The Roles and Responsibilities of the Controlled Drug Accountable Officer - Canice Ward-Medicines Regulatory Group - March 2021
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The Roles and Responsibilities of the Controlled Drug Accountable Officer Canice Ward- Medicines Regulatory Group – March 2021
BACKGROUND
On 31 January 2000, Harold Shipman was convicted of murder
of 15 patients. However actual death toll around 200.
Inquiry chaired by Dame Janet Smith
6 reports including recommendations
https://www.bbc.co.uk/iplayer/episodes/m000n1h4/the-
shipman-files-a-very-british-crime-story
SHIPMAN INQUIRY
Fourth Report – Regulation of Controlled Drugs in the Community
Fifth
Report – Safeguarding patients: Lessons from the Past –
Proposals for the Future
Dame Janet Smith praised the centralised nature of the inspection
arrangements for controlled drugs in Northern Ireland
Recommendations from 4th and 5th reports can be seen in changes
to Misuse of Drugs Regulations and through the Health Act 2006HEALTH ACT 2006 Provides the legislative basis for the Relevant Authority to make Regulations to ensure the safe & effective management of CDs in healthcare Sets out the scope of what those Regulations might include eg CDAOs, DBs, sharing of information, collaboration, enforcement…. EmpowersPolice and Enforcement Bodies to enter premises, inspect, seize documents etc Creates offences for obstructing Police and Enforcement Bodies Gives the Relevant Authority the power to issue guidance to Designated Bodies in relation to how the duties of the CDAO is being fulfilled and to Responsible Bodies concerning their duty to collaborate in matters related to CDs In NI the Relevant Authority is the Department of Health
The Controlled Drugs (Supervision of
Management and Use) Regulations
(Northern Ireland) 2009
https://www.legislation.gov.uk/nisr/2009/225/contents/madeTHE CONTROLLED DRUGS (SUPERVISION OF MANAGEMENT AND USE) REGULATIONS
(NORTHERN IRELAND) 2009
Made under Health Act 2006
Similar to England/Scotland/Wales
Into operation 1 October 2009, amended July 2015
Create/harness structures and processes that ensure the safe management and use
of controlled drugs
Formalised, to some extent, existing arrangements
Legislation relates to all CDs (Sch 1 to Sch 5)
Often referred to as ‘ The Accountable Officer Regulations’THE CONTROLLED DRUGS (SUPERVISION OF MANAGEMENT AND USE) REGULATIONS (NORTHERN IRELAND) 2009 Identifies Designated Bodies (DB) Appointment of Accountable Officer by DBs Roles and Responsibilities of AOs Responsible Bodies Duty of collaboration
DESIGNATED BODIES Identifies Designated Bodies HSC Board HSC Trusts Relevant Independent Hospitals Northern Ireland HQ of regular or reserve forces
ACCOUNTABLE OFFICERS (AO)
Each
Designated Body must appoint or nominate a CD
Accountable Officer (AO)
Therole of the AO is to ensure the safe and effective management
of controlled drugs throughout his/her designated body and to
ensure that any person acting on behalf of, or providing services
under arrangements made with, his designated body also has
appropriate systems in place to ensure the safe and effective
management of controlled drugs
Each designated body that has an AO shall provide them with the
funds and other resources necessary to enable the AO to discharge
their responsibilitiesACCOUNTABLE OFFICERS (AO) - APPOINTMENT TheAO must be a ‘Senior Officer/Manager’, ‘ an officer or employee of the Designated Body’ who is ‘fit, proper and suitably experienced person’ and who ‘does not, or does only exceptionally, prescribe, supply, administer or dispose of controlled drugs’ as part of their duties Thereare 20 AOs at present – a list is held by the Department of Health - https://www.health- ni.gov.uk/sites/default/files/publications/dhssps/accountable- officer-contact-list.pdf TheAO may appoint a Designated Officer to assist with their responsibilities (This is not part of the legislation)
ACCOUNTABLE OFFICERS (AO) - REMOVAL TheDesignated Body may remove its AO if they are no longer considered to be fit to be so or if their role changes in that they no longer satisfy the aforementioned conditions. A person shall be presumed (unless the contrary is proved) to be unfit to be an AO if they wilfully, negligently or through lack of competence breach their duties as an AO.
ACCOUNTABLE OFFICERS (AO) - ROLE
AOs must:
secure the safe management and use of CDs
ensure adequate destruction and disposal of CDs
ensure monitoring and auditing of the management and use of CDs
ensure relevant individuals receive appropriate training
maintain
a record of concerns and, assess, investigate and take
appropriate action on well-founded concerns
ensureappropriate arrangements for ensuring the proper sharing of
informationENSURING THE SAFE AND EFFECTIVE MANAGEMENT OF CONTROLLED DRUGS TheAO must establish appropriate arrangements throughout his Designated Body to ensure compliance with Misuse of Drugs legislation whilst having regard to best practice in relation to the management and use of CDs. The AO must ensure any person acting on behalf of, or providing services under arrangements made with, his designated body complies with legislation and best practice also. The AO must ensure these arrangements are reviewed
ENSURING THE SAFE AND EFFECTIVE MANAGEMENT OF CONTROLLED DRUGS -SOPS Ensure adequate and up to date SOPs are in place to cover: Who has access to CDs Where they are stored Security during storage and transport Disposal and destruction Who to alert if complications arise Record keeping (including CD register & patient returned S2 CDs) Prescribing, supply and administration of controlled drugs, and Clinical monitoring of patients who have been prescribed controlled drugs
DESTRUCTION AND DISPOSAL Ensure appropriate destruction and disposal arrangements are in place for CDs: Obsolete/Out of Date stock/ Damaged stock (Authorised Witness) Patient returns Patient's own drugs Suspected Illicit CDs/Drugs https://www.health-ni.gov.uk/sites/default/files/publications/health/doh-cd- destruction-guidance.pdf
ENSURE MONITORING AND AUDITING OF THE MANAGEMENT
AND USE OF CDS
An accountable officer shall—
(a)
establish and operate, or ensure that his designated body establishes and
operates, appropriate arrangements for monitoring and auditing his
designated body's management and use of controlled
These may include:
Using data analytic tools
Having a system in place to alert the AO of any incidents,concerns,complaints
Having an incident reporting system in place, and
Having appropriate arrangements in place to be able to analyse and respond
to incidentsDECLARATION AND SELF-ASSESSMENT-
MONITORING/AUDITING
HSC BOARD: from GPs and dentists
RQIA: from HSC Trusts or any person registered with RQIA
who provides healthcare
DEPARTMENT: from registered pharmacieshttps://www.health- ni.gov.uk/sites/default/files/p ublications/health/Declaratio ns-and-Self-Assessments- 2020.pdf
ENSURE RELEVANT INDIVIDUALS RECEIVE APPROPRIATE TRAINING An accountable officer shall ensure that relevant individuals with the designated body involved in the management and use of controlled drugs receive periodic training to carry out their responsibilities. This shall include: Training on CD SOPs upon initiation Receiving updates when CD SOPs change
RESPONSIBLE BODIES
Legislation also identifies Responsible Bodies
Includes all
Designated Bodies, the Department, RQIA,
CFPS BSO, Regulatory Bodies and PoliceMAINTAIN A RECORD OF CONCERNS AND, ASSESS, INVESTIGATE AND TAKE APPROPRIATE ACTION ON WELL- FOUNDED CONCERNS Accountable Officer must: Monitor & audit the use of controlled drugs by Relevant Individuals Assess and record concerns Request assistance from/share concern with Responsible Bodies Investigate where appropriate Take action where appropriate
ARRANGEMENTS FOR SHARING INFORMATION
An accountable officer shall establish and operate appropriate arrangements for
ensuring the proper sharing of information by his designated body with other
responsible bodies regarding the management and use of controlled drugs.
The Accountable Officer of the HSCB shall operate a Local Intelligence Network
The purpose of the LIN is to facilitate the co-operation of responsible bodies who are
members of the LIN in connection with—
the identification of cases in which action may need to be taken in respect of matters
arising in relation to the management or use of controlled drugs by relevant persons;
the consideration of issues relating to the taking of action in respect of such matters;
the taking of action in respect of such matters.DUTY OF COLLABORATION
Legislation
requires communication and co-operation between
Responsible Bodies
Provides a statutory basis for sharing information about Relevant
Individuals
This
allows for collation and sharing information from
concerns/incidents involving CDs
Ensureseffective inspection, investigation and collaboration on
controlled drug mattersLOCAL INTELLIGENCE NETWORK (LIN)
BSO
GMC Trust s
Relev ant
I ndependent HSCB
Hospit als
Local
I ntelligence
Network
PSNI -Police RQI A
Depart ment of
NMC Healt h
Pharmaceut ical
Societ yTHE CONTROLLED DRUGS (SUPERVISION OF MANAGEMENT AND USE) REGULATIONS (NORTHERN IRELAND) 2009 Identifies Designated Bodies (DB) Appointment of Accountable Officer by DBs Routine Monitoring Investigating concerns Duty of collaboration
QUESTIONS?
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