The Danish Health and Medicines Agency - also a supervisory organisation 

1. The Danish Health and Medicines Agency - also a supervisory organisation Anne Mette Dons, MD Head of Department Supervision and Patient Safety

2. The Danish Population • 5.4 million inhabitants • 1 million younger than17 years 1 million over 60 years • 5 regions and • 98 municipalities

3. 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

4. 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

5. Health sector and Health personnel • The new Agency covers many areas • We cover: • The Health Care Sector • Health Care Personnel

6. We are • One central department Supervision and Patient Safety • Three regional departments • Regional Public Health Medical Officers • East • North • South 9th of February

7. Main obligations of The National Board of Health(The Health Act) • Surveillance • Counseling • Supervision

8. Other institutions in Patient Safety/rights National Agency for Patients' Rights and Complaints The Patient Insurance Association

9. 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.

10. 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

11. Now - The Whole Bunch…

12. How did we get there? • The PRESS • Almost all changes in legislation came after a scandal

13. 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.

14. 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

15. Risk organisation Is the incident due to the organisationand not the individual? • Working conditions • Local manuals • Collaboration within the hospital

16. 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

17. Risk areas - examples • Identification of patients • Resuscitation • Constraint in psychiatry • Mammography • Imaging • Psycho-pharmacological treatment • Treatment of substance abuse

18. Information Surveillance National Board of Health Supervision Sundhedsstyrelsen Guidance Supervision

19. Quality and supervision Quality Good Quality Acceptable medical standard Supervision Bad Quality

20. Challenges or miss-match • Speed • Muscles • Action Is it possible to meet all expectations in a time with financial cuts?

21. 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”

22. 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

23. 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

24. 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?