RESEARCH
The Development of the Croatian Competency Framework for Pharmacists
Iva Mucalo, PhD, MPharm,a Maja Ortner Hadziabdic, PhD,a Tihana Govorcinovic, MSc, MPharm,b
Martina Saric, MPharm,c Andreia Bruno, PhD, MPharm,d Ian Bates, PhD, BPharm,d
a University of Zagreb Faculty of Pharmacy and Biochemistry, Zagreb, Croatiab Croatian Chamber of Pharmacists, Zagreb, Croatiac Community Pharmacy Kuzma and Damjan, Zadar, Croatiad FIP Collaborating Centre, University College London School of Pharmacy, London, United Kingdom
Submitted August 7, 2015; accepted November 11, 2015; published October 25, 2016.
Objective. To adjust and validate the Global Competency Framework (GbCF) to be relevant forCroatian community and hospital pharmacists.Methods. A descriptive study was conducted in three steps: translation, consensus development, andvalidation by an expert panel and public consultation. Panel members were representatives fromcommunity pharmacies, hospital pharmacies, regulatory and professional bodies, academia, andindustry.Results. The adapted framework consists of 96 behavioral statements organized in four clusters:Pharmaceutical Public Health, Pharmaceutical Care, Organization and Management, and Personaland Professional Competencies. When mapped against the 100 statements listed in the GbCF, 27matched, 39 were revised, 30 were introduced, and 24 were excluded from the original framework.Conclusions. The adaptation and validation proved that GbCF is adaptable to local needs, theCroatian Competency Framework that emerged from it being an example. Key amendments weremade within Organization and Management and Pharmaceutical Care clusters, demonstrating thatthese issues can be country specific.
Keywords: competency, behavioral statement, competency framework, Global Competency Framework,Croatian Competency Framework
INTRODUCTIONImplementation of pharmacy competencies as a ba-
sic prerequisite for providing pharmaceutical care andensuring patient treatment outcomes is increasingly sup-porting the development of pharmacists across sectors.1,2
Competency pertains to knowledge, skills, attitudes,and behaviors that affect an individual’s role or respon-sibilities, relate to job performance, and are subjectto improvement through training and development ac-tivities.3 Competency-based developmental frameworksare increasingly common among health professions inhigh-income countries and are frequently used to definestandards for education and training and for career pro-gression.4 They contain a structured assembly of behav-ioral competencies that can contribute to supportingpractitioner development and allow for effective and sus-tained performance.
Culture can influence expectations of pharmaceuti-cal services by public and regulatory bodies, and religion,traditions, history, experiences, and perceptions of med-ications all challenge the unified understanding ofcompetencies in pharmacy.5 Therefore, the InternationalPharmacy Federation, through the Pharmacy EducationInitiative (FIPEd) developed an evidenced-based GlobalCompetency Framework (GbCF), a document that con-tains a core set of behavioral competencies that should begenerally applicable for the pharmacy workforce world-wide.6 The GbCF does not imply that there should bea single global curriculum that would fit all countries,but rather that it can be taken by other countries andadapted to their own needs.
Development of a national competency frameworkfor pharmacists in Croatia was important as it could laythe foundation for bridging the gap between traditionalpharmacy education and the ever-changing demands ofmodern health care systems. One of the major drawbacksof the Croatian continuing eduaction (CE) model is lackof a supporting system that could assist pharmacists inidentifying their learning needs and supporting their
Corresponding Author: Iva Mucalo, University of ZagrebFaculty of Pharmacy and Biochemistry, A. Kovacica 1, 10 000Zagreb, Croatia. Tel: 13851-6394-411. Fax: 138591-48.E-mail: [email protected]
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
1
development. Therefore, development of the CroatianCompetency Framework (CCF) for pharmacists, withminimum competencies required, was a way to resolvethose issues, namely assessing the differences betweenthe established and desired levels of their performanceand informing development of a competency-based cur-riculum to achieve the desired level of competency, aspreviously conducted on a “pharmaceutical care com-petencies” cluster.7 Furthermore, strategies for qualityimprovement of CE and continuous professional devel-opment (CPD) educational activities have been offeredand could serve as a complementary supporting systemfor continuing education development.8
The Croatian Competency Framework could assistindividuals and organizationswith career planning oppor-tunities and allow the pharmacy sector to implement use-ful and harmonized professional development on nationallevel. Therefore, the aim of this research was to adapt andvalidate the GbCF to be relevant for Croatian communityand hospital pharmacists.
METHODSTo develop a competency framework for community
and hospital pharmacists inCroatia, aGbCFdeveloped bythe FIPEd was used.6 A descriptive study was conductedin three consecutive steps: translation, consensus devel-opment, and validation by an expert panel and publicconsultation. Each subsequent phase was informed byand built upon the preceding phase.
Following the standard methods of translation, theoriginal English version of the GbCF was translated intothe Croatian language by expert pharmacists familiarwith terminology of the area covered by the frameworkand knowledgeable of English-speaking culture. Basedon the Brislin translationmodel, the frameworkwas thenback-translated by two bilingual translators, both ver-sions were compared for accuracy and equivalence,and any discrepancies that had occurred during theprocess were negotiated.9 It was further refined by phar-macists’ perceptions and input from lay readers. Theprocedures of translation and back-translation of theframework did not reveal any changes from the original(English) version of the instrument, except the contextu-alization of background information relevant and appli-cable to the Croatian context.
During the next stage, a consensus developmentpanel convened consisting of 10 pharmacists with exper-tise in community practice (n54), hospital pharmacy(n52), industry (n51), regulatory affairs (n51), and ac-ademia (n52), who reviewed the list of behavioral state-ments to adjust the GbCF according to Croatian national
needs. In adapting the GbCF, consideration was given tothe current pharmacy practice at the primary care level inCroatia to ensure its relevance for pharmacists working ina community and hospital sector. From the beginning ofthe data-reviewing process, an iterative process of 18rounds of consensus development panels in the periodfrom February to July 2014 was undertaken to evaluateand make changes to the initial competency framework.Each panel session was facilitated by a pharmacist withexpertise in community pharmacy and regulatory poli-cies, and with knowledge of the GbCF.
The group sessions lasted 180 minutes and wereguided by a moderator who used an interview guide toprobe participants’ perceptions regarding the knowledgeand skills a pharmacist must possess to meet the require-ments of professional practice at a foundation level. Fol-lowing the introductory lecture, panel members wereintroduced to the GbCF’s development and validationprocess, protocol, and structure of the panel sessions. Ob-jectives that needed to be addressed during the adaptationprocess were presented and included the following con-siderations: whether the language was clear and under-standable; whether the clustering was correct (ie, whetherthe labels assigned to each cluster made sense and if not,whether they could be rephrased or replaced; whetherthere was any competency and/or behavior missing con-sidering the Croatian setting; and whether there was anycompetency and/or behavior not applicable to the Croa-tian setting.
Panel members were then asked to reach consensuson each behavioral statement bearing in mind its useful-ness and applicability, and recommend amendments andinclusions if necessary. Finally, panel members wereasked to categorize the competencies into clusters. Thepanel sessions were audio recorded. Within a week aftera session, member checking was performed by e-mailinga summary of the discussion to the participants and askingthem to confirm its accuracy.
The draft framework that emerged from the consen-sus development group was evaluated for content validityby pharmacists with experience in community pharmacy(n52), hospital pharmacy (n51), professional body(n51), regulatory body (n51), and academia (n52). In-dividuals who participated in the expert panel group didnot attend the consensus development panels.
An iterative process of five rounds of expert panelgroups in the period from July to September 2014 wasundertaken to evaluate and make changes to the compe-tency framework yielded by the previous group. At thestart of each session, the procedure was explained briefly,and theoretical saturation was considered to have beenreached when a new session yielded no new information.
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
2
Each revised competency cluster was reviewed toensure consistency of terminology and overall content,and to reevaluate its applicability and usefulness forgeneral level primary care. Before the first meeting, thepanel members were invited to rank the relevance (on a5-point Likert scale where 15not relevant and 55veryrelevant) and wording of the behaviors and competen-cies, after which they received written feedback com-prising the means and standard deviations of therelevance scores and a summary of the textual com-ments. They were also asked to edit or reword each state-ment they felt needed revision and to provide additionalinformation as appropriate. In the absence of an existingstandard, a strict definition of consensuswas used: a com-petency had to be rated as relevant (4) or very relevant (5)by at least 80% of panel members.10 Minor revisionswere made to the wording in response to comments frompanel members.
The amended framework underwent a final review(fifth session) by an expert panel before distribution tomembers of the Croatian Pharmacy Chamber, all regis-tered pharmacists, for final critique. The final compe-tency framework resulting from this process was madeavailable for a public consultation with the aim of col-lecting comments and suggestions frommembers of theCroatian Pharmacy Chamber before drafting the finaldocument. The process consisted of three related formsof interaction with interested members of the pharmacypublic: notification, consultation, a 2-way flow of in-formation, using an online survey-tool via the cham-ber’s website, and participation, an active meeting ofinterest groups, held at the University of Zagreb Facultyof Pharmacy and Biochemistry to increase the sense ofownership of, or commitment to, the framework beyondwhat is likely to be achieved via a purely consultativeapproach.
All participants in the consensus developmentgroups and the expert panel groups gave informed consentin response to a letter that explicitly stated that participa-tion was voluntary and that gave assurance of full confi-dentiality, pursuant to the Croatian “regulations on the
duty of protection of professional and official confidentialinformation” (IRB number: 330-02-114-10).
RESULTSThe purpose of this study was to adapt and validate
a framework of pharmacy competencies relevant for com-munity and hospital setting by examining whether phar-macy experts could reach consensus. In this sample of 17pharmacists [gender: all female; mean age 42.15 (18.2)years], overall mean duration of work experience in thepharmacy setting was 18.15 (9.2) years.
An initial draft of the CCF for pharmacists was de-veloped from the source framework GbCF and methodsfor establishing and developing consensus followed bypublic consultation. One hundred behavioral statements,grouped in four competency clusters, were used for thereview from the GbCF. The mapping of the behavioralstatements from the source document and expert panelconfirmed the importance of these four existing com-petency clusters, although amendments were necessary(Table 1).When CCFwasmapped against the 100 behav-ioral statements listed in the GbCF, 27 could be found inthe adapted framework, 39 were revised, 30 were newlyintroduced, and 24 from the original framework wereexcluded. A detailed overview of amendments can befound in Table 2. The scope of the CCF encompassesfoundation-level or early-years practice and representsnational consensus on the capability competencies ofthe outcomes of registration levels of initial career edu-cation and training.
The panel members of the consensus developmentgroup agreed about changing some competency headings,behavior wording and descriptors for clarification pur-poses, amalgamation of two competencies into one as todisplay the process of working (such as procurement andthe ancillary supply chain management) as intercon-nected, transfer of a competency from one cluster to an-other, change of behavioral statement order within thecompetency to present the sequence of activities in amorelogical manner, and the change of competency orderwithin clusters. Some of themost significant amendments
Table 1. A Comparison between the Global Competency Framework (GbCF) and Croatian Competency Framework (CCF) inNumber of Competencies and Behavioral Statements Across Four Clusters
Competency Cluster
No. of Competencies No. of Behavioral Statements
GbCF CCF GbCF CCF
Pharmaceutical Public Health 2 1 4 3Pharmaceutical Care 6 5 25 36Organisztion and Management 6 5 32 31Personal and Professional 6 6 39 26Total 20 17 100 96
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
3
Table
2.MappingoftheGlobal
Competency
fram
ework
totheAdaptedCroatianCompetency
Framew
ork
Competency
Cluster
Behaviors
thatMapto
GbCF(n=27)
Revised
Behaviors
(n=39)
New
lyIntroducedBehaviors
(n=30)
Excluded
Behaviors
(n=24)
Pharm
aceutical
Public
Health
Assessthepublichealthneedsof
alocalpopulation.
Advisepopulationonhealth
preservation,disease
prevention,
healthylifestyle,andsafe
and
rational
use
ofmedicationsand
devices.
Initiate,organizeandparticipatein
publichealthprojectsbased
on
localpopulationneeds.
Identify
sources,retrieve,
evaluate,
organise,
assess
and
disseminaterelevant
medicines
inform
ation
accordingto
theneedsof
patientsandclientsand
provideappropriate
inform
ation.
Pharm
aceutical
Care
Apply
guidelines
andtreatm
ent
protocols.
Apply
theprinciplesofevidence-
based
pharmacy(tomakesound
clinical
decisions)
Confirm
theidentity
andqualityof
entry/raw
materials.
Learn
from
andactupon
previousnearmissesand
dispensingerrors.
Appropriatelyselect
medicines
anddevices
accordingto
the
governmentpolicy,drug
accessibility/availability,and
patientandhospital
needsand
financial
capabilities.
Appropriatelyselect
medicines
and
devices
accordingto
thepatient
symptomsanddiagnosis.
Ascertain
thequalityofgalenic
preparation.
Ensure
appropriatemedicines,
route,time,
dose,
documentation,action,form
andresponse
forindividual
patients.
Determineandensure
the
requirem
entsforpreparation
andstoringofmagistral
and
galenic
preparations
When
selecting,identify,prioritise
andactuponmedicine-medicine
interactions;medicine-disease
interactions;medicine-patient
interactions;medicines-food
interactions.
Accurately
label
magistral
and
galenic
preparations.
Apply
firstaidandactupon
arrangingfollow-upcare.
Compoundmagistral
andgalenic
preparationsaccordingto
professional
principles,
literature,andguidelines.
Establish
accuracy
andlegalityof
prescriptionsandcertificationsof
medical
devices
andvalidatethem
appropriately
Appropriatelystore
galenic
preparations.
Assessanddiagnose
based
on
objectiveandsubjective
measures.
Accurately
repackagemedicines
and/ormedicaldevices
fromthe
original
packagingand
accurately
label
Accurately
dispense
prescribed
medicines
Understanddiagnosisand
therapeuticgoals.
Label
medicines
andmedical
devices
withtherequired,
precise,andcomprehensible
instructionsforpatientsor
healthcare
workersin
hospital
Accurately
dispense
medical
devices
based
oncertificationofmedical
device
Advisepatients/healthcare
professionalsin
hospital
on
proper
disposalofunused
medicines
andmedical
devices
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
4
Table
2.(C
ontinued
)
Competency
Cluster
Behaviors
thatMapto
GbCF(n=27)
Revised
Behaviors
(n=39)
New
lyIntroducedBehaviors
(n=30)
Excluded
Behaviors
(n=24)
Reportsuspectedqualitydefects
ofmedicines
andmedical
devices
totheappropriate
authorities
Advisepatients/healthcare
professionalsin
hospital
onproper
storageconditionsofthe
medicines
andmedical
devices
Establish
atrustingand
collaborativerelationship
with
thepatient
Identify,prioritize,andresolve
patients’pharmaceutical
problems
Obtain
anddocumentpatients’
medical
andsocial
history
Introduce
patientwithhis
pharmaceuticalproblemsand
clearlystateallpossible
options
thatcould
beundertaken
tosolve
thepharmaceuticalcare
problemsidentified.
Recognizeandreportadverse
drugreactionsto
the
appropriateauthorities
Advisepatientonproper
medicine
andmedicaldeviceuse
(eg.inhaler
technique)
Advisepatientonhealth
preservationandhealthylifestyle
Contact
orreferappropriatelyto
the
medical
doctor
Explain
what
todoandwhom
tocontact
incase
ofanew
therapeuticproblem
Documentanyintervention
Regularlymonitorandbeupto
date
withmedicationerrorreports
Ensure
therapeuticmonitoringof
medicines
andmedical
devices
Beupto
datewiththeactual
inform
ationrelatedto
medication
safety
Note,preventandactupon
medicationerrors
Documentmedicationerrors
ininternal
medicationerrorreportingsystem
sdRegularlyreportmedicationerrors
tointernalCommittees/appropriate
authorities,ifpossible
Organization
and
Managem
ent
Dem
onstrate
knowledgeofthe
organizational
structure
of
communitypharmacy/
institution.
Understandandadhereto
the
financial
planofcommunity
pharmacy/institution.
Dem
onstrate
knowledgeofthe
relationship
betweencommunity
pharmacy/institutionandother
stakeholders.
Dem
onstrate
organizational
and
managem
entskills(eg,know,
understandandlead
on
medicines
managem
ent;risk
managem
ent;self
managem
ent;time
managem
ent;people
managem
ent;project
managem
ent;policy
managem
ent.).
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
5
Table
2.(C
ontinued
)
Competency
Cluster
Behaviors
thatMapto
GbCF(n=27)
Revised
Behaviors
(n=39)
New
lyIntroducedBehaviors
(n=30)
Excluded
Behaviors
(n=24)
Ensure
theabilityto
monitorthe
conduct
offinancial
transactions.
Properly
invoiceandcharge
dispensedmedicines
andmedical
devices
andensure
theproper
documentation.
Adhereto
national
directives
and
guidelines
inrelationship
with
stakeholders.
Identify
andmanagehuman
resources
andstaffingissues.
Address
andmanageday
today
managem
entissues.
Recognizetheneedsandpotential
of
each
mem
ber
ofthestaffand
enable
theirpersonal
and
professional
development.
Monitorandreportonuse
of
medicines
andmedical
devices.
Participate,
collaborate,advise
intherapeuticdecision-
makinganduse
appropriate
referral
inamulti-disciplinary
team
.Developandim
plement
contingency
planformedicines
andmedical
devices
shortages.
Ensure
thework
timeisappropriately
planned
andmanaged
accordingto
directives,internal
decisionsand
needsofthework.
Assigntasksto
employees(each
mem
ber
ofthestaff)within
the
scopeoftheirjobdescription.
Recognisethevalueofthe
pharmacyteam
andof
amultidisciplinaryteam
.
Organizeprocurementin
linewith
contractsandpayment
capabilities.
Follow
andbeupto
datewiththe
new
sondrugmarket
andrely
on
reliable
inform
ationnecessary
for
theprocurementprocess.
Monitorwork
ofem
ployeesand
evaluatetheircompetency.
Ensure
thereisnoconflictof
interest.
Ensure
proper
documentationand
record
keeping.
Ensure
themostcost-effective
medicines
andmedical
devices
intherightquantities
based
on
availabilityofthedrugmarket.
Encourageem
ployees’
self-
conscience
andtheirprofession
affiliation.
Superviseprocurement
activities.
Understandthetenderingmethods
andevaluationoftender
bids.
Organizereliable
procurementof
medicines
andmedical
devices
inatimelymanner.
Encouragepositiveworking
atmosphere,
open
communicationand
collaborationwithin
theworking
environment.
Dem
onstrate
knowledgein
store
medicines
tominim
iseerrors
andmaxim
iseaccuracy.
Ensure
medicines
andmedical
devices
areofappropriatequality,
within
expirydateandarenot
counterfeit.
Encouragepositiveworking
atmosphere,
open
communicationand
collaborationwithother
health
care
professionals.
Ensure
accurate
verificationof
rollingstocks
Ascertain
theaccuracy
ofmedicines
andmedical
devices
delivery.
Ensure
adherence
totherulesof
Goodpharmacypractice.
Ensure
effectivestock
managem
entandrunningof
servicewiththedispensary.
Ensure
storageofmedicines
and
medical
devices
inacorrectly
manner.
System
atically
transfer
ethical
and
moralvalues
toem
ployeesand
lead
byexam
ple.
Takeresponsibilityfor
quantificationofforecasting.
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
6
Table
2.(C
ontinued
)
Competency
Cluster
Behaviors
thatMapto
GbCF(n=27)
Revised
Behaviors
(n=39)
New
lyIntroducedBehaviors
(n=30)
Excluded
Behaviors
(n=24)
Apply
thecorrectprocedure
of
interventionim
port.
Dem
onstrate
theabilityto
take
accurate
andtimelydecisions
andmakeappropriate
judgments.
Ensure
accurate
proceduresof
return
ofmedicines
andmedical
devices.
Ensure
theproductionschedules
areappropriatelyplanned
and
managed.
Form
pricesin
linewithprocedures
andinstitutionpolicy.
Recogniseandmanage
pharmacyresources
(eg,
financial,infrastructure).
Ensure
appropriatecategory
managem
entin
linewith
communitypharmacy/institution
policy.
Personal
and
Professional
Dem
onstrate
culturalandsocial
awarenessandsensitivity.
Communicateclearly,precisely,
objectivelyandappropriately.
Dem
onstrate
negotiatingskillsin
theeventofproblemsand
conflicts.
Tailorcommunicationsto
patientneeds.
Evaluateownworking
perform
ance.
Evaluatecurrency
ofknowledgeand
skillsandidentify
learningand
professional
developmentneeds.
Dem
onstrate
knowledgeoflabour
legislation.
Evaluatelearning.
DocumentCPD
activities.
Continuouslydevelopto
answ
erthe
identified
learninggaps.
Learn
from
previousunwanted
occurrencesandpreventfurther
ones.
Understandthestepsneeded
tobringamedicinal
product
tothemarket
includingthe
safety,quality,efficacy
and
pharmacoeconomic
assessmentsoftheproduct.
Dem
onstrate
knowledgeofthe
fundam
entalsoflegislationin
financial
managem
entand
intellectual
property
rights.
Exchangeandtransfer
professional
knowledge.
Recogniseownprofessional
limitations.
Dem
onstrate
knowledgeand
apply
legislationrelatedto
drugswiththepotential
for
abuse
andfollow
amendments.
Understandandapply
healthcare
and
pharmaceuticalactivity
legislation,andfollow
amendments.
Apply
research
findingsand
understandthebenefitrisk
(eg,pre-clinical,clinical
trials,experim
entalclinical-
pharmacological
research
and
risk
managem
ent).
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
7
Table
2.(C
ontinued
)
Competency
Cluster
Behaviors
thatMapto
GbCF(n=27)
Revised
Behaviors
(n=39)
New
lyIntroducedBehaviors
(n=30)
Excluded
Behaviors
(n=24)
Ensure
confidentialityofpatient’s
personal
data.
Dem
onstrate
knowledgeandapply
fundam
entalsoflegislationin
marketing,advertisingandsales.
Ensure
appropriatequality
controltestsareperform
edandmanaged
appropriately.
Obtain
patientconsent,when
necessary.
Act
inlinewithCodeofEthicsand
deontologyandGoodpharmacy
practice.
Takeresponsibilityforownaction
andforpatientcare.
Monitorthequalityofpharmacy
services.
Develop,im
plement,andconduct
standardoperatingprocedures
(SOPs).
Improvecurrentandintroduce
new
services.
Evaluateanddevelopself-
confidence
andself-
consciousness.
Encourageandconduct
research
attheworkplace.
Documentandtakecare
ofunwanted
occurrencesat
theworkplace
and
inform
theinternal
departm
ent/
bodyofcommunitypharmacy/
institutionthereof.
Dem
onstrate
interest,initiativeand
innovation.
Dem
onstrate
time-managem
ent
skills.
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
8
to the CCF included addition of new competencies (eg,“Assurance of safe medicines use” in the PharmaceuticalCare cluster, “Organization” in the Organization andManagement cluster) and exclusion of three competen-cies (“Medicines information and advice” from the Phar-maceutical Public Health cluster, “Medicines” and“Monitor medicines therapy” from the PharmaceuticalCare competences cluster).
Further amendments encompassed exclusion ofcompetencies that were too broad or unspecific, immea-surable (eg, “Recognize the value of the pharmacy teamand of a multidisciplinary team”), not yet present in Cro-atian pharmacy practice (eg, “Ensure appropriate qualitycontrol tests are performed and managed appropriately inQuality Assurance and Research in the workplace com-petency), or too advanced for foundation level framework(eg, Apply research findings and understand the benefitrisk (eg, preclinical, clinical trials, experimental clinical-pharmacological research and risk management).
Several statements of similar content (eg, “Identifyif expertise needed outside the scope of knowledge”and “Identify learning needs”) were replaced for one be-havioral statement. Additional modifications includedclarifying the “Compoundmedicines” competency by in-cluding additional behaviors regarding extemporaneouspreparations compounding and storage; combining “Pro-curement” and “Supply-chain management” competen-cies and adding behaviors regarding procurement andsupply chain management; adding behaviors relating to“Patient consultations” competency in the Pharmaceuti-cal Care cluster; and adding behavior statements regard-ing human resources and workplace management in theOrganisation and Management cluster.
After the adaptation process, the mean relevancescores of each behavioral statement and some minoradjustments of the competencies (eg, wording) werereached by the expert panel members. A summary ofrelevancy mean scores and standard deviations for all be-havioral statements is detailed in Table 3. Ninety-fourpercent (n590) of behavioral statements were rated asrelevant by more than 80% of respondents. During thevalidation process, consensus was reached on keepingthe remaining six statements as they were considered rel-evant for Croatian practice. The “Encourage and conductresearch at the workplace” [3.9 (0.69), N57], “Under-stand the tendering methods and evaluation of tenderbids” [3.7 (1.11), N57], and “Monitor and report on useof medicines and medical devices [3.9 (0.69), N57],showed the least relevance. This may reflect the absenceof workplace research culture. Furthermore, tendering isa method applicable for hospital pharmacy and a smallproportion of community pharmacies supplying prison
and nursing home facilities and was thus recognized asimportant by a lower proportion of pharmacists present inthe expert panel. Moreover, monitoring and reporting onthe use of medications and medical devices is usuallycarried out by a community or hospital pharmacy man-ager and so was not recognized by the remaining phar-macy personnel as highly important. Nevertheless, thesestatements followed the validation process consideredimportant for foundation level practice, and consensuswas reached on retaining them.
The expert panel agreed to the majority of amend-ments proposed by the consensus development panel andfurther refined the framework in terms of uniformity oflanguage, wording, and some minor amendments not af-fecting the content itself, bearing in mind the perspectiveand the context of the Croatian pharmacy profession.
After public consultation with all registered pharma-cists (n53431), only 26 responses were received, all ofwhich were included in the final draft. Those commentsaddressed the issues related to procurement and supplychainmanagement and patient consultation competenciesclarification, distinctions between hospital and commu-nity pharmacy dispensing and adverse drug reactionsreporting, and organizing and providing competency-informed education for registered pharmacists. The big-gest fear expressed by pharmacists was not being up todate with knowledge and skills to satisfy the competen-cies in the competency framework. All pharmacists foundthe framework clear and easy to understand and statedthat the framework reflected the core competencies of acommunity/hospital pharmacist. Many useful commentsand suggestions were also received from pharmacists onhow the framework could be improved, and pharmacistsprovided additional behaviors useful to the framework.The framework could, therefore, be considered the com-petency standards set by both the regulatory body and theprofession itself.
Upon consultation with the profession, the frame-work was updated and finalized to reflect the commentsand suggestions received during the consultation process.The final framework consisted of 96 behavioral state-ments, grouped in 17 competencies under four maincompetency domains: Pharmaceutical Public Health,Pharmaceutical Care, Organisation and Management,and Personal and Professional. A detailed overview ofthe framework is given in Table 3.
DISCUSSIONThis is the first comprehensive Croatian Compe-
tency Framework eligible for supporting pharmacistsworking in community and hospital sector in Croatia.
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
9
Table
3.Overview
oftheAdaptedCroatianCompetency
Framew
ork
andMeanRelevancy
ScoresforEachStatement
Competency
BehaviorStatement
Mean
Relevance
Score
(SD)
PharmaceuticalPublicHealth
Health
promotion
Assessthepublichealthneedsofalocalpopulation
4.1
(0.7)
Initiate,organizeandparticipatein
publichealthprojectsbased
onlocalpopulationneeds
4.6
(0.5)
Advisepopulationonhealthpreservation,disease
prevention,healthylifestyle
andsafe
andrational
use
ofmedicines
and
devices
5.0
(0.0)
PharmaceuticalCare
Assessm
entof
medicines
and
medical
devices
Apply
theprinciplesofevidence-based
pharmacy(tomakesoundclinical
decisions)
4.9
(0.4)
Apply
guidelines
andtreatm
entprotocols
5.0
(0.0)
Appropriatelyselectmedicines
anddevices
accordingtothegovernmentpolicy,drugaccessibility/availability,andpatientand
hospital
needsandfinancial
capabilities
5.0
(0.0)
Appropriatelyselect
medicines
anddevices
accordingto
thepatientsymptomsanddiagnosis
4.9
(0.4)
When
selecting,identify,prioritise
andactuponmedicine-medicineinteractions;medicine-disease
interactions;medicine-
patientinteractions;medicines-foodinteractions
5.0
(0.0)
Compoundingof
magistral
and
galenic
preparations
Determineandensure
therequirem
entsforpreparationandstoringofmagistral
andgalenic
preparations
4.9
(0.4)
Compoundmagistral
andgalenic
preparationsaccordingto
professional
principles,literature
andguidelines
5.0
(0.0)
Confirm
theidentity
andqualityofentry/raw
materials
4.6
(0.5)
Ascertain
thequalityofgalenic
preparation
4.7
(0.5)
Accurately
label
magistral
andgalenic
preparations
5.0
(0.0)
Appropriatelystore
galenic
preparations
5.0
(0.0)
Dispensing
medicines
and
medical
devices
Establish
accuracy
andlegalityofprescriptionsandcertificationsofmedical
devices
andvalidatethem
appropriately
4.7
(0.5)
Understanddiagnosisandtherapeuticgoals
4.7
(0.5)
Accurately
dispense
prescribed
medicines
5.0
(0.0)
Accurately
dispense
medical
devices
based
oncertificationofmedical
device
4.9
(0.4)
Accurately
re-packagemedicines
and/ormedical
devices
from
theoriginal
packagingandaccurately
label
5.0
(0.0)
Label
medicines
andmedical
devices
withtherequired,precise
andcomprehensible
instructionsforpatientsorhealthcare
workersin
hospital
5.0
(0.0)
Advisepatients/healthcare
professionalsin
hospital
onproper
storageconditionsofthemedicines
andmedical
devices
5.0
(0.0)
Advisepatients/healthcare
professionalsin
hospital
onproper
disposalofunusedmedicines
andmedical
devices
4.6
(0.5)
Reportsuspectedqualitydefectsofmedicines
andmedical
devices
totheappropriateauthorities
5.0
(0.0)
Patient
consultation
Establish
atrustingandcollaborativerelationship
withthepatient
4.7
(0.5)
Obtain
anddocumentpatients’medical
andsocial
history
4.1
(0.7)
Identify,prioritise
andresolvepatients’pharmaceuticalproblems
4.7
(0.5)
Introduce
patientwithhispharmaceuticalproblemsandclearlystateallpossibleoptionsthatcould
beundertaken
tosolvethe
pharmaceuticalcare
problemsidentified.
4.7
(0.5)
Advisepatientonproper
medicineandmedical
deviceuse
4.9
(0.4)
Advisepatientonhealthpreservationandhealthylifestyle
4.9
(0.4)
Contact
orreferappropriatelyto
themedical
doctor
4.9
(0.4)
Explain
what
todoandwhom
tocontact
incase
ofanew
therapeuticproblem
4.7
(0.5)
Documentanyintervention
4.7
(0.5)
Ensure
therapeuticmonitoringofmedicines
andmedical
devices
4.6
(0.8)
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
10
Table
3.(C
ontinued
)
Competency
BehaviorStatement
Mean
Relevance
Score
(SD)
Assurance
ofsafe
medicines
use
Note,preventandactuponmedicationerrors
5.0
(0.0)
Documentmedicationerrors
ininternal
medicationerrorreportingsystem
s4.3
(0.8)
Regularlyreportmedicationerrors
tointernal
Committees/appropriateauthorities,ifpossible
4.2
(0.8)
Regularlymonitorandbeupto
datewithmedicationerrorreports
4.6
(0.5)
Recognizeandreportadverse
drugreactionsto
theappropriateauthorities
5.0
(0.0)
Beupto
datewiththeactual
inform
ationrelatedto
medicationsafety
4.9
(0.4)
OrganizationandManagem
ent
Organization
Dem
onstrate
knowledgeoftheorganizational
structure
ofcommunitypharmacy/institution
4.2
(0.8)
Dem
onstrate
knowledgeoftherelationship
betweencommunitypharmacy/institutionandother
stakeholders
4.4
(0.8)
Adhereto
national
directives
andguidelines
inrelationship
withstakeholders
4.0
(1.0)
Finance
managem
ent
Understandandadhereto
thefinancial
planofcommunitypharmacy/institution
4.6
(0.5)
Properly
invoiceandchargedispensedmedicines
andmedical
devices
andensure
theproper
documentation
4.7
(0.5)
Ensure
theabilityto
monitortheconduct
offinancial
transactions
4.9
(0.4)
Monitorandreportonuse
ofmedicines
andmedical
devices
3.9
(0.7)
Hum
anresources
managem
ent
Assigntasksto
employees(eachmem
ber
ofthestaff)within
thescopeoftheirjobdescription
4.6
(0.8)
Monitorwork
ofem
ployeesandevaluatetheircompetency
4.4
(0.5)
Recognizetheneedsandpotential
ofeach
mem
ber
ofthestaffandenable
theirpersonal
andprofessional
development
4.7
(0.5)
Encourageem
ployees’
self-conscience
andtheirprofessionaffiliation
4.6
(0.5)
Workplace
managem
ent
Address
andmanageday
today
managem
entissues
4.7
(0.8)
Ensure
thework
timeisappropriatelyplanned
andmanaged
accordingto
directives,internaldecisionsandneedsofthework
4.6
(0.8)
Encouragepositiveworkingatmosphere,
open
communicationandcollaborationwithin
theworkingenvironment
4.6
(0.8)
Encouragepositiveworkingatmosphere,
open
communicationandcollaborationwithother
healthcare
professionals
4.7
(0.5)
Ensure
adherence
totherulesofGoodpharmacypractice
5.0
(0.0)
System
atically
transfer
ethical
andmoralvalues
toem
ployeesandlead
byexam
ple
4.9
(0.4)
Procurement
andsupply
chain
managem
ent
Followandbeupto
datewiththenew
sondrugmarketandrely
onreliableinform
ationnecessary
fortheprocurementprocess
4.9
(0.4)
Ensure
themostcost-effectivemedicines
andmedical
devices
intherightquantities
based
onavailabilityofthedrugmarket
5.0
(0.0)
Developandim
plementcontingency
planformedicines
andmedical
devices
shortages
4.6
(0.5)
Organiseprocurementin
linewithcontractsandpaymentcapabilities
4.3
(0.8)
Organizereliable
procurementofmedicines
andmedical
devices
inatimelymanner
4.7
(0.8)
Apply
thecorrectprocedure
ofinterventionim
port
5.0
(0.0)
Ensure
medicines
andmedical
devices
areofappropriatequality,within
expirydateandarenotcounterfeit
4.9
(0.4)
Ascertain
theaccuracy
ofmedicines
andmedical
devices
delivery
4.7
(0.5)
Ensure
storageofmedicines
andmedical
devices
inacorrectlymanner
4.7
(0.5)
Ensure
accurate
proceduresofreturn
ofmedicines
andmedical
devices
4.4
(0.8)
Ensure
proper
documentationandrecord
keeping
4.7
(0.5)
Form
pricesin
linewithproceduresandinstitutionpolicy
4.6
(0.8)
Ensure
appropriatecategory
managem
entin
linewithcommunitypharmacy/institutionpolicy
4.0
(0.8)
Understandthetenderingmethodsandevaluationoftender
bids
3.7
(0.1)
(Continued)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
11
Table
3.(C
ontinued
)
Competency
BehaviorStatement
Mean
Relevance
Score
(SD)
Personal
andProfessional
Com
munication
skills
Communicateclearly,precisely,objectivelyandappropriately
4.9
(0.4)
Dem
onstrate
culturalandsocial
awarenessandsensitivity
4.9
(0.4)
Dem
onstrate
negotiatingskillsin
theeventofproblemsandconflicts
4.3
(0.8)
Continuing
Professional
Development
(CPD)
Evaluatecurrency
ofknowledgeandskillsandidentify
learningandprofessional
developmentneeds
4.7
(0.5)
Continuouslydevelopto
answ
ertheidentified
learninggaps
4.7
(0.5)
Evaluateownworkingperform
ance
4.6
(0.5)
Exchangeandtransfer
professional
knowledge
4.7
(0.5)
DocumentCPD
activities
4.4
(0.5)
Legal
and
regulatory
practice
Understandandapply
healthcare
andpharmaceuticalactivitylegislation,andfollow
amendments
4.6
(0.5)
Dem
onstrate
knowledgeofthefundam
entalsoflegislationin
financial
managem
entandintellectual
property
rights
4.0
(0.8)
Dem
onstrate
knowledgeandapply
legislationrelatedto
drugswiththepotential
forabuse,andfollow
amendments
4.6
(0.8)
Dem
onstrate
knowledgeandapply
fundam
entalsoflegislationin
marketing,advertisingandsales
4.1
(0.7)
Dem
onstrate
knowledgeoflabourlegislation
4.4
(0.5)
Professional
and
ethical
practice
Act
inlinewithCodeofEthicsanddeontologyandGoodpharmacypractice
5.0
(0.0)
Ensure
confidentialityofpatient’spersonal
data
4.9
(0.4)
Obtain
patientconsent,when
necessary
4.7
(0.5)
Takeresponsibilityforownactionandforpatientcare
4.9
(0.4)
Improvem
entof
serviceand
quality
assurance
Monitorthequalityofpharmacyservices
4.7
(0.5)
Improvecurrentandintroduce
new
services
4.6
(0.5)
Develop,im
plementandconduct
StandingOperatingProcedures(SOP’s)
4.7
(0.5)
Encourageandconduct
research
attheworkplace
3.9
(0.7)
Documentandtakecare
ofunwantedoccurrencesat
theworkplace
andinform
theinternal
departm
ent/bodyofcommunity
pharmacy/institutionthereof.
4.6
(0.5)
Learn
from
previousunwantedoccurrencesandpreventfurther
ones
4.7
(0.5)
Personal
development
Evaluateanddevelopself-confidence
andself-consciousness
4.4
(0.8)
Dem
onstrate
interest,initiativeandinnovation
4.4
(0.8)
Dem
onstrate
time-managem
entskills
4.4
(0.8)
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
12
The adapted framework reflects the current status of phar-macy practice in Croatia and lays foundation for the newpharmacy contract with Croatian Health Insurance Fundregarding the provision of advanced services. Moreover,Croatia is among the first non-English speaking countriesin Southeastern Europe to have used, properly adjusted,and validated the global framework, adapting it to itsnational needs. The assessment of Croatian communitypharmacists’ patient care competencies using the GeneralLevel Framework was previously investigated and pro-vided a foundation for the enforcement of the currentstudy.11 Other countries from the region that are develop-ing competency frameworks include Serbia,12 Slov-enia,13 and Monte Negro, whereas Lithuania andTurkey have recently started with implementation. TheCCF employed methodology similar to the one used byIreland, the first country to have adapted the GbCF, withthe exception of translation and cross-cultural adapta-tion.14 Both frameworks, although similar in structure,yielded two dissimilar documents.
Croatia has a different pharmacy practice traditioncompared to Anglo-Saxon countries that already usecompetency frameworks in various health care sectorsand are consequently more accustomed to it.15-22 Con-cepts of pharmaceutical care and clinical pharmacy,namely patient-centred practices are underdevelopedand lack inclusion in the nation’s health care system. Inaddition, competencies per se are a part of educationalparadigm which is not yet fully implemented in our edu-cational system and much effort was invested to dissem-inate information regarding its relevance and educatepharmacy public on the matter. The process is not com-pleted and time is needed for the concept to be compre-hended and accepted by Croatian pharmacists.
Despite the fact that the adaptation of a culturallydifferent GbCF presented quite a challenge, we stronglybelieve that the process could serve as an example to otherEuropean countries with similar pharmacy practice-related issues that have not yet developed their owncountry-specific framework. We found that althoughthere were barriers in the process of creating the na-tional competency framework, they could be overcomeby taking into account standard methods of translationand cross-cultural adaptation.23-26 Furthermore, we con-firmed that the methodology used in this process couldyield a country-specific framework that we recommend toother countries.
When comparing GbCF and CCF, most differencesare in the Pharmaceutical Care and Organization andManagement competency clusters. Although consider-able congruence was noticed between the original andadapted document in Pharmaceutical Care, additional be-
haviors were needed. The framework was primarily mod-ified within the Patient Consultation competency, whichgrew to 10 from the original six statements. For years,Pharmaceutical Care remained unrecognized and unprac-ticed along with its key patient-centered skill, patientconsultation, and pharmacists weremerely advice-givers.In the light of changes and acknowledged necessity forpharmaceutical care development, as well as the impor-tance of the consultation skills as a 2-way process, authorsconsidered it essential to disassemble this composite pro-cess to consecutive steps and add more behaviors as tofamiliarize pharmacists with the sequence of activitieswithin the Patient Consultation cluster.
The most amended cluster was Organization andManagement, where approximately half of the competen-cies were replaced and the other half were revised. Thishighlights the importance of adapting the generic globalcompetency framework in organizational andmanagerialissues to the local and national circumstances, as these canbe country-specific. Although pharmaceutical care isa universal practice not necessarily related to culture,tradition, and history, it differs from country to countrydepending on the level of its development.
As for statements that represent the future pharma-cists’ roles but are not yet incorporated in the healthcare system (eg, reporting document medication errorsin internal medication error reporting systems; report-ing medication errors to internal committees/appropriateauthorities), most were retained with an aim of raisingawareness about them, especially when using the frame-work in the undergraduate context.
Following public consultation, a low response ratewas obtained, as expected, reflecting pharmacists’ poorengagement, initiative, and interest in competencies andtheir implementation. Unfortunately, this is a result of thelack of understanding of the concept and importance ofcompetencies by the pharmacy profession. However, anunexpectedly high proportion of pharmacists (N598) an-swered the invitation and participated in the closing event,reporting that they wanted to contribute to the final draft.This demonstrated a slow, but existent, shift in pharma-cists’ perceptions and assisted in forming a new climate inCroatian community and hospital setting.
The adapted framework was created following anevidence-based approach and was validated by an expertand individual pharmacists’ opinion. The pharmacistsworking across various pharmacy sectors received an of-ficial invitation for participation in the project from theCroatian Pharmacy Chamber, and had subsequently beenrecruited. A pragmatic approach to recruitment was adop-ted because of the high level of commitment required ofparticipants over a long period of time. Within the study
American Journal of Pharmaceutical Education 2016; 80 (8) Article 134.
13
period, 23 session rounds (workshops with an averageduration of 180 minutes) were organized, suggestinga high level of enthusiasm and support. All participatingpharmacists continued their involvement in the projectthroughout the one-year period as they were eager to con-tribute to the development of the framework, which con-firmed the need for a competency framework.
The adapted framework will inform the curriculumdevelopment, serve as a basis for pharmacists’ training incommunity and hospital setting, provide a foundation fora newCPDmodel, and offer support for workforce devel-opment. The CCF will be tested among student popula-tions during their 6-month preregistration period andamong practicing pharmacists, duringwhich their clinicalactivities will prospectively be recorded at several timepoints. Twomethods of students’ competency assessmentwill be employed: self-assessment by students at twotime-points (following six weeks and six months) andvertical assessment conducted on behalf of students’mentors/preceptors at the end of the preregistration train-ing to evaluate student performance. The evaluation of theCCF will demonstrate whether the adapted frameworksustains pharmacists’ development and is efficient at de-veloping the competence of students in community andhospital pharmacy towards a registered pharmacist. Fol-lowing the initial implementation of the framework, au-thors intend to continue refining and validating theframework in regard to ambiguities, inapplicability, orlack of clarity of certain behaviors.
Further research is needed to determine whether themethodology applied in our study can serve as amodel foradapting and developing other countries’ frameworks,especially in the countries with similar pharmacy practicepolicy, and whether the CCF can role-model and informthat development.
We instigated this research as the profession needsa systematic and standardized platform to demonstrateto other health care professionals, patients, and pharma-cists the role we play in the safe and responsible pharma-ceutical care provision. By actively incorporating qualityimprovement through competency-based framework,pharmacists can bring about systematic changes abouthow patient care is delivered.
The current study was limited in several ways. First,the selection of the expert panelmembers and the questionof sample representativeness was raised, especially whenconsidering that all participants were female. However,consensus panel methodology typically utilizes non-random sampling because of the need for expert iden-tification; in fact, literature consistently supports theuse of selected panelists.27,28 Additionally, based on thedata from Croatian Chamber of Pharmacists, gender
distribution is predominantly female (93%). Further is-sues included: panel members not being a representativepopulation, which makes the findings difficult to general-ize; participants having subjective views that may havefluctuated over time; and group dynamics potentiallyrestricting some panel members from voicing their opin-ions. To minimize those limitations, the facilitatorattempted to enable a balanced discursive contributionamong panel members. Another limitation was that theCCF is specifically tailored to the country’s current phar-macy practice situation.
Considering the changing environment of pharmacypractice, we recommend an ongoing process of compe-tency framework evaluation and validation to ensure itssustained value in the future. Finally, an issue on equalcompetency comprehension by all pharmacists wasraised. Indeed, without the description of each behavioralstatement, one could not be certain that all pharmacistscomprehended the listed competencies and the pertainingbehaviors in the same manner, even with the providedexplanation in a form of a handbook.
CONCLUSIONThis adaptation and validation demonstrated that
a global framework can be adaptable to local needs, asthe Croatian Competency Framework emerged from theGbCF, and can be used for creating a country-specificmapping tool. Key amendments were made in the Orga-nization andManagement and Pharmaceutical Care com-petencies clusters, demonstrating that these issues can becountry-specific.
ACKNOWLEDGMENTSThe authors wish to thank panel members and col-
leagues who provided assistance with the research.
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