Vaccine Policy Storage and Monitoring Type: Policy Register No: 10077 Status: Public Developed in response to: Local Need Contributes to CQC Outcome Number: 9 Consulted With Post/Committee/Group Date Jane Giles Chief Pharmacist 22/09/2014 Professionally Approved By Dr A Jackson MMSG Chairman s action October 2014 Version Number 2.1 Issuing Directorate Pharmacy Ratified by: Document Ratification Group Chairmans Action Ratified on: 29th October 2014 Trust Executive Date November 2014 Implementation Date 3rd November 2014 Next Review Date October 2017 Author/Contact for Information Lesley Stuart Policy to be followed by (target staff) All staff responsible for handling vaccines Distribution Method Trust Intranet & Website Related Trust Policies (to be read in conjunction with) 08085 Policy for the Storage of Medicines in Clinical Areas Document Review History Version No Authored/Reviewed by Date 1.0 Sarah Ferguson 27th May 2010 2.0 Sarah Ferguson October 2014 2.1 Lesley Stuart, related policies and author November 2014 1
Index 1. Purpose 2. Background 3. Scope 4. Training 5. Equality and diversity 6. Responsibilities 7. Storage 8. Refrigeration failure 9. Receipt of vaccines 10. Packaging and delivery of vaccines 11. Disposal of vaccines and waste 12. Monitoring 13. Communication 14. References 2
1. Purpose 1.1 To remain potent, vaccines must be stored within the temperature range +2 to +8C. Incorrect storage is not only wasteful and costly to the NHS, but the failure to store vaccines correctly can reduce vaccine effectiveness and cause vaccine failure. 1.2 The purpose of this procedure is to provide guidelines on the safe storage and handling of vaccines. 2. Background 2.1 The maintenance of the cold chain in the delivery of vaccines in the UK is subject to a very vigorous and robust procedure. In the unlikely event of a break in this cold chain during the delivery process, vaccines can be traced and recalled, and individual patients who have received them can be identified within a matter of hours using tested recall procedures. Once vaccines have been delivered to providers however, the maintenance of the cold chain and the storage of vaccines may, on occasion, fall short of manufacturers recommendations. 3. Scope 3.1 Any persons involved in the storage and handling of vaccines in the dispensary and on the wards, including pharmacy technicians and nurses. 4. Training 4.1 Training is delivered in accordance with the training needs analysis (Mandatory training Policy) and will form part of the induction training. 5. Equality and diversity 5.1 MEHT is committed to the provision of a service that is fair, accessible and meets the needs of all individuals. 6. Responsibilities 6.1 It is the responsibility of any person involved in the handling of vaccines to ensure that they are handled, stored and transported correctly maintaining the cold chain. 6.2 It is the responsibility of the person where stock is located to ensure that all fridges are monitored on a daily basis to ensure temperature is kept between +2 to +8C. Each fridge will have a monitoring log form which is to be completed and retained on ward. 3
6.3 It is the responsibility of the person ordering stock to ensure that rotation and regular checks on expiry dates are carried out. 7. Storage 7.1 It is the responsibility of all areas that store vaccines that they are stored in their original packaging at +2 to +8C and protected from light, as exposure to light can cause loss of potency. All vaccines are sensitive to some heat and cold. Heat will speed up the decline in potency, thus reducing their shelf life. Freezing may cause reactogenicity and loss of potency; it can also degrade the original container which may cause contamination. 7.2 All vaccines are Prescription only medicines and should be stored in a lockable refrigerator. This refrigerator should be of pharmaceutical grade and should not be used for the storage of food items. 7.3 Vaccines should not be stored in fridge doors and the contents of the fridge should be stored so that air can freely circulate within the fridge. This will maintain the temperature throughout the fridge. 7.4 It is the responsibility of staff where stock is located to ensure that the minimum and maximum temperature of the fridge is recorded daily and any deviations to the correct temperature are reported to the ward sister initially and to the ward pharmacist/ technician or Medicines Information x 4822. 7.5 If external thermometers are used these should be annually calibrated to check their condition. BME should be contacted to arrange annual calibration, and if needed supply of new thermometer. 7.6 On receipt of vaccines it is the responsibility of the person receiving the order to check for any discrepancies in the order and for any damage and to ensure that they are placed in the correct storage area 8. Refrigerator Failure 8.1 In the event of a fridge failure the minimum and maximum temperature that the fridge has reached should be noted along with the fridge contents, this information is to be recorded on a DATIX form. 8.2 The stock within this fridge should be removed to a working fridge and marked as not for use. Further stocks may be required in the interim period and these should be ordered from Pharmacy. 8.3 It is the responsibility of the person completing this form to ensure that this information is then forwarded to the Pharmacy department. 4
8.4 The pharmacy department on receipt of this information will then determine if the stock is fit for use or is to be placed for destruction. 9. Receipt of Vaccines 9.1 On receipt of a vaccine order, staff must check the order for any discrepancies and any damage; they must be refrigerated on receipt to maintain the cold chain. 10. Packaging and delivery of Vaccines 10.1 All cool boxes used for the transportation of vaccines should be validated to ensure that they are effective in maintaining the cold chain; this is the responsibility of any person or company involved in the supply chain of vaccines. 10.2 On packaging of vaccines for delivery the cold chain must be maintained and an ice pack placed in the cool box. The ice pack should not be placed directly on the original packaging. 11. Disposal of Vaccines and waste 11.1 Any sharps waste generated syringes and needles and any vials used including part used vials should be disposed of according to local policy in the designated sharps bin for vaccine disposal. Until collection of the waste all sharps bins should be placed in the designated area for waste collection and should be correctly sealed and labelled. 12 Monitoring 12.1 An audit of vaccine storage and temperature will be carried out on a yearly basis by the pharmacy department. 12.2 It is the responsibility of the nurse in charge of the ward to inform the pharmacy department of any concerns they have regarding vaccine storage and handling and complete a DATIX form. Any concerns raised will be investigated by pharmacy according to their procedures and conclusions fed back to the nurse in charge. 13. Communication 13.1 Once professionally approved and ratified by DRAG this policy will be placed on the Trust s internet and highlighted via the Trust s weekly newsletter Focus. The policy will also be highlighted to pharmacy via their in-house meeting. 13.2 Areas of the policy relating to nurses will be addressed at the mandatory training for nurses delivered by the Pharmacy Department 5
13.3 Areas of the policy relating to Pharmacy will be addressed at mandatory induction training and the completion of a training material relating to the storage and supply of medicines. 13.4 Reporting of Near Misses and any training identified from a near miss will be communicated to staff via weekly staff meetings and via the blooper newsletter. 14. References Newcastle Upon Tyne PCT Storage, handling, disposal policy MHRA NPSA alert vaccine cold storage World Health Organization Protocol for a cold chain survey Guidelines to Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) 6