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Enforcement and Penalties
The enforcement of Controlled Drug regulations is carried out
by various agencies, including the police, the Home Office,
and regulatory bodies such as the General Pharmaceutical
Council (GPhC). Penalties for breaches of the regulations can
be severe, ranging from fines to imprisonment, depending on
the class of drug and the nature of the offence.
Confusing isn’t it! All important stuff though so we need to
understand what it all means in practice.
I have published the table below before, but I think it will be
useful to provide it again because it really does capture all
the important legal requirements in a simple reference tool.
Drugs Schedule 2 Schedule 2 Schedule 4 Parts I & II Schedule 5
(CD POM) (CD No register POM) (CD Benz POM & CD Anab (CD inv P & CD inv POM)
(Entries required in POM) (Preparations of certain
CD register) controlled drugs exempt
from full control by
virtue of being low
strength)
Examples Morphine, Diamorphine, Buprenorphine, Part I: Oramorph 10mg/5ml
(not exhaustive) Oxycodone, Temazepam, Tramadol, Diazepam, Lorazepam, Kaolin & Morphine
Methylphenidate, Midazolam, Loprazolam, Lormetazepam, Codeine tablets/oral
Tapentadol, Methadone, Phenobarbital, Nitrazepam, Chlordiazepoxide, solution Pholcodine.
Pethidine, Amfetamines, Gabapentin, Pregabalin. Oxazepam, Zopiclone, Zolpidem.
Quinalbarbitone, Part II:
Ketamine. Testosterone, Somatropin.
Safe Custody Yes Yes (Many are No No
Requirement (some exceptions e.g. exempted,
quinalbarbitone) e.g. phenobarbitone,
midazolam, Tramadol,
gabapentin, Pregabalin).
Prescription Yes Yes No No
Requirements
(see below)
Prescription Valid For 28 days (any owings must also be supplied within this time) 6 Months (any owings
must also be supplied
within this time)
Requisition necessary Yes Yes No No
Invoices NICE recommends retaining all CD invoices for 6 years
Quantity Should not exceed 30 days (unless exceptional, justifiable, genuine circumstances) Not restricted
Prescribed
Collector to sign back Yes (Good practice – not actually a legal No No
of prescription requirement)
ID check required Yes No No No
(see below)
Denaturing required Yes Yes Yes (Part I only) No
for destruction
Authorised witness for No, but it is good practice to have this witnessed by another member of staff. N/A
destruction of Sch.2 CD returns & their subsequent destruction should be recorded in the separate
patient returns patient returns register.
Authorised witness for Yes & entry to be made No but good practice No
destruction of in CD register. for another member of
expired/obsolete staff to witness.
dispensary stock
Prescription Requirements Include: ID checks:
? A clear dose (does not need to be in words and figures): • For schedule 2 CDs it is a legal requirement to establish
(As directed, when required, as per chart, weekly, decrease dose by 1 whether the person collecting is the patient, representative or a
ml every 3 days etc. are not acceptable. One as directed, two when healthcare professional (name & address is needed for healthcare
required, one prn, three ampoules as directed etc. are acceptable). professionals)
? Formulation must be stated (abbreviations ‘tabs’ & ‘caps’ are • ID should be requested (unless the person is known)
acceptable) • CDs may still be supplied if ID is not shown.
? Strength if more than one available
? Total quantity in words and figures
? The words “for dental treatment only ” if issued by a dentist
38 PS Magazine | Controlled Drugs Buy direct online at PSUK.co.uk
09/07/2024 10:31:01
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