1. Legal and Ethical Issues in Medicines Information
Bridget Rankin
Principal Pharmacist, Medicines Information
Maidstone & Tunbridge Wells NHS Trust
July 2010
Acknowledgements: Maggie Fitzgerald, Michael Currie, Janet West
Legal and Ethical Issues in Medicines Information

2. Aim of the Session
Consider how to identify and deal with legal and ethical problems that may be encountered when providing a Medicines Information service
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.
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. Objectives
Define commonly used legal and ethical concepts in the context of MI
Identify situations where legal or ethical considerations may come into play
Explain how legal and ethical considerations can influence the outcome of a situation
Discuss how such situations can be dealt with effectively

4. Session Outline
Important legislation and legal principals relevant to MI
Ethical issues
Professional code of conduct
Discussion – scenarios
Developing frameworks to support our work
Break it up a bit with some discussions

5. Laws protect the patient and public
Laws protect the patient and public. As Pharmacist we have not had much exposure or practice at dealing with litigation in UK.
Changes in culture in NHS – CG
But more litigation – desire to place blame
There have been cases in the USA where pharmacists have been found to be negligent in failing to monitor drug therapy, in neglecting to protect a patient from harm, in failing to warn either the patient or the prescriber on the prescribing of a contraindicated drug and failure to warn patients of adverse effects.
The more we hold ourselves out to be professionals with a specialist role the more likely it is that legal expectations will also expand. Given that we access to more and more information the defence of a lack of knowledge would difficult to maintain.
July Horner v Spalitto
Legal duty for pharmacists to monitor drug therapy
August Morgan v Wal-Mart Stores
Pharmacist may be held liable for neglecting to protect a patient from harm in the face of information on a reasonably prudent pharmacist would have acted.
Sept Happel v Wal-Mart Stores
When contra-indicated drug is prescribed the pharmacist has a duty to warn either the prescriber or patient from potential harm
Feb Sanderson v Eckerd Corp
Pharmacist has a legal duty to act with reasonable care in providing services that are designed to detect potential adverse drug outcomes and warn patients of potential for harm.

6. Constraints
Legal
Ethical
Professional
Organisational

7. Discuss in small groups…
What laws /legal issues are relevant to MI
Make a list of ethical issues that we may need to consider in MI
Are there any particular issues that make the group feel uneasy or vulnerable.
You may find it helpful to think of the constraints in the previous slide
Use flip chart

8. Where do laws come from? Laws can originate from two sources:
Common (case) law – cases tried in courts of law, giving rise to rulings that set precedents
Statutory law (legislation) – issued by the Government, normally as an Act of Parliament
Law may be further divided into:
Public law or private law
Criminal or civil law

9. What is Medical Law? Medical (or health care) law is a branch of law
It covers health care professionals (including institutes) and patients
Encompasses many areas of law, such as tort law, criminal law, public and administrative law, and family law
Problems that arise in medical law always include an ethical issue
Tort law is a body of law that addresses, and provides remedies for, civil wrongs not arising out of contractual obligations
The word tort comes from the Latin term torquere, which means "twisted or wrong.“
The law of torts is derived from a combination of common-law principles and legislative enactments.
The touchstone of tort liability is negligence.
First, the plaintiff must establish that the defendant was under a legal duty to act in a particular fashion. Second, the plaintiff must demonstrate that the defendant breached this duty by failing to conform his or her behavior accordingly. Third, the plaintiff must prove that he suffered injury or loss as a direct result of the defendant's breach.
Unlike criminal prosecutions, which are brought by the government, tort actions are brought by private citizens.
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 rea (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.

10. Laws that may affect provision of MI
Medicines Act 1968 (unlicensed meds)
Misuse of Drugs Act 1971
The Data Protection Act 1998
The Copyright, Designs and Patents Act 1988 (amended 2003)
Human Rights Act 1998
The Access to Health Records Act 1990
The Access to Medical Reports Act 1988
The Freedom of Information Act 2000
Also consider
Negligence
Confidentiality
Consent

11. When things go wrong… Professional Negligence
A person may be considered negligent if their conduct falls short of what a reasonable person would be expected to do in order to protect another from a foreseeable risk of harm
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)

12. Discuss in small groups…
Do you see any obstacles to applying this definition?
What needs to be established to prove negligence?
Elizabeth Lee to appeal dispensing error conviction
Chris Chapman
Locum Elizabeth Lee is to appeal against her criminal conviction for making a single dispensing error by early this summer, the Pharmacists’ Defence Association (PDA) has revealed.
But the appeal may be complicated by a coroner’s inquest set to rule on the case this week, chairman Mark Koziol added at the PDA’s annual conference in Birmingham this weekend.
Mrs Lee, of Windsor, Berkshire, was handed a three-month suspended sentence last April for a single dispensing error, despite a judge ruling she had no responsibility for the death of the patient.
The case shocked the pharmacy profession, prompting the Department of Health to ask the Crown Prosecution Service to issue guidelines to prevent similar prosecutions until the law could be reviewed.
Mrs Lee had been granted right to appeal both conviction and sentence on February 8, Mr Koziol said.
Her case would now be heard at the Royal Courts of Justice in “late spring or early summer,” he added.
Mr Koziol said the PDA was confident progress would be made on the case for both Ms Lee and the profession.

13. Negligence
Professional persons such as Pharmacists owe a duty of care to patients or other persons with whom they are in professional relationship. To succeed in an action for negligence the claimant would have to show that the defendant failed to exercise the skill and knowledge which a professional person could reasonably be expected to have i.e. a breach of duty of care
Once a duty has been recognised, then for negligence to be proved there must be an accompanying breach.

14. 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.”
Consider:
Which of the three aspects of negligence might this principle be used in (the “Bolam test”)?
We asked the question ‘What is reasonable’
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.

15. Proving Negligence
According to English Law, in order to prove negligence the prosecution has to demonstrate that:
There was a duty of care to the affected party, and
That duty of care was breached, and
The breach resulted in the injury or damage.
The Paisley Snail (or Donoghue v Stevenson)
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.
Donoghue (or M’Alister) v Stevenson ([1932]
Famous cases in British legal history. T
The decision of the House of Lords founded the modern tort of negligence
The case originated in Paisley, but the House of Lords declared that the principles of their judgment also applied in English law. It is often referred to as the "Paisley snail" or the "snail in the bottle" case.
Key principles
until Donoghue, the duty of care was still limited in English law to a narrow number of relationships.
The case is perhaps most well known for the speech of Lord Atkin and his "neighbour" or "neighbourhood" principle, where he applied Luke 10 to law - that is, where an established duty of care does not already exist, a person will owe a duty of care not to injure those who it can be reasonably foreseen would be affected by their acts or omissions.
The practical effect of this case was to provide individuals with a remedy against suppliers of consumer products,.

16. Gross negligence Negligence cases are normally tried as civil cases
If a case is sufficiently serious, the plaintiff may attempt to sue under criminal law for gross negligence
This is negligence of a greater degree, if it can be demonstrated that the defendant is guilty of reckless indifference
Criminal prosecution. Prosecution must prove (beyond reasonable doubt)
Existence of duty Breach of duty causing death
Gross negligence to justify a criminal conviction
The Royal Pharmaceutical Society is working hard to address the issues associated with stress and workplace pressure through its Workplace Pressure Campaign.
A part of the cause of stress in the profession is fear of prosecution for making a mistake. Until recently, this fear had not been a major cause of stress, since most pharmacists believed that the law was unlikely to be used against pharmacists who made genuine errors. However, the Lee case in April 2009 changed this.
This case was different from any that had gone before and shook the profession to the core.
Need to persuade Parliament and the public There were a number of arguments why this particular law was unjust. It created an automatic offence such that the mere fact that an error had occurred was sufficient to result in a conviction. In most legal cases, the prosecution must prove both that the act had occurred and that it was either wilful or negligent.
However, a conviction under the parts of the Medicines Act which cover dispensing errors can be obtained without any proof of intent or negligence. The other important part of this is that the effect of this provision of the Act is that effectively the whole of the pharmacy profession will have committed a criminal act, since all pharmacists are likely to make a dispensing error at some time in their careers.
about the issue. Refer to RPSGB recent statement
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.

17. Confidentiality Not an Act of Parliament, but built up from case law.
Key principle is that information confided should not be used or disclosed further, except as originally understood by the confider, or with their subsequent permission.
Exceptions – solving a serious crime
Information relating to patients should be regarded as confidential
We are required to obtain confidential personal information.
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.
Duty of confidence does not extend to anonymised personal information
Confidentiality v Privacy
Protecting confidence an aspect of privacy but not the same:
protection of confidence – protecting unauthorised disclosure of personal information
privacy – beyond unauthorised disclosure so as to include other unauthorised or improper use of information (law deals with misuse of personal information via Data Protection Act)

18. Confidentiality
Confidentiality concerns the keeping of confidential information private, i.e. not sharing it with those who are not entitled to have it
Where else is confidentiality enshrined?
Hippocratic Oath
Geneva Declaration
The Caldicott Report
Professional guidelines
Report on the review of patient-identifiable information
Document type:
Report
Author:
Department of Health, The Caldicott Committee - Chair: Dame Fiona Caldicott
Published date:
1 December 1997
Primary audience:
Professionals
Alternative title:
The Caldicott Report
Product number:
11934
Gateway reference:
1997
Pages:
137
Copyright holder:
Crown
Following the production of The Protection and Use of Patient Information in 1996, the Chief Medical Officer of England commissioned the Caldicott Committee to review the transfer of patient-identifiable information from NHS organisations to other NHS and non-NHS organisations. The background to the review and the methodology and findings are explained in this report. Some 86 flows of patient-identifiable information were mapped relating to various planning, operational or monitoring purposes. The Committee found that all of the information flows were for justified purposes, though some did use more patient-identifiable information than was needed for their purposes. The Committee puts forward 16 recommendations and suggests six principles which can be applied to current flows and any flows proposed in the future.

19. Discuss in small groups…
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.

20. BE CAREFUL WHAT YOU WRITE

21. 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.

22. Data Protection Act Updated in 1998
Seeks to strengthen an individual’s right to privacy in terms of processing personal data
Eight principles apply
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:
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.

23. The Data Protection Act 1998
The Data Protection Principles state that personal information should be:
Fairly and lawfully processed
Processed for limited purposes
Adequate, relevant and not excessive
Accurate and up-to-date
Not kept for longer than necessary
Processed in line with your rights
Secure
Not transferred to other countries without permission

24. Human Rights Act
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.

25. Freedom of Information Act
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.

26. Consent Department of Health guidance on patient consent March 2001
Health care professionals need consent from patients before examining, treating or caring for competent adults
Patients need sufficient information before they can decide whether to give consent
Informed consent also applies to use of personal data
Update 2009
Takes into account Mental Capacity Act 2005
It is a general legal and ethical principle that valid consent must be obtained before starting treatment or physical investigation, or providing personal care, for a person. This principle reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice. A healthcare professional (or other healthcare staff) who does not respect this principle may be liable both to legal action by the patient and to action by their professional body. Employing bodies may also be liable for the actions of their staff.
While there is no English statute setting out the general principles of consent, case law (‘common law’) has established that touching a patient without valid consent may constitute the civil or criminal offence of battery. Further, if healthcare professionals (or other healthcare staff) fail to obtain proper consent and the patient subsequently suffers harm as a result of treatment, this may be a factor in a claim of negligence against the healthcare professional involved. Poor handling of the consent process may also result in complaints from patients through the NHS complaints procedure or to professional bodies.
This document provides guidance on English law concerning consent to physical interventions on patients – from major surgery and the administration or prescription of drugs to assistance with dressing – and is relevant to all healthcare practitioners (including students) who carry out interventions of this nature.
Chester v Afshar (see chapter 1, paragraph 17).9 The House of Lords judgment held that a failure to warn a patient of a risk of injury inherent in surgery, however small the probability of the risk occurring, denies the patient the chance to make a fully informed decision. The judgment held that it is advisable that health practitioners give information about all significant possible adverse outcomes and make a record of the information given.

27. Take a break here or do some of the workshop questions to break up the talk.

28. 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.
Consider Gillick competence
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?

29. Unlicensed Material
The enquirer should always be advised when a medicine is unlicensed or to be used in an unlicensed manner.
Off-licence vs unlicensed
Medicines Act 1968 and off/unlicensed drug use
Liability and unlicensed drugs
Strict liability or fault (negligent) liability
The underlying principle of the Medicines Act 1968 is that subject to some exceptions no medicine may be placed on the market without an authorisation. The authorisation guarantees the quality, safety, efficacy of medicinal products. The centralised licensing system is administered by the EMEA and enables the granting of an EU wide marketing authorisation. The regulatory bodies can regulate sale and supply but cannot regulate the practice of medicine – doctors are free to prescribe an approved drug for any purpose they deem necessary.
Off licence vs unlicensed use
Many enquiries in MI relate to off-licence/unlicensed drug use.
Liability in relationship to unlicensed medicines may relate to strict liability (defective product) or fault (or negligent liability – prescriber gives unlicensed or off-label drug and prescribes or administers it negligently or fails to inform patient it is unlicensed/off-label or fails to get consent or inform patient of ADRs). Example ticlodipine and blood dyscrasias.

30. Public Domain Information
Most information used in MI is in the public domain and not confidential
Ask yourself whether it is fair if the enquirer be given the information
Consider whether it is appropriate to give the information to the patient (or whether it is more appropriate to be given to the GP)
Most of the information that is used in MI is in the public domain – ie it is not confidential and is freely available to anyone. However, you should be cautious about assuming that members of the public should be given information, just because you have it available to give. You need to be sensitive to the consequences of providing information. (For example Mrs X collects her neighbours prescription from the surgery for tamoxifen and wants to know what its for. Although she could go to the library and look in the BNF or look on the internet, you need to consider whether its fair to tell her that tamoxifen is for breast cancer).
Ask yourself if it is fair that the enquirer be given this information. Consider whether it is appropriate that the information comes from an MI pharmacist on the other end of a telephone, who is not in a position to change therapy or offer counselling, and who is unlikely to have complete clinical details. (For example pregnant mum taking potential teratogen for epilepsy).
Consider aspects of autonomy and justice

31. Copyright, Designs and Patents Act 1988 (as amended)
Copyright is the right granted by law to the creators of literary, dramatic, musical or artistic works the ability to control ways their work is used.
The Act sets out specific actions that only the author (or other copyright owner) may carry out, also known as restricted acts.
If a restricted act is carried out without the authorisation of copyright owner, this is an infringement of copyright and may be a civil or criminal offence.

32. Copyright provisions for the NHS
The NHS, as a large organisation, has a license that covers copying and scanning from magazines, books, journals and other periodicals.
A copy of the agreement is available at for you to inspect in your own time
It is important that you become familiar with the agreement and with what is allowed under it
The NHS has a copyright agreement which permits NHS personnel to copy protected material from textbooks and journals (up to 15 copies per act of photocopying or 25 copies for a meeting)
One chapter of a book
2 articles of an issue of a journal
Any number of articles dealing with a theme within an issue
An entire case report
5% of publication if > above
Changes in NHS licence
centrally negotiated NHS copyright agreement with CLA
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.
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.

33. When Things Go Wrong
Injury must be shown to be due to the failure to practice properly.
Litigation serves several functions
Seeking apologies and being held accountable
Incentive to HCPs to maintain a high standard of care
Retribution against HCPs (civil vs criminal)
Compensation
- Causation

34. Liability
RPSGB Code of Ethics requires professional indemnity arrangements
NHS hospital pharmacists covered under the clinical negligence funding scheme for contracted duties.
Ensure job descriptions up-to-date
Guild of Hospital Pharmacists
If advice is given to a clinician and that advice is acted upon causing damage to the patient then both the clinician and the pharmacist are liable

35. Professional code of conduct
Pharmacists are guided by the Code of Ethics for Pharmacists and Pharmacy Technicians
This is based on seven principles, all equally weighted, designed to guide the work of pharmacists and pharmacy technicians and to support the decisions they make as they carry out their professional responsibilities
Pharmacists are expected to abide by these principles – otherwise, their registration is at risk
1. MAKE THE CARE OF PATIENTS YOUR FIRST CONCERN
2. EXERCISE YOUR PROFESSIONAL JUDGEMENT IN THE INTERESTS OF
PATIENTS AND THE PUBLIC
3. SHOW RESPECT FOR OTHERS
4. ENCOURAGE PATIENTS TO PARTICIPATE IN DECISIONS ABOUT THEIR CARE
5. DEVELOP YOUR PROFESSIONAL KNOWLEDGE AND COMPETENCE
6. BE HONEST AND TRUSTWORTHY
7. TAKE RESPONSIBILITY FOR YOUR WORKING PRACTICES

36. Ethics
Ethics has been described as the systematic study of moral choices.
A code of behaviour considered correct, especially of a profession or individual.
They are moral principles or values held by an individual or group.
The Medicines, Ethics & Practice 33rd 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.
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.

37. Some ethical theories Absolutism Aristotelean ethics Conscience
Determinism
Deontology
Egoism
Emotivism
Kantian ethics
Naturalism
Objectivism
Platonic ethics
Prescriptivism
Relativism
Subjectivism
Teleology
Virtue ethics

38. Some common theories explained
Deontology
Group of ethical theories founded on a sense of duty (“deon”) of one person towards another
Teleology
Actions are judged based on the final outcomes of those actions (“telos”) and not on the motivation behind them
Virtue theory
The moral quality of an action is determined with reference to the virtue of the one performing the action rather than the outcome
The end justifies the means
The means justify the ends

39. Bioethical principles
In medicine and (more broadly) bioethics, the following principles apply:
Beneficence
Non-maleficence
Autonomy
Justice
Autonomy
Autonomy is a general indicator of well being of Individual, profession and society
By considering Autonomy as a gauge parameter for (self) health care, the medical and ethical perspective both benefit from the implied reference to Health.
Beneficence
core values of health care ethics. Some scholars, such as Edmund Pellegrino, argue that beneficence is the only fundamental principle of medical ethics. They argue that healing should be the sole purpose of medicine, and that endeavors like cosmetic surgery, contraception and euthanasia fall beyond its purview.
[edit] Non-Maleficence
In practice, however, many treatments carry some risk of harm. In some circumstances,
risky treatments that stand a high chance of harming the patient will be justified, as the risk of not treating is also very likely to do harm. So the principle of non-maleficence is not absolute, and must be balanced against the principle of beneficence (doing good).
"Non-maleficence" is defined by its cultural context. Every culture has its own cultural collective definitions of 'good' and 'evil'. Their definitions depend on the degree to which the culture sets its cultural values apart from nature. In some cultures the terms "good" and "evil" are absent: for them these words lack meaning as their experience of nature does not set them apart from nature. Other cultures place the humans in interaction with nature, some even place humans in a position of dominance over nature. The religions are the main means of expression of these considerations.
Depending on the cultural consensus conditioning (expressed by its religious, political and legal social system) the legal definition of Non-maleficence differs. Violation of non-maleficence is the subject of medical malpractice litigation. Regulations thereof differ, over time, per nation.
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. 

40. Framework for making ethical decisions
Learn to recognise moral issues
Gather all relevant information
Identify and clarify the ethical problem(s)
Analyse the problem by considering the various ethical theories or approaches
Explore the range of options or possible solutions
Make a decision
Implement and then reflect on your decision
Recognise that there is often no right answer

41. General Principles
You do not have to answer every question that you are asked
Always give yourself appropriate thinking time
Consult with an appropriate colleague and/or manager before answering
Document your decision making process
Give examples (eg time for cannabis to leave body before a drug screen, what is the lethal dose of an drug from a member of the public). However 2005 UKMI conference had session from lawyer who indicated that if you do not answer a question you have to document exactly why you chose not to.
Important to give yourself thinking time and consult with a colleague, does not force you into an answer.

42. Ethical Dilemmas Many situations faced are unambiguous
Ethical decision making
Recognises problem needs to be solved or difficult choice made
Identifies the possible courses of action
Chooses and takes one course of action
Accepts responsibility for the action taken and must be able justify action
Different MIPs may reach different decisions in same circumstances
From time to time you may be faced with conflicting professional obligations or legal requirements. In these circumstances you must consider fully the options available to you, evaluate the risks and benefits associated with possible courses of action and determine what is appropriate in the interests of patients and the public.
Many situations faced are unambigious and the decision will be obvious.
Ethical decision making is the process whereby one recognises that a problem needs to be overcome or a difficult choice made, identifies the possible courses of actions, chooses one, takes it, and then accepts responsibility for the outcomes which are a result of the choices made. As a health professional, judgement requires identification and evaluation of the risks and benefits associated with possible courses of action. There may or may not be a right or wrong answer. Different people may reach different decisions on a single set of circumstances.
In MI, ethical dilemmas usually involve a conflict between your job (providing information) and a duty to someone else (eg privacy of a third party). They are enquiries that make you feel uncertain about what to do. As before, with ethical dilemmas encountered in MI, need to use professional judgement to decide on the most appropriate course of action. Need to able to justify action to peers and any organisation or individual affected by choices made. Need to be accountable for actions
In practice most ethical dilemmas involve enquiries from members of the public. Remember that what may be an ethical dilemma from your point of view, is often simply a request for help or information from the enquirer’s perspective.
Apart from enquiries from the public, other ethical dilemmas can involve enquiries from the police. Here you should only supply information that it is legitimate for the police to ask for in the course of solving a crime and you should always ask for this to be confirmed in writing (TICTAC enquiries may be an exception if you answer police TICTAC enquiries). Enquiries from legal representatives or the media can also sometimes be problematic: follow your MI centre or employer’s policy in dealing with these. UKMi has issued guidance for all three areas.

43. General Principles
There is no one “right” answer to most dilemmas but you should be able to justify what you do
Do not answer queries that are beyond you sphere of expertise or available resources
Research you answers thoroughly and document everything you do
Example for second point – media call about overdose of a particular drug – if not a Poison’s Centre – may be outside your sphere of expertise. In most circumstances okay to refer calls.

44. Constraints
Legal
Ethical
Professional
Organisational

45. Professional Constraints
Overlaps with ethical constraints
Principal functions of professional bodies
Maintain a register of qualified practitioners
Remove those unfit to practise due to ill health or misconduct
Oversee professional education
Give guidance on professional ethics
Self-regulation vs external accountability
Relationship between patients and HCPs is based largely on the trust that the latter are competent. Membership of our profession should indicate a level of training and expertise which enables the public to rely on the skill of the practitioner. This depends on the efficacy of the bodies which regulate the professions. This relationship of trust has been dented by a series of recent scandals such as the Bristol Royal Infirmary children’s cardiac investigation which resulted in the Kennedy enquiry which recommended that professional self-regulation should be overseen by another professional body.
Professional regulation in the UK remains built on the principle of self-regulation rather than external accountability. The use of the power to set standards of conduct is more patient focused than previously in all the professions. Professional regulation in the UK remains a self regulatory model but it is one that is becoming increasingly responsive to the broader agenda of public accountability.
The GMC investigate serious professional misconduct only whereas the RPSGB investigate all allegations of professionals misconduct even if not deemed serious.

46. Organisational Constraints
Check if your Centre/Trust has a policy for
Enquiries from the media
Enquiries involving legal proceedings (including those against your own Trust)
Enquiries from the police

47. 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