The Danish Health and Medicines Agency - also a supervisory organisation
Anne Mette Dons, MDHead of DepartmentSupervision 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 departmentsRegional 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
Now - The Whole Bunch…
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 investigationCan be on the basis of complaints
Often in writing, response is mandatoryUn-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 conditionsLocal 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
SundhedsstyrelsenNational Board
of Health
Supervision
Surveillance
Guidance
Supervision
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
Quality and supervision
Good Quality
Quality
Bad Quality
Supervision
Acceptable medical standard
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?