Clinical Governance, Law, Responsibility

Question 1

Definition of unlicensed medication

Answer 1

No marketing authorisation or license for use in the UK

Question 2

Definition of off-label medication

Answer 2

Medicine with marketing authorisation / license but prescribed for an unlicensed indication e.g. amitriptyline for neuropathic pain

Question 3

What can Pharmacist IPs prescribe?

Answer 3

WITHIN SCOPE = Licensed, unlicensed, off-label, CDs 2-5, borderline substances

Question 4

What is clinical management plan (CMP)?

Answer 4

• Specific document followed by supplementary prescribers
• voluntary
• IP must be a Dr or Dentist
• supplementary prescribers and employers responsible and liable
• NOT group of patients.
• Patient specific name, medical condition, POM, warnings, review/follow up, aims of treatment, use by names
• benefit for long-term conditions
• review at least at 6 months

Question 5

The Human Medicines Regulations 2012

Answer 5

Regulates the licensing, sale, supply and use of medicines by pharmaceutical industry, healthcare professionals and the public

Question 6

MHRA

Answer 6

• medicines and healthcare products regulatory agency
• Government regulatory agency
• Licensing of medicines in UK

Question 7

MHRA “blue guide” 2005

Answer 7

Pharmaceutical companies cannot advertise to general public that one product better than other

Question 8

Name the 4 types of law

Answer 8

1. Employment
2. Contract
3. Criminal
4. Tort (Negligence)

Question 9

Define negligence

Answer 9

Breach of duty, foreseen, causes harm/injury (not liable in harm/injury would occur regrdless of decision)

Question 10

Define accountability

Answer 10

Pharmacist responsibility for clinical decisions

Question 11

Duty of Care

Answer 11

• Employers responsibility for HCP actions
• HCP owe duty of care to patient / patient centred care
• starts at acceptance of patient for treatment / first contact
• match standards of reasonably competent practitioner
• within scope of practice
• safetynet

Question 12

Vicarious Liability

Answer 12

Indemnity insurance, professional regulatory bodies, compensation, revalidation and CPD, employer liability

Question 13

Consent

Answer 13

Implied / oral / written
Provide adequate info
Given freely, no deceit
Overrule if patient changes mind
Own >16yrs with capacity
Parents if <16 years

Question 14

Exceptions to consent

Answer 14

Emergency, implied, day to day contact

Question 15

Mental Capacity Act 2005

Answer 15

Legal framework for acting and making decisions on behalf of a patient who lacks mental capacity to make decision for themselves

Best interest of the patient

Adults >16yrs without capacity (only overruled by court)

Vulnerable adults who lack capacity

Power of attorney
Advanced care planning

Accompanied by the Mental Capacity Act 2005 Code of Practice

Question 16

Capacity

Answer 16

Decision making
Functional tests
Recall info
Review

Question 17

Freedom of information act 2000

Answer 17

Law in the UK that grants the public the right to access information held by public authorities.

• patient right
• info request
• response within 20 days
• complaints procedure
• public schemes
• exemptions of confidential date / info that cause cause harm

Promotes transparency and holding public authorities accountable

Question 18

Clinical Governance

Answer 18

Duty of care
Quality improvements, risk managements, clinical effectiveness, patient involvement, education and training, governance and leadership, safeguarding

Individual = NHS
National = commission for health improvements (CHI)

Question 19

Care Quality Commission (CQC)

Answer 19

Independent regulator of health and social care services in England.

Established under the Health and Social Care Act 2008.

Responsible for monitoring, inspecting, and regulating healthcare and social care services to ensure they meet fundamental standards of quality and safety.

1. Treat with care and dignity
2. Food and drink meets needs
3. Enviro clean and safe
4. Manage staff and services

Question 20

Francis Report 2013

Answer 20

Investigation of patient safety experience and clinical effectiveness

Purpose to make recommendations for changes to improve patient safety, the quality of care, and the overall functioning of the NHS

Question 21

x7 pillars of clinical governance

Answer 21

1. consultation
2. clinical risk management
3. clinical audit
4. research and effectiveness
5. staffing and management
6. education, training, CPD
7. Use of patient info

Question 22

Name given for a newly qualified IP

Answer 22

V300 prescriber

Question 23

What legislation is for the sale, use and production of medicines including prescribing rights

Answer 23

1) Medicines act 1968
2) POM order 1997

Question 24

What is a borderline substance ?

Answer 24

• Product that doesn’t fall into a particular area
• Not specifically identified as a medicinal product
  E.g. cosmetic or food

Question 25

What is a black list medication?

Answer 25

• list of medications that won’t be funded by NHS without exemption
• Part XVIIIA of the Drug Tariff
• endorse any Rx as SLS (selective list scheme)
• IPs should avoid prescribing

Question 26

Mental Capacity Act 2005 Code of Practice

Answer 26

Statutory principles: protect people who lack capacity, help them take part as much as possible in decisions that affect them (not restrict or control)
X5 principles:
1. A person much be assumed to have capacity unless established that he lacks
2. A person is not treated as unable to make a decision unless all steps to help have been taken with no success
3. A person is not treated as unable to make a decision just because they make an unwise decision - human right, own believes, values, preference. Monitor for unsafe
4. Best interest of patient
5. Less restrictive action / decision made to maintain patients rights and freedom of action - alternatives