The Misuse of Drugs Regulations 2001 (and subsequent amendments) define the classes of person who are authorised to supply and possess controlled drugs while acting in their professional capacities and lay down the conditions under which these activities may be carried out. In the regulations drugs are divided into five schedules each specifying the requirements governing such activities as import, export, production, supply, possession, prescribing, and record keeping which apply to them.
- Schedule 1: includes drugs such as lysergide which is not used medicinally. Possession and supply are prohibited except in accordance with Home Office authority.
- Schedule 2: includes drugs such as diamorphine (heroin), morphine, nabilone, remifentanil, pethidine, secobarbital, glutethimide, the amfetamines, sodium oxybate, and cocaine and are subject to the full controlled drug requirements relating to prescriptions, safe custody (except for secobarbital), the need to keep registers, etc. (unless exempted in Schedule 5).
- Schedule 3: includes the barbiturates (except secobarbital, now Schedule 2), buprenorphine, mazindol, meprobamate, midazolam, pentazocine, phentermine, temazepam, and tramadol. They are subject to the special prescription requirements. Safe custody requirements do apply, except for any 5,5 disubstituted barbituric acid (e.g. phenobarbital), mazindol, meprobamate, midazolam, pentazocine, phentermine, tramadol, 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).
- Schedule 4: includes in Part I benzodiazepines (except temazepam and midazolam, which are in Schedule 3), zaleplon, zolpidem, and zopiclone which are subject to minimal control. Part II includes androgenic and anabolic steroids, clenbuterol, chorionic gonadotrophin (HCG), non-human chorionic gonadotrophin, somatotropin, somatrem, and somatropin. Controlled drug prescription requirements do not apply and Schedule 4 Controlled Drugs are not subject to safe custody requirements.
- Schedule 5: includes those preparations which, because of their strength, are exempt from virtually all Controlled Drug requirements other than retention of invoices for two years
Standards and safety checks
NMC(standards for medicine management)
-Controlled drugs are kept in a locked cabinet and the keys are carried by the nurse in charge (access to the keys and the CD cabinet is restricted to authorised registrants). CD stationery which is used to order, return or distribute controlled drugs should be kept in the locked cabinet. No other medicines or items to be stored in the controlled drug cupboard.
-There should be a list of the CDs to be held in each ward as stock items, only the CDs listed may be routinely requisitioned or topped-up.
-A copy of the signature of each authorised signatory should be available in the pharmacy department for validation.
-When CDs are delivered to a ward they should be handed to a designated person, under no circumstances should they be left unattended. After the delivery, the registrant in charge and a witness (another registrant) should check the CDs against the requisition, place the CDs in the CD cupboard, enter the CDs into the ward controlled drug record book, update the running balance and check that the balance tallies with the quantity that is physically present.
-All entries in the controlled drug record book must be signed by two registrants.
-Checking the balance in the controlled drugs register against current stock should be done twice a day, recording stock checks along with the date and signature of both health professionals carrying out the check.
-The registrants should record the amount given and the amount wasted (if there is any) when administering a CD.
-Audits should be carried out to ensure that the record keeping is up to date and correct.
-Controlled drugs: safe use and management(2016) NICE guideline NG46
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