Frequently Asked Questions
These Frequently Asked Questions have been written in response to queries we have received about the implications and working practices of The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 which came into operation on 1 October 2009. The responses are based on the Medicines Regulatory Group’s interpretation of this legislation.
The questions raised may not in all cases address the specific circumstances within your own organisation. You should therefore carefully consider the applicability of responses within the context of your governance arrangements and seek legal guidance where you consider that they do not adequately reflect your organisational arrangements or issues.
The Medicines Regulatory Group of DHSSPS will make every effort to regularly review these FAQs to ensure that they are both current and accurate reflecting legislative changes and policy developments. Reliance on information, material, advice, or other linked or recommended resources, shall be at your sole risk, and DHSSPS assumes no responsibility for any errors, omissions, or damages arising. Users of this information are advised to seek legal advice if embarking on any actions that could carry personal or organisational liabilities.
If there is an issue which requires further clarification please send an email to: shona.coy@dhsspsni.gov.uk
- Role of the Accountable Officer (AO)
1.1 Which organisations require an Accountable Officer?
1.2 For the purposes of the safe management and use of controlled drugs (CD), how is an independent hospital defined?
1.3 As a registered manager of an independent hospital I am occasionally called on to supply, administer or dispose of controlled drugs– can I be the Accountable Officer?
1.4 As an Accountable Officer am I accountable in law as opposed to being accountable to an individual or to the organisation?
1.5 Who can witness the destruction of CDs? - Local Intelligence Network
2.1 Who can attend the Local Intelligence Network?
2.2 My organisation has no concerns – do I have to send an Occurrence Report?
2.3 I have a concern which relates to a patient. Do I report this to the Local Intelligence Network? - Declarations and self assessments
3.1 I know that community pharmacies have to complete a declaration and self-assessment form - do secondary care pharmacies also need to complete one and, if so who should sign this form? - Private practice and CDs
4.1 There is a slimming clinic in my area. Who is responsible for regulating their safe management and use of CDs? - Prisons
5.1 Which Accountable Officer is responsible for ensuring the safe management and use of CDs in my local prison and how is this managed?
- Role of the Accountable Officer
The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 state that all Designated Bodies must appoint an Accountable Officer (AO).
In Northern Ireland the Designated Bodies defined by the legislation are:
- The HSC Board
- HSC Trusts - 5 in total
- Northern Ireland Ambulance Service
- Independent Hospitals ( including hospices)
The Designated Bodies are defined in Regulation 3 while Regulation 4 confirms that each of these Designated Bodies is required to appoint or nominate an AO.
AOs must notify the DHSSPS in writing of the appointed/nominated AO and also of their removal.
An independent hospital is defined by the Regulation and Quality Improvement Authority (RQIA) as a hospital which is not managed by a health and social care trust. Independent hospitals, which include hospices, registered with RQIA are Designated Bodies under the regulations governing the management of controlled drugs, and therefore must appoint an Accountable Officer and register these details with the DHSSPS.
1.3 As a registered manager of an independent hospital I am occasionally called on to supply, administer or dispose of controlled drugs– can I be the Accountable Officer?
Regulation 5 of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 states that the Accountable Officer (AO) must not routinely supply, administer or dispose of controlled drugs as part of their duties.
It can sometimes be difficult for AOs working in small organisations to be excluded entirely from the supply (which may include prescribing), administration or disposal of controlled drugs. The organisation should consider who else they have that could be suitable.
In relation to involvement in an on-call rota it is important to consider if the involvement is ‘routine’ in nature. We would suggest that if someone has a regular practice session involving CDs then that is 'routine'.
If total separation is not possible can you build a transparent team arrangement so that there is someone else that can step in should an issue arise in the practice area of the AO? These are the issues that an organisation needs to consider in making their appointment.
Regulation 5 prescribes the persons who may be appointed as AOs. While an organisation must appoint within these parameters the decision as to who will be nominated AO is down to local determination.
There is also the option to change an AO nomination at any time if roles change within the organisation.
1.4 As an Accountable Officer am I accountable in law as opposed to being accountable to an individual or to the organisation?
It is not a question of being accountable to a particular person or organisation. As an Accountable Officer you are the person who is responsible for certain functions set out in the legislation and responsible for ensuring that those functions are carried out in accordance with the legislation.
Any stocks of obsolete, expired or unwanted Schedule 2 controlled drugs (not ‘patient returned’ controlled drugs), which require destruction can only be destroyed in the presence of a person authorised by the DHSSPS.
Authorised witnesses currently include pharmacy inspectors and other named persons employed by Trusts who have been authorised and trained by DHSSPS.
Authorised witnesses who are Trust employees are authorised to carry out this activity strictly related to the business of their employing Trust.
An Accountable Officer (AO) cannot routinely be involved in the activity of destroying or witnessing the destruction of CDs as AOs must be independent of any day-to-day disposal of CDs.
2. Local Intelligence Networks
Regulation 18 of The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 indicates those bodies which are to be included as members of the Local Intelligence Network (LIN). The list given is not exhaustive and it is for the network to determine what, if any, additional bodies should be involved.
An organisation does not therefore have to be defined as a Responsible Body in Regulations to be included in the LIN.
Yes, you are required to complete and submit an Occurrence Report to the chair of the LIN even if you have no concerns to report.
Regulation 29 of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 requires all Accountable Officers to return a quarterly Occurrence Report to the chair of the LIN, with details of any concerns or, as in this case, confirmation that they have no concerns (sometimes called a nil return).
2.3 I have a concern which relates to a patient. Do I report this to the Local Intelligence Network?
Regulation 25 of The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 requires Responsible Bodies to co-operate by disclosing information as regards relevant persons.
Regulation 23 of the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 defines all groups who are to be considered as relevant persons. These include health professionals and employees who are not health professionals engaged in the provision of services directly to, or on behalf of, a designated body.
It follows therefore that, unless the concern relates to an individual who is included within this list then, it does not have to be reported to the Local Intelligence Network.
In response to the question the answer is no – if the patient is not listed under Regulation 23 the concern does not have to be reported.
Any person whether professional, member of the public or a patient may report concerns about CDs to the relevant Accountable Officer.
The Accountable Officer list is in the public domain at www.dhsspsni.gov.uk/index/pas/pas-accountable-officer/pas-contact-details.htm
3. Declarations and self-assessments
3.1 I know that community pharmacies have to complete a declaration and self-assessment form - do secondary care pharmacies also need to complete one and, if so who should sign this form?
DHSSPS issues a declaration and self-assessment form annually to all community pharmacies and HSC Trust pharmacies in Northern Ireland.
These are to be completed and retained in the front of the Controlled Drug register. This will become part of the routine record-keeping which will be examined by the Pharmacy Inspectors during their visits.
In answer to the question of who should sign the declaration and self-assessment form then this should be the responsibility of the senior pharmacist within your organisation. There is no reason why the person who has day-to-day responsibility for the management of controlled drugs could not complete the declaration and self-assessment form but the responsibility for providing this assurance should rest with the senior pharmacist within your organisation.
4. Private Practice
4.1 There is a slimming clinic in my area. Who is responsible for regulating the safe management and use of CDs by the clinic?
Fully Private Doctors / Independent Clinics are registerable with the Regulation & Quality Improvement Authority (RQIA) under the HPSS (Quality,Improvement and Regulation) (Northern Ireland) Order 2003. However, if the Doctor has any HSC practice, however small, they are exempt from registration. Therefore, some slimming clinics may fall outside of registration.
The main CD issues in slimming clinics are around the handling and management of the schedule 3 drugs phentermine and diethylpropion.
If the slimming clinic is registered with RQIA any CD concerns / issues should be reported to the RQIA as an untoward incident and RQIA takes the lead in following up, as stated in Regulation 25 of the Controlled Drugs (Supervision of Management and Use) Regulations 2009.
However, if the clinic is not registered with RQIA then the HSC Board has both the responsibility and right of entry to inspect and follow up.
5. Prisons
5.1 Which Accountable Officer is responsible for ensuring the safe management and use of CDs in my local prison and how is this managed?
Prisons are not Designated Bodies in regulation and so are not required to appoint their own Accountable Officer (AO).
The HSC Board commissions the services from the South Eastern HSC Trust and the SEHSCT AO is therefore responsible for assuring that the prison has suitable arrangements in place for the safer management of CDs.
Prisons 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 SEHSCT AO.
The AO can, but is not required to, carry out routine CD inspections. They should however have some mechanism for regular feedback on assurance, and be informed about concerns. The local arrangements for following up concerns should be set out in a standard operating procedure.
