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.

Plan

Medical Heath Law & ethics Legal aspects Professional codes Ethics

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

Requirements for proving negligence:

– Duty

– Breach – Causation

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

Any questions?