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The Danish Health and Medicines Agency - also a supervisory organisation . Anne Mette Dons, MD Head of Department Supervision and Patient Safety. The Danish Population. 5.4 million inhabitants 1 million younger than17 years 1 million over 60 years 5 regions and 98 municipalities.
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The Danish Health and Medicines Agency - also a supervisory organisation Anne Mette Dons, MD Head of Department Supervision and Patient Safety
The Danish Population • 5.4 million inhabitants • 1 million younger than17 years 1 million over 60 years • 5 regions and • 98 municipalities
Structure and roles • Ministry of Health and Prevention • Political prioritisation, financial frame, legislation • The Danish Health and Medicines Agency • The health professional knowledge. The highest health authority. Delivers Independent Advise and Supervision. Monitoring health Care. Regulation and approval of drugs and medical devices • The Regions • Run the Hospitals, psychiatry, GP’s and specialised healthcare • The Municipalities • Prevention, rehabilitation, nursing and dependency treatment
The Danish Health and Medicines Agency • Established in 2012 • Merging • National Board of Health and The Danish Medicines Agency • National Board of Health was established in 1909
Health sector and Health personnel • The new Agency covers many areas • We cover: • The Health Care Sector • Health Care Personnel
We are • One central department Supervision and Patient Safety • Three regional departments • Regional Public Health Medical Officers • East • North • South 9th of February
Main obligations of The National Board of Health(The Health Act) • Surveillance • Counseling • Supervision
Other institutions in Patient Safety/rights National Agency for Patients' Rights and Complaints The Patient Insurance Association
IKAS – the Danish Health Care Quality Programme • An accreditation programme since 2005 • So far hospitals, pre-hospital care, pharmacists • A collaboration between the Central government and the Danish regions • Governed by Board • the Danish Health and Medicines Authority, • the Ministry of Health, the Danish Regions, • LGDK (Local Government Denmark), • the Danish Organisation of Private Hospitals • the Association of Danish Pharmacies.
Supervision from 1934-2000 • Only incidence reports • Almost only with focus on malpractice • Means • Revocation of authorisation due to illness, abuse or severe malpractice (danger for patients) • Limitation of the prescription right • Issuing of Statutory Orders and Binding Guidelines
How did we get there? • The PRESS • Almost all changes in legislation came after a scandal
What did we get? • A clear range of sanctions from “intensified supervision” to revocation of authorisation of the individual health personnel (2000-2013) • Inspection of nursery homes (2002) • Inspection of cosmetic treatment clinics (2008) • Inspection of clinics or hospitals where doctors perform private medical treatments (2012) • Sanctions to boards: Injunction as to which patient safety requirements the board has to comply with. DHMA can temporarily suspend the practice in whole or in part.
Risk Personnel - Malpractice DHMA decides if there is to be an investigation Can be on the basis of complaints • Often in writing, response is mandatory • Un-announced inspection possible • Publication of all sanctions on the web site
Risk organisation Is the incident due to the organisationand not the individual? • Working conditions • Local manuals • Collaboration within the hospital
Risk Areas – Focused inspections • Yearly subjects, chosen from complaints, insurance, incidents, adverse events • Examples • Patients rights, Safe medication, documentation in medical records, use of antipsychotic medicine
Risk areas - examples • Identification of patients • Resuscitation • Constraint in psychiatry • Mammography • Imaging • Psycho-pharmacological treatment • Treatment of substance abuse
Information Surveillance National Board of Health Supervision Sundhedsstyrelsen Guidance Supervision
Quality and supervision Quality Good Quality Acceptable medical standard Supervision Bad Quality
Challenges or miss-match • Speed • Muscles • Action Is it possible to meet all expectations in a time with financial cuts?
The first changes • In 2007 the Public Health Medical Officers merged with the DHMA • 15 institutions 5 departments in DHMA • Still separate electronic filing system • Transfer of cases between departments • 2010 Project “active supervision”
Changes in Supervision 2011 • More action and no duplication of work processes • Regional departments are always first instance in the handling of an incidence or inspection • Two coordinating work-groups with people from both the central and the regional departments • Use of new technology e.g. common filing system and video conferences • Goal: to strengthen patient safety, enhance quality and uniform processes and incident handling
Right now • Task Force since 1 June 2013 • Weekly meeting • Employees from the Central Department and the Regional Department • To ensure rapid progress • Emphasis on action plan in all cases • The Central Department has the coordinating responsibility • New clear performance targets
How do we meet the challenge? • Focusing the supervision within the legislative measures • Be open about what we can not do within our financial frame?