Re-engineering the Drug Preparation: The Swedish Model Transformation

1. R1 Re-engineering the drug preparation- the Swedish modelDr Eva Sjökvist SaersAPLApotek Produktion & Laboratorier ABSweden

2. Disclosure Eva SjökvistSaers, CEO of APL ApotekProduktion & LaboratorierAB • APL is a state-owned company and a national centre of excellence for compounded pharmaceuticals. • APL is a “extempore pharmacy”, with license from MPA, that offers compounding services (development and manufacturing of extemporaneous preparations and stock preparations) to community and hospital pharmacies, either directly according to agreements as a part of the hospital pharmacy or as a subcontractor. • APL offers its services according to equal and non-discriminating conditions, as an assignment from the government. • The compounding sector is today on a competitive market • APL is also a CDMO (Contract Development and Manufacturing Organisation) that offers development and manufacturing services to companies within Life Science.

3. To move from onemodeltoanotherRe-regulationof the pharmacy market in Sweden – consequences on the hospital pharmacieswith focus on compounding

4. Earliermodel Re-regulationof the pharmacy market in Sweden – consequences on the hospital pharmacies • Until 2009/2010 the state-ownedcompany Apoteket hadthe exclusive right toselldrugs in Sweden – community and hospital pharmacies • All hospital pharmacieswererun by Apoteket, on behalfofeachcounty council accordingtoagreements. • Preparations ofcytotoxics and sterile individual preparations weremade at the hospital pharmacies • Compounding(extemporaneous preparations, stock preparations) was centralised to the fourproductionunitsofAPL (earliersubsidiaryto Apoteket) • Onenational process owner for the ”manufacturing/compounding process” at Apoteket/APL

5. Earliermodel Developmentofcompounding -earliermodel • The process ownerof the manufacturing/compounding process waschairmanof a ”manufacturing forum” • Holistic viewofactivitiesongoing at the hospital pharmacies, with a focus on compounding • Local and national initiatives – joint activities • Topicse.g.- qualityassurance/patient safety- workingenvironment/ergonomics- harmonisation/standardisation/efficiency- IS/IT- communication/collaborationswithhealthcare- dosebanding- automation

6. APL’sextemporaneouspharmaceuticals • > 10.000 compositions in data base • ~ 2.000 compositions manufactured frequently • About 300 stock preparations, of which 140 with a national license from MPA • Therapeutic areas e.g.: • Pediatrics • Pain • Dermatology • Dental care • Cardiovascular • Stomach/intestine • Eyes/ear • Gynecology • Urology • Veterinary

7. Non-sterileSemi-solids Ointments /creams Gels Lotions Suspensions Liquids Oral solutions Emulsions Suspensions Solid preparations Capsules Extemporaneous pharmaceuticals – dosage forms by APL Aseptic/Sterile • Parenteral preparations • Vials • Bottles • Ampoules • Bags • Eye/Ear preparations • Drops • Ointment • Gels • Ambulatory systems EAHP 2014 - Eva Sjökvist Saers, Sweden

8. APL largescalemanufacturingof stock preparationsand extemporaneousmanufacturing Umeå Sterile and asepticmanufacturing Clinical trials materials Göteborg Non-sterile manufacturing Oral solutions SupplyChain & LogisticsExtemporaneouspharmaceuticals Stockholm Solid preparations Clinical trials materials Pharmaceutical/AnalyticaldevelopmentAPL Customer Services Extemporaneouspharmaceuticals Malmö Non-sterile manufacturing Semi solids Preparation at hospitals (tender) West Sweden: Varberg, Sahlgrenska, Östra, Uddevalla, Skövde, Borås Stockholm: Solna and Stockholm

9. Developmentofindividualisedmedicines for patients with special needs APL Customer Services Product range specialist Formulation specialist Procurement/Logistics Medical Products Agency (MPA) Extemporaneous preparations/Stock preparationsSupply Individualisedmedicines EAHP 2014 - Eva Sjökvist Saers, Sweden

10. Currentmodel Health care at hospitals in Sweden • At the regional level, responsibility for financing and providing health care is decentralized to the county councils (regions). • 21 regions areresponsible for the organisation and management ofhealthcare at the hospitals in eachregion • Hospital pharmacy management – procurement process withstrictrequirements. The requirementsare set by the respective regions. • Onlyone region manages the hospital pharmaciesin-house (Jönköping) Stockholm Gothenburg Malmö

11. Currentmodel Contracted services

12. Currentmodel Procurement process of hospital pharmacyactivities • Accordingto the law on public procurement • Strictrequirements- all mandatory and needto be fulfilled by the provider • Providers present tender withtheir suggestions on howtoprovide the services • The decision is announced • The decision can be appealedagainst by the contractor/s whodid not win the procurement • The lengthof the contractvaries - e.g. 3+2, 4+2, 6+4 years Balancebetween quality and cost

13. Requirementspecifications(no of mandatory claims)Tender in Stockholm county council for extemporaneousmanufacturing • Supplyreliability (3) • Openinghours and avaliability (7) • Monitoring (4) • Principles for pricing (8) • Clinical trial materials (5) • Environmentalissues (2) • Performance (14) • Approx. 190 mandatory claims • Tender invitation (general claims 34) • Assignment (4) • Organisation (23) • Quality management (11) • Supplyofgoods (22) • Ordering process (29) • Distribution (23)

14. Contractors to date * extempore pharmacy ** pharmacychainwithcommunity and hospital pharm.

15. Increased focus on optimal drugutilisation and patient safety in the countycouncils • Increasedcompetence • Experience from hospital pharmacy management • Moreinitiatedprocurersof services • Some services performed in-house • Innovation in partnership Pharmacistsemployed by the countycouncils Number Year

16. Forum for national developmentofactivities at hospital pharmaciesincl. extemporaneous preparations • Swedish SocietyofPharmaceuticalsciences - Swedish Societyof Hospital Pharmacy Section for members from e.g. hospital pharmacies, countycouncils, authorities • Swedish Association ofLocalAuthorities and Regions Workinggroup for pharmacistsemployed by the countycouncils

17. Someconsequencesof the currentmodel • Fragmentationwith less overview • Regional aspectsratherthan national • Costcuttingcanleadto less time for continoustraining/educationofstaff • Competitionleadsto less opennessbetweenplayers • Competition and diversity drive innovation • Competitionlowers the price • A varietyof services and solutions available from different providers • Someissuesbecomemoresignificant (IT, logistics etc)

18. Thanksto Lars-Åke SöderlundSwedish SocietyofPharmaceuticalsciences (board) /Apoteket Sari Frigård Swedish Societyof Hospital Pharmacy (chairman) / Apoteket Magnus Munge Swedish Societyof Hospital Pharmacy(board) / County council of Kronoberg Eva Einarsson Apotek Hjärtat Business unit Health care

19. eva.sjokvistsaers@apl.se Thankyou! Together we contribute to drugsthat improve and save lives!We are proud of that!