Legal aspects of Vaccination

Amanda Lee

By the end of this session the attendees will be able to;

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• Review how data protection underpins professional obligations in vaccination

• Summarise their professional obligations in managing the process of informed consent

• Appraise the capacity to provide consent in a legal framework.

• Compare the legal and professional obligations regarding documentation, prescription, administration, supply and storage of vaccinations.

So we will frame this session into the following subheadings:

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• CONFIDENTIALITY

• CONSENT– INFORMATION TO ENSURE INFORMED

CONSENT• CAPACITY TO INFORM AND PROVIDE CONSENT

• THE LEGALITIES OF; – SUPPLY– PRESCRIPTION– ADMINISTRATION OF VACCINES

DOCUMENTATION AND RECORDKEEPING

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• NMC CODE (2015) PRIORITISING PEOPLE, PRACTICE EFFECTIVELY, PRESERVE SAFETY, PROMOTE PROFESSIONALISM AND TRUST .

• Respect people’s right to privacy and confidentiality

• Always practise in line with the best available evidence

• Communicate clearly

• Keep clear and accurate records relevant to your practice

• Advise on, prescribe, supply, dispense or administer medicines within the limits of your training and competence, the law, our guidance and other relevant policies, guidance and regulations

Confidentiality offers a better title than ‘The Data Protection Act

and our legal and professional obligations’

DPA

Data Protection Act (www.dataprotection.gov.uk)

• The 1998 Data Protection Act set standards which must be satisfied when obtaining, holding, using or disposing of personal data

• The Data Protection Act covers anything with personal identifiable information (e.g. health, personnel, occupational, finance, suppliers, and contractors)

• You are required by law to comply with the Data Protection Act 1998

What does this all mean to me ?

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• Well – if you are HOLDING, RECORDING, MANAGING data from patients, then you have a legal and professional responsibility to adhere to the DPA – a report by Caldicott (1996) identified 6 principles which are relevant to all healthcare professionals who use, record or supply patient data;

• These are called CALDICOTT PRINCIPLES

• You will have a nominated CALDICOTT GUARDIAN in your NHS trust or organisation who you may consult to discuss this further.

CALDICOTT PRINCIPLES

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1. Justify the purpose(s) for using patient data 2. Don't use patient-identifiable information unless it is absolutely necessary 3. Use the minimum necessary patient-identifiable information 4. Access to patient-identifiable information should be on a strict need to know basis 5. Everyone should be aware of their responsibilities to maintain confidentiality 6. Understand and comply with the law, in particular the Data Protection Act

WHAT DOES THIS MEAN TO ME AS A ‘VACCINATOR’ ?

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• date of administration

• title of vaccine(s) administered

• batch number• expiry date

• site(s) of administration

information as appropriate is sent to CHIS; GP record; patient-held record e.g. PHCR, travel card.

WHAT SHOULD WE TELL THE PATIENTS / PARENTS OR SIG OTHERS ABOUT THE RECORDS WE ARE KEEPING ?

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• How their data on immunisation is stored• How it may be used• Who will be able to access it

• So why DO we keep this data ? • monitor efficacy of vaccination programmes• Manage safety in vaccination strategies• Protect the public from harm

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ANY ADMINISTRATOR OF MEDICINES IS RESPONSIBLE FOR THE MONITORING

OF EFFICACY, SAFETY AND SIDE EFFECT PROFILE OF THE MEDICATION

OR VACCINE. THIS IS ‘PHARMACOVIGILANCE’. THE MHRA

ARE THE GOVERNMENTAL AGENCY RESPONSIBLE FOR

PHARMACOVIGILANCE AT NATIONAL LEVEL AND REQUIRE THIS BASIC

MINIMAL INFORMATION.

ADDITIONALLY – DOCUMENTATION SHOULD INCLUDE

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LEGIBLE HANDWRITING

SIGNED (WITH JOB TITLE AND NAME PRINTED)

CONTEMPORANEOUSLY RECORED

FACTUAL (NO ABBREVIATIONS)

INCLUDE CLEAR EVIDENCE OF DISCUSSIONS HELD AND INFORMATION SHARED TO OBTAIN CONSENT

IDENTIFY ANY RISKS NOTED AT CONSULTATION

THIS IS SOME OF THE LEGISLATION WHICH UNDERPINS ONE VACCINATION

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• European Convention on Human Rights Act 1950; National Health Service Venereal Disease Regulations (SI 1974 No 29); Access to Health Records (1990) The Computer Misuse Act 1990; Human Fertilisation and Embryology Act 1990; The Civil Evidence Act (1995); Caldicott Report (DH) 1997; Access to Medical Reports Act (1998); Data Protection Act (1998); The Road Traffic Act 1998; The Data Protection Order (2000); The Electronic Communications Act (2000); The Freedom of Information Act 2000; The Terrorism Act 2000; The Freedom of Information (Scotland) Act 2002; The Communications Act 2003; Confidentiality: NHS Code of Practice (2006); Security Management NHS Code of Practice (2007); NHS Information Governance Guidance on legal and professional obligations (2007); Records management best practice in relation to the creation, use, storage, management and disposal of NHS records Scotland (2008).

CONSENT

Consent – giving permission for something to happen.

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• For consent to be valid, it must be voluntary and informed. • The person consenting must have capacity to make the decision.

• Voluntary – the decision to either consent or not to consent to vaccination must be made by the person without pressure from clinical staff, friends or family.

• Informed – the person has a right to all information about the vaccination, including risks and benefits. Alternative treatments should be discussed, as well as what may happen if the treatment does not go ahead.

• Capacity – the person must be capable of giving consent. They must be able to fully understand all information provided, so that they can make an informed decision.

What is consent ?

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• Consent must always be obtained before every immunisation

• Giving and obtaining of consent should be viewed as a process and not a one-off event

• Must be given voluntary and freely, after achieving an understanding of what is involved

• Person providing consent should be offered as much information as they reasonably need to make their decision

Immunisation Department, Centre for Infections

How should consent be sought?

• Consent should be sought on the occasion of each immunisation visit

• Health professional providing the immunisation should ensure consent has been obtained

• Prior agreement for the child to be included in the immunisation programme is not valid consent

Immunisation Department, Centre for Infections

Consent process should include

• what immunisation(s) are to be given• which disease(s) will be prevented• benefits and risks of immunisation versus

risks of disease(s)• possible side effects and how to treat• any follow-up/action required • any new information• agreement to proceed

Information to support informed choice

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Information leaflets / posters / factsheets and websites

PHE offer a range of information and advice– https://www.gov.uk/government/collections/immun

isation#immunisation-leaflets-and-guidance-for-parents

The green book – https://www.gov.uk/government/collections/immun

isation-against-infectious-disease-the-green-book

So – where can we find information ?

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• SPC - http://www.medicines.org.uk/emc/

• PIL - http://xpil.medicines.org.uk/BrowsePils.aspx

Vaccination updates – https://www.gov.uk/government/collections/vaccin

e-update– https://public.govdelivery.com/accounts/UKHPA/s

ubscribers/new?preferences=trueMHRA reports of safety, efficacy and profiles of vaccine strategies

– https://www.gov.uk/drug-safety-update/reporting-suspected-adverse-drug-reactions-to-vaccines-and-biological-medicines

CAPACITY

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Immunisation Department, Centre for Infections

Capacity to consent

•Key question:• “can this patient understand and weigh up the information needed to make this decision?”

•http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4006131

Immunisation Department, Centre for Infections

Who can consent?

•ADULTS: aged 18 or overmust consent to their own treatmentno-one can give consent for an adult who is unable to consent for him/herself unless there is a Lasting Power of Attorney (LPA) in place

LPA is a formal, legal document of two types:1. personal welfare, including healthcare 2. property and affairs (financial matters) LPA must be set out on the right form and registered with the Office of the Public Guardian to be valid and before it can be usedA personal welfare LPA will only take effect when a person has lost capacity to make a particular decision

Lasting Power of Attorney (LPA)

Principles include:•A person must be assumed to have capacity unless it is

established that he lacks capacity

•A person is not to be treated as unable to make a decision unless all practicable steps to help him have been taken without success

•A person is not to be treated as unable to make a decision merely because he makes an unwise decision

•An act done, or decision made, under this Act for or on behalf of a person who lacks capacity must be done, or made, in his best interests

•Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action

•If a personal welfare LPA does not include the authority to make the decisions which now need to be made, health and social care staff will make the necessary best interests decisions, but they should consult with the attorney and those close to the patient

Lasting Power of Attorney

Immunisation Department, Centre for Infections

Adolescents and younger children

•Young people can consent to their own treatment provided they are:Aged 16 -17 years Considered “Gillick competent”

•X parent cannot over-ride competent child’s consent to treatmentparents can over-ride competent child’s refusal for treatment

Immunisation Department, Centre for Infections

Babies and Younger Children

•Person with parental responsibility:

•Parental Responsibility is defined in the Children Act 1989 as:

• "All the rights, duties, powers, responsibilities and authority which by law a parent of a child has in relation to a child and his property."

•Mothers: automatic •Father: if married to mother either when baby born or marries subsequently•Unmarried father: if name appears on birth certificate (since 01.12.03) or legally acquired •Others – legally acquired

Parental responsibility

Parental Responsibility Agreement – signed, properly witnessed and sent for registration to Principal Registry or the Family Division (High Court) Parental Responsibility Order – granted by the courtResidence Order – granted by the court

Legal acquirement of parental responsibility

Immunisation Department, Centre for Infections

Who brings the child?

There is no requirement for the parent to be present, nor for such arrangements to be in writing (see Green Book, chapter 2)

People looking after a child do not have parental responsibility but can be authorised by parent to take medical decisions

“...may arrange for some or all of it to be met by one or more persons acting on his behalf” (Section 2(9), Children Act 1989)Vaccine should be given provided:Professional is satisfied that person with parental responsibility:

- has made arrangements- information has been given- there is no (recorded) disagreement with immunisation

Immunisation Department, Centre for Infections

Written consent No legal requirement for consent to be in writingSignature on a consent form not conclusive proof that consent has been givenShould record the decisions and discussions that have taken place and type of information supplied to support the decisionWhere individuals/parent(s) disagree with immunisation, this should be shared/ recorded with all members of the Primary Health Care TeamConsent law: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4006131

LEGAL ISSUES IN SUPPLY

ADMINISTRATIONPRESCRIBING

OF VACCINATIONS

Immunisation Department, Centre for Infections

Non medical prescribing

NMPs are independent prescribers who may be NURSES, PHARMACISTS, PHYSIOTHERAPISTS, OPTOMETRISTS, PODIATRISTS OR CHIROPODISTS.

Nurse and pharmacist independent prescribers can prescribe any medicine for any medical condition within their competence. This includes schedule 2,3,4 or 5 controlled drugs and vaccinations within their sphere of competence.

So – if you are NOT a NMP you will supply and administer vaccinations - • Against a script written by an authorised prescriber

• Under a PGD – a multidisciplinary developed authorisation which identifies parameters under which specific health professionals may administer a particular medicine directly (ie school vaccinations) to patients with an identified clinical condition (ie schoolchildren aged xx years).– In 2014, NHS England have published a suite of PGDs for

vaccines to identify core legal requirements of PGDs.• Under a PSD - A written instruction, signed by an authorised

prescriber - for medicines to be supplied and/or administered to a named patient after the prescriber has assessed the patient on an individual basis (Ie routine immunisations)

Immunisation Department, Centre for Infections

Immunisation Department, Centre for Infections

When should a PSD be used?

Usual method for vaccine supply and administration for routine childhood schedule

Authorised by GP/independent nurse prescriber at 6-8 week check and written instruction recorded in PCHR or

scheduled/unscheduled clinic list signed by prescriber Technically a patient assessment by the healthcare

professionals instructed to supply/administer the vaccine should not be requiredBUT

• Please note: Good practice dictates the immuniser check the recipient is fit and well and there are no contraindications, prior to vaccination.

PGDs

are nothing to do with nurse prescribingare legal documents for the supply and administration of Prescription Only Medicines (POMs) only qualified, fully competent and properly trained healthcare professionals can sign up and work to PGDshealthcare professional is responsible for assessing that the patient fits the criteria in the PGDthere can be no deviation from the PGD

Immunisation Department, Centre for Infections

When should a PGD be used?

Limited situations where it offers advantages for patient care without compromising safety

A nurse led clinic may have several PGDs which cover immunisation of the patient groups they are likely to see

•eg: Travel vaccination clinics

• Immunisation sessions in schools/prisons

• Vaccination of refugees, asylum seekers, looked after children

•

Must contain specific informationBe drawn up by multidisciplinary groupSigned by doctor, pharmacist and organisational leadSigned by named healthcare professionalsEvery patient must fit exactly criteria in PGDMust have start/expiry dateMust be reviewed at least every two yearsEvidence changes nullify existing PGDs

PGDs

Immunisation Department, Centre for Infections

Scope and Limitations of PGDs

PGDs are not a form of prescribing but provide a legal framework for the supply and/or administration of vaccinesHealthcare professionals signing up to PGDs must be fully competent qualified and trained in all aspects of immunisationPatient’s may present directly to a healthcare professional working to PGDs in their service, without seeing a doctorHealthcare professionals working to a PGD is responsible for assessing that the patient fits the criteria in the PGD

Changes in legislation

•HSC 2000/026 - modifications of Medicines Act 1968•Prescription Only Medicines Human Use Amendment Order 2000•Medicines (Sale and Supply) (Miscellaneous Provisions) Amendment No 2 Regulations 2000

Centre for Infections, Immunisation Department

PRESCRIBINGPt assessed by Independent prescriber or supplementary

prescriber

PATIENT

Written

PATIENT SPECIFIC DIRECTIONS

PRESCRIPTION

For medicine issued

Medicine DISPENCED

by PHARMACIST

PATIENT GROUP DIRECTIONSPatient assessed and a PGD used by one of the following health care professional:Midwife, nurse, pharmacist, optometrist, podiatrist, chiropodist, radiographer, orthoptist physiotherapist, ambulance paramedic

Exemptions from the Medicines Act allow for the sale, supply and/or administration of some medicines by specific health care professionals

Supply and/or administration of a medicine DIRECTLY to the patient

Supply and /or administration of a medicine DIRECTLY to the patient

How Patients Receive Their Medicines

NHS National Prescribing Centre Patient Group Directions(2004):A practical guide and framework of competencies for all professionals using patient group directions www.npc.co.uk/publications/pgd/pgd.pdf

Immunisation Department, Centre for Infections

What is Clinical Governance?

Framework through which NHS organisations are accountable for continuously improving standards of patient care and the quality of their servicesSafeguarding high standards of health care deliveryCreating an environment of consistent high quality and clinical care excellence

Immunisation Department, Centre for Infections

How does this relate to Immunisation?

•Clinical governance is relevant across all area of immunisation practice

•For example:Ensuring all immunisers are trained and regularly updatedVaccines are correctly stored and handled

•Adherence to Clinical governance framework should be monitored through regular audit of the vaccine service offered by the Trust

Further information

• Consent a guide for young people (Please note this is due to be updated Feb 2016)http://www.nhsinform.co.uk/rights/publications/leaflets/~/media/hrisdocuments/leaflets/consent%20%20rights%20leaflet%20yp%20v4%202013.ashx

• A guide for parents on consent http://www.nhs.uk/NHSEngland/AboutNHSservices/Documents/Consent_%20aguideforparentsDH_4117353.pdf

• On the NHS vaccination schedule http://www.nhs.uk/Conditions/vaccinations/Pages/vaccination-schedule-age-checklist.aspx Immunisation Department, Centre for Infections

Thank you for listening.

I must acknowledge the sources of this information which consisted of -

The Green Book; for legislation, Consent and Immunisation by nurses.

The MHRA and PHE sites for hyperlinks and information.

Please note that all this slide show is based upon the Minimum slide set – originally created by: Immunisation, Hepatitis and Blood Safety Department, Centre for Infections, Health Protection Agency.

These were updated on 08/01/16 by Amanda Lee

Immunisation Department, Centre for Infections