Bridget Rankin Principal Pharmacist Medicines Information Maidstone Tunbridge

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Bridget Rankin Principal Pharmacist, Medicines Information Maidstone & Tunbridge Wells NHS Trust July 2010

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

Aim of the Session �Consider how to identify and deal with legal and ethical

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

Objectives �Define commonly used legal and ethical concepts in the context of MI �Identify

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

Session Outline �Important legislation and legal principals relevant to MI �Ethical issues �Professional code

Session Outline �Important legislation and legal principals relevant to MI �Ethical issues �Professional code of conduct �Discussion – scenarios �Developing frameworks to support our work

Constraints Legal Ethical Professional Organisational

Constraints Legal Ethical Professional Organisational

Discuss in small groups… �What laws /legal issues are relevant to MI �Make a

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.

Where do laws come from? � Laws can originate from two sources: �Common (case)

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 �Public law or private law �Criminal or civil law into:

What is Medical Law? � Medical (or health care) law is a branch of

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

Laws that may affect provision of MI � Medicines Act 1968 (unlicensed meds) �

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

When things go wrong… Professional Negligence �A person may be considered negligent if their

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

Discuss in small groups… �Do you see any obstacles to applying this definition? �What

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

Negligence Professional persons such as Pharmacists owe a duty of care to patients or

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

Bolam v Friern Hospital Committee 1957 � “A person is not negligent if they

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”)?

Proving Negligence � According to English Law, in order to prove negligence the prosecution

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)

Gross negligence � Negligence cases are normally tried as civil cases � If a

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

Confidentiality � Not an Act of Parliament, but built up from case law. �

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

Confidentiality concerns the keeping of confidential information private, i. e. not sharing it with

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 �

Discuss in small groups… � You’re in MI and have completed an enquiry due

Discuss in small groups… � You’re in MI and have completed an enquiry due for 5. 30 pm. It’s now 5. 25 pm and the caller really wanted the answer by the end of the day. � You call the enquirer on their landline and get voicemail. It’s the only contact number you have for them. Their answer phone activates.

Caldicott Principles �Principle 1 - Justify the purpose(s) for using confidential information �Principle 2

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 comply with the law

Data Protection Act � Updated in 1998 � Seeks to strengthen an individual’s right

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

The Data Protection Act 1998 � The Data Protection Principles state that personal information

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

Human Rights Act � Establishes the right to respect for private and family life.

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.

Freedom of Information Act � The Act gives right to access information held by

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.

Consent � Department of Health guidance on patient consent March 2001 � Health care

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

Case Study - Consent A patient doesn’t speak English and is receiving chemotherapy at

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. �

Unlicensed Material � The enquirer should always be advised when a medicine is unlicensed

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

Public Domain Information � Most information used in MI is in the public domain

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)

Copyright, Designs and Patents Act 1988 (as amended) Copyright is the right granted by

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. �

Copyright provisions for the NHS The NHS, as a large organisation, has a license

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 www. cla. co. uk 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 �

When Things Go Wrong Injury must be shown to be due to the failure

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

Liability RPSGB Code of Ethics requires professional indemnity arrangements � NHS hospital pharmacists covered

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 �

Professional code of conduct Pharmacists are guided by the Code of Ethics for Pharmacists

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 �

Ethics � Ethics has been described as the systematic study of moral choices. �

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.

Some ethical theories Absolutism Aristotelean ethics Conscience Determinism Deontology Egoism Emotivism Kantian ethics Naturalism

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

Some common theories explained Deontology • Group of ethical theories founded on a sense

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

Bioethical principles � In medicine and (more broadly) bioethics, the following principles apply: �Beneficence

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

Framework for making ethical decisions Learn to recognise moral issues Gather all relevant information

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

General Principles � You do not have to answer every question that you are

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

Ethical Dilemmas � Many situations faced are unambiguous � Ethical decision making �Recognises problem

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

General Principles � There is no one “right” answer to most dilemmas but you

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

Constraints � Legal � Ethical � Professional � Organisational

Constraints � Legal � Ethical � Professional � Organisational

Professional Constraints Overlaps with ethical constraints � Principal functions of professional bodies � �Maintain

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

Organisational Constraints � Check if your Centre/Trust has a policy for �Enquiries from the

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

Guidance General �Medicines, Ethics and Practice Guide: a guide for pharmacists ○ Act in

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 �