Immunisation dilemmas: consent for childhood vaccinations

Questions around consent for childhood immunisations are among the most frequently asked in general practice nurse forums. This guide to consent aims to shed some light on the issues

You can be in the wrong for doing things, and you can also be in the wrong for not doing things. Indeed, every decision has advantages and disadvantages, so you can even be ‘damned if you do, and damned if you don’t’.¹ This dilemma of the human predicament has been clearly recognised for more than 200 years, and remains to taunt us still today.

Never blame or criticise a parent for being worried about having their child vaccinated. Having children is the best way known of making you feel inadequate and guilty. The little mites are so precious that you want to do everything in your power to keep them safe, and yet you are bombarded by information about how you can do it wrong. Breastfeeding, potty training, dummies – the list is apparently endless. It even starts before they are born – cigarettes, alcohol, did you take the right vitamins and avoid soft cheese? You wonder why people give themselves all this grief, but then he or she gives you a smile and all your worries become irrelevant.

Those of you who are parents will readily understand the problem. ‘What if I am allowing something to happen to my baby which may – however remote the risk and however compelling the evidence – just may cause damage?’ Even when you are a consummate healthcare professional with an impressive depth of knowledge and a full grasp of statistics and risk, you can always convince yourself that things do not quite apply to your baby. It is not just access to the facts that is at issue – it is your emotional response to the facts. This is of course a major reason why the Nursing and Midwifery Council (NMC) advises that prescribing for friends and family members is a bad idea2 – when you are emotionally involved it turns your professional judgement to blancmange.

TOO MUCH INFORMATION

Information is cheap. Anyone with access to an smart phone has a direct portal into far more information than any individual GPN can hold in her memory. Healthcare professionalism has moved on from an obligation to know the facts towards an obligation to assess and work with the facts. The days when you knew more medicine than your patients have long gone.

So parents making a decision about having their baby vaccinated are not short of advice. Indeed, it is perfectly possible to be overwhelmed by the information on offer, or else to zoom in on one piece of evidence to the exclusion of all others. This is one reason why your patients will ask you, not necessarily just in the context of infant vaccination: ‘Nurse, what would you do?’

WHY ARE INFANT VACCINATION RATES IN THE UK FALLING?

Rates of infant vaccination reached a peak in 2011, and have been in decline since. In England in 2015-16, 93.6% of children reaching their first birthday had completed their primary immunisation courses against Diphtheria, Tetanus and Pertussis, Polio and Haemophilus Influenzae type b (DTaP/IPV/Hib). This compares with 94.2% in 2014-15 and 94.3% in 2013 -143. This may not seem like a big drop, and indeed the numbers are still among the best in the world, but they could be better. In Slovenia parents are fined if they do not have their children vaccinated for a number of specified diseases, and rates over 95% are achieved.⁴

The reasons for this fall in vaccination rate are a matter for speculation:⁵

• Falling vaccination rates are an English problem. Rates in Wales, Scotland and Northern Ireland remain above 95%. Healthcare is a devolved power to other UK national parliaments. Lower vaccination rates are found in areas of deprivation so may be sensitive to economic policies.
• In the ‘post-truth’ age of ‘alternative facts’ it may be difficult to sort the informational wheat from the chaff. So when Andrew Wakefield⁶ (now struck off the Medical Register) falsified his research findings to suggest that the MMR vaccine causes autism, his opinion was presented in the media as: ‘Doctors disagree on safety of MMR’, and not: ‘There is Wakefield on one side, and everybody else on the other’ – it sells more papers. This unfortunate state of affairs has resurfaced recently as Wakefield ‘secretly’ attended the UK premiere of the anti-vaccination documentary ‘Vaxxed’.⁷ The US President Donald Trump has also publicly stated his support for Wakefield’s discredited views.
• The number of health visitors (HVs) rose considerably from 2010 to 2015, with a corresponding reduction in their caseload. Since October 2015, local authorities have been responsible for Public Health services (including HVs), and their budgets have been cut spectacularly.
• Because of the success of the vaccination programme (amongst other things), there are few people left in the UK who have witnessed the illnesses being vaccinated against, and we have forgotten how nasty they are. For example, up until the middle of the 20th century, there were about 500,000 cases of measles and 100 deaths each year in the UK. After the introduction of the measles vaccination in 1968 these numbers dropped rapidly, so that measles has become – for most people – a distant memory. When I was a young GP in the 1980s, the identification of a case of measles required daily home visits to monitor progress and to make sure complications had not set in – diarrhoea and vomiting; ear infection; eye infection; pneumonia. At best measles is miserable. And yet measles is an apparently gentle word, and seems unbefitting to such a foul illness.
• Some, particularly affluent parents, feel that they can safely avoid any vaccination risks by carefully supervising their children’s social contacts so that they only mix with children whose parents think the same way. This micromanagement of the risk has been studied in California, but not yet in the UK.⁵

Every parent who declines to have their child vaccinated will have their own reasons for the decision, reasons that you as a healthcare professional will only be aware of if you ask. Only when any fears have been uncovered can an attempt be made to deal with them.

The World Health Organization suggests that a population vaccination coverage of 95% is necessary for ‘herd immunity’.⁵ Those of you familiar with this term will be aware that herd immunity is the situation where the illness being vaccinated against is unlikely to affect anybody: some babies will not be vaccinated because it in contra-indicated, or for other reasons, but all babies are protected because there are not enough other unvaccinated babies around to catch the illness from. Hitting the 95% is therefore really quite important. In days long ago when whooping cough and not MMR was the bête noir of vaccinations, I was regularly surprised by the effectiveness of this argument. Despite refusal to vaccinate being a decision very much focussed on their own baby, many parents were persuaded by the need to protect the whole community of babies and not just their own.

INFORMED CONSENT

All the wisdom on vaccination in the UK that you could ever hope for is contained in the ‘Green Book’, which used to be an actual book, but now is only available on-line.⁸ The Green Book in particular emphasises the infant vaccination programme, but also covers other vaccination issues such as travel vaccinations. Chapter Two deals will the question of consent.

If a healthcare professional inflicts any treatment or procedure (such as a vaccination) on a patient without their consent it is deemed to be an assault. Just what this means in practice depends on several factors, including the state of the law, and the standards expected of healthcare professionals by their professional bodies. A signature on a piece of paper is considered ‘good practice’, but of itself does not confirm that consent has been given and is not a legal requirement.⁹ Consent should be regarded as a process so that, for example, if a programme of vaccinations is ongoing then verbal consent should be sought at each vaccination attendance to make sure the consent remains valid.

Consent should be informed: your patients should know what they are letting themselves in for. This consists of providing your patient with as much information as they need to make a decision whether or not to proceed. There is lots of information out there in the form of leaflets or videos in a variety of languages to suit every need. A good starting point would be the excellent material published by NHS Choices.¹⁰ But be aware that 16% of the UK population have a literacy level less than would be expected from an 11-year old,11 so any publications should be appropriate. A further caveat: a quick look at YouTube with the search term ‘infant vaccination’ yields a whole plethora of dodgy-looking material, which you may not agree with.

Your patient should be aware:

• Which vaccinations are being given
• What illness is the vaccination against
• The risks of not having the vaccination
• The side effects of the vaccination and what to do about them
• If any follow-up is required

By way of example the NHS Choices leaflet on the measles, mumps, rubella (MMR) vaccine¹² has sections on:

• Who should be vaccinated
• How the vaccination works
• Does MMR cause autism (it doesn’t)
• Side effects of the vaccine (mild and non-contagious forms of measles and mumps, proving there has been an immunological response which is what you want)
• A link to another page on the infections measles, mumps and rubella – the illnesses the vaccination protects against.

Adults can give their own consent for vaccination, but for babies the consent needs to be sought from someone with parental responsibility. Where this person brings the child in response to an invitation for immunisation and, following an appropriate consultation (where any relevant information is provided), presents the child for that immunisation, these actions may be considered evidence of consent.⁹ The consent should be recorded in the medical/nursing record.

Sometimes there is a question about who has parental responsibility for a child, and at this juncture the waters can become a little murky. According to the Children Act 1989, the child’s mother automatically has parental responsibility.¹³ If the child’s father is married to the mother at the time of birth, or gets married to her later, then he also has parental responsibility. For anyone else, parental responsibility can only be granted by a court order, i.e. a legal process has to be enacted. This can get complicated.

The person with parental responsibility does not have to be present when the baby is vaccinated. So, for example, it is perfectly OK if a grandparent or a child-minder brings the baby for the jabs.⁹ But in order to proceed with the vaccination you need to be satisfied that:

• The person with parental responsibility has consented to the vaccination i.e. has been counselled and received all the information, and
• The person bringing the child has permission from the person with parental responsibility to attend for the vaccination

If there is any doubt, then the person with parental responsibility should be contacted before going ahead with the vaccination.

Of course, people may change their mind and withdraw consent at any stage. If this happens, make a record in the notes, and do not proceed with the vaccination.

INCOMPLETE VACCINATIONS

What do you do about patients who have not completed a vaccination programme? Some general principles can be suggested:

• If there is no record or an unreliable record of past vaccinations, then start again from the beginning
• If there is a good vaccination record but the programme has not been finished, then just carry on. There is no need to repeat doses.
• Try to keep the number of vaccination visits required to a minimum

Beyond this matters get complicated, and the more immunisations that are involved, the more complicated it gets. For example, doses of the Meningitis B vaccine should be given 2 months apart, but they can be given one month apart if it makes life easier and ensures a timely completion of the programme.

Do not try and commit this to memory. It is impossibly complex, and it is likely to be changed without warning. An excellent – if busy and hard-to-read – algorithm is available at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/533831/phe-algorithm-2016-08.pdf. I recommend you refer to it.¹⁴

CONCLUSION

In terms of doing good to the largest number of people, vaccination is probably one of the more important public health things that general practice does. GPNs need, if not a comprehensive and complete knowledge of the topic, at least the awareness of when an irregular situation is occurring, and who to ask or where to look up the answer.

For most of history people have only consulted a healthcare professional when they were ill and had symptoms. Prevention of disease and the management of risk are relatively new ideas. The skills to manage these new responsibilities are relatively under-developed, but are becoming increasingly important.

REFERENCES

1. Lorenzo Dow circa 1834, quoted in Wallechinsky D & Wallace I. The People’s Almanac.

2. The Code. Nursing and Midwifery Council. https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

3. National Statistics/NHS Digital. NHS Immunisation Statistics. England, 2015-16. http://content.digital.nhs.uk/catalogue/PUB21651/nhs-imms-stat-eng-2015-16-rep.pdf

4. Walkinshaw E. Mandatory vaccinations: The international landscape

CMAJ November 8, 2011 vol. 183 no. 16 http://www.cmaj.ca/content/183/16/E1167

5. Anon. Why are vaccination rates in England falling? The Conversation. September 12, 2016. http://theconversation.com/why-are-vaccination-rates-in-england-falling-64931

6. Godlee F. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 2011; 342 doi: http://www.bmj.com/content/342/bmj.c7452

7. Forster K. MMR fraud doctor Andrew Wakefield ‘returns to UK for secretive screening of anti-vaccine film’. Independent 16 February 2017. http://www.independent.co.uk/news/uk/home-news/mmr-andrew-wakefield-fraud-doctor-anti-vaccine-film-return-uk-secret-screening-vaxxers-vaccinations-a7583021.html

8. Public Health England (PHE). Vaccination against infectious disease. https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

9. PHE. Consent: the green book, chapter 2. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/144250/Green-Book-Chapter-2-Consent-PDF-77K.pdf

10. NHS Choices. Vaccinations. http://www.nhs.uk/Conditions/vaccinations/pages/vaccination-schedule-age-checklist.aspx

11. National Literacy Trust. How many illiterate adults are there in England? http://www.literacytrust.org.uk/adult_literacy/illiterate_adults_in_england

12. NHS Choices. MMR Vaccine. http://www.nhs.uk/Conditions/vaccinations/Pages/mmr-vaccine.aspx

13. legislation.gov.uk. Children Act 1989. http://www.legislation.gov.uk/ukpga/1989/41

14. PHE. Vaccination of individuals with uncertain or incomplete immunisation status. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/533831/phe-algorithm-2016-08.pdf