led to a large reduction, and in some cases eradication, of disease. It is important therefore that confidence in the immunisation programme is not compromised. It is, however, also important to ensure that immunisation programmes remain effective.
Evidence supplied by a single PCT in the UK suggests that the issue of incorrect vaccination storage, and lack of rigour in monitoring that storage, could be substantial, and can lead to both financial waste of resource (vaccinations), worry for patients and their families, potential recall programmes being instigated and a potential increase in disease. It is possible that similar problems could be found in other NHS organisations across the UK.
1. National Patient Safety Agency. Rapid Response Report Supporting Information. 21 January 2010. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=66111
2. National Patient Safety Agency. Rapid Response Report 2010/RRR008 Vaccine Cold Storage.
21 January 2010. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=66111
3. Department of Health. Immunisation against infectious disease – The Green Book. Third edition. London: DH; 2006. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPoli...
National Patient Safety Agency
UK Medicines Information – The Fridge Database