1. LEGAL AND ETHICAL ISSUES IN MEDICINES INFORMATION Maggie Fitzgerald L.LB BPharm MRPharmS Senior Pharmacist, Medicines Information

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

3. 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

4. Constraints Legal Ethical Professional Organisational

6. Legal Issues DEFINITIONS  Statutory law  Common (case) law  Public law and Private law  Criminal law and Civil law

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

8. 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

9. Negligence Requirements for proving negligence:  Duty  Breach  Causation

10. Negligence The duty of a health care professional is to exercise reasonable care and skill.  What is reasonable?

11. Negligence Professional 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

12. 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

13. Negligence “The categories of negligence are never closed” Donaghue v Stevenson 1932

14. Gross Negligence Criminal prosecution. Prosecution must prove (beyond reasonable doubt)  Existence of duty  Breach of duty causing death  Gross negligence to justify a criminal conviction

15. 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

16. 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

17. Working with Information Common Law of Confidentiality Data Protection Act 1998 Human Rights Act 1998 Freedom of Information Act 2000

18. 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

19. 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.

21. 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

22. Data Protection Act Updated in 1998 Seeks to strengthen an individual’s right to privacy in terms of processing personal data Eight principles apply

23. 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.

24. 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)

25. 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.

26. 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

27. 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.

29. 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

30. 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

31. Constraints Legal Ethical Professional Organisational

32. 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.

33. Two ethical theories Deontology Consequentialism

34. Ethical Principles Autonomy Beneficence Non-maleficence Justice

35. 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 action  Chooses and takes one course of action  Accepts responsibility for the action taken and must be able justify action Different MIPs may reach different decisions in same circumstances

36. 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

37. 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

38. 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

39. 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?

40. Constraints Legal Ethical Professional Organisational

41. 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

42. Constraints Legal Ethical Professional Organisational

43. Organisational Constraints Check if your Centre/Trust has a policy for  Enquiries from the media  Enquiries involving legal proceedings (including those against your own Trust)  Enquiries from the police

44. ? Any Questions

45. Ethical Dilemmas