The following types of independent healthcare organisations are designated bodies under the regulations governing the management of controlled drugs, and therefore must appoint an accountable officer and register their officer's details with the Care Quality Commisision.

All organisations defined in Regulation 3 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006 must appointment an accountable officer as defined in Regulation 4.

If your CD activity is minimal then the responsibilities for the accountable officer should also be proportionately small. But you will still need to link with your Local Intelligence Network (as required by Part 4 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006) to share information and be aware of any issues in your area.     

An amendment to The Misuse of Drugs Regulations 2001 came into force on 16 August 2007 enabling and permitting AOs to authorise people or groups of people to witness the destruction of CDs in compliance with these regulations.

The Department of Health published supporting guidance about the destruction of CDs to accompany these amendments:

“Guidance on the destruction of controlled drugs – new role for Accountable Officers – Authorising people to witness the destruction of CDs”

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_078034

If a problem in a care home is reported to the accountable officer, they should liaise with the local CQC (who will now cover the previous Commission for Social Care Inspectorate areas) Local Intelligence Network member. As their regulator, and member of the Local Intelligence Network (as a Responsible Body) CQC should lead any discussions/interactions with the homes and establishments registered with them (Regulation 19 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006).

CQC will also bring any relevant CD concerns or investigation outcomes from care homes to the Local Intelligence Network.

The Misuse of Drugs Act 1971 states that a person may not legally have a CD in their possession unless the Regulations allow them to do so. Unlawful possession of any CD in Schedules 2 to 4 (Part1) is a criminal offence.

Mountain rescue teams are not specifically referenced in the Regulations, but they may legally possess if they have been licensed by the Home Office Drugs Licensing and Compliance Unit to do so.

From a PCT AO’s perspective, the issue will therefore be focused on firstly confirming they have the relevant licence from the Home Office and then ensuring that their CDs are being supplied, stored, administered, recorded, and disposed of correctly.

The Controlled Drugs (Supervision of Management and Use) Regulations 2006 Regulation 18 indicates those bodies to be included as members of the Local Intelligence Network (LIN). The list given is not exhaustive and it is for  networks to consider which bodies should be involved as determined by local circumstance. To clarify an organisation does not have to be defined as a Responsible Body in Regulations to be included in the LIN.

However, in considering this specific question we need to look at in a broader context. LINs are there to share information/intelligence from different sources, which could include information about individual contractors. As a result, there would be a clear conflict of interests if contractor representatives (LMC/LPC) were members of your LIN. For the same reason, you should not invite superintendent pharmacists to be part of your LIN.

There is no specific reference to undertakers within the Regulations. The key issue is do undertakers have a legal authority to be in possession of a controlled drug in the circumstances described.

As an undertaker, they are not empowered to be in possession of CDs under Regulation 10 of the 2001 Misuse of Drugs Regulations.

The follow up question then becomes is the coroner able to empower the undertaker to be in legal possession of CDs. Reference to Regulation 10 of the 2001 Misuse of Drugs Regulations again confirms that a coroner or coroner’s court do not have the authority to possess controlled drugs. This also applies if the coroner is a medical practitioner because in this instance, they are acting as a coroner and any legal power they may have to possess CDs relates to their role as a medical practitioner only.    

Therefore, it is clear that neither the coroner nor an undertaker have the legal power to be in possession of a controlled drug.

However, as an accountable officer you may find yourself in the position whereby the local coroner, or their office, are undertaking an investigation and need to know what drugs were prescribed and had been taken. In this instance the patients note would indicate what was to be taken. Work that Department of Health is taking forward around a Controlled Drug Record Card has the potential to provide a full audit trail.     

The Misuse of Drugs Act 1971 states that a person may not legally have a CD in their possession unless the Regulations allow them to do so. Unlawful possession of any CD in Schedules 2 to 4 (Part1) is a criminal offence.

However, Regulation 6 of the Misuse of Drugs Regulation 2001 contains a list of persons who have general authority to supply and possess any controlled drug and this includes “a person engaged in conveying the drug to a person who may lawfully have that drug in his possession”. It is important to note that this person is only authorised to convey the drug and the authority does not extend to allow them to make the supply from stock to recipient.

The Misuse of Drugs Act 1971 states that a person may not legally have a CD in their possession unless the Regulations allow them to do so. Unlawful possession of any CD in Schedules 2 to 4 (Part1) is a criminal offence.

The Misuse of Drugs Regulations covers to vets in the terms “Practitioners” (which also includes doctors and dentists) and they both have similar authorisation under them.  They do not specifically state that a vet should be qualified to supply a CD, but registration with their professional body is the means of meeting this definition.

Veterinary medicinal products that are also Controlled Drugs are classified as POM - V and therefore can only be prescribed by vets registered with the Royal College of Veterinary Surgeons (RCVS). Human Controlled Drugs can be used in animals under the Cascade, but again they could only be prescribed by a vet registered with the RCVS. [The Cascade is a long-standing legal flexibility providing a rational balance between the legislative requirement for veterinary surgeons to prescribe and use authorised veterinary medicines where they are available, and the need for professional freedom to prescribe other products where they are not. It is intended to increase the range of medicines available for veterinary use.]

Response agreed by Department of Health, Care Quality Commission, Home Office  on 24 April 2009.
Minor typo corrected by DH on 23 September 2009.

The Home Office has recently clarified the position on group licences (see “What’s New” at http://drugs.homeoffice.gov.uk/drugs-laws/licensing/?version=2%20 for further information).  Registered paramedics are covered by group authorities, which allow them to possess and administer, and therefore obtain by way of wholesale, certain Controlled Drugs, namely, morphine sulphate and diazepam for the purposes of administration for the immediate necessary treatment of sick or injured persons.

The Home Office has recently revised the group authorities so they now cover NHS ambulance trusts, NHS paramedics and privately employed (including self-employed) paramedics. Under the group authorities, a registered paramedic (working in either the NHS or privately) can obtain morphine sulphate injection (to a maximum strength of 20mg), morphine sulphate oral and diazepam by way of wholesale from a registered pharmacy.

Yes, they are able to use a private CD requisition (in effect a letter) without a cross reference to a private CD number.

Fully Private Doctors/Independent Clinics are registerable with the
Care Quality Commission under the Care Standards Act. However, if the Doctor has any NHS practice, however small, they are exempt
from registration. Therefore, some slimming clinics do fall outside of registration.

The main CD issues in slimming clinic are around their handling and management of the schedule 3 drugs phentermine and diethypropion.

If any CD concerns/issues are brought to attention in a registered clinic the Care Quality Commission should be informed to take the lead in following up, as stated in Regulation 19 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006.

However, if the clinic is not registered then the PCT has both the responsibility and right of entry to inspect and follow up as in the first part of Regulation 19 of the same Regulations.

Private dental practice is not regulated under the Care Standards Act.
Regulation of the dental professionals in the UK is the responsibility of the General Dental Council (GDC).

If a dentist wishes to prescribe schedule 2 or 3 CDs then they are required to request and use the new private prescription forms. The PCT will therefore be aware of any private CD prescribing by dentists in their area.

All healthcare professionals have a duty to comply with the safer management of controlled drugs principles, and not just to those within the designated bodies. The Controlled Drugs (Supervision of Management and Use) Regulations 2006 further expands this to include all relevant persons who may be employed by healthcare professionals and so involved in handling CDs in the course of their practice (regulation 23).

Therefore, there is no barrier to any professional, a member of the public or a patient being able to report any concerns about CDs to local Accountable Officers/PCT Accountable Officers leading Local Intelligence Networks.

Prisons are not Designated Bodies in regulation and so are not required to appoint their own accountable officer.

As with Prison Health, where making suitable arrangements for this are the responsibility of the local PCT, the PCT accountable officer also has the responsibility to assure that the Prison has suitable arrangements in place for the safer management of CDs. How this happens in practice is for local determination.

Prisons, including Prison Health are subject to inspection by Her Majesty's Inspectorate of Prisons (HMIP).

HMIP have a service level agreement with the Royal Pharmaceutical Society of Great Britain who undertake the medicines inspection on behalf of HMIP. This includes CDs, and the CD element of the inspection report is now sent as a matter of routine to the PCT accountable officer.

The CQC also has a service level agreement with HMIP and check on how the PCT discharges its responsibilities for Prison Health. This includes asking how the PCT accountable officer is discharging their responsibilities in regard to CDs in the Prison, with questions such as who is the main point of contact on matters concerning CDs, and how is this relationship managed.

The answer to this question is under discussion currently and it would be best to refer the company running the Private Prison to the Home Office Drugs Licensing and Compliance Unit for a definitive answer.

Currently, prisons are not one of the bodies designated as exempt from the new legislation regarding the new style CD registers and so all prisons are required to have one of the new-style CD registers to record their deliveries into the prison ( in prisons where there is an on-site pharmacy, this is the register they use).

However, on a prison wing or treatment room there is no legal requirement to maintain a CD register (as with a hospital ward). However, it is strongly advised as good practice that each prison wing or treatment centre should  maintain a CD register, although this does not need to be in the new style.  
These registers should have fields for the person administering and witness signatures as well as the date and time of administration, are more suitable for the treatment rooms.