Controlled Drugs – an introduction Catherine Dewsbury (with thanks to Andrew Lea) Objectives for this lecture series By the end of this series of lectures we will have covered • The relevant legislation with regards to the control and supply of controlled drugs in the UK • How controlled drugs are classified and controlled • How controlled drugs are safely stored and kept secure • The prescription requirements for controlled drugs and instances where they can be supplied without prescription • How controlled drugs are supplied to patients • The record keeping requirements for controlled drugs Next session – in dispensary  PGD,  Emergency supply  Installments  Drug misuse What are controlled drugs? • The term ‘Controlled drugs’ is commonly used in the UK • It is used to define drugs that have the potential to be misused or abused. • ‘Controlled drugs’ refers to the sale, supply and administration of the medicine, not the nature of use of the drug Legislation affecting pharmacy • • • • Misuse of Drugs Act 1971 Misuse of Drugs Regulations 2001 (as amended) Misuse of Drugs (Safe Custody) Regulations 1973 Health Act 2006 and the CDs (Supervision and Management of Use) Regulations 2013 • Misuse of Drugs (Notification and Supply to Addicts) Regulations 1997 • Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 • Human Medicines Regulations 2012 Misuse of Drugs Act 1971 and associated legislation. • Misuse of Drugs Act 1971 is referred to as primary legislation • It gives ministers the powers to write secondary legislation • With regard to controlled drugs the most important pieces of secondary legislation are The Misuse of Drugs Regulations 2001 (as amended) The Misuse of Drugs (Safe Custody) Regulations 1973 (as amended) Misuse of Drugs Act 1971 Categorises controlled drugs in three distinct classes • A • B • C Class A drugs are considered to be the most harmful these classes refer to the criminal classification of these products, the penalties for illegal manufacture sale, supply, use or possession. Not the medicinal use. Misuse of Drugs Act 1971 Offences include • Possession of a controlled substance unlawfully • Possession of a controlled substance with intent to supply it • Supplying or offering to supply a controlled drug • Allowing premises you occupy or manage to be used unlawfully for the purpose of producing or supplying controlled drugs. The Misuse of Drugs Regulations 2001 (as amended) • Controlled drugs legislation was significantly altered as a result of the actions of one evil man • New regulations were written in 2001 and were amended in 2006 as a result of the public enquiries into his actions The Misuse of Drugs Regulations 2001 (as amended) These regulations determine • How controlled drugs are prescribed on prescription • How they are handled and stored by pharmacists • How controlled drugs are supplied to patients • The regulations contain a set of five Schedules, all of which are relevant to daily practice CD Lic (Schedule 1) • With the exception of Cannabis these drugs do not have a medicinal use • Mephedrone • LSD • Bufotenine • Coca leaf and Cocaethylene • Concentrate of poppy straw • Ecstacy (MDMA) • Fungus containing psilocin or an ester of psilocin • Raw opium CD POM (Schedule 2) • Licence required for import or export • Can be manufactured/compounded by a pharmacist • Pharmacist can supply on instruction from an appropriate practitioner • Can only be prescribed by UK registered practitioners • Emergency supplies and repeat prescriptions are not allowed • Examples include: CD No Reg POM (Schedule 3) • Controls for Schedule 3 drugs are similar to Schedule 2 • No record keeping required • Thought to be less likely to be abused / less harmful than Schedule 1 and 2 drugs Examples include: buprenorphine, barbiturates and gabapentin, tramadol • Also includes a few benzodiazepine temazepam and midazolam CD Benz POM (Schedule 4 part 1) Contains most of the benzodiazepines Regulation of these drugs is less restrictive Examples include • Benzodiazepines – e.g diazepam, lorazepam • Z-drugs - e.g zopiclone and zolpidem • Others - eg sativex CD Anab POM (Schedule 4 part 2) • Contains the anabolic steroids • Regulation of these drugs is less restrictive • Examples include: stanozolol, fluoxymesterone, CD Inv POM / CD Inv P (Schedule 5) • Difference between POM and P variants is usually pack size • Not injection • Examples include dihydrocodeine, codeine pholcodeine • Co-codamol 30/500 = POM • Co-codamol 8/500 = P or POM • Pholcodeine linctus = P • Strong pholcodeine linctus = POM The Misuse of Drugs (Safe Custody) Regulations 1973 (as amended). • These regulations set out the storage conditions for controlled drugs • Safe custody requires pharmacists to keep controlled drugs in a locked cabinet when not currently in use • The storage requirement for controlled drugs also varies depending on the Schedule set out in the Misuse of Drugs Regulations 2001(as amended) . Standard controlled drugs cabinets Health Act 2006 and the CDs (Supervision and Management of Use) Regulations 2013 • The Health Act required certain health bodies to appoint an accountable officer • Under the regulations above NHS England must appoint a CD accounting officer (CDAO) CDAOs must ensure bodies providing NHS services • have arrangements in place to manage CDs effectively • Comply with legislation • Report incidents • CDAO do not inspect premises inspected by the GPhC Misuse of Drugs (Notification and Supply to Addicts) Regulations 1997 • Any patient addicted to certain controlled drugs must be reported to the National Drug Treatment Monitoring System (NDTMS) • Prescribers are not allowed to prescribe certain drugs without a home office licence unless treating that patient for a disease or injury • Prescribers must use specific prescription forms FP10NC or FP10MDA Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 Human Medicines Regulations 2012 • Under RP regulations you are required to ensure procedures are in place and that the pharmacy staff follow these procedures • Prescriptions for controlled drugs must comply with the requirements of the Human Medicines Regulations 2012 in addition to the MODR POSSESSION, SUPPLY AND RECORD KEEPING Possession of controlled drugs • It is illegal to be in possession of all controlled drugs other than those in Schedule 5 unless; • You have an appropriate licence from the Home Office • You are specified in the Misuse of Drugs Regulations 2001 (as amended) • The Misuse of Drugs Regulations 2001 (as amended) say possession of the drug is not unlawful. Obtaining stock and record keeping on purchase Level of security and record keeping depends on the Schedule Schedule 2 drugs Schedule 3 drugs Schedule 4 drugs Schedule 5 drugs Prescription requirements (Schedule 2 and 3)  Schedule 2 and 3 – legal requirements  Name and Address of the patient – NO PO BOX !  Formulation must be stated  Total quantity in words and figures  Example Sixty tablets (60)  Liquids must have total volume in words and figures 100mLs (one hundred millilitres)  Must not use total dosage supply for example you cannot write supply 100mg when you mean supply 10 x 10mg tablets  Dose directions must be specific cannot use “As directed” or “take when required” can use “take one as directed” “take 5mLs when required”  Prescription only valid for 28 days frm the appropriate date Shoulds not must!  Medicines that are not CDs should not be one for with CD Prescription requirements (Schedules 4 & 5) Schedule 4 and 5 – legal requirements as for any other prescription except Rx fotr Schedule 4 is valid for 28 days Validity of prescriptions and duration of treatment Prescription validity • Schedules 2-4 • Schedule 5 Duration of treatment. • Good practice for prescribers to write prescriptions for Schedule 2 3 and 4 controlled drugs for 30 days supply or less. • In some instances, for example adult mental health, it may be necessary for prescribers to prescribe more than 30 days supply Technical errors • Minor typographical errors or spelling mistakes or doesn’t include quantity in words and figures • Can be amended on the prescription in ink or otherwise indelibly • Must indicate on the prescription who made the amendment • You are legally liable for any amendment you make!! Private prescriptions Private Prescriptions for Schedule 2 and 3 • Must be written on the correct form – England - FP10PCD – Scotland – Wales • Must have the prescribers unique identification number • Looks like an FP10 form except for the exemption box on the back is blank • Must be sent to NHSBSA at end of month FP10PCD • The letters CD must appear after the drug, strength and form e.g • Methadone 5mg Tablets CD • The private CD prescriber description should be printed in capitals and right aligned. e.g PRIVATE PHARMACIST PRESCRIBER • Lets look at a sample prescription form Supply to the patient When supplying controlled drugs to patients or their representative the pharmacist should: • Ensure the medicine is being given to the correct person • Ask for the ID of the person collecting • Obtain a signature on the back of an NHS or Private prescription for Schedule 2 and 3 controlled drugs NB: It is NOT a criminal offence to supply Schedule 2 controlled drugs without ID Why do you think this is the case? Record keeping and endorsement on supply Endorsement • Prescriptions must be endorsed on the day of supply Record keeping • Electronic registers available since 2005 • Whilst design and layout varies there are minimum record keeping requirements for both purchases and supplies. Record keeping and endorsement Information that legally needs to be recorded for sales and supplies of Schedule 2 controlled drugs • The date of supply • The name and address of the person supplied • The authority to possess • Who collected the medication, • Whether proof of identity was requested (a simple yes or no is all that needs to be recorded) • Whether proof of identity was provided (again a simple yes or no is all that needs to be recorded) • The amount supplied. Running balances • • • • Currently not a legal requirement Good practice only No defined right way for recording balance checks A standard operating procedure (SOP) should be in place and should cover how running balances are maintained? • Solid dosage forms quite easy • Liquids approximate balance only? RESTRICTIONS ON PRESCRIBERS  Dentists, nurse IP and Pharmacist IP - no diamorphine, dipipanone and cocaine for drug misusers  Paramedics  Optometrists  Nurse and Pharmacist SP – not restrictions if the medicine is in the clinical management plan