Legal Aspects of Prescribing

Steve BrownDirector of Pharmacy, UBHT

Legal Aspects of Prescribing

You will be familiarised with the legislation governing the release and marketing of drugsYou will learn about what is acceptable prescription writing and what is notYou will learn about good practice in prescription writing

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

‘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 AuthorisationProduct Licence (Parallel Import)Manufacturers’ Licence“Specials” Manufacturers’ LicenceWholesale Dealers’ Licence

See Medicines Compendium / Summary of Product Characteristics / Data Sheet or www.medicines.org.uk

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

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

Unlicensed or off label?

Off label – use (or route) outside the licensed indication of the productEg 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

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

MHRAMedicines 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)

Conditions for granting a PL/MA

satisfied as to the Safety Quality Efficacy

of the product.

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?

NICETechnology 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.

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).

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

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’ remediesFoods and cosmeticsSmall retail packs E.g.. Paracetamol x 16 tablets

Pharmacy Only Medicines (P)

Any medicine which is not GSL or POMMust 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 oneselfTo anyone except injectionsA practitioner or in accordance with the directions of a practitionerInjections for the purpose of saving lifeMidwives, chiropodists, opticians & paramedics

PrescriptionsIn the community FP10 - GPs FP14 - dentists FP10HNC - hospitals FP10MDA-SS - for addicts

Private prescriptionsHospital in-patient charts not prescriptions but records of

administration

Prescription requirements for POMs

Be signedIn ink or otherwise indelible Repeat once only if repeatableDispensed within 6 monthsAddress of practitionerIndicate if doctor or dentist (or nurse or pharmacist)

DateName & address of patientAge, if under 12-years

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

Prescription Abbreviations

od - once a daybd - twice a daytds - three times dayqds - four times a dayom : on - in the morning : at nightprn - when requiredsos - if necessarystat - immediately

Route

IM – intramuscularIV – intravenousO – oralPR – per rectumPV – per vaginaSC – subcutaneousTOP – topicallyINH – inhaled via inhalerNEB – inhaled via nebuliser

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 √ .050mgX

but 0.05mg can be confusing If < 1gram use mg If < 1mg use micrograms If < 1 microgram use nanograms Use ml not cc

NPSA – National Patient Safety Agency

www.npsa.nhs.ukIntrathecal chemotherapyInjection of strong potassium solutionsOral methotrexateInjectionsAnticoagulantsEpiduralsOral syringesDiamorphine and morphineParaffin

‘Black’ List

Since 1985 certain medicines have not been available on NHS. Include: indigestion remedies analgesics hypnotics & anxiolytics

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

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. 1No specific requirements for those in Sch 4&5Sch. 2 & 3 have specific requirements Must specify: Form, e.g. tablets Strength (if appropriate) Total quantity in words and figures

Controlled Drugs

Register and RecordsStorageInspection of premise and records

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)

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)

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)

Other Prescribers

Independent Prescribers: Nurses Pharmacists

Supplementary Prescribers: 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 (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’ 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 DirectionsEnables nurses, midwives, pharmacists, optometrists, chiropodists, radiographers (and others) to supply or administer medicines

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’

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

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

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

ADRs – only 10% reported

BANs – Changes to approved names

British Approved Name (BAN) to adopt recommended international nonproprietary name (rINN) See BNF for full listAdrenaline and Noradrenaline to remain as European names – manufacturers to show rINN in addition (epinephrine / norepinephrine)

New BANs – examples

OldAmoxycillinCephradineFrusemideDothiepinHydroxyureaMustineStilboestrolThyroxine sodiumTrimeprazine

NewAmoxicillinCefradineFurosemideDosulepinHydroxycarbamideChlormethineDiethylstilbestrolLevothyroxine sodiumAlimemazine

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