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Legal Aspects of Prescribing

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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

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