Legal requirements for stock CDs
The Misuse of Drugs Regulations (MoDR) 2001 allow dentists, when acting in their professional capacity, to procure, possess, and supply CDs (except Schedule 1). Dentists are therefore not required to hold a Home Office CD license to obtain CDs for use on their patients.
However, stock medicines available for use by any team member are not held by any particular dentist. The Care Quality Commission (CQC) advise that a stock drug is one that has not already been prescribed, administered, and/or supplied to an individual.
If a CD is to be held as stock by a service, a Home Office CD licence may be required. Examples are:
- fentanyl (schedule 2)
- midazolam within a dental emergency kit (schedule 3)
- midazolam or other CDs used by sedation practices (schedule 3)
- nitrous oxide (schedule 5)
- temazepam (schedule 3)
Nitrous oxide is a CD. However, MoDR 2001 Regulation 4C provides that any person may possess it unless they intend to wrongfully inhale it or enable another to do so. A Home Office licence is therefore not required for the possession of a stock supply of nitrous oxide.
Practices should check the Home Office document, Domestic Controlled Drug Licensing in Healthcare settings and/or contact the Home Office for advice.
Obtaining schedule 2 and 3 CDs
MoDR 2001 Regulation 14 directs that Schedule 2 and 3 CDs must be ordered using an official requisition form. This applies regardless of where the CDs are ordered from or whether the CDs are intended for private or NHS use.
The official requisition form for Schedule 2 and 3 CDs is FP10CDF.
The BNF lists which drugs belong to which Schedule.
Obtaining FP10CDF forms
FP10CDF forms can be downloaded from the NHSBSA website.
Completing an FP10CDF
Only the dentist has the legal authority to sign a CD requisition; this cannot be delegated to any other member of the dental team.
The dentist must have a prescriber number, which is supplied by NHS Regional Controlled Drug Accountable Officer (CDAO). It is not the same as the dentist’s GDC number. Our article Controlled drugs governance for dental teams (SPS page) has further information.
Requisitions can be completed online before downloading. However, all forms must be downloaded, printed, and signed manually in ink.
The FP10CDF has five parts (A to E); the dentist must complete parts B and C. Instructions for completing the FP10CDF are included with it (part D).
The form must include:
- the name, form and strength of the drug (part B)
- the total quantity of the drug (part B)
- the purpose for which the drug is required (part B), such as ‘for use within practice or surgery’
- the dentist’s name, address and professional qualification or occupation (part C)
- the dentist’s prescriber number (part C)
- the signature of the dentist (this must be handwritten and indelible) (part C)
The dentist’s GDC number should be included on the requisition to enable the supplier to verify the form’s validity.
Obtaining schedule 4 and 5 CDs
Schedule 4 and 5 CDs do not have any special requirements and may be ordered the same way as non-CDs. Examples include:
- diazepam (Schedule 4)
- nitrous oxide (Schedule 5).
Suppliers of controlled drugs
CDs may be ordered from a dental wholesaler or community pharmacy.
The CQC advise only manufacturers’ original packs may be issued against a requisition.
Dental wholesalers
Dental wholesalers supplying pharmaceutical preparations can supply CDs against an FP10CDF.
Even if an order for CDs is placed electronically, the supplier will still require the original FP10CDF signed by the dentist. In practice, this may often be handed to the delivery driver.
Community pharmacies
Community pharmacies can only supply medicines against an FP10CDF if they have a private CD account number.
MoDR 2001 Regulation 14 states that practice team members collecting CDs from the pharmacy must have a note authorising them to possess the CD. The note must be signed by the dentist who requisitioned the CDs, and the supplying pharmacy must be ‘reasonably satisfied’ that it is genuine.
Using midazolam in an emergency
Midazolam is a Schedule 3 CD included in the Dental Emergency Drugs list in the BNF for management of status epilepticus. It is also used for conscious sedation in dental practice.
Stock midazolam
Midazolam is not included in Schedule 17 of the Human Medicines Regulations 2012, which lists drugs dental hygienists or therapists may administer.
Dental hygienists and therapists may generally work under patient group directions (PGDs). However, they are not among the professions listed in MoDR 2001 Schedule 8 who are permitted to administer a CD under PGD. A PGD therefore cannot be used to allow dental practice staff to administer midazolam in an emergency.
Administration of stock midazolam, whether by injection or buccally, must therefore be done under the direction of a dentist. In the absence of the dentist, this can only be done if a patient specific direction was added to the patient’s record before the appointment.
Our article Patient Specific Directions (PSD) (SPS page) has further information on PSDs.
The patient’s own buccal midazolam
Any person may administer a patient’s own supply of buccal midazolam to them in an emergency, if it is available.
Practices should ensure that staff are trained and competent to do so.