1. Legal Aspects of Prescribing
Steve Brown
Director of Pharmacy, UBHT

2. 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

3. TL
TR Granisetron 1mg
Dexamethasone 8mg
BL NaCl (Sodium Chloride 0.9%) 1 litre 1 hour
5% dextrose 250ml 2 hour
+ ??
I think!!

4. Medicines Act 1968 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

5. ‘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

6. 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

7. Summary of Product Characteristics (Data Sheet / Medicines Compendium)
Name
Presentation
Uses
Dosage and administration
Contra-indications, warnings etc
Inc precautions, interactions, side-effects, overdosage
Pharmaceutical precautions
Legal category
Package quantities
Further information
PL numbers

8. Unlicensed Medicines ‘Specials’ Imports Extemporaneous preparations
.. manufactured to meet the special needs …
Imports
.. imported to meet the special needs …
Extemporaneous preparations
.. 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

9. Unlicensed or off label?
Off label – use (or route) outside the licensed indication of the product
Eg in Paediatric Medical Wards
Licensed 54%
Unlicensed 7%
Off label 39%
67% of patients received unlicensed or off label medicine
Conroy et al BMJ 2000; 320:79-82

10. Liability
Generally where a licensed medicine is prescribed and administered in accordance with the SPC then no liability will attach to the prescriber if:
Correct diagnosis
Correct choice of medicine
Patient warned of potential adverse events

11. MHRA Medicines and Healthcare Products Regulatory Agency
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)

12. Conditions for granting a PL/MA
satisfied as to the
Safety
Quality
Efficacy
of the product.

13. MHRA and NICE MHRA / PL : safety, quality and efficacy
Does it work?
Is it safe?
NICE : cost-effectiveness
How good is it?
What is its value?

14. NICE Technology appraisals – Clinical guidelines –
guidance on the use of new and existing medicines and treatments within the NHS in England and Wales.
Clinical guidelines –
guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales.
Interventional procedures –
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.

15. 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).

16. NICE Technology Appraisal Guidance
National decision
Avoids postcode prescribing
Statutory requirement
Since Jan 02 – funding and resources for NICE approved treatments
Implement within 3 months
(unless specified exemption)

17. NICE - TAGs

19. Classification of medicinal products
General Sale List (GSL)
Pharmacy Only Medicines (P)
Prescription Only Medicines (POM)
Controlled Drugs (CD)

20. General Sale List (GSL)
Those which can be safely sold without the supervision of a pharmacist
‘Simple’ remedies
Foods and cosmetics
Small retail packs
E.g.. Paracetamol x 16 tablets

21. Pharmacy Only Medicines (P)
Any medicine which is not GSL or POM
Must be sold under supervision of a pharmacist

22. 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

23. 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

24. Prescriptions In the community Private prescriptions
FP10 - GPs
FP14 - dentists
FP10HNC - hospitals
FP10MDA-SS - for addicts
Private prescriptions
Hospital in-patient charts
not prescriptions but records of administration

26. 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
(or nurse or pharmacist)
Date
Name & address of patient
Age, if under 12-years

27. Prescribe by generic / drug name
Use trade names only for:
Medicine brands which differ in bioavailability, eg
SR theophylline
SR diltiazem
Multi-ingredient products not given a title in BNF

28. 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

29. 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

30. Safe Prescribing Write units not u Write micrograms not mcg
Leading zero before decimal expression
eg 0.5mg √ .5mg X
No trailing zero after decimal expression
eg 0.05mg √ mg X
but 0.05mg can be confusing
If < 1gram use mg
If < 1mg use micrograms
If < 1 microgram use nanograms
Use ml not cc

31. NPSA – National Patient Safety Agency
Intrathecal chemotherapy
Injection of strong potassium solutions
Oral methotrexate
Injections
Anticoagulants
Epidurals
Oral syringes
Diamorphine and morphine
Paraffin

32. ‘Black’ List
Since 1985 certain medicines have not been available on NHS. Include:
indigestion remedies
analgesics
hypnotics & anxiolytics

33. Controlled Drugs Misuse of Drugs Act 1971: Five Schedules
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

34. Addicts
Cocaine, diamorphine and dipipanone (Diconal) can only be prescribed for treatment of addiction by specially authorised doctors with a Home Office licence.

35. Prescriptions for CDs Cannot prescribe Sch. 1
No specific requirements for those in Sch 4&5
Sch. 2 & 3 have specific requirements Must specify:
Form, e.g. tablets
Strength (if appropriate)
Total quantity in words and figures

37. Controlled Drugs Register and Records Storage
Inspection of premise and records

38. CD legislation post Shipman (1)
Monitoring and Inspection
Accountable Officer (2006)
Statutory duty of collaboration between designated bodies (2006)
Restrictions on Prescribers
New GMC ethical guidance (2006)
Guidance on prescribed quantities (2006)
Rx validity reduced to 31 days (2006)

39. CD legislation post Shipman (2)
Audit Trail
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)

40. CD legislation post Shipman (3)
Information for Patients
Media re handling and disposal (2005)
Information leaflet - generic (2006)
Information leaflets – CD specific (2006)
Education and CPD
Undergrad and postgrad curricula (2006)
Training (2006)
CDs in appraisal and revalidation (2006)

41. Other Prescribers Independent Prescribers: Supplementary Prescribers:
Nurses
Pharmacists
Supplementary Prescribers:
… to include optometrists and other AHPs

42. 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’

43. Supplementary Prescribing (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

44. Patient Group Directions (1)
‘Crown’ report – ‘Review of prescribing, supply and administration of medicines’
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

45. Patient Group Directions (2)
HSC 2000/026:
‘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’

46. Safe Prescribing Practice 1
Building a Safer NHS for Patients – Improving Medication Safety (2004) Recommendations for safer prescribing:
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

47. Safe Prescribing Practice 2
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

48. Safe Prescribing Practice 3
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

49. ADRs – only 10% reported

50. 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)

51. 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

52. BNF and BNF for Children
BNF - Guidance on Prescribing
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

53. TL Confusing!
TR Ibuprofen 200mg tds