Kniga na apstrakti book of abstrcts

Pharmacoeconomics & Outcomes Research Perspectives
in Health Care Sector
Aleksandar Cvetkovski, Vladimir Zah,
ZRx Outcomes Research Inc, Unit 402, 48 Galaxy Blvd. Toronto, ON M9W 6C8, Canada
The objective of this presentation is to introduce pharmacoeconomics and outcomes research as established
and accepted applied scientific skills for leverage and evaluation of pharma market and therapy regimens. The role
of ISPOR (International Society for Pharmacoeconomics and Outcomes Research) as leading international commu-
nity, its direction and ISPOR local chapters will be introduced.
Outcomes Research (OR) is scientific discipline that evaluates the effect of healthcare interventions on patient
well-being through clinical, humanistic and economic outcomes. Pharmacoeconomics (PE) is a type of economic
outcomes that evaluates the effect (clinical, humanistic, and economic) of drug interventions on patients, health sys-
tems, or society. PE and OR have become increasingly important to a range of stakeholders in the healthcare mar-
ket. Key driver for this is the expanding demand for healthcare products and services, including incremental increas-
es in the number and complexity of healthcare treatments during the last 15 years. Many Developed countries have
developed some form of PE and OR requirements that either represent “fourth hurdle” to the launch of new prod-
ucts, or post-launch guidance on clinical use and reimbursement.
This presentation will provide audience with introduction to PE and OR, background and development of
this science, executive brief on different approaches to PE and OR studies and future developments. It will also pro-
vide executive brief to ISPOR society.
ISPOR society mission is to translate PE & OR into practice; ensure that society allocates scarce healthcare
resources wisely, fairly and efficiently.
Macedonian pharmaceutical bulletin 53 (1,2) 129 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Studying of the influence of National Drug Strategy document 
in Republic of Macedonia on the prescribing practice 
and rational use of medicines
Bistra Angelovska
1
, Guenka I. Petrova
2
1
National health insurance fund, Skopie, RM,  
2
Faculty of Pharmacy, Sofia, 2 Dunav Str., Bulgaria, 
The National Drug Policy as a written professional and political statement is a guide for action for profes-
sionals and regulators for better supply and improving peoples’ access and affordability of medicines. The main goals
of such a document are ensuring the quality, safety, efficacy and rational use of medicines at national level but these
goals have different prioritization on country level.
In 2001 the Government of Republic of Macedonia accepts the National Drug Strategy (NDS) aiming to
define the mechanisms for supporting affordability, quality and efficacy of medicines and their rational use in the
country but the changes on country level have not been analyzed at the moment.
The goal of this study is to analyze the changes in the drug usage, prescribing practice and rational use of
medicines in RM after the creation of the NDS and to compare with the previous situation. The main study question
is: “Did the endorsement of NMS document Republic of Macedonia improves affordability and rational use of med-
icines?”
The methods used of this study is analysis of sample prescriptions before and after adoption of NMS docu-
ment, systematized according to ATC group of medicines and analyzed for correspondence with the morbidity, share
of prescribed essential medicines, injections, and combinations.
The results show that the prescribing practice corresponds with the leading diagnoses but it is focused on a
limited number of medicines and this is questioning the physicians’ free choice of contemporary therapy.
The comparison with the previous situation revealed that there is improvement in prescribing practice. 
As future priorities on national level we can recommend the introduction of the generic drug policy, précis-
ing the drug selection criteria, rationalizing the antibiotic therapy and connecting the reimbursement policy with the
generic ones.
Macedonian pharmaceutical bulletin 53 (1,2) 130-131 (2007)
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FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Isleduvawe na vlijanieto na dokumentot 
za Strategijata za lekovi na RM vrz propi{uvaweto 
i racionalnata upotreba na lekovite 
Angelovska Bistra
1
, 
Genka I. Petrova
2
1
Fond za zdravstveno osiguruvawe na Makedonija, Skopje, [e-mail]
2
Farmacevtski fakultet, Sofija, Dunav 2, Bugarija [e-mail]
Nacionalnata strategija za lekovi e pismen politi~ki i profesionalen dokument koj pretstavu-
va vodi~ za deluvawe na profesionalcite i politi~arite za podobro snabduvawe i podobruvawe na
fizi~kata i finansiska dostapnost na lekovite do naselenieto. Glavnata cel na takviot dokument e da
obezbedi kvalitet, bezbednost, efikasnost i racionalna uptreba na lekovite na nacionalno nivo, no tie
celi imaat razli~en ptioritet na nivo na zemjata.
Vo oktomvri 2001 godina Vladata na Republika Makedonija ja usvoi Strategijata za lekovi na
Republika Makedonija so cel da gi definira mehanizmite za podr{ka na dostapnosta, kvalitetot i efikas-
nosta na lekovite i nivnata racionalna upotreba vo zemjata, no promenite na nivo na zemjata ne bea anal-
izirani do ovoj moment.
Cel na ovaa studija e da gi analizirame promenite vo upotrebata na lekovite, praksata za propi-
{uvawe i racionalnata upotreba na lekovite vo Republika Makedonija pred i po izgotvuvaweto na doku-
mentot Strategijata za lekovi na Republika Makedonija. Glavnoto pra{awe na ovaa studija e: “Dali usvo-
juvaweto na dokumentot Strategijata za lekovi na Republika Makedonija pridonese za podobruvawe na
dostapnosta i racionalnata upotreba na lekovite?“
Metodi koristeni vo ovaa studija se: analiza na primeroci na propi{ni lekovi pred i posle done-
suvaweto na Strategijata za lekovi na Republika Makedonija, sistematizirawe po ATC kod i analiza vo
odnos na morbiditetot, u~estvo na propi{ani esencijalni lekovi, iwekcii i kombinacii.
Rezultatite poka`aa deka praksata na propi{uvawe odgovara so vode~kite dijagnozi no
propi{uvaweto e fokusirano vrz ograni~en broj na lekovi i se postavuva pra{aweto na mo`nosta za slo-
boden izbor na lekarite na ponovi lekovi I voveduvawe na sovremena terapija.
Sporedbata so situacijata pred donesuvaweto na dokumentot poka`a deka praksata za propi{uvawe
e podobrena.
Idni prioriteti na nacionalno nivo bi mo`ele da bidat voveduvawe na generi~ka politika za
lekovi, precizirawe na kriteriumite za selekcija na lekovite, racionalizirawe na antibiotskata ter-
apija i povrzuvawe na politikata na reimbursirawe so generi~kata politika za lekovi.
Macedonian pharmaceutical bulletin 53 (1,2) 130-131 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Analyzing the consumption of thirty most issued medicines 
with prescription in the transition period
Slavica Maleska Stojadinovic
1
, Bistra Angelovska
2
1
JZU Opsta bolnica, 6000 Ohrid, Macedonia
2
FZO,1000 Skopje
Republic of Macedonia was involved in so-called transition period while becoming independent in early
90-ties. This transitional period is still lasting, and is characterized by numerous changes which impact on medi-
cines consumption, habits of prescribing and use of drugs, such as: significant changes in pharmaceutical market
induced by lack and unsteady providing of numerous medicines from former united Yugoslavian market, financial
instability of state funds, receiving bigger amounts of medicaments as humanitarian help in the crisis days, changes
of regulations about health and finances, changes in Positive drugs list, introduction in centralized system for pro-
viding medications using public tenders for medications from Positive drugs list, introducing obtaining of medica-
tions using INN, etc.
Analyzing the consumption of drugs in the period of 1996 until 2006 year is interesting challenge for analyzing.
Aim of the work is to make analysis of consumption of thirty most present drugs issued with prescription
in year 1990, and after that, we follow their consumption in 1991, 2001 and 2006, using parameters from comput-
er processed prescriptions from pharmacies in Republic of Macedonia.
While preparing the work, we were using method of analysis of statistical reports for medicines issued with
prescription, systematized by ATC code and aligned by frequency of issuing by INN and with commercial names.
The results lead us to the conclusion that in the transition period the habits of prescribing and use of medi-
cines are changed. Issued medications are concentrated in few ATC groups, and with the changing the Positive drugs
list and the method of providing with centralized tenders by INN, issuing of drugs is concentrated more frequently
to the generic products and relatively narrow choice of original products and brands from renowned manufacturers.
Macedonian pharmaceutical bulletin 53 (1,2) 132-133 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Analiza na potro{uva~ka na triesette najizdavani lekovi 
na recept vo tranziciskiot period
Slavica Maleska Stojadinovi}
1
, Bistra Angelovska
2
1
JZU Op{ta bolnica, 6000 Ohrid, Makedonija
2
FZO, 1000 Skopje
Republika Makedonija vleze vo takanare~eniot tranziciski period so osamostojuvaweto vo rani-
te 90-ti godini. Toj period se u{te trae, a go karakteriziraat brojni promeni koi vlijaat vrz potro{u-
va~kata na lekovite, navikite za propi{uvawe i upotreba na lekovite kako {to se: zna~ajnite promeni na
farmacevtskiot pazar predizvikani od nedostigot i neredovnoto snabduvawe so golem broj na lekovi od
biv{iot edinstven jugoslovenski pazar, finansiskata nestabilnost na dr`avnite fondovi, dobivaweto
na pogolemi koli~estva na lekovi kako humnaitarna pomo{ vo kriznite periodi, promenata na zakonska-
ta regulativa vo oblasta na zdravstvoto i finansiite, promena na Pozitivnata lista na lekovi, voveduva-
we na centraliziran sistem na snabduvawe preku objava na javni tenderi za lekovite od pozitivnata lista,
voveduvawe na nabavki na lekovi spored INN, i drugo.
Sledeweto na potro{uva~kata na lekovite vo periodot od 1990 do 2006 godina pretstavuva intere-
sen predizvik za analiza. 
Cel na trudot e da napravime analiza na potro{uva~kata na triesette najzastapeni lekovi izda-
deni na recept vo 1990 godina i ponatamu da ja sledime potro{uva~kata na istite vo 1991 godina, 2001 go-
dina i 2006 godina, spored podatocite dobieni so sledewe na kompjuterski obrabotenite izdadeni recep-
ti vo aptekite vo Republika Makedonija.
Pri izrabotkata na trudot go koristevme metodot na analiza na statisti~kite izve{tai za izda-
deni lekovi na recept, sistematizirani po ATC kod i podredeni spored ~estotata na izdavawe po INN
i za{titeni imiwa.
Dobienite rezultati poka`uvaat deka vo tranziciskiot period navikite za propi{uvawe i upotre-
ba na lekovite se promeneti. Izdadenite lekovi se koncentrirani vo nekolku ATC grupi, a so promenata
na Pozitivnata lista i na~inot na nabavka so centralizirani tenderi po INN, izdavaweto na lekovite
e koncentrirano po~esto na generi~ki proizvodi i na zna~itelno potesen izbor na originalni produkti
i brendovi od poznati proizvoditeli.
Macedonian pharmaceutical bulletin 53 (1,2) 132-133 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Short inerviews for problem identification with the use of drugs
Kolarova S., Lazarova B., Mihailova L.
PH pharmacy “Sofija” Hristijan Karpos 24a Stip; General hospital Ljuben Ivanov bb, Stip, R. Makedonija
In Stip private pharmacy SOFIJA has a tradition in addition to written information that is in drug package,
patients are given specific oral information on their medication, especially for the drug usage and possible adverse
drug reactions. In this pharmacy this is a standard procedure since 2004 year.
Objective: To establish whether the patients are listening for the pharmacist instruction and reading the
instruction from the package or not. 
Materials and methods: A group of 94 patients (49 male, 45 female) from 51 to 67 years old who were received
Amlodipine for chronic disease were interviewed in a period of 3.5 months. The patients were asking short ques-
tions about dosage, timing of application, liquid for oral application of the drug and possible problems that appears
after starting drug usage. The questions asked were short and simple formed because the patients are always in hurry
when they are in pharmacy.
Results: 3 patients declared that they have feet ankle swelling which do not understand like adverse effect
but it is a result of long standing. Sometimes they had feet ankle swelling before staring the drug, so did not tell any-
thing for this condition to their doctor. 5 patients got face redness that was lost after 3-4 hours and did not pay atten-
tion to this. 3 patients did not respect the time of application because they thought that is not important. 2 patients
did not respect the prescribed dose and they thought that the dose is to high for them. The rest of the patients read the
instruction from the drug package, understood pharmacist instruction and strongly respect it.
Conclusion: Short and simple questions which can be asked when the patients are taking the drug second
time is effective method to identify some problems which appears with drug usage whether they are adverse effects
or other nature.
Macedonian pharmaceutical bulletin 53 (1,2) 134-135 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Kratki intervjua za identifikacija na problemite 
koi se javuvaat pri upotreba na lekovite
Kolarova S., Lazarova B., Mihailova L.
PZO apteka Sofija Hristijan Karpo{ 24a [tip: 
JZU Op{ta bolnica Quben Ivanov bb [tip R. Makedonija 
Voved: Vo apteka Sofija vo [tip pri izdavawe na lek na recept sekoga{ na pacientite im se davaat
soodvetni usni upatstva kako {to i pravilno treba da se postapuva pri ekspedicija na lek, osobeno ako
pacientot za prv pat go upotrebuva propi{aniot lek koj ponatamu e namenet za terapija na hroni~no
zaboluvawe
Cel na trudot: Da se utvrdi kolku pacientite gi slu{aat farmacevtite koga tie davaat soodvet-
ni upatstva i dali gi primenuvaat istite. So drugi zborovi kolku pacientite imaat doverba vo farmace-
vite kako stru~ni lica.
Materijali i metodi: Opfatena e grupa od 94 pacienti koi po~nuvaat so terapija za hroni~no zabolu-
vawe vo period od 3.5 meseci i toa za preparatot Amlodipin tableti. Od 94 pacienti 49 se ma`i i 45 se
`eni, a celata grupa e na vozrast od 51 do 67 godini. Postvuvani se kratki pra{awa vo vrska so dozirawe-
to na lekot, tajmingot na aplikacija na lekot, vidot na te~nosta so koj se pie lekot i mo`nite problemi
koi se javile otkako pacientot po~nal da go pie lekot. Pri izveduvaweto na intervjuto sekoga{ se vnima-
va{e pra{awata da se vo ednostaven oblik i kratki bidejki pacientite koga se vo apteka sekoga{ brzaat.
Rezultati: Od 94 pacienti trojca izjavile deka imaat otoci vo zglobovite na nozete, no toa ne go
sfa}aat kako nesakan efekt od lekot tuku deka se rezultat na podolgo stoewe bidejki takvi otoci im se
javuvale od vreme na vreme i pred upotrebata na lekot, pa zatoa ne go obavestile mati~niot lekar za ovaa
pojava. Pet pacienti dobile crvenilo na liceto koe se gubelo posle 3-4 ~asa, pa ne mu posvetuvale vni-
manie na istoto. Tri pacienti ne go po~ituvale na~inot na upotreba na lekot vo pogled na vremeto na
aplikacija bidejki smetale deka toa ne e va`no. Dvajca pacienti ne ja po~ituvale propi{anata doza zatoa
{to smetale deka taa e pregolema za niv. Site ostanati go pro~itale upatstvoto, dobro ja razbrale instruk-
cijata od farmacevtot i strogo se pridr`uvale na ka`anoto.
Zaklu~ok: So ovoj trud sepak mo`e da se zaklu~i deka so ednostavni pra{awa pri povtorno zemawe
na ist lek farmacevtot mo`e da identifikuva odredeni problemi koi se javuvaat pri upotrebata na istiot
bez razlika dali tie problemi se od nesakanite efekti ili od druga priroda.
Macedonian pharmaceutical bulletin 53 (1,2) 134-135 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Reporting for advers drug reactions and doctor’s contributions for this
Lazarova B., Mihailova L., Kolarova S.
General Hospital Ljuben Ivanov bb Stip, community pharmacy “Sofia”
Hristijan Karpos 24a Stip, R. Makedonija
Adverse drug reactions (ADRs) pose a challenge to prescribing physicians, especially when they are con-
siderably compromises the patient’s quality of life and thus affect compliance. Adverse events that do not pose a
severe threat to the patient’s health and therefore considered no serious are understudied in pharmacotherapy.
Identification of ADRs has improved dramatically since ADR surveillance was instituted about 40 years ago. Safety
requirements before drug approval combined with post marketing surveillance provide a network ready to capture
severe ADRs even if they are rare. No serious ADRs are generally not identified or quantified with the same dili-
gence. Health care professionals must be aware not only of sere ADRs but also less severe ones, their incidence and
possible dose dependency such knowledge affects the choice of most appropriate among alternative options and is
critical to the recognition of the adequate management of ADRs. Making patients aware of such potential reactions
in advance when a drug is prescribed may contribute to good compliance and early control of ADRs. We analyzed
the health care professionals in General hospital in Stip and their contributions in ADRs detection and reporting. The
conclusion I very disappointed because the doctors know very well what means ADRs but they did not report them
from different reasons. Some of them are afraid from criticism, some of them said that they did not have enough free
time to fill up lists for ADRs and sent them to the national center for reporting ADRs and some did not know that
this center exist. In the last 10 years only 2 cases with AD were reported from this hospital from anesthesiologists.
We can conclude although a large number of clinical trials are performed during preaproval and postaproval phases
on efficacy of drugs, capture of ADRs is often inadequate.
Macedonian pharmaceutical bulletin 53 (1,2) 136-137 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Prijavuvawe na nesakanite efekti na lekovi 
i pridonesot na lekarite za istite
Lazarova. B., Mihailova. L., Kolarova. S.
JZU Op{ta bolnica Quben Ivanov bb [tip; PZO apteka Sofija 
Hristijan Karpo{ 24a [tip, R. Makedonija
Nesakanite efekti od lekovite (NEL) pretstavuvaat predizvik za lekarite koi prepi{uvaat
lekovi, osobeno koga tie lekovi go izlo`uvaat na rizik kvalitetot na `ivot na pacientot, a so toa vli-
jaat i na usoglasenosta na terapijata. Nesakanite efekti koi ne pretstavuvaat silna zakana za zdravjeto
na pacientot se smetaat za ne seriozni i se prou~eni vo farmakoterapijata. Identifikacijata na NEL
od pred 40 godini dramati~no se zgolemi bidejki toga{ vo svetot se formiraa institucii za nadzor na
istite. Barawata za bezbednost na lekot pred negovo odobruvawe za upotreba kombinirani so postmar-
ketin{ki nadzor ~inat mre`a za sobirawe na podatoci za seriozni NEL duri i ako tie se mnogu retki.
Neserioznite NEL vo glavno ne se identifikuvani ili kvantificirani so ist intenzitet kako seri-
oznite. Zdravstvenite profesionalci mora da bidat svesni ne samo za serioznite nesakani efekti tuku
iza neserioznite, za nivnata incidenca i mo`nata zavisnost od dozata. Poznavaweto na NEL mo`e da vli-
jae na izborot na najsoodvetnata terapija od pove}eto alternativni terapii. Ova e krucijalno i za pre-
poznavawe na soodvetno menaxirawe na NEL. Postignuvajki ja celta pacientite da se nateraat da gi pre-
poznavaat NEL mo`e da se doprinese do dobro usoglasuvawe na terapijata i kontrola na NEL. Napravena
e analiza na zdravstvenite profesionalci vo JZU Op{ta bolnica [tip i nivniot pridones za otkrivawe
na NEL. Zaklu~okot e porazitelen bidejki doktorite go znaat mnogu dobro zna~eweto na NEL, no ne gi
prijavuvaat istite od razli~ni pri~ini: nekoi se pla{at da ne bidat kritikuvani, nekoi smetaat deka
nemaat dovolno slobodno vreme za da popolnuvaat formulari i gi ispra}aat istite do nacionalniot cen-
tar za prijavuvawe na nesakani efekti, a nekoi pak voop{to neznaat deka postoi takov centar. Vo ovaa
bolnica vo poslednite 10 godini prijaveni se samo 2 slu~ai na seriozni nesakani efekti od strana na
anesteziolozite.
Od ova mo`e da se zaklu~i deka i ako golem broj na klini~ki ispituawa se izveduvaat i vo fazata
pred odobruvawe na lekot i vo fazata posle odobruvawe za pu{tawe vo promet na lekot, sepak sobirawe-
to na podatoci osobeno posle odobruvaweto na lekot e neadekvatno. 
Macedonian pharmaceutical bulletin 53 (1,2) 136-137 (2007)
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^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION