Information Governance - 2

Question 1

What is consent? Why is it important?

Answer 1

consent is “to express willingness, give permission, agree”

administration of a treatment to a patient without their consent, involving any kind of physical contact may be considered under English law as

• battery (non-consensual physical contact)
• negligence (failure to inform the patient and seek consent) under English law

Question 2

What are the different types of consent? How can they be obtained?

Answer 2

implied/implicit consent
- the patient indicates their consent by their action (indirectly)
= e.g. a patient who brings their prescriptions to you to dispense

explicit consent
– the patient actively indicates their consent

= verbally by saying yes or no
= in writing as the patient signs a document stating they provide consent e.g. for physical examination or diagnostic testing

Question 3

What is required for consent to be valid?

Answer 3

For consent to be valid, the patient must:

1 - have capacity
= in England and Wales, a person lacks capacity if at the time the decision needs to be made, they are unable to make or communicate the decision because of an ‘impairment or disturbance’, that affects the way their mind or brain works

2 - be acting voluntarily
= must not be under pressure from the pharmacist or anyone else

3 - be provided with enough, balanced information to enable him/her to make the decision

4 - be capable of using and weighing up the information provided in the decision-making process

5 - understand the consequences of not giving consent

Question 4

What information do you need to provide to allow the patient to make an informed decision/give consent?

Answer 4

1 - the service or activity they are being asked to consent to

2 - the benefits and risks of providing consent for the proposed intervention

3 - what the intervention will involve

4 - the actual and possible implications of not having the intervention

5 - the alternatives that may be available to them

Question 5

When is a person capable of having capacity?

Answer 5

adults over the age of 18 are presumed to have capacity to make decisions about their healthcare unless demonstrated otherwise

young people (aged 16 or 17) are considered to have capacity to provide consent, unless demonstrated otherwise

children (< 16) are not assumed to have capacity to consent and must demonstrate their competence
- can only give consent if they show that they have “sufficient understanding and intelligence to enable him/her to understand fully what is proposed”

Question 6

What should the patient be able to do in order to make an informed decision?

Answer 6

To make an informed decision the patient should be able to:

1 - retain the information you provided
2 - understand the information you provided
3 - understand the implications of their decision
4 - communicate their decision to you (by any means)

Question 7

What is the Mental Health Capacity Act 2005?

Answer 7

establishes principles and safeguards for vulnerable adults, including when a patient lacks capacity

grants legal authority to certain people to make decisions on behalf of patients who lack capacity

Question 8

What are the principle of the Mental Health Capacity Act?

Answer 8

Principles include:

1 - individuals have the right to be supported to make their own decisions

2 - individuals retain the right to make what might be seen as eccentric or unwise decisions

3 - interventions for people without capacity must be the least restrictive possible

4 - any action taken on behalf of a person without capacity must be in their best interest (not that of the health professional or their organisation)

Question 9

Who must obtain consent?

Answer 9

the person treating or providing a service to the patient should obtain the consent

Question 10

What should SOPs include for the process of obtaining consent?

Answer 10

Which activities within the pharmacy require patient consent?

Which activities require the pharmacist to obtain consent?

Which member of staff can obtain consent on your behalf?

The information that should be provided

The type of consent required; implied, written or verbal

Question 11

What happens if patients refuse to give consent?

Answer 11

an adult with capacity may refuse treatment even if that results in harm

• must respect their decision, even when you think it is wrong
• does not apply when law says otherwise
• record of refusal must be made together with the discussions taken place and advice given

In England and Wales where children under 16 and those aged 16-17 refuse consent their decisions may, exceptionally be overridden (parents, the courts), where it’s in the patients best interests

In Scotland – can’t be overridden

Question 12

What are advance decisions? How can they be effected by emergencies?

Answer 12

advance decisions

• people who understand the implications of their choices can say in advance how they want to be treated if they later suffer loss of mental capacity
• must meet criteria set out in Mental Health Capacity Act or it does not apply

emergencies

• treatment may be provided without consent in an emergency when necessary to save a life or prevent deterioration in the patients condition
• if you know there is a valid advance decision to refuse a particular treatment then you can’t help them

Question 13

When must a pharmacist disclose confidential information?

Answer 13

these are when a pharmacy professional:
- has the consent of the person under their care
- has to disclose by law
= police, healthcare regulator, NHS fraud investigation officer, coroner, judge
- should do so in the public interest
= prevent crime, prevent serious injury or damage, disclosure is necessary for the protection of children or vulnerable adults
- must do so in the vital interests of a person receiving treatment or care
= e.g. if a patient needs immediate urgent medical attention

Question 14

What should do the pharmacist do before disclosing confidential information?

Answer 14

• pseudonymise information or make it anonymous, if they do not need to identify the person receiving care
• disclose only the information needed for the particular purpose
• make sure that, if they disclose confidential information, the people receiving the information know that it is confidential and is to be treated as such
• make appropriate records to show: who requested, was consent obtained, what they disclosed, how it was ensured to be confidential, what lawful authority or provision the request/disclosure was made

Question 15

What should records include when disclosing confidential information?

Answer 15

• who the request came from
• the reasons for releasing the information without consent
• whether you attempted to obtain patient consent, and if not why not
• why patient consent was refused
• what information was disclosed

Question 16

Is patient consent required to keep patient medication records (PMR)? What happens if consent is refused?

Answer 16

under GDPR, the pharmacy contractor is the data owner

explicit consent is not required to keep PMRs but patients must be made aware that records are being kept for them and the purpose for which they are to be used

if a patient demands that their record is removed, the benefits of keeping the records to patients and the difficulties that would arise if they were not kept should be explained
- could get the patient to sign a disclaimer, (e.g. “I understand that removal of my patient medication records means that the pharmacist is not able to check previous medications, dose changes and interactions”) to deter the patient from having the records removed