1. Legal and Ethical Issues in Medicines Information
All discussions during this session will be treated in confidence.
Has anyone in the course of their career been faced with an ethical dilemma or legal issue?
Does everyone understand a need to be aware of legal and ethical issues?
Maggie Fitzgerald
Medicines Information Pharmacist
8th January 2008
Acknowledgements: Richard O’Neill; Advancing the Provision of Pharmacy Law and Ethics Teaching - APPLET (Nottingham University)

2. Session aim
Identify legal and ethical problems that may be encountered when providing medicines information.
Before we get too involved, lets start with the basics and look at Law and Ethics separately – though in practice the two usually exist together. Aim is to give you confidence in handling these enquiries.
No guidance however comprehensive can hope to cover every possible situation. Each problem encountered will be different and will require an element of professional judgement, discretion and experience which cannot be conveyed in guidelines.
To date, haven’t found any legal proceedings directed towards an MI pharmacist.
May be some situations where patient may be suing Trusts and at some point had contact with MI such that the Trust lawyers may request the enquiry as part of their evidence. Probably because of my legal background but possibly as an MI pharmacist I have been asked to comment on cases the Trust is involved in and based on my report have had to give evidence to a Coroners court.
As a result – the cases we will discuss will be generic to pharmacy & medical practice overall – to highlight issues and increase your awareness.

3. Plan Medical Heath Law & ethics Legal aspects Professional codes
All of this will relate to MI since there is nothing specific to MI. Cover areas usually encountered in MI.
Not going to cover every law or ethical aspect possible – focus specifically on medical aspects:
Medical/Healthcare law
discrete and developing area of law: concerned with interactions between healthcare professionals, and patients, health care organisations, the NHS and government – specific material usually refers to Drs but equally justifiable to all healthcare professionals.
Medical/Healthcare ethics
branch of applied ethics: concerned with obligations of a moral nature which govern healthcare professions and professional practice
There has been a cultural shift in attitudes to the medical profession and the growth of legal services ‘industry’.
7500 clinical negligence claims annually
total cost to NHS £446M (
1% of NHS budget.
Not going to cover every law or ethical aspect possible – focus specifically on medical aspects:
Medical/Healthcare law
discrete and developing area of law: concerned with interactions between healthcare professionals, and patients, health care organisations, the NHS and government – specific material usually refers to Drs but equally justifiable to all healthcare professionals.
Medical/Healthcare ethics
branch of applied ethics: concerned with obligations of a moral nature which govern healthcare professions and professional practice
There has been a cultural shift in attitudes to the medical profession and the growth of legal services ‘industry’.
7500 clinical negligence claims annually
total cost to NHS £446M (
1% of NHS budget.

4. Legal aspects DEFINITIONS Statutory law Common (case) law
Public law and Private law
Criminal law and Civil law
Ask audience – what are laws? Why have them?
Law - represents minimum standards & applies broad societal standards and expectations.
Laws are the body of rules and regulations that govern society and protect the health, safety and welfare of its citizens.
There are various types of Law – to keep things simple, these are ones you may have heard of (ask audience if they know what each related to)
Statutory law is established and enforced by the State in response to perceived needs for social regulation.
Common (or case) law is law established by judicial decisions.
Public law and Private law both involve statute and case law. Public law involves the state or government and comprises criminal law, administrative law and constitutional law. Private or civil law comprises contract law, tort law, property law, family and welfare law.
Criminal law comprises laws that affect the whole of society.
A Crime is an act in violation of criminal law made with criminal intent
Actus reus (criminal act) refers to either an act that the law forbids or an omission of an act that the law requires.
Mens reas (criminal intent) refers to the state of mind of the person who commits a criminal act.
Civil law is law that affects the individual rather than the whole of society. A Tort is a wrongful act committed against another person.

5. The concept of medical (health care) law
This brings us to Medical law - THE CONCEPT OF MEDICAL (HEALTH CARE) LAW:
Medical, or healthcare, law is the branch of law concerned with the relationship between healthcare professionals (as well as healthcare institutions such as hospitals and other public bodies) and patients. It concerns itself with many areas of law, notably tort, criminal, public and administrative law, and family law.
Ethical issues, and those concerning human rights, permeate all the problems that arise in medical law. This means each case is different and outcomes may not be clear cut.
A branch of law.
Healthcare professionals (including institutes) and patients.
Covers a lot of areas of law: tort, criminal, public and administrative law, and family law.
Ethical issues are involved in all the problems that arise in medical law.

6. Laws protect the patient and public.

7. Professional Negligence
“We must take reasonable care to avoid acts and omissions which you can reasonably foresee would be likely to injure your neighbour ...”
Lord Atkin in Donoghue v Stevenson (1932)
Medical Law breaches are often associated with - Malpractice/Negligence:
Negligence is conduct that falls short of the standard expected of a person where a duty of care is owed and which causes foreseeable damage to another person. The duty applies to both acts and omissions.
“We must take reasonable care to avoid acts and omissions which you can reasonably foresee would be likely to injure your neighbour”…..”
Lord Atkin in Donoghue v Stevenson (1932)
This cases also stated that ‘the classes of negligence are never closed’. – involved a snail in a bottle of beer!!

8. Professional Negligence
Requirements for proving negligence:
Duty
Breach
Causation
For negligence to be established and number of factors must be proven by the person making the claim, e.g. a patient against a health care professional.
To establish negligence (or malpractice) on the part of a health care professional, a patient must prove (on the balance of probabilities):
Duty - that a duty was owed to the patient (plaintiff) in the particular situation;
Breach - that the professional (defendant) breached this duty in failing to conform to the standard of care required by the law;
Causation - that the patient suffered harm (that was not too remote) as a result of the defendant’s actions.

9. Professional Negligence
English Law
The duty of a health care professional is to exercise reasonable care and skill.
What is reasonable?
So how does negligence affect use?
It is well established in English law that a duty of care exists between health care professionals and their patients.
As a professional we have a higher level of duty ie duty as a professional whose advice is respected, when giving advice within our field of expertise.
And the duty of the HCP is to exercise reasonable care & skill – what is reasonable? See example on next slide.

10. Bolam v Friern Hospital Committee 1957
“A person is not negligent if they acted in accordance with accepted practice at the time as decided by a responsible body of competent professional opinion.”
The standard of care required by law was outlined in the leading case of Bolam v Friern Hospital Management Committee (1957) by McNair, J:
“The test is the standard of the ordinary skilled man exercising and professing to have that special skill.”
This a based on the case of a depressed man (John Bolam) who failed medical therapy and was admitted to Friern Barnet Hospital for ECT. ECT has the ADR of inducing seizures and pre-disposing fractures.
Some hospitals at the time were using GA to avoid this ADR.
FB Hospital were not using GA for ECT patients and JB ended up having a fracture due to a seizure during his ECT. JB sued FB hospital. JB claimed that he had gone to another hospital he would have had a GA and had any fractures. FB hospital were able to establish that a reasonable body of psychiatrists would also have performed ECT without a GA. The above statement on the slide was given by the judge.

11. Professional Negligence
Gross negligence.
Criminal prosecution.
Prosecution must prove (beyond reasonable doubt)
Existence of duty
Breach of duty causing death
Gross negligence to justify a criminal conviction
Negligence that is so severe as to warrant punishment under criminal law is described as gross negligence.
A step further on is when patient is not merely harmed but dies and the potential for a charge of manslaughter on the grounds of gross negligence.
If a patient dies as a result of negligent (or reckless) treatment, a health care professional could face criminal prosecution.
The prosecution must prove (beyond reasonable doubt) the two elements of the Actus reus (guilty act) and the mens rea (intention, recklessness or negligence).
In manslaughter cases the ordinary principles of the law of negligence applied to ascertain whether the defendant had been in breach of duty to the person who had died. If so the jury must go on to consider whether that breach of duty should be characterised as gross negligence and therefore as a crime. That would depend on the seriousness of the breach in all the circumstances in which the defendant was placed when it occurred.
The jury must then consider whether the extent to which the defendant's conduct departed from the proper standard of care incumbent upon him, involving as it must have done, a risk of death to the patient, was such that it should be judged criminal. the ingredients of involuntary manslaughter in breach of duty which needed to be proved were: (a) the existence of the duty (b) the breach of the duty causing death and (c) gross negligence which the jury considered justified a criminal conviction.

12. Data Protection Act 1998 DPA 1998 effective from March 2000.
We are concerned with the protection of personal information of the patient where data processing is involved.
The Act provides a framework that governs the processing of personal data of the living. Processing includes holding, recording and using information and the Act applies to paper records as well as other media.
Data Protection Act 1998 came into force in March It seeks to strengthen the individual’s right to privacy in terms of data processing by applying 8 principles:
1.     Personal data shall be processed fairly and lawfully
2.     Personal data shall be obtained for one or more specified lawful purposes and not further processed
3.     Personal data shall be adequate, relevant and not excessive
4.     Personal data shall be accurate and kept up to date
5.     Personal data shall not be kept for longer than is necessary for that purpose
6.     Personal data shall be processed in accordance with the rights of data subjects under this Act
7.     Measures shall be taken against unauthorised or unlawful processing of personal data and against accidental loss or damage
Personal data shall not be transferred out of the European Economic Area
Need to keep all data for at least 10 years, and specific data involving obstetrics and children for at least 25 years. Can keep for longer & most MI services do so – consider scanning enquiries for example.
With respect to confidentiality, principles 1, 2 and 7 are most significant.
DPA 1998 effective from March 2000.
Provides a framework that governs the processing of personal data of the living.
Seeks to strengthen the individual’s right to privacy in terms of data processing by applying 8 principles.

13. Data Protection Act 1998
1.  Personal data shall be processed fairly and lawfully
2. Personal data shall be obtained for one or more specified lawful purposes and not further processed
3. Personal data shall be adequate, relevant and not excessive
4. Personal data shall be accurate and kept up to date
5. Personal data shall not be kept for longer than is necessary for that purpose
6. Personal data shall be processed in accordance with the rights of data subjects under this Act
7. Measures shall be taken against unauthorised or unlawful processing of personal data and against accidental loss or damage
8. Personal data shall not be transferred out of the European Economic Area

14. Freedom of Information Act 2000
The Act gives right to access information held by public bodies including the NHS
If patients wish to obtain information about themselves then the DPA 1998 applies.
If the information is not about them but about a public authority then the FOI applies.
Access to the health records of living patients is governed by the Data Protection Act 1998. . Access to the health records of a deceased person is governed by the Access to Health Records Act 1990.
The Freedom of Information (FOI) Act 2000 received Royal Assent on 30 November The Act supersedes the Code of Practice on Access to Government Information 1997
The Act gives right to access information held by public bodies including the NHS. If patients wish to obtain information about themselves then the DPA 1998 applies. If the information is not about them but about a public authority then the FOI applies.
Check with Trust for local guidance.
Effective as of Aim was to improve the openness of the government following the issues arising in the USA with regards to the US government being forced to disclose information into the public domain, e.g. WMD
Act must be enforced by all areas of the public domain which includes us. It also covers information held before the 1st of Jan hence may have noticed a lot of shredding going on towards the end of December.
The FOI allows anyone from anywhere to request any information from the public domain. Exceptions:
Information under DPA 1998
Information with staff specific details
Commercially sensitive information such as trade secrets.
Unless it is in the public interest to disclose such information.
FOI covers all formats of information from post its to manuscripts and s. Drafts may be requested if the contain comments. Information marked private or confidential is not excluded.
Any personal details such as names in minutes should be blacked out or only initials used.
Requests must made in writing and can be from anyone – staff, MOP, patient, etc. requestor’s status makes no difference. These usually go to a coordinating office at the Trust who will then decide if the request is valid. The Trust office will then contact the relevant dept if they need assistance and will do so in writing.
The CATCH: Trust has 20 days to respond to request – by the time you get it, you may only have 5-10 days.

15. Copyright Changes in NHS licence What’s allowed Staying legal
centrally negotiated NHS copyright agreement with CLA
What’s allowed
Staying legal
Outcomes of breaching
Copyright law protects the economic and other interests of copyright holders (authors, creators and publishers) from reproduction and reselling of their works.
 In the UK the 1998 Copyright, Designs and Patents Act protects the economic and moral rights of creators, authors and publishers. It also enables individuals to make copies of works provided certain restrictions are observed.
 For several years the NHS has paid the Copyright Licensing Agency for a license which removed some of the restrictions of the Act. The decision has been taken not to renew this license because of well publicised pressure on budgets and because it is still possible for staff to continue to photocopy without infringing the Act.
The Licence has now been renewed and allows users to make multiple copies of single articles and to copy several articles from a single issue of a journal.
The Copyright Act allows individuals to make a single copy of a book or journal provided all the following apply: 
The copy does not affect the economic rights of the rights holder (“fair dealing”). As a rule of thumb, a single article from a journal or a single chapter from a book is likely to be acceptable
The copy is will not lead to personal financial benefit (i.e. is for non-commercial purposes). Making a copy to assist NHS services, for private study or publicly funded research is acceptable. Making copies to support activities that you stand to gain from financially is not acceptable.
Individual members of a journal club should obtain their own copy of an article. The easiest way to facilitate members of a journal club is to use electronic versions of journals. Many electronic journals are freely available on the Web.
You may be able to borrow a complete issue of a journal from a library or consult it online. But you should not photocopy more than one article of a paper issue. Printing more than one article of an electronic journal may be acceptable.
Staying legal
 We do not recommend that individual NHS entities take out a licence
Use electronic resources wherever possible
Make sure that a compliance notice is posted by photocopiers.
Include a section on legal photocopying in staff handbooks
Avoid multiple copies from paper journals
Library staff should obtain signed declarations and page charges for inter library loans and document delivery supplied articles
For lesser offences, such as multiple copying of a journal article, damages may be awarded following a civil court action taken by the rights holder against the person making the copies. Damages are awarded in proportion to the degree of economic loss suffered by the rights-holder. Personal liability for Directors is limited to their actual knowledge.
For more serious offences such as counterfeiting and resale, unlimited fines and/or up to 10 years in prison can apply.

16. Confidentiality in the NHS.
Careful what you write!

17. Confidentiality Professional obligation – moral duty Hippocratic oath
Whatever I see or hear, professionally or privately, which ought not to be divulged, I will keep secret and tell no one.
Geneva Declaration
I WILL RESPECT the secrets which are confided in me, even after the patient has died
Professional guidelines
Codes of Ethics & Practice
We are required to obtain confidential personal information. So confidentiality is one aspect which is bounded about MI a lot.
We have a professional obligation to maintain confidentiality.
Key principle that information confided should not be used or disclosed further except as originally understood by the confider or with their subsequent permission.
The UKMi enquiry answering standards state that the the following are required to score 5 on documentation – group will understand this more in Clinical Governance session.
·         legible; with correct spelling and no unfamiliar abbreviations;
·         enquirer details complete (full name, address/contact). If the enquirer wished to remain anonymous, this is stated;
·         patient’s details are present if relevant,
·         the question is documented in sufficient detail to allow a third party to tackle it without further contact with the enquirer;
·         details of resources are complete including edition numbers;
·         names of others contacted with regard to the enquiry are recorded;
Duty of confidence does not extend to anonymised personal information

18. Human Rights Act 1998
Establishes the right to respect for private and family life.
Underscores the duty to protect the privacy of individuals and preserve the confidentiality of their health records.
The HRA 1998 establishes the right to respect for private and family life. This underscores the duty to protect the privacy of individuals and preserve the confidentiality of their health records. Current understanding is that compliance with the DPA 1998 and the common law of confidentiality should satisfy Human Rights Requirements.
Legislation generally should also be compatible with the HRA98, so any proposal for setting aside obligations of confidentiality through legislation must
Pursue a legitimate aim
Be considered necessary in a democratic society
Be proportionate to the need
There is also a more general requirement that actions that interfere with the right to respect for private and family life (eg disclosing confidential information) must also be justified as necessary to support legitimate aims and be proportionate to the need.

19. Information information confidential in nature
information imparted in circumstances that impose/confer obligation on confident to respect confidentiality
• where information obtained directly from the patient (or by his own examination/observation) - clearly obligation of confidence attaches to this information
• where information obtained by third party:
- in professional capacity/third party aware of practitioner-patient relationship – professional obligation of confidence
- in situation where third party is unaware of relationship? – professional obligation likely - patient’s trust in a doctor not revealing any clinical information without permission extends to all information however received
Important legal case:
R v Department of Health, ex parte Source Informatics Ltd (1999): the Court of Appeal was asked to rule on the legality of disclosing data that were rendered anonymously to a data collecting company that wished to sell it to pharmaceutical companies to assist in the marketing of their products.
The data collecting company had approached GPs and pharmacists to obtain patient treatment information. Pharmacists were asked to provide details of the general practitioners prescribing habits, with all data stripped of patient identifiers before being passed on. The Department of Health advised that the patient would not have entrusted the information to either the GP or the pharmacist to give to the data company and that this practice was a breach of patient confidentiality. Further, it maintained that disclosure of dispensing information to data companies could not be argued to be in the public interest. The judge accepted that there would be a breach of confidence if the company were given access to the confidential information given by the patient to the pharmacist. The case went to a Court of Appeal where the first ruling was overturned.
The Court of Appeal held that there could be no breach of confidentiality because the concern of the law here is to protect the confider’s personal privacy and that patient’s privacy was not under threat because there was no realistic possibility that a patient’s identity could be revealed. Therefore, the breach of confidence does not extend to disclosure of personal information that has been rendered anonymous.
Guidance on using confidential patient information Section 60 of the Health and Social Care Act 2001
allows for the use of non-anonymised information about patients to support essential NHS activity,
where seeking patient consent would be either impracticable or inappropriate. Section 60 support
may be sought for medical purposes such as audit, service planning/commissioning, screening programmes
or medical research. The implementation of Section 60 is overseen by the Patient Information Advisory Group
(PIAG). PIAG has produced a leaflet for medical professionals and researchers that explains its role and
provides guidance on using information about patients, and how to apply for Section 60 support where this
is appropriate. The leaflet is available at: bodies.doh.gov.uk/piag

20. Breach of confidentiality
Justifications:
Statutory requirements
patient threatens harm to self
patient threatens harm to others
when required by law:
communicable disease
occupational diseases
suspected abuse
Statutory requirements:
In certain situations statues expressly require that patient confidentiality should be broken (to specific authorities only)
e.g. where information is required in the investigation of a crime (Police and Criminal Evidence Act 1984)
or on public health grounds (Public Health (Control of Disease) Act 1984 – notifiable diseases such as cholera; plague; typhus) or when under a court order.
These are contained mainly in the Abortion Regulations 1991, the Public Health (Control of Disease) Act 1984, and the Police and Criminal Evidence Act 1984 and further.
There are now a number of statutory provisions that require disclosure of information to a public body (and/or confirm the strict nature of the duty of confidentiality).They include the following – for example:
Public Health (Control of Diseases) Act requires the notification of certain diseases to the local authority.They include: cholera; plague; small pox; typhus; acute meningitis; relapsing fever; TB; whooping cough; and food poisoning etc. For this purpose,AIDS is not a notifiable disease.
National Health Service (Venereal Diseases) Regulations 1974 require every health authority to take all necessary steps to secure information that could identify an individual who has or is receiving treatment for any sexually transmitted disease. This information
should not be disclosed except for the purpose of communicating the information to a doctor or someone working under his direction in connection with the treatment of persons suffering from the disease or the prevention of its spread.
Police and Criminal Evidence Act 1984 permits specific access in a criminal investigation to what is called excluded material.Section 11 defines excluded material as, for example,“human tissue or tissue fluid which has been taken for the purposes of diagnosis or medical treatment and which a person holds in confidence”. Section 12 permits access to personal records,which relate to an individual’s physical or mental health.However, an order for the seizure of personal records can only be made in limited circumstances,and only by a circuit judge (not with a magistrate’s warrant).The order gives the right to enter premises and search for the personal records.
Prevention of Terrorism (Temporary Provisions) Act 1989 requires anyone to disclose to the police, as soon as possible, any information that they may have that may help prevent an act of terrorism connected with Northern Ireland, or assist in apprehending or prosecuting such terrorists.
Misuse of Drugs (Notification of and Supply of Addicts) Regulations 1973 impose an obligation on doctors treating drug addicts to send the Chief Medical Officer at the Home Office details of people who they consider, or suspect are addicted to certain controlled drugs
Abortion Act 1967 requires doctors to give the Chief Medical Officer notice of pregnancy terminations, including the name and address of the woman concerned.

21. Confidentiality in the NHS
Ethics & Guidelines
professional ethical codes
professional guidelines
NHS guidelines
contract of employment
Caldicott Guardians
Statutes relating to
patient information
in health records
Data Protection Act 1998
Access to Medical Reports 1988
Access to Health records Act 1990
Access to Personal Files Act 1987
Various statutes provide patients with legal right to see their health records:
Data Protection Act 1998 – see previous slide
Access to Medical Reports Act patients provided with restricted right of access to medical reports supplied by a medical practitioner concerning employment/insurance purposes
Access to Health Records Act replaced by Data Protection Act 1998 except in relation to records of deceased persons – executor or administrator of a deceased person’s estate can apply under this act for access to health records
Access to Personal Files Act provides restricted right of access to personal social services files

22. Caldicott Principles
Principle 1 - Justify the purpose(s) for using confidential information
Principle 2 - Only use it when absolutely necessary
Principle 3 - Use the minimum that is required
Principle 4 - Access should be on a strict need-to-know basis
Principle 5 - Everyone must understand his or her responsibilities
Principle 6 - Understand and comply with the law
The Caldicott Principles as laid down by the NHS Executive must also be followed by the Trust:
Caldicott Committee recommended that every flow of patient-identifiable information should be regularly justified and routinely tested against the principles developed in the Caldicott Report. HSC 22 January 1999, instructed CEs of NHS organisations to appoint a Caldicott Guardian by 31 March 1999 and to advise the NHS Executive of their Guardian’s name and address details for inclusion on a national Register of Caldicott Guardians.
Principle 1 - Justify the purpose(s) Every proposed use or transfer of patient-identifiable information within or from an organisation should be clearly defined and scrutinised, with continuing uses regularly reviewed by an appropriate guardian. Principle 2 - Don't use patient-identifiable information unless it is absolutely necessary Patient-identifiable information items should not be used unless there is no alternative.
Principle 3 - Use the minimum necessary patient-identifiable information Where use of patient-identifiable information is considered to be essential, each individual item of information should be justified with the aim of reducing identifiability. Principle 4 - Access to patient-identifiable information should be on a strict need to know basis Only those individuals who need access to patient-identifiable information should have access to it, and they should only have access to the information items that they need to see. Principle 5 - Everyone should be aware of their responsibilities Action should be taken to ensure that those handling patient-identifiable information - both clinical and non-clinical staff - are aware of their responsibilities and obligations to respect patient confidentiality.
Principle 6 - Understand and comply with the law Every use of patient-identifiable information must be lawful. Someone in each organisation should be responsible for ensuring that the organisation complies with legal requirements.

23. Confidentiality breach in the NHS
Possible consequences
• complaint to the Information Commissioner for breach of the Data Protection Act 1998
• professional disciplinary proceedings (misconduct)
• employer disciplinary proceeding (breach of contract of employment)
• civil court action - breach of confidence
• criminal court action where breach of statute
Self explanatory slide

24. Case Study: Confidentiality
You’re in MI and have completed an enquiry due for 5.30pm. It’s now 5.25pm and the caller really wanted the answer by the end of the day.
You call the enquirer on their landline and get voic . It’s the only contact number you have for them. Their answer phone activates.
You’re in MI and have completed an enquiry due for 5.30pm. It’s now 5.25pm and the caller really wanted the answer by the end of the day.
You call the enquirer on their landline and get voic . It’s the only contact number you have for them.
Is it OK to leave an answer phone message on their phone that says that you are calling from the hospital and that you have their answer ready?
Issues:
Duty of confidentiality – would you be breaching confidentiality concerning a patient?
Discuss - Duties – patient welfare/best interests
Professional judgement
Confidentiality
Ethics – patient rights, relationship between HCP & patient, consent to disclose
Principles – Autonomy, non-malficience, consequentialism
In essence:
Duty of care owed to all patients
Care with divulging any information about a patient
Patient may disclose information to HCP alone – not trust anyone else.
In general, confidential information shouldn’t be shared unless patient or law says it can.
Could agree with caller if OK to leave a message initially.
Another example – A PCT sends out letters to newly pregnant women after notification by their GP. It arrives in a white window envelope containing the address. The first line of the letter reads ‘Dear Mother-To-Be’ (this can be read without opening the letter) – are there any issues?

25. Take a break here or do some of the workshop questions to break up the talk.
May be worth selecting the unlicensed scenario to discuss off label & unlicensed and liability – including SPC.
Issues raise by case:
1 – unlicensed medication & liability
2 – Confidence in other health professionals – patient relationships
3 – Human rights – forced therapy
4 – Tablet ID and confidentiality
5 – Tablet ID by police (useful to do after case 4 to raise any differences if police ask)
6 – Advice on medical treatment researched by patients
7 – Solicitor and drug driving case
8 – HIV, confidentiality & a dentist

26. Gillick Competence - Consent
Special cases
children
with capacity– obligation of confidence
without capacity– law requires ‘best interests’ approach
In 1983: A Mother lost a contraception test case. A mother of 10 children failed to prevent doctors prescribing contraception to under-16s without parental consent. Victoria Gillick appeared at the High Court seeking a declaration that none of her five daughters - aged 1 to 13 -could be prescribed or advised on birth control until they were 16.
The judge ruled against her application and also rejected her attempt to prevent the Department of Health and Social Security (DHSS) distributing a circular advising doctors they can give contraception to under-16s without parental consent.
The 1985 House of Lords' ruling in the Gillick (Gillick v Wisbech and W Norfolk AHA) case established the current legal position in England and Wales that people under 16 who are able fully to understand what is proposed and its implications are competent to consent to medical treatment regardless of age (Scottish law goes further to recognise certain rights to self-determination of young people. The Age of Legal Capacity (Scotland) Act 1991 assigns various legal rights to people over the age of 12 but, as in England and Wales there is no minimum age for legal capacity to consent to medical treatment). Thus, people under 16 are legally able to consent on their own behalf to any surgical, medical or dental procedure or treatment if, in the doctor's opinion, they are capable of understanding the nature and possible consequences of the procedure. Clearly, the more serious the medical procedure proposed, a correspondingly better grasp of the implications is required.
The result is that a doctor, if s/he judges the child to be 'Gillick competent', can only disclose information to the parent with the child's consent, regardless of Parental Responsibility.
No minimum age for legal capacity to consent to medical treatment. Young children and adults without capacity to consent to treatment – general law requires a best interests approach – likely to be reflected in the law of confidence – very strong presumption in favour of disclosure to parents, etc.
(In Scotland the Age of Legal Capacity (Scotland) Act 1991 gives various legal rights to ‘mature’ children under 16 years including right to confidentiality and right to give consent to release medical notes).
(Note: School sent girl home to have secret abortion (Daily Telegraph 13/05/2004) - girl aged 14 was sent to hospital for an abortion without the knowledge of her mother, on the advice of a health visitor at her school.

27. Case Study: Consent
A patient doesn’t speak English and is receiving chemotherapy at the hospital.
Her family translate to her what the hospital staff say.
You tell the family that this particular chemo can cause hair loss as a side effect.
The family decide not to tell the patient this since they know it will upset her.
The patient has to sign the consent form for chemo.
A patient doesn’t speak English and is receiving chemotherapy at the hospital. Her family translate to her what the hospital staff say. You tell the family that this particular chemo can cause hair loss as a side effect. The family decide not to tell the patient this since they know it will upset her. The patient has to sign the consent form for chemo. In the interests of the patient – do you tell the patient or follow the family’s good intentions?
Notes:
Consent & truth telling, and confidentiality are issues
To participate in with-holding the truth from the patient?
With holding information at request of family?
Confidentiality – family do not need to know about patients care
Truth is a matter of judgement
Who should make the disclosure?

28. Professional codes DEFINITIONS Accountability Character traits
Ethical code
Professional etiquette
Responsibility
PROFESSIONAL codes - as a professional would be expected to act in accordance with these codes
DEFINITIONS
Accountability means answerability and comprises personal accountability (to oneself and the patient), professional accountability (to ones profession) and public accountability (to an employer and to society), and entails associated duties and responsibilities
Character traits establish an individual’s moral character and represent a disposition or readiness to act in certain ways, (for example honesty, compassion, commitment to competence, and courage) and are frequently referred to as virtues 
Ethical code(Code of Ethics) is a written list of a professions values and standards of conduct
Professional etiquette represents expected professional behaviours typically established in ethical codes 
Responsibility is concerned with duties and obligations. It includes accountability but is a wider concept being associated with expectations as well as commitment and responsiveness. Responsibility extends to oneself (for example to maintain integrity and to engage in self-improvement) as well as to others.

29. Code of ethics Codes of Ethics Professional responsibilities
duties and obligations
Professional relationships
professional behaviour
good communication
Accountability
The Medicines, Ethics & Practice 31st ed goes into a lot more detail & don’t propose to regurgitate it here since should be familiar with it already – if not, suggest you do become familiar with the under pinning aspects in the ‘code of ethics and standards’.
Professional bodies which regulate health care professionals have traditionally provided ethical guidance in the form of oaths or codes (for example The Hippocratic Oath associated with the medical profession).
There is, however, the tendency for professional codes to be more concerned with specifying rules of etiquette and responsibilities rather than being truly concerned with ethics.
Professions have a responsibility to define what their goals are and the expected role and accompanying duties of practitioners.
Duties can translate into lists of obligations associated with skills and responsibilities, whereas goals are something to aspire to and represent the ethically optimal position. The important moral feature of professional codes may be the way they encourage striving for aspirations.
Health care professionals, like patients, have their own values which influence their practice. A professional is required to continue to maintain a high level of professional competence. Professional responsibilities are expressed, and are continually developing, in professional codes.
The RPSGB website ( was upgraded in June 2006 – very useful and covers material from the Society’s law & ethics department based on FAQs and recent changes in Laws – section: Protecting the Public.
In addition, should be aware that there is a consultation on a new code of ethics for pharmacists & technicians given the significant changes in roles and extended practice plus changes in Law – will also try an make it apply to all sectors of pharmacy. Deadline for comments – 8th September, see PJ 17 June 2006 or go online to register comments.

30. Guidance
General
Medicines, Ethics and Practice Guide: a guide for pharmacists
Act in the interest of patients and other members of the public
Ensure knowledge, skills and practice are up to date
Demonstrate integrity and probity, adhere to accepted standards of conduct and do not bring the profession into disrepute
Specific
UKMi Guidance
Police, media, third party, legal proceedings…..

34. Ethics DEFINITIONS THE CONCEPT OF ETHICS
Values
Morals  
Ethics
Ethical dilemma
THE CONCEPT OF ETHICS
‘ethics’ is derived from the Greek term ethos, which means customs, habitual usage, conduct, and character
 DEFINITIONS
Values - are concepts or ideals that give meaning to an individual’s life and provide a framework for decisions and actions. They can include religious beliefs, family relationships, prejudices, and roles.
Morals - can be defined as the standards of right and wrong associated with individuals, groups, and society in general.
Ethics - can be defined as declarations of what is right or wrong and what ought to be.
Ethical dilemma - ethical dilemmas arise when moral claims conflict with each other – and represent a difficult problem seemingly incapable of a satisfactory solution, or a situation involving choice between equally unsatisfactory alternatives
THE CONCEPT OF ETHICS
Ethics is a branch of philosophy (the study of beliefs and assumptions) dealing with the moral dimension of life. Morals are the basic standards for what we consider right and wrong. Morals or standards are often based on religious beliefs, social influence and group norms.
Each person (and each society) has a differing set of values, most commonly derived from societal norms, religion, and family orientation. These provide the framework for making decisions about the actions people take. Having a good understanding of one’s own beliefs and values is helpful when you are faced with an ethical dilemma.
An ethical dilemma occurs when an individual must choose between two unfavourable alternatives and requires the application of critical thinking.
Decisions regarding ethical and moral issues are primarily concerned with what is “right” or “best” for an individual, their families and society in general. This requires some knowledge of ethics, morality, and the process of ethical decision-making.

35. Common ethical (moral) theories
Teleology - actions are ‘right’ or ‘wrong’ according to the balance of their good or bad consequences
Utilitarianism is a teleological theory that judges acts based on their utility or usefulness
Deontology - actions are performed out of duty or moral obligation; every person is an end and not solely a means to another person’s end.
Virtue theory - places value on the moral character of the actor rather than acts or outcomes of acts
Consequentialism – considers the consequence of the action with a view to doing the greatest good for the greatest number.
COMMON ETHICAL (MORAL) THEORIES
ETHICAL THEORIES
An ethical theory is a moral principle or a set of moral principles that can be used to assess what is morally right or morally wrong in a given situation
Several theories have been developed by philosophers to help guide decision-making. By analyzing the common moral theories and noting that they often conflict with one another, it is possible to see where ethical dilemmas come from.
Major theories:
A. Teleology has no strict principles, duties or moral codes to determine conduct in particular situations - actions are ‘right’ or ‘wrong’ according to the balance of their good or bad consequences - Utilitarianism is a teleological theory that judges acts based on their utility or usefulness
B. Deontology: actions are performed out of duty or moral obligation. Every person is an end and not solely a means to another person’s end.
C. Virtue theory: places value on the moral character of the actor rather than acts or outcomes of acts
Others include:
D. Altruism: the proper goal of a person’s actions is the welfare of society
E. Egoism: the proper goal of a person’s actions is self-interest and self-preservation (opposite of altruism)
F. Rights: justified claims that individuals and groups can make upon others or upon society
G. Distributive Justice: distribution of rights and responsibilities as well as goods and services by some measure of fairness
H. Casuistry: bases decisions on the analysis of similar previous cases

36. Bioethical principles
ETHICAL PRINCIPLES WITHIN HEALTHCARE
Medical ethicists have generally adopted principle-based ethics as their basic guide for practice today. It is a neutral ethics devoid of the philosophical controversies engendered by one or another of the systems based upon libertarianism, utilitarianism, deontology, distributive justice, or a theology which reflects a given religious creed. Such principles enable varying weight to be given to various duties, rights and responsibilities and so help to guide action when applied to every-day ethical decision-making.
The Four Major Bioethical/Moral Principles in Healthcare:
1. The Principle of Autonomy - an individual's action ought to be the result of his or her own choices;
Persons ought to be self-determining;
2. The Principle of Non-Maleficence - Avoid harm;
3. The Principle of Beneficence - act in ways that promote the well being of others; prevent or remove harm; promote good. 
4.The Principle of Justice  - treat similar cases in similar ways; distribute all benefits and burdens equally; distribute goods and services based on need. 
In a bit more detail on next few slides.
Four Major Bioethical Principles in Healthcare
The Principle of Autonomy
The Principle of Non-Malficence
The Principle of Beneficence
The Principle of Justice 

37. The Principle of Autonomy
Principle of self-rule
right to participate in and decide on a course of action; freedom to act independently
competent adult’s informed decision to refuse (even life-saving) treatment supersedes offer of treatment
 The Principle of Autonomy
An individual's action ought to be the result of his or her own choices.
Persons ought to be self-determining
Example – Jehovah’s witness patients and refusal for blood transfusion. Based on a passage from the Bible – Jehovah's witness’ abstain from blood. At times, these patient’s have had to turn to courts to exercise this right.

38. The Principle of Non-Maleficence
Principle of avoiding harm to the patient
justification for ‘acts and omissions’ distinction in law (withholding/withdrawing treatment that is not benefiting patient)
The Principle of Non-Maleficence
Avoid harm  
Example -
In the course of caring for patients, there are some situations in which some type of harm seems inevitable, and we are usually morally bound to choose the lesser of the two evils, although the lesser of evils may be determined by the circumstances. For example, most would be willing to experience some pain if the procedure in question would prolong life. However, in other cases, such as the case of the patient dying of painful intestinal carcinoma, the patient might choose to forego CPR in the event of a cardiac or respiratory arrest, or the patient might choose to forego life sustaining technology such as dialysis or a respirator. The reason for such a choice is based on the belief of the patient that prolonged living with a painful and debilitating condition is worse than death. It is also important to note in this case that this determination was made by the patient, who alone is the authority on the interpretation of the "greater" or "lesser" harm for him.

39. The Principle of Beneficence
Principle of doing what is best for the patient
promotion of patient’s best interests
prevent or remove harm
encompasses sanctity of life principle
when in conflict, non-malficience supersedes the principle of beneficence.
The Principle of Beneficence
Act in ways that promote the well being of others
Prevent or remove harm.
Promote good. 
Example –
When the patient is incapacitated by the grave nature of accident or illness, we presume that the reasonable person would want to be treated aggressively, and we rush to provide beneficent intervention by stemming the bleeding, mending the broken or suturing the wounded.

40. The Principle of Justice
Principle based on fairness, equity and equality
treat similar cases in similar ways
distribute health care resources (goods and service) fairly
proper distribution of benefits and burdens
The Principle of Justice 
Treat equal cases equally.
Distribute all benefits and burdens equally.
Distribute goods and services based on need. 

41. Ethical decision-making within healthcare
Ethical decisions are not made in a vacuum. Many factors influence decision-making, for example, religious beliefs; personal life experiences; professional codes of ethics; socio-cultural changes; legal issues; and advances in science, technology and health. A combination of such factors is likely to be involved. 
Ethical decision-making usually involves at least one of four basic concepts or principles: non-malficience; beneficence; autonomy, and justice.
Principles for ethical decision-making:
-  respect the autonomy of the individual
- avoid harm
- where possible achieve benefit
-  consider, fairly, the interests of all those affected
Autonomy, non-malficience; beneficence; and justice.
Principles for ethical decision-making:
- respect the autonomy of the individual
- avoid harm
- where possible achieve benefit
- consider, fairly, the interests of all those affected

42. Case Study : Ethics
What should you say to a patient who phones the Helpline to ask how many tablets of drug X they need to take to kill themselves?
What should you say to a patient who phones the Helpline to ask how many tablets of drug X they need to take to kill themselves? You do not know if they have already taken the drug and whether this was done in error or on purpose. Also, you do not know if the patient plans to kill themselves in the future. What would you say? Is it your place to counsel the patient?
Issues:
Truth telling, confidentiality & self-harm
Pharmacists prime concern is safety of patient and public
For incompetent patients – dr’s duty to treat them
Aims of medicine include promotion of health and life
Disclosure of information without consent may be justified where failure may expose the patient to risk of death or serious harm.

43. Framework for ethical decision-making
Begin by learning to recognise a moral issue
Step 1: Gather all relevant information
Step 2: Identify and clarify the ethical problem(s)
Step 3: Analyse the problem by considering the various ethical theories or approaches
Step 4: Explore the range of options or possible solutions
Step 5: Make a decision
Step 6: Implement and then reflect on the decision
FRAMEWORK FOR ETHICAL DECISION-MAKING
The following framework may be useful when discussing a particular case in a health care team setting – a guide not a recipe:
Step 1: Gather All Relevant Information
- gather as much relevant information about the situation as possible in order to get the facts clear; establish the facts of the situation and identify what you don’t know; identify all the relevant parties involved; identify expectations and responsibilities; consider the context of the decision-making (clinical issues; patient preferences; quality of life/death social issues; legal and professional aspects)
Step 2: Identify and Clarify the Ethical Problem(s)
- review the situation and identify the ethical problem(s) being faced and the values that are in conflict; identify the type of ethical problem(s) faced and the decision(s) to be made; identify the roles and relationships of all those who may be involved in the decision; consider duties and preferred outcomes; consider what ethical principles such as autonomy, beneficence, non-malficience, justice, fidelity and veracity that might be involved, and how they may conflict and which should be given priority; identify what other factors may influence the decision and what further information is needed
Step 3: Analyse the Problem by Considering the Various Ethical Theories or Approaches
- consider the ethical theories of utilitarianism, deontology, and virtues and any relevant ethical concepts
Step 4: Explore the Range of Options or Possible Solutions
- identify the anticipated outcome of the various possible solutions; be fair and open-minded (be aware of own value-system); apply critical thinking and logically valid argument; look for best consequences overall; consider what would a virtuous person do; consider the impact of each option on those involved, including society as a whole; consider what if everyone in similar circumstances did the same, i.e. formulate your choice into a general maxim for all similar cases; are you comfortable with the decision?; explore how each option compares with the basic principles of each theory; identifying preferences for resolution of the problem
Step 5: Make a Decision
- chose the option which you feel is the right thing to do; justify the decision (explain and support decision); anticipate criticisms and formulate responses
Step 6: Implement and then reflect on the decision
- carry out your decision; assess the outcomes as the processes go forward; evaluate and reconsider; continue to seek new insights into the situation; consider its relevance for a wider range of situations and concerns;  use this situation as a foundation from which to grow and develop; consider what you have I learned that will be useful in the future, what you would I do in another similar situation and what would I change.

44. Guiding principles when dealing with dilemmas
respect for autonomy of the patient (self-determination)
beneficence (do good)
non-malficience (do no harm)
fidelity (truthfulness and confidentiality)
veracity (honesty)
justice (equitable distribution of benefits/burdens)
There is often no right answer

45. Any questions?
Run few the workshop questions if time allows as a group or in two small groups (10 in overall group – two groups of 5)
In essence – all these issues can arise in practicing MI. They will overlap in reality and you will sometimes have the final decision and at other times you may be advising others since we know from the talk that we need to know what other health professionals would do in the same circumstances at the time of the event, i.e. Frien Barnet vs Bolam.
Remember – you are not legal experts just because you’ve been to this session – know what your options are and take time to think – hence you should never respond to an enquiry straight away under pressure.