Finland - experience with eprescription national and cross-border

Finland - experience with eprescription national and cross-border Viveca Bergman, Development Manager, THL EXPAND Multi-Stakeholder Engagement Workshop 28th January 2015, Brussels

Aim of the presentation To highlight impact and implications of adopting the ep service, in terms of legal, organizational, technical and semantic requirements To help interested delegates to prepare for deployment of ehealth cross-border services in order to encourage further uptake of services and EXPAND assets 29/01/15 Viveca Bergman / THL 2

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ehealth Status Finland 100% EHR coverage in both specialised and primary care on local and regional level. The rolling out of the National Archive of Health Information, the Kanta Services is still ongoing but covers 87% of population. Finland experiencing a rapid pace of ICT development in a highly decentralised health care system facing major structural reforms. eprescription in production since 2010. Full scale roll-out in public and private health practically finished to date (over 90% of all prescriptions). THL (National Institute for Health and Welfare) responsible for operational management and Kela (Social Insurance Institution of Finland) for technical deployment. The roles in national and cross border settings defined by law. epsos provided a timely opportunity to develop and implement cross-border use of ep 29/01/15 Viveca Bergman / THL 4

EHRs in Finland Primary Health Care Specialised Health Care Ei Oetojärjestelmää, 10.06% Oma Oetojärjestelmä, 1.41% Muut, 7.65% Acute, 7.81% Dapal, 3.16% DomaCare, 0.91% Safe, 2.16% Promeda, 4.32% Mexwin, 0.17% SoMMedic, 9.06% EPR:s MediPro, 8.89% in private sector DynamicHealth (Doctorex), 36.24% Mediatri, 2.16% Meditree, 1.33% Maestro, 0.17% Hilkka, 3.16% Elbit, 1.33% Population of Finland 28.1.2015: 5 475 614 29/01/15 Viveca Bergman / THL 5

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edispensations and reimbursed prescriptions 01/2009 12/2014 in Finland Miljoonia reseptejä 5.0 Apteekit 31.03.2012 Julkinen terveydenhuolto 31.03.2013 Yksityinen terveydenhuolto 31.12.2014 (>5000 res/v) 4.5 4.0 eprescriptions 3.5 Reimbursed prescriptions 3.0 2.5 2.0 1.5 1.0 0.5 0.0 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 2009 2010 2011 2012 2013 2014 2015 2014: 40 000 000 edispensations 29/01/15 Viveca Bergman / THL 7

The use of eprescriptions (%) in the public health care December 2014 Pohjoinen Lappi (05/2014): 85 % Länsi-Pohja: 94 % Pohjois-Pohjanmaa: 86 % Kainuu (05/2014): 94 % Keski-Pohjanmaa: 86 % Approximately 92 % Käyttöaste (%) = 100 * (n/n), jossa n = sähköisten lääkemääräysten lkm N = kaikki potilastietojärjestelmiin kirjattujen lääkemääräysten lkm (Laskennassa ovat mukana ensimmäisen kerran kirjoitetut ja uudistetut sähköiset lääkemääräykset) Keskinen Etelä-Pohjanmaa: 98 % Pirkanmaa: 91 % Päijät-Häme: 93 % Kanta-Häme: 92 % Itäinen Keski-Suomi : 93 % Pohjois-Savo: 92 % Etelä-Savo (05/2014): 85 % Itä-Savo: 95 % Pohjois-Karjala: 96 % Läntinen Vaasa: 83 % Satakunta: 94 % Varsinais-Suomi: 97 % All pharmacies and public health care organisations have joined the ep Centre. Lähde: STM Sairaanhoidon erityisvastuualueet, sairaanhoitopiirit ja keskussairaalat 1.2.2013 Eteläinen Etelä-Karjala: 93 % Kymenlaakso: 93 % Helsinki-Uusimaa: 94 % 29/01/15 Viveca Bergman / THL 8 8

What had to be done? - a brief history of the Finnish eprescription Government decision in 2002: Finland should have a nationwide interoperable EHR system by the end of 2007 By 2005 agreement on the National Archive of Health Information (KanTa) : eprescription service, Patient Access and Patient Data Repository. Architecture of centralized storage (Kanta) with Pharmacy Information Systems and HIS systems as the clients. Messaging based on structured documents. Act on Electronic Prescriptions in 2007 New legislation was needed to allow the new features Placing the centralized service to the Social Insurance Institution of Finland (Kela) Consent management, privacy & security aspects Mandated the adoption of the eprescription system for pharmacies, for health care units and for doctors and dentists practicing in health care unit (remaining voluntary for doctors and dentists not practicing in these units).. The purpose of the Act was to improve patient and drug safety and to facilitate and streamline the prescribing and dispensing of pharmaceuticals. Amendments to Act on Electronic Prescriptions and Act on the Electronic Processing of Client Data in Social and Health Care in 2010 which re-scheduled National Health Information System project, and in 2014 a new Amendment making the eps mandatory for all actors as of 2017. 29/01/15 Viveca Bergman / THL 9

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Enablers in place for cross-border services Mature national ehealth infrastructure; nationwide coverage of ep and ed < Kanta EU-level produced common/additional services and specifications < epsos Robust standards-based national system with data in structured form Roles of competent actors in cross border deployment regulated by law. 29/01/15 Viveca Bergman / THL 13

FI-SE Pilot Use cases and coverage ep and ed as Country A and B Operation Dec 2013 June 2014 Country A coverage national, Country B limited to a border region in Northern Finland consisting of pharmacies in 3 municipalities Cross-border UC regarded as a natural extension of the Nordic agreement on exchange of prescriptions the national ep Services (EU prescription was on paper) 29/01/15 Viveca Bergman / THL 14

epsos building blocks now available as EXPAND assets were taken into use. 29/01/15 Viveca Bergman / THL 15

Core components from epsos - 29/01/15 Viveca Bergman / THL 16

Circle of trust of epsos and LFA 29/01/15 Viveca Bergman / THL 17

epsos Web Portal 29/01/15 Page 18

combined with national assets My Kanta - National Patient Portal for consent giving a specific epsos consent was required 29/01/15 Viveca Page Bergman 19 / THL

Legal framework permitting the dispensation of foreign eps not fully compliant with the Finnish eps Laki sähköisestä lääkemääräyksestä annetun lain (61/2007) muuttamisesta Eduskunnan päätöksen mukaisesti lisätään 23 a Rajat ylittävä sähköinen lääkemääräys Muualla kuin Suomessa laadittu sähköinen lääkemääräys voidaan hyväksyä ja toimittaa Suomessa toimivassa apteekissa, vaikka lääkemääräys ei täytä kaikkia tässä laissa sähköiselle lääkemääräykselle säädettyjä vaatimuksia. Hyväksymisen edellytyksenä on kuitenkin, että se täyttää Euroopan unionissa hyväksytyt tai Euroopan unionin ja Euroopan talousalueen jäsenvaltioiden kesken sovitut vaatimukset ja lääkemääräys välitetään suomalaiseen apteekkiin lääkemääräyksen oikeellisuuden varmistavan ulkomaisen ja Suomen kansallisen yhteyspisteen kautta. Tämän lain mukainen sähköinen lääkemääräys voidaan vastaavasti luovuttaa potilaan suostumuksella toimitettavaksi muualla kuin Suomessa. Edellytyksenä lääkemääräyksen luovuttamiselle ulkomaille on, että luovutus tapahtuu Suomen ja vastaanottajamaan kansallisen yhteyspisteen kautta. Kansaneläkelaitos toimii Suomessa kansallisena yhteyspisteenä reseptikeskuksen, apteekkien ja ulkomaan kansallisen yhteyspisteen välillä. Kansaneläkelaitos on kansalliseen yhteyspisteeseen tallennettavien tietojen rekisterinpitäjä. 29/01/15 Viveca Bergman / THL 20

The path towards implementation 2011-2014 No major technical issues encountered, but the preparation phase exposed legal, organizational and semantic issues that had to be addressed Within the given time frame full integration of epsos solutions into national infrastructure not possible > chosen ed portal solution not a sustainable approach. Organisational: localisation of FWA not a mere translation, responsibilities according to national law differed from those set out in FWA. Semantic: challenges in mapping (e.g. EDQM, ATC, UCUM). Unstructured data > ep incomplete and certain types of prescriptions were ruled out. Legal: not possible to establish NCP at Kela without revision of national legislation 29/01/15 Viveca Bergman / THL 21

We got there the first ever medication dispensed abroad on an eprescription in Europe 29/01/15 Viveca Bergman / THL 22

Succesful dispensation abroad and up-to date dispensation information in the patient portal at home 29/01/15 Viveca Page Bergman 23 / THL

Real-life FI-SE pilot also revealed shortcomings For example in FI-SE pilot: 17 dispensations made successfully 34 cases: patient had not given consent or pharmacist entered patient id wrongly 15 cases: prescription out of the scope of the pilot, of which 2 time-based prescriptions (not based on prescribed amount) 4 combination medications 9 prescriptions in which package size not structured Negative feedback on cross-border service reported to PGEU by SE/FI pharmacists http://www.ehealth2014.org/wp-content/uploads/2014/07/pres_wilkinson_j.pdf 29/01/15 Viveca Bergman / THL 24

Prescriptions out of scope, case Finland No Description Reason Sugges+on with regards to pivot 1 central nervous system drugs Difference in classificaoon (what is a CNS No change drug and what is not) in different countries 2 drugs with potential for recreational use (narcotics) Out of scope of epsos in general No change 3 drugs to be prepared in the pharmacy PreparaOon instrucoons only in Finnish/ Swedish 4 base creams No ATC code or strength, which are mandatory in pivot 5 clinical nutritional preparations No ATC code or strength, which are mandatory in pivot 6 care accessories, dietary supplements and bandages No ATC code and some other information which is mandatory in pivot No change Include à make ATC code and strength opoonal in pivot Include à make ATC code and strength opoonal in pivot No change 7 prescriptions valid for defined time periods No informaoon on package size and number of packages 8 iterated prescriptions Difficult to calculate the remaining amount. IteraOon rules vary among countries. 9 combination medications ATC code system not designed for this use case. Text- based strength not allowed. 10 combination packages Package size is difficult to structure. No change 11 the prescription is in held state NaOonal rules No change 12 the prescription is in reservation state NaOonal rules No change 13 package size is not in structured form Package size is difficult to structure. No change No change. Some countries are able to send suitable info (amount to be dispensed at once). No change. Some countries are able to send suitable info (amount to be dispensed at once). Allow providing non- structured strength informaoon (text) 29/01/15 Viveca Bergman / THL 25

Reflections based on our experience In order to be able to sustain the services, continuous support for centralized cross-border services is required: Reliable maintenance (including support, development, and version management) of the common components produced by epsos Reliable maintenance of the semantic infrastructure established by epsos Cooperation with the standardization bodies Features to be developed and maintained at EU rather than national level: Standards, common terminologies, classifications, code sets, and other specifications. 29/01/15 Viveca Bergman / THL 26

National deployment requires mature assets. It is not possible to introduce a cross-border service at national level if the service is significantly different from the national standards. In the pharmacies the sustainable solution is an integrated crossborder functionality not causing extra work load. Minor and major issues identified during the operation as regards the epsos Pivot (semantics) > extension needs. Status quo may become a risk for sustained interoperability. Focus should be on securing the operational use of the existing UCs, and not that much on inventing new ones. The real challenge now lies with deployment. Supportive infrastructure and collaboration between all the relevant national authorities required (In Finland: Kela, THL, Population Register Centre, Finnish Medicines Agency, Pharmaceutical Information Centre, and the National Supervisory Authority for Welfare and Health, and Data Protection Authority). NB: also beyond the ehealth domain.. 29/01/15 Viveca Bergman / THL 27

Cost estimation National deployment? Kanta services: estimates 200 500 ME Savings - yes Cross-border ep/ed: Technical development: 245 000 e (in-house) Infrastructure & testing: 45 000 e /yr 29/01/15 Viveca Bergman / THL 28

Thank you! Viveca.bergman@thl.fi 29/01/15 Viveca Bergman / THL 29