Anne Mette Dons, MD Head of Department Supervision and Patient Safety 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 Three regional departments 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 § 2 Overvågning Følge sundhedsforholdene Jf. Professor Lars Nordskov Nielsen i boneloc-sagen Tilsynsforpligtigelsen: indhente oplysninger foretage undersøgelser, herunder inspektioner Orientere vedkommende myndighed ved mangler/overtrædelser forudsætter et aktivt tilsyn Interventionstilsynet bygger på professor Lars Nordskov’s fortolkning af centralstyrelseslovens § 2 - § 3 Rådgivning Yder rådgivning og anden bistand i sundhedsfaglige spørgsmål til offentlige myndigheder § 4 Tilsyn Tilsyn med enkelt personers sundhedsfaglige virksomhed Individorienteret Baseret på det personlige ansvar jf. aut. lovene Reaktionstilsyn Forudsætter hændelser før reaktion

Other institutions in Patient Safety/rights National Agency for Patients' Rights and Complaints The Patient Insurance Association Forskellige forslag til ændringer: Lægeforeningen Sundhedsministeriet lagt på is til efteråret

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.

Only incidence reports Means 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 1.1.1956 Fratagelse af ordinationsret

Now - The Whole Bunch… Risk Areas Risk Organisations Risk personnel

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 organisation and 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 17

Information National Board of Health Supervision Sundhedsstyrelsen   National Agency for Patients' Rights and Complaints The Patient Insurance Association Health Personnel Adverse events Dentist complaint system National patient diagnoses and treatment registrar The scientific societies The Accreditation programme (IKAS) The Press Surveillance National Board of Health Supervision Sundhedsstyrelsen Guidance Supervision .

Quality and supervision 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?