LEGAL AND ETHICAL ISSUES IN MEDICINES INFORMATION

Maggie FitzgeraldL.LB BPharm MRPharmSSenior Pharmacist, Medicines Information

Aim

To be aware of the legal and ethical problems that may be encountered when providing medicines information

Plan To be aware of Malpractice Law, liability

and negligence issues as they apply to MI

To describe the legal constraints of working with patient information and unlicensed medicines

To be aware of Copyright Law To describe key ethical theories,

principles and codes of practice

Constraints

Legal

Ethical

Professional

Organisational

Legal Issues

DEFINITIONSStatutory lawCommon (case) law

Public law and Private lawCriminal law and Civil law

Legal Issues

Negligence Confidentiality Data protection Act 1998 Human Rights Act 1998 Freedom of Information Act 2000 Consent Unlicensed medicines (Medicines Act 1968) Copyright

Negligence

“We must take reasonable care to avoid acts and omissions which you can reasonably foresee would be likely to injure your neighbour ...”

Donaghue v Stevenson 1932

Negligence

Requirements for proving negligence:

Duty Breach Causation

Negligence

The duty of a health care professional is to exercise reasonable care and skill.

What is reasonable?

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

Negligence

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

Negligence

“The categories of negligence are never closed”

Donaghue v Stevenson 1932

Gross Negligence

Criminal prosecution. Prosecution must prove (beyond

reasonable doubt)Existence of dutyBreach of duty causing deathGross negligence to justify a criminal

conviction

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

Working with Information

Common Law of Confidentiality

Data Protection Act 1998

Human Rights Act 1998

Freedom of Information Act 2000

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

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.

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

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.

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

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

Copyright The NHS has a copyright agreement

which permits NHS personnel to copy protected material from textbooks and journals (up to 15 copies per act of photocopying or 25 copies for a meeting)

One chapter of a book 2 articles of an issue of a journal Any number of articles dealing with a

theme within an issue An entire case report 5% of publication if > above

Constraints

Legal

Ethical

Professional

Organisational

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.

Two ethical theories

Deontology

Consequentialism

Ethical Principles

Autonomy

Beneficence

Non-maleficence

Justice

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 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

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

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

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

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?

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

Constraints

Legal

Ethical

Professional

Organisational

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

?Any Questions

Ethical Dilemmas