informed consent

Question 1

what ways can you work in partnership with the patient?

Answer 1

• Communicate with Patient;
• Respect Patient Viewpoint;
• Discuss Diagnosis, Prognosis, Clinical Treatment &
Clinical Care Plan;
• Share ALL Clinical Information with Patient;
• Maximise Opportunities for Patient Decision Making; and
• Respect Patient’s Decisions on Diagnosis, Prognosis, Clinical
Treatment & Clinical Care Plan;

Question 2

what are the basis of pharmacist’s partnership with patient?

Answer 2

openness
mutual trust
good communication skills

Question 3

what is the check list for patient informed consent?

Answer 3

• Full Clinical Explanation;
• Option to Refuse Consent; and
• Monitoring of Behavioural Signs from Patient

Question 4

what approach would you use to provision of clinical information and treatment options?

Answer 4

• Patient’s Expressed Wishes;
• Patient’s Personal Priorities;
• Patient’s Knowledge and Understanding;
• Nature of the Clinical Condition;
• Complexity of Clinical Treatment and Clinical Care Plan; and
• Nature & Level of Risk in Clinical Treatment &
Clinical Investigation

Question 5

what are forms of clinical hazards?

Answer 5

• Clinical Side Effects;
• Clinical Complications; and
• Failure of Clinical Investigation or Clinical Treatment

Question 6

how do you delegate clinically responsibility for informed consent?

Answer 6

• Clinically Trained & Professionally Qualified;
• Professional Knowledge & Clinical Skill;
• Knowledge of Potential Clinical Hazards & Side Effects; and
• Experience in Approved Clinical Practice

Question 7

what is the clinical basis for acquisition of patients informed consent?

Answer 7

• Clinically Complex & Significant Clinical Risks;
• Significant Personal Implications;
• Provision of Clinical Care NOT Primary Purpose; and
• Research Programme or Innovative Clinical Plan

Question 8

what is the clinical requirement for updated patient informed consent?

Answer 8

• Significant Time Lapse;
• Material Change;
• Availability of Additional Clinical Information

Question 9

how do you clinically assess a patient of mental capacity?

Answer 9

• Understand Clinical Information;
• Retain Clinical Information;
• Comprehend Clinical Information; and
• Communicate a Personal Decision

Question 10

what are the clinical precautions for changes in patient mental capacity?

Answer 10

• Clinical Discussions with Mentally Competent Patient;
• Assist Patient Memory & Recall; and
• Confidential Consultations with Clinical Team & Patient Family

Question 11

who are the clinical team assessment of patient mental capacity?

Answer 11

• Clinical Care Team;
• Clinical Support Staff; and
• Clinical Specialists

Question 12

how do you clinically decide and mentally incompetent a patient?

Answer 12

• Prioritise Patient’s Best Interests;
• Respect Patient Individuality;
• Encourage and Support Patient Decision-Making; and
• Prevent Patient Discrimination

Question 13

what are the factors for clinical assessment of mental capacity?

Answer 13

• Temporary or Permanent Lack of Mental Capacity;
• Appropriate Clinical Options for Optimal Clinical Benefit;
• Least Restrictive Clinical Option on Patient Choices;
• Documentary Evidence of Advance Healthcare Planning;

Question 14

what are the factors for clinical assessment of mental capacity?

Answer 14

• Patient’s Legal Power of Attorney;
• Expressed Views of Patient Family & Next of Kin; and
• Professional Opinions of Clinical Care Team

Question 15

what does a patient with mental capacity have the legal right to?

Answer 15

Informed Consent
for any form of Clinical Investigation or Clinical Treatment.
Any Pharmacist who treats a Patient without Informed Consent is
Guilty of the Tort of Battery.

Question 16

what is a pharmacist who treats a patient without informed consent guilty of?

Answer 16

tort of battery

Question 17

what is the constituent elements of the tort of battery?

Answer 17

a Pharmacist must acquire the Patient’s Informed Consent for any
Clinical Investigation, Invasive Procedure or Clinical Treatment

Question 18

what is the tort of battery and assault?

Answer 18

If a Pharmacist fails to acquire the Patient’s Informed Consent and it
was Clinically Feasible to do so, an Allegation of Assault under the
Criminal Law may arise.

Question 19

what are the legal requirements for patient informed consent?

Answer 19

• Voluntary;
• Mental Capacity; and
• Access to Relevant Clinical Information
A Pharmacist owes a General Duty to Warn a Patient about
Statistical Risks of Clinical Hazards in a Clinical Procedure.
A Patient has a Legal Right to be Clinically Warned of Potential Harm
or Injury in a Clinical Procedure

Question 20

what are the legal forms of infomred consent?

Answer 20

• Express Consent; and

* Implied Consent

Question 21

what are the different approaches to disclosure of clinical information and acquisition of informed consent?

Answer 21

• Pharmacist-Centred Approach; or

* Patient-Centred Approach

Question 22

what is the legal test of materiality?

Answer 22

The Test of Materiality requires a Pharmacist to provide ALL Clinical
Information, e.g., “Material Risk” the Patient would “Attach
Significance To” in the Clinical Process of Informed Consent.

Question 23

what does ln Re F mean?

Answer 23

(Legal Distinction between Mental Disability & Mental Illness)

Question 24

what is ln Re C?

Answer 24

(Mental Illness NOT Absence of Mental Capacity)

Question 25

what is ln Re MB?

Answer 25

(Extreme Clinical Condition Form of Undue Influence)

Question 26

ln Re B?

Answer 26

(Right to Refuse Clinical Treatment as Mental Capacity NOT | Clinically Impaired)

Question 27

what is ln Re T?

Answer 27

(Undue Influence of Patient’s Close Relative negates Patient Mental Capacity

Question 28

what is the legislative framework regarding mental capacity?

Answer 28

S.2(1) Mental Capacity Act 2005 (Legal Test for Mental Capacity) S.3(1) Mental Capacity Act 2005 (Legal Criteria Defining Mental Capacity)

Question 29

what is the legal assessment of mental capacity?

Answer 29

* Presumption of Mental Capacity; * Exhaustion of Clinical Options; * Unwise Decision NOT Lack of Mental Capacity; * Act in Patient’s Best Interests; and * Prioritisation of Patient’s Rights & Freedom of Action

Question 30

what does fraser guidance assess?

Answer 30

• Comprehension of Clinical Advice; • Non-Persuadable on Parental Involvement; • Threat to Physical and/or Mental Health; and • Clinical Advice and Clinical Treatment in Minor Patient’s Best Interests