Professional governance and clinical negligence

Question 1

How the law is (broadly) organised

Answer 1

• Statutory
  
  • Criminal legislation
  • Administrative legislation
  • Professional legislation
• Common (civil)
  
  • E.g. negligence trespass, defamation

Question 2

Fitness to practice

Answer 2

• A pharmacy professional is fit to practise when they have the skills, knowledge, character and health necessary to do their job safely and effectively and when they act professionally and meet the prinicples of good practice set out in our various standards, guidance and advice

Question 3

Registered pharmacy professionals must

Answer 3

• Complete an annual fitness to practise declaration
• Let the GPhC know within seven days if they become aware of an issue which may affect their fitness to practise
• A complete revalidation including 4 CPD records, a peer review and a short reflective account

Question 4

GPhC standards for pharmacy professionals

Answer 4

Question 5

Pharmacists and pharmacy technicians order 2007- impairment

Answer 5

• A person’s fitness to practise may be impaired by reason of any of following
  
  • Misconduct
  • Deficient professional performance
  • Adverse physical or mental health
  • Failure to comply with Reasonable requirement by assesor
  • A conviction for a criminal offence-British isles
  • A police caution- British isles
  • Finding impaired fitness to practice by health or social care regulatory body

Question 6

Public interest

Answer 6

• Committes must act in the public interest when considering fitness to practise issues
  
  • Protect members of the public
  • Maintain public confidence in the profession
  • Declare and uphold proper standards of conduct and behaviour

Question 7

Fair trial

Answer 7

• Registrant is entitled (common law) to
  
  • An unbiased tribunal
  • A right to be present and to be represented
  • A right to reason for any decision
• Also European convention on human rights, Art, registrant is entitled to
  
  • A fair and public hearing
  • Within a reasonable time
  • By an independent and impartial tribunal established by law

Question 8

Proportionality

Answer 8

• Committee
  
  • Exercises discretion in a way that is fair and Reasonable
  • Weighs interests of practitioner against the wider ‘public intrest’
  • Considers range of sanctions available to it

Question 9

Purpose of saction

Answer 9

• Protect the public
• Maintain public confidence in the profession
• Maintain proper standards

Question 10

Bolton v Law society

Answer 10

• The reputation of the profession is more important than the fortunes of any individual member
• Membership of a profession brings many benefits, but that is part of the price

Question 11

Raising concerns

Answer 11

• Every pharmacy professional has a duty to raise any concerns about individuals, actions or circumstances that may be unacceptable and that could result in risks to patient and public safety

Question 12

The GPhC investigates a wide range of fitness to practise issues including

Answer 12

• Errors in dispensing medication
• Sexual misconduct
• Pharmacy professionals working under the influence of alcohol or drugs
• Fraud
• Theft
• Dishonesty

Question 13

Operation of FTP

Answer 13

Question 14

Referral to investigating committee

Threshold criteria

Answer 14

• The registrar should not refer a case to the IC unless the evidence as a whole suggests that
• Conduct, performance
  
  • It presents an actual or potential risk to the patient or public safety
  • It undermines or is likely to undermine, confidence in the pharmacy professions
  • There has been a serious or persistent failure to meet any of the standards for pharmacy professionals or
  • The honesty or integrity of the pharmacy profession can no longer be relied upon
• Health- there is adverse physical or mental health which presents a risk to the pharmacy professionals ability to practice safely or effectively
• Public interest- and it is the public interest to refer

Question 15

From the GPhC

Answer 15

• Regulation should not create unnecessary burdens, but be proportionate to the risk it addresses and benefit it brings
• It should support and enable the working lives of pharmacists and pharmacy technicians and open up pathways to a satisfying career, rather than being seen purely as a means of discipline

Question 16

Laws and the legal system

Answer 16

• Statute law- This is law which has been laid before parliament and enshrined in acts, orders, regulations
• Common law- The is law that has arisen from the courts system
  
  • The law of tort is part of common law

Question 17

The law of negligence

Answer 17

• If a healthcare professional commits a tort or breaks a contract, they are liable for any damage caused and may be sued in a court of law
• Liability= having a legal obligation
• The law of negligence applies when a person’s property has been damaged or they suffer an injury through someone else’s careless action
• The injury caused could be financial or physical

Question 18

Proving negligence

Answer 18

• The plaintiff (injured person) must prove three things in a court of law
  
  • A duty of care exists
  • There was a breach of that duty
  • That breach resulted in damage to the plaintiff
• All three elements must be proven
• If the court is not satisfied that all three have been proven, the case will fail

Question 19

A duty of care exists when

Answer 19

• The damage caused was reasonably foreseeable AND
  
  • There was a sufficiently proximate relationship between the parties
    
    • That breach resulted in damage to the plaintiff

Question 20

What is a foreseeable damage

Answer 20

Question 21

What is a proximate relationship

Answer 21

Question 22

Proximity

Answer 22

• Somebody is proximate if they will be directly affected by your act to the extent that you ought to have them in your mide when performing that act (you do not need to be physically touching them for them to be legally ‘proximate’ to you)

Question 23

Does a duty of care exist

Answer 23

• Look at some cases
• Apply the three legal tests to see whether there is a legal duty of care owed
• Our concern is not whether it seems morally or professionally right to assign a duty of care, nor is it whether we feel the act is negligent
• Simply interested in the legal position regarding the duty of care

Question 24

Our four cases

Answer 24

1. Rendering first aid in a road traffic accident- you move the injured party from the road and this results in spinal damage
2. Rendering first aid in the pharmacy- you do not clean the wound properly and infection results
3. Giving advice regarding a prescription medication- your advice is incorrect and the patient takes too much of the product
4. A woman for who you dispense a broad spectrum antibiotic also takes an oral contraceptive; you do not counsel her appropriately and pregnancy results

Question 25

Professional vs Individual roles

Answer 25

• There is no legal imperative to assist the victim of an accident, just because they might benefit from the assistance (there may be a professional requirement)
• You only have a legal duty of care if it exists because of your job
• So a patient in a pharmacy can reasonably expect to receive care from a HCP

Question 26

Breach of the duty of care

Answer 26

• Centres on the standard of care given
• A breach of the duty of care is proven if the professional did not reach the standard of practice required by the law

Question 27

The legal standard of care is defined by

Answer 27

• Bolam test- if the claim for negligence arises from an action or omission to act
• Montgomery test - if the claim for negligence arises from a failure to secure adequate consent

Question 28

The bolam test

Answer 28

• Accepted standard of care- that which is thought to be acceptable to HCP’s professional peers
• So a HCP cannot be held negligent if s/he acts in a manner which is acceptable to their professional pears
• Their peers may not have acted in the same way but must regard the defendant’s action as falling within the range of acceptable practice
• The HCP is negligent if the care that her or she provides falls below the minimum standard of skill or care which the medical (or pharmaceutical) profession regards as acceptable in the particular circumstances
• Importantly, this means that the medical professional (or pharmacist) will not be judged by the standard of the elite but will be expected to reach the standard of the average competent doctor

Question 29

The Bolam test

Answer 29

• Is very well established in English law and is applied to all health care professionals
• Is subject to additional interpretations, for example if 2 sets of professional witness disagree with another
• However, a more in depth treatment is beyond the scope of this course
• In any case, you will hopefully never have the bolam test applied to you

Question 30

The Montgomery test

Answer 30

• The accepted standard of care is that HCP must take ‘reasonable care to ensure that the patient is away of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’

Question 31

The breach caused injury or damage

Answer 31

• This can be the most difficult element to prove (although it is sometimes relatively straightforward)
• Even if the defendant is clearly at faulty, if it cannot be proven that their actions caused the damage, the claim will fail

Question 32

A landmark case

Answer 32

• A man presented to A&E complaining of stomach pain
• The attending doctor failed to examine him but told him to present to his GP is the pain persisted
• The man died before he could get to his GP
• Was the A&E doctor guilty of negligence

Question 33

Not according to the courts

Answer 33

• He certainly had a duty of care, and he failed to meet the standard of care
• BUT- his action did not cause the main to die
• The man was suffering from arsenic poisoning
• Even if he had been examined, it was too late to administer and antidote, and he would have died in any case

Question 34

Four important cases

Answer 34

• The migril case 1982
• The Daonil 1988
• The Epilim case 2000
• The dexamethasone 2006

Question 35

Sir Brian Leveson

Answer 35

• The implications for medical and other professions would be serious because people would be guilty of gross negligence manslaughter by reason of negligent omissions to carry out routine eye, blood and other tests which in fact would have revealed fatal conditions notwithstanding that the circumstances were such that it was not reasonably foreseeable that failure to carry out such test would carry an obvious and serious risk of death