This handbook for students has been produced within Leonardo da Vinci-programme as a transfer of innovation project “Learning Materials for Pharmaceutical Assistant’s annd Technician’s Foreign Work Placements”,

acronym PHARLEMA (2011-1-FI1-LEO05-06161) during 01.10.2011– 30.09.2013. The publication has been co-funded by the European Comission. The Commission accepts no responsibility for the contents of the publication.

Slovenia

Pharmaceutical Assistant’s and Technician’s Work Placements

Srednja šola za farmacijo, kozmetiko in zdravstvo

Acknowledgements

This handbook has been produced by Mrs. Ljubica Gabrovšek and Mrs. Katarina Vrhovnik who offer grateful thanks to the following for their guidance, support, donation of appropriate materials and proof reading for accuracy of this package of information.

All materials of the project are downloadable for free from partner colleges’ websites:• www.bmetc.ac.uk/home.aspx• http://hesotenet.edu.hel.fi/english/etm2/pharlema/index.htm • www.kellebeek.nl• www.ssfkz.si• http://www2.stjohnscollege.ie/• www.ttk.ee

Copyright is the property of all partnership colleges represented by Srednja šola za farmacijo, kozmetiko in zdravstvo, Ljubljana, Slovenia. Altering of the materials is prohibited without permission from the partnership group represented by Srednja šola za farmacijo, kozmetiko in zdravstvo.

• SŠFKZ students contributing the dairy of the descriptions of daily work: Ms. Veronika ŠilcMs. Maja Žugec• Gimnazija in srednja kemijska šola Ruše Mrs. Lea Levstik• Šolski center Novo mestoMrs. Breda Drenek Sotošek • Celjske lekarne javni zavodMrs. Mihaela Tršinar• Javni zavod Mestne Lekarne Mrs. Nasta Vodnik• Lekarna Murgle LjubljanaMrs. Mirjam Kljucvevšek• Lekarna Prule-Trnovo LjubljanaMr.Venco Ristov• Splošna bolnišnica Celje, LekarnaMr. Franci Tratar• Univerzitietni klinicvni center Ljubljana, LekarnaMrs. Maja Osmanagic

• Birmingham Metropolitan CollegeMr. Robert BiggsMrs. Deborah CooperMrs. Karen Socci

• Helsinki Vocational CollegeMrs. Asta Lehtinen, Mrs. Kirsi Rosenqvist and Mr. Matti RemsuHelsinki Vocational College students Ms. Jenna Ahokas and Mr. Juuso Lehtinen

• Kellebeek CollegeMrs. Angela Deelen and Mrs. Gerda van der MeerKellebeek College students Ms. Kübra Bozali, Ms. Lieke van Drunen and Ms. Semanur Sahin, Ms. Danielle Thomassen

• St. John’s Central CollegeMrs. Sarah Magner and Mrs. Majella O´DriscollSt. John’s Central College students Ms. Ciara Healy, Ms. Stephanie Miller, Ms. Jennifer Ray and Ms. Sarah-Louise Scanlon

• Tallinn Tervishoiu KõrgkoolMrs. Merle Kiloman and Mr. Alar SeppTallinn Tervishoiu Kõrgkool student Ms. Kristi Lemmik, Ms. Liis Märss and Ms. Karolin Nõmm

• Coordination of the project: Mr. Matti Remsu, Helsinki Vocational College• Editing and layout: Rhinoceros Ltd• Translation: Mrs. Olga Shrestha

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Pharmaceutical Assistant’s and Technician’s Work Placements in Slovenia

Content

1. Introduction 2

2. EducationalSystem 42.1. SlovenianEducationalSystem2.2. PharmaceuticalEducation2.3. CurriculumContent

3. StructureofPharmaceuticalSectorinSlovenia 83.1. MedicinalProductManufacturersand MarketingAuthorisationHolders3.2. WholesalersofMedicines3.3. Pharmacies,BranchPharmaciesandHospitalPharmacies3.4. SpecialisedShopsforMedicinalProducts3.5. PrescribingofMedicines3.6. MedicinalProductPricesandReimbursementfor PrescriptionMedicines

4. DefinitionofProfession 144.1.RetailPharmacy4.2. HospitalPharmacy

5. NationalLegislation 34

6. References 37

7. Glossary 39

Appendix 40

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1. Introduction Dear Student

u This information package is designed to give you an overall view of vocational education and work in the pharmaceutical sector in Slovenia, together with some useful background information related to legislation on and dispensing of pharmaceuticals. We hope that the package will help you in preparing for your period of practical training in our country. On reading this material package you may find both differences and similarities in pharmaceutical work in comparison to your country. However, due to your position as a foreign student at your placement address your duties may be limited to those you would be allowed to carry out in your own country.

From a learning viewpoint it might be beneficial for you to go through both your own country’s material package and that of your destination country and to compare the two.

In Chapter 2 you will find a general description of our country’s education system and more information on how pharmaceutical training is provided in our country.

Chapter 3 gives an overview of the structure of the pharmaceutical sector and how it is organised.

Chapter 4 defines how pharmaceutical professions are defined and their core expectations. This chapter focuses on the services that are available for foreign students as placement opportunities in our country. The sub-chapters also include descriptions of daily work which are intended to assist you in defining the work you will encounter during your practical training period. These “snap shot” descriptions have been written by students during their practical training periods.

Chapter 5 describes the most relevant legislation governing the pharmaceutical sector in Slovenia.

Chapter 6 has some links to help you with search for more detailed information.

Chapter 7 describes some specific terms and acronyms.

We hope you will find this information package useful and we wish you every success with your practical training period in our country!

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Welcome to Slovenia!

u We are pleased that you have chosen our small country as the site for practical training in the course of your studies. Slovenia (officially the Republic of Slovenia) is a Central European country. It covers a territory of 20,273 km2 with 2,051,000 inhabitants. The capital of Slovenia is Ljubljana. It is situated in the central part of Slovenia and has 265,000 inhabitants.

The official language is Slovene; Hungarian and Italian are also official languages in the respective ethnically mixed areas. With the majority of the population you can easily communicate in English. Many people also understand German and, in the areas bordering on Italy, mainly Italian.

The Republic of Slovenia is a young country. It declared its independence from the former Socialist Federal Republic of Yugoslavia by plebiscite on 25 June 1991. By 1 May 2004, the Republic of Slovenia became a full member of the European Union. The monetary unit Euro was introduced in Slovenia on 1 January 2007.

Although Slovenia is a small country, its landscape is outstandingly diverse and interesting. It is in this tiny piece of Europe that four geographical units, the

Alps, the Panonian Plain, the Karst and the Mediterranean are joined. Therefore, Slovenia is the only European country where you can enjoy swimming in the Mediterranean Sea, climb 2000 m high peaks in the Alps, explore the rich underground world in some of its 9,000 caves, or take a leisure bicycle ride through the meadows and fields of the Panonian Plain.

Piran

Ljubljana

Lake Bled

4   

u IntheRepublicofSloveniachildrenstartattendingtheprimaryschoolat6yearsofage.Primaryschooliscompulsoryandlasts9years.Aftercompletedprimaryschool,youngstersmaychoosebetweenseveraltypesofoptionaleducationinsecondaryschools.Theyhaveachoiceofgeneraleducationordifferentformsofvocationalandsecondaryprofessional,vocationalandtechnicaleducation.Generaleducationiscompletedwiththebaccalaureate(maturityexamination),whichfacilitates

2.  Educational System2.1. Slovenian Educational System

thecandidate’stransitiontothetertiarylevelofeducation:studyatuniversities,academiesoratdifferentprofessionalcolleges.

Youngpeoplewishingtoobtaintheirprofessionfaster,mayjoinvariousformsofvocational,secondarytechnicalorvocational-technicaleducation.Schooling,withrespecttotheprogramchosen,takes2to4years.TheschoolsystemintheRepublicofSloveniaisshowninthediagram1.

2.2. Pharmaceutical Education

u Youngpeoplepursuingtheirprofessionaleducationintheareaofpharmacy,mayenrolintheprogrammeofsecondaryvocational-technicaleducationtoqualifyforthepostofpharmacytechnician.Schoolingtakes4years.Itiscompletedwithavocationalmaturaexamination.StudentsthataresuccessfulenoughandwishtocontinuetheirstudiesattheFacultyofPharmacymustpassanadditionalgeneralmaturaexameitherinphysicsorchemistry.Thestudyofpharmacytakes5yearsandenablesthecandidatetoobtainthetitleofMasterofPharmacy.

InSlovenia,thesecondaryprofessionaleducationprogrammeforthepostofpharmacytechnicianisprovidedbythreesecondaryschools:bytheSecondarySchoolforPharmacy,CosmeticsandHealthcareinLjubljana(Srednjašolazafarmacijo,kozmetikoinzdravstvoLjubljana),byGymnasiumandSecondaryChemistrySchoolRuše(GimnazijainsrednjakemijskašolaRuše)andbySchoolCenterNovomesto(ŠolskicenterNovomesto).TheuniversitystudyofpharmacyisprovidedbytheFacultyofPharmacyinLjubljana.

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23 5 University 22 4 ofPharmacy 21 3 (5years) Firstcycle 20 2 MASTEROF professional Higher 19 1 PHARMACY education vocational (Pharmacist) (3years) (2years) Bachelor’sdegree

       Tertiary education

MCorME

18 4 Generalupper Vocationalupper 17 3 secondary secondary Vocational 16 2 (Gymnasium/ (4years) upper Vocational 15 1 Grammarschool) PHARMACEUTICAL secondary upper (4years) TECHNICIAN (3years) secondary (2years)

      Upper Secondary education

14 9 Basiceducation13 8 (PrimarySchool)12 711 610 5 9 4 8 3 7 2 6 1

      Compulsory education

1–5 Pre-schooleducation(Kindergarten)

Age Class

MCBaccalaureate(maturacourse(1year))MEAdditionalexaminonematuracourse

Diagram 1. Educational system in Slovenia with placement of pharmaceutical education.

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2.3. Curriculum Content

deepeningandupgradingexpertknowledge.Theschooldecideswhichcontentsoftheopencurriculumwillbeofferedasoptional,whileothersmaybeprescribedascompulsoryforallstudents.

Medicinesrepresentthemainareaofoccupationalactivityofpharmacytechnicians.Inthecourseoftheirstudy,prospectivepharmacytechniciansobtaindifferentexpertknowledgeandpracticalskillsnecessaryforqualityperformanceofworkwithintheframeworkoftheiroccupationalcompetencies.Theydeveloppersonalitytraits,suchasdiligence,perseverance,accuracy,independence,responsibilityandcommunicationskills.Theybecomequalifiedforparticipationinsmallergroupsandteams.Theylearntomakeuseofup-to-dateinformationtechnologyandexpertliteratureandhowtousetheobtainedinformationcorrectly.Theybecomecapableofresponsibleandconscientiousmanagementofdocumentation.Theydevelopapositiveattitudetohealthylifestyleandhealthprotectionalongwithmoralandethicalconscientiousnessandempathytowardspeople.Theylearnhowtobehaverationallywithrespecttotheuseofenergy,resourcesandtime,andresponsiblytowardstheenvironment.Theydeveloptheabilityforpreciseobservationandcriticalmind.

u Duringthefouryearsofstudy,studentsattendlessonsingeneralsubjectsandvocationalmodules.Generalsubjectsaremainlymandatory.Mostofthemarecoveredinthefirsttwoyearsofthestudy.Vocationalmodulesprevailinthelasttwoyears(Curriculumcontent,vocationalmodulesandcorecompetencesaredescribedintheAppendix).

Duringtheirstudieseachstudentperforms443hoursofpracticeatschooland190hoursofpracticaltrainingatwork.

Apartofprogrammeofsecondaryvocational-technicaleducationistheopencurriculum.Thiscurriculumcovers562hours,andtheschoolformsitquiteindependently.ThecontentsoftheopencurriculumaredesignedbytheschoolincooperationwiththeSocialPartnersandwithintheframeworkoftheirorganisationalcapacities.Therefore,thecontentsmayvaryandmaydifferamongvarioussecondaryschoolsofferingeducationprogrammesforpharmacytechnicians.Someoptionalmoduleswithintheopencurriculumhavecataloguesofknowledgelaiddownatthenationallevel.Afewhoursoftheopencurriculumaregenerallydedicatedtotheupgradingofbasicskills,suchasmathematicsandchemistry.Mosthoursoftheopencurriculumareintendedfor

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Theylearntopreparedifferentpharmaceuticalforms,andconductchemical,physicalandmicrobiologicalanalyses,whichensurethequalityofmedicines.Theylearnabouttheeffectsofactiveingredientsandherbaldrugsandobtainskillsfordispensingandprovidinginstructionsfortheuseofmedicines,medicaldevices,foodsupplementsandhealthcareproducts,whichareobtainablewithoutmedicalprescriptioninpharmaciesandspecialisedshops.

Duringstudies,basictheoreticalknowledgeiscomplementedbypracticaltrainingatschoolandpracticaltrainingthroughworkplacement.Thepracticaltrainingatschooliscarriedoutwithintheframeworkofindividualvocationalmodulesinspecialisedlaboratoriesandclasses.

Inthe3rdand4thyear,studentsupgradetheirknowledgewithpracticaltrainingthroughwork.Mostofthestudentscarryouttheirpracticaltrainingbyworkinginpharmacies,hospitalpharmaciesorspecialisedshops,andsomealsointhepharmaceuticalindustry.Duringtheirpracticaltrainingthroughwork,thestudentslinkgeneralexpertknowledgewithpracticalskillstouseitinnewsituationsatsolvingactualproblemsencounteredintheworkplace.Theyattainskillinappropriatebusinesscommunicationintheworkplace:withsuperiors,otheremployeesandclients.Theybecomeawareofthe

importanceofcooperationatworkandteamwork.Theyupgradetheirabilitytoplan,followupandanalyseone’sownworkandtheworkofthegroup.Theygettrainedinbusinessetiquette,attaintheabilitytoquicklyadapttotheworkplaceandgreaterlabourmobility,anddevelopmotivationforlifelonglearning.

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3.  Structure of Pharmaceutical   Sector in Slovenia

u Thesupplychainofmedicinesconsistsofseveralelements,whichareinterconnectedandfunctioninalegallyregulatedandcontrolledsystem.Medicationsareproductsofspecialimportanceandtheirmarketissubjecttodetailedlegalregulation.ThePublicAgencyforMedicinalProductsandMedicalDevicesoftheRepublicofSlovenia(JAZMP)isresponsiblefortheimplementationofregulatory,developmentalandprofessionaltasksintheareaofmedicines.SupervisionoftheworkofthePublicAgencyiscarriedoutbytheministryresponsibleforhealth.InaccordancewiththeMedicinalProductsActandthePharmaciesAct,pharmacies,wholesalersandmarketingauthorisationholdersormanufacturersofmedicinesarerequiredtoensureregularanduninterruptedsupplyofmedicinestothepopulationandhealthinstitutions.

Diagram 2. Structure of pharmaceutical sector in Slovenia

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3.1. Medicinal Product Manufacturers and Marketing Authorisation Holders

u Medicinalproductmanufacturersormarketingauthorisationholdersrepresentthefirstlinkinthesupplychain.AnymanufacturerwishingtomarketmedicinesintheRepublicofSloveniamustregisterorobtainmarketingauthorisationforeachmedicinalproduct.Marketingauthorisationisaguaranteeofthequality,safetyandeffectivenessofthemedicinalproduct,aswellastheconfirmationoftherelevantdataverification.

Diagram 3. The healthcare system in Slovenia

ForeignmedicinalproductmanufacturershavetheirrepresentativesinSlovenia,whichtakecareofmarketing,promotionandinformingtheexpertpubliconmedicines.AllrelevantmanufacturesofgenericandproprietarymedicineshavetheirrepresentativeofficesintheRepublicofSlovenia.

InSlovenia,thepharmaceuticalindustryhastraditionandrepresentsasignificantshareintheeconomicsector.

10   

whicharesoldinmorethanseventycountries,isorganisedinSlovenia,Poland,RussianFederation,CroatiaandGermany.

Lekpharmaceuticalcompanywasestablishedin1946.TodayitisamemberofSandozgroup,thegenericdivisionofNovartis,thepioneerintheareaofsimilarbiologicalmedicinesandbigmanufacturerofgenericmedicines.

Wehavetwolargepharmaceuticalfactories,whichproducegenericmedicines,i.e.KrkaandLek–amemberoftheSandozgroup.

Krkacompanywasestablishedin1954.Todayitisapubliclimitedcompanyandmajority-ownedbytheSlovenianshareholdersandranksamongthemajormanufacturersofgenericpharmaceuticalpreparations.Themanufactureofitsproducts,

3.2. Wholesalers of Medicines

u Wholesalersofmedicinesareanimportantdistributionbridgebetweenthemanufacturersandpharmacies,hospitalpharmacies,healthcareinstitutes,veterinaryclinics,andspecialisedshopssellingmedicinesandmedicaldevices.Theyconductthebusinessofwholesaledistributionofdrugsandmedicaldevicesexclusivelytolegalentitiesandpersonsauthorizedforwholesaleorretailtradeinmedicines,andtopharmacies.Inaccordancewiththelegislation,medicinalproductsshallbedeliveredonlytoregisteredbuyers.Thebasictaskofthewholesalersinmedicinalproductsistoprovideregularandappropriatechoiceofmedicinesthatsatisfytherequirementsofacertaingeographicalregion,andinanappropriatelyshorttime,delivertherequiredsuppliestotheentireregioninquestion.Theymusthaveasufficientstockofmedicinestobeabletofulfil

ordersinduecourse.Theymustestablish,implementandmaintainaneffectivequalityassurancesysteminallareasoftheiractivity.Theymusthavesuitablepremisesandequipmentinaccordancewiththeprinciplesofgooddistributionandgoodstoragepractices.Theyshouldappointapersonresponsibleforreception,storage,dispensingandtransportofmedicinesandoverviewofdocumentationthatenablestraceabilityofmedicines.Thepersonresponsibleshallholdauniversitydegreeinpharmacy.IntheRepublicofSloveniatherearefivebiggerandanumberofsmallerwholesalersofmedicines.

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3.3. Pharmacies, Branch Pharmacies and Hospital Pharmacies

u Generalsupplywithmedicinesinthenarrowsensecoversthedispensingofprescriptionandnon-prescriptionmedicinesaswellasthepreparationofextemporaneousmedicinalproducts.Pharmaciesandtheirbranches,whichmaybepubliclyorprivatelyowned,supplythepopulation,healthfacilitiesandotherorganisationswithmedicines.

Pharmaciesinthepublicsectorareorganisedaspublicpharmacyinstitutionsestablishedbythelocalcommunity(municipalityortown).Generally,publicpharmacyinstitutionsconsistofseveralorganisationalunits,pharmaciesandbranchpharmacies,spreadthroughawidermunicipalityortownarea.

Amunicipalityortownmaygranttoanindividual–thepharmacistwhomeetstheconditions,aconcessionfortheperformanceofpharmacyserviceinaprivatepharmacyinthearea.Abranchpharmacymaybeopenedonlyinaplacewherethereisnopharmacy,despitetheneedformedicinedispensing.Itmayfunctiononlyunderthetechnicalsupervisionofthepharmacythatestablishedit,anditmustensureatleasttheprovisionofready-mademedicines.

Anindividualpharmacymay,intheplacewherethedoctorworks,organize

aconvenientsupplyofmedicinesforthedoctor.Thistypeofsupplywithmedicinesispractisedparticularlyinremote,scarcelyinhabitedplaces,wherethereisnopharmacyoritsbranch.Apharmacymaykeepahandysupplyofmedicinesalsoinsocialcarefacilitiesorotherinstitutionsthatofferhealthcareservicestotheirresidents,irrespectiveofthedistancetothenearestpharmacy.

Inhospitals,thesupplyofmedicinesandmedicaldevicesusedforthetreatmentandcareofhospitalisedpersonsisprovidedbyhospitalpharmacies.Hospitalpharmaciestoomayhaveseveralorganizationalunits.Thus,fortheneedsofacomprehensivesupplyofmedicines,theycanorganizewardpharmacies,galeniclaboratories,control-analyticallaboratories,alaboratoryforthemanufactureofparenteralsolutions,forthesupplyofradiopharmaceuticalsaswellasaradiopharmaceuticalpharmacy.

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3.4. Specialised Shops for Medicinal Products

u Certainnon-prescriptionmedicines,whichhavebeenauthorisedbythecompetentauthority,mayalsobedispensedbyspecialisedshops.Adepartmentofashopmaybeconsideredaspecialisedshop,providedthatitisstructurallyseparatedfromotherdepartmentssothatthesaleofotherproductscannotaffectthemedicines.Theymustemployatleastonequalifiedpersonwithminimumsecondaryeducationinpharmacy

andpassedproficiencyexamination.Thispersonisresponsibleforthepurchasing,storingandsaleofmedicinesaswellasforkeepingdocumentation,andshouldbepresentthroughouttheworkinghoursoftheshop.Inadditiontoretailsaleofmedicines,amongtheircommercialactivitiesspecializedshopsmayalsosellmedicaldevices,cosmetics,dietarysupplementsandfoodsforparticularnutritionalpurposes.

3.5. Prescribing of Medicines

u Medicinalproductsforhumanusemaybeprescribedbyphysicianswhohavetherighttoindependentlypursuetheirprofessionalactivity;theymayprescribeonlythosemedicinesthataremarketedundertheMedicinalProductsAct.Inexceptionalcases,medicinesforhumanusemaybeprescribedbydoctorsofveterinarymedicine,however,onlyforanimalsandprovidedthatsuchusewasapprovedbytheministerresponsibleforveterinarymedicine.

Forprescribing,therequiredgreenandwhiteprescriptionformsandorderformsformedicinesareused.Medicinesthatarecoveredbythehealthinsuranceareprescribedonthegreenprescriptionform.Thewhiteprescriptionformisgenerallyusedforprescribingmedicinesinprivatedispensaries,whicharenot

coveredbycompulsoryandvoluntaryinsurance.Oneprescriptionformmaybeusedforprescribingonemedicinalproductinaquantitysufficientforuptothreemonthsoftreatment.Arenewableprescriptionallowsamedicinalproducttobesuppliedrepeatedlywithinayear.Physicianschoosetoprescribemedicinesontherenewableprescriptionformforpatientswithwell-managedchronictherapy,whomusttakemedicineregularly.Theorderformedicinesisatypeofmedicalprescriptionbywhichapublichealthinstitutionoralegalentityornaturalpersonprovidinghealthservicesprescribesmedicinesfortheneedsoftheirservices.

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3.6. Medicinal Product Prices and Reimbursement for Prescription Medicines

u Pricesofmedicinesforhumanuse,whicharecoveredbypublicfunds,areregulatedinaccordancewiththeMedicinalProductsAct.Criteria,methodandprocedurefortheformulationanddeterminationofmaximumpricesarespecifiedintherelatedrules.

TheHealthCareandHealthInsuranceActlaysdownthecompulsoryandvoluntaryhealthinsurance.Thislawalsospecifiestherightsofinsuredpersonstomedicines.Onlythelistedmedicinesandfoodstuffsforspecialmedicalpurposesmaybeprescribedontheaccountofcompulsoryhealthinsurance.

Medicinesareclassifiedintotwopositiveandoneintermediatelist.Withintheframeworkofthe

compulsoryinsurance,thehealthinsurancecompanywillcoverthetotalcostsofmedicationsthatareprescribedonaspecialform(theso-calledgreenprescription)andprovidedthattheprescribedmedicationisonthe100%positivelist.Iftheprescribedmedicationisonthe75%positiveorontheintermediatelist,fullcostcoveragerequiresanadditionalvoluntaryhealthinsurance.Whentheprescribedmedicationsarenotoneitheroftheabovepositivelists,thecostsarecoveredbytheuserorbyasuperiorhealthinsurance.

Forcertaingroupsofmedicationswiththesameactiveingredient,strengthandpharmaceuticalformthehighestapprovedpricethatiscoveredbyhealthinsurance(compulsoryandvoluntary)hasbeendetermined.

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4.  Definition of Professionu Pharmacytechniciansmaybeemployedinpharmacies,hospitalpharmacies,specialisedshopsformedicinalproducts,galeniclaboratories,inthepharmaceuticalindustry,incontrolandanalyticallaboratoriesandaswholesalers.Certificateholderisqualifiedto:

•manufactureapharmaceuticalproductinlinewiththeregulationandincompliancewithgoodmanufacturingpractice;

•dispenseandprovideinstructionsforuseofnon-prescriptionmedicinesinapharmacyunderthesupervisionofapharmacist;

•dispenseandprovideinstructionsforuseofnon-prescriptionmedicinesinaspecialisedshop;

•dispenseandprovideinstructionsforuseofherbaldrugsandnaturalcompounds;

•performqualitative,semi-quantitativeandquantitativeanalysesofmedicinesandstabilitytestsformedicines;

•evaluatetheactivity,applicationandmostfrequentadverseeffectsofnon-prescriptionmedicines;

•communicateeffectivelywithpeople.

Apharmacytechnicianwhoobtainedadditionalknowledgeandskillsforworkinginapharmacyoraspecialisedshopisfurtherqualifiedfor:

•sellingandprovidinginstructionsforuseoffoodsupplementsand

otherproductsformaintenanceandprotectionofhealth;

•communicationwithclientsinapharmacyoraspecialisedshop.

Apharmacytechnicianwhoobtainedadditionalknowledgeandskillsforworkinginthepharmaceuticalindustryisfurtherqualifiedfor:

•performinganalysesandteststoassesstheidentity,purityandcontentofactiveingredients,excipients,pharmaceuticalforms,packaginganddressingsbymeansofinstrumental,biologicalandmicrobiologicalmethods;

•manufacturingliquid,semi-solid,solidandsterilepharmaceuticalformsonanindustrialscale.

Akeypartofthesupplyofdrugstakesplaceinpharmaciesandhospitalpharmacies.

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4.1. Retail Pharmacy – Core Expectation, Health and Work Safety

u Animportantpartofhealthcareservicestakesplaceinpharmaciesandtheirbranches,namelythesupplyofpopulationandhealthcareinstitutionswithprescriptionandnon-prescriptionmedications,andthepreparationofextemporaneousmedicinalproducts.Thisisapublicserviceandanexclusivefunctionthateveryverifiedpharmacyisboundtoprovide,irrespectiveofitssize(asmallaffiliatebranchorabigpharmacy)andownershipstatus(privateorpublic).

Medicationsareproductsthatproveeffectiveonlywhenusedcorrectly,andthereforeappropriatecounsellingasregardsprescribinganduseofmedicationsisofkeyimportanceforqualitysupply.

Dependingontheneeds,besidesmedicationsforhumanuse,mostpharmaciesalsodispenseprescriptionandnon-prescriptionveterinarymedicines.Somepharmaciesalsodispensehomeopathicpreparations.

Inpharmacies,peoplearesuppliednotonlywithmedicinesbutalsowithproductsforhealthprotection,ancillarymedicinalagents,variousorthopaedicandmedical-technicaldevices,cosmeticsproducts,dietfood,foodsupplementsandmanyotheritemsofgeneraluse.

Self-treatmentwithnon-prescriptionmedicationshasnowadaysbecomeawidespreadformofalleviationofhealthproblemswithoutconsultingaphysician.Inlastdecadesithasbeengaininginimportanceparticularlybecauseoftherisingcostsoftreatmentthathealthinsurancesfindincreasinglydifficulttomanage,aswellasbecauseoftheraisingawarenessofpeopleabouttheneedtocarefortheirownhealth.Pharmacieshaveanimportantroleinself-medication,becausepeoplewhooptforthistypeoftreatment,mostoftenturnforadvicetothedispensingpharmacistorpharmaceuticaltechnician.

Recently,pharmaceuticalcarehasbecomeanincreasinglyimportantactivitybywhichpharmacistsinthepharmacythroughvariousmeasurestrytoprevent,detectandsolveproblemsassociatedwithmedicationsthatmayadverselyaffecttreatmentoutcome.Theconceptofpharmaceuticalcareisprimarilyintendedforthegroupsofpatientswhoaremorepronetomedications-relatedproblems.Thesearechronicpatientsusingseveralmedications,aswellastheelderly,adolescentsandchildren.

Pharmaciesalsoprovidesettingsformentoringactivity,wheresecondaryschoolstudentsandcollegestudents

16   

ofpharmacygainpracticalexperienceneededforcompetentandqualityperformanceoftheirfutureprofession.Tutors-pharmacistsalsolookafterthetraineeswhoundergocompulsorypracticaltrainingpriortotakingtheproficiencyexam.

Majorpharmacies,especiallypublicinstitutionsthatcombinemanyorganizationalunits,havehighlydevelopedpharmacy-informationactivitywhichisintendedtoinformemployeesaboutnewdevelopmentsinlegislationandregulationsaswellasintheprofession,whileitalsoperformsanimportantfunctionofpublicrelations.

Pharmacieshaveanimportantroleinpublichealthcareinthelocalcommunityandcarryoutvariousactivitiestopromotehealthylifestylesandpreventionofmoderndiseases.

Publicpharmaciesmayruntheirownmanufacturingunits,galenicandanalyticalcontrollaboratories,wheremedications,ancillarymedicinalagentsandgalenicproductsaremanufacturedandtested.Galenicproductisamedicinethatispreparedinagaleniclaboratoryofthepharmacyinaccordancewiththevalidpharmacopoeiaandisintendedforretailsaleinthepharmacyconcerned.Insomegaleniclaboratories,besidessmall-scaleproductionofgalenicproducts,theyalsomanufacturefoodsupplements,cosmeticsandmedicinesthatareauthorizedandmarketedin

theentireterritoryofSloveniaaswellabroad.Galeniclaboratoriesmusthaveadequatefacilitiesandequipment,well-definedproductionprocessesintermsofGMPandthestaffofadequatelytrainedprofessionals.Analyticalcontrollaboratoryperformssupervisionoverthequalityofproductsmanufacturedbythegaleniclaboratory,andtakespartinthequalityassuranceasregardsproductsandserviceswithinthedomainofpublicpharmacies.Analyticalcontrollaboratorymusthaveapharmacistonstaffwhohasappropriateknowledgeofdrugtestingandwhoisresponsibleforthereleaseofproducts.

Opening Hours and Designation Signs Pharmacymustbedesignatedwiththeinscription“LEKARNA”,withilluminatedpharmacysymbolingreencolourandtheshapeofacrosswiththesnakeandthechalice,andtheinformationonownership,businesshoursandthenearestpharmacyonduty.Openinghoursofpharmaciesshallbebasedonthelocalneedsformedicinessupply,andshouldnotbelessthan40hoursaweek.

Illuminated pharmacy symbol 

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On-duty serviceDuringthetimewhenpharmaciesareclosed,theymustensurethata24-houremergencyserviceisavailableinalargerareathroughwhichpeoplecanbesuppliedwithmedicinesatanytime.Inanareawherethereareseveralpharmacies,theseshouldagreeonthescheduleofon-dutyserviceanddeterminethesequenceorderofthenight,Sundayandholidayavailability.Ifthepharmaciescannotreachanagreement,thesequenceordershallbedeterminedbytheChamberofPharmacywithrespecttothenumberofpharmacistsemployedinindividualpharmacies.

Professional staffPharmaceuticalprofessionalworkinapharmacyisperformedbypharmacistandpharmacytechnicians.Headofthepharmacyisapharmacist,whoisresponsiblefortheorganisationofworkandpharmacymanagement.

Pharmaceuticalprofessionalstaffmayperformtheirworkindependentlyaftertheyhavecompletedtheirtraineeperiodandproficiencyexam.Theymusttakecareoftheirhealthandhygiene,considerhealthprotectionmeasuresanduseprotectiveequipmentduringwork.Theymustundergocontinuousprofessionaltrainingandrespectthecodeofethicsforpharmacists.

Inpharmacies,pharmacistswhopassedtheproficiencyexammaydispensemedicationsindependently.Non-

prescriptionmedicinesthatmaybeissuedonlyinpharmaciesmaybedispensedbypharmacistsaswellasbypharmacytechnician,however,onlyunderthesupervisionofapharmacists.Therestofthepharmaceuticalprofessionalstaffperformotherprofessionaltasks,forwhichtheyarepersonallyresponsiblewithinthelimitsoftheircompetences.

Organisation and equipmentThepremisesmustbearrangedandequippedsoastoprovidequalityworkinaccordancewithgoodpharmacypractice.Theymustbefunctional,wellmaintainedandreasonablyequippedtoallowtheimplementationofadministrativetasks,manufacturingextemporaneousmedicinalproducts,storageandtransferofmaterials,segregationofcleanandlesscleanprofessionalactivitiesandinparticularthedispensingofmedicationsandothergoods.Personnelmustbeallowedunhinderedmovementandhavethepossibilityofadequatecontactwiththeusers.

Eachpharmacymusthavethefollowingfacilities:

•placefortheacquisitionofgoodsdelivered;

•placefordispensingmedicines;

•placeforstorageofmedicinesandothergoods;

•placeforthemanufacturingofextemporaneousmedicinalproducts;

•placeforcleaningtoolsandpackaging;

18   

•placeforcounselling;

•placeforperformingprofessional-administrativetasks;

•toiletsandcloakroom;

•placeforon-dutyservicesiftheseareperformedbythepharmacy.

Pharmacymusthavetheequipment,whichenablesthemanufacturingofsolid,semi-solid,liquidandsterilepharmaceuticalpreparations.

Professional literature and regulationsProfessionalstaffmustalwayshaveaccesstocontemporaryprofessionalliteratureforinformationandadviceonmedicinalproducts,manufacturingandqualityassuranceofmedicinesandallthehealthregulationsgoverningpharmacy,medicines,medicaldevicesandillicitdrugs(eitherinpaperorelectronicform).

Quality and documentationPharmaciesmusthaveaqualitysystemestablishedand,withrespecttothescopeofwork,maintainthefollowingdocumentation:

•recordofthetraceabilityofpharmaceuticalsubstances;

•recordoftheacquisitionanddispensingofillicitdrugs;

•recordofcomplaintsandrecallsofmedicines,medicaldevicesandotherproducts;

•recordofstorageconditionsofmedicines;

•recordofmedicinesdispensedonrenewablemedicalprescriptions;

•recordofcleaningandmaintainingpremises;

•recordsofequipmentmaintenance;

•documentationofcalibrationandvalidationofequipmentandworkprocesses;

•instructionsorproceduresforperformingprofessionaltasks.

Work activities Allactivitiesinthepharmacymustbecarriedoutinaccordancewiththeprinciplesofgoodpharmacypracticedeterminingthecorrectworkflowinthepharmacy.Apharmacymusthavestandardoperatingprocedurespreparedforalltheactivitiesthatweresubjecttoitsverification.

Professionalstaffmustensurethatthepharmacyhasadequatestockofmedicines,theingredientsforthepreparationofextemporaneousmedicinalproducts,medicaldevicesandothergoods.Theyareboundtothisbylawandeconomicinterests.Iftheproductisnotinstock,theymustensurethatthepatientreceivesitinduetime.

Thestaffcarefullyreviewseachconsignmentofgoods,checkstheirquantityandquality,arrangesthemontheshelvesandstorestheminaccordancewiththeprinciplesofgoodstoragepractice.Goodstoragepracticeisaqualitysystemrelatingtotheorganization,implementationandmonitoringofthestorageofproductsinaspecifiedorder

   19

beforefurtheruse.Medicinesandothergoodsshouldbestoredinapharmacyunderconditionsthatmeetthemanufacturer’sinstructions,andinaccordancewiththeregulationsoftheapplicablepharmacopoeiaandthelaw.Thepackagingmustensuremaintenanceofcoldchainandproperandsafestorageofflammableandcorrosivepharmaceuticalsubstances.Medicinescontainingillicitnarcoticsmustbekeptinametalcabinetwithlock.Uselessandrecalledmedicines,orthoserejectedduetocomplaints,mustbekeptseparatefromothergoodsandlocked.

Staffshouldregularlytestthestorageconditions(temperatureandhumidity),calibratetheequipment,checkexpirydatesandkeepcorrespondingrecordsofthesedata.

Manufacturingofextemporaneousmedicinalproductsisstillpartofthedailyroutine.Extemporaneousmedicinalproductsaremedicinesthatarecreatedinthepharmacyforaparticularpatientbasedontherecipechosenandprescribedbyhis/herdoctor.Inmanufacturingextemporaneousmedicinalproduct,theymustfollowtheprinciplesofgoodmanufacturingpracticesandlabelthemcorrectly.Forthemajorityofextemporaneousmedicinalproduct,thepharmacieshavestandardoperatingprocedures(SOP)andinstructionsprepared,which

regulatethemanufacturingprocessindetail.ThemajorityofformulaeforextemporaneousmedicinalproductsarepublishedintheCodeofExtemporaneousmedicinalproducts,verifiedbytheexpertcommitteeattheSlovenianChamberofPharmacy.Thisensurestheirqualityandconsistentcompositionirrespectiveoftheplaceofmanufacture.Themostcommonextemporaneousmedicinalproductsaredividedpowders,eyedropsandavarietyofdermalformulations.Insomepharmacies,wheretheyhavesuitableconditions,theyalsomanufactureextemporaneousmedicinalproductsthatcontaincytotoxicagents.

Themainactivityinthepharmacyisthedispensingofprescriptionandnon-prescription(OTC)medications,medicaldevices,dietarysupplementsandcosmeticproducts,andcounsellingontheirproperuse.Inadditiontoexpertise,goodcommunicationbetweenpharmacistsorpharmaceuticaltechniciansandusersiscrucialforsuccessfulwork.Theaimofcommunicationistohelp,toobtaintherightinformationforcounselling,tounderstandcorrectly,tosuggestcorrectmedicationsandtoimprovequalityoflife.Atthesametime,theaimofcommunicationistogaintheusers’confidence,sothattheywillkeepcomingbacktothepharmacybecauseofthequalityofserviceandexcellentadvice.

20   

Pharmacy technician student’s working day in the retail pharmacy Apharmacywithastatusofateachinginstitutioncanacceptstudentsonworkplacements.Theyworkinthepharmacyunderthesupervisionofatutor.Intheperformanceofworkplacementsofstudentsfromabroadtheworkhastobecustomizedtocertainextentbecauseoflanguagebarriers.Studentsperformthesametasksasdescribed.TheyhelpinpreparingprescriptionmedicinesfordispensingandforresidentsoftheResidentialHomefortheElderlyaswellasextemporaneousmedicinalproducts,andparticipateinthereceiptofmedicinesandothergoodsandstorethemontheshelves.ThepharmacyisalsovisitedbyEnglish-speakingtourists.Insuchcases,studentsfromabroadareincludedintheprocessofself-medicationcounselling.

Thepharmacist-tutortalkswithstudentsfromabroadalotandtheybothlearnaboutthedifferencesbetweenthetwocountries.Theycomparethecourseofeducationandtrainingforparticularprofessions,differencesintheoperationofpharmacies,differencesinhealthcarelegislation,andpeople’sattitudetomedicinesandhealth.Afewminutesaredevotedtootherissues–mutualacquaintanceandcomparisonofourtraditions.Eachdayinpharmacyisdifferent.Thepharmacystafflikestoworkwithyoungcolleaguesandtheyarepleasedwhentheylearntogetherandenricheachother.

Pharmacists-tutorstakecarethatstudentslearnandacquirethefollowingskills:

•theprocessesofdispensingmedicinesandmedicaldevicesonprescription;

•theprocessesofdispensingnon-prescriptionmedicinesandcounsellingonself-treatment;

•safe,correctandeffectiveuseofmedicines,medicaldevicesandhealthprotectionproducts;

•preparationofextemporanouesmedicalproductsforpatients;

•supplywithmedicinesandmedicaldevices(stockmanagement);

•keepingrecordsanddocumentation;

•knowledgeandimplementationofthelawinpractice;

•healthandsafetyrequirements,

•pharmacyinformationsystem(computerskills),and

•anappropriateattitudetowardscolleaguesandvisitorstothepharmacy.

Working time of the student is from 7:30 to 14:00 (possiblytwiceaweekfrom13:00to19:30).

Upontheirarrivaltowork,thestudentsmakenoteofthetemperatureandhumidityinthedispensingunitandthelaboratory.Theycheckthetemperatureintherefrigeratorsandoperationofthescaleswithcontrolweightsandfillintherelevantrecords.

Theycheckthesupplyofmedicinesontheshelvesandindrawersandfillthem.Theyhelptomaintainthestock

   21

ofmedicines,medicaldevicesandotherproducts.

TheyprepareprescriptionmedicinesprescribedfortheHomefortheelderly,and(togetherwithmentor)reviewtheadministrativeandtechnicalpartoftheprescription.

Underthesupervisionofamentor,theydispenseprescriptionmedicinesandmedicinesthatmaybeissuedwithoutaprescription,medicaldevices,andparticipateinself-medicationandcounselling.Intheirwork,theyuseprofessionalliteraturefromthepharmacy’s“library”,databases,pharmacyinformationsystems,andprotocolsforself-medication.Withtheirmentortheytalkalotaboutcounselling,attitudetoclients,appropriatecommunicationandprofessionalethics.Thementorencouragesthemtobeprofessionalandatthesametimerelaxedatwork,andtogethertheyresolveallqueries.In

preparingextemporaneousmedicinalproductsunderthesupervisionofamentortheyreadadministrativeandtechnicalpartoftheprescription.Theycheckthedosageandincompatibilitiesandselectappropriateaccessoriesforthemanufactureandpackaging.Theyelaboratepreparationandsignit;ontheprescriptiontheyindicatewhichcomponentshavebeenusedtoensuretraceability.Attheendtheyputinorderandcleantheworkingareasandequipment.

Ataroundnoon,thewholesalerdeliversmedicinesandothergoods.Studentshelpincontrollingthequantityofgoodsaccordingtothedeliveryform,andpackagingappearance.Theystoreawaymedicinesthatrequire“coldchain”andcheckshelflife.Afterwardstheyputtheremainingmedicinesandgoodsontheshelvesandentertheincomingsubstancesandchemicalsintherecordsoftraceabilityofthestartingmaterials.Mentoralertsstudentstofollowingtheprinciplesofgoodpracticesandstandardoperatingprocedures.

Intheafternoon,studentsagaincheckthetemperatureandhumidityinthedispensingunitandinthelaboratory.Theyfillinrecordsandcheckthetemperatureintherefrigerators.

Oncetheplannedworkisdone,students,togetherwiththeirmentor,makeaplanforthenextdayandgohome.

22   

A working day from the diary of a student on work placement in the pharmacyMynameisMajaandIamafourth-yearstudentofthepharmaceuticalprogramattheSecondarySchoolofPharmacy,CosmeticsandHealthcare.Atthebeginningofthisschoolyear,Iperformedaworkplacementinapublicpharmacy.

Myworkingdayinthepharmacystartedat7:00a.m.,asalways.InthecloakroomIhadmylockerwhereIcouldstoreclothingandpersonalbelongingsafterIchangedmyclothesandshoes.Myworkuniformconsistedofawhiteoverallcoatandslippers.Iamalreadyusedtothisoutfitsinceitisalsocompulsoryatschool.

Afterwehadourusualquickcupofteawiththestaff,webrieflydiscussedwiththementormyschedulefortheday.

Myfirsttaskinthemorningwasalwaysthesame.Ireadthetemperatureandhumidityinthedispensary,storage,laboratoryandtherefrigeratorandenteredtheobtaineddataintothedailycontroltable.Ialsocheckedtheaccuracyofscalesinthelaboratory.Iplacedacalibratedweightonthescalesandenteredthereadinginthediary.Iperformedthistaskindependently.

Then,togetherwithapharmaceuticaltechnician,Ihelpedintakingoverthegoodsdeliveredfromthewholesaler.Wecheckedthecomplianceofthecon-

signmentwiththedeliverynote,reviewedshelflifeandplacedmedicinesandmedicaldevicesonthecorrespondingshelvesinthestoragecloset.Medicinesthatmustbekeptinacoolplace,Icarefullyplacedintherefrigerator.

Then,togetherwithapharmaceuticaltechnician,Iwipedthedustofftheshelves.Thenwereviewedtheshelvesanddrawersinthedispensaryandwrotedownmedicationsthatneededtobebroughtfromthestorage.Inthestoragecloset,Iplacedtherecordedmedicinesonthecartand,assistedbyapharmaceuticaltechnician,Iputthemawayinappropriateplaces.Ialsocheckedtheshelflifeoneachstackedcarton.By8:00a.m.,whenthepharmacyopenedforcustomers,alltheshelvesanddrawershadbeenfilled.

Mymentorgavemeanewtask.Followingtherecipe,underthetutor’ssupervision,Iprepared2000gofcoolingointmentforstock.

Manufacturingformula:

•Ceralanae 600,0

•Vaselinumalbum 600,0

•Aquapurificata 600,0

•Olivaeoleum 200,0

FirstIwashedmyhandsanddisinfectedtheworksurface.Ipreparedtheaccessoriesandcomponents.

Duringtheprocedure,Icarefullyweighedoutingredientsandconfirmedeachrecordedmasswithmysignature.

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Iweighedwhitesoftparaffinandlanolinintoamixingbowlandheateditinawaterbathuntiltheingredientsmeltedandreachedthetemperatureof70ºC.Iaddedoliveoilintothemeltedlipophilicphase.Then,whilestirringcontinuously,Iaddedtothemoltenlipophilicphaseboiledpurifiedwaterheatedtothesametemperatureandmixeduntilcool.Ifilledthemixtureinto100gcontainersandlabelledthemasappropriate.Coolingointmentprotectstheskinagainstirritantsthatcauseinflammation.Waterevaporationslightlycoolstheskin.

Whentheointmentwasready,Ifilledtenbottleswithparaffinoilandlabelledthemasappropriate.Paraffinoilisusedforsofteningearwaxandisalwayspreparedinthepharmacyinadvance.

At10:00a.m.,Ihadlunch.

Mymentorbroughtaprescriptionforpowders:Rp./Tocopherolplv.a0,005Lactosumq.s.M.f.plv.D.t.dos.No.XXX(triginta)D.S.:Twopowders3-timesdaily

Togetherwithmymentor,wecheckedcorrectnessofthedosage.Icalculatedthenecessaryquantitiesofactiveingredientandfilledthem.Lactoseismostfrequentlyusedasafillerinthemanufactureofdividedpowders.Mymentorcheckedthecorrectnessof

calculationandweighedtheingredientsonthechart.Imixedtheingredientsinamortarfollowingtheprincipleofincreasingweightsandkeptmixingfor10minutes.Whilestirringthepowders,Irepeatedlyscrapedthemoffthemortarwall.Iweighedthirthypowdersandfilledthemintopapercapsules.Underthementor’ssupervision,Iclosedthecapsulesandlabelledthemasappropriate.

Mymentorshowedmehowtoentertheextemporaneousmedicinalproductsintothecomputerandprintaninvoice.

Mynexttaskwastoweighteas.Althoughshopsofferalargevarietyofteas,peoplestillliketobuyteasinapharmacybecausetheyhavemoreconfidenceinpharmacists.Inadditiontotea,theyalwaysgetakindwordandgoodadvice.Iweigheda50mgofyarrowherb(Millefoliiherba)perpaperbag.Ilabelledthebagsasappropriateandaddedinstructionsforuse.

Instructionsforuse:Pour1–2teaspoonswith2dlofhot(notboiling)water.Coverandletstandfor10–15minutes.Strainanddrink2–3timesaday.

Then,underthesupervisionofmymentor,Ipreparedaprescriptionointmentaccordingtothealreadyknownprocedure.Togetherwithmymentor,wefirstcheckedcorrectnessofthedosageandpreparedeverythingnecessaryforwork.

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Rp./Diprosonecr. 15,0Belobazae 30,0Olivaeoleum 0,5M.f.ung.D.S.:Applytotheaffectedareaoncedaily.

Myworkingdaypracticeendedat2:00p.m.

4.2. Hospital Pharmacy

u Hospitalpharmaciesareorganisedbyhospitals.Theypurchuase,anddispenseready-madeprescriptionandnon-prescriptionmedicines,manufactureanddispenseextemporaneousmedicinalproductsandgalenicpreparations.Theyalsodispensesanitarysuppliesandmedicaldevicesusedforthetreatmentandcareofhospitalisedpersons.IntheRepublicofSlovenia,thereare26hospitalpharmacies.

Themaintaskofthehospitalpharmacyistosupplypatientswhoaretreatedonwardsandinoutpatientdepartmentsofthehospitalwithmedicinesandothermedicalsupplies.Besidestheattentionofphysiciansandmedicalstaffontheward,alotofcarefullyplannedprofessionalactivitiescarriedoutbythepharmacistsandpharmacytechniciansinthehospitalpharmacyareneededtoensurethathospitalisedpatients

willreceiveappropriatemedications.Theseprofessionalworksinclude:

•purchasinganddispensingofmedicinesandothermaterials;

•manufacturingextemporaneousmedicinalproducts(includingcytotoxicdrugsandradio-pharmaceuticalsandthoseforcompleteparenteralnutrition–CPN);

•manufacturingofparenteralpreparations,sterileproducts,galenicproducts,manufacturingandpreparationofcosmeticandhealthprotectionproducts;

•manufacturingofpurifiedwater;

•qualitycontrolofgalenicproductsandpharmaceuticalsubstances;

•verifyinganalysisreports;

•managementoftherequireddocumentation;

•carryingoutconsultingandprofes-sionalinformationactivitiesregardingtheuseofmedicines,medicaldevicesandhealth-protectionproducts;

•carryingoutscientificresearchandparticipationinclinicalstudies;

•controlofmedicinesonhospitalwards;

•monitoringofadversereactionstodrugsandmedicaldevices.

Nevertheless,professionaltasksperformedbyeachhospitalpharmacydependonthetypeandsizeofthehospitalandpersonnelinthehospitalpharmacy.

Professional staffProfessionalworkinahospitalpharmacymaybeperformedindependentlybypharmacyprofessionalswhohave

   25

adequatedegreeinpharmacyandhavepassedproficiencyexam.Professionalstaffinahospitalpharmacyincludespharmacists,pharmacyengineersandpharmacytechnicians.Hospitalpharmacycanbeheadedbyapharmacistwhohaspassedtheproficiencyexam.He/sheisresponsiblefortheorganisationofworkandprofessionalperformanceofpharmacyservices.

OrganisationInordertosupplypatientswithmedicinesandmedicaldevices,thehospitalpharmacycanorganizewardpharmaciesonindividualwards.Awardpharmacymusthaveatleasttworooms:aplaceforthereceiptofmedicinesandmedicaldevicesandaroomfordispensingmedicines.Whenawardpharmacyorganizesthemanufactureofextemporaneousmedicinalproducts,itmusthaveasuitableroomavailableforthatandaroomforcleaningutensilsandpackaging.

Insome,mainlylargerhospitalpharmacies,theymanufactureavarietyofparenteralsolutions,antitumourmedicinesandradio-pharmaceuticalproducts.Ahospitalpharmacywhereextemporaneousmedicinalproductscomprisingcytotoxicagentsandradio-pharmaceuticals,extemporaneousmedicinalproductsforcomplementaryparenteralnutrition,parenteralpreparations,homeopathicandgalenicproductsaremanufacturedandthequalitycontrolofgalenicproductsandpharmaceuticalsubstancesisperformed,

musthavesuitablepremisesandequipmentavailabletoperformtheseactivities.

Professional literature and regulationsAhospitalpharmacymustalwayshaveaccesstocontemporaryprofessionalliteratureforinformationandadviceonmedicines,manufacturingandqualityassuranceofmedicinesandallthehealthregulationsgoverningpharmacy,medicines,medicaldevicesandillicitdrugs(eitherinpaperorelectronicform.ThelistofprofessionalliteratureandregulationsshallbespecifiedbytheSlovenianChamberofPharmacy.

Documentation managementAhospitalpharmacymustmaintaindocumentation,whichcomprises:

•recordofthetraceabilityofpharmaceuticalsubstances;

•recordoftheacquisitionanddispensingofillicitdrugs;

•recordofcomplaintsandrecallsofmedicines,medicaldevicesandotherproducts;

•recordofstorageconditionsofmedicines;

•recordofmedicinesdispensedonrenewablemedicalprescriptions;

•recordofcleaningandmaintainingpremises;

•recordsofequipmentmaintenance;

•documentationofcalibrationandvalidationofequipmentandworkprocesses;

•instructionsorproceduresforperformingprofessionaltasks.

26   

Ifthehospitalpharmacyhasgaleniclaboratoryandlaboratoryforthemanufactureofparenteralsolutionsorganized,itmustkeeprecordsofitsactivityinaccordancewithgoodmanufacturingpracticeforpharmaciesandgoodstoragepractice.Thedocumentationmustensuretraceabilityofstaff,materials,processes,products,manufacturingconditionsandallqualityassuranceprocedures.Analyticalcontrollaboratorymustkeepthedocumentationprovidedforbythegoodlaboratorypracticeofqualitycontrol,whichispartofgoodmanufacturingpractice.

Work activitiesInordertofacilitatetheperformanceofprofessionaltasks,ahospitalpharmacymayorganiseindividualorganisationalunitsorwardstocarryoutspecificworkactivities.Eachsuchdepartmentshallbeheadedbyapharmacist,whoplansandorganizesworkandcooperateswiththeircolleaguesbothwithinthedepartmentaswellasinotherdepartments.

Dispensaryisthedepartmentordering,receivinganddispensingmedicinesandprovidinginformationaboutmedicines.Pharmacistsdailyprocurethenecessarymedicines,medicaldevices,disinfectantsanddressingsmaterial.Uponthearrivalofgoodsinthedispensary,pharmacytechniciansunderthesupervisionofapharmacistareinvolvedinthereceiptofgoods.Uponthe

receipt,goodsshallbeinspected,recordedandstoredasappropriate.Themedicinesshallbeallthetimehandledsoastoensuretheirsafetyandeffectiveness.Medicinesshallbekeptinstorage,takingintoaccountshelflife,controlledtemperatureandhumidityintheroomand,wherenecessary,providingcoldchain.Toxicomanogenicsubstancesshallbekeptseparatelyinsafes.Pharmaceuticaltechnicians,underthesupervisionofapharmacistarealsoinvolvedindispensingmedicines,medicaldevicesandothermaterialtohospitalwards.Medicinesprescribedbyaphysicianinthehospital’soutpatientdepartmentandintendedforthetreatmentofpatientsaftertheirdischargefromhospitalmayonlybedispensedbypharmacist.

Indispensingmedicinestohospitalwards,pharmacistscooperatewithphysiciansandothermedicalstaff,thuscontributingtoaquality,safeandrationaluseofmedicines.Everyday,theycarefullyprepareinstructionsandwarningsforproperandsafeuseofmedicines,keeprecordsofthedispensedmedicationsandmonitormedicinalproductsinstock.

Animportantprofessionaltaskofthedispensary,whichalsorequiresparticipationofpharmacytechnicians,isthecollectingofmedicineswithexpiredshelflife.Suchmedicinesinintactimmediatepackagingarecollectedinspecialcontainers,

   27

intendedforthispurpose.Thecontainersarethenforwardedtothesuppliers,whomakesurethattheyaredestroyedasappropriate.

Currentrecordsarekeptofalltheactivitiesperformed.

Majorhospitalpharmaciesmanufactureseveralmedicinesthemselves.Themanufacturingofmedicinestakesplaceinthegaleniclaboratory.Theretheyproducepharmaceuticalpreparationsfortheneedsofhospitalisedpatientsaswellasforpatientsdischargedfromhospital.Theproductsincludeavarietyofcreams,ointmentsandointmentbases,suppositoria,powders,ethanolsolutions,solutionsofreagentsanddisinfectants,asepticallyprepareddifferenteyeproductsandsolutionsforinhalation.

Massproductionfacilitatesmanufacturingoflargerquantitiesofproducts.Alltherecipes/formulaearemanagedbycomputer,themanufacturingprocessisaccompaniedbyamanufacturingsheetandeachproductreceivesaserialnumber.Thewholegalenicpreparationmanufacturingprocessissupervisedbyapharmacist,whilepharmacytechniciansimplementandmonitorindividualtechnologicaloperations,suchasweighing,mixing,dissolving,measuringtemperature,fillingintheappropriatepackagingandlabellingoftheproduct.Theykeepcurrentrecordsofalltheactivitiesperformed.

Hospitalpharmaciesalsomanufactureextemporaneousmedicinalproducts.Theseareintendedspecificallyforaparticularpatient.Extemporaneousmedicinalproductsareproducedmainlywhencertainmedicinesarenotavailableonthemarketorthedoseand/orpharmaceuticalformneedtobeadaptedtothepatient.Thisisparticularlycommoninpaediatrics,whene.g.tabletsareusedforpreparinganoralsuspensionforeasierintake.Extemporaneousmedicinalproducts,similarlyasgalenicpreparations,aremanufacturedbypharmacytechniciansunderthesupervisionofpharmacists.

Thequalityandsafetyofpreparationsareensuredbytheanalyticalcontrollaboratory.Intheanalyticalcontrollaboratory,theycheckthequalityofallstartingmaterialsforthemanufacturingofpreparations,packagingandpharmacy-producedbatchesofmedicinesbeforetheyarereleasedforuse.Analyticalproceduresareperformedinaccordancewithapplicableregulationsandtakingintoaccountthecurrentpharmacopoeia,suchasPh.Eur.,BP,USP,bestpractices,e.g.,goodmanufacturingpracticeandgoodlaboratorypracticeandthelegislationinforce.Onlyafteranalyticalmethodsintheanalyticalcontrollaboratorydemonstratethattheproductsareofappropriatequality,theyareequippedwithananalyticalcodeandreleasedforuse.Precisionandconscientiousnessintheperformanceofworkintheanalyticallaboratory

28   

isparticularlyimportant.Therefore,accurateandpreciserecordsthatfacilitatetraceabilityshouldbekeptofalltheactivitiesperformed.

Intheanalyticalcontrollaboratory,apharmacytechnician,supervisedbyapharmacist,mayperformthefollowingtasks:takingandpreparingsamplesforanalysis,measuringpH,performingtitrimetric,polarimetricandspectrometricanalysesandhigh-performanceliquidchromatography(HPLC),preparingandlabellingreagentsandotherchemicals,cleaningandcalibratingtheapparatusesusedforanalyticalprocedures,andkeepingrecordsoftheproceduresperformed.

Inlargehospitalswithmanypatients,theworkofpharmacyismuchmoreextensiveandthereforeahospitalpharmacymayhaveotherdepartments,inwhichthemanufactureofvariousparenteralsolutions(infusionandinjectionsolutions)takesplace.Theycanmanufacturepreparationsintendedforindividualandparenteraltherapy(parenteralpreparationsforthetreatmentwithcytotoxicagentsandpreparationsforfullparenteralnutrition).Workinallspecializeddepartmentsiscarriedoutundercontrolledconditionstopreventcontaminationofproductswithmicroorganisms,pyrogenicsubstancesandvariousparticles.Inthepreparationofcytotoxictherapy,anadditionalattentionshouldbepaidtoprotectthestaffandenvironment.Pharmaceutical

technicianswhoarespeciallytrainedforthepurpose,participateintheprocessofmanufacturingproductsforparenteraluseunderthesupervisionofapharmacist.

Hospitalsperformingtreatmentwithradio-pharmaceuticalsmusthavetheirownradio-pharmacy.Pharmaceuticalprofessionalsworkingintheradio-pharmacy,musthavethenecessaryadditionalknowledgeandauthorisationtoworkwithunsealedradioactivesources.Radio-pharmacymustbeprotected.Equipmentandmaterialsintheradio-pharmacymustcomplywiththeregulationsonprotectionagainstionisingradiation.Workinthesepharmaciesmustbecarriedoutinaccordancewiththerequirementsofgoodmanufacturingpractice,goodpharmacypracticeandrecommendationsoftheEuropeanAssociationofNuclearMedicine,whichensureconsistentmanufactureandcontrolofradio-pharmaceuticalsunderthecriteriaofqualityandfitnessforpurposeofuseasrequiredbythespecificationoftheproductorthemarketingauthorizationofradio-pharmaceuticals.

Student’s working day in the hospital pharmacy (Univerzitetni klinicvni center – UKC Ljubljana)MynameisMajaOsmanagic.Iamapharmacytechnicianbyprofession,andhavebeenworkinginthepharmacyoftheUKCLjubljanaforacoupleofyearsnow.

   29

ThepharmacyoftheUKCLjubljanaprovidesongoingsupplyofmedicinestopatientstreatedontheUKCwardsaswellasthesupplyofunregisteredmedicationstopatientstreatedonoutpatientbasis.Apartfromitsroleashospitalpharmacy,thepharmacyinDr.PeterDržajHospitalalsorunsapublicpharmacyservice.TheprevailingvolumeofworktakesplaceintheCentralPharmacylocatedinthemainbuildingoftheUKC.

Forthispurpose,thepharmacyhasseveraldepartments:

•dispensary;

•galeniclaboratory;

•qualitycontroldepartment;

•departmentforparenteralsolutions;

•departmentforpreparingcytotoxictherapy;

•departmentforpreparingfullparenteralnutrition.

Pharmacytechniciansparticipateinallprocessesofsupplyandmanufacturingofmedicinesthattakeplaceinvariouspharmacydepartments.Alltheworkprocessesarecarriedoutunderthepharmacist’ssupervision.Becauseofthediversityofworkinindividualdepartments,Ihavechosentodescribetheworkofpharmacytechnicianinthedispensaryofahospitalpharmacy.

Dispensaryisthatpartofthepharmacywherethepreparationanddispensingofmedicinesforclinicalwardstakesplace.ThepharmacyoftheUKCLjubljanaprovidesmedicinesto80

clinicaldepartmentsofthehospital.Themajoruniversityhospitals,suchasUniversityDepartmentsofPaediatrics,Gynaecology,Surgery–ClinicalDepartmentofTraumatology,DermatologyandVenerology,OtorhinolaryngologyandCervicofacialSurgery,Ophthalmology,andtheDepartmentofInfectiousDiseasesandFebrileConditionsarealsopartsoftheUKCLjubljana,butare–becauseoftheirsize–situatedoutsidetheCentre’smainpremises.OwingtothedistancefromtheUKC’smainpremises,theymaintaintheirownpharmacydepartmentswherepharmacytechniciansunderthesupervisionofapharmacistareinchargeoforderinganddispensingmedicines,parenteralsolutionsandmedicalconsumables.Inthisway,theyprovideafast,secureandefficientsupplyofmedicinesandothermaterialsneededtoensurepropertreatmentandcareofpatientsonwards,whichwouldotherwisenotbefeasible.

Dispensingofmedicinestothewardsstartsat8:00a.m.andclosesdownat7:00p.m.Earlyshiftisfrom7:30a.m.to3:00p.m.,andafternoonshiftfrom11:15a.m.to19:00p.m.

Pharmacytechniciansstarttheirworkinthedispensaryat7:30a.m.Ateamofsixpharmacytechniciansisresponsibleforthepreparationofmedicinesandcomputerregistrationofthereceiptofdeliveredmedicines.

30   

Inthemorning,pharmacytechniciansfirstfilluptheshelveswithmissingmedicines,whichweredispensedtothewardsonthepreviousday.Aftereighto’clockinthemorning,ordersforthewardsaresenttothepharmacythroughthecomputer.Pharmacytechniciansprinttheorderforms,preparethemedicinesorderedandwriteoutadispensingform.

Pharmacytechnicianspreparethemedicinesfordispensinginaccordancewiththeorderformandplacethemonspecialtrolleys.EachmedicineisenteredintothecomputerprogrammewithitsIDcodeunderwhichthemedicine’sname,pharmaceuticalformandstrengtharespecified.BesidestheIDcodewiththename,formandstrengthofthemedicine,theorderformalsocomprisesthedataonthestockofmedicineinthepharmacyandthequantityrequiredbyward.Afterpreparingmedicines,thepharmacytechnicianenterstheordersintotheinformationsystemtobeexemptedfromthepharmacystock.Afterbeingcheckedbyapharmacist,themedicinesaredispensedasspecified.Wardnursesresponsibleforthetasktakeoverthemedicinespreparedinthepharmacyandtransportthemtothewards.

Whenpreparingmedicinesbyorders,ifindoubtasregardstheirstrength,quantityorpharmaceuticalform,thepharmacytechnicianshallconsultapharmacist,whomayalsocallthewardnurseresponsiblefortheorder,when

necessary.Intheeventthattherequiredmedicineisnotinthemarket,theyalsonotifythewardsofthepossibilitiesforitsreplacement,ashorterperiodofuse,etc.Ifapharmacytechnician,whenpreparingmedicinesbyorders,findsoutthatthestocksofcertainmedicineshavebeenreduced,he/sheinformsaboutthatthepharmacist,whoprovidesthenecessaryorder.Itmayhappenthatthewardswillordermedicineswhicharenotonstockinthepharmacy.Inthiscase,themedicine,ifavailableonthemarket,isorderedandtheorderforthewardleftopenuntiltheproductisdeliveredtothepharmacy.Uponthereceiptofthemedicine,theorderformisprocessedandthewardisnotifiedthattheycancometocollectthemedicine.Inpreparingorders,thetechniciansoftenhavetohandlemedicinesthatrequirestorageintherefrigerator.Inthiscase,thepharmacytechnicianshallmarkthemedicinewithalabel:“CAUTION,STOREINAREFRIGERATOR!”andtakeallthenecessarystepstoensurethecoldchain.

Weeklysuppliesforwardpharmaciesarepreparedintheafternoon.Anexactdayintheweekisspecifiedforthepreparationofmedicinesforeachindividualhospital.

Incarryingouttheirwork,pharmacytechnicianshavecertaindutiesandresponsibilities.Inordertoperformtheirwork,theyneedknowledgeofcomputerprogramsforcomputer-

   31

assistedoperationsandareresponsiblefortheprofessionalandtimelypreparationofmedicinesorderedaswellasforpreciseperformanceofthetasksthataffectthequalityofmedicines,i.e.,theacquisition,keepingandstorageofmedicines.

Secondary-schoolstudentsarewelcometoassistusinthepreparationofmedicinesintheUKCPharmacyaswellasinthepreparationofmedicines,parenteralsolutionsandconsumablesinallwardpharmacies,thusbeingofferedtheopportunityofgettingacquaintedwithhospitalmaterial.

Pharmacytechniciansatthedepartmentsinvolvedinthepreparationofparenteralsolutions,fullparenteralnutritionandcytotoxictherapy,workunderspecialconditionsintheasepticchambers.Duetothehighcomplexityandrisksposedbythesemedicines,studentswhoarewithusonworkplacement,areonlyenabledtohavealookatthepremisesandlearnabouttheworkprocessthroughtheouterwindow.

Studentsarealsowelcometoworkinthegaleniclaboratory,wheretheycanhelpinclosingandlabellingpowders,creams,ointments,solutions,disinfectantsandethanolpreparations.Underthesupervisionofapharmacytechnician,theycanthemselvesweighthenecessaryingredientsandpreparecertainsolutions,thusacquiringtheappropriateknowledge,whichis

actuallythemainobjectiveoftheirworkplacement.

Thecontentandadequacyofpreparationsareestablishedatthequalitycontroldepartment,wherestudentsgetaninsightandexplanationofanalyticalcontrolprocedures.

Studentsonworkplacementinahospitalpharmacyareexpectedtohavethefollowingskills:

•awarenessofhealthandsafetyrequirements;

•knowledgeofthecodeofethicsforpharmacists;

•knowhowtoworkwithacomputerandusemodernsoftware;

•knowhowtoprepareanextemporaneousmedicinalproduct;

•knowhowtostoremedicinalproducts,takingaccountoftheirshelflife,andknowhowtoprovidecoldchain(storageinarefrigerator)whennecessary;

•participateintheprocurementofmedicinalproducts;

•knowhowtocorrectlyhandlemedicinalproductswithexpiredshelflife;

•communicatecorrectlywithotheremployeesinthepharmacy;

•knowhowtousetimerationallyandorganisetheirwork;

•areaccurateandresponsibleintheirwork.

32   

A working day from the diary of a student on work placement in the hospital pharmacy

IamVeronika,a3rd-yearstudentoftheeducationprogrammeforpharmacytechnicians.Ispentmymandatoryworkplacementinthegaleniclaboratoryofahospitalpharmacy.

Myworkingdaystartedat7:30a.m.Uponarrival,Iregisteredmypresenceinanotebookforevidencingthepresenceofstaffintheworkplace,thenIchangedinacloakroomwhereIputonacleanoverallcoatandcomfortableworkingshoes.

Inthemorning,Ihelpedinthemanufacturingoftwogalenicproducts.First,weprepareddividedpowders,whichareusedforbowelcleansingpriortocolonoscopy(coloncleansingpowder).Beforemakingtheproduct,aprintoutofcomputer-processedmanufacturingsheetwasmade,whichcomprisedthecompleterecipeforproductmanufacture,thenumberofmanufacturingprocess,productserialnumber,itsexpirydate,andmassofthepreparationafterfilling,withthepermittedlimitsoftolerance.Assistedandsupervisedbyapharmaceuticaltechnician,Ihelpedweighingredients.Beforeweighingeachindividualingredientintherecipe,Icheckedthecontrolnumberoftheingredientanddulyenteredtheindividualweighedquantitiesintheaccompanyingsheet.Imixedalltheweighedingredients

intoahomogenouspowder.ThenIdividedthepowderbyweighingitintoaprescribednumberofunitsandfilleditinpaperbags.Iclosedthebagsandlabelledthemasappropriate.

ThenIhelpedprepareagelforthetreatmentoforalmucosa.Wepreparedagel,whichcontained1%lidocaineasalocalanaesthetic(1%lidocainehydrochlorideinOrabaseoralgel).Iparticipatedinthefillingandlabellingoftheproduct.Wefilledthegelinto10gtubes,sothatwefilledeachtubewith7,00gofgel.Ilabelledthetubesasappropriate.

LateronIparticipatedinthepreparationofdifferentdisinfectantsolutions.Wehadtoprepare12lof0,1%solutionofchlorhexidinedigluconate.Forthepreparationweneeded(20%)ofchlorhexidinedigluconateandpurifiedwater.Therequiredquantityofdisinfectantwaspreparedinaspecialcontainerwithabuilt-instirrer.Imeasuredtherequiredquantity(60ml)ofchlorhexidinedigluconateconcentrate(20%solution)andputitintothecontainerwithbuilt-instirrer.Iaddedpurifiedwatertothelevelof12,000ml.Aftermixing,Ihelpedtofilltheobtainedsolutioninto200mlbottles.Ilabelledthebottlesasappropriate.Ikeptcurrentrecordsofallthetasksperformed.

InasimilarwayIhelpedinthepreparationofotherdisinfectantsolutions.Thus,wepreparedaworking

   33

disinfectantsolution,whichisusedforcleaninganddisinfectionofsurgicalinstrumentsandendoscopes.

Afteralunch-breakIworkedintheroomwherethemanufacturingofextemporaneousmedicinalproductstakesplace.Wehadtoprepare60mloforalsuspensioncontaining2,5mg/mloftheophyllineforachild.Thereisnoready-mademedicationwiththeprescribedcontentoftheophyllineintheformoforalsuspensionavailableintheSlovenianmarket.Theextemporaneousmedicinalproductwasmanufacturedfromtheactivesubstanceinpowderform(theophyllineplv.Ph.Eur.)andready-madevehiclesfororalsuspensions(Ora-Sweet®andOra-Plus®).

Forthemanufacturingoforalsuspensionweneededthefollowingingredients:Rp./Theophyllineplv.(Ph.Eur.) 125mgOra-Plus® 25mlOra-Sweet® ad50ml

Underthesupervisionofapharmacytechnician,Iweighedtheophyllinepowderandputitinamixingbowl.IaddedpartofOra-Plus®vehicleandmixeduntilasmoothpastewasformed.Whilestirring,IaddedtherestofOra-Plus®vehicle.IaddedOra-Sweet®toobtain50mlofsuspensionandmixedit.Itransferredtheobtainedsuspensionintoabeaker.Iplacedthebeakeronamagneticstirrerandlefttomixfor15

minutes.After15minutesofmixing,Itransferredthehomogenoussuspensionintoa50mldarkbottle.Iclosedthebottle,addedadosingspoonandlabelleditasappropriate.

Inmanufacturingthisextemporaneousmedicinalproduct,Ilearnedhowthepharmaceuticalformanddosagearetailoredtotheneedsofaparticularpatient.

InallthetasksIwasassistedbyapharmaceuticaltechnician.Myworkingdayendedat2:00p.m.

34   

u Themanufacturing,marketinganduseofmedicinalproductsintheterritoryoftheRepublicofSloveniaisregulatedbythenationallegislationandtheEUregulations.

ThePublicAgencyforMedicinalProductsandMedicalDevicesoftheRepublicofSlovenia(JAZMP)isabodycompetentformedicinalproductsandmedicaldevicesforhumanandveterinaryuse,andforbloodandbloodproducts,tissuesandcells;italsoperformsthetasksofanofficialcontrollaboratory.Itsmissionistoimplementthenationalpolicyandlegislationintheareaofmedicinalproductsandmedicaldevices,blood,tissuesandcellswiththeaimofpublichealthprotection.IttakespartinthedelegationoftheRepublicofSloveniainprofessionalbodiesandworkinggroupsoftheCounciloftheEuropeanUnionandtheEuropeanCommissioninthefieldofmedicinesandmedicaldevices,andparticipatesintheEuropeannetworkofofficialcontrollaboratoriesaswellasinthenetworkofthebodiescompetentformedicinesandmedicaldevicesintheEuropeanUnion.

JAZMPperformssupervisoryactivitiesandfunctionsasmisdemeanorsbodyintheareaofmedicinalproducts.Supervisionisperformedbypharmaceuticalsupervisors,whomonitorcompliancewithgoodmanufacturingpractice(GMP)intheareaofmedicinalproducts.

AnimportantpartoftheJAZMP’sactivitiesistheestablishmentofapharmacovigilancesystem.Pharmacovigilanceisthesystemofassessment,collectionandevaluationofadversereactionstomedicinesandotherinformationaboutthesafetyofmedicinesandactionstakentomanageandreducerisksassociatedwithmedicines.IntheentireterritoryoftheEuropeanUnionpharmacovigilanceiscoordinatedbytheEuropeanMedicinesAgency(EMA),whichmanagesadatabaseofadversereactionstomedicinesobservedthroughouttheEU.

TheEuropeanMedicinesAgencyisadecentralisedagencyoftheEuropeanUnion(EU),responsibleforscientificevaluationofmedicinesdevelopedbypharmaceuticalcompaniesandintendedforuseintheterritoryoftheEU.TheroleoftheAgencyistoco-operatewiththeEuropeanCommission,EUMemberStates,EuropeanEconomicArea(EEA)MemberStatesandseveralothergroupsinthepublicandprivatesectors.

The Medicinal Products ActTheMedicinalProductsActregulatestheareaofmedicinesforhumanandveterinaryuseandlaysdowntheconditionsandmeasurestoensuretheiradequatequality,safetyandefficacy,requirementsandproceduresfortheirtesting,manufacturing,pricesofmedicines,marketing,official

5.  National Legislation

   35

controlandsupervisioninordertoprotectpublichealth.ThisActshalltransposethecontentsoftheEUdirectivesregulatingcertainissuesoftheimplementationofregulationsintheareaofmedicinalproductsintothelegislationoftheRepublicofSlovenia.

Decree on the management of waste medicinesThisdecreeregulatestheareaofdrugresiduesanduselessdrugs,whichofcoursedonotfallwithinthenormalmunicipalwaste.Pharmaceuticalhealthprofessionalsmustraiseawarenessofpeoplehowtodealwithwastemedicines,andinformthemofthepossibilityofdisposalofwastemedicinesinpharmacies.

The Pharmacies ActThePharmaciesActregulatestheareaofpharmacyservicesaspartofhealthcaresupplyingthepopulation,healthfacilitiesandotherorganisationswithmedicines.TogetherwiththeRulesontherequirementstobemetbythepersonsengagedinpharmacyactivities,theActstipulateswhomayhavetherighttoestablishapharmacyorgettheconcession,andwhatarethetasksofpharmacies.Itlaysdowntherequirementsforpersonnel,facilitiesandequipmentaswellasthepharmacyverificationprocedure.

Health Services ActPharmacyservicesarepartofhealthcare.TheiractivitiesareregulatedinaccordancewiththeHealthServices

Act.Healthactivityincludesmeasuresandactivitiesperformedbyhealthcareprofessionals,followingthemedicaldoctrineandusingmedicaltechnology,inhealthprotection,prevention,detectionandtreatmentofpatientsandinjuredpersons.

Health Care and Health Insurance ActTheHealthCareandHealthInsuranceActisalegalbasisfortheimplementationofcompulsoryandvoluntaryhealthinsurance.Compulsoryhealthinsuranceisguidedbytheprinciplesofsocialjusticeandsolidaritybetweenthehealthyandthesick,theoldandtheyoung,therichandthepoor,andisimplementedbytheHealthInsuranceInstituteofSlovenia(HIIS).Voluntaryhealthinsuranceisimplementedbyotherhealthinsurancecompanies.

Compulsoryhealthinsuranceenablestheinsuredpersonstoexercisetherighttohealthservices,medicines,medicaldevicesandtocashcompensationsuchassalarycompensationduringsickleaveandothercostsrelatedtotheexerciseofrightstohealthservices.EnsuredpersonsclaimhealthcareservicesonthebasisoftheverifiedandvalidSlovenianHealthInsuranceCard.SomeservicesarefullycoveredbyHIIS,whileforotherstheinsuredpersonsmustpaythedifferencetothefullvalueofservicesfromtheirownfunds,unlesstheyhaveavoluntary(supplementary)healthinsurance.

36   

Foreigners,whoarenotcoveredbyhealthinsuranceintheRepublicofSlovenia,havetherighttoemergencyornecessaryhealthcareservicesforwhichthepaymentshallbemadeinaccordancewiththeEUlegislation,internationalagreementsorfromthestatebudget.

Patients Rights ActThePatientsRightsActregulatestheareaofsafeguardingandexercisingthefundamentalrightsofpatients.TherightswhicharegovernedbythePatientsRightsActarenottherightsarisingfromthecompulsoryorvoluntaryhealthinsurance,buttherightsconnectedwiththese,theso-calleduniversalrightsthateveryuserofhealthservicesisentitledto;theyreferinparticulartotherespectforpatients’autonomyinmakingdecisionsabouttheirownhealthcare,privacy,personaldataprotection,equalityandsafety,theprotectionofpatients’bestinterests,andaccesstoinformation.PatientsmaycontacttheRepresentativeofPatients’Rightsforfreeadvice,helporevenamandatetorepresenttheminexercisingtheirrightsunderthisAct.

Slovenian Chamber of PharmacyThetaskoftheChamberofPharmacyistoensureefficientandprofessionalpharmacyservices.Thisisanindependentprofessionalorganization,establishedtorepresentthepharmacyservicesandpharmacyprofession.Ittakescareoftheprofessionaldevelopmentoftheactivity,protectsthe

honouroftheprofession,takescareofthefulfilmentofprofessionalobligations,andprotectstheprofessionalandeconomicinterestsofitsmembers.TheChambermembershipismandatoryforpublic–retail-pharmacies,pharmacists-concessionairesandhospitalsthathavehospitalpharmaciesorganisedontheirpremises.MembershipintheChamberisalsoopentolegalentitiesandprivateentrepreneursinvolvedinthemanufacturingandmarketingofmedicinesandmedicalsupplies.AnimportanttaskoftheChamberistoprovideexpertsupervisionofthepharmacyservices,draftrulesofgoodpharmacypracticesandtakemeasuresinthecaseoftheirviolation.ThearbitraltribunalfunctioningwithintheChamberdealswithcomplaintsthattheusersofpharmacyservicesmayhavewithregardtoprofessionalconductinindividualpharmacies.

Code of Ethics for PharmacistsTheChamberofPharmacyisresponsiblefortheadoptionandrespectoftheCodeofEthicsforpharmacists.PharmacistsadopttheCodebysigningapersonaldeclarationwherebytheyundertaketoperformtheirworkdiligently,professionallyandwithdignity,andthatinexercisingtheirprofessiontheywillnotallowdifferentiationonthebasisofgender,religion,racenationality,politicalaffiliationorsocialstatus,thattheywillprotecttheclassifiedinformationandwillshowduerespecttowardstheirteachersandcolleagues.

   37

Slovenian Pharmaceutical SocietySlovenianPharmaceuticalSocietyhasbeenactivesince1950,bringingtogetheronavoluntarybasisprofessionalsworkingindifferentbranchesofthepharmaceuticalindustry,inpharmacies,educationalandresearchinstitutions,industryandstateadministration.MembershipintheSlovenianPharmaceuticalSocietyisopentoallpharmaceuticalprofessionalsandotherassociateprofessionalsoperatinginpharmacyoralliedfields,studentsoftheFacultyofPharmacyorto4thyearstudentsofthesecondaryschoolofpharmacy.Membershipisorganisedintoaffiliatesbyregionalprincipleandintosectionsbyprofessional

interest.Theactivitiesarecarriedoutin9affiliatesand11sections.TheSocietyorganizesanumberofprofessionalandsocialgatheringsofitsaffiliates,andthemostdeservingmembersareawardedtheMinarvik’srecognition.Itpublishesprofessionalbooks,publications,andFarmacevtskivestnikandFarmakonperiodicals.SlovenianPharmaceuticalSocietyisamemberofmanyinternationalorganizations(FIP–InternationalFederationofPharmacists,EUFEPS–EuropeanFederationofPharmaceuticalSciences,ESCP–EuropeanSocietyofClinicalPharmacists,EAHP–EuropeanAssociationofHospitalPharmacies,andEFMC–EuropeanFederationforMedicinalChemistry),andorganizesscientificsymposiaundertheirauspices

1. Cv

ufar,A.:Vpogledvzakulisjezdravljenjazzdravili.KCinterno.InternoglasiloUniverzitetnegaklinicvnegacentraLjubljana,Ljubljana,februar2011.

2. Tršan,M.:Predstavitevdelakontrolnoanaliznegalaboratorijalekarneklinicvnegacentra.LekarnaUKCLjubljana.Internogradivo.

3. Plevcvak,D.,Grzinicv N.:IzdelavaparenteralnihpripravkovzaindividualnooskrbobolnikovvlekarniUKC.Predavanje,maj2011.

4. www.cpi.si/srednje-strokovno-izobrazevanje.aspx#Farmacevtskitehnik

5. Direktiva2001/83/ESEvropskegaparlamentainSvetazdne6.Novembra2001ozakonikuSkupnostiozdravilihzauporabovhumanimedicini,zvsemidopolnitvami.Evropskakomisija.EUzakonodaja.Eudralex.

6. Pravilnikopogojihzaopravljanjelekarniškedejavnosti.UradnilistRS,št.39/2006

7. Pravilnikorazvršcvanju,predpisovanjuinizdajanjuzdravilzauporabovhumanimedicini.UradnilistRS,št.86/08in45/10.

6.  References

38   

8. Resolucijaonacionalnemplanuzdravstvenegavarstva2008−2013.UradnilistRS,št.72/2008

9. Shranjevanjeinunicvevanjezdravil.Strokovnoizpopolnjevanjeinženirjevfarmacijeinfarmacevtskihtehnikov,LekarniškazbornicaSlovenije2010

10. Tršan,M.:Predstavitevdelakontrolnoanaliznegalaboratorijalekarneklinicvnegacentra.LekarnaUKCLjubljana.Internogradivo.

11. Uredbaoravnanjuzodpadnimizdravili.UradnilistRS,št.105/2008

12. Zakonolekarniškidejavnosti.UradnilistRS,št.36/2004

13. Zakonozdravilih.UradnilistRS,št.31/06

14. Zakonozdravstvenidejavnosti.Uradni.listRS,št.9/1992(26/1992popr.)

15. www.cpi.si/srednje-strokovno-izobrazevanje.aspx#Farmacevtskitehnik

16. www.krka.si

17. www.lek.si

18. www.zzzs.si

19. http://www.sfd.si/modules/catalog/products/prodfile/fv_4_2011_nr.pdf

20. http://www.sfd.si/modules/catalog/products/prodfile/fv_4_2011_nr.pdf

21. http://www.sfd.si/modules/catalog/products/prodfile/fv_2_2010.pdf

22. http://www.sfd.si/modules/catalog/products/prodfile/fvst2_2006posebnaizdaja.pdf

23. http://www.zd-lj.si/zdlj/images/stories/urska/pdf/pacientove%20pravice%20brosura.pdf

24. http://www.mz.gov.si/si/o_ministrstvu/strateski_svet_za_zdravila/

25. http://www.uradni-list.si/files/RS_-2008-072-03163-OB~P026-0000.PDF

26. www.sfd.si

27. www.slovenia.info/

28. www.mss.gov.si/si/solstvo/

29. www.eurydice.si/

30. http://ec.europa.eu/health/documents/eudralex/vol-3/index_en.htm.Dostop20-2-2012

31. www.jazmp.si

32. http://www.lek-zbor.si

   39

Galenski izdelek–Galenicproduct–amedicinethatispreparedinsmallseriesinagaleniclaboratoryofthepharmacyinaccordancewiththevalidpharmacopoeiaandintendedforretailsaleinthepharmacyconcerned

Galenski laboratorij–Galeniclaboratory–apartofapharmacywheregalenicproductsareproduced

Lekarna–Pharmacy

Bolnišnicvna lekarna–Hospitalpharmacy

Bolnišnica–Hospital

Medicinski pripomocvek–Medical-technicaldevice

Zdravilo–Medicine

Recept–Prescription

Magistralno zdravilo–Extemporaneousmedicinalproductsaremedicinesthatarecreatedinthepharmacyforaparticularpatientbasedontherecipechosenandprescribedbyhis/herdoctor

7.  Glossary

40   

Curriculum content, vocational modules and core competences 

Mandatory Total number Module Aimvocational modules of hours

HealthEducation 68 Theaimofthemoduleistoensurethatthestudentwillhavethenecessaryknowledgeandunderstandingtobeabletoundertakehelathpromotingactivitiesinallstagesoflife.

Anatomyand 102 TheaimofthemoduleistoprovidethePhysiology studentwithknowledgeofthestructureand

functioningofhumanbody.

Microbiologyand 102 TheaimofthemoduleistoensurethatEpidemiology thestudentwillhavethenecessary

knowledgeandunderstandingtobeabletoworksafelyinamicrobiologylaboratory.

LaboratoryWork 102 TheaimofthemoduleistoensurethattheinPharmacy studentwillhavethenecessaryknowledge

andunderstandingtobeabletoperformvarioustechnologicaloperations(weighing,sifting,mixing…)andtousetheequipmentinapharmaceuticallaboratorycorrectly.

Medicinal 255 TheaimofthemoduleistogetthestudentProducts acquaintedwiththeactivity,useandadverse

sideeffectsofactivesubstances,andindetailwithmedicinesthatcanbeobtainedinpharmacieswithoutprescription.Thestudentwillalsogetacquaintedwithmaincategoriesofmedicinalproductsthataresubjecttomedicalprescription.

Productionof 221 TheaimofthemoduleistoensurethattheMedicines studentwillobtainthenecessaryknowledge

andunderstandingtobeabletoproducedifferentextemporaneousmedicinalproductsforpatientsthatareeffectiveandsafeforuse.

Appendix

   41

Medicinal 170 TheaimofthemoduleistoensurethattheProductAnalysis studentwillobtainthenecessaryknowledge

andunderstandingtobeabletocarryoutanalyses(e.g.volumetricandgravimetric)andtestsinaccordancewithgoodpractices(GP).

HerbalMedicines 272 TheaimofthemoduleistogetthestudentandNatural acquaintedwiththestructureofherbsasCompounds wellasthefunctioninganduseofrelevant

herbaldrugsinpharmacy.Thestudentwillalsogetabroadinformationoftheactivityanduseofnaturalcompoundsinpharmacy.

An example of optional vocational modules (implemented at Srednja šola za farmacijo, kozmetiko in zdravstvo, Ljubljana)

Optional Total number Module Aimvocational modules of hours

Genetics 34 Theaimofthemoduleistoprovidethestudentwiththebasicinformationaboutgeneticsingeneral,geneticdisorders,heredityandgenetechnology.

Informationand 70 Theaimofthemoduleistoprovidethecommunication studentwithknowledgeandskillsneededtechnology touseICTequipmentandsoftware.

BusinessSkills 102 Theaimofthemoduleistogetthestudentand acquaintedwiththeroleandimportanceCommunication ofbusinessskills.Thestudentwillget

acquaintedwiththeprinciplesofgoodinterpersonalcommunication,developsocialskills,teamworkandtheprinciplesofeffectiveconversation.

Dispensingof 102 TheaimofthemoduleistogetthestudentMedicinal acquaintedwiththelawsandregulationsinProductsin theareaofhealthcare.ThestudentwillbePharmaciesand trainedinthecommunicationwithclientsSpecialisedShops ofpharmaciesandspecialisedshops.The

studentwillgetthenecessaryknowledgetobeabletogiveadviceonself-healingandrecognizeriskgroupsofusersandalarmingsymptomsthatrequireconsultationwithapharmacistoraphysician.

42   

Preparingfor 16 Theaimofthemoduleistohelpstudentsvocationalmatura topreparethemselvesforthefinalexamininexpert expertknowledge.knowledge

CosmeticProducts 102 Theaimofthemoduleistoprovidethestudentwiththeknowledgeofthestructureoftheskin,hairandnails,andthemajordiseasesoftheskin.Thestudentwillbeabletounderstandtheimportanceofingredientsincosmeticproducts,advancedtechnologicalformsofcosmeticproductsandtheactivityanduseofcosmeticproducts.

HospitalPharmacy 34 Theaimofthemoduleistogetthestudentacquaintedwiththespecificityofhospitalpharmacyworkandtechnologicalprocessesaswellaswithworkingconditionsforthepreparationofspecifictherapies(workinanasepticunit,fullparenteralnutrition,therapywithcytotoxicdrugs).

Productionof 68 TheaimofthemoduleistoupgradetheMedicines– students’knowledgeofmanufacturingSelectedchapters ofmedicinalproducts.Theywillget

acquaintedwiththespecificfeaturesofvariouspharmaceuticalformsthatarenotmanufacturedinpharmacies,suchasdifferenttypesoftablets,andthey,aspharmacytechnicians,havetoknow.

MedicinalProducts 34 Theaimofthemoduleistoupgradethe–SelectedChapters student’sknowledgeoftheactivity,useand

adversesideeffectsofmedicines.

This handbook for students has been produced within Leonardo da Vinci-programme as a transfer of innovation project “Learning Materials for Pharmaceutical Assistant’s annd Technician’s Foreign Work Placements”,

acronym PHARLEMA (2011-1-FI1-LEO05-06161) during 01.10.2011– 30.09.2013. The publication has been co-funded by the European Comission. The Commission accepts no responsibility for the contents of the publication.

Slovenia

Pharmaceutical Assistant’s and Technician’s Work Placements

Srednja šola za farmacijo, kozmetiko in zdravstvo

Acknowledgements

This handbook has been produced by Mrs. Ljubica Gabrovšek and Mrs. Katarina Vrhovnik who offer grateful thanks to the following for their guidance, support, donation of appropriate materials and proof reading for accuracy of this package of information.

All materials of the project are downloadable for free from partner colleges’ websites:• www.bmetc.ac.uk/home.aspx• http://hesotenet.edu.hel.fi/english/etm2/pharlema/index.htm • www.kellebeek.nl• www.ssfkz.si• http://www2.stjohnscollege.ie/• www.ttk.ee

Copyright is the property of all partnership colleges represented by Srednja šola za farmacijo, kozmetiko in zdravstvo, Ljubljana, Slovenia. Altering of the materials is prohibited without permission from the partnership group represented by Srednja šola za farmacijo, kozmetiko in zdravstvo.

• SŠFKZ students contributing the dairy of the descriptions of daily work: Ms. Veronika ŠilcMs. Maja Žugec• Gimnazija in srednja kemijska šola Ruše Mrs. Lea Levstik• Šolski center Novo mestoMrs. Breda Drenek Sotošek • Celjske lekarne javni zavodMrs. Mihaela Tršinar• Javni zavod Mestne Lekarne Mrs. Nasta Vodnik• Lekarna Murgle LjubljanaMrs. Mirjam Kljucvevšek• Lekarna Prule-Trnovo LjubljanaMr.Venco Ristov• Splošna bolnišnica Celje, LekarnaMr. Franci Tratar• Univerzitietni klinicvni center Ljubljana, LekarnaMrs. Maja Osmanagic

• Birmingham Metropolitan CollegeMr. Robert BiggsMrs. Deborah CooperMrs. Karen Socci

• Helsinki Vocational CollegeMrs. Asta Lehtinen, Mrs. Kirsi Rosenqvist and Mr. Matti RemsuHelsinki Vocational College students Ms. Jenna Ahokas and Mr. Juuso Lehtinen

• Kellebeek CollegeMrs. Angela Deelen and Mrs. Gerda van der MeerKellebeek College students Ms. Kübra Bozali, Ms. Lieke van Drunen and Ms. Semanur Sahin, Ms. Danielle Thomassen

• St. John’s Central CollegeMrs. Sarah Magner and Mrs. Majella O´DriscollSt. John’s Central College students Ms. Ciara Healy, Ms. Stephanie Miller, Ms. Jennifer Ray and Ms. Sarah-Louise Scanlon

• Tallinn Tervishoiu KõrgkoolMrs. Merle Kiloman and Mr. Alar SeppTallinn Tervishoiu Kõrgkool student Ms. Kristi Lemmik, Ms. Liis Märss and Ms. Karolin Nõmm

• Coordination of the project: Mr. Matti Remsu, Helsinki Vocational College• Editing and layout: Rhinoceros Ltd• Translation: Mrs. Olga Shrestha