Medico-legal aspects of “off-licence” prescribing in Obstetrics ENTER 2006 CONFERENCE

1. Medico-legal aspects of “off-licence” prescribing in ObstetricsENTER 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. Liabilities • Public • Criminal Law • Criminal Courts • Patient • Civil Law • Civil Courts DOCTOR • Profession • Code of Professional Conduct (GMC) • Professional Conduct Committee of GMC • 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