Module 4

• Valid consent is legally and ethically required before starting personal care, treatment, or investigations.
• Consent reflects an individual's right to decide what happens to their body.
• Lack of respect for consent principles can lead to legal action.
• Consent should be given freely, voluntarily, and by an informed person with the mental capacity to consent.
• Individuals have the right to be involved in their treatment and care decisions.
• Information exchange between healthcare provider and individual is essential for informed consent.
• Consent is a continuous process, not a one-time event.
• It can be withdrawn at any time.
• Consent for one immunization doesn't cover future doses unless initially agreed upon as a full course.
• Re-seek consent if new information arises.
• Individuals must be listened to and given the necessary information, time, and support to make decisions about immunization.
• Information should include details of the process, benefits, risks (including side effects), and what to do if side effects occur.
• Healthcare professionals should find out what matters to individuals to share relevant information.
• Assume all adults have the capacity to consent unless indicated otherwise.
• If capacity is questioned, assess it per legal requirements and consult those close to them or those with legal authority if they lack capacity.
• Document discussion and consent obtained as good clinical practice.

Consent to Immunization

• Gaining consent to immunization serves two purposes: legal defense and clinical cooperation.
• Legally, it provides a defense against criminal charges of assault or battery, or civil claims for damages for trespass to the person or negligence.
• Clinically, it ensures cooperation from the individual, builds confidence in the treatment, and encourages the patient to proceed.

Parental Consent Considerations

• Parental consent rules need to be followed.
• A person with parental responsibility must give consent, provided they are capable of consenting.
• A person with parental responsibility may arrange for some or all of it to be met by one or more persons acting on his behalf"
• There is no requirement for this arrangement to be in writing (Section 2 (9) Children Act 1989).

Children

• Children may have the capacity to consent depending on their understanding and whether they are deemed to be Gillick competent.
• A child should be able to: understand and retain relevant information about their care, use this information to consider whether to consent, and communicate their wishes.
• Health professionals should be satisfied that a person with parental responsibility has consented in advance to the immunization.
• They also need to be satisfied that they have arranged for the other person to bring the child to the appointment and provide the necessary consent.
• There should be no recorded disagreement with immunization.

Not the Parent

• If someone other than the parent brings a child (without capacity) for a vaccine, consent is required from a person with parental responsibility.
• This person must be capable of consenting.
• Parental responsibility can be delegated, without needing to be in writing according to Section 2 (9) Children Act 1989.

16 Years Old

• An older child may have the capacity to consent depending on their understanding and whether they are deemed to be Gillick competent.
• A child needs to be able to: understand and retain pertinent information, use it to consider consenting, and communicate their wishes.

Important Considerations

• Health professionals must ensure the person with parental responsibility has given consent in advance, has arranged for the other person to bring the child, and provide consent.
• There should be no disagreement with immunization.

Patient Specific Direction & Patient Group Direction (PSD & PGDs)

• A Patient Specific Direction (PSD) is a written instruction from a healthcare professional for medicine to be supplied/administered to a named patient after assessment.
• PSD includes the patient's name, medication details, dose, frequency, route of administration, and start/end dates.
• PSDs are tailored to individual patient needs.
• A Patient Group Direction (PGD) is a written instruction for the supply/administration of medicine to patient groups not individually identified before treatment.
• PGDs are developed by a multi-disciplinary group including a doctor, a pharmacist, and healthcare team representatives.
• PGDs are for planned circumstances where it benefits the patient without compromising their safety.
• They must include the business name, start/end dates, medicine description, and the clinical situation to which the PGD applies.
• PSDs are specific to individual patients, while PGDs are used for groups in specific situations.
• PSDs ensure personalized care, while PGDs provide efficient and safe treatment for groups under specific conditions.

The Cold Chain

• Understanding vaccine storage, cold chain management, and expiry dates is crucial for safety and efficacy.
• Vaccines are biological products that lose potency over time.
• This process is irreversible and accelerated if recommended storage conditions are not followed.
• The 'cold chain' is the system of transporting and storing vaccines.
• Vaccines must be stored within +2°C to +8°C from manufacture.
• A cold chain breach occurs when vaccines are stored outside this temperature range.
• Maintaining proper storage conditions ensures vaccines remain potent and safe.

Vaccine Sensitivity

• Some vaccines are sensitive to freezing, some to warm temperatures, and some to light.
• Vaccines must be protected from temperatures outside the recommended range and from all sources of light to maintain potency.
• Packaging protects vaccines from sunlight and strong artificial light, including fluorescent light, which can affect the potency of some vaccines.
• Examples of vaccines sensitive to light include BCG, MMR, and Rotavirus vaccines.
• Vaccine manufacturers issue a Summary of Product Characteristics (SPC) for each vaccine.
• The SPC details all licensing requirements, including storage conditions.