Transcript LEGAL AND ETHICAL ASPECTS OF MEDICINES INFORMATION

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