The Misuse of Drugs Act 1971 as amended (herein referred to as 'the 1971 Act')The Misuse of Drugs Regulations 2001 as amended The Misuse of Drugs (Safe Custody) Regulations 1973 as amended (herein referred to as 'Safe Custody Regulations')The Health Act 2006Controlled Drugs (Supervision of Management and Use) Regulations 2013 which affect England and Scotland.
allow for the lawful possession and supply of controlled (illegal) drugs for legitimate purposes.They cover prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of controlled drugs to prevent diversion for misuse.
the main law to control and classify drugs that are 'dangerous or otherwise harmful' when misused.The act lists all illegal (or controlled) drugs in the UK and divides them into one of 3 'classes' - A, B and C - based on the harm they cause to individuals and society. Class A drugs are considered the most harmful. This is commonly known as the drug classification system.The act makes it illegal for people to:possess illegal drugspossess illegal drugs with intent to supplysupply or offer to supply illegal drugs (including giving them away for free or sharing with others)produce illegal drugsimport or export illegal drugsallow a house, flat or office to be used by people to undertake any of these unlawful activities
5 schedules Schedule 1 (CD Lic POM)Schedule 2 (CD POM)Schedule 3 (CD No Register POM)Schedule 4 (CD Benz POM and CD Anab POM)Schedule 5 (CD INV P and CD INV POM).
The Misuse of Drugs Regulations 2001 (and subsequent amendments) defines the classes of person who are authorised to supply and possess Controlled Drugs while acting in their professional capacities and lays down the conditions under which these activities may be carried out
drugs not used medicinally such as hallucinogenic drugs (e.g. LSD), ecstasy-type substances, raw opium, and cannabis.-home office license required for their production, possession, or supply. A Controlled Drug register must be used to record details of any Schedule 1 Controlled Drugs received or supplied by a pharmacy.
includes preparations of certain Controlled Drugs (such as codeine, pholcodine or morphine) which due to their low strength, are exempt from virtually all Controlled Drug requirements other than retention of invoices for two years.
SignatureDate (valid for 28 days sch 2-4, 6 months sch 5)Prescribers addressName of CDFormulationStrengthDoseQuantity (written in words and figures)Name of ptAddress of ptDental prescriptions (for dental treatment only)
UK, Doctor, dentist veterinary surgeonpharmacist- supplementary prescribers-Physiotherapists IPPodiatrist IPEEA doctor or dentist Pharmacist or nurse prescriber (depending on home country)
- (schedule 2-5 but not cocaine, diamorphine and dipipanone for addiction) have prescribed methadone and buprenorphine for addition under clinical management plans under drug treatment services to ensure pt can be seen on a regular basis
- (CDs for treatment of organic disease or injury ONLY but have to be administered by a specified method- formulation ie diazepam, dihydrocodeine, lorazepam, morphine, oxycodone and temazepam can be given orally via physio. Morphine can also be prescribed as injection, if necessary, fentanyl can be prescribed via transdermal(patch)limited)
They are able to prescribe for the treatment of organic disease or injury provided that the Controlled Drug is prescribed to be administered by the specified method:Diazepam;Dihydrocodeine;Lorazepam; andTemazepamby oral administration.
- 4 & 5 only (prescriptions from approved prescribers and approved countries (EEA + Switzerland) will be able to write prescriptions, cant prescribe schedules 1,2 and 3 ) From 2021 onwards highlight the countries that are allowed-BE AWARE OF LIST
Under misuse of drug regulations who can supply CDs via PGD
o Registered nurse of pharmacist for treating a sick or injured person NOT FOR ADDICITION could supply morphine and diamorphine under PGDo Ketamine and midazolam sch 2 & 3 can be used in specific circumstances - normally hospital by healthcare professionals who cano Sch 4 & 5 are available to be supplied for healthcare prof who have right to supply/administer via a PGDo Sch 2- morphine, diamorphine, ketamine, sch 3- midazolam ,sch 4 & 5 all drugs except anabolic steroids injectables for addiction in sch 4.?o
- HMR 224,225- Regularisation for supplies of phenobarbital-phenobarbital [also known as pheno- barbitone or pheno-barbitone sodium] for epilepsy by a UK-registered prescriber)in addition to schedule 4 & 5 drugs
- sch 2,3 4 are valid for 28 days from appropriate date- sch 5 is valid for 6 months- its good practice for prescribers to give 30 supply of a medicine on prescription and no more (exceptions - adults and children mental health care services)
- 2015 was the major change to allow an advanced electronic signature for sch 2- 5 CDs- Introduction of electronic prescription forms- Successful trial and roll our of EPS nationwide- Liquid methadone and instalment prescription not possible as some systems can't process packaged dose endorsements- but will change- All prescriptions will have total quantity in words and figures which is useful as will prevent errors- Need to get token signed- FP10PCD form has been signed using NHS form some versions of EPS will allow you to write FP10PCD electronically
- Sch 2 & 3 drugs (most) must be stored in a CD cabinet or equivalent- Keys must remain on pharmacist during hours of use and locked in the company safe at the end of the day- CDs should only be out of the cupboard when they arrive and then entered in register and placed in or when being dispensed forpatient, or when in transportation but should be in a safe locked van- Safe custody requires pharmacist to keep CDs in a locked cabinet when not currently in use (deadbolt lock and bolted to floor or solid wall)- Misuse of drugs regulation 2001 as amended and misuse of drugs, safe custody regs are separate- Safe custody applies to pharmacies and care homes
The Safe Custody Regulations refer to the physical security of certain Schedule 2 or 3 CDs. It requires that pharmacies, private hospitals and care homes keep relevant CDs in a 'locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs'. For settings other than those listed above, these regulations are considered minimum standards for safe custody.
- Date supplied- Name and address of person or firm supplied- Details of authority to possess-prescriber or licence holder details- Quantity supplied- Who collected it; pt representative or a HC professional- If a HC professional acting on behalf or pt; their name address- Was ID requested and or obtained (yes/no)
Where a prescription for a Schedule 2 or 3 CD contains a minor typographical error or spelling mistake, or where either the words or figures but not both) of the total quantity has been omitted,a pharmacist can amend the prescription indelibly so that it becomes compliant with legislation.100% liable for any changes made
What is a controlled drug accountable officer CDAO (role appointed by)
-responsible for supervising and managing the use of CDs in their organisation or setting. Their roles and responsibilities include:- Appointed by NHS england - hospital trust, private hospital and any NHS organisation that is involved in the handling of CDs- SOPs for handling must be in place- Oversee the handling of CDs in NHS bodies and providers of NHS services- Community pharmacy wouldn't have its own CDAO but if they had multiple incidents must report to local NHS England CDAO for contractual purposes- All community pharmacies and NHS bodies must declare whether they holds CDs and what they are doing
- must be kept for 2 years for human use, must be kept for 5 years if requisition is required by a veterinary surgeon or practitioner- Legal requirement to do
This allows pharmacies to sortand dispose of CDs and to comply with the 2001 Regulations by denaturing them prior to disposal. This exemption needs to be registered with the Environment Agency,
- A temp class order it introduced when a new potentially dangerous substance is identified to restrict its use until it can be added to the misuse of drugs act- Gov had 12 months to class drug as a , b or c under a temp class- Misused of drugs act 1971 penalties apply except for possession- Gives advisory council on the misuse of drugs time to provide advice for legislators- Legislation then brought forward to amend misuse of drugs act 1971
- Came into force 2016- Bans the sale supply distribution and production of all psychoactive substances- Psychoactive substance is a substance producing a psychoactive effect in a person who consumes it - drunk or smoked- Poppers (amyl nitrate) exempt as home office claim they are not psychoactive as they do produce a psychoactive effect but not under legislation- Primary effect of legislation is for nitrous oxide- Alcohol tobacco caffeine, medicines with a license, unlicensed medicines for medicinal use CD for medicinal use and poppers and exempt from this act- Police have powers to issue prohibition notices closure of premises orders, criminal offence to ignore order, powers to search premises- 7 years for dealing 2 years for possession