An investigation has been launched and hundreds of patients are being contacted after vaccines were found to have been stored in health centre fridges at the wrong temperature.
A routine check at the Lerwick Health Centre on 19th February found some vaccines had been kept above the recommended temperature range of between 2ºC and 8ºC for short periods since 1st August last year.
NHS staff have apologised and offered reassurances. They insist the vaccines will not cause any harm if given to patients but warn they may not provide the level of immunity required.
A case by case review has identified 171 children and teenagers and 91 adults who will be offered re-vaccinations.
Those affected will be predominantly from Lerwick, although a “very small” number of people who have moved away are also being contacted.
The flu vaccine has not been affected and no re-vaccination for flu is required.
Letters have been sent out notifying patients. A dedicated telephone number – 01595 743324 – has been set up for anyone seeking further advice. The number will be staffed during health centre opening times. The first re-vaccination clinic has already been scheduled to take place on Saturday.
The vaccines involved prevent the potentially serious diseases of tetanus, diphtheria, polio, whooping cough, haemophilus influenza B, hepatitis B, pneumococcal disease, meningococcal disease, measles, mumps, rubella and rotavirus infections.
Other vaccines affected include the shingles vaccine for older people and some travel vaccines.
Top-ranking staff at NHS Shetland revealed the problems and announced the moves to address it this morning.
Director of community health and social care, Simon Bokor-Ingram said there were two parts to the message he wanted to convey to patients.
“One is reassurance. Firstly, having had the vaccine that was in this affected period of time, that wouldn’t have caused any harm.
“We’re taking this really seriously and are acting on it, and anyone who needs re-vaccination will be contacted.
“The second part of it is a sincere apology. We’re really sorry that this has happened, because we appreciate this can cause anxiety. It can create a lack of confidence in what we are doing, and we’re really sorry this has happened.”
Asked exactly what had gone wrong, he replied: “I think at this stage we’re doing a full investigation. It would be wrong to draw conclusions at this stage.
Clearly we did have a system and a process in place, but it didn’t work. We’ve done a lot of testing of equipment. We’re looking at the human angle as well.
“Until that’s concluded it would be wrong to draw conclusions.”
Mr Bokor Ingram said concerns raised by nursing staff led to more testing of the fridge. He added the vaccines were taken out to allow a team led by director of pharmacy Chris Nicolson to do more checks on the fridge over a number of days. That found that the temperature was fluctuating.
Whilst we have systems in place to prevent such events it is clear that on this occasion these did not work as intended. We are thoroughly investigating this so that we can minimise the risk of this happening again. SIMON BOKOR-INGRAM
Action has been taken to ensure the fridge temperatures in Lerwick are now being “appropriately monitored” to ensure they are maintained within the correct range.
However, Mr Bokor Ingram said no other health centre was affected by the problem.
“We’ve done a check on all the other nine health centres and are assured that their fridges are working properly, so we’ve done that.”
Chief community nurse Edna Mary Watson said investigations were normally completed within a four-week time period.
“Any investigation might cause us to look into other issues as we become aware of them. It’s difficult to give an exact time-frame, but the reality is we’ll probably be looking at four to six weeks.”
In a statement, Mr Bokor-Ingram said: “I am very sorry that this situation has arisen, and particularly for affected patients and parents.
“Whilst we have systems in place to prevent such events it is clear that on this occasion these did not work as intended. We are thoroughly investigating this so that we can minimise the risk of this happening again.
“Our priority is to move quickly to offer re-vaccination to those affected, and I am grateful to our staff who have reacted with speed to this situation, with our first re-vaccination clinic happening on Saturday 24th March.”
Director of public health for NHS Shetland and NHS Grampian, Susan Webb, said: “Our concern is that the effectiveness of the vaccines may have been compromised so they may not provide the necessary long-term protection that was intended.
“The expert advice we have received is that boosters should be offered as a precautionary measure, and we can reassure patients and parents that there is no significant risk from additional doses of vaccine.
“The welfare of patients remains our highest priority, and we are satisfied that re-vaccination is the best way to ensure long-term protection against infection. We would urge patients and parents to take up the appointments offered by the practice.
“We are sorry for the inconvenience this will cause but would remind patients that immunisation remains the best way to protect against infection.”