Transcript Legal and Ethical Issues in Medicines Information

Bridget Rankin
Principal Pharmacist, Medicines Information
Maidstone & Tunbridge Wells NHS Trust
July 2010
Acknowledgements: Maggie Fitzgerald, Michael Currie, Janet West
Aim of the Session
 Consider
how to identify and deal
with legal and ethical problems that
may be encountered when providing
a Medicines Information service
Objectives
 Define commonly used legal and
ethical concepts in the context of MI
 Identify situations where legal or
ethical considerations may come into
play
 Explain how legal and ethical
considerations can influence the
outcome of a situation
 Discuss how such situations can be
dealt with effectively
Session Outline
 Important
legislation and legal
principals relevant to MI
 Ethical issues
 Professional code of conduct
 Discussion – scenarios
 Developing frameworks to
support our work
Constraints


Legal
Ethical

Professional

Organisational
Discuss in small groups…
 What
laws /legal issues are
relevant to MI
 Make a list of ethical issues that
we may need to consider in MI
 Are there any particular issues
that make the group feel uneasy
or vulnerable.
Where do laws come from?
 Laws
can originate from two
sources:
 Common (case) law – cases tried in courts
of law, giving rise to rulings that set
precedents
 Statutory law (legislation) – issued by the
Government, normally as an Act of
Parliament
 Law may be further divided
 Public law or private law
 Criminal or civil law
into:
What is Medical Law?
 Medical
(or health care) law is a
branch of law
 It covers health care professionals
(including institutes) and patients
 Encompasses many areas of law,
such as tort law, criminal law, public
and administrative law, and family law
 Problems that arise in medical law
always include an ethical issue
Laws that may affect provision of MI
Medicines Act 1968 (unlicensed meds)
 Misuse of Drugs Act 1971
 The Data Protection Act 1998
 The Copyright, Designs and Patents Act
1988 (amended 2003)
 Human Rights Act 1998
 The Access to Health Records Act 1990
 The Access to Medical Reports Act 1988
 The Freedom of Information Act 2000

When things go wrong…
Professional Negligence
 A person
may be considered
negligent if their conduct falls short of
what a reasonable person would be
expected to do in order to protect
another from a foreseeable risk of
harm
Discuss in small groups…
 Do you see any obstacles to
applying this definition?
 What needs to be established to
prove negligence?
Negligence
Professional persons such as
Pharmacists owe a 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
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.”
 Consider:
 Which of the three aspects of
negligence might this principle be used
in (the “Bolam test”)?
Proving Negligence
According to English Law, in order to
prove negligence the prosecution has to
demonstrate that:
 There was a duty of care to the
affected party, and
 That duty of care was breached, and
 The breach resulted in the injury or
damage.
 The Paisley Snail (or Donoghue v
Stevenson)

Gross negligence
 Negligence
cases are normally tried as
civil cases
 If a case is sufficiently serious, the plaintiff
may attempt to sue under criminal law for
gross negligence
 This is negligence of a greater degree, if
it can be demonstrated that the
defendant is guilty of reckless
indifference
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
Confidentiality
Confidentiality concerns the keeping of
confidential information private, i.e. not sharing
it with those who are not entitled to have it
 Where else is confidentiality enshrined?
 Hippocratic Oath
 Geneva Declaration
 The Caldicott Report
 Professional guidelines

Discuss in small groups…

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
The Data Protection Act 1998

The Data Protection Principles state that
personal information should be:
 Fairly and lawfully processed
 Processed for limited purposes
 Adequate, relevant and not excessive
 Accurate and up-to-date
 Not kept for longer than necessary
 Processed in line with your rights
 Secure
 Not transferred to other countries without
permission
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.
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
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)
Copyright, Designs and
Patents Act 1988 (as amended)
Copyright is the right granted by law to the
creators of literary, dramatic, musical or artistic
works the ability to control ways their work is
used.
 The Act sets out specific actions that only the
author (or other copyright owner) may carry out,
also known as restricted acts.
 If a restricted act is carried out without the
authorisation of copyright owner, this is an
infringement of copyright and may be a civil or
criminal offence.

Copyright provisions
for the NHS
The NHS, as a large organisation, has a license
that covers copying and scanning from
magazines, books, journals and other
periodicals.
 A copy of the agreement is available at
www.cla.co.uk for you to inspect in your own
time
 It is important that you become familiar with the
agreement and with what is allowed under it

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
Professional code of conduct



Pharmacists are guided by the Code of Ethics
for Pharmacists and Pharmacy Technicians
This is based on seven principles, all equally
weighted, designed to guide the work of
pharmacists and pharmacy technicians and to
support the decisions they make as they carry
out their professional responsibilities
Pharmacists are expected to abide by these
principles – otherwise, their registration is at
risk
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.

Some ethical theories
Absolutism
Aristotelean
ethics
Conscience
Determinism
Deontology
Egoism
Emotivism
Kantian
ethics
Naturalism
Objectivism
Platonic
ethics
Prescriptivis
m
Relativism
Subjectivism
Teleology
Virtue ethics
Some common theories
explained
Deontology
• Group of ethical theories founded on a sense of duty
(“deon”) of one person towards another
Teleology
• Actions are judged based on the final outcomes of those
actions (“telos”) and not on the motivation behind them
Virtue theory
• The moral quality of an action is determined with reference
to the virtue of the one performing the action rather than
the outcome
Bioethical principles

In medicine and (more broadly) bioethics,
the following principles apply:
 Beneficence
 Non-maleficence
 Autonomy
 Justice
Framework for making
ethical decisions



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


Learn to recognise moral issues
Gather all relevant information
Identify and clarify the ethical problem(s)
Analyse the problem by considering the various
ethical theories or approaches
Explore the range of options or possible
solutions
Make a decision
Implement and then reflect on your decision
Recognise that there is often no right answer
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
 Document your decision making
process

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
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

Constraints

Legal

Ethical

Professional

Organisational
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
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
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