legal and ethical issues in medicines information maggie fitzgerald medicines information pharmacist...
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Legal and Ethical Issues in Medicines Information
Maggie Fitzgerald
Medicines Information Pharmacist
8th January 2008
Acknowledgements: Richard O’Neill; Advancing the Provision of Pharmacy Law and Ethics Teaching - APPLET
(Nottingham University)
Session aim
Identify legal and ethical problems that may be encountered when providing medicines information.
Legal aspects
DEFINITIONS– Statutory law– Common (case) law
– Public law and Private law– Criminal law and Civil law
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.
The concept of medical (health care) law
Professional Negligence
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)
Professional Negligence
English Law The duty of a health care professional is to
exercise reasonable care and skill.
– What is reasonable?
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.”
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
Data Protection Act 1998
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.
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
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.
Copyright
Changes in NHS licence centrally negotiated NHS copyright agreement with
CLA www.cla.co.uk
What’s allowed Staying legal Outcomes of breaching
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
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.
Information
information confidential in nature
information imparted in circumstances that impose/confer obligation on confident to respect confidentiality
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
Confidentiality in the NHS
Ethics & Guidelines
professional ethical codes
professional guidelines NHS guidelines contract of employment Caldicott Guardians
Statutes relating topatient informationin health records
Data Protection Act 1998 Access to Medical Reports
1988 Access to Health records Act
1990 Access to Personal Files Act
1987
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
Confidentiality breach in the NHSPossible 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
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.
Gillick Competence - Consent
Special cases– children
• with capacity– obligation of confidence• without capacity– law requires ‘best
interests’ approach
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.
Professional codes
DEFINITIONS – Accountability – Character traits – Ethical code – Professional etiquette– Responsibility
Code of ethics
Codes of Ethics Professional responsibilities
• duties and obligations
Professional relationships• professional behaviour
• good communication
Accountability
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…..
Ethics
DEFINITIONS– 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
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.
Bioethical principles
Four Major Bioethical Principles in Healthcare
The Principle of Autonomy The Principle of Non-Malficence The Principle of Beneficence The Principle of Justice
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 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)
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
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
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
Ethical decision-making within healthcare
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?
Framework for ethical decision-making
Begin by learning to recognise a moral issue
Step 1: Gather all relevant informationStep 2: Identify and clarify the ethical problem(s)Step 3: Analyse the problem by considering the
various ethical theories or approachesStep 4: Explore the range of options or possible
solutionsStep 5: Make a decisionStep 6: Implement and then reflect on the decision
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