(a) check that GP practices were acting in accordance with the relevant regulations (see below)

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1 REPORT ON VACCINE STORAGE IN GP PRACTICES Scope and Purpose 1. This report sets out the findings of a two part survey, carried out in 2006 and 2007, of all GP practices in Scotland concerning the proper storage of vaccines on their premises, and the subsequent action taken. The survey was conducted by NHS Boards on the instructions of Primary Care Division of the Scottish Government Health Department (SGHD). 2. The purpose of this report is to inform SGHD and relevant stakeholders of compliance of contractors against contractual and public health arrangements, for the whole of Scotland. Specifically, the survey was carried out in order to: (a) check that GP practices were acting in accordance with the relevant regulations (see below) (b) indicate where, in the event of a contractor failing to meet these regulations, there was a requirement for a re-vaccination programme for affected patients. 3. The action following the survey also helped to ensure an appropriate, consistent and proportionate response across NHS Boards to any immunisation issues which emerged as a consequence of the survey. Background 4. The survey was conducted in two parts, with an initial request for information in November 2006 and a follow up request for further information in April The initial part of the survey was implemented in response to an incident at a GP practice in Grampian, where a routine investigation by NHS Grampian highlighted that vaccines may have been stored inappropriately (outwith the 2-8º C range) because of irregularities in the monitoring and recording of storage temperatures. 6. Inappropriate vaccine storage is very serious and has the potential to present a public health problem and constitute a risk to patient safety. It also constitutes a breach of the NHS (General Medical Services Contracts) (Scotland) Regulations 2004, a set of governing regulations for general medical services contract holders, and of the corresponding NHS (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 for holders of Section 17C contracts. Specifically these regulations require the contractor to ensure that: (a) all vaccines are stored in accordance with the manufacturers instructions; and (b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that readings are taken on all working days. 7. Failure to comply with these regulations can lead to the contractor receiving a remedial order (the equivalent of a written warning) from their NHS Board. 8. However, it is important to note that only in the most serious of cases would a failure to meet the regulations be likely to lead to a need for revaccination of some patients. 1

2 9. Following the Grampian incident, Health Protection Scotland (HPS) issued advice, at very short notice, on the management of incidents when vaccines have been stored and exposed to temperatures outside those recommended by the manufacturer. Communications 10. A number of communications have gone from SGHD to NHS Boards regarding this matter: On the 8 November 2006, we asked NHS Boards to request the last three months temperature readings from each of their GP practices. On 2 April 2007, this was followed-up with a further request for information, to build on earlier survey findings and to confirm any potential for further revaccinations. This was linked to the prospect of there being a revaccination incident in NHS Forth Valley. On 15 March 2007, SGHD issued a circular (NHS HDL (2007) 18) requiring NHS Boards to enforce the relevant regulations and to issue remedial notices to contractors where appropriate. 11. Copies of these communications are shown at Annex A. Key Findings and Risks Revaccination of patients 12. Based on returns from NHS Boards to the audit letter of 2 April 2007, there was a total of 4 GP practices where Boards identified the need for revaccination of patients. 13. NHS Forth Valley and NHS Grampian identified a total of 4 practices (2 from each Board area) where revaccination was required. Both revaccination programmes have been completed. All remaining NHS Boards confirmed they had identified no need to revaccinate patients. Adherence to Regulations 14. The storage of vaccines is legislatively controlled through regulations as set out above. 15. Regarding adherence to regulations, we asked NHS Boards the following questions: 1. How many GP practices were in breach of one or more of the conditions laid down in the above regulations. 2. On follow up to practices where compliance with the regulations was not apparent at the initial audit: 2

3 a. How many practices were only required to improve monitoring and logging of fridge temperatures, but otherwise showed no evidence of unsatisfactory storage of vaccines. b. How many GP practices showed evidence that vaccines were not stored in accordance with manufacturers instructions. 16. Annex B summarises the responses to these questions by NHS Board. The results varied significantly between each NHS Board area with only two NHS Board areas where all GP practices were fully compliant with the regulations. 17. The returns showed that out of 1,030 practices for the whole of Scotland, a total of 503 practices were not fully compliant (Question 1). However, the majority of these practices (335) reported only minor issues relating to monitoring and logging of fridge temperatures (Question 2a). A further 148 practices required improvement in the storage of vaccines to comply with manufacturers instructions (Question 2b) but only 4 practices to such a degree that revaccination was considered necessary 18. A risk assessment was conducted in each case where non-compliance with manufacturers instructions was identified. In the majority of instances the duration and/or degree of non-compliance was assessed as being insufficient to have significantly compromised the effectiveness of the stored vaccine. Revaccination was therefore not clinically indicated. Revaccination is only considered where there is extreme departure from storage instructions which puts at risk the effectiveness of the vaccine. HPS guidance has been developed as at paragraph 9. Actions Taken 19. The survey identified a number of areas of concern which required action. Prior to these findings, on 15 March 2007, the Department issued a circular requiring NHS Boards to enforce the relevant regulations and to issue remedial notices to contractors where appropriate. 20. Specifically, the circular asked NHS Boards to put the following arrangements in place: GP practices should keep a log of all fridge temperature readings on all working days including maximum, minimum and actual temperature, and the time of day at which the reading was taken. This should also include any action resulting from readings outside the range, and should note who carried out the readings. The log should be available for inspection by Board staff on request and at a minimum should be inspected at the annual contract review visit. NHS Boards should ensure that practices are using appropriate fridge(s) with uniform temperature throughout, min-max thermometers and proper safeguards against power failure. 3

4 GP practices should be strongly encouraged to ensure that all relevant staff meet the minimum standards for immunisation training. This should be achieved wherever possible by completing the HPS/NES immunisation e-learning package. NHS Boards should also remind practices they have a contractual requirement to comply with these arrangements. 21. These arrangements have since been confirmed in writing to the Department. Conclusion 22. As a result of this survey, Health Protection Scotland has worked closely with NHS Boards to improve current practice. A workshop identified key issues on policy and good practice in relation to vaccine storage and the maintenance of the cold chain. Guidance on Vaccine Handling for Clinics, Hospitals, Community Pharmacies and GP Practices has been produced and is currently out for consultation. 23. In addition, HPS and the Scottish Government have agreed that HPS will co-ordinate the development of good practice guidance on immunisation in primary care, which would include guidance on vaccine storage. This guidance will be used by Boards to ensure practices adhere to current regulations for storage of vaccines in practices, supplementing and clarifying the manufacturers instructions. HPS is not directly involved in monitoring practices. 4

5 Annex A Vaccine Incident - GP Fridge T... Vaccine Incident- NHS HDL ( Vaccine Incident - Letter to N... 5

6 Annex B Responses by NHS Board Area to Question on Compliance with Regulations Governing Vaccine Storage NHS Board No. of GP Practices Question 1 Question 2a Question 2b Ayrshire & Arran Borders Dumfries & Galloway Fife Forth Valley Grampian Glasgow & Clyde Highland Lanarkshire Lothian Orkney Shetland Tayside Western Isles Total Table 2 6