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?