Download Medico-legal aspects of “off

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
Other
General
Surgery
Accident &
Emergency
Anaesthetics
Orthopaedics
Gynaecology
30%
25%
20%
15%
10%
5%
0%
Obstetrics
Closed Claims
Identifying Clinical Risk through Claims: UK experience
(March 1993 - July 1995)
PRESCRIBING AND THE LAW
Liabilities
Liabilities
Public
Patient
• Criminal Law
• Civil Law
• Criminal Courts
• Civil Courts
DOCTOR
Profession
Employer
• Code of Professional
Conduct (GMC)
• Contract of
Employment
• Professional Conduct
Committee of GMC
•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