Last update: - November 15th 2023

Background

Not only is it a criminal offence under the Misuse of Drugs Act 1971 to contravene a condition of the licence but also many hundreds of casualties would suffer if it was revoked. Team members must ensure that they are aware of the conditions laid out in the licence and follow them ' to the letter' [John Ellerton, Casualty Care in Mountain Rescue, 2006]

Current guidance states “This is a rare privilege, and all team members should understand the significance of this. Their actions as individuals in respect of CD handling could fundamentally affect the whole organisation’s ability to retain a licence, not just the team to whom the individual belongs”, 1 .The issue of morphine and mountain rescue must have been a defining one for mountain rescue in the early years. There can be little doubt that strong analgesia is required in some rescues to relieve suffering.

This section is divided into two parts. The first section defines the classes of drugs and the specific legal requirements. The second section describes the responsibilities of ordinary team members. The main points have been taken from a number of documents. A fact sheet about Controlled Drugs published by the Home Office is available for download from this website.  

The Law and Controlled Drugs

Legislation

There is much relevant legislation and guidance - e.g. see below. You don't have to read the original documentation, but should be aware that the matter of controlled drugs is taken very seriously by the authorities:

1. Home Office and MHRA. Mountain Rescue Teams – Controlled Drugs Factsheet. December 2022

2. Controlled Drugs (Supervision of Management and Use) Regulations 2006

3. Home Office Drugs and Licensing Unit. Security guidance for all existing or prospective Home Office Controlled Drug Licensees and/or Precursor Chemical Licensees or Registrants. January 2014

4. Home Office CD Requisition Form (Sched 2 & 3) - 6-1387-Form_FP10CDF_v5_final

5. NHS Prescription Services - Controlled Drug prescribing

6. National Institute for Health Care & Clinical Excellence. Controlled drugs: safe use and management. Guidance ng46. April 2016

What is a controlled drug?

The Misuse of Drugs Act (1971) and Misuse of Drugs Regulations (2001) divide Controlled Drugs (CDs) into five schedules corresponding to their therapeutic usefulness and misuse potential. The ones relevant to MR are:

• Schedule 2 (Controlled Drugs) - includes morphine, diamorphine, fentanyl and ketamine

• Schedule 3 - includes a number of stimulant drugs and sedative drugs e.g. midazolam

What does the law require?

As many CDs have a legitimate medical purpose, the above legislation authorises and governs certain activities that otherwise would be illegal under the Act. The Regulations identify those people who may legitimately possess and supply CDs. There are separate licenses for both of these so just because one can possess and use a drug doesn't mean they can supply drugs to others. The regulations also establish a regime of control around prescribing, administering, safe custody, dispensing, record keeping and destruction or disposal.

Schedule 2 Drugs

Subject to safe custody requirements:

• Building: The main stock must be in a locked receptacle, usually in an appropriate CD cabinet or approved safe, which can only be opened by the person in lawful possession of the CD or a person authorised by that person. The locked safe must also be inside a locked cabinet or room. There should be no hint on the outside of the cupboard that drugs are stored within.

• Vehicle: CDs must be stored in an immovable locked container in an attended vehicle or in a locked vehicle as long as the keys are not on the vehicle e.g. in an external key safe. If the keys are left in the key safe, the CDs must be removed and carried by authorised personnel

• People who can administer a CD: The drug may be administered to a patient by anyone with a current Casualty Care certificate, a doctor, a appropriate registered healthcare professional or a dentist.

• Records: A register must be kept for CDs and this register must comply with the relevant current regulations. The current legal requirement is to keep the record for two years but in practice, it is wiser to keep records permanently.

• Destruction of CDs: The destruction of CDs must be done by an appropriately authorised person and must be witnessed by someone who is authorised to do so.

• Notification to the Home Office: Report stocks and usage annually, and all theft or losses to the Home Office immediately.

Schedule 3 Drugs - specifically midazolam

• The Act says that midazolam is treated similarly to Schedule 2 CDs in respect of safe custody, recording and disposal requirements.

All Invoices must be retained for a minimum of two years.
 

The current CD licence for MR

Other than for patients, without a licence, it is a criminal act to be in possession of CD drugs. In terms of the Home Office Licence, ultimately the MREW Medical Officer is responsible for CDs. However, as this is not practical, teams must appoint a ‘Responsible Servant’ or 'Accountable Officer'. This is often (but not necessarily) the Medical Officer (if the team has a Doctor), or failing that, a team member appointed by the team. In LAMRT, it is Prof Roger Barton.

The licence has the following features:

• The Licence now has to be renewed every three years and there is a fee paid by MREW.

• The Licence is for schedules of controlled drugs (see above) rather than individual drugs. It applies to drugs to schedules 2 and 3.

• The Licence is only for possession and administration (not for supplying CDs).

• The administration of CDs is covered by the MREW amendment in the Medicines Act.

• The Licence holder (Dr Alistair Morris on behalf of all Mountain Rescue and Cave Rescue teams) is required to submit an Annual Return for all drugs that are handled by teams by the end of January each year as well as an Annual Statement of Compliance. The ‘Responsible Servant’ of the team must ensure that a stock balance (as of January 1st) and a copy of the Drug Register showing the last year’s transactions are supplied to the MREW Medical Officer by January 15th. Failure to do so means that the Team’s CDs would no longer be covered by the MREW Licence.

The role of the responsible servant

• Ensure the safe custody of the CDs at all times

• Keep records in accordance with the Act

• Send (by the 15th of January) a copy of the CD register to the MREW Medical Officer

• Report thefts and losses to the Police and the MREW Medical Officer as soon as possible

• Provide information and allow inspection of the CDs on request from appropriate persons

• CDs must be recorded in the CD register at the Base
   

Important conditions and obligations of the MR CD license

This list is taken verbatim from the current license:

• You must ensure that your activities and handling of Controlled Drugs are fully compliant with current legislation, including and applicable security, storage and record keeping requirements, and any additional conditions specified in the licence or accompanying letter.

• That you immediately report any Thefts or Losses to both the Police and the Home Office Drug Licensing & Compliance using the proforma on our (Home Office) website.

• On request, you complete an Annual Statistical Return (import/export, manufacturing and wholesale activities) by 31 January each year, using the forms available on our website, and ensure they are electronically submitted.

Compliance Visits
The Home Office aim to visit each licensed premises every 3-5 years. Where possible they will advise us if it is likely they will need to visit us at the next renewal cycle.

The responsibility of Team Members (i.e. YOU) when using Controlled Drugs

Please note: the information here only contains an overview. For full details, please see the LAMRT CD Standard Operating Procedure (below)

Who can give CDs?

The Mountain Rescue amendment of the Medicines Act allows only mountain rescue team members with a valid Casualty Care certificate to give the drug. (A passing doctor or NHS paramedic can use the team's CDs but are acting independently of MREW insurance. Check their identity & credentials, obtain their professional registration number and a signature from them that they have given the CD.) Inform Base by radio that a CD has been given, particularly if it by someone who is not a team member.
 

Storage in a vehicle

All CDs must be locked in a CD safe when not in use. There should be controlled access to CDs balancing security considerations with the operational needs to have the drugs readily available. Importantly, during transit, whilst in the physical possession of a team member, the drugs do not have to be locked in a container. However, as above, CDs must not be left in the safe of a locked vehicle if the keys to the vehicle are in the external key safe.
 

CD Register

The CD register is a legal document that has to meet specific standards. It is a paper audit trail to assure the Government that the drugs are not being misused.

• It must be kept on the same premises as the drugs and be a bound book, not loose-leaved.

• We keep CDs in the locked safe in the Base.

• There must be a separate page for each different drug or presentation of a drug. For example, morphine 10mg ampoules, diamorphine 5 mg ampoules, fentanyl lozenges and midazolam 10mg ampoules all have separate pages.

• Entries should be made in chronological order and written in indelible ink. They should be written on consecutive lines (no blank lines). Any errors should be crossed through with a single line and left visible. The correction should be signed and dated in the margin. Above all, Tippex (or similar) must not be used.

• A stock check should be carried out periodically. Put the date and the names of the people carrying out the check and confirm that the running balance is correct.
   

What to record

Record this information on the appropriate page in the Drugs Register AS SOON AS POSSIBLE after drug administration. In practice, this will mean when you return to Base after a rescue.

• Entries should be in chronological order

• Date

• Time

• Patient's name

• Signature of person administering the drug + professional registration number if appropriate (i.e. doctors and paramedics)

• Signature of person witnessing the drug administration. Ideally, the witness should also be someone who has the Casualty Care certificate.

• Amount of drug administered

• Amount of drug wasted

• If you make a mistake, do not tear out the page. Put a line through the incorrect entry but without obscuring the initial entry. Sign and date the incorrect entry and then put the right entry in the correct place.

Record the above for every occasion when a CD ampoule or package (fentanyl) is opened, whether it is actually given to a patient or opened in error and then destroyed.

When a page is full, details must be transferred to the next available new page. Update the index at the front of the CD Register by writing a new entry with the new page number. Record the number of the new page at the bottom of the finished page, with “Records transferred to page ...” On the new page, fill in the correct details of the drug, strength and form, together with “Records transferred from page ...” Finally, check the stock balance with a witness and record it on the new page.
 

Essential notifications

Any discrepancies in CD drug stock numbers, losses or thefts must be reported to the Team Leader, a DTL or the Team Doctor as soon as they have been discovered. They will in turn inform the police and the MREW Medical Officer.
 

LAMRT CD Standard Operating Procedure

In line with Home Office instructions, we now have a Standard Operating Procedure (SOP) for CDs. This is shown below. A copy of this is available in the Base and one is here for downloading. Please make sure you read the SOP. It's not complicated and knowing what you should and shouldn't do will help avoid mistakes, and potentially a lot of aggravation, in the future. 

Download a copy here