UK: GP surgeries audit raises vaccine fears

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GP surgeries audit raises vaccine fears

Published Date: 24 May 2009

By Kate

A SAFETY audit of every GP surgery in Scotland has revealed that

hundreds of family doctors have wrongly stored vaccines used to

protect children and adults against life-threatening diseases, raising

fears about the effectiveness of some jabs.

The study states that 148 surgeries failed to keep to the vaccine

makers' storage guidelines and says that " inappropriate vaccine

storage is very serious and has the potential to present a public

heath problem " .

The ish Government Health Department report says that a risk

assessment was carried out at all the affected surgeries and has

concluded that the effectiveness of the stored vaccines had not been

" significantly compromised " and revaccination was not " clinically

indicated " .

But an expert said it may make the vaccines less likely to be

effective, and politicians and patients' groups said the report raised

serious questions.

The audit was launched after four scares in 2007 involving over 1,000

patients who had to be revaccinated when it emerged the jabs they had

received had not been stored correctly. The snapshot audit figures are

from 2007.

Every year, staff at surgeries immunise around 100,000 children

against a number of illnesses including measles, mumps, rubella,

tetanus, meningitis, polio and diphtheria. Vaccines have a shelf life

of around two years, but many are designed to give lifelong immunity.

The audit ordered by the ish Government Health Department found

that out of 1,030 GP practices, a total of 503 were not fully

compliant with regulations on storing vaccines during a three-month

period. Of those, 148 were not storing their vaccines in accordance

with manufacturers' instructions.

They were in six health boards: Ayrshire and Arran, Forth Valley,

Grampian, Glasgow and Clyde, Highland, and Tayside. Only two boards,

NHS Borders and NHS Shetland, reported no problems with vaccine

storage. The report said: " Inappropriate vaccine storage is very

serious and has the potential to present a public health problem and

constitute a risk to patient safety. "

It went on to say that a risk assessment was carried out in the 148

cases where vaccines were not being stored correctly. It concluded

that the " duration or degree of non-compliance was assessed as

insufficient to have significantly compromised the effectiveness of

the stored vaccine " and ruled out revaccinating patients as this is

only carried out where there is an " extreme departure from storage

instructions " .

Factors such as temperature, exposure to light and shelf life can be

crucial to the effectiveness of a vaccine. Many were being stored in

domestic fridges which experts say are not always fit for the job. But

an expert warned that even if the vaccines were not judged to be

damaged enough to be thrown out, they may not be 100 per cent

effective.

Dr Cavanagh, an expert in vaccines at the Institute of

Immunology and Infection Research at Edinburgh University, said of the

report: " That does not sound great, and is of concern. We have measles

back in the UK, which is to do with the MMR uptake, and the

implications of not storing vaccines correctly are much the same. If

you give it to 100 per cent of people but 30 per cent of the vaccines

are knackered because they were not stored in the correct conditions,

you effectively have the same problem.

" Sometimes the wrong temperature would make a live vaccine degrade. If

you store it for three months it may lose 10 per cent of its activity

but still be acceptable. But that would depend on temperature, and if

it is rising and falling, particularly below zero, that's not good for

live vaccines.

" One of the problems could be that people don't have high-enough

specification fridges. Fridges and freezers also break down a lot.

Domestic fridges are of variable quality and a lot have a frost-free

facility that stops them from icing up, by raising the temperature in

a cycling system to melt the ice. Unstable temperature storage would

always adversely affect vaccines, " he added.

" It means people may not make a good response to the vaccine, and it

may leave people open to infection when they shouldn't be. In terms of

routine food storage it makes little difference, but it's not a great

idea for vaccines. "

The investigation was sparked after problems were found at four

surgeries which had faulty fridges, meaning the vaccines were rendered

ineffective by being stored at the wrong temperatures.

Vaccines are supposed to be kept at temperatures between 2-8°C in

order to protect the live component that provides protection. Staff

are required to monitor fridge temperatures each working day. In 2007,

a total of 1,023 adults and children had to be revaccinated in Forth

Valley and Grampian after investigations found faulty fridges were

causing vaccines to freeze and defrost.

Following the disclosure, the ish Government ordered health

boards to request the last three months' temperature readings from

each of their GP practices. The results were published yesterday.

Labour health spokesman Simpson warned the issue raised

serious questions about safe storage of the swine flu vaccine. He

said: " As we prepare to go into a potential pandemic, it's crucial

that health boards ensure fridges are compliant and systems are

adequate. The question is whether people who have been vaccinated are

actually immune, or whether we have been given a false sense of

security. "

ish Conservative health spokeswoman Scanlon said: " This is

quite shocking. Due to the uncertainty it's impossible to estimate how

many people should be revaccinated. This could also scupper the

seasonal and swine flu vaccination campaign if there are storage

issues. "

Dr Dean Marshall, chairman of the British Medical Association's GP

committee, said: " Practices have to look at their own systems and make

sure they are totally compliant. Guidance is updated regularly and I

would expect most practices would have updated their systems by now. "

A ish Government spokeswoman last night said improvements have

now been made to the system. She added: " In the vast majority of

instances where practices did not completely comply with regulations

these related to minor issues involving monitoring and logging fridge

temperatures. The vaccines were not compromised. Revaccination is only

considered where the effectiveness of the vaccine could have been

compromised. This involved only four of the 1,030 practices surveyed. "

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

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