Transcript Prescibing - Dental Students

Legal Aspects of Prescribing
Steve Brown
Director of Pharmacy, UBHT
Legal Aspects of Prescribing
You will be familiarised with the
legislation governing the release and
marketing of drugs
You will learn about what is acceptable
prescription writing and what is not
You will learn about good practice in
prescription writing
Medicines Act 1968
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Licensing system
Sales promotion of Medicinal Products
Retail Pharmacy businesses
Pharmacy medicines
General Sale medicines
Prescription Only Medicines
Exemptions from controls
Wholesale dealing
Homoeopathic medicines
Herbal remedies
Veterinary drugs
Containers, packaging, identification
Pharmacopoeias
‘Medicinal Product’
Definition (s.130):
 “...any substance or article ……………
administered for a medicinal
purpose ...” ie
 treating or preventing disease
 diagnosing disease or ascertaining
the existence, degree or extent of a
physiological condition
 preventing or interfering with a
normal physiological function
 inducing anaesthesia
 contraception
Licensing
Product Licence = Marketing
Authorisation
Product Licence (Parallel Import)
Manufacturers’ Licence
“Specials” Manufacturers’ Licence
Wholesale Dealers’ Licence
See Medicines Compendium / Summary
of Product Characteristics / Data Sheet
or www.medicines.org.uk
Summary of Product Characteristics
(Data Sheet / Medicines Compendium)
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Name
Presentation
Uses
Dosage and administration
Contra-indications, warnings etc
 Inc precautions, interactions, side-effects, overdosage
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Pharmaceutical precautions
Legal category
Package quantities
Further information
PL numbers
Unlicensed Medicines
‘Specials’
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.. manufactured to meet the special needs …
Imports
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.. imported to meet the special needs …
Extemporaneous preparations
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.. medicinal product prepared in a pharmacy …
Generally the responsibility for use of an
unlicensed medicine, or a licensed medicine
for an unlicensed indication, rests with the
prescriber
Unlicensed or off label?
Off label – use (or route) outside the licensed
indication of the product
Eg in Paediatric Medical Wards
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Licensed 54%
Unlicensed 7%
Off label 39%
67% of patients received unlicensed or off label
medicine
 Conroy et al BMJ 2000; 320:79-82
Liability
Generally where a licensed medicine is
prescribed and administered in
accordance with the SPC then no
liability will attach to the prescriber if:
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Correct diagnosis
Correct choice of medicine
Patient warned of potential adverse events
MHRA
Medicines and Healthcare Products
Regulatory Agency
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Executive Agency of the Department of Health
protecting and promoting public health and patient
safety by ensuring that medicines, healthcare
products and medical equipment meet appropriate
standards of safety, quality, performance and
effectiveness, and are used safely
MCA and MDA combined 2003
CSM incorporated
Clinical Trials legislation introduced 2004
Defective medicines
Harmonisation with EMEA (European Evaluation
Agency for Medicinal Products)
Conditions for granting a PL/MA
satisfied as to the
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Safety
Quality
Efficacy
of the product.
MHRA and NICE
MHRA / PL : safety, quality and efficacy
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Does it work?
Is it safe?
NICE : cost-effectiveness
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How good is it?
What is its value?
NICE
Technology appraisals –
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guidance on the use of new and existing
medicines and treatments within the NHS in
England and Wales.
Clinical guidelines –
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guidance on the appropriate treatment and care of
people with specific diseases and conditions within
the NHS in England and Wales.
Interventional procedures –
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guidance on whether interventional procedures
used for diagnosis or treatment are safe enough
and work well enough for routine use in England,
Wales and Scotland.
NICE
Technology Appraisal Guidance
medicines
medical devices (for example, hearing aids or
inhalers)
diagnostic techniques (tests used to identify
diseases)
surgical procedures (for example, repairing
hernias)
health promotion activities (for example,
ways of helping people with diabetes manage
their condition).
NICE
Technology Appraisal Guidance
National decision
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Avoids postcode prescribing
Statutory requirement
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Since Jan 02 – funding and resources for
NICE approved treatments
Implement within 3 months
(unless specified exemption)
www.nice.org.uk
NICE - TAGs
Classification of medicinal
products
General Sale List (GSL)
Pharmacy Only Medicines (P)
Prescription Only Medicines (POM)
Controlled Drugs (CD)
General Sale List (GSL)
Those which can be safely sold without
the supervision of a pharmacist
‘Simple’ remedies
Foods and cosmetics
Small retail packs
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E.g.. Paracetamol x 16 tablets
Pharmacy Only Medicines (P)
Any medicine which is not GSL or POM
Must be sold under supervision of a
pharmacist
Prescription Only Medicines
(POM)
May only be sold or supplied in
accordance with a prescription of a
‘practitioner’, i.e. doctor, dentist or
authorised nurse or pharmacist
Administration of POMs
Can administer to oneself
To anyone except injections
A practitioner or in accordance with the
directions of a practitioner
Injections for the purpose of saving life
Midwives, chiropodists, opticians &
paramedics
Prescriptions
In the community
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FP10 - GPs
FP14 - dentists
FP10HNC - hospitals
FP10MDA-SS - for addicts
Private prescriptions
Hospital in-patient charts
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not prescriptions but records of
administration
Prescription requirements for POMs
Be signed
In ink or otherwise indelible
Repeat once only if repeatable
Dispensed within 6 months
Address of practitioner
Indicate if doctor or dentist
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(or nurse or pharmacist)
Date
Name & address of patient
Age, if under 12-years
Prescribe by generic / drug name
Use trade names only for:
Medicine brands which differ in
bioavailability, eg
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SR theophylline
SR diltiazem
Multi-ingredient products not given a
title in BNF
Prescription Abbreviations
od - once a day
bd - twice a day
tds - three times day
qds - four times a day
om : on - in the morning : at night
prn - when required
sos - if necessary
stat - immediately
Route
IM – intramuscular
IV – intravenous
O – oral
PR – per rectum
PV – per vagina
SC – subcutaneous
TOP – topically
INH – inhaled via inhaler
NEB – inhaled via nebuliser
Safe Prescribing
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Write units not u
Write micrograms not mcg
Leading zero before decimal expression
 eg 0.5mg
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√
.5mg
No trailing zero after decimal expression
 eg 0.05mg √
.050mg
 but 0.05mg can be confusing
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X
If < 1gram use mg
If < 1mg use micrograms
If < 1 microgram use nanograms
Use ml not cc
X
NPSA –
National Patient Safety Agency
www.npsa.nhs.uk
Intrathecal chemotherapy
Injection of strong potassium solutions
Oral methotrexate
Injections
Anticoagulants
Epidurals
Oral syringes
Diamorphine and morphine
Paraffin
‘Black’ List
Since 1985 certain medicines have not
been available on NHS. Include:
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indigestion remedies
analgesics
hypnotics & anxiolytics
Controlled Drugs
Misuse of Drugs Act 1971:
Five Schedules
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Sch. 1 - non-medicinal use
Sch. 2 - opiates & stimulants
Sch. 3 - barbiturates
Sch. 4.1 – benzodiazepines
Sch. 4.2 – anabolic steroids
Sch 5 - dilute Sch. 2’s
Addicts
Cocaine, diamorphine and dipipanone
(Diconal) can only be prescribed for
treatment of addiction by specially
authorised doctors with a Home Office
licence.
Prescriptions for CDs
Cannot prescribe Sch. 1
No specific requirements for those in
Sch 4&5
Sch. 2 & 3 have specific requirements
Must specify:
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Form, e.g. tablets
Strength (if appropriate)
Total quantity in words and figures
Controlled Drugs
Register and Records
Storage
Inspection of premise and records
CD legislation post Shipman
(1)
Monitoring and Inspection
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Accountable Officer (2006)
Statutory duty of collaboration between
designated bodies (2006)
Restrictions on Prescribers
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New GMC ethical guidance (2006)
Guidance on prescribed quantities (2006)
Rx validity reduced to 31 days (2006)
CD legislation post Shipman (2)
Audit Trail
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Electronic CD Rxs and Registers (2005)
NHS Rx to capture CD and pt ID (2007)
New private CD Rx (2006)
Unique identifier for all Rxers (2007)
New ethical guidance from GMC and RPSGB
(2006)
SOPs for using CDs (2006)
Patient drug record card (2006)
Recovery & destruction of unwanted CDs (2006)
CD legislation post Shipman (3)
Information for Patients
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Media re handling and disposal (2005)
Information leaflet - generic (2006)
Information leaflets – CD specific (2006)
Education and CPD
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Undergrad and postgrad curricula (2006)
Training (2006)
CDs in appraisal and revalidation (2006)
Other Prescribers
Independent Prescribers:
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Nurses
Pharmacists
Supplementary Prescribers:
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Nurses
Pharmacists
… to include optometrists and other AHPs
Supplementary Prescribing
(1)
‘a voluntary prescribing partnership
between an independent prescriber and
a supplementary prescriber, to
implement an agreed patient-specific
clinical management plan with the
patient’s agreement’
Supplementary Prescribing
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(2)
Independent prescriber makes diagnosis
Written CMP specific to named patient and
patients condition
Both prescribers need access to common patient
record
Patient involvement and agreement
No CDs or unlicensed drugs
Consultation re extending to optometrists,
physiotherapists, chiropodists and radiographers
Patient Group Directions
(1)
‘Crown’ report – ‘Review of prescribing,
supply and administration of medicines’
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March 1998 ‘A report on the supply and
administration of medicines under group protocol’
(HSC 1998/051)
March 1999 ‘Final report’
HSC 2000/026 (August 2000)
Patient Group Directions
Enables nurses, midwives, pharmacists,
optometrists, chiropodists, radiographers
(and others) to supply or administer
medicines
Patient Group Directions
(2)
HSC 2000/026:
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‘written instructions for the supply or
administration of medicines to groups of patients
who may not be individually identified before
presentation for treatment’
‘should be reserved for those limited situations
where this offers an advantage for patient care
(without compromising patient safety) and where
it is consistent with appropriate professional
relationships and accountability’
Safe Prescribing Practice 1
Building a Safer NHS for Patients –
Improving Medication Safety (2004)
Recommendations for safer prescribing:
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All serious prescribing errors and ‘near
misses’ should be reported to the NPSA
Prescriptions should always carry patient
directions and never be issued with the
instruction ‘as directed’
Particular attention should be paid to
checking the accuracy of complex dose
calculations
Safe Prescribing Practice 2
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The treatment plan, including how the
response to drug therapy is to be
monitored, should be clearly documented
in the patient’s clinical notes
Prescribers should have access to a
pharmacist who is able to provide advice
on the drug treatment plan
Where possible aims and side effects of
drug treatment should be discussed with
the patient or their representative
Safe Prescribing Practice 3
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Prescribers should be trained and assessed
as competent before being required to
prescribe
Prescribers should follow local and national
prescribing standards
Where available, electronic prescribing
systems should always be used
Actual and potential prescribing errors
should be recorded and reviewed regularly
to raise awareness of risk
ADRs – only 10% reported
BANs – Changes to approved
names
British Approved Name (BAN) to adopt
recommended international
nonproprietary name (rINN)
See BNF for full list
Adrenaline and Noradrenaline to remain
as European names – manufacturers to
show rINN in addition (epinephrine /
norepinephrine)
New BANs – examples
Old
Amoxycillin
Cephradine
Frusemide
Dothiepin
Hydroxyurea
Mustine
Stilboestrol
Thyroxine sodium
Trimeprazine
New
Amoxicillin
Cefradine
Furosemide
Dosulepin
Hydroxycarbamide
Chlormethine
Diethylstilbestrol
Levothyroxine sodium
Alimemazine
BNF and BNF for Children
BNF - Guidance on Prescribing
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Page 1 – General guidance on prescribing
Page 4 – Prescription writing
Page 7 – Controlled drugs
Page 10 - Adverse reactions to drugs
Pages 11 on – Prescribing … for children, in
palliative care, for the elderly