Transcript LEGAL AND ETHICAL ASPECTS OF MEDICINES INFORMATION …
LEGAL AND ETHICAL ISSUES IN MEDICINES INFORMATION Maggie Fitzgerald L.LB BPharm MRPharmS Senior Pharmacist, Medicines Information
Aim
To be aware of the legal and ethical problems that may be encountered when providing medicines information
Plan
To be aware of Malpractice Law, liability and negligence issues as they apply to MI To describe the legal constraints of working with patient information and unlicensed medicines To be aware of Copyright Law To describe key ethical theories, principles and codes of practice
Legal
Ethical Professional Organisational
Constraints
Legal Issues
DEFINITIONS Statutory law Common (case) law Public law and Private law Criminal law and Civil law
Legal Issues
Negligence Confidentiality Data protection Act 1998 Human Rights Act 1998 Freedom of Information Act 2000 Consent Unlicensed medicines (Medicines Act 1968) Copyright
Negligence
“
We must take reasonable care to avoid acts and omissions which you can reasonably foresee
would be likely to injure your neighbour ...” Donaghue v Stevenson 1932
Negligence
Requirements for proving negligence:
Duty
Breach
Causation
Negligence
The duty of a health care professional is to exercise reasonable care and skill.
What is reasonable?
Pharmacists owe a
Negligence
Professional persons such as 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
Negligence
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
Negligence
“The categories of negligence are never closed” Donaghue v Stevenson 1932
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
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 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
Working with Information
Common Law of Confidentiality Data Protection Act 1998 Human Rights Act 1998 Freedom of Information Act 2000
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
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 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 - 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
Data Protection Act
Updated in 1998 Seeks to strengthen an individual’s right to privacy in terms of processing personal data Eight principles apply
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.
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)
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 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 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 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
Copyright
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
Legal
Ethical
Professional Organisational
Constraints
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.
Two ethical theories
Deontology Consequentialism
Autonomy Beneficence Non-maleficence Justice
Ethical Principles
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
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
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
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
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?
Legal Ethical
Professional
Organisational
Constraints
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
Legal Ethical Professional
Organisational
Constraints
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
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