Frequently asked questions (FAQ's)
The following frequently asked questions have been developed as a result of queries received by the NPC. The answers have been reviewed by the NPC and the Department of Health.These FAQs are composed using the English and Scottish Controlled Drug Regulations (for colleagues in, Wales and Northern Ireland you will need to refer to your own administration’s regulations). In reading and interpreting these FAQs, please be mindful that the views given are in general terms and that any response will need to be more focused on the individual case within the context of local governance arrangements of your own organisation.
FAQs will be updated in response to policy developments and issues raised via the National Prescribing Centre’s Accountable Officer’s website discussion forum.
1 What is the legislation governing the use controlled drugs?
2 Which organisations require an Accountable Officer?
3 My organisation is defined as a designated body in Regulations but we do not administer or hold CDs, are we required to appoint an Accountable Officer?
4 How do the new services coming into Care Quality Commission (CQC) registration affect the Accountable Officer role?
5 What will happen to the National Prescribing Centre’s (NPC) programme on Controlled Drugs following the merger with the National Institute for Health and Clinical Excellence (NICE)?
6 How do I notify the Care Quality Commission that I am a Accountable Officer?
7 What are my responsibilities as an Accountable Officer?
8 Do I need to have Standard Operating Procedures in place?
9 As an Accountable Officer what are my responsibilities around authorising witnesses for the destruction of CDs?
10 What action can a PCT take when a pharmacy multiple is not applying for their own authorised witnesses for the destruction of CDs?
11 How do PCT AO recognise who are the authorised witness for the destruction of controlled drugs in Pharmacy multiples?
12 What are the legal requirements in connection with information sharing?
13 What is a CD local intelligence network and what is my role in them?
14 What impact will the changes to the structure of the NHS have on PCT Accountable Officer role and the CD Local Intelligence Networks?
15 I have concerns about a healthcare professional in their use of CDs, who should I talk to?
16 Can the Local Medical Committee (LMC) or the Local Pharmaceutical Committee (LPC) be part of a Local Intelligence Network?
17 Is the Accountable Officer responsible for investigating CD problems in a care home?
18 Other than, the person for whom the controlled drugs were prescribed who else can be in legal possession.
19 Who is responsible for doctors when they are mainly employed by the NHS but on occasion engage in Private Practice when concerns arise over their private practice?
20 How should organisations obtain and use CDs when providing private or voluntary sector ambulance/paramedic services?
21 Should doctors working at a sporting or similar events, for the purpose of immediate and necessary treatment, order their supply of CDs through one doctor, or should each order their own supply?
22 Can paramedics use a CD requisition form without a private CD number?
23 There is a slimming clinic in my area, who is responsible for regulating their safe management and use of CDs?
24 Is there a listing of private dentists and how are they regulated?
25 Does the safer management of controlled drugs regulations and guidance apply to private dentists?
26 As a PCT Accountable Officer what are my responsibilities for ensuring the safe management and use of CDs in my local prison?
27 Does a private prison require a licence from the Home Office to hold CDs
28 How are the police involved in the day-to-day inspection of Controlled Drugs in community pharmacies and their destruction?
29 I am aware that Vets in my area are in possession of CDs. Who is responsible for ensuring their safe management and use?
National and Regulatory Bodies contacts
The Department of Health (DH)
DH has published guidance on several pieces of specific areas in relation to the management and use of CDs including good practice guidance in secondary care. Guidance can be found on the Department’s website at:
(www.dh.gov.uk/en/Healthcare/Medicinespharmacyandindustry/Prescriptions/ControlledDrugs/index.htm).
The National Prescribing Centre (NPC)
The NPC has developed resources that will help Accountable Officers carry out their statutory obligations. The resources are all available on the AO website at:
(www.npc.nhs.uk/controlled_drugs/).
Regulatory bodies
In additional, the regulatory bodies also produce specific literature, information and guidance that is relevant to the role of the AO, which can be found on:
The Care Quality Commission
(www.cqc.org.uk/guidanceforallhealthcarestaff/managingrisk/controlleddrugs.cfm).
What is the legislation governing the use controlled drugs? |
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Response |
As an Accountable Officer (AO), you must be familiar with all key legislation. The overall legislative framework is the Medicines Act 1968 and its associated legislation. Controlled drugs are additionally defined and governed by the Misuse of Drugs Act 1971 and associated regulations, principally the Misuse of Drugs Regulations (MDR) 2001.
(www.legislation.gov.uk/uksi/2001/3998/contents/made). Your will also need to be aware of the “The Health Act 2006” and its associated regulations - principally “The Controlled Drugs (Supervision of Management and Use) Regulations 2006”, both contain measures relating to the arrangements underpinning the safe management and use of CDs in England and Scotland.
(www.legislation.gov.uk/ukpga/2006/28/pdfs/ukpga_20060028_en.pdf).
(www.legislation.gov.uk/uksi/2006/3148/introduction/made). The Department of Health published, in October 2007, guidance on “Safer management of Controlled Drugs – A guide to good practice in secondary care (England)” The guidance is to promote the safe and effective use of controlled drugs in healthcare organisations providing secondary care in England. It aims to set out robust systems for procuring, storing, supplying, transporting, prescribing, administrating, recording and disposing of CDs while at the same time helping to ensure appropriate and convenient access for those patients that require them. It is not designed to provide advice on the clinical; choice or use of CDs.
(www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_079591.pdf). AOs are not usually notified of changes to legislation and it is advisable to keep yourself up to date by visiting the websites of organisations listed below. National and Regulatory bodies have on their websites published material and guidance relevant to controlled drugs, the address of these organisations can be found at the end of the FAQs. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office on 22 February 2011 |
Which organisations require an Accountable Officer? |
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Response |
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 define that all designated bodies must appoint an AO. Regulation 3 defines what a designated body is, (for example; NHS Trusts, Foundation PCTs and Independent Hospitals) and Regulation 4 confirms the requirement for an AO. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 21st February 2011 |
My organisation is defined as a designated body in Regulations but we do not administer or hold CDs, are we required to appoint an Accountable Officer? |
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Response |
All organisations defined in Regulation 3 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006 must appointment an AO as defined in Regulation 4. If your CD activity is minimal then the responsibilities for the AO should also be proportionately small. But you will still need to link with your CD Local Intelligence Network (CD LIN) (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. Regulation 29 requires all Controlled Drug Designated Bodies to return a quarterly occurrence report detailing concerns or confirmation that they have no concerns to the PCT AO leading the CD LIN. This also applies to those with minimal CD handling. However, if you have minimal CD handling it is likely the quarterly response will also be minimal, i.e. to confirm no change or concerns, or to report any CD concern that could still be encountered through client or staffing issues. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
How do the new services coming into Care Quality Commission (CQC) registration affect the Accountable Officer role? |
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Response |
The new services coming into registration with CQC in 2011 and 2012 will not have an impact on Controlled Drug Designated Body status. The designated bodies that are required to appoint an AO are defined in The Controlled Drugs (Supervision of Management and Use) Regulations 2006 and are a Primary Care Trust (PCT), an NHS Trust, an NHS foundation Trust and English independent hospitals. However, there will be impact in terms of following up of CD issues as detailed in Regulation 19 of the regulations, whereby the PCT AO should carry out periodic inspections of premises used in connection with controlled drugs and not subject to inspection by the Care Quality Commission. |
Audit trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
What will happen to the National Prescribing Centre’s (NPC) programme on Controlled Drugs following the merger with the National Institute for Health and Clinical Excellence (NICE)? |
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Response |
The NPC is to merge with NICE from April 2011. The NPC and NICE already share a history of close working, and integration will further strengthen how they support the NHS. This merger will not affect the current Controlled Drugs programme carried out by the NPC on behalf of the Department of Health. Neither the Department of Health nor the NPC have made any decisions in relation to the future work on the Controlled Drugs programme. Before any decisions are made, the NPC will to continue working on developing guidance to assist in the safe management and use of Controlled Drugs. |
Audit trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
How do I notify the Care Quality Commission that I am an Accountable Officer? |
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Response |
Regulation 4 of the ‘Controlled Drugs (Supervision of Management and Use) Regulations 2006’ state that the designated body must notify the Care Quality Commission (CQC) when an AO is nominated or appointed as soon as possible. This is done by the online registration form on the CQC’s website: The designated body is also required to notify the CQC when the AO is removed. This is usually done by using the web form to notify the CQC of the new AO appointment. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
What are my responsibilities as an Accountable Officer? |
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Response |
Responsibilities of an AO are specified in Part 2 of ‘The Controlled Drugs (Supervision of Management and Use) Regulations 2006’. Key responsibilities are to:
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Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
Do I need to have Standard Operating Procedures in place? |
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Response |
The legal requirement for SOPs is set out in Regulation 9 (2) (b) of the ‘The Controlled Drugs (Supervision of management and Use) Regulations 2006’. The regulation states that AOs must ensure that their designated body (or any body or person acting on behalf of, or providing services under arrangements made with the designated body) has adequate and up to date SOPs in place in relation to the safe management and use of CDs. SOPs must cover all aspects of risk management and include procedures around audit trails for ordering, storing, prescribing, dispensing, recording, supplying, administration and destruction of CDs appropriate to the setting and the team. In addition, SOPs should also highlight the accountabilities and roles of all members of the relevant healthcare teams. The Department of Health published guidance in January 2007 “Safer management of CDs: guidance on SOPS for controlled drugs’ provides advice on the areas that might be considered for inclusion in an SOP. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
As an Accountable Officer what are my responsibilities around authorising witnesses for the destruction of CDs? |
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Response |
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 AOs – Authorising people to witness the destruction of CDs” www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_078034 An AO cannot be involved in the activity of destroying or witnessing the destruction of CDs as AOs must be independent of any day-to-day management of CDs. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
What action can a PCT take when a pharmacy multiple is not applying for their own authorised witnesses for the destruction of CDs? |
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Response |
It is important that all pharmacies do not build up stocks of expired or unwanted CD stocks by ensuring that they are destroyed as soon as is practicable. However, multiple organisations cannot be forced to apply for their own witnesses but they should be mindful of the resource implications for the PCT AO to provide sufficient witnesses. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
How do PCT AO recognise who are the authorised witness for the destruction of controlled drugs in Pharmacy multiples? |
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Response |
A person authorised by an AO should be authorised to witness the destruction of controlled drugs in any pharmacy or premises owned by the body corporate employing the individual in England. It is not intended that such an individual would be authorised by the accountable officer in every PCT area in which he or she may undertake the witnessing of destruction. However, should an AO wish to check the credentials of an authorised person they are at liberty to do so with the PCT AO where the body corporate has its headquarters. The National Prescribing Centre’s AO website has an up to date list of PCT AOs who have authorised witnesses for destruction of CDs for the pharmacy multiple. The PCT AO is usually where the multiple pharmacy has its headquarters, in the first instance you should contact the PCT AO where the pharmacy multiple is based. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
What are the legal requirements in connection with information sharing? |
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Response |
The “Controlled Drugs (Supervision of management and Use) Regulations 2006, part 4, regulations 22 to 31, sets out the legal requirements for the sharing of information. The regulations deals with the co-operation between a number of listed health care bodies and other organisations in regards to the disclosure, the sharing and the recording of information. In addition, you will need to be aware of the legal requirements for the storage of information relating to CD incidents and monitoring which must be compliant with the ‘Data Protection Act’ 1998 and ‘Caldicott Guidance’. Regulation 18 of the ‘Controlled Drugs (Supervision of Management and Use) Regulations 2006’ place a statutory duty of collaboration on healthcare organisations, police forces, social services authorities and the relevant inspection and regulatory bodies to enable them to share information about potential CD offences and potential system failures. AOs should note that there is a legal requirement to share personal information related to possible breaches or offences and this requirement takes precedent over the Data Protection Act. It is important that PCT AOs leading a CD LIN ensure that their arrangements for information sharing are robust and up to date particularly as the NHS enters its tansitionary period. Information Sharing Agreements (ISAs) |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
What is a CD local intelligence network and what is my role in them? |
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Response |
A CD Local Intelligence Network (CD LIN) is the arrangement through which designated and responsible bodies come together to share information and intelligence (which could include the concerns or activities of a healthcare professional) with regard to the safe management and use of CDs. The establishment and leadership of the CD LIN lies with the PCT AO as set out in regulation 18 of the ‘The Controlled Drugs (Supervision of management and Use) Regulations 2006’. The regulations state those bodies which are to be included as members of the CD LIN, the list given in regulations is not exhaustive and it is for the CD LIN to determine what, if any, additional bodies should be involved. Please note: the CD LIN meeting is a forum time for all bodies to gather and share concerns and intelligence rather than a time to analyse and discuss prescribing data. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
What impact will the changes to the structure of the NHS have on PCT Accountable Officer role and the CD Local Intelligence Networks? |
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Response |
Currently the PCT responsibilities remain unchanged until 2013. PCTs are still expected to continue to discharge their statutory functions, as well as continue with self-assessments of services they contract. At the moment we do not know what the future arrangements will be. However, it is likely the arrangements may require a change to existing legislation. It is therefore important to concentrate on ensuring current arrangements are as robust as possible, to enable any smooth transition when the future arrangements are known. It is also important not to speculate as to what form the new arrangements may take. |
Audit trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
I have concerns about a healthcare professional in their use of CDs, who should I talk to? |
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Response |
Should you become aware of an issue, you must talk to your local Accountable Officer (AO). If you are the PCT AO regulation, 18 of the “The Controlled Drugs (Supervision of management and Use) Regulations 2006” requires that you have in place appropriate arrangements to handle concerns that have been raised about the performance of all relevant persons including healthcare professionals (Regulations 23 to 25). |
Audit trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
Can the Local Medical Committee (LMC) or the Local Pharmaceutical Committee (LPC) be part of a Local Intelligence Network? |
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Response |
It is inappropriate to have LMC or LPC representative as part of the membership of a CD LIN, as their presence may inhibit other responsible bodies from sharing information about individual practitioners. The purpose of the CD Local Intelligence Network (LIN) is to share information and intelligence from different sources, which could include information about individual contractors. There would be a clear conflict of interests if representatives from the LMC or LPC were also members of LINs. This, however, does not prevent the lead PCT AO from discussing issues raised at the LIN with the LMC / LPCs outside of the LIN meeting but they should be mindful of confidentiality issues. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
Is the Accountable Officer responsible for investigating CD problems in a care home? |
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Response |
Care homes are required to notify the Care Quality Commission (CQC), as their regulator, of deaths and other specified incidents. These include theft of property, incidents of abuse and incidents reported to or investigated by the police. A serious controlled drug concern will need to be reported to the PCT AO that is leading the CD Local Intelligence Network (CD LIN), but some controlled drug breaches (e.g. a cupboard irregularity, a minor recording error) will be handled by the regulator and will not necessarily need to be reported to the CD LIN. The care home provider is responsible for having procedures in place which they monitor and review to share concerns about the mishandling of Controlled Drugs. In practice this means that concerns will usually be brought to the CD LIN by CQC, although the Care Home manager will also need to be aware of the role of the PCT AO and could also report to the LIN through them. In the case of any very serious concern escalation would need to be sooner than waiting for the next CD LIN meeting. 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). Care homes usage of controlled drugs is very small in comparison with other health provider units. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
Other than, the person for whom the controlled drugs were prescribed who else can be in legal possession. |
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Response |
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 their 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. Local SOPs should cover this area and who are allowed to collect CDs out-of-hours. It is recommended that the nominee carry a letter of authorisation issued by the relevant head or manager of the service they provide as this will help should they be questioned or an incident arise. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office and the General Pharmaceutical Council on 22 February 2011 |
Who is responsible for doctors when they are mainly employed by the NHS but on occasion engage in Private Practice when concerns arise over their private practice? |
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Response |
The general rule is that the responsibility for the doctor whilst carrying out their NHS work falls to the main NHS employing body or with the organisation providing the private treatment. However, it can become more difficult to distinguish responsibilities should the problem arise with the private practice of the doctor. If the private practice is in a private hospital then the AO of that private organisation should share their concerns with other AOs where they are working and include the CD LIN. The Health and Social Care Act (Section 119 part 5) introduced the Responsible Officer (RO). One of the new roles of the RO is to ensure that doctors who fall short of the professional standards expected, receive appropriate remedial, performance or regulatory action. The Act states that every doctor will have an RO who will be responsible for oversight of all aspects of that doctor's practice. The Trust’s RO for whom the doctor spends the majority of their professional time will be responsible for the doctor. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
How should organisations obtain and use CDs when providing private or voluntary sector ambulance/paramedic services? |
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Response |
State Registered Paramedics are covered by Group Authorities, which allow them to possess and administer, and therefore obtain certain CDs namely, morphine sulphate injection and diazepam for the purposes of administration for the immediate necessary treatment of sick or injured persons. The Group Authorities, also cover NHS ambulance trusts, NHS paramedics and privately employed (including self-employed) paramedics. State Registered Paramedics are also covered, when acting in their capacity as such, to supply or offer to supply, under and in accordance with the terms of a patient group direction, any drug specified in Schedule 4 or Midazolam to any person who may lawfully have that drug in his possession, except for: Companies operating private paramedic services who want to hold a stock of drugs in circumstances not covered by the above authorities must apply for the relevant licensing. Further information on licensing can be found at: www.homeoffice.gov.uk/drugs/licensing/domestic-licences/ The Department of Health is leading a working group, which is looking in to the safer management of CDs by Ambulance and Paramedics; the group will report the findings back in the Spring and followed by guidance later in 2011. Guidance on licensing can be obtained from the Home Office Drugs Licensing and Compliance Unit. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission , Home Office on 22 February 2011 |
Should doctors working at a sporting or similar events, for the purpose of immediate and necessary treatment, order their supply of CDs through one doctor, or should each order their own supply? |
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Response |
If a private/voluntary ambulance service employs a doctor then he or she could obtain their own supplies of CDs. The Home Office recommends that as best practice transfers of CDs between two doctors should be witnessed by another member of staff, who must sign the CD register to confirm the transaction. However, if robust arrangements are not in place, each doctor should obtain their own individual supplies of CDs whilst ensuring they each have in place proper accountability for the supply, storage, administration and destruction of the CDs. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office on 22 February 2011 |
Can paramedics use a CD requisition form without a private CD number? |
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Response |
Yes, they are able to use a private CD requisition (in effect a letter) without a cross reference to a private CD number. AOs may wish to support any private paramedics based in their area by working with pharmacists to ensure that their identities are confirmed before CDs are supplied and their use, storage, record keeping and disposal are monitored. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
There is a slimming clinic in my area, who is responsible for regulating their safe management and use of CDs? |
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Services provided in a slimming clinic consisting of advice or treatment by, or under the supervision of, a medical practitioner, including the prescribing of medicines for the purposes of weight reduction is a Regulated Activity under the Health and Social Care Act 2008 and are required to be registered with the Care Quality Commission (CQC). There remain some exemptions in the regulations that may apply to slimming services. These are where slimming services are being provided in a surgery or consulting room by an individual medical practitioner or a group of medical practitioners all of whom also provide services (whether there or elsewhere) under arrangements made pursuant to the 2006 Act. An exemption also applies where medical services by a provider whose sole or main purpose is the provision of primary medical services for specific circumstances, which will cease on 1st April 2012. The main CDs used in slimming clinics are the schedule 3 drugs phentermine and diethypropion. Lawful possession of these remains the responsibility of the medical practitioner concerned and there is no lawful authority for clinic managers or unqualified personnel to undertake this activity. The Home Office does not issue controlled drug licences to slimming clinics for the this purpose. Regulation 19 of the Controlled Drugs (Supervision of Management and Use) Regulations 2006 states that any CD concerns/issues concerning registered slimming clinics must be brought to attention of the CQC, to take forward. However, if the clinic is not registered with the CQC, the PCT has both the responsibility and right of entry to inspect and follow up issues as set out in the first Part of Regulation 19 of the above Regulations. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office on 22 February 2011 |
Is there a listing of private dentists and how are they regulated? |
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Response |
No. Regulation of the dental professionals in the UK is the responsibility of the General Dental Council (GDC). From 1st April 2011 dental practices will be required to register under the Health and Social Care Act 2008 with the Care Quality Commission (CQC). |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
Does the safer management of controlled drugs regulations and guidance apply to private dentists? |
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Response |
Yes. The Health Act 2006 applies to all healthcare professionals and so all 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). |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission on 22 February 2011 |
As a PCT Accountable Officer what are my responsibilities for ensuring the safe management and use of CDs in my local prison? |
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Response |
Prisons themselves are not Designated Bodies under the regulations and therefore are not required to appoint their own AO. Prisons, including Prison Health are subject to inspection by Her Majesty's Inspectorate of Prisons (HMIP). HMIP have a service level agreement with the General Pharmaceutical Council 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 PCTAO. The healthcare provision within Prisons is commissioned by the local PCT, the PCT AO 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 and should be detailed in the commissioning documents. In ensuring suitable arrangements are in place for the safe delivery of CDs it may be helpful to have in place an appropriate lead in the prison to ensure there is an effective dialogue and feedback mechanism to the AO. The Department of Health is leading a working group, which is looking in to the safer management of CDs in Prisons and Offender Health; the group will report the findings back in the Spring and followed by guidance later in 2011. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office and the General Pharmaceutical Council on 22 February 2011 |
Does a private prison require a licence from the Home Office to hold CDs? |
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Response |
Yes. There are two types of licensing: one to cover healthcare settings and the other offender management settings (e.g. the possession for disciplinary purposes the illicit drugs discovered on routine search. Healthcare providers (other than PCTs directly providing services in HMP settings) must be licensed in their own right and licences are applied for via the Home Office DLCU website (www.drugs.homeoffice.gov.uk/drugs-laws/licensing) |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission, Home Office and the General Pharmaceutical Council on 22 February 2011 |
How are the police involved in the day-to-day inspection of Controlled Drugs in community pharmacies and their destruction? |
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The police role is to provide support to all AOs and LINs in investigation of incidents and concerns involving controlled drugs. In line with this, the police are involved in supporting intervention with a range of partner organisations through use of their powers of entry and inspection. The General Pharmaceutical Council (GPhC) is the regulator for the safe management, use of controlled drugs in community pharmacy and interact with the police CD Liaison Officer through LINs. Neither the police nor the GPhC Inspectors routinely witness destruction. This has allowed the police greater emphasis on investigation, intelligence and partnership working, particularly through LINs. |
Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
I am aware that Vets in my area are in possession of CDs. Who is responsible for ensuring their safe management and use? What are the regulations around the Safe Management of Controlled Drugs for a Racecourse |
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Response |
The Veterinary Medicines Directorate (VMD) regulates the use of veterinary medicinal products, including those that are CDs, and the use of human products in animals, including those that are CDs. New provisions for Vet inspections were first introduced in the Veterinary Medicines Regulations 2007 and came into force on 1 April 2009. The inspections will be carried every 4 years as a minimum. The objective is to enable checks on compliance with the Regulations on the storage and supply of veterinary medicines, including CD's. 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 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 CDs are classified as POM - V and therefore can only be prescribed by vets registered with the Royal College of Veterinary Surgeons (RCVS). Human CD can be used in animals under the Cascade system, but again they could only be prescribed by a vet registered with the RCVS. The Cascade system 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.
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Audit Trail |
Response agreed by Department of Health, Care Quality Commission and the General Pharmaceutical Council on 22 February 2011 |
