Prescibing - Dental Students

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

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)

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 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 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 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) 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? 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. 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 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 remedies Foods and cosmetics Small retail packs 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 FP10 - GPs

FP14 - dentists FP10HNC - hospitals FP10MDA-SS - for addicts Private prescriptions Hospital in-patient charts 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 (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 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 Write units not u Write micrograms not mcg Leading zero before decimal expression eg 0.5mg

.5mg No trailing zero after decimal expression eg 0.05mg .050mg but 0.05mg can be confusing X X

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.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: 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. 2s 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: 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 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 patientspecific clinical management plan with the patients 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 Directions Enables 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 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

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 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

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

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