Skabt af: Lægemiddelstyrelsen, Sundhedsstyrelsen, Lægemiddelstyrelsen.

Læger, tandlæger og jordemødre har en pligt til at foretage indberetning af formodede bivirkninger til Lægemiddelstyrelsen, ligesom patienter, pårørende og borgere i al almindelighed har mulighed for at foretage indberetning. Sentinel anvendes til at overvåge lægemidlers sikkerhed og føre register over alle danske indberetninger om formodede bivirkninger ved lægemidler til mennesker.

Skabt af: Lægemiddelstyrelsen, Sundhedsstyrelsen, Lægemiddelstyrelsen.

GoPro skal • Sikre at Lægemiddelstyrelsen lever op til god forvaltningsskik og andre relevante krav i lovgivningen i forbindelse med journalisering og arkivering af sager • Være Lægemiddelstyrelsens arkiv og indeholde alle relevante sager og dokumenter. Digitale sager og dokumenter er det juridisk bindende medium. Der findes ikke officielle papirarkiver, dog opbevares ikke skanningsegnet materiale i vores arkiver. Papir er et arbejdsredskab, som smides væk efter brug. • Være et grundlag for effektiv videndeling i Lægemiddelstyrelsen • Fungere som dagligt arbejdsværktøj for medarbejderne som et integreret led i arbejdsprocessen • Bidrage til kvalitet og ressourceeffektivitet i arbejdsprocesser gennem understøttelse af standardiserede arbejdsprocesser, integration til fagsystemer, genbrug af data og i videst muligt omfang automatisk opmærkning af sager og dokumenter • Understøtte sagsstyring og dannelse af ledelsesinformation, herunder både sagsstatistik og overblik over journaliseringskvalitet

Skabt af: Psykiatrisk Center København, Merete Nordentoft.

Objective: To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual. Design: Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. Setting: Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark. Participants 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203). Interventions OPUS treatment consists of three core elements-modified assertive community treatment, family involvement, and social skill training-with a patientcase manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment. Main outcomes:Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation. Results Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference-0.10 (95% confidence interval 0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment were more likely to remain in contact with specialised mental health services (90.4% v 55.6%, P < 0.001), had higher client satisfaction (estimated mean difference 2.57 points (95% confidence interval 1.36 to 3.79), P< 0.001), and had a stronger working alliance(estimated mean difference 5.56 points (95%confidence interval 2.30 to 8.82), P=0.001) thanthe control group. Conclusions: This trial tests SEI treatment for upto five years for patients with first episodeschizophrenia spectrum disorder; previous trialshave found treatment effects for programmeslasting from one to three years. The prolongedSEI treatment had few effects, which could bedue to the high level of treatment provided tocontrol participants and the late start ofspecialised treatment.