Regulation by the Care Quality Commission (CQC)
The Care Quality Commission (CQC), as the regulator of health and social care services, is responsible for ensuring service providers manage and use CDs safely.
The CQC have produced guidance and self-assessment tools to help organisations establish whether they have the right governance processes in place.
The CQC produces some of its ‘Mythbusters’ series for dentists, but does not have a dental-specific CD Mythbuster. However, much of the information in their GP Mythbuster 28: Management of controlled drugs is equally applicable to dentists.
CD leadership within organisations
All healthcare organisations should appoint a named person to oversee CD management and governance.
Controlled Drug Accountable Officers (CDAOs)
The Controlled Drugs (Supervision of Management and Use) Regulations 2013 require CDAOs to be appointed in NHS organisations and private hospitals. CDAOs are responsible for managing all aspects of the use and handling of CDs in their organisation.
The following organisations must appoint a CDAO and register their details with the CQC:
- NHS trusts
- NHS England Local Area Teams
- independent hospitals in England
- headquarters in England of the regular or reserve Armed Forces
There is a list of all CDAOs in England on the CQC website, including those in NHS regional teams. It is updated monthly and includes their contact details. To open the list in Excel, follow the link and choose ‘Find out more’ then ‘View our current register’.
CDAOs and obtaining a dentist prescriber number
The NHS regional CDAOs are responsible for issue of the dentist prescriber numbers for all private and NHS dentists. Dentist prescriber numbers are used when:
- ordering CDs using the required form FP10CDF
- ordering and completing private CD prescription forms FP10(PCD)
To obtain a dentist prescriber number, contact the relevant CDAO. They will send an application form for completion and return. They will also provide the information needed to order FP10 (PCD) forms.
CD leads in smaller organisations
Small organisations are not required to appoint a CDAO. However, NICE guidance on Controlled drugs: safe use and management advises appointing a named CD lead to oversee CD management and governance.
Standard operating procedures (SOPs)
The 2013 Regulations require healthcare organisations to have SOPs for use and management of CDs. SOPs should cover all aspects of CD management, including:
- security, including access to CDs
- ordering and receipt
- record-keeping, including regular stock check and audit requirements
- prescribing and clinical monitoring
- administration, including any witness requirements
- denaturing and disposal, including any witness requirements
- transport (including transfer between care settings), including records
- reporting and investigation of incidents, concerns and complaints, including how to contact the relevant NHS regional lead CDAO
SOPs should be readily accessible to all staff, and should highlight accountabilities and roles of all members of the dental team when managing CDs.
All staff should be trained and have the relevant knowledge and skills to undertake the tasks required of them to manage CDs safely.
Reporting adverse incidents involving CDs
All organisations within an NHS region are required to report CD incidents and concerns to their local or regional CDAO, ideally within 48 hours of identifying the incident.
NHS Regional CDAOs collate incidents involving CDs reported to them including those from dental practices. Incidents of significant concern occurring locally and involving CDs are shared by CDAOs through a cascade alert with healthcare professionals, including dental practices.