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

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; 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 – • 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

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

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 √ .050mg 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 • 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. 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: • 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 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)