Controlled Drugs Flashcards
What are controlled drugs
- A ‘controlled drug’ refers to medicines that are controlled under The Misuse of Drugs legislation (and subsequent amendments).
- Controlled drugs are subject to strict legal controls and legislation determines how they are prescribed, supplied, stored and destroyed.
- CD’s are closely regulated as they are susceptible to being misused or diverted and can cause harm
Legislation for managing and using CDs
Misuse of Drugs Act 1971
Misuse of Drugs (Safe Custody) Regulations 1973
Misuse of Drugs (Supply to Addicts) Regulations1997
Misuse of Drugs Regulations 2001
Human Medicines Regulations 2012
Controlled Drugs (Supervision of Management and Use) Regulations 2013.
Misuse of drugs act 1971
- Prohibits certain activities in relation to ‘controlled drugs’, in particular their manufacture, supply and possession.
- The penalties applicable to offences involving different drugs are guided broadly according to the harmfulness attributable to a drug when it is misused
- For this purpose the drugs are defined into three classes: A,B and C
Classes and schedules
- The Misuse of Drugs Act 1971 classes a drug according to the harmfulness attributed it is misused
- The Misuse of Drugs Regulation 2001 divides drugs into schedules according to how they are governed, including prescribing, storage, shipment, and suppling
- In order to be able to regulate and manage the possession of controlled drugs, they are placed into five ‘Schedules’ corresponding to their therapeutic usefulness and misuse potential.
- The 2001 regulations divided CD’s into 5 Schedules. Maximum control Schedule 1- minimal controls in Schedule 5
Schedule 1
Drugs with no medicinal or therapeutic use.
Production, possession and supply are only allowed for the purposes of research or other special purposes.
A Home Office License is required
e.g. LSD, ecstasy, cannabis
Schedule 2
- Schedule 2 Controlled Drugs are subject to the full Controlled Drug requirements relating to prescriptions, safe custody (except forquinalbarbitone (secobarbital) and some liquid preparations), and the need to keep a Controlled Drug register, (unless exempted in Schedule 5).
Possession, supply and procurement is authorised for pharmacists and other classes of persons named in the 2001 Regulations.
Must be stored in a locked receptacle i.e an appropriate CD cupboard which can only be opened by an authorised individual.
May be administered under the direction of a qualified prescriber.
Destruction must only take place in the presence of an authorised person.
examples include- diamorphine, morphine, methadone, cocaine, ketamine
Schedule 3
- They are subject to the special prescription requirements.
Safe custody requirements do apply, except for any 5,5 disubstituted barbituric acid (e.g. phenobarbital), gabapentin, mazindol, meprobamate, midazolam, pentazocine, phentermine, pregabalin, tramadol hydrochloride, or any stereoisomeric form or salts of the above.
Records in registers do not need to be kept (although there are requirements for the retention of invoices for 2 years).
Barbiturates (except secobarbital, now Schedule 2), buprenorphine, gabapentin, mazindol, meprobamate, midazolam, pentazocine, phentermine, pregabalin, temazepam, and tramadol hydrochloride.
Schedule 4
- Part I drugs are those that are subject to minimal control
Part II includes androgenic and anabolic steroids
Controlled drug prescription requirements do not apply and Schedule 4 Controlled Drugs are not subject to safe custody requirements. Records in registers do not need to be kept (except in the case of Sativex®).
Part I: Benzodiazepines (except temazepam and midazolam, which are in Schedule 3), non-benzodiazepine hypnotics (zaleplon, zolpidem tartrate, and zopiclone) and Sativex®
Part II: Androgenic and anabolic steroids, clenbuterol, chorionic gonadotrophin (HCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin.
Schedule 5
- Schedule 5 contains preparations of certain controlled drugs (e.g. codeine, pholcodine, morphine) that are exempt from full control when present in medicinal products of low strengths, as their risk of misuse is reduced.
There is no restriction on the import, export, possession, administration or destruction of these preparations and safe custody regulations do not apply
Making and recording prescribing decisions
- The benefits of controlled drug treatment
- The risks of prescribing, including dependency, overdose anddiversion
- All prescribed and non‑prescribed medicines the person is taking (particularly any centrally acting agents) and whether the person may be opioid naive
- Evidence‑based sources, such as NICE and theBritish national formulary(BNF), for prescribing decisions when possible
CD Prescription requirements
- Indelible
- Signed by Practitioner. Advance electronic signatures are accepted if EPS used.
- Dated
- Prescribers Address Specified
- Patients Name and Address Specified
- State form and Strength of Preparation
- State total Quantity in both WORDS and FIGURES
- Dose must be clearly defined
- NB a controlled drug prescription is valid for 28 days
