WK7 Healthcare Law and Ethics in Pharmacy Practice

Question 1

What is the reasonable man test?

Answer 1

• The law assumes that everyone is unreasonable and will apply the “reasonable man test”
• A reasonable person / pharmacist will be used as a reference point for comparison and evaluation, to see what they will do in the same scenario
• Must be of same competency when comparing

Question 2

What are torts? What are some examples of torts?

Answer 2

Wrongful Acts:

• Individual and corporate level
• Examples:

1. Negligence
   a. Standard of care – Bolam test as supplemented by Bolitho case and confirmed by Gunapathy case
   b. Bolam – accepted current practice
   c. Bolitho – evidence-based medicine + logical
2. Trespassing of lands
3. Defamation
4. Assault, battery (intentional tort)
5. Occupier’s liability
   a. All occupiers owe a duty of care to all users and visitors of their facilities e.g. safe infrastructure and facilities
   b. Occupier’s viability eg sell clothes, then water becos flooding, then the building person have to pay the person for the clothes they have to throw away since it is wet

Question 3

Explain vicarious liability.

Answer 3

Doctrine of Vicarious Liability:

• An employer is vicariously liable for the torts committed by its employees
  o E.g. NUH is liable for their doctors’ actions
  o Include both patientcare and non-patient care
  o Conditions:
  –> Master-servant relationship / employer-employee relationship
  –> Within employment (job scope and responsibilities)
• An organisation is liable to its non-employees who act as ostensible agents
  o E.g. NUH is liable to its supplier
  o E.g. outsourced services e.g. CSSD, Radiology, delivery services)

Question 4

Explain what is independent contractor and who will be liable if an independent contractor did something wrong.

Answer 4

Independent Contractor:

• An organisation is not liable in the context of independent contractor
  o Independent contractor = principal has no right of control over the manner how an agent work is to be done
  o E.g. (Dennis Mathew Harte v Dr Tan Hun How and Another) Surgeon using Gleneagles OT as independent contractor, and patient cannot sue Gleneagles due to surgeon’s negligence (can sue the surgeon)
  o patient can’t sue the operator but the doctor usually happen in the private sector, but if done in inpatient then the hospital will be sued (under the occupier’s viability)

Question 5

What are the sources of law in the Singapore legal system? Give examples of each of them.

Answer 5

Sources of law:

1. Legislations / Statutes

• Healthcare services act 2020
• Misuse of drugs act
• Infectious diseases act
• Infectious diseases (COVID-19 Stay Orders) Regulations 2020
• Penal Code 1871
• Personal Data protection Act
• Mental Health (Care and Treatment) Act

2. Common / Case Law

• Case Precedents
• Decisions of Judges – Law Report

A precedent is a principle or rule established in a previous legal case that is either binding on or persuasive for a court or other tribunal when deciding subsequent cases with similar issues or facts

Question 6

What are the types of law under wrongful acts?

Answer 6

Criminal law + Civil law
(both are under legal liability)

Question 7

What are the 2 routes of civil liability?

Answer 7

1. tortiously liable
2. contractually liable

Question 8

How to classify a wrongful act?

Answer 8

Wrongful acts
–> Criminal liability AND/OR civil liability (tortiously liable / contractually liable)

• A wrongful act can be both criminal and civil liabilities
• Civil liability can only be proceeded via 1 route – tort or contract
• A wrongful act can result in ethical implications that are handled by relevant professional entities e.g. SPC, SNB, SMC)

Extra notes:

• tend to sue less on the contract side of things, unless breach of contract is v clear
• eg pharmacist in US supposed to hold a huge box of vaccines (in the initial stage of vaccine), purposely not put in the fridge, so huge amount of loss to pharmacy group and reputation of it
• wrongful act
• not criminal liability (since it’s not an offence against the state)
• thus under civil liability → put under tort (intentionally bring out vaccine and stay at room temp., so huge loss to company)
• US will bring out the contract law, must ensure that 100% are kept within the right condition
• but in Sg most likely will sue the pharmaceutical law (tortiously liable) which is similar to British law

Question 9

What is the difference between criminal law and civil law?

Answer 9

1. Criminal Law

• Reference Source: legislation / statutes
• Guilty / Not Guilty
• Burden of Proof: 100% (beyond reasonable doubt)
• Guilty = Sentence to fine, caning, jail term, and/or death

2. Civil Law

• Reference Source: contract law / law of torts
• Liable / not liable
• Burden of proof = 51% (balance of probabilities)
• Liable = damages, specific performance, and/or injunction

Question 10

What are the 6 principles of the medical ethics?

Answer 10

1. Autonomy
2. beneficence
3. non-maleficence
4. justice
5. fidelity
6. veracity

Question 11

Explain autonomy.

Answer 11

1. Autonomy
   o Respect for patients’ needs/desires/preferences
   o Freedom to form his/her own judgements and choose his/her own actions
   o Even if others strongly believed that his/her evaluations are inappropriate/wrong
   o E.g. at-own-risk discharge/discharge against advice
   o Important to inform patients of pros and cons of both receiving treatment or refusing treatment

Question 12

When is autonomy absent?
What are the legal considerations in play?
What are the acts and frameworks in place to protect these vulnerable people (5)?

Answer 12

Autonomy is absent in:

1. Coercion (force)
2. Ignorance
3. Immaturity – Less than legal age but can comprehend 100% of what is happening
4. Mental incapacity

Legal considerations in play:

• Mental capacity act
• Lasting power of attorney
• Gillick Awareness/ Competence
  o eg. 15 y/o just give me antibiotics becos I’m scared of STD, but don’t tell my parents (Gillick Awareness → pros and cons well documented then need to respect this person) (Caveat: if person say im being raped, criminal law comes in place, the criminal law will precede everything)
• Court Appointed Deputy
• Mental health (care and treatment) act

Question 13

Explain beneficence. What are the 4 elements of beneficence?

Answer 13

2. Beneficence
   o Contribute to patients’ welfare and well being
   o Responsibility of HCP to do good to patients and the general public
   Four elements:

• Not to inflict harm
• Prevent harm
• Remove harm
• Do or promote good

Question 14

Explain non-maleficence.

Answer 14

3. Non-maleficence
   o Do no harm
   o Obligation not to inflict harm intentionally

Question 15

Explain justice.

Answer 15

4. Justice
   o Equitable distribution of benefits/burdens
   o Fairness
   o Like cases should be treated alike
   o People who are equally qualified for a service should have equal access to it

Question 16

Explain fidelity.
What are the exceptions to patient confidentiality?

Answer 16

Fidelity
o Truthfulness and confidentiality
o Exceptions to patient confidentiality:

1. When a patient consents
2. To other HCP caring for patients
3. Statutory duty by Dr (Infectious disease Act)
4. Disclosure under court order
5. Discovery of documents in court proceedings
6. Public interest (e.g. injuries indicative of child/elderly abuse, rape, crimes)

Question 17

Explain veracity.

Answer 17

Honesty.
(Having mutual trust between the HCP and patient)

Question 18

What is the litmus test and the main point of it?

Answer 18

Litmus Test:
* acting ethically when nobody is watching you
* doing the right thing when nobody is looking at you

Question 19

What is the definition of prosecute and sue?

Answer 19

Definitions:
“Prosecute” only done by authorities to institute/conduct criminal proceedings e.g. police (criminal cases)
“Sue” used in civil cases only

Question 20

What are the different types of liabilities? State and explain.

Answer 20

“Liability” is fundamentally about assigning responsibility.

Legal liability – criminal and civil liability

Criminal Liability: If you are criminally liable, you are likely to be held responsible for breaking the law

Civil liability is the legal responsibility for a payment to an aggrieved third party, due to the violation of a civil law,** tort**, or a breach of contract.

Ethical Liability: Normatively, we can judge a liability rule as “ethical” if it places responsibility on a party that we feel should be held responsible for a given situation

You can be prosecuted or sued for a legal liability, but not for an ethical liability
You can be punished for an ethical liability

Question 21

What are the 3 aspects of medical negligence?

Answer 21

Medical Negligence:
1. Wrong diagnosis
2. Wrong treatment
3. Inadequate information disclosure

• Did not do properly (failure)
• Did not do what was supposed to be done (omission)
• Did what was not supposed to be done

Question 22

What is negligent misstatement?

Answer 22

Negligent Misstatement:
Party A has carelessly made a statement to Party B, where the relationship between the parties is such that Party A owes Party B a duty of care.

• If you know that the information was required for the transaction contemplated by the patient
• If you know that it would be communicated to the patient
• If you know that patient would rely on the information
• If patient does rely on the information

Question 23

What are the 4 components needed to prove medical negligence?

Answer 23

1. duty of care
2. breach of standard of care
3. causation
4. forseeable damages / injuries

Question 24

What are the principle and liabilities that act as the foundation for the duty of care?

Answer 24

1. Duty of Care

• Neighbour principle – ensure not to cause foreseeable harm to another
• Vicarious liability – hospital is liable for an employee’s negligence committed during the course of employment
• Occupier’s liability – hospital expected to provide safe premises to everyone on its premises
• Hospital and staff owe a duty of care to patients
  o Duty to provide proper facilities and equipment
  o Duty to provide proper healthcare services
  o Further owed to third parties e.g. family (so that they do not sustain mental distress)
• Pharmacists’ duty of care to patients is subjected to the scope of responsibilities assigned by the hospital and pharmacy department
• The moment we start instructing, assessing and giving advice to patient, or performing CPR, we owe them a duty of care

Question 25

When do people start owing others the duty of care?

Answer 25

The moment we start instructing, assessing and giving advice to patient, or performing CPR, we owe them a duty of care

Question 26

What is the standard of care based on?
What tests are used to see whether a person has breached the standard of care?

Answer 26

2. Breach of standard of care
   * Standard of care is based on “reasonable man test”
   * HCP must be reasonably competent when compared to his/her fellow peers

• Bolam test came first, then Bolitho case show how it is interpreted, then Gunapathy case shows how it is implemented
• Bolam test – a doctor must demonstrate that at least 1 other medical professional with an ordinary level of skill would have acted in the same way in delivering an ordinary level of care
  o HCP is judged against the standards of their peers
  o Not guilty of negligence if he/she acted in accordance to the current accepted practice (constantly evolving)
• Bolitho test – evidence based medicine that is logical
  o To tell whether it was logical, look at e.g.:
  o Recommendations of antibiotics
  o Guidelines
  o Guidance documents

Question 27

What is causation?
What is the patient’s defence?
What is the HCP defence?

Answer 27

3. Causation

• HCP’s lack of care that results in patient’s injury/harm
• Patient’s defence
  o Facts speak for themselves(res ipsa loquitor)
  o The law can help patients in situations where it is unfair or difficult to identify the errors or causes of injuries
  o If the defendant HCP is unable to give a satisfactory explanation, he/she will be liable for the damages/injuries caused to the patient
• HCP’s defence
  o Contributory negligence
   Patient contributed to his/her injury through own negligence on top of HCP’s negligence, his damages will be reduced
   E.g. don’t want to disclose critical information about themselves
  o Consent to the risk (volenti non fit injuria)
   Patient was already informed of the benefits and risks, he understood and made an informed decision

Question 28

Explain what is forseeable damage.

Answer 28

1. Foreseeable damages / injuries
   * The damage / loss must not be too remote (meaning it needs to be foreseeable)

Question 29

What are the patient’s rights?

Answer 29

Patient’s rights and responsibilities:
Patient’s Rights:

1. Receive clear explanation of diagnostic tests, diagnoses, treatment options, medications, prognosis
2. Understand treatment options and their pros and cons
3. Participate in and make care decisions
4. Monitored during treatment processes
5. Accept or reject care interventions
6. Receive timely response to their care needs
7. Have privacy and confidentiality (unless exceptions apply)
8. Be discharged (unless exceptions apply)
9. Choose their HCP
10. Transfer and choose another hospital
    o Except patients who are mentally incapacitated or who are placed under Mental health care and treatment act
11. To access their medical records
    o Can consent family member to access his/her medical records or obtain update of his/her medical conditions
12. Know their HCP involved in their care
13. Receive considerate and respectful care from competent HCP

Question 30

What are the patient’s responsibilities?

Answer 30

Patient’s responsibilities:

1. Keep to scheduled TCU
2. Reschedule missed TCU
3. Understand instructions and education provided
4. Clarify if in doubt
5. Provide relevant information to HCP in a timely and accurate manner
   o E.g. symptoms, changes in medical conditions, medications from other HCP