The legal and ethical aspects of working with information about medicines

Angela Emerson

Wessex Regional Drug and Medicines Information Centre

Aim

To be able to make decisions taking into account legal and ethical considerations when working with information about medicines.

Objectives

By the end of this session you will be able to:– Handle ethical dilemmas in MI

– Describe key legislation that impacts upon MI practice

Decision-making process

Ethical

Legal

Professional

Organisational

Ethical constraints

What are ethics…..

– A code of behaviour considered correct, especially of a profession or individual.

– They are moral principles or values held by an individual or group.

Ethical theories Consequence-based approach

– The consequences of what we do matter…but matter to whom?

– Lying is wrong because of the negative consequences it may cause but in certain circumstances it may be okay

Rule-based approach (aka deontology) – The rules matter– Lying is always wrong, regardless of any potential good

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 the outcomes which are a result of the choices made

Ethical decision-making in MI

How long does it take for cannabis to leave the body?

Enquirer going for a job interview tomorrow.

Ethical decision-making in MI

Many situations faced are unambiguous – the decision will be obvious

Often a conflict between your job (providing information) and duty to another person

Different MIPs may reach different decisions in same circumstances

Ethical decision-making in MI

In practice most arise from members of the public

May also arise from police, media, legal representatives

Often not perceived as an ethical dilemma from the enquirer’s perspective

General principles

You do not have to answer every question that you are asked – how to say ‘no’

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 resources

Research you answers thoroughly and document everything you do

Guidance

General– Medicines, Ethics & 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 etc.

Constraints

Ethical

Legal

Professional

Organisational

Legal considerations

Data Protection Act (DPA) 1998 Common Law of Confidentiality Human Rights Act 1998

Medicines Act 1968 and off/unlicensed medicines

Malpractice Law

Working with information Justification for observing confidence

The obligation of confidence– Negligence and professional misconduct– Exceptions (patient consent, need to know [vs. curiosity], threat to

others, public debate and press freedom [health professionals with HIV])

DPA 1998 Common Law of Confidentiality Human Rights Act 1998

Caldicott Guardians

DPA 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.

DPA 1998 Processed fairly and lawfully Obtained for one or more specified lawful purposes

and not further processed– Research– Disease registers

Adequate, relevant and not excessive Accurate and kept up to date Not be kept for longer than is necessary for that

purpose Be processed in accordance with the rights of data

subjects under this Act Avoid unauthorised or unlawful processing of personal

data and accidental loss or damage Not be transferred out of the EEA

Common Law of 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

Human Rights Act 1998 Article 8

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 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.

Working with off/unlicensed medicines

Off-licence vs unlicensed

Medicines Act 1968 and off/unlicensed drug use

Liability and unlicensed drugs– Strict liability or fault (negligent) liability

Working with off/unlicensed medicines

– Tell the patient about known ADRs and that there may be other unknown ADRs

– Tell the patient about that the drug/dose/indication is not licensed by the authorities

– Reassure yourself that the body of opinion supports the use of the drug in these circumstances

– Keep detailed records (eg in notes) surrounding decision to use

– Review the patient regularly to assess benefit and ADRs

Working with copyright

Centrally negotiated NHS copyright agreement with CLA (www.cla.co.uk)

All NHS personnel

Breaching copyright is a legal offence and it is your responsibility to keep within the law.

When things go wrong – Malpractice Law

Malpractice 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

When things go wrong – Malpractice Law

Majority of malpractice cases brought under the law of negligence

3 key factors must be proved– Duty of care– Failed to reach the standard required by the law,

that is a standard acceptable to their peers– Injuries were due to the failure to practice properly

and not another unrelated accident – the ‘but for’ test

When things go wrong – Malpractice Law

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.

When things go wrong – Malpractice Law

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

Constraints

Ethical

Legal

Professional

Organisational

Professional constraints

Overlaps with legal and 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

Constraints

Ethical

Legal

Professional

Organisational

Organisational constraints

Overlaps with legal 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

Workshop

5 groups of 5-6

20 minutes

Feedback

Learning outcomes

By the end of this session you will be able to:– Handle ethical dilemmas in MI

– Describe key legislation that impacts upon MI practice