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- •Pharmaceutical Practice
- •Contributors
- •Preface
- •Acknowledgements
- •About this book
- •The NHS drugs budget
- •The NHS workforce
- •The current and future roles ofpharmacists
- •Introduction
- •The changing role of pharmacy
- •The extended role
- •The profession
- •Pharmacy education
- •Conclusion
- •Introduction
- •Healthcare systems
- •Education of pharmacists
- •Registration as a pharmacist
- •Community pharmacy
- •Hospital pharmacy
- •Conclusion
- •Introduction
- •Defining health and illness
- •Dimensions of health
- •Determinants and models ofhealth
- •Process of illness
- •Health knowledge, beliefs andattitudes
- •Decision analysis andbehavioural decision theory
- •The treatment process
- •Introduction
- •Functions of medicines
- •A societal perspective onrational use of medicines
- •Use of medicines
- •Pharmacies and the pharmacyprofession
- •Outcomes of medical treatment
- •Introduction
- •What is public health pharmacy?
- •Wider determinants of health
- •Lifestyle determinants of health
- •Measuring deprivation
- •Changing habits and lifestyle
- •Conclusion
- •Introduction
- •Types of cost sharingarrangements
- •Protection mechanisms andexemptions
- •Impact of cost sharing on druguse and health outcomes
- •Impact of cost sharing onpatients and healthcareprofessionals
- •The role of communitypharmacies
- •Conclusion
- •Introduction
- •The World Health Organization
- •WHO’s work in essentialmedicines
- •The essential medicinesconcept
- •The Model List of EssentialMedicines
- •The WHO Model Formulary
- •The need for essentialmedicines for children
- •Conclusion
- •Introduction
- •Clinical governance
- •Quality
- •Clinical governance andpharmacy
- •Professional governance andregulation procedures inpharmacy
- •When things go wrong
- •Introduction
- •Human error models
- •Risk management tools
- •Risk to patients in the pharmacysetting
- •Developments in health policy
- •National Patient Safety Agency(NPSA)
- •The risk management process
- •Conclusion
- •Introduction
- •What is continuing professionaldevelopment?
- •CPD cycle
- •Recording CPD
- •Fitness to practise
- •Conclusion
- •Introduction: what is audit?
- •Relationship between practiceresearch, service evaluationand audit
- •Types of audit
- •What is measured in audit?
- •The audit cycle
- •Learning through audit
- •Introduction
- •Morals, values and ethics
- •Ethical theories
- •Principlism and the four ethicalprinciples
- •Principlist ethics and research
- •Morals and law
- •Applied and professional ethics
- •Ethical issues in health care
- •Ethics and pharmacy
- •Conclusion
- •Introduction
- •Assumptions and expectations
- •What is communication?
- •Listening skills
- •Questioning skills
- •A model for guiding thepharmacist–patient interview
- •Patterns of behaviour incommunication
- •Empathy
- •Barriers to communication
- •Confidentiality
- •Special needs
- •Difficult situations in pharmacy
- •Conclusion
- •Introduction
- •What is teamwork?
- •The healthcare team
- •The community healthcare team
- •Role of the pharmacist inteamwork
- •Conclusion
- •Introduction
- •Why keep records?
- •What to record?
- •Barriers to record keeping
- •The future of records
- •The Data Protection Act 1998
- •Confidentiality
- •Records of supply
- •Clinical governance records
- •Consultation records
- •Introduction
- •Independent prescribing
- •Supplementary prescribing
- •Patient group directions
- •Minor ailment schemes
- •Influences on prescribing
- •Clinical governance inprescribing
- •Code of Ethics
- •Introduction
- •The prescribing process
- •Evidence-based medicine
- •Different types of formularies
- •Formulary development
- •Formulary managementsystems
- •Safety, efficacy and economy
- •Pre-marketing studies
- •Post-marketing studies
- •Pharmacoeconomic evaluationof medicines
- •Drug utilization review andevaluation
- •Introduction
- •Extent of use of CAM
- •Reasons for use of CAM
- •Regulation of CAM
- •Pharmacy and provision of CAM
- •Efficacy and safety of CAMapproaches
- •The future for complementarymedicines
- •Introduction
- •Routes of administration
- •Dosage forms
- •Introduction
- •The concept and growth ofself-care
- •Getting information from thepatient
- •Drawing together information
- •Picking up on non-verbal cues
- •Outcomes from the consultation
- •Conclusion
- •Introduction
- •Where does information existand how can it be retrieved?
- •Directory of useful websites
- •Searching the Internet
- •The sequence of information
- •Information services
- •Conclusion
- •Introduction
- •Information required on aprescription
- •Types of prescription forms
- •Routine procedure fordispensing prescriptions
- •Introduction
- •The working environment andprocedures
- •Equipment
- •Manipulative techniques
- •Ingredients
- •Problem solving inextemporaneous dispensing
- •Counting devices
- •Automated dispensing systems
- •Conclusion
- •Introduction
- •Expressions of concentration
- •Calculating quantities from amaster formula
- •Changing concentrations
- •Calculations where quantity ofingredients is too small to weighor measure accurately
- •Solubilities
- •Calculations involving doses
- •Reconstitution and infusion
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Primary and secondarypackaging
- •Packaging materials
- •Closures
- •Collapsible tubes
- •Unit-dose packaging
- •Paper
- •Patient pack dispensing
- •Introduction
- •Standard requirements forlabelling dispensed medicines
- •Additional labellingrequirements
- •Legal requirements in certaincircumstances
- •Errors in labelling
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Sterile product production
- •Premises
- •Environmental control
- •Environmental monitoring
- •Aseptic preparation
- •Testing for sterility
- •Introduction
- •Solutions for oral dosage
- •Solutions for otherpharmaceutical uses
- •Expression of concentration
- •Formulation of solutions
- •Oral syringes
- •Diluents
- •Introduction
- •Pharmaceutical applications ofsuspensions
- •Properties of a goodpharmaceutical suspension
- •Formulation of suspensions
- •The dispensing of suspensions
- •Introduction
- •Pharmaceutical applications ofemulsions
- •Emulsion types
- •Formulation of emulsions
- •Dispensing emulsions
- •Introduction
- •Types of skin preparation
- •Ingredients used in skinpreparations
- •Dispensing of externalpreparations
- •Transdermal delivery systems
- •Introduction
- •Suppository bases
- •Preparation of suppositories
- •Containers for suppositories
- •Shelf life
- •Labelling for suppositories
- •Patient advice
- •Introduction
- •Powders for internal use
- •Powders for external use
- •Introduction
- •Tablets
- •Capsules
- •Other oral unit dosage forms
- •The role of the pharmacist
- •Introduction
- •The inhaled route
- •Inhaled medicines used forasthma and COPD
- •The peak flow meter
- •Types of inhaler device
- •Introduction
- •Administration procedures
- •Products for parenteral use
- •Formulation of parenteralproducts
- •Large-volume parenteralproducts
- •Introduction
- •Anatomy and physiology of theeye
- •Formulation of eye drops
- •Preparation of eye drops
- •Labelling of containers
- •Instillation of eye drops
- •Formulation of eye lotions
- •Formulation of eye ointments
- •Ophthalmic inserts
- •Contact lenses and theirsolutions
- •Contact lenses
- •Hard lens solutions
- •Soft lens solutions
- •Advice to patients
- •Introduction
- •Cancer chemotherapy
- •Classification of drugs used incancer chemotherapy
- •Targeted therapies
- •Dose and schedule ofchemotherapy
- •Occupational exposure risks
- •Provision of a pharmacy-basedchemotherapy preparationservice
- •Administration of cytotoxicmedicines
- •Provision of chemotherapyat home
- •Centralized intravenous additiveservice (CIVAS)
- •Infusion stability and shelf lifeassignment
- •Introduction
- •Provision of nutritional support
- •Indications for TPN
- •Assessment of the patient inhospital
- •The nutrition team
- •Components of a TPNformulation
- •Compounding of TPN and HPNformulations
- •Compounding of HPNformulations by commercialcompanies
- •Potential complications arisingduring compounding andadministration of TPNformulations
- •Addition of medicines to a TPNor HPN bag
- •Administration of TPN/HPNformulations
- •Potential problems for HPNpatents
- •Training for HPN patients
- •Services provided by home-carecompanies
- •The British Parenteral NutritionGroup
- •Introduction to kidney diseaseand dialysis therapy

Audit CHAPTER 11
The changes proposed to improve practice must be
closely tailored to the underlying cause of the suboptimal audit results. They should be specific to the
situation which has been audited, rather than general.
They should be non-threatening and may need to be
introduced gradually. Change may require resources,
including time. It may also have other knock-on
effects which need to be anticipated. The effect of
changes must be monitored, to see whether they have
been successful. This can be done by re-audit or by
continuous monitoring if routinely collected data can
be used.
Re-audit
Sometimes it may be appropriate to reconsider the
standards before undertaking a further period of data
collection.
Standards which were set too high may always be
unattainable, although this may not have been apparent before practice was measured. It is equally possible to have used low standards and to have found they
were surpassed. In this case it may be appropriate to
raise them, which is a good way of improving practice.
Whether or not the standards remain the same, a
second period of measuring practice is needed if
changes have been implemented, so that the effectiveness of these changes can be determined.
It is always difficult to change behaviour and
improvements in practice may be short-lived. It may
therefore be necessary to repeat audits at regular
intervals to reinforce the desired practice and maintain the improvement in service.
Learning through audit
If the prevailing view of an audit which shows performance to be less than the standard set is that there are
lots of reasons which could excuse this result, then
little has been learned from undertaking the audit.
Evaluating your service may be difficult, but it may
also teach you a lot about yourself and the staff with
whom you work. For example, it is of little use to
suggest that the reason there were so many dispensing
errors during the audit was that there was a new
locum employed for part of the time. It is much more
valuable to consider what information you have
available for locums about your dispensing procedures and indeed whether your dispensing procedures
are adequate.
If the results of an audit were suboptimal, but
much as expected, is this because staff have been
accepting of poor practices in the past? Have staff
been aware of the need for improvements in systems
but felt unable to suggest changes? Have staff been
wanting more training but known that there is no
money available to pay for it? All these are hypothetical situations, but you can see how conducting audit
may have more learning than just what needs to be
done to improve services. In this way, carrying
out audit can contribute to continuous professional
development and so has benefits both for you and,
ultimately, for the patient.
KEY POINTS
*
Pharmacists need to audit their practice to show
that they meet appropriate standards
*
The main aim of audit must be to improve
standards of service and outcomes for patients
*
There are similarities and differences between
audit, service evaluation and practice research
*
The three main types of audit are self-, peer and
external audit
*
An audit may examine structures, processes or
outcomes
*
Criteria should be formulated into standards for
audit which may be ideal, optimal or minimal
*
Standard setting should involve at least all those
involved in delivering the service being audited
*
Data collection must address the purpose of the
audit and have the potential to identify reasons for
failure to meet the standard
*
Sampling must ensure that the data collected in an
audit are representative of the total activity
*
Piloting the data collection tool ensures that it is
suitable and comprehensive
*
Comparison with standards will normally involve
very simple descriptive or statistical analysis
*
Confidentiality must be respected, but outcomes
should be shared with all the audit team
*
Implementing change is a key part of audit
*
Re-audit tests whether changes have led to
improved achievement of standards
109

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Chapter Twelve
Ethics
Richard C. O’Neill
12
STUDY POINTS
*
The major ethical theories and principles applied to
decision making in health care
*
The key limitations of each ethical theory
*
The distinction between morals, ethics and law
*
Ethical decision-making frameworks
*
Ethics relating to pharmacy
Introduction
The aim of this chapter is to introduce the concept of
ethics, briefly explain ethical theories and principles
and relate these to issues of relevance in pharmacy
and healthcare practice.
Morals, values and ethics
The terms ‘ethics’ and ‘morals’, ‘ethical’ and ‘moral’
are often used interchangeably. They are almost synonymous in that an ethical action is one that is morally
acceptable. However, they are not identical. Morals
usually refers to practices; ethics is concerned with
evaluating such practices. Morality is concerned with
the standards of right or wrong behaviour, the values
and duties adopted by individuals, groups and society.
Personal morals arise from religious beliefs, political
views, prejudices, cultural and family backgrounds.
Values are those ideals, beliefs, attitudes and characteristics considered to be valuable and worthwhile
by an individual, a group or society in general. Personal values are acquired over a long period of time
through interaction with family,friends, school, work,
colleagues and role models, and develop and change
throughout life. The way in which a person makes
personal and professional judgments and choices is
influenced by the way they organize, rank and prioritize values in a personal value system.
Ethics is the branch of philosophy that deals with
the moral dimension of human life. Ethics deals with
what is right and wrong, good and bad, what ought and
ought not to be done. It is concerned with actions and
judging whether an action is right or wrong and justifying this. The study of ethics is commonly grouped
into three areas:
*
Descriptive ethics simply describes the way things
are – how people in different societies actually
behave
*
Meta-ethics is concerned with analysis of the
language people use when they discuss a moral
issue, for example the meaning of the words ‘right’
and ‘wrong’
*
Normative ethics is concerned with how things
ought to be, how people should behave and how
people justify decisions when faced with situations
of moral choice. It attempts to generate the norms
or standards of the right action.
Descriptive ethics is about facts while normative
ethics is about values. One cannot argue from the
one to the other. The way things are is not necessarily
a guide to how they should be.
Ethical theories
Ethical theories provide a framework within which
the acceptability of actions and the morality of judgments can be assessed. Absolutist theories rest on the
assumption that there is an absolute right or wrong.

SECTION TWO Governance and good professional pharmaceutical practice
Relativistic or reason-based theories rest on the assumption that right or wrong can depend purely on
what any society, group or individual believes.
Normative theories of ethics
Normative theories are distinguished by the way in
which they provide ethical guidance:
*
Virtue ethics locate the highest moral value in the
development of persons
*
Consequentialist (or utilitarian) theories evaluate
actions by reference to their outcomes
*
Deontological theories hold that actions are
intrinsically right or wrong.
These are summarized in Table 12.1.
Virtue ethics
The word ethics is derived from the Greek ethos,
meaning a person’s character, nature or disposition.
Virtue ethics has its roots in the work of Socrates,
Table 12.1 Comparison of main ethical theories
Plato and Aristotle, and places emphasis on the character of the person performing the action rather than
on the action itself.
Virtue ethicists stress the importance of inner character traits such as honesty, courage, faithfulness,
trustworthiness and integrity. Healthcare professionals are expected to demonstrate such characteristics (or virtues), having been inculcated in them
throughout education and training.
Socrates (470–399
BC) taught the priority of per-
sonal integrity in terms of a person’s duty to himself.
Plato (427–347
BC) emphasized four cardinal vir-
tues: wisdom, courage, temperance and justice.
Others virtues were fortitude, generosity, selfrespect, good temper and sincerity. Hierarchies of
virtues have changed over time.
Aristotle (384–322
BC) was concerned with what
makes a good person rather than what makes a good
action. He believed that being moral involved rationally applying good sense to find the middle way between
one extreme or another, for example courage is the
mean between cowardice and rashness (Box 12.1).
Ethical theory Virtue based Duty based (deontology) Consequentialism (utilitarianism)
Perspective Actor based Action based Action based
Features Emphasis placed on
character and motivation
Morally correct
action
Strengths More personal; supports actions
Weaknesses No universally agreed list of
Right action is that which a
virtuous person would do
done for virtuous reasons; not
bound by rules
virtues; concerned with good
character rather than the specific
problem; difficulties in resolving
moral conflicts or competing
claims in practice; may do harm
despite virtue
Emphasis on the manner of the
action; act out of a sense of
duty; moral rules are those
that pass the categorical
imperative test; means
count; never right to treat
people as just means to an end
Right action is that following duty Right action is that with the greatest
Sets clear rules/moral boundaries;
follow duty not inclination; based
on reason–no subjectivity; consistent
Questions about where rules
originate; can be inflexible; not
as simple as consequentialism;
difficulties when rules conflict;
follow duty regardless of results;
ends cannot justify means even
if outcome is good
Emphasis on the outcome or outcome of
the action; no action in itself is good or
bad; ends count
usefulness; greatest good for the
greatest number
Practical; flexible; results orientated;
no conflicting rules; moral form of
democracy
Relies on single criterion when many
factors need to be considered; difficulties
in identifying who and what should be
considered; difficulties quantifying utility;
uncertainties in consequences of actions/
speculative; can lack justice; does not
consider individual rights; ends can
justify means; bad or unjust acts
permissible
112

Ethics CHAPTER 12
Box 12.1
Examples of Aristotle’s moral virtues and the
golden mean
Excess Mean Deficiency
Rashness Courage Cowardice
Boastfulness Truthfulness Understatement
Irascibility Patience Lack of spirit
Vulgarity Magnificence Pettiness
Modern Aristotelians believe that ethics should be
concentrating more on how people should live their
lives, advising which ethical characteristics people
should try to develop and habituating people into
having good dispositions so that moral behaviour
becomes almost instinctive.
Consequentialism and utilitarianism
For consequentialists, whether an action is morally
right or wrong depends on the action’s ‘ethos’ or
usefulness.
Utilitarians consider that an action should be
judged according to the results it achieves. Bentham
argued that actions are right if they maximize pleasure
(good) and minimize pain (evil) for the majority of
people. Since he believed everyone had an equal right
to pleasure, everyone counted in the assessment of
benefits of an action.
Later it was argued that not all forms of pleasure
and happiness were equal and other values such as
duty, love and respect should be considered. The goal
of ethics is not only the pleasure (happiness) of the
individual, but also the greatest pleasure (happiness)
for the greatest number.
Recent utilitarian theorists have advocated taking
into account the preferences of persons concerned.
This approach has become widely used in areas of
applied and professional ethics and assumes that there
should be equal consideration of interests. While
accepting that not all have equal interests (animals
compared with humans for example), all should be
treated in a way that is appropriate.
The simplicity and practical usefulness of utilitarianism is one of its main benefits. If an act is likely to
produce the greatest good for the greatest number
then it is right – if it does not, it is wrong.
are referred to as non-consequentialist since some
actions are inherently right or wrong, regardless of
their consequences. There are acts we have the duty
to perform because these acts are good in themselves
(i.e. intrinsically good); and we have a duty to refrain
from acts that are intrinsically bad or wrong.
Kantianism
Kantianism is the most comprehensive deontological
ethical theory named after Immanuel Kant (1724–
1804). He believed that people, not God, imposed
morality because they were rational beings. Kant suggested that moral duty could be determined by the
use of reason about the act in question. This categorical imperative exists as several versions, the two best
known being:
*
First version: ‘Act only on that maxim through
which you can at the same time will that it
should become a universal law.’
This means that ‘unless you are able to say that everyone must act like this, then you should not act like
it’. Something is morally right, or wrong, only if it
applies for everyone. It would be inconsistent and
irrational to decide, for example, that you could steal
from others, but they could not steal from you. Thus,
reason demands that we do not steal unless everyone
is allowed to steal.
*
Second version: ‘Act in such a way that you always
treat humanity, whether in your own person or in
the person of any other, never simply as a means,
but always at the same time as an end.’
People must be treated as ends in themselves and not
as a means to an end. This means that all people are
equal and deserve equal respect. There are certain
ways we must not treat people, no matter how much
usefulness might be produced by treating them in
those ways (for example not lying to a patient). A
consequentialist, by contrast, does not believe it is
wrong to use people as means – if the ends justify
the means, lying is permissible.
This second version has been very influential in
medical ethics as it can be translated as saying it is
necessary to treat people as autonomous agents capable of making their own decisions. The concept of
autonomy and respecting an autonomous decision
demonstrates respect for the person as an ‘end in
itself’.
Deontology
Deontology refers to a group of normative ethical
theories that emphasize moral duties and rules. They
Ross’sprimafacieduties
Ross recognized that a number of obligations present
themselves in practical situations and that we must
113

SECTION TWO Governance and good professional pharmaceutical practice
weigh up the various options available when deciding
which course of action is morally correct (Hawley
2007). Ross distinguished duties as ‘ prima facie’ or
‘actual’ duties. A prima facie duty is one that is always
to be performed unless it conflicts with an equal or
stronger duty. The stronger duty becomes an actual
duty that must be carried out for the action to be
morally correct. The prima facie duty to keep a promise (fidelity), for example, could be over-ridden if it
was not in a person’s best interests. Ross identified
seven prima facie duties:
*
Fidelity – duty to keep promises, honour contracts
and agreements, tell the truth, be faithful
*
Reparation – duty to rectify a wrong done to
another
*
Gratitude – duty to repay acts of kindness
*
Beneficence – duty to make things better for
other persons
*
Non-maleficence – duty not to make other
persons worse off
*
Justice – duty to distribute pleasure or
happiness, goods and benefits in accordance with
the merit of persons concerned
*
Self-improvement – duty to improve one’s own
condition.
Conflict of duties can only be resolved by considered
judgment in a particular situation: there is no general
ranking of the duties. The morally correct action is the
one that produces the greatest balance of prima facie
rightness to prima facie wrongness. However, the
principle of non-maleficence is considered to take
precedence over the principle of beneficence when
they come into conflict. Ross’s theory has greatly
influenced the ‘four-principles’ approach to medical
ethics (see later) as it introduced the idea of sorting
and weighing principles.
Deontology and rights
The rights of persons are closely associated with duty.
Using someone as a means to an end infringes that
person’s ‘rights’, such as rights to freedom and choice.
This ‘right’ could be derived from the capacity to
reason or to make choices, so that healthcare professionals, for example, are obliged to respect rational
wishes of patients.
In every case the deontological norm has boundaries. What lies outside those boundaries is not forbidden. Thus lying is wrong while withholding a truth
may be perfectly permissible. This is because withholding a truth is not lying. If more than one option is
morally acceptable, the individual can choose which
to carry out. By contrast, a consequentialist must
always select the best option.
Principlism and the four ethical principles
Principlism, introduced in the late 1970s, is now a
widely applied bioethical framework for identifying
key moral issues and as a starting point for looking at
ethical dilemmas. It identifies four prima facie moral
commitments relevant in health care and compatible
with the major ethical theories. These enable a simple, accessible approach when the ethical theories
themselves can be considered to be too general to
guide particular decisions. Being conditional, the principles allow a stronger case to overrule a weaker one in
a particular circumstance.
The four ‘principles’ are:
*
Autonomy – self governance and respect for
persons
*
Non-maleficence – avoiding harm
*
Beneficence – providing good
*
Justice – fairness.
These are supplemented with four ‘rules’:
*
Veracity
*
Privacy
*
Confidentiality
*
Fidelity.
Autonomy
Autonomy encompasses the capacity to think, decide
and act freely and independently. Respect for autonomy flows from the recognition that all rational beings
have unconditional worth, and each has the capacity
to determine his or her own destiny. People should be
seen as ends in themselves and not treated simply as
means to the ends of others.
Autonomy generally brings about the best outcome. Individuals should be allowed to develop their
potential according to their own personal convictions
provided these do not interfere with a like expression
of freedom by others. A person’s autonomy should be
respected unless it causes harm to others. Liberty
should not be limited on the sole grounds that a person’s choice would harm them – competent adults
should be free to risk their own health and well-being
without interference. Respectfulness can be considered a characteristic of a virtuous person.
114

Ethics CHAPTER 12
Three types of autonomy have been suggested:
*
Autonomy of thought – thinking for oneself,
making decisions, believing things, making moral
assessments
*
Autonomy of will (intention) – freedom to do
things on the basis of one’s deliberations
*
Autonomy of action – ability to act.
Autonomy is perhaps the dominant principle of medical ethics. Autonomy is the basis of informed consent
and truthfulness, privacy and confidentiality. Other
proposed ‘principles’ such as fidelity (faithfulness)
and veracity (truthfulness) can be considered to come
under the umbrella of autonomy. Autonomy means
that patients can choose what type of treatment they
would prefer given a choice, and even choose not to be
treated. Autonomy also involves helping the patient to
come to his or her own decision. Where a patient is
able to make an informed decision, this should be
respected even when it appears to be detrimental,
illogical or immoral. However, healthcare providers
must also be able to recognize situations where a
patient is unable to act autonomously. Of course, a
person may even make an autonomous decision to
leave decision making to someone else.
Autonomy and patient preferences or wishes are
not absolute and must be weighed against competing
liberties and interests. The opposite of autonomy is
paternalism. Paternalism over-rides the principle of
respect for autonomy and involves making decisions
on behalf of another, usually justified by appealing to
the principle of beneficence (the duty to do good) or
non-maleficence (the duty not to harm). In the past
paternalistic practice was common, but in modern
society it is less acceptable, although weak (soft)
paternalism can be justified in some cases, such as
when acting in the best interests of an incompetent
patient. However, strong (hard) paternalism, ignoring
or over-ridinga competent person’s wishes, is difficult
to justify.
individual ability and doing everything to avoid making mistakes that can harm the patient. Healthcare
providers have an ethical (if not legal) obligation to
report behaviours by others that adversely (or could
adversely) affect the health, safety or welfare of
patients – an obligation to report others who are incompetent, impaired (such as from fatigue, alcohol,
drugs or mental illness) or are unethical.
Beneficence
Beneficence is an obligation to do good. To benefit the
patient is a fundamental goal of health care. Most
people enter a healthcare profession because of the
opportunity to help others and each profession will
have its own definition of what ‘good’ means.
Beneficence and non-maleficence are often seen as
two sides of the same coin. However, while there is a
general positive obligation not to do harm, providing
benefit (typically to a specific individual) is not always
possible.
Desire to help others can come into conflict with
the principle of autonomy,as when a patient chooses a
course of action that does not appear to coincide with
his or her best interest. Beneficence also frequently
comes into conflict with non-maleficence. Most medical and therapeutic interventions are associated with
some harm (for example, the pain associated with
immunization) and benefits have to be balanced
against risks. In such instances, we rely on beneficence
to ensure that any harm is performed for a greater
good.
Beneficence involves doing what is best for the
patient. This does raise the question of who should
judge what is best. Conflicts between beneficence
and autonomy can occur when a competent patient
chooses a course of action that the healthcare professional does not consider is in his or her best
interests.
Non-maleficence
Non-maleficence means not doing harm, often
expressed as ‘ First, do no harm’ – a simplification
from the Greek 4th century
Non-maleficence requires healthcare providers to
do everything in their ability to avoid causing, and
where possible actively avoid causing, either intentional or unintentional harm. This would include
maintenance of competence through continuing education, always acting within the scope of practice and
BC Hippocratic oath.
Justice
Justice is often synonymous with fairness and equity:
a moral obligation to act on the basis of fair adjudication between competing claims. All people of equal
need are entitled to be treated equally in the distribution of benefits and burdens regardless of race,
gender, religion and socio-economic status, etc.
Justice requires that only morally defensible differences among people be used to decide who gets
what. Decisions should not be based on capricious
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SECTION TWO Governance and good professional pharmaceutical practice
or illogical reasons. The logical opposite of justice is
discrimination.
Various factors can be used as criteria for the distribution of various resources, for example to each
(after Beauchamp & Childress 2001):
*
According to their need
*
According to their merit
*
According to their worth/contribution to society
*
An equal share
*
According to their effort.
Justice is about equal access to health care. Not all
patients have an equal need and it is not always possible to provide the same level of care to all patients at
all times. Consequently,a system has to be established
to provide care as fairly as possible. For example, in
emergency departments, a system of triage is applied
in which the most critical patients are treated first on
the basis of clinical need.
The four rules
Beauchamp & Childress (2001) analysed veracity, privacy, confidentiality and fidelity in the context of the
professional–patient relationship.
often conflicts with obligations of confidentiality
and privacy.
Whistle blowing, calling the attention of authorities to unethical, illegal or incompetent actions of
others, is based on the ethical principles of nonmaleficence and veracity.
Privacy
An obligation to respect privacy can be seen to come
under the ethical principle of respect for a person’s
autonomy. Privacy relates to a right to restrict access
to what a person regards as private and personal and
not to be invaded. Beauchamp & Childress consider
privacy to include decisions about sharing or withholding information about one’s body or mind, one’s
thoughts, beliefs and feelings.
Confidentiality
Confidentiality relates to the duty to maintain confidence and thereby respect privacy. Beauchamp &
Childress define privacy as allowing individuals to
limit access to information about themselves and confidentiality as allowing individuals to control access to
information they have shared.
Veracity
Veracity is the obligation to tell the truth and is an
essential component of informed consent and hence
respect for autonomy. It is also closely linked to obligations of fidelity, trust and promise keeping. Veracity
is not limited to cases of informed consent. Veracity
provides for open and meaningful communication
that is an absolute necessity in any moral relationship
between two persons. The relationship between
healthcare professional and patient needs to be based
on mutual trust and honesty.
To Beauchamp & Childress, veracity is prima facie
binding. It is not absolute, and non-disclosure, deceiving and lying could be justified when veracity conflicts
with other principles such as non-maleficence. Nondisclosure or benevolent deception, but not involving
lying, would be more easily justified, as it is less likely
to threaten the relationship of trust.
With the complexity and uncertainties of modern
medicine, complete honesty and ‘whole truth’ can be
an oversimplification. Just what the truth is can be a
matter of clinical judgment. Issues concerning how
much information should be given, to whom and in
what circumstances create continuing difficulties for
healthcare professionals. The obligation of veracity
Fidelity
Fidelity is the obligation of faithfulness and is concerned with acting in good faith, keeping promises,
fulfilling agreements, integrity and honesty. Among
the duties of fidelity is the duty of loyalty and an
obligation to put the patient’s interest first. Issues
can arise when there are conflicts of interest or divided loyalties.
Principlist ethics and research
Principlist ethics have dominated the field of health
research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, in the Belmont Report of 1979,
identified three basic ethical principles (the so-called
Belmont principles):
*
Respect for persons
*
Beneficence
*
Justice.
Respect for persons incorporated two ethical convictions: that individuals should be treated as autonomous agents; and that persons with diminished
autonomy are entitled to protection.
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Ethics CHAPTER 12
Beneficence required that persons be treated in
an ethical manner and their decisions respected and
protected from harm. It incorporated the concept of
non-maleficence by maximizing possible benefits and
minimizing possible harms.
Justice required fairness in distribution of benefits
and burdens associated with research and subject
selection.
Morals and law
Both laws and morals can be considered to be guidelines for conduct. Laws establish minimum standards
of behaviour that everyone must meet. The law is
influenced by moral and ethical principles but they
do not necessarily match. Laws may not necessarily
be ethical and many things that are not illegal may still
be wrong. Morality is a system of right and wrong
enforced through societal pressure. Morals tend to
be simple and general rather than precisely defined.
They provide general rules that should be applied in
particular instances according to circumstances and an
individual’s conscience. In general, morals correspond
to what is done in a society and accord with customs
and traditions. Personal morals relate to the values and
beliefs that provide the framework for an individual’s
decisions and actions. Ethics lies somewhat between
law and morality. Ethical standards need to be precisely defined but are subject to individual interpretation.
Ethics seeks ideal or maximal standards of behaviour.
All law has some moral basis, and in medicine, law,
morality and ethics are inextricably linked. Many acts
of parliament associated with health care are far from
ethically neutral. There are many areas – research on
embryos and embryonic stem cells for example – that
are a source of deep moral divisions. Sometimes the
law acts almost in a knee-jerk fashion, responding to
society’s moral disquiet, for example the Surrogacy
Arrangements Act 1990 prohibiting commercialization of surrogacy and the Human Reproductive Cloning Act 2001 prohibiting the planting of cloned
embryos in a womb were both rushed through parliament. Medical science and technology are continuously advancing and at a pace. Situations are having
to be addressed before society has had time to thoroughly think them through.
Applied and professional ethics
Applied ethics is the branch of ethics that is concerned with the analysis of specific, controversial
issues, arising in specific cases. It uses ethical theories
and principles to form judgments. Applied ethics
covers a number of areas including business ethics,
environmental ethics and bioethics. Bioethics, a contraction of biomedical ethics, is concerned with the
interface between the life sciences and ethics. It
encompasses medical or healthcare ethics and focuses
on issues that arise in healthcare or clinical settings.
Professional ethics includes group standards and
norms as well as individual ethics.
Ethical issues in health care
Advances and changes in health care and medical
technology, the changing relationship between professional and patient and the changing interprofessional
roles and their relationships all require an increased
ethical awareness in healthcare professionals. Healthcare professionals need to be able to answer ethical
questions, work out solutions to ethical problems and
resolve ethical dilemmas. Some current issues such as
medical research and resource allocation (rationing)
appear to reflect a more utilitarian approach to ethics.
Issues surrounding the beginning and end of life, cloning and reproductive technologies, and genetic testing
clearly do not evoke utilitarian principles alone. In a
pluralistic society, there are many different and
strongly held moral viewpoints (moral pluralism)
which apply to medicine, as is clearly demonstrated
with issues such as abortion and euthanasia.
One area, for example, where significant challenges in ethics are likely to occur is in relation to
death and dying. The issue of euthanasia encompasses
a number of concepts used in moral discussion, such
as autonomy, the sanctity of life, quality of life, medical futility, best interests, acts and omissions, double
effect and slippery slopes.
The doctrine of double effectembracestwo effects,
an intended good effect and an unintended secondary
bad effect. This justifies giving pain-relief treatment to
terminally ill patients provided it is given with the
primary intention of relieving pain, and excuses any
unavoidable, but unwanted, life-shortening effect of
doing so. The central core of the doctrine is the moral
distinction between intention and foresight.
The moral distinction between passive and active
euthanasia rests largely on the distinction between
acts and omissions. To actively end life is both morally
and legally wrong, whereas to withhold life-saving
treatment could, in some circumstances, be seen as
the right thing.
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SECTION TWO Governance and good professional pharmaceutical practice
The slippery slope argument is one used against the
practice of voluntary euthanasia. The sanctioning of
some mildly objectionable practice inevitably leads to
some highly objectionable practice. Thus by permitting voluntary euthanasia this will lead down a slippery slope to involuntary active euthanasia.
Ethics and pharmacy
There are legal, ethical and professional implications
to every decision and action taken by a pharmacist.
While dramatic ethical dilemmas may not be the
norm of everyday practice, each encounter with a
patient raises ethical issues. Most do not present a
dilemma. A dilemma arises from fundamental conflicts among beliefs, duties and principles. An expanded role and increased patient contact increases the
opportunity for ethical issues to arise. Pharmacists
need to become more comfortable with decision making in conditions of uncertainty. Ethics in practice
involves such varied issues as pharmacist – patient relationships, empathy, responsibility and accountability,
privacy and confidentiality issues, compliance and adherence, responding to errors, maintaining competence, supply of emergency contraception, abuse of
over the counter medicines, supply of homoeopathic
medicines, supply of unlicensed medicines, etc. (see
Chs 6, 10, 13, 14, 20, 44, 46, 47, 48 and 49).
Ethical dilemmas are not restricted to clinical
issues. Studies have reported a willingness of students
to engage in some sort of academic dishonesty (Aggarwal et al 2002; Rennie & Crosby 2001). This demonstrates the importance of nurturing and enhancing
ethical behaviour in students and helping them to find
their ‘moral compasses’. Dilemmas may also arise in
areas of practice, for example areas of possible conflict of interest, areas concerning NHS fees and remuneration (e.g. dispensing a prescription item at a
loss; Thimbleby 2003), as well as personal behaviour,
whistle blowing and research, etc.
However, the law is seen as setting minimum standards, while the others aim for the maximum.
Professional ethics are concerned with the principles of professional conduct concerning the rights and
duties of the profession and the professional person
himself or herself.
Professional codes and oaths
Professional ethics are concerned with professional
values and philosophies. Health professions articulate
their profession’s values and standards of conduct,
and the rights and responsibilities of their members
in an ethical code. Codes exist to encourage optimal
behaviour and promote a sense of community between members. While codes tend to emphasize
duties and responsibilities (deontologically based), a
feature of many is their aspirational nature – they
strive for upper ideals. They make explicit, to both
members and the public, the expectations and ideals
central to the profession and so help ensure public
trust and confidence in professional practice. Law
and professional guidelines alone are unlikely to be
an effective way of maintaining professional competence and behaviour. Standards of care are as much
about ethics as they are about skills.
Various oaths and codes exist in health care (e.g.
the Hippocratic oath), their content having evolved
(Box 12.2). Reference to autonomy and justice, as
well as the obligation and virtue or veracity, has traditionally been ignored in medical codes (Gillon 1985)
and also in pharmacy codes (Rogers & John 2006).
Both law and ethics influence the formulation of
the code of ethics and, more recently,so do the ethical
principles: respect for people is related to autonomy,
competence to non-maleficence and integrity to fidelity. The Code of Ethics for Pharmacists and Pharmacy
Technicians 2007 now adopts a principled approach,
identifying ethical principles and including inherent
value attitudes and behaviours that characterize a
Professional ethics and law
Laws can be considered an empowering force in
healthcare ethics. They define the legal aspects of
practice, rights of patients and duties of healthcare
professionals. Negligence involves a failure to meet
obligations to others and, by attributing fault or blame,
clearly has a moral dimension. Standards of care have a
moral as well as legal and professional dimension.
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Box 12.2
Origins of codes of ethics
Traditional Contemporary
Duty based Principles based
Stress beneficence, non-maleficence
and professional etiquette
Stress autonomy
and justice
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