1. 1 Pharmacy ethics and prescription medicines Dr David Badcott Centre for Applied Ethics Cardiff University UK Email: badcottd@cf.ac.uk.

2. 2 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.

3. 3 Pharmacy ethics and prescription medicines “To everyone who proposes to have a good career moral philosophy is indispensable”. [Cicero, De Officiis (duty), 44 BC]

4. 4 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.

5. 5 Pharmacy ethics and prescription medicines (a) Primary or intrinsic vulnerability: due to disease or illness (b) Secondary vulnerability: exposure to treatment

6. 6 Pharmacy ethics and prescription medicines 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

7. 7 Pharmacy ethics and prescription medicines Vulnerability Obligation Trust Principled patient autonomy Context of ethical relationships

8. 8  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

9. 9 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)

10. 10 Pharmacy ethics and prescription medicines “Georgetown mantra” (GTM):  Beneficence  Nonmaleficence  Autonomy  Justice Plus: veracity, privacy, confidentiality and fidelity

11. 11 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.

12. 12 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.]

13. 13 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

14. 14 Pharmacy ethics and prescription medicines 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?

15. 15 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 …”.

16. 16 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.

17. 17 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).

18. 18 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

19. 19 Pharmacy ethics and prescription medicines Considerations and concerns: context of patient vulnerability and trust 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, autonomy Code of ethics.

20. 20 Pharmacy ethics and prescription medicines RPSGB Code of Ethics for Pharmacists and Pharmacy Technicians (August 1 st 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”. Considerations and concerns: context of patient vulnerability and trust

21. 21 Pharmacy ethics and prescription medicines RPSGB Code of Ethics for Pharmacists and Pharmacy Technicians (August 1 st 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”. Considerations and concerns: context of patient vulnerability and trust

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