Pharmacy ethics and prescription medicines

Dr David Badcott
Centre for Applied Ethics
Cardiff University
UK
Email: badcottd@cf.ac.uk.

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 Summary Slide
• Pharmacy ethics and prescription medicines
1. Concepts of vulnerability, obligation and trust.
Recognition of “principled autonomy”.

2. An ethical “aide memoir”: the “Georgetown mantra”.

3. Ethical compliance and prescription medicines:

(a) generics
(b) counterfeit products
(c) matters of conscience (beginning-of-life and end-of-
life issues. 2
Pharmacy ethics and prescription medicines

“To everyone who proposes to have a good career

moral philosophy is indispensable”.
[Cicero, De Officiis (duty), 44 BC]

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Pharmacy ethics and prescription medicines

I want to suggest that there is an ethical

dimension that applies to the majority of
pharmacists who work in general practice
(community) pharmacy, and hospitals and that
the basis of this is patient vulnerability and
professional obligation.

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Pharmacy ethics and prescription medicines

(a) Primary or intrinsic vulnerability: due to disease

or illness

(b) Secondary vulnerability: exposure to treatment

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 Pharmacy ethics and prescription medicines

Tacit understanding

I (the patient), am vulnerable, need your help and expertise –

you (the pharmacist or other healthcare professional)

undertake to provide it – in accepting, you incur a consequent

obligation toward me.

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Pharmacy ethics and prescription medicines

Trust
Context of
ethical
Vulnerability Obligation relationships

Principled patient
autonomy
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Pharmacy ethics and prescription
medicines

Professional obligation in pharmacy

has two main components:

(1) Relating to technical and legal

aspects of pharmacy

(2) Ethical aspects

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Pharmacy ethics and prescription medicines

 The law informs you about what you must

do or must not do

 Ethics helps you to decide what you ought to

do when the law is silent

(Pharmacy 543 Course Outline, Washington

School of Pharmacy 2005)

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Pharmacy ethics and prescription medicines

“Georgetown mantra” (GTM):

 Beneficence
 Nonmaleficence
 Autonomy
 Justice
Plus: veracity, privacy, confidentiality and
fidelity
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Pharmacy ethics and prescription medicines

RPSGB Code of Ethics for Pharmacists and Pharmacy

Technicians

• Make the care of your patients your first concern.

• Exercise your professional judgment in the interests of
patients and the public.
• Show respect for others.
• Encourage patients to participate in decisions about
their care.
• Develop your professional knowledge and competence.
• Be honest and trustworthy.
• Take responsibility for your working practices. 11
Pharmacy ethics and prescription medicines

“It is clear, however, that ethics is nothing to do

with punishment and reward in the normal sense of
these words. …There must indeed be some kind of
ethical reward and ethical punishment, but they
must reside in the action itself”. [Tractatus Logico-
Philosophicus. London: Routledge and Kegan
Paul.]

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 Pharmacy ethics and prescription medicines
Prescription medicines

Pharmacist has both technical and ethical responsibility for

all pharmaceutical medicines that he or she supplies.
Technical, legal and ethical responsibilities are sometimes
difficult to separate or disentangle.
Particular problems may be associated with
(a) generics
(b) counterfeit medicines.
(c) beginning and end-of-life “moral” issues 13
 Pharmacy ethics and prescription medicines
Considerations and concerns: context of
patient vulnerability and trust

Considerations Possible concerns

Source of supply? Reliable/validated/counterfeit?

Potential bioequivalence Acceptable rate of absorption

problems? (pharmacokinetics &
pharmacodynamics) confirmed?

Physical appearance Possible confusion for elderly

(shape/colour/texture) and patients?
organoleptic properties? 14
Pharmacy ethics and prescription medicines

FIP policy statement (Vancouver September 1997)

indicates that:

(1) “…responsibility for selection of the medicinal

product will be that of the pharmacist (made within
specified criteria) and

(2) regulatory authorities and manufacturers should

provide to pharmacists and prescribers, bioavailability
and other relevant data relating to all medicinal
products, where these are important factors relative to
efficacy …”.
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Pharmacy ethics and prescription medicines

The RPSGB “Accreditation of UK Pharmacy Degree

Courses published 16 May 2002, p.5 indicates under
“Outcomes” that:
– the graduate…
is able to interpret and evaluate, for safety, quality, efficacy
and economy, prescriptions and other orders for
medicines, and to advise patients and other healthcare
professionals about medicines and their usage.
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Pharmacy ethics and prescription medicines

American Academy of Neurology concerns about

generic substitution of anticonvulsant drugs
where it is claimed that:

(a(a) “the US Food and Drug Administration

allows for significant differences between name-
brand and generic drugs” (but)
(b(b) “ for some patients with epilepsy, even minor
differences in the composition of anticonvulsant
drugs can make a big difference” (Medscape
Medical News, April 19, 2007). 17
Pharmacy ethics and prescription medicines

Counterfeit variants:

Genuine drug diluted

Misbranding
Unapproved version
No active content
Contaminated or adulterated
 Post expiry date
Legal obligations?
Ethical obligation?
Patient`s vulnerability
and trust
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 Pharmacy ethics and prescription medicines
Considerations and concerns: context of patient
vulnerability and trust

Beginning-of-life and end-of-life issues

Considerations Possible concerns

Legal requirements. Individual conscience in context of

Moral sensitivities of both obligation.
patient and pharmacist. Patient vulnerability, autonomy
Code of ethics.

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Pharmacy ethics and prescription medicines
Considerations and concerns: context of
patient vulnerability and trust

RPSGB Code of Ethics for Pharmacists and

Pharmacy Technicians (August 1st 2007)
Section:

3.1 “Recognise diversity and respect the cultural

differences, values and beliefs of others”.

3.2 “Treat others politely and considerately”.

3.3 “Make sure that your views about a person`s

lifestyle, beliefs, race, gender, age sexuality, disability
or other perceived status do not prejudice their treatment 20
or care”.
Pharmacy ethics and prescription medicines
Considerations and concerns: context of
patient vulnerability and trust

RPSGB Code of Ethics for Pharmacists and

Pharmacy Technicians (August 1st 2007)

Section 3.4: Show respect for others

“Ensure that if your religious or moral beliefs prevent

you from providing a particular professional service, the
relevant persons or authorities are informed of this and
patients are referred to alternative providers for the
service they require”.
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