1 pharmacy ethics and prescription medicines dr david badcott centre for applied ethics cardiff...

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Pharmacy ethics and prescription medicines

Dr David Badcott

Centre for Applied Ethics

Cardiff University

UK

Email: [email protected].

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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.

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“To everyone who proposes to have a good career

moral philosophy is indispensable”.

[Cicero, De Officiis (duty), 44 BC]

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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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(a) Primary or intrinsic vulnerability: due to disease

or illness

(b) Secondary vulnerability: exposure to treatment

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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.

Tacit understanding

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Vulnerability Obligation

Trust

Principled patient autonomy

Context ofethical relationships

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Professional obligation in pharmacy

has two main components:

(1) Relating to technical and legal

aspects of pharmacy

(2) Ethical aspects

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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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“Georgetown mantra” (GTM):

Beneficence

Nonmaleficence

Autonomy

Justice

Plus: veracity, privacy, confidentiality and

fidelity

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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.

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“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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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

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Considerations and concerns: context of patient vulnerability and trust

Considerations

Source of supply?

Potential bioequivalence problems?

Physical appearance (shape/colour/texture) and organoleptic properties?

Possible concerns

Reliable/validated/counterfeit?

Acceptable rate of absorption (pharmacokinetics & pharmacodynamics) confirmed?

Possible confusion for elderly patients?

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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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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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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).

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

Considerations

Legal requirements.Moral sensitivities of both patient and pharmacist.

Possible concerns

Individual conscience in context of obligation.Patient vulnerability, autonomyCode of ethics.

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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 or care”.


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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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1 pharmacy ethics and prescription medicines dr david badcott centre for applied ethics cardiff...

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