Medico-legal aspects of “off-licence” prescribing in Obstetrics ENTER 2006 CONFERENCE Saj Shah...
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Transcript of Medico-legal aspects of “off-licence” prescribing in Obstetrics ENTER 2006 CONFERENCE Saj Shah...
Medico-legal aspects of “off-licence” prescribing
in Obstetrics
ENTER 2006 CONFERENCE
Saj Shah
Solicitor/Pharmacist
3 May 2006
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
• Risk management
• Clinical Governance
• Patient experience
• Medical litigation
Adverse events in healthcare
Identifying Clinical Risk through Claims: UK experience (March 1993 - J uly 1995)
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Gen
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Sur
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Oth
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Clo
sed
Cla
ims
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?
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
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