Vedtekter for Sykehusapotek Nord HF

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1 Styresak nr: Behandles: 25. februar 2011 Saksbehandler: Vedlegg: Espen Mælen Hauge Vedtekter for Sykehusapotek Nord HF FORSLAG OM VEDTEKTSENDRING I Sykehusapotek Nord HFs vedtekter fremgår under 4 blant annet at foretaket skal medvirke til at Helse Nord RHF kan oppfylle de sektorpolitiske målsettingene slik de fremkommer i nasjonale helsepolitiske, forskningspolitiske og utdanningspolitiske vedtak og planer. Sykehusapotek Nord HF s iverksetting skjer innen rammen av Helse Nord RHF s konkretiserende planer og vedtak. Virksomheten skal drives innenfor de mål, resultatkrav og rammer som fastsettes gjennom vedtekter, beslutninger truffet i foretaksmøtet, tildelte bevilgninger og vilkår knyttet til bevilgningsvedtakene. Hensynet til brukerne skal legges til grunn for foretakets samlede virksomhet. I vedtektene 4 er også det en opplisting av foretakets kjerneoppgaver og ansvarsområde. Forholdet til kommunehelsetjenesten er ikke nedfelt. Fremtidens helsetjeneste vil som følge av samhandlingsreformen karakteriseres av kortere liggetid på sykehusene, økt poliklinisk behandling, hjemmebehandling og mer avansert behandling og sykere pasienter i kommunehelsetjenesten. Ved å bidra til bedre rutiner for informasjonsflyt, samt god kunnskap om legemiddelbruk både i kommuneog spesialisthelsetjenesten, mener vi at Sykehusapotek Nord HF kan bidra til bedre samhandling mellom omsorgsnivåene og dermed bedre pasientsikkerhet.. Derfor ønsker vi nå et større fokus på å utvide tjenesteområdet til kommunehelsetjenesten. Dette kommer nærmere til uttykk i strategiplan for Endring av vedtektene skal skje av Foretaksmøte etter forslag fra helseforetakets styre, jfr. vedtektene 13: Endringer i vedtektene vedtas av foretaksmøtet. Styret for Sykehusapotek Nord HF tar eventuelt opp forslag til endringer i vedtektene dersom dette er nødvendig for å ivareta Sykehusapotek Nord HF sitt formål og hovedoppgaver. Styret for Sykehusapotek Nord HF mener at vedtektene således må endres slik at de samsvarer med de sektorpolitiske målsettingene slik de fremkommer i nasjonale

2 helsepolitiske planer, det regionale helseforetakets og sykehusapotekforetakets strategier. På denne bakgrunn foreslår styret for Sykehusapotek Nord HF følgende tilføyelse i 4, nytt fjerde avsnitt: Sykehusapotek Nord HF skal videreutvikle høy faglig kompetanse og en infrastruktur som er tilrettelagt for spesialisthelsetjenestens behov og være leverandør av varer og tjenester til sykehusene i Helse Nord. I tillegg skal det farmasøytiske tilbudet til sykehusenes pasienter og andre brukere av Sykehusapotek Nord HF, herunder pasientene i kommunehelsetjenesten, utvides og videreutvikles. Innstilling til vedtak: 1. Styret ved Sykehusapotek Nord HF foreslår for Foretaksmøtet å vedta følgende tilføyelse i helseforetakets vedtekter 4. Sykehusapotek Nord HF skal videreutvikle høy faglig kompetanse og en infrastruktur som er tilrettelagt for spesialisthelsetjenestens behov og være leverandør av varer og tjenester til sykehusene i Helse Nord. I tillegg skal det farmasøytiske tilbudet til sykehusenes pasienter og andre brukere av Sykehusapotek Nord HF, herunder pasientene i kommunehelsetjenesten, utvides og videreutvikles. 2. Styret ber Direktøren oversende saken til Foretaksmøtet for videre oppfølning. Espen Mælen Hauge direktør

3 SYKEHUSAPOTEK NORD HF VEDTEKTER 1 Navn Helseforetakets navn er Sykehusapotek Nord HF. 2 Eier Sykehusapotek Nord HF eies av Helse Nord RHF. 3 Helseforetakets formål Sykehusapotek Nord HF skal yte gode og likeverdige apotektjenester og skal legge til rette for forskning og undervisning. 4 Helseforetakets virksomhet Sykehusapoteket Nord HF skal medvirke til at Helse Nord RHF kan oppfylle de sektorpolitiske målsettingene slik de fremkommer i nasjonale helsepolitiske, forskningspolitiske og utdanningspolitiske vedtak og planer. Sykehusapotek Nord HF s iverksetting skjer innen rammen av Helse Nord RHF s konkretiserende planer og vedtak. Virksomheten skal drives innenfor de mål, resultatkrav og rammer som fastsettes gjennom vedtekter, beslutninger truffet i foretaksmøtet, tildelte bevilgninger og vilkår knyttet til bevilgningsvedtakene. Hensynet til brukerne skal legges til grunn for foretakets samlede virksomhet. Virksomheten omfatter de fagområder og funksjoner som var godkjent gjennom tildelte spesialiteter og funksjoner i helseforetakets virksomhet i Det geografiske ansvarsområdet for tjenestene, på de ulike nivå og innen de ulike fagfelt, omfatter de områder som helseforetakets virksomheter hadde ansvar for i 2001 med eventuelle endringer som vedtaes av RHF. Hovedoppgavene som helseforetaket skal bidra til å utføre er følgende: 1. Være en leverandør av de legemidler og apotekvarer som helseforetakene i regionen bestiller 2. Drive detaljsalg av legemidler til sykehusenes brukere 3. Produksjon av legemidler som vanskelig kan anskaffes som farmasøytisk spesialpreparat 4. Yte farmasøytiske tjenester for å fremme faglig og økonomisk rasjonell legemiddelbruk, herunder informasjon og rådgivning til helsepersonell og pasienter 5. Samordne apotektjenestene i regionen slik at helseforetakene kan yte kostnadseffektive tjenester av høy kvalitet 6. Kunne bidra med kompetanse og produksjonsfasiliteter ved beredskapsproduksjon av legemidler til den samlede helsetjenesten samt opprettholde et beredskapslager av legemidler Postadresse: Besøksadr.: Telefon: Telefax: Helse Nord RHF Sjøgata Epost: postmottak@helse-nord.no 8038 BODØ Organisasjonsnummer:

4 Helseforetaket skal i sin samlede oppgaveløsning ta hensyn til kapasitet og kompetanse i andre helseforetak. Helseforetaket skal drive faglig kvalitetssikring innen rammen av nasjonale og regionale standarder. Sykehusapotek Nord HF skal levere tjenester innen helsemessig og sosial beredskap slik dette er vedtatt av Helse Nord RHF / relevant beredskapsmyndighet. Sykehusapotek Nord HF skal drive forskning og utdanning på høyt nasjonalt og internasjonalt nivå innen de områder som naturlig følger av de funksjoner helseforetaket har som del av en universitetsklinikk. Sykehusapotek Nord HF skal etablere og delta i nødvendig samarbeid med universitet, høgskoler og andre relevante forsknings- og utdanningsinstitusjoner. Sykehusapotek Nord HF skal drive undervisning av pasienter og pårørende i tråd med bestemmelser i spesialisthelsetjenesteloven.. Sykehusapotek Nord HF er som del av en universitetsklinikk det fremste kompetansesenter innen sykehusapotek i Helse Nord RHF. Sykehusapotek Nord HF skal ivareta en sentral plass i det faglige nettverk i landsdelen. Helseforetaket skal delta i faglige og organisatorisk utrednings- og utviklingsarbeid. Sykehusapotek Nord HF skal delta i faglig nettverkssamarbeid. 5 Hovedkontor Sykehusapotek Nord HF har sitt hovedkontor i Tromsø kommune. 6 Styrende organer Sykehusapotek Nord HF ledes av et styre. Styret skal ha fra fem til åtte medlemmer. Foretaksmøtet velger leder og nestleder. Med utgangspunkt i de partforhold som da vil gjelde, deltar styremedlemmer som er valgt av de ansatte ikke i behandling av saker som gjelder arbeidsgivers forberedelse til forhandlinger med arbeidstakere, arbeidskonflikter, rettstvister med arbeidstakerorganisasjoner eller oppsigelse av tariffavtaler. Den daglige ledelse av Sykehusapotek Nord HF utøves av den styret ansetter. 7 Rapportering til eier Styret skal hvert år sende en melding til Helse Nord RHF som omfatter: styrets plandokument for virksomheten styrets rapport for foregående år Sykehusapotek Nord HF rapporterer for øvrig til eier i tråd med de krav Helse Nord RHF setter. 2

5 8 Medvirkning fra pasienter og pårørende Styret skal påse at pasienters og pårørendes rettigheter og interesser blir ivaretatt, blant annet gjennom et fast samarbeid med deres organisasjoner. Styret skal også påse at erfaringer, behovsvurderinger, prioriteringer og synspunkter som innhentes fra pasienter og pårørende og deres organisasjoner, gis en sentral plass i arbeidet med planleggingen og i driften av virksomhetene. Melding fra pasientombudene skal legges ved meldingen til Helse Nord RHF, jf. 7. Styret må også påse at samiske organisasjoner, nasjonale minoritetsorganisasjoner og innvandrerorganisasjoner i helseregionen blir hørt. 9 Låneopptak Sykehusapotek Nord HF kan ikke ta opp lån fra andre enn Helse Nord RHF. Sykehusapotek Nord HF gis en total låneramme på 5 millioner kroner. Sykehusapotek Nord HF kan dog ikke ta opp lån eller driftskreditt som samlet overskrider årlige rammer for trekkrettighet / konsernbankkreditt og årlige interne lånerammer fastsatt av Helse Nord RHF. 10 Foretaksmøte Det skal avholdes et årlig foretaksmøte innen utgangen av juni måned hvert år til behandling av årsregnskap, årsberetning og årlig melding som omtalt i 7. Foretaksmøtet i Helse Nord RHF skal treffe vedtak i alle saker som antas å være av vesentlig eller prinsipiell betydning helsepolitisk, forskningspolitisk, utdanningspolitisk eller samfunnsmessig, jf. helseforetaksloven 30. Det gjelder blant annet saker som: utskilling av større deler av virksomheten deltakelse i omfattende samarbeid eller vesentlige endringer i dette omfattende endringer i tjenestetilbudet Det samme gjelder salg av sykehusvirksomhet. Styret skal innen rimelig tid oversende saker som nevnt i 2. og 3. ledd til Helse Nord RHF. Vedtak om salg av fast eiendom skal treffes av helseforetakets foretaksmøte. Pantsettelse av fast eiendom gjennomføres i tråd med helseforetaksloven. Etablering / utvidelse av / nedleggelse eller reduksjon av faglige tilbud som påvirker arbeidsdelingen til andre helseforetak i eller utenfor Helse Nord RHF skal vedtas av Sykehusapotek Nord HF s foretaksmøte. Ytterligere foretaksmøter besluttes av Helse Nord RHF. 11 Universitetenes og høyskolenes oppgaver Styret skal, innenfor sitt ansvarsområde, bidra til at universiteters og høgskolers rettigheter og interesser i tilknytning til undervisning og forskning blir ivaretatt. 3

6 Helseforetaket skal videreføre de rettigheter og plikter universitet og høgskoler hadde mot de virksomheter som ble lagt under helseforetaket ved dets stiftelse. Dette omfatter alle rettigheter som universiteter og høgskoler har til å bruke foretakets faste eiendom, utstyr og andre formuesgjenstander, både rettigheter som fremgår av avtaler, vilkår for bevilgninger og lignende. Ved nåværende avtalers utløp, eller innen rimelig tid, skal det etableres nye avtaler som presiserer omfang, art, ansvar og evt. kompensasjon. Alle vesentlige avtaler skal godkjennes av Helse Nord RHF. Instruksen, vedtatt i Helse Nord RHF s foretaksmøte den , utfyller denne bestemmelsen. 12 Arbeidsgivertilknytning Sykehusapotek Nord HF skal være tilknyttet Arbeidsgiverforeningen NAVO. 13 Endringer i vedtektene Endringer i vedtektene vedtas av foretaksmøtet. Styret for Sykehusapotek Nord HF tar eventuelt opp forslag til endringer i vedtektene dersom dette er nødvendig for å ivareta Sykehusapotek Nord HF sitt formål og hovedoppgaver. 4

7 Styresak nr: Behandles: 25. februar 2011 Saksbehandler: Espen Mælen Hauge Oppfølgning av sak: 46-2/ 2010 AVDELINGSVISE PRESENTASJONER OG VERDIBASERT HVERDAG Som faste styresaker i 2011 vil ansatte ved for Sykehusapotek Nord i hvert møte presentere sitt fagfelt og avdelings ansvarsområde og arbeidsoppgaver. Formålet er at styret skal kunne få en grundigere innsikt i sykehusapotekets kjernevirksomhet og bedre kunnskap om oppgavene og daglig drift. I tillegg vil presentasjonene fokusere på hvordan avdelingene arbeider med verdiene kvalitet, trygghet og respekt, slik dette er formildet gjennom Helse Nords prosjekt Verdibasert hverdag. I dette møtet vil avdelingsleder Camilla Bjørnstad ved avdeling for farmasifaglig rådgivning i Sykehusapoteket i Tromsø presenterer avdelingene med dette arbeidsområdet. Innstilling til vedtak: Styret ved Sykehusapotek Nord HF tar presentasjonen til orientering. Espen Mælen Hauge direktør

8 Styresak nr: Behandles: 25. februar 2011 Saksbehandler: Espen Mælen Hauge ORIENTERINGSSAKER 1. Artikler a. Pingvinen januar 2011 om generisk forskrivning ved UNN (vedlegg) b. Artikkel i tidskriftet ClinicoEcon Outome Res The economic burden of TNF alpha inhibitors" (vedlegg) c. Artikkel i tidsskriftet Pharmacoepidemiology and Drug Safety: MAT-CHDSP, a novel medication assessment tool for evaluation of secondary prevention of coronary heart disease. (vedlegg) d. Kronikk Nordlys (vedlegg) 2. Nasjonale arenaer a. Almid-utvalgets NOU/konferanse b. Nasjonal utredning av legemiddelberedskap c. Revidering av nasjonale retningslinjer antibiotikabruk d. Pasientsikkerhetskampanjen "I trygge hender" e. LIS-styremøte f. Markedsutvalget 3. Kompetanseplan Etablering av bandasjistvirksomhet 5. Søknaden om kvalitetsmidler: a) e-læring i legemiddelhåndtering b) rekvirering cytostatika Innstilling til vedtak: Styret ved Sykehusapotek Nord HF tar sakene til orientering. Espen Mælen Hauge direktør 1

9 Sykehusapotek Nord - Styresak 11/2011 Orienteringssaker

10 pharmacoepidemiology and drug safety (2010) Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: /pds.2054 ORIGINAL REPORT MAT-CHDSP, a novel medication assessment tool for evaluation of secondary prevention of coronary heart disease Beate Hennie Garcia 1,2 *,JuneUtnes 2, Liv Unni Naalsund 2 and Trude Giverhaug 3 1 Hospital Pharmacy of North Norway Trust, Tromsø, Norway 2 Department of Pharmacy, Faculty of Health Science, University of Tromsø, Tromsø, Norway 3 Regional Drug Information Center of North Norway, University Hospital of North Norway, Tromsø, Norway ABSTRACT Background Quality of health performance is of increasing international importance. The potential value of the implementation of a guideline-based medication assessment tool (MAT) has been evaluated in order to measure and improve adherence to guideline recommendations in secondary prevention of coronary heart disease (CHD). Method An existing MAT developed in the UK based on internationally recognised clinical evidence has been further developed [with criteria extended to secondary prevention of CHD only] for application in Norway. Content validity was demonstrated using a two round Delphi process among an expert group (12 reviewers, consensus threshold 75%). Inter- and intra-observer reliability testing was conducted with agreement expressed by Cohen s kappa (k). The designed MAT was applied in a pilot study and application time was measured to inform clinical utility of the tool in real world settings. A total of 85 patients (69% male) undergoing coronary angiography were included. Mean age was 65.4 years (SD 11.6). Results The new MAT is named MAT-CHDSP and comprises 21 review criteria. Consensus among the expert group (n ¼ 12) was obtained for all final criteria. Reliability testing showed k in the range ( ). Applicability in the pilot study was 63% (n ¼ 1106) and adherence was 65%, 95% CI (64 66) (n ¼ 791). The mean application time for the experienced user was 1.5 minutes (SD 0.3). Conclusion MAT methodology might merge the increasing demand for continuous assessment of quality of health performance with the clinical pharmacist s need for a standardised and explicit working tool. Copyright # 2010 John Wiley & Sons, Ltd. key words secondary prevention; coronary heart disease; medication; assessment tool; quality of prescribing; guideline; recommendations; pharmaceutical care; pharmacist Received 19 March 2010; Revised 17 August 2010; Accepted 19 August 2010 INTRODUCTION Several studies have concerned the systematic identification of drug related problems (DRPs). 1 9 DRPs also comprise inappropriate prescribing and non-adherence to guideline recommendations with respect to medication use. Considerable amounts of studies concerning identification of DRPs are described in literature. Available tools in this respect are mostly developed for use in elderly people. Four tools to evaluate the potentially inappropriate medication (PIM) being prescribed are described by Page et al. 10 These tools * Correspondence to: B. H. Garcia, Hospital Pharmacy of North Norway Trust, Tromsø Postboks 6147, Tromsø 9291, Norway. beate@unn.no do not define review criteria and cannot be used directly, e.g. as clinical tools or in clinical audits. A novel tool, medication assessment tool (MAT), comprise review criteria based on clinical guideline recommendations and has been developed for application in clinical audits. The MAT is designed to evaluate the quality of prescribing in order to identify areas of improvement. MATs for use in patients with heart failure, diabetes (MAT-CHD) and cancer pain (MAT-CP) are described in literature In addition to the MAT s properties as a clinical audit tool, the MAT may also have clinical application in standardising the medication review process. It may as such be used for identification and prevention of PIM prescribing. It may also serve as a research tool, monitoring changes in guideline adherence. Copyright # 2010 John Wiley & Sons, Ltd.

11 Within the therapeutic field of coronary heart disease (CHD), several studies have provided evidence of suboptimal secondary prevention, e.g. low use of b- blockers and statins. 13,17 19 This paper describes the development and validation of a MAT concerning secondary prevention of CHD only. The main purpose of this new MAT is to serve as a clinical tool for identification of PIM prescribing regarding secondary prevention of CHD in patients discharged from hospital. The MAT will also be applied as a research tool. METHODS Development of MAT criteria The most recently published MAT-CHD, which is based on guidelines issued by the Scottish Intercollegiate Guideline Network, was used as a starting point. 15 The new MAT is based on guideline recommendations issued by the European Society of Cardiology (ESC) in addition to national recommendations The MAT was subjected to validity tests to establish content validity, reliability and feasibility (see Figure 1). Content validity of the initial-mat was demonstrated through a two round modified Delphi-technique. 25,26 The process was restricted to two rounds since the criteria were developed from already validated b. h. garcia ET AL. guidelines The expert panel was invited via and selected from geographically diverse parts of Norway to represent potential different therapy traditions. Initially, 64 participants (47 physicians and 17 pharmacists) were invited. A total of 15 replied to the invitation and finally 12 (19%), five cardiologists and seven pharmacists, completed both rounds of the survey. Two reminders were sent in both rounds. Based on the Delphi survey, the criteria were modified and the adjusted MAT is referred to as the test-mat. Reliability of the test-mat was demonstrated by inter- and intraobserver agreement, using Cohen s Kappa (k) statistics. 27 Two observers applied the test-mat with 35 existing medication profiles (MPs) of patients with established CHD as information source. The application time was denoted. Criteria were modified based on validation results and the adjusted MAT after reliability testing is referred to as the draft-mat. To ensure consistency in application and interpretation, an application guide was developed. The MP layout was redesigned. Pilot study Feasibility of the draft-mat was demonstrated during a pilot study including patients consecutively admitted to hospital for planned coronary angiography during 9 weeks in autumn Patients with established CHD were eligible for inclusion. MPs were created by the main researcher at discharge. Standard documents (admission papers and discharge papers) in the electronic medical records were used in addition to laboratory values. Two observers subsequently applied the draft-mat and results in terms of inter- and intra-observer agreement (reliability), application time, applicability and adherence to criteria were obtained. Statistics Figure 1. The development process of the MAT-CHDSP. Content validity was measured as a percentage agreement within the expert group (consensus threshold ¼ 75% agreement). Reliability was demonstrated using inter- and intra-observer tests and expressed by Cohen s Kappa (k), k 0.75 considered as excellent agreement. 28 Data was managed and analysed using Microsoft 1 Office Excel 2002 and SPSS for Windows. Adherence to guideline recommendations was calculated by summing yes responses to the standard and expressing them as percentage of applicable cases, excluding those lacking information in the qualifier or standard. Differences in mean application time between the two observers were tested by t-tests. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

12 Ethical considerations The project protocol was approved by the Norwegian Regional Committee for Medical Research Ethics North Norway and the Norwegian Social Science Data Services. Written informed consent was obtained from all patients included in the pilot study. RESULTS Criteria development The final MAT is named MAT-CHDSP, SP for secondary prevention (Figure 2) and comprises 21 criteria. Ten criteria from the original MAT-CHD 15 were kept but modified or merged with each other. The criteria left out from the original MAT-CHD were either not concerning secondary prevention or not in accordance with ESC guidelines. A total of 14 new criteria were added; three concerning clopidogrel prescription (nos 2 4), one reflecting simvastatin as first choice statin (which now is invalid as atorvastatin is the first choice statin also in Norway) (no. 6), one concerning prescription of an angiotensin receptor blocker (ARB) in diabetics and heart failure patients without documentation of contraindication to an angiotensin converting enzyme (ACE) inhibitor (no. 14), one concerning blood glucose measurement (no. 15), three concerning follow-up issues if standards of previous criteria are not met (nos 18, 11 and 16) and five concerning lifestyle modifications (nos 17 21). Content validity During the first Delphi round, consensus (75% agreement) was achieved for 15/22 criteria and comments were received from participants. During the second Delphi round, consensus was obtained for 19/22 criteria. Two of the criteria were amended in accordance with the expert comments. Concerning the third criterion, Patient with CHD has a documented HbA 1c 6.5%, agreement was only 72% due to a strict HbA1c threshold. The threshold value was kept as it directly reflects guideline recommendation but the criterion was merged with the blood glucose criterion (no. 15). Pilot study A total of 210 patients were asked to participate and 101 (48%) accepted. Coronary angiography excluded CHD in 16 patients, and 85 patients were finally included. See Table 1 for demographics and Table 2 for adherence to draft-mat-chdsp criteria. Figure 3 elaborates interpretation of the data given in Table 2. mat-chdsp: medication assessment tool for chd Justified non-adherence (Nj) indicates a documented reason for non-adherence. In the application guide, this is defined as (a) advised by the general practitioner (GP), (b) explicitly documented contraindication or intolerance, (c) documented allergy or (d) documented prescriber choice. An additional point (e) documented patient choice has been included as patients are free to accept therapy or not. If a patient abstains from recommended therapy, this cannot be regarded as nonadherence to guideline recommendations from the physician s side. In our study, point (e) was never applied. Point (d) documented prescriber choice was the most frequently applied reason for Nj, mostly due to instructions in the discharge papers on how the GP should adhere to the guideline recommendations. Overall adherence to draft-mat-chdsp criteria was 63% (in 1106 applicable cases). Only for criterion 4, prescription of clopidogrel after percutaneous coronary intervention (PCI) with stent implantation, adherence was 100%. Adherence to aspirin and statin prescription (1 and 5) was close to 100%. Criteria 2 and 3, were not applicable in this population. For criterion 14, documentation of contraindication/intolerance to ACE-inhibitor, information was missing in the 22 applicable cases. Concerning criterion 19, weight reduction advice if overweight, data on weight and height was missing in 24 patients and BMI could not be calculated. In the 15 patients for whom weight and height was available and BMI calculated to be >30 kg/m 2, no weight reduction advice was documented. Missing data was primarily experienced for criterion 19. Reliability Reliability based on Cohen s kappa is regarded as excellent if agreement between observers is 75%. 28 Reliability tests of the test-mat-chdsp showed overall inter- and intra-observer agreement with k ¼ 0.79, 95% CI ( ) and k ¼ 0.85, 95% CI ( ), respectively. Exact inter- and intra-observer agreement were in the range and %, respectively. Due to lower k-values and percentage agreement for some single criteria, two general modifications of the criteria were made: (1) simplifications of language and (2) removal of time aspects and contraindications/ intolerances (CIs/Is) from the criteria to the application guide as specified reasons for justified non-adherence. For example, for criterion 7, duration of therapy <4 6 weeks is defined as a justified reason for not achieving therapy goal for cholesterol values and not an applicability restriction in the qualifying statement. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

13 b. h. garcia ET AL. Figure 2. Draft-MAT-CHDSP. During the pilot study, reliability tests of the draft- MAT-CHDSP showed overall inter-and intra-observer agreement with k ¼ 0.82, 95% CI ( ) and k ¼ 0.90, 95% CI ( ), respectively. Exact agreements during inter- and intra-observer tests were in the range and %, respectively. Application time Application time for MAT-CHDSP versions for the nonexperienced users, who applied the draft-mat-chdsp while reading the MPs, varied from 3 to 17 minutes, (see Figure 4). For the draft-mat-chdsp, mean Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

14 Table 1. Demographic data for n ¼ 85 patients in pilot study Patient characteristics Gender Male 59 (69%) Female 26 (31%) Age (years) Mean (SD) 65.4 (11.6) Median 65.0 Range (min max) 56 (31 87) Result of coronary angiography Stent 38 (45%) CABG surgery 10 (12%) Medical therapy 36 (42%) Further investigation 1 (1%) BMI (m/kg 2, n ¼ 57) Mean (SD) 28.1 (5.3) Median 27.3 Range (min max) 27.7 ( ) (16%) Diabetes mellitus Type 1 2 (2%) Type 2 19 (22%) Blood pressure (mmhg) Systolic Mean (SD) 143 (21) Range (min max) 96 ( ) Diastolic Mean (SD) 79 (10) Range (min max) 45 (60 105) Serum cholesterol at hospital admission (mmol/l) Total Mean (SD) 4.8 (1.3) Range (min max) 6.4 ( ) LDL Mean (SD) 3.0 (1.1) Range (min max) 5.5 ( ) Smoking status Smokers 17 (20%) Non-smokers 23 (27%) Ex-smokers 44 (52%) Unknown 1 (1%) application time for the most experienced user (1.5 minutes, SD 0.3) was significantly lower than mean application time for the less experienced user (6.1 minutes, SD 1.2), p < Intra-observer mean application time was significantly lower during second application (6.1 minutes, SD 1.2) compared to first application (8.4 minutes, SD 2.2), p < Notice that the experienced user applied the draft-mat-chdsp directly after MP development, which might contribute to the significant difference in application time. DISCUSSION Methodology Delphi technique. During the Delphi process, experts from seven different institutions in Norway were represented. Distributing questionnaires by mat-chdsp: medication assessment tool for chd minimised time consumption and expenses. Unfortunately, only 12 experts (five cardiologists and seven pharmacists) finalised the survey. The reason for the low response is unknown, though we noticed that people not acquainted with our research group did not respond. One could clearly question the low number of experts, but the Delphi technique is described to work with a panel of experts comprising between 10 and 50 members. 26 In addition, MAT-CHDSP criteria were developed based on already accepted guideline recommendations, and agreement was 75% for 19 of the 22 criteria after the second Delphi survey. The latter three criteria were amended according to the response. We argue that the draft-mat-chdsp criteria possess content validity. Reliability testing Inter- and intra-observer agreement tests resulted in overall Cohen s kappa >75% both during testing phase and pilot study. Despite high agreement, some single criteria achieved lower agreement for which the most frequent reasons was misinterpretation of data in the MP. New reliability tests should be performed using a clinical pharmacist as the second observer. MAT-CHDSP criteria Criteria structure. Ten criteria were included from the original MAT-CHD. 15 Application was difficult for some of the criteria due to the structure of the qualifying statement. For example, the original criterion 1 (patient with no apparent contraindication or intolerance to aspirin is prescribed aspirin in a daily dose of 75 mg) is applicable in patients without CIs/Is (which is most of the patients). In practice, the user searches for CIs/Is only when aspirin is not prescribed. Consequently, the standard is tested before applicability is confirmed. A more feasible structure for our purpose is (patient with CHD is prescribed a daily dose of aspirin), with the preferred dose of 75 mg described in the application guide. The criterion is thus applicable for all patients with CHD and the standard can subsequently be tested. The dose specification has been left out to test for aspirin prescription in itself. For some patients, e.g. 150 mg aspirin daily may be clinically correct depending on their comorbidities and MAT application will still be Y. This approach requires that CIs/Is are explicitly defined in the application guide and denoted as justified nonadherence (Nj) when appropriate. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

15 Table 2. Criterion focus b. h. garcia ET AL. Measured adherence to draft-mat-chdsp guideline criteria during pilot study (n ¼ 1106 total criteria) in 85 patients with established CHD Applicable cases Adherence Justified nonadherence y n % n % 95% CI n % 95% CI Antithrombotic therapy 1 Prescription of aspirin Prescription of clopidogrel if CIs/Is to aspirin Prescription of clopidogrel if acute coronary syndrome and no coronary stent implanted 4 Prescription of clopidogrel if coronary stent implanted Subtotal (4 criteria) Lipid-lowering therapy 5 Prescription of statins Prescription of simvastatin when prescribed a statin Achievement of lipid therapy goals with total cholesterol 4.5 mmol/l and LDL cholesterol 2.5 mmol/l 8 Therapy adjustment z if lipid values above therapy goal Subtotal (5 criteria) Antihypertensive and cardiac protective therapy 9 Prescription of a beta-blocker Achievement of blood pressure therapy goal with systolic blood pressure 130 mmhg and diastolic blood pressure 80 mmhg 11 Therapy adjustment z if blood pressure above therapy goal 12 Prescription of ACE x inhibitor or ARB ô if left ventricular dysfunction with ejection fraction <45% 13 Prescription of ACE x inhibitor or ARB ô if diabetes mellitus with hypertension or nephropathy 14 Documentation of contraindication or intolerance if ARB ô and not ACE x inhibitor is prescribed Subtotal (6 criteria) Glycemic control and modifiable risk factors Documentation of Blood glucose measurements <7.0 mmol/l New measurement of blood glucose or HbA1c jj if first measurements 7.0 mmol/l 17 Documentation of smoking cessation advice given Documentation of body mass (weight, height or waist circumstance) 19 Weight reduction advice if overweight (BMI 30 kg/m 2 ) 20 Documentation of dietary advice given Documentation of advice given concerning physical activity Subtotal (7 criteria) Total criteria Adherence is calculated from applicable cases. y Justified reasons for non-adherence are specified in application guide. z Includes increase of dose, addition of a drug and change of drug. x Angiotensin converting enzyme. ô Angiotensin receptor blocker. jj Glycosylated haemoglobin. Body mass index. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

16 Figure 3. Interpretation of numbers in Table 2, illustrated with criterion no. 7.Y ¼adherence, N ¼ non-adherence, Nj ¼ justified non-adherence. Patient maintained on lipid-lowering therapy, has achieved target cholesterol levels of total cholesterol 4.5 and LDL cholesterol 2.5 mmol/l. The criterion was applicable in 81 patients, meaning that 81 of 85 patients were maintained on lipid-lowering therapy. From the table we read that 30 (37%) patients had achieved the therapy goals (light grey above). Thus, 51 (63%) had not. However, we see that 20 (25%) had a justified reason for nonadherence (white above). Consequently, for 31 (38%) (dark grey above), lipid therapy goals had not been achieved and no documentation for justified non-adherence was noted in the patient records. Application was difficult for original criteria involving time aspects in the qualifying statement, e.g. the original criterion 19 (patient maintained on the same dose of statin for 6 weeks has achieved a re-test total cholesterol level of <5 mmol/l). Lack of information concerning therapy duration in hospital records oftenleadtoinsufficientdata in the qualifying statement. We amended the criterion to rather test if the recommended levels had been achieved mat-chdsp: medication assessment tool for chd (patient on lipid-lowering therapy has achieved both therapy goals for cholesterol, total cholesterol 4.5 mmol/ L and LDL cholesterol 2.5 mmol/l). In addition, we added a criterion to test if therapy was amended during hospital stay if therapy goal was not achieved at admission, see New Criteria Section. This approach requires that duration of therapy <6 weeks is defined as a justified reason for non-adherence in the application guide. With this approach, insufficient data rarely becomes a problem. However, in cases where therapy goals have not been achieved and duration of therapy is unknown, the application will be N instead of previously insufficient data. This must be taken into consideration when interpreting data. Therapy goal thresholds influence results when applying the MAT-CHDSP. For example, for criterion 7, a total cholesterol value of exactly 4.5 mmol/l gives a negative result when testing for a value <4.5 and a positive result when testing for 4.5. In clinical practice, we argue that therapy will rarely be amended if values are at threshold. Consequently, criteria involving thresholds (i.e. criterion 7, 10 and 15) was amended to test for a value the recommended value. One exception was made for the threshold of fasting blood glucose, which is <6.0 mmol/l in this patient group. We argue that no action will be taken on a value of e.g. 6.1 mmol/l. Thus, the threshold used in the draft-mat-chdsp is <7.0 mmol/l since fasting blood glucose 7.0 mmol/l is a diagnostic criterion for reduced Figure 4. Application time of test- and draft-mat-chdsp for all observers. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

17 glucose tolerance and diabetes mellitus according to WHO recommendations. 29 New criteria. In patients where values of cholesterol, blood pressure and/or blood glucose are documented above therapy goals at hospital admission, we wanted to explore if medical therapy is amended during hospital stay. Three follow-up criteria was thus defined (nos 8, 11 and 16), directly derived from nonadherence to the criteria concerning achievement of therapy goals (nos 7, 10 and 15). Thus, follow-up issues can easily be identified by the clinical pharmacist. In draft-mat-chdsp, focus has also been put on non-medical therapy, i.e. smoking cessation, weight reduction and physical activity. It might be argued that these criteria do not have a place in a MAT as they do not assess the medication regime. Pilot study. The draft-mat-chdsp worked very well in a clinical setting and the ability to identify nonadherence with guideline recommendations is reflected in Table 2. Both good clinical performances as well as improvement potentials were identified. As reflected in Table 2, Justified non-adherence has been applied in 6% of the applicable criteria, which was mostly due to instructions to the GP in the hospital discharge letter on how to adhere to guideline recommendations. The rational in this might be argued upon, as the instructions might be overlooked by the GP. Criterion 3 was not applicable in this patient population, and may thus be excluded from the MAT-CHDSP. Criterion 2 was neither applicable and might rather be merged with criterion 1. Adherence to criterion 19 was 0% due to the lack of information on weight reduction advice in patient records. Despite this, the criterion will be kept due to the importance of weight reduction in obese patients in this population. The results show that this is indeed an area of improvement. Criterion 12 (ACE inhibitor or ARB in heart failure patients) was applicable in seven patients only, and should be placed in a MAT concerning heart failure patients. Concerning criteria 20 and 21 (advice on lifestyle and diet), adherence was high, 82 and 87%, respectively. This was mostly due to a standard statement in the patients discharge papers related to advice concerning smoking cessation, diet, lifestyle and physical. A standard statement gives rise to uncertainty, whether advice actually has been given. We thus argue that in further audit processes, this standard formulation cannot justify adherence to these criteria, and the criteria will be reformulated. b. h. garcia ET AL. Mean application time of draft-mat-chdsp for the experienced user was 1.5 minutes (SD 0.3), and significantly lower than for the less experienced user, p < Patient data was already denoted in MPs, making application straight forward and not time consuming. This is actually how it works in real life when clinical pharmacists make MPs for medication review. Existing MPs might easily be designed to also collect MAT data. We believe in the idea of developing valid MATs for a variety of diseases so that the suitable MATs can be chosen and applied for the right patients. This will facilitate, standardise and structure evaluation of drug regimes. And last but not the least, PIM prescribing can easily be detected and patient care be improved. CONCLUSION The draft-mat-chdsp reflects 21 internationally agreed and validated guideline recommendations concerning secondary prevention of CHD. One of the original criteria, no. 6 concerning simvastatin as the preferred statin, is now outdated, leaving 20 criteria for the final-mat-chdsp. The criteria are explicitly defined and content validity, reproducibility and feasibility have been explored with good results. The MAT-CHDSP has served as a clinical tool with low application time. It seems to be suitable in the daily work of the clinical pharmacist, then working as a checklist for optimising secondary prevention at discharge from hospital. It has also served as a research tool, where retrospective application revealed both areas of good clinical performance as well as areas for improvement at our hospital. With MAT methodology, the increasing demand for continuous assessment of KEY POINTS MAT-CHDSP comprises valid international clinical recommendations concerning secondary prevention of coronary heart disease. MAT-CHDSP may be applied in a clinical setting and thus aid and standardize the medication review process. MAT-CHDSP may be applied in a research setting, assessing the quality of clinical performance. MAT-CHDSP include life-style recommendations and aids the identification of clinical follow-up issues. MAT-CHDSP needs continuously updating in accordance with guideline recommendations. Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

18 qualityofhealthperformancemaybemergedwiththe clinical pharmacist s need for an explicit working tool. ACKNOWLEDGEMENTS Thanks to Professor Steve Hudson and Dr. Gro D. Haakonsen for instructions and help on criterion development. Thanks to the expert group with participants from the University Hospital of North Norway, University of Oslo, Oslo University College, Rikshospitalet University Hospital, Lovisenberg Hospital, Sørlandet Hospital HF and Hospital pharmacy of North Norway. Thanks to the participants of the pilot study. CONFLICT OF INTEREST The authors declare no conflict of interest. REFERENCES 1. Paulino EI, Bouvy ML, Gastelurrutia MA, Guerreiro M, Buurma H. Drug related problems identified by European community pharmacists in patients discharged from hospital. Pharm World Sci 2004; 26(6): Hammerlein A, Griese N, Schulz M. Survey of drug-related problems identified by community pharmacies. Ann Pharmacother 2007; 41(11): Viktil KK, Blix HS, Moger TA, Reikvam A. Interview of patients by pharmacists contributes significantly to the identification of drugrelated problems (DRPs). Pharmacoepidemiol Drug Saf 2006; 15(9): Hanlon JT, Weinberger M, Samsa GP, et al. A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med 1996; 100(4): Till LT, Voris JC, Horst JB. Assessment of clinical pharmacist management of lipid-lowering therapy in a primary care setting. J Manag Care Pharm 2003; 9(3): Bailey TC, Noirot LA, Blickensderfer A, et al. An intervention to improve secondary prevention of coronary heart disease. Arch Intern Med 2007; 167(6): Axtell SS, Ludwig E, Lope-Candales P. Intervention to improve adherence to ACC/AHA recommended adjunctive medications for the management of patients with an acute myocardial infarction. Clin Cardiol 2001; 24(2): Chapman NR, Fotis MA, Yarnold PR, Gheorghiade M. Pharmacist interventions to improve the management of coronary artery disease. Am J Health Syst Pharm 2004; 61(24): Horning KK, Hoehns JD, Doucette WR. Adherence to clinical practice guidelines for 7 chronic conditions in long-term-care patients who received pharmacist disease management services versus traditional drug regimen review. J Manag Care Pharm 2007; 13(1): Page RL, Linnebur SA, Bryant LL, Ruscin JM. Inappropriate prescribing in the hospitalized elderly patient: defining the problem, evaluation tools, and possible solutions. Clin Interv Aging 2010; 5: McAnaw JJ. Development of novel approaches to demonstrate quality of drug therapy use, PhD thesis, University of Strathclyde, Glasgow, mat-chdsp: medication assessment tool for chd 12. McAnaw JJ, Hudson S, McGlynn S. Development of an evidence-based medication assessment tool to demonstrate the quality of drug therapy use in patients with heart failure. Int J Pharm Pract 2003; 11(Suppl.): R17, Reference type: abstract. 13. Chinwong S, Reid F, McGlynn S, Hudson S, Flapan A. The need for pharmaceutical care in the prevention of coronary heart disease: an exploratory study in acute myocardial infarction patients. Pharm World Sci 2004; 26(2): Ernst A, Kinnear M, Hudson S. Quality of prescribing: a study of guideline adherence of medication in patients with diabetes mellitus. Practical Diabetes Int 2005; 22(8): Kamyar M, Johnson BJ, McAnaw JJ, Lemmens-Gruber R, Hudson SA. Adherence to clinical guidelines in the prevention of coronary heart disease in type II diabetes mellitus. Pharm World Sci 2008; 30(1): Hakonsen GD, Hudson S, Loennechen T. Design and validation of a medication assessment tool for cancer pain management. Pharm World Sci 2006; 28(6): Kulkarni SP, Alexander KP, Lytle B, Heiss G, Peterson ED. Long-term adherence with cardiovascular drug regimens. Am Heart J 2006; 151(1): Sud A, Kline-Rogers EM, Eagle KA, et al. Adherence to medications by patients after acute coronary syndromes. Ann Pharmacother 2005; 39(11): Wei L, Flynn R, Murray GD, MacDonald TM. Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf 2004; 13(11): Graham I, Atar D, Borch-Johnsen K, et al. European guidelines on cardiovascular disease prevention in clinical practice: full text. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil 2007; 14(Suppl. 2): S Task FM, Silber S, Albertsson P, et al. Guidelines for percutaneous coronary interventions: the task force for percutaneous coronary interventions of the European Society of Cardiology. Eur Heart J 2005; 26(8): Task FM, Bassand JP, Hamm CW, et al. Guidelines for the diagnosis and treatment of non-st-segment elevation acute coronary syndromes: the task force for the diagnosis and treatment of non-st-segment elevation acute coronary syndromes of the European Society of Cardiology. Eur Heart J 2007; 28(13): Task FM, Mancia G, De Backer G, et al guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2007; 28(12): Folketrygdloven. x 5 14 jf blåreseptforskriften x9, punkt 12l med virkning fra 1. juni 2005 [national legislation]. 25. Campbell SM, Braspenning J, Hutchinson A, Marshall MN. Improving the quality of health care: research methods used in developing and applying quality indicators in primary care. BMJ 2003; 326(7393): Hearnshaw HM, Harker RM, Cheater FM, Baker RH, Grimshaw GM. Expert consensus on the desirable characteristics of review criteria for improvement of health care quality. Qual Saf Health Care 2001; 10(3): Cohen J. A coefficient for agreement for nominal scales. Educ Psychol Measure 1960; 20(1): Robson C. Real World Research. A Resource for Social Scientists and Practioner Researchers (2nd edn). Blackwell Publishing: Malden, WHO/IDF. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation Copyright # 2010 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety, (2010) DOI: /pds

19 KOMPETANSEPLAN 2011

20 Forord Kompetanseplanen er en veileder for hvilke kurs og møter som foretaket ønsker å prioritere i Den inneholder også hvilke krav som skal oppfylles for at ansatte skal oppnå kompetansetillegg. I SOP Kompetanseplan og kursdeltagelser (PR9733) er det mer inngående beskrevet blant annet hvilket ansvar den enkelte har mht. kompetanseplan og kompetansebygging. Hvor stort kompetansetillegget er, blir avtalt i lønnsforhandlingene. De faglige prioriteringene er gjort ut fra avdelingenes mål og prosjekter, og i samsvar med de nasjonale satsningsområdene som sykehusapotekene er blitt enige om. For 2011 er ernæring det faglige hovedsatsningsområdet. De tidligere satsningsområdene KOLS, kreft og diabetes videreføres. Kompetanseplanen for foretaket er ikke fullstendig, det vil si at andre kurs kan søkes, men de kursene som er ført opp i planen under hver avdeling vil ved søknad prioriteres. I tillegg til foretakets kompetanseplan har hver enkelt ansatt ansvar for å ta initiativ til å utarbeide en personlig kompetanseplan i samråd med sin avdelingsleder. Foretakets kompetanseplane skal evalueres jevnlig gjennom året på lederteamsnivå og i avdelingsledergruppene ved hver enhet.

21 1.0 Krav for spesielt kompetansetillegg 1.1 Teknikere Spesielt kompetansetillegg for teknikere gis for gjennomført: Ett med eksamen i relevant fagområde* og Tre internkurs med kursprøve eller 4 internkurs med kursprøve Eksempel: Ev@-kurs i smertebehandling Internkurs sykepleiemateriell Internkurs diabetes Internkurs farmakologi Spesielt kompetansetillegg for alle teknikere som mottar opplæring i produksjonen gis for gjennomført: 1. Intern opplæring med validering av arbeidsteknikk (buljongproduksjon). Det er kun valideringen som gjennomføres under opplæringen som gir kompetansetillegg. 2. Ett kurs rettet mot produksjon. Det må minimum være på samme nivå som internkurs vi selv arrangerer. 3. Eksternt kurs i steril produksjon eller hospitering med fokus på steril produksjon 4. Ekstern kurs i GMP eller hospitering med fokus på GMP Ytterligere kompetansetillegg for teknikerne i produksjonen kan bygges etter personlig kompetanseplan satt opp i samarbeid med avdelingsleder. Det er krav om fire gjennomførte kurs for hvert videre kompetansetillegg. For de som jobber i produksjon skal opplæring i steril produksjon og GMP repeteres når det er gått mer enn 5 år. Oppfriskning i steril produksjon og GMP vil kunne brukes i oppbyggingen av videre kompetansetillegg. 1.2 Farmasøyter og sykepleiere Spesielt kompetansetillegg for farmasøyter og sykepleiere gis for: Gjennomført spesialisering/fordypning i eget spesialområde og Gjennomført prosjekt i eget spesialområde eller Laget og gjennomført ett internkurs for teknikerne i et av satsningsfeltene, omfang ca 8 timer undervisning pluss kursprøve. Spesialisering innen eget område for farmasøyter skal omfatte: - Minst to videregående kurs innenfor samme temaområde med kursevaluering (eksamen, kursprøve, prosjektoppgave). Aktuelle kurs som kan telle er kurs arrangert av Legeforeningen, Universitet eller Høgskole. For sykepleiere bør kursene være godkjent av NSF for godkjenning til spesialist i sykepleie/spesialsykepleie. - Prosjekt innen eget område skal omfatte utarbeidelse av protokoll, praktisk gjennomføring og skriving av prosjektrapport eventuelt artikkel til tidsskrift (NFT, Tidsskr Norske Legeforening, Pingvinen eller internasjonale vitenskapelige tidsskrifter) eller foredrag eller poster på kongress nasjonalt eller internasjonalt. Spesielt kompetansetillegg for tilsynsfarmasøyter i tilsynsavdelingen gis for: Grunnkurs i tilsyn med veiledning og