Controlled Drug in the United Kingdom
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The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances as a controlled substance. The act allowed and regulated the use of some Controlled Drugs (designated CD) by various classes of persons (e.g. doctors) acting in their professional capacity.
In clinical practice, this mostly applies to the use of strong opiates for pain management and some amphetamine-like stimulants used for Attention-deficit hyperactivity disorder; both of which are regulated under Schedule 2.
The Royal Pharmaceutical Society maintains a live database of the legal classification of medicines.[1]
Schedules
editSpecial responsibilities are placed upon pharmaceutical wholesalers, pharmacies and doctors in the stocking, distribution, issuing of prescriptions, supply and disposal of items listed under the first three of the schedules. The regulations have been further tightened since Dr. Harold Shipman used diamorphine to murder hundreds of his patients during the late 20th century.
Schedule 1 - CD Lic
editDrugs which are not used medically, and thus their possession and supply is prohibited; e.g. DMT and LSD except when licensed by the Home Office to carry out research.
Schedule 2 - CD
editSubstances subject to the full controlled drug requirements; e.g. Cannabis, diamorphine (heroin), pethidine, cocaine, methadone, methylphenidate, dextroamphetamine, fentanyl and oxycodone. Under the Act, a prescription for these drugs need to show full details including the form and strength of the preparation, with the total quantity written out in both words and figures. It is an offence for a doctor to issue an incomplete prescription or for a pharmacist to dispense a controlled drug unless all the required details are given.
It is the prescriber's responsibility to minimize the risk of dependence or misuse by ensuring that such drugs are not started for a particular patient without good cause, that the dose is not increased to the point where dependency is more likely, and to avoid being an unwitting source of supply for addicts. The quantities of controlled drugs prescribed should match the likely needs of the patients until the next clinical review and prescription forms should be secured against theft.
Requirements for safe custody in pharmacies apply to all Sch 2 Controlled Drugs except quinalbarbitone.
The safe custody requirements ensure that pharmacists and doctors holding stock of controlled drugs must store them in securely fixed double-locked steel safety cabinets. In addition to traditional written registers, which must be bound, contain separate entries for each drug, and be written in ink with no use of correction fluid, electronic controlled drugs registers are now also permitted under the Misuse of Drugs Regulations 2001 (as amended). These electronic systems must comply with specific regulatory standards to ensure the accurate recording and tracking of controlled substances, and there are a range of commercially available electronic CD registers. Disposal of expired stock must be witnessed by a designated inspector (either a police officer or a suitably qualified official).
Until 2005 prescriptions for most schedule 2 & 3 drugs required certain details to be handwritten by the prescriber, unless he or she held a handwriting exemption certificate. The Shipman Inquiry however, found that this was one of the weaknesses in the audit system. Whereas computer generated prescriptions automatically left an audit trail which was easy to follow, handwritten prescriptions did not, even though all filed prescriptions are eventually sent to a central UK depositary. Therefore, good practice now calls for these prescriptions to be computer generated.[2]
Schedule 3 - CD No Reg
editInclude drugs subject to the same prescription requirements as Schedule 2 drugs, but without the requirement to maintain registers. With the exception of phenobarbitone or related drugs for treatment of epilepsy, no Sch 3 drug can be given as an emergency supply. Safe custody is currently only required for Tenuate Dospan (diethylpropion), buprenorphine products, temazepam and flunitrazepam (Rohypnol). Neither phenobarbitone nor midazolam require safe custody. Other Sch 3 drugs can be stored in the general dispensary.
Schedule 4
editControlled drug prescription requirements and safe custody requirements do not apply. Included drugs are Benzodiazepines (Subclass CD Benz), other than temazepam, flunitrazepam or midazolam, and androgenic and anabolic steroids (Subclass CD Anab). However CD Benz products- which also include mild stimulants such as mesocarb and fencamfamine, formerly prescribed as anorectics- are illegal to supply or possess without prescription and all Sch 4 drugs cannot be legally supplied without medical authority.
As of April 2014 "Sativex", the cannabis derived medicine prescribed for spasticity due to Multiple Sclerosis, is listed as a Schedule 4 Part 1 drug, whereas before that date it was a Schedule 1 drug requiring reporting and recording protocols (as earlier indicated on this page).[3]
Schedule 5 - CD Inv P & CD Inv POM
editIncludes items which, because of their strength, are exempt from all requirements other than the need to retain invoices for two years.
See also
editReferences
edit- ^ "Royal Pharmaceutical Society's professional guidance on the safe and secure handling of medicines". www.rpharms.com. December 2018. Retrieved 2022-02-02.
- ^ Home Office (2005). Explanatory memorandum to the misuse of drugs and the misuse of drugs Archived December 16, 2010, at the Wayback Machine (supply to addicts) (amendment) regulations 2005.No.2864. Accessed 20-10-03
- ^ "DDA - Dispensing Doctors' Association | Sativex classification changes". 2014-02-22. Archived from the original on 2014-02-22. Retrieved 2022-02-02.
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External links
edit- British Medical Association; Pharmaceutical Society of Great Britain (2010). British national formulary. London: British Medical Association and Royal Pharmaceutical Society of Great Britain. ISBN 978-0-85369-929-3. OCLC 780551036.