Controlled drugs (CDs) are drugs that are regulated by the Misuse of Drugs Act 1971  and subsequent regulations. CDs are classified into five schedules with different legal requirements . Midazolam is a Schedule 3 CD and is the only CD that primary care dental practices are justified to stock. Midazolam can be used, buccally, as an emergency drug to treat patients with status epilepticus. It can also be used as a sedative by those who have been trained in the provision of conscious sedation.
Under the Controlled Drugs (Supervision of Management and Use) Regulations 2013 , Health Boards in Scotland are required to appoint a Controlled Drugs Accountable Officer (CDAO) , who has overall accountability for ensuring that appropriate systems are in place for the safe management and use of CDs. Dental practices that stock midazolam for use in medical emergencies or for providing conscious sedation must comply with relevant legislation.
- General Requirements for Midazolam
- Ordering and Receipt of Midazolam
- Use, Destruction and Disposal of Midazolam
- Incident Reporting
General Requirements for Midazolam
Although midazolam does not require to be kept in a locked CD cabinet or documented in a CD register, it is subject to restrictions with respect to ordering, prescription writing and denaturing. In addition, it is an offence to be in possession of midazolam unless exempted under the Misuse of Drugs Regulations 2001 . Dentists are legally entitled to be in possession of CDs, but must have standard operating procedures and adequate controls in place to cover all aspects of the use of midazolam and to prevent it falling into the possession of someone who does not have these legal rights. The same requirements apply whether midazolam is kept in buccal liquid form or as an injection solution.
Appoint a dentist to have overall responsibility for midazolam and know how to contact your local Controlled Drugs Accountable Officer (CDAO).
Have in place a Controlled Drug standard operating procedure (SOP) (Word)that covers all aspects of the management of midazolam (obtaining, recording, security, storage, denaturing etc.) and describes the responsibilities of individuals .
Keep midazolam for use in medical emergencies with other emergency drugs so that they can be easily accessed in an emergency.
In practices that are set up to provide conscious sedation, keep midazolam in appropriate storage facilities i.e. locked cupboard.
If midazolam is used to provide conscious sedation, ensure that appropriate antagonist injection is available (i.e. flumazenil).
Ordering and Receipt of Midazolam
A Controlled Drug Requisition Form (CDRF), available from your Health Board, should be used to order midazolam from a community pharmacy .
- In exceptional circumstances, practice headed notepaper can be used to order midazolam from a community pharmacy or wholesaler .
- Community NHS dentists may obtain midazolam from their local hospital pharmacy service, following their local procedure.
- Dentists may obtain an Emergency Dental Box from NHS Scotland Pharmaceutical ‘Specials’ Service (formerly Tayside Pharmaceuticals) ,which includes midazolam injection labelled for buccal use.
Order the minimum quantity required for anticipated use (based on previous usage).
Keep records of orders for a minimum of 2 years.
When you receive a delivery of midazolam, check that it matches the order placed, leaving the tamper-evident seal intact in full packs or within the NHS Scotland Pharmaceutical ‘Specials’ Services Emergency Dental Box.
If there is a discrepancy in the order, notify the supplier and do not accept delivery unless there are exceptional circumstances preventing return. In this case, record receipt of stock and return stock to the supplier as soon as possible.
Sign the delivery note and keep a copy for a minimum of 2 years.
Store midazolam in the storage location designated in your SOP immediately following receipt.
Use, Destruction and Disposal of Midazolam
Verify the patient’s identity before administering midazolam.
Record in the patient’s clinical record that midazolam has been administered and include the date, time, strength, presentation and form of administration, dose, and the name and position of the dental team member who administered the drug.
Following the agreement that, due to supply and shelf life issues, the injection formulation of midazolam will replace Midazolam Oromucosal Solution in emergency dental kits, NHS Education for Scotland (NES) have prepared a training video to enable dental teams to familiarise themselves with the buccal administration of the injection solution. This can be accessed on TURAS Learn at Emergency treatment of a prolonged epileptic seizure using buccally administered 10mg in 2ml Midazolam using an oral syringe | Turas | Learn (nhs.scot)
Return used or expired Emergency Dental Boxes to NHS Scotland Pharmaceutical ‘Specials’ Serviceswho will ensure appropriate denaturing, disposal and replacement of the contents.
Midazolam stock that is expired or no longer required must be denatured (rendered irretrievable) using a controlled drug denaturing kit available from community pharmacies or waste management companies [9-11].
Dispose of the denatured midazolam by placing it in an appropriate waste container for destruction by incineration. Sharps are not disposed of by incineration; therefore use of sharps boxes is not appropriate.
Community NHS dentists obtaining midazolam from their local hospital pharmacy service may return expired or surplus midazolam stock to this pharmacy for disposal following their local procedure.
Guidance on reporting incidents, near misses and concerns (PDF)and, if necessary, a Controlled Drug Incident Report (Word)are provided.
If any incidents or concerns occur when prescribing or using any CD, including midazolam, record these and investigate as for any other incident, and notify your NHS Board CDAO  as soon as possible without compromising the steps required to ensure patient safety.
Notify the CDAO of the outcome of CD related incidents, any learning points and actions taken to prevent recurrence of the incidents.
In the event of a serious incident or concern, notify the CDAO within three working days.
Report any suspected loss or theft of any prescription or requisition stationery to your Health Board as soon as possible and include the approximate number of lost or stolen forms, their serial numbers and where and when they were lost or stolen.
If any criminal activity is suspected, notify the police as well as the CDAO.
Additional information for dentists on handling controlled drugs has been produced by the UK Medicines Information Service .
Controlled Drugs Incident Report to Controlled Drugs Accountable Officer (Word) (provided by Controlled Drug Accountable Officers’ Network, Scotland, NHS Scotland)
Controlled Drug Standard Operating Procedure (SOP) Template for GDPs (Word) (provided by Controlled Drug Accountable Officers’ Network, Scotland, NHS Scotland)
Sources of Information
- Misuse of Drugs Act 1971 www.legislation.gov.uk/ukpga/1971/38/contents
- Joint Formulary Committee. British National Formulary, Edn 82, London. British Medical Journal Group and Pharmaceutical Press (2021) bnf.nice.org.uk/
- Controlled Drugs (Supervision of Management and Use) Regulations 2013. www.legislation.gov.uk/uksi/2013/373/contents/made
- Safer Management of Controlled Drugs: Guidance on Strengthened Governance Arrangements HDL (2007) 12. Scottish Executive https://www.scot.nhs.uk/sehd/mels/HDL2007_12.pdf
- Misuse of Drugs Regulations 2001 www.legislation.gov.uk/uksi/2001/3998/contents/made
- Healthcare Improvement Scotland Register of Controlled Drug Accountable Officers (Scotland). www.healthcareimprovementscotland.org/our work/governance and assurance/controlled drugs/cdao register.aspx
- Safer Management Of Controlled Drugs: Standard Operating Procedures. CEL 14 (2007) Scottish Government www.sehd.scot.nhs.uk/mels/CEL2007_14. (PDF)
- Safer Management Of Controlled Drugs: Private Requisition Forms for Schedules 1, 2 and 3 Controlled Drugs. CEL 16 (2007) Scottish Government www.sehd.scot.nhs.uk/mels/CEL2007_16. (PDF)
- NHS Scotland Pharmaceutical ‘Specials’ Services (PSS)
- Denward Manufacturing Ltd
- phs Group
- How should dentists prescribe, store, order and dispose of controlled drugs? Medicines Q&A 178.3. UK Medicines Information www.sps.nhs.uk/articles/how-should-dentists-prescribe-store-order-and-dispose-of-controlled-drugs-2/