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Medico-legal aspects of “off-licence” prescribing in Obstetrics ENTER 2006 CONFERENCE. Saj Shah Solicitor/Pharmacist 3 May 2006. INTRODUCTION. CURRENT ISSUES AND TRENDS. Prevalence. Off-licence drugs in pregnancy. Unique patient population

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medico legal aspects of off licence prescribing in obstetrics enter 2006 conference

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

Saj Shah


3 May 2006

off licence drugs in pregnancy
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
important considerations
Important considerations
  • Risk management
  • Clinical Governance
  • Patient experience
  • Medical litigation
  • Public
  • Criminal Law
  • Criminal Courts
  • Patient
  • Civil Law
  • Civil Courts


  • Profession
  • Code of Professional Conduct (GMC)
  • Professional Conduct Committee of GMC
  • Employer
  • Contract of Employment
  • Employment Tribunal
clinical negligence
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?
licensing of medicines
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
development of a drug
Development of a drug

Reference: ABPI website: ‘Medicines: Tried and Tested – Or an Unknown Risk?’ (2004)

importance of the spc
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

failure in licenced drug therapy
Failure in LICENCED drug therapy
  • Manufacturer liable in design, manufacture and marketing:
    • Negligence
    • Strict liability under the Consumer Protection Act 1987
failure in off licence drug therapy
Failure in OFF LICENCE drug therapy
  • Defence for the manufacturer
    • Negligence and Strict liability
    • “Informed intermediary doctrine”
  • Implications
    • Pharmacological; and
    • Legal
legal implications
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
practical aspects off licence medicines
Practical aspects: off-licence medicines


  • Logical analysis
  • Compare with gold standard scrutiny of licensing process
practical aspects off licence medicines22
Practical aspects: off-licence medicines


  • 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
risk management considerations
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)
sensible prescribing
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
let doctors prescribe as they see fit
“Let doctors prescribe as they see fit”
  • Absence of evidence of harm is NOT the same as evidence of absence of harm