Module 3, ethical & legal considerations in complex clinical cases

Question 1

What is legal behaviour?

Answer 1

The law informs you about:

• what you must, and what you must not do
• criminal law: designed to protect society as a whole from wrongful actions e.g. traffic/ road laws, public order laws, property laws and people laws e.g. smoking in public places
• common law: help to solve problems which occur between individuals or groups e.g. employment law, contract law, family law, law of torts (e.g. compensation)
• health service law e.g. health servces act, TGA, medicines and poisons law, mental health act

Question 2

What is legal behaviour?

Answer 2

Principle moral principal:

• doing good
• avoiding causing harm

In professional pharmacy context:

• complying with rules about the rghts and responsibilities of pharmacists, patients and other healthcare professionals
• helps you decide what you should do when there are no relevant laws
• ethical behaviour is where your actions may affect the rights of others, may cause others harm or benefit, particularly in their health, or may dis/ respect their values and culture

Question 3

Whats the difference between ethical and legal behaviour?

Answer 3

• ethical standards are based on human principles of what is right and wrong, and conform to professional and cultural norms
• legal standards are based on written laws
• an action could be legal, but not ethical and vice versa

Question 4

What are the code of ethics for Pharmacists?

Answer 4

Question 5

What are examples of ethical issues?

Answer 5

• abortion
• assisted reproduction
• assisted suicide & euthanasia
• confidentiality
• EC
• OC
• research methods
• promotion of prescription medicines
• substance abuse and dependance
• withholding or withdrawal of treatment interventions

Question 6

Discuss legal and ethical aspects related to research ethics…

Answer 6

• research is an integrall part of clinical pharmacy practice
• historic lack of ethics in research lead to development of:
  
  • declaration of helsinki
• in addition, pharmacists involved in research must comply with the National Statement on Ethical Conduct in Human Research and local Human Research Ethics Committee
• Approval of research proposals is based on decisions regarding:
  
  • relative risk to subjects
  • subject identification and selection
  • consent procedures and documentation
  • method od ensuring subject confidentiality

Question 7

Discuss legal and ethical aspects related to confidentiality…

Answer 7

• common ethical issue for healthcare professionals
• basic moral right of the patient
• trust relationship between patients and pharmacists
• info obtained by pharmacists should only be shared with healthcare professionals involved with patients care
  
  • access to written & electronic records e.g. medication history
  • discussion about patients
  • discussion with patients
• PrIVACY ACT
  
  • regulates how personal info is handled

Question 8

Define autonomy

Answer 8

• Free will: ability of patients to make their own decisions and pursue their own actions in line with their ability to be open to reason and consider the consequences
• Contributes to the other 3 principles
• In reality, our rights and abilities to decide are impacted by the law and circumstances

Question 9

Define beneficience…

Answer 9

• Obligation to help patients

Question 10

Define justice

Answer 10

• People in similar situations should be treated equitably
• Fairness and freedom from discrimination
• Often relates to access to healthcare

Question 11

Define non maleficence

Answer 11

• Do no harm
• Ensuring that potential benefits outweigh potential risks

Question 12

Scenario: Pharmacist working under the influence of alcohol

• Your pharmacy assistant tells you that she saw your regular locum pharmacist who covers on your day off, sitting in his car at lunch-time drinking a can of Johnnie Walker with cola. There seemed to be a few cans on the passenger seat
• She adds that the same afternoon, the locum pharmacist made a number of errors when dispensing prescriptions in the outpatient pharmacy
• The locum pharmacist is a good friend of yours, and infact you recommended him for the job!
• What will you do?

Answer 12

Stage 1: Gather relevant facts

• Nature and quantity of the medicines supplied with errors
• Terms of Service of the pharmacy
• Principles of negligence
• Key responsibilities of a pharmacist within the Code of Ethics
• Good practice: dispensing; management of alcohol abuse
• Use of outside resources e.g. PSA, SHPA, PBA
• CAUTION: some of the information you have been given will need to be confirmed e.g. could drop into the pharmacy one afternoon when your friend is working

Question 13

What criminal law applies?

Answer 13

• Not against the law to be drunk in charge of a pharmacy
• The law still sees your friend as the pharmacist in control of the pharmacy
• You know, however, that your friend drives a car (and was sitting in the car while drinking): concerns about fitness to drive
• Supplying the wrong medicine is a breach of the Medicines and Poisons Act and a criminal offence (although charges are rarely laid). If such errors resulted from reckless / irresponsible behaviour (rather than human error), prosecution may be more likely, and if the error resulted in patient death, the pharmacist could be charged with manslaughter

Question 14

What health service laws or protocols apply?

Answer 14

• Terms of service provisions do not include specific conditions about remaining sober, but dispensing a medicine that is not “as ordered” by a prescriber is a breach
  
  • May lead to financial and administrative sanctions
  • Employment law provides power to enforce service provisions; employees can be performance managed and disciplinary action taken

Question 15

What common laws apply?

Answer 15

• Serious civil liabilities could be incurred by you and your friend
• You have a duty of care to your patients / customers: any dereliction of that duty that results in harm to patients will make you and your friend liable for damages / compensation (proportionate to the extent of harm; which may be different for different types of patients)
• Less likely: defamation of character if you were to publicise your suspicions about your friend

Question 16

Guidance from the code of ethics…

Answer 16

• Drunkenness is not directly prohibited but the issue is implicit in your responsibilities as a pharmacist – duty to act in the interests of patients and the public
• Responsibility to avoid any activity that would impair confidence in the profession or bring it into disrepute
• Obligation to help a colleague to cope with a possible serious problem

Question 17

What professional knowledge applies? Where can i look/ ask for help?

Answer 17

• All of your training tells you that this is an unsafe situation that cannot be ignored
• Need to review the previously dispensed prescriptions and take reasonable steps to follow up those already supplied to patients
• Pharmacists’ Support Service http://www.supportforpharmacists.org.au/
• Next Step Drug and Alcohol Services
• Alcoholics Anonymous
• SHPA or PSA and / or Pharmacy Board of Australia

Question 18

What is stage 2?

Answer 18

Prioritise and assign values

• Protecting the public must be your first concern
• Priority: ? serious, but not urgent for you: could avoid using your friend for a while until you decide on the best course of action
• But, you must consider the consequences of your friend working in other pharmacies in the same state, and the consequences for your friend himself
• Whatever your sympathies and loyalties, they cannot overrule your duty of care to your patients
  
  • Probably best to limit yourself to discreetly voicing “concern” while establishing the extent of the risk being created
• Also need to exercise discretion when talking to your staff
  
  • Will need the assistant to write a statement about what they observed / heard; remind them of the need for confidentiality
  • You may feel a conflict of loyalty between your friend and dealing with the situation appropriately
  • Must be objective and make careful observations before jumping to conclusions

Question 19

What is stage 3?

Answer 19

Generate options

1. Do not offer your friend work again
2. Do not offer your friend work again, and report your suspicions to the Pharmacy Board of Australia (PBA)
3. Keep observing your friend and tell the PBA and Pharmacists’ Support Service
4. Confront your friend with your suspicions

Question 20

What is stage 4?

Answer 20

Choose an option

• Situations such as this are vey complex, and which option you choose may change depending in the specific circumstances and information gathered
• In this scenario provided you do not find serious and frequent errors that resulted from your friends behaviour, option 3 may be best
• If you uncover serious problems, then you may need to choose option 2: dismiss your friend, and alert the PBA, perhaps locum agencies and local pharmacies as soon as you can

Question 21

Scenario 2: A neighbour is in hospital and her mother asks you about her condition

• You are a clinical pharmacist working on a psychiatric ward. On a routine ward visit, you are surprised to see your young neighbour, Emma, who has been admitted.
• After chatting briefly you continue to the ward round. As you are leaving, Emma’s mother, who you also know, confronts you on the ward. She is very agitated and demands to know what is wrong with Emma, what she is taking and when she will be well again.
• What will you do?

Answer 21

Stage 1: Gather relevant facts

• Privacy
• Health service policies, standards, guidelines and procedures
• Principles of negligence; breach of confidentiality
• Key responsibilities of a pharmacist within the Code of Ethics
• Nature of Emma’s condition and treatment

Question 22

What criminal law applies?

Answer 22

• The Privacy Act would apply for all data concerning Emma’s condition inc. medical records, treatment details and care plan
• Exemptions to the Act apply where disclosure is needed for clinical management purposes and is to a healthcare professional directly involved with her care, and is bound by a duty of confidentiality
• This exemption does not apply to relatives

Question 23

What Health Service laws or protocols apply?

Answer 23

• Hospitals and contractors providing health services are expected to maintain confidentiality.
• Be aware of WA Health Confidentiality Policy http://www.health.wa.gov.au/circularsnew/pdfs/13317.pdf
• Be aware of your hospital’s policies and procedures on confidentiality of patient information, and what guidance, if any, is given to address this particular situation
• This may be useful source of defence if you cannot help Emma’s mother

Question 24

What common laws apply?

Answer 24

• Disclosure of Emma’s details to her mother may not result in physical injury to Emma, but that is not the only type of damage that can result in compensation for a breach of duty of care
• Anxiety or distress caused by careless disclosure of patients’ details could be deemed negligent
• Even if such an action did not result, the non-consensual disclosure could jeopardise Emma’s progress or treatment and could result in a measureable injury
• Damages could include financial loss e.g. loss of earnings caused by a delay in Emma’s return to work

Question 25

Where can I look / ask for help?

Question 26

What is Stage 2?

Answer 26

Prioritise and assign values

• Emma’s wishes and interests must prevail in this scenario
• She has capacity to give consent – you know this because you have spoken with her. So, there is no reason why she cannot be consulted
• Your professional knowledge may hinder dealing with Emma’s mother’s demands – you may be aware that Emma has a serious condition with a poor prognosis
• You may also feel that Emma’s mother should also be aware of this so that she can support Emma. But this is not appropriate as Emma is an adult and competent in the law to manage her own affairs. You should, however, consider options to alleviate her mother’s distress e.g. offer her a chair, cup of tea, and try to find out what her worst fears are and what she knows already
• The other members of the healthcare team may already know how much information Emma wants disclosed to her mother at this stage  You may seek guidance from a pharmacy colleague, but be aware of the need to comply with confidentiality procedures. It would not be appropriate to discuss the case at home e.g. with your partner

Question 27

What is stage 3?

Answer 27

Generate options

1. Tell Emma’s mother what you know
2. Tell Emma’s mother that you cannot discuss the matter at all
3. Take time to sit with Emma’s mother and explain why you cannot divulge the information she wants, and then decide what further action to take

Question 28

What is stage 4?

Answer 28

1. Tell Emma’s mother what you know
2. Tell Emma’s mother that you cannot discuss the matter at all
3. Take time to sit with Emma’s mother and explain why you cannot divulge the information she wants, and then decide what further action to take

Record your actions in Emma’s patient notes

Question 29

Confidentiality scenario:

Answer 29

• Scenario: (2013, USA) Jenna, 20 year-old university student, made an appointment with her life-long GP to start oral contraception
• Jenna’s mother and older sister were also under the GP’s care
• After the consultation, Jenna told the receptionist that she would pay for the visit herself - she didn’t want her mother to know the reason for the visit
• The practice’s billing system was undergoing a software upgrade. So, Jenna asked that the bill be sent to her university address
• Approx. 2 weeks later, Jenna’s mum came to see the GP for a routine appointment. When she checked in, she asked the receptionist to check a notice of insurance claim that had come though related to an appointment by her daughter who was away at university.
• During her consultation with the GP, the GP mentions what a beautiful, intelligent young woman Jenna has become.
• Ethical Issue: breach of confidentiality
• Consequence: Loss of trust, emotional upset, damage to reputation, increased scrutiny into professional and business conduct, loss of earnings / business loss

Question 30

Confidentiality and Business Continuity scenario: