Maggie Fitzgerald Principal Pharmacist, Medicines Information Royal Cornwall Hospitals NHS Trust September 2013

Transcription

1 Maggie Fitzgerald Principal Pharmacist, Medicines Information Royal Cornwall Hospitals NHS Trust September 2013

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

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

5 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.

6 Constraints Legal Ethical Professional Organisational

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8 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

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

10 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

11 Discuss in small groups Do you see any obstacles to applying this definition? What needs to be established to prove negligence?

12 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

13 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 )?

14 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. Donoghue v Stevenson (or The Paisley Snail)

15 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

16 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

17 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

18 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.

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20 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-toknow basis Principle 5 - Everyone must understand his or her responsibilities Principle 6 - Understand and comply with the law

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

22 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

23 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.

24 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.

25 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

26 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.

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28 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

29 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)

30 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.

31 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

32 When Things Go Wrong Harm 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

33 Liability GPC 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 (Unite) 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

34 Constraints Legal Ethical Professional Organisational

35 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.

36 Some ethical theories Absolutism Aristotelean ethics Conscience Determinism Deontology Egoism Emotivism Kantian ethics Naturalism Objectivism Platonic ethics Prescriptivis m Relativism Subjectivism Teleology Virtue ethics

37 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

38 Bioethical principles In medicine and (more broadly) bioethics, the following principles apply: Beneficence Non-maleficence Autonomy Justice

39 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

40 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

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

42 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

43 Constraints Legal Ethical Professional Organisational

44 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

45 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

46 Constraints Legal Ethical Professional Organisational

47 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

48 Any Questions