1. Medico-legal aspects of “off-licence” prescribing in Obstetrics ENTER 2006 CONFERENCE Saj Shah Solicitor/Pharmacist 3 May 2006

2. INTRODUCTION

3. CURRENT ISSUES AND TRENDS

4. Prevalence

5. Off-licence drugs in pregnancy Unique patient population Reluctance to undertake trials in vulnerable population Survey of 731 birthing women: 23% received off-licence drugs [Rayburn and Farmer, 1997] In some cases prescribing in pregnancy is unavoidable

6. Which drug should be prescribed? Efficacy Safety Cost

7. Important considerations Risk management Clinical Governance Patient experience Medical litigation

8. Adverse events in healthcare

9. PRESCRIBING AND THE LAW

10. Liabilities

11. DOCTOR Profession Code of Professional Conduct (GMC) Professional Conduct Committee of GMC Public Criminal Law Criminal Courts Patient Civil Law Civil Courts Employer Contract of Employment Employment Tribunal

12. Clinical negligence Duty of care Established law Breach of duty of care Standard of an ordinary skilled man exercising and professing to have that special skill “…a doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion Caused injury, loss or damage “but-for” test?

13. Vicarious liability

14. “OFF-LICENCE” MEDICINES AND THE LAW

15. Licensing of medicines Thalidomide tragedy Medicines Act 1968 New licensing legislation implemented (MAR 1994) Administered by MHRA / EMEA Purpose – ensure efficacy, safety and quality Rigorous testing

16. Development of a drug Reference: ABPI website: ‘Medicines: Tried and Tested – Or an Unknown Risk?’ (2004)

17. Importance of the SPC “SPC is the most authoritative source of information available on drug doses and indications and contains essential practical prescribing information” Sir Michael Rawlins – previous Chairman of Committee Safety of Medicines, UK “The SPC is the basis of information for health professionals on how to use the medicinal product safely and effectively” European Commission guidance

18. Failure in LICENCED drug therapy Manufacturer liable in design, manufacture and marketing: Negligence Strict liability under the Consumer Protection Act 1987

19. Failure in OFF LICENCE drug therapy Defence for the manufacturer Negligence and Strict liability “Informed intermediary doctrine” Implications Pharmacological; and Legal

20. Legal implications Liability falls to the prescriber Increases own responsibility Carries burden of patients welfare May be called upon to justify actions if damage results

21. Practical aspects: off-licence medicines BREACH OF DUTY Logical analysis Compare with gold standard scrutiny of licensing process

22. Practical aspects: off-licence medicines CONSENT Failure to warm/inform Chester v Afshar – October 2004 (House of Lords) Traditionally strong defence rejected Implications are significant Poses problem for those prescribing off-label medicines Must advise patient on risks, benefits and alternatives

23. Consenting process flow chart

24. Risk management considerations Does alternative licensed medicine meet patient needs? Is there high quality evidence supporting efficacy or effectiveness? Doctor must: Take responsibility for prescribing Make accurate record of reasons Obtain appropriate consent (written)

25. Sensible prescribing Deviation from SPC has potential to endanger public safety and breach legal and professional requirements Overriding issue – will it affect the patient? Only consider if: Imperative to continue treatment; and No alternative available

26. “Let doctors prescribe as they see fit” Absence of evidence of harm is NOT the same as evidence of absence of harm