The Regulation and Quality Improvement Medicines Regulatory Group (MRG) Authority (RQIA) routinely monitors the inspectors conduct a cycle of compliance management of controlled in relevant visits to ensure that management of registered facilities, through its regulatory controlled drugs in the Trust pharmacies activity. complies with legislation and good practice. The notifications to RQIA of incidents and near misses involving controlled drugs have highlighted anomalies in the Hospices administration of prescribed controlled drug patches. The most frequent reported a cycle of compliance visits by MRG occurrence continues to be the late inspectors takes place on a thirty six administration of patches. Registered month basis at these facilities. Routine establishments are encouraged to analyse inspections are not due again until all incidents and implement any learning 2018. Interim visits are made, when which could improve practice. The requested by staff, to witness the importance of ensuring controlled drug destruction of unwanted or date-expired patches are administered in accordance Schedule 2 controlled drugs. with the prescriber’s directions is emphasised at all relevant inspections and RQIA inspectors continue to monitor Contract Research this. Organisations When concerns are identified in relation to Compliance visits by MRG inspectors, in the management of controlled drugs, relation to Misuse of Drugs legislation and these are discussed with registered associated good practice for the providers and when appropriate are management of controlled drugs, are referred to the Accountable Officer in the conducted at two facilities conducting relevant Trust. Phase I-II clinical trials. Routine inspections of the establishments were If any notifiable event reported to RQIA conducted in February and March 2015. identifies issues in relation to the prescribing or dispensing of controlled Authorised Witnesses drugs these are referred to the Health and Social Care Board. Misuse of Drugs legislation requires that As part of the regulatory activity in date-expired or otherwise unwanted medicine management inspections Schedule 2 controlled drugs stock be took place in the independent hospitals destroyed only under the supervision and which are required to appoint an direction of a witness authorised by the Accountable Officer. These evidenced Department. A programme for the training that the hospitals had robust systems in and authorisation of witnesses in Trusts place for the management of controlled and the larger community pharmacy drugs. chains continues to be managed by MRG. During 2015-16, RQIA engaged with the DoH to contact several independent 7. The Regulation and Quality hospitals in order that DoH could Improvement Authority determine if the hospitals met the definition of Independent ‘Relevant
Medicines Regulatory Group (MRG) inspectors conduct a cycle of compliance visits to ensure that management of controlled drugs in the Trust pharmacies complies with legislation and good practice. Hospices a cycle of compliance visits by MRG inspectors takes place on a thirty six month basis at these facilities. Routine inspections are not due again until 2018. Interim visits are made, when requested by staff, to witness the destruction of unwanted or date-expired Schedule 2 controlled drugs. Contract Research Organisations Compliance visits by MRG inspectors, in relation to Misuse of Drugs legislation and associated good practice for the management of controlled drugs, are conducted at two facilities conducting Phase I-II clinical trials. Routine inspections of the establishments were conducted in February and March 2015. Authorised Witnesses Misuse of Drugs legislation requires that date-expired or otherwise unwanted Schedule 2 controlled drugs stock be destroyed only under the supervision and direction of a witness authorised by the Department. A programme for the training and authorisation of witnesses in Trusts and the larger community pharmacy chains continues to be managed by MRG. 7. The Regulation and Quality Improvement Authority The Regulation and Quality Improvement Authority (RQIA) routinely monitors the management of controlled in relevant registered facilities, through its regulatory activity. The notifications to RQIA of incidents and near misses involving controlled drugs have highlighted anomalies in the administration of prescribed controlled drug patches. The most frequent reported occurrence continues to be the late administration of patches. Registered establishments are encouraged to analyse all incidents and implement any learning which could improve practice. The importance of ensuring controlled drug patches are administered in accordance with the prescriber’s directions is emphasised at all relevant inspections and RQIA inspectors continue to monitor this. When concerns are identified in relation to the management of controlled drugs, these are discussed with registered providers and when appropriate are referred to the Accountable Officer in the relevant Trust. If any notifiable event reported to RQIA identifies issues in relation to the prescribing or dispensing of controlled drugs these are referred to the Health and Social Care Board. As part of the regulatory activity in medicine management inspections took place in the independent hospitals which are required to appoint an Accountable Officer. These evidenced that the hospitals had robust systems in place for the management of controlled drugs. During 2015-16, RQIA engaged with the DoH to contact several independent hospitals in order that DoH could determine if the hospitals met the definition of ‘Relevant Independent
The-Accountable-Officers-Report-2015-16.docx