Legal Aspects of Prescribing

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
(No Transcript)
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
  www.medicines.org.uk

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
• .. 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 32079-82

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
• 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
NICETechnology 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)
• www.nice.org.uk

17
NICE - TAGs
18
(No Transcript)
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
• FP10 - GPs
• FP14 - dentists
• FP10HNC - hospitals
• FP10MDA-SS - for addicts
• Private prescriptions
• Hospital in-patient charts
• not prescriptions but records of administration

25
(No Transcript)
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 v .5mg X
• No trailing zero after decimal expression
• eg 0.05mg v .050mg X
• but 0.05mg can be confusing
• If lt 1gram use mg
• If lt 1mg use micrograms
• If lt 1 microgram use nanograms
• Use ml not cc

31
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

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. 2s

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 45
• Sch. 2 3 have specific requirements Must
  specify
• Form, e.g. tablets
• Strength (if appropriate)
• Total quantity in words and figures

36
(No Transcript)
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
• Nurses
• Pharmacists
• Supplementary Prescribers
• Nurses
• Pharmacists
• 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 patients 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 patients 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
(No Transcript)