Bridget RankinPrincipal Pharmacist, Medicines Information

Maidstone & Tunbridge Wells NHS TrustJuly 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

ObjectivesDefine commonly used legal and

ethical concepts in the context of MIIdentify 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 into:Public law or private lawCriminal or civil law

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?

NegligenceProfessional 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, andThat duty of care was breached, andThe 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 negligenceThis 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 OathGeneva DeclarationThe Caldicott ReportProfessional 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 PrinciplesPrinciple 1 - Justify the purpose(s) for using

confidential informationPrinciple 2 - Only use it when absolutely

necessaryPrinciple 3 - Use the minimum that is

requiredPrinciple 4 - Access should be on a strict

need-to-know basisPrinciple 5 - Everyone must understand his

or her responsibilitiesPrinciple 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 processedProcessed for limited purposesAdequate, relevant and not excessiveAccurate and up-to-dateNot kept for longer than necessaryProcessed in line with your rightsSecureNot 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

Some common theoriesexplained

Bioethical principles In medicine and (more broadly) bioethics,

the following principles apply:BeneficenceNon-maleficenceAutonomyJustice

Framework for making ethical decisionsLearn to recognise moral issuesGather all relevant informationIdentify and clarify the ethical problem(s)Analyse the problem by considering the various

ethical theories or approachesExplore the range of options or possible

solutionsMake a decisionImplement and then reflect on your decisionRecognise that there is often no right answerRecognise 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 madeIdentifies the possible courses of actionChooses and takes one course of actionAccepts 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 practitionersRemove those unfit to practise due to ill

health or misconductOversee professional educationGive guidance on professional ethics

Self-regulation vs external accountability

Organisational Constraints

Check if your Centre/Trust has a policy for

Enquiries from the mediaEnquiries 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

SpecificUKMi Guidance

○ Police, media, third party, legal proceedings