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

• 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

Which drug should be prescribed?

• Efficacy

• Safety

• Cost

Important considerations

• Risk management

• Clinical Governance

• Patient experience

• Medical litigation

Adverse events in healthcare

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PRESCRIBING AND THE LAW

Liabilities

Liabilities

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

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?

Vicarious liability

“OFF-LICENCE” MEDICINES AND THE LAW

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

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

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

• Manufacturer liable in design, manufacture and

marketing:• Negligence• Strict liability under the Consumer Protection Act

1987

Failure in OFF LICENCE drug therapy

• Defence for the manufacturer•Negligence and Strict liability•“Informed intermediary doctrine”

• Implications•Pharmacological; and•Legal

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

BREACH OF DUTY

• Logical analysis

• Compare with gold standard scrutiny of licensing

process

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

Consenting process flow chart

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

• 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”

• Absence of evidence of harm is NOT the same as

evidence of absence of harm