Kniga na apstrakti book of abstrcts

Voveduvawe na
99m
Tc – EDDA/HYNIC-TOC,
aktuelen radiofarmacevtik vo nuklearnata onkologija
S. Kuzmanovska
1
, 
O. Vaskova
1
, T
. Tripunoski
1
, 
M. Ko~ovska - Zdraveska
1
, 
C. Decristoforo
2
1
Institut za patofiziologija i nuklearna medicina, 
Medicinski fakultet, Skopje, R. Makedonija
2
Universitatsklinik fur Nuklearmedizin, Innsbruk, Austria
Cel: Upotrebata na radioobele`eni peptidni ligandi kako dijagnostici i terapevtici e denes osobeno
aktuelna vo nuklearnata medicina. Eden od naj~esto koristenite radiofarmacevtici e 
99m
Tc-EDDA
/HYNIC-TOC, somatostatinski analog koj specifi~no se vrzuva za odredeni tipovi na somatostatinski
receptori, eksprimirani kaj nekoi nevroendokrini tumori (limfomi, feohromocitomi, adenomi na hipo-
fiza, insulinomi). Radiofarmacevtikot ne e komercijalno dostapen i na{a cel be{e da go vovedeme kako
“in house” preparat, vo ramkite na me|unaroden proekt vo sorabotka so IAEA. Voveden be{e protokol za pri-
gotvuvawe na radiofarmacevtikot, izvedeni studii za kontrola na kvalitet i napraveni prvite scinti-
grafii na pacienti.
Materijal i metodi: Za obele`uvawe be{e koristen peptidot Tyr
3
-octreotid, kowugiran so hidrazi-
no nikotinamid (HYNIC-TOC), dobien od Polatom, Polska. Radio-farmacevtikot be{e prigotven spored
t.n. “vla`na” postapka, pri koja HYNIC-TOC, so dodatok na koligandite etilen diamin diocetna kiselina
(EDDA) i tricin, se obele`uva so 1 GBq sve` generatorski eluat 
99m
Tc-pertehnetat vo prisustvo na kalaj
hlorid dihidrat. Rastvorot be{e termi~ki inkubiran na 70ºC za vreme od 30 min. Po prigotvuvawe, radio-
farmacevtikot be{e pro~isten preku SepPak mini kartrix (Waters, Milford, USA) i steriliziran so fil-
tracija. Radiohemiska ~istota be{e odredena preku ITLC Silica gel (Merck, 5553) so upotreba na solventite
metil etil keton, Na-citrat i acetonitril. Biolo{kata raspolo`livost na preperatot ja izvedovme na
zdravi staorci od tipot Wistar, so scintigrafija pod gama kamera (Siemens e.cam, USA) vo intervali od 15
min. i 4 ~asa po aplikacija. Normalnata biodistribucijata po organi be{e izvedena so merewe na radioak-
tivnosta vo organite od interes (krv, hepar, bubrezi, slezena, pankreas, adrenalni `lezdi, `eludnik i mus-
kuli) i be{e izrazena kako % na injektirana doza/g organ. Prvite scintigrafski isleduvawa bea napraveni
kaj pacienti pod suspekcija za feohromocitom. 
Rezultati: Radiohemiskata ~istota na obele`eniot peptid, odredena so ITLC-SG, be{e sekoga{ >
95%. Frakcijata na sloboden
99m
Tc-pertehnetat, odreden so metiletil keton (Rf=1) iznesuva{e 0.4% ± 0.26;
za 
99m
Tc-ne peptidno vrzani ne~istotii presmetavme 2.8% ± 1.08 (vo Na-citrat), dodeka 
99m
Tc-koloidni
ne~istotii, odredeni so 50% acetonitril bea 1.23% ± 0.37. Biodistribucijata po organi po 4 ~asa od
aplikacija poka`a deka radiofarmacevtikot se zadr`uva najmnogu vo bubrezite 3,2%ID/g, vo heparot
1.3%ID/g, a najmalku vo muskulite 0.15%ID/g. Ovie naodi bea potvrdeni i od stati~nite scintigrami na
`ivotnite. Na scintigramite od prvite pacienti (vkupno 3), napraveni po 15 min i 4 ~asa po aplikacija
na preparatot, ne zabele`avme patolo{ki akumulacii vo predelot na adrenalnite `lezdi, dodeka najgole-
ma retencija na preparatot ima{e vo bubrezite, slezenata i heparot.
Zaklu~oci: Sledej}i gi propi{anite kondicii za obele`uvawe na peptidot, dobivme radiofar-
macevtik koj gi zadovoluva kriteruimite za kontrola na kvalitet vo pogled na radiohemiskata ~istota i
biodistribucija. Na{ata sledna etapa e po{iroka klini~ka evaluacija na reprezentativna grupa od dobro
selektirani pacienti.
Macedonian pharmaceutical bulletin 53 (1,2) 104-105 (2007)
PP - 38
105
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Intrahospitalni infekcii i nivna kontrola 
spored studijata na Rozental
Aleksandra Dimitrovska
1
, Bojana Filipovska
1
, Katerina Bicevska-Spasovska
2
, Irina Lu~eska
2
,
1
Fila-Farm, 
2
Kardiohirurgija Filip Vtori
Voved: Specijalnata bolnica za Kardiohirurgija Filip Vtori od 11/2006 e del od multicentri~nata
studija Rozental za kontrola na intrahospitalnite infekcii (IHI). 
Cel: Prikaz na pre`ivuvawe, kontrola, analiza na ekstra tro{oci, ekstra denovi, ekstra mortal-
itet i nivna redukcija so pomo{ na Rozental studijata.
Materijal i metodi: Na sekoj hospitaliziran pacient na intenzivna nega se vodi evidencija za inci-
dencata na kateter infekcii, ventilator asocirani infekcii (VAP), urinarni infekcii, evidencija na
miokropri~initelite na infekciite, kako i higiena na race na personalot {to raboti na intenzivnata
nega, urednost na prevrskite na invazivnite linii (centralen venski kateter, arterijska linija, intraven-
ski kanili) toaletata na tubusite kaj intubiranite pacienti, kako i pravilno postavenite urinometri.
Podatocite se evidentiraat na specijalno oformeni obrasci. Analizata na podatocite se vr{i
vo Centralnoto sedi{te ne studijata.
Rezultati: Najvisoka incidenca se ventilator asociranite infekcii (VAP) so 57,1%, urinarnite
infekcii so 21,4% i krvnite infekcii so 21.4%. Od pri~initelite so 66,7% e zastapen Staphilococus aureus,
i 33,7% Escherihia coli. Vo tek na ovie 8 meseci vklu~enost vo studijata zabele`ana e redukcija na inciden-
cata na intrahospitalnite infekcii od 16% vo mesec Noemvri na 1% vo mesec Juni. Registrirano e
podobruvawe na odr`uvawe na higienata na racete na sredniot i visokiot medicinski personal (kako
najva`en vektor faktor vo intrahospitalnite infekcii). Invazivnite linii vo mesec Juni bea so 100%
ispravnost na prevskata. VAP se u{te perzistira so ista zastapenost {to e povrzano i so endogenite fak-
tori na samite operirani pacienti. Redukcija na mortalitetot kaj pacientite so VAP e zabele`ana za
5%, dodeka kaj pacientite so krvni infekcii e za 7%.
Zaklu~ok: Aktivnoto vklu~uvawe vo studijata pridonese za namaluvawe na incidencata na IHI,
racionalizacija vo koristeweto na antibiotskata terapija, namaluvawe na stapkata na mortalitet i
namaluvawe na brojot na bolni~ki denovi.
Macedonian pharmaceutical bulletin 53 (1,2) 106 (2007)
PP - 39
106
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Study of the Antibiotic Prescription Practice for Safety Purposes 
for Inpatients Hospitalized Due to Pneumonia
Getov I. N., Velikov M. R., Dimitrova M. J.
Faculty of Pharmacy, Medical University – Sofia, Bulgaria
Introduction
Patient safety is suddenly high on the public agenda. Healthcare is not as safe as it should be. Improving the
safety of patient is significant challenge for the national health systems, as it is for many health services around the
world. The safety of patients in hospital is a small part of a developing scenario in increased perception and reduced
acceptance of risk. Treatment in hospital is more complex than it used to be. More competition in medical care
between providers, hospitals, and third party payers, cost-containing and pressure on efficiency has resulted in reduced
staff, shorter hospital stays and more intensive treatment. Different health professionals are involved in patient med-
ication use through dispensing, prescribing and administering medicines. An open dialogue and communication
between health professionals is a positive means towards improving patient safety in medication use. This allows
both patient and health professionals to monitor the medical condition and to take appropriate actions, if patient safe-
ty problem occurs. Community-acquired pneumonia (CAP) is a common, potentially life-threatening disease that is
associated with high morbidity, mortality and use of healthcare resources. 
Aim of Work
The study was planned to clarify and evaluate: the frequency of antibiotics’ prescribing for inpatients, hos-
pitalized due to pneumonia, leading factors for prescriptions’ changes during treatment and medical doctors’ attitude
to patient safety problem.
Materials and Methods
We conducted a retrospective investigation of the medical records in a specialized clinic of pneumology and
phthisiology at the university hospital. The used methods were pseudo-randomization; experts’ analysis and phar-
macoepidemiologycal evaluation of the frequency and factors for changes in antibiotics’ prescriptions. We also used
standardized questionnaire to interviewing medical doctors in order to study barriers for appropriate antibiotic use
for CAP and assess the attitude to patient safety problem.
Results
Data analysis shows that for 35% of treated patients with pneumonia have been performed change in the
therapy. Most common change in the therapy is adding another antibiotic (67%) due to lack of therapeutic effect
(63%) or specifying the diagnosis (26%). 
Regarding patient safety the interviewed people declared problems about healthcare system financing, insti-
tutional limitations, diagnostics, lack of clear rules and standards. Regarding the timelines of antibiotic administra-
tion, barriers such as conflicting guidelines and organizational factors (delayed laboratory results, antibiotics not
directly available, lack of time, and restriction of taking decisions) were reported. The data is under processing and
statistical analysis will be performed.
Conclusion
The study shows that medical doctors do not realize the significance of patient safety problems and its influ-
ence on hospital level. We prove the importance of the patient safety incident reporting system on hospital level once
again. Reporting and collection of incident data is meaningful only if the data is analyzed and evaluated. The feed-
back could be given to all of the professionals and others who would like to learn more from the events’ analysis.
Efforts to improve the use of antibiotics for inpatients with CAP should consider the range of barriers that care
providers face in everyday practice.
Macedonian pharmaceutical bulletin 53 (1,2) 107 (2007)
PP - 40
107
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Bioequivalence studies and metabolite(s) measurement issues
S. Yanev
Dept. Drug Toxicology, Inst. Neurobiology, Bulgarian Academy of Sciences., Sofia, Bulgaria
When to consider plasma metabolite(s) measurements in bioequivalence (BE) studies?
1. The parent drug cannot be measured due to insufficient sensitivity of the analytical method.
2. The parent drug undergoes a rapid and complete conversion to metabolite.
3. The parent drug levels give unreliable or unacceptable bioavailability parameters.
4. The parent drug and metabolite are equipotent, with the measured metabolite levels being much higher 
than those for the parent drug.
5. The parent drug is inactive, and metabolite is responsible for the efficacy and/or toxicity 
of the drug product (pro-drug).
6. The pharmacokinetic profile of the parent drug is non-linear (dose dependency).
7. The drug has high level of “first pass” metabolism.
Can we conclude BE based on metabolite(s) kinetics?
The following cases will be discussed:
• In cases of drugs with linear pharmacokinetics and no first-pass effect.
• In case of drugs with first-pass effect.
• In case of high variability drugs with linear kinetics and first-pass metabolism.
The European regulation stated:
“If metabolites significantly contribute to the net activity of an active substance and the pharmacokinetics
is non-linear, it is necessary to measure both parent drug and active metabolite(s) plasma concentrations and evalu-
ate them separately.”
How correct is this statement in the view of the current knowledge will be discussed.
Macedonian pharmaceutical bulletin 53 (1,2) 108 (2007)
PP - 41
108
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Sensibility and resistance of isolates from hemoculture from new-born
with sepsis in Bitola in the period from 1999 to 2002 year
Blazevska I.
1
, Adamovska E.
2
, Djarlieva M.
3
, Trombeva D.
4
.
1
Warehouse for sanitary matherial, ARM-Skopje, RM  
2
Public health institute-Bitola, RM 
3
Department for neonatology Clinical hospital-Bitola, RM 
4
Department for control of medicaments, Clinical hospital- Bitola, RM
The aim of this work is to show sensibility and resistance of isolates from hemoculture from new-born with
sepsis in department of neonatology in Clinical hospital in community of Bitola.
Matherial and methods: an analysis of positive findings from hemoculture is done. The period from 1999 to
2002 years is included. A disk diffusion tehnique is used. The data are elaborated with standard statistical methods.
Results: From total 282 analysed hemocultures, 104 or 36,9% were positive. Staphylococcus koagulasa neg-
ative is the most frequent isolated (68%). Staphylococcus koagulasa negative shows high sensibility against cefa-
clor (87,3%) and lesser against macropen (4,2%), while the resistance is the most high against penicilin (71,8%) and
ampicilin (49,3%). Staphylococcus aureus shows high sensibility against klindamicin (87,5%) and high resistance
against penicilin (79,2%) and ampicilin (54,2%). Streptococcus faecalis shows high sensibility against eritromicin
and sulfonamides (100%), and resistance against penicilin, ampicilin, klindamicin and cefalosporin. Klebsiella species
shows sensibility against cefaclor, azitromicin, amikacin, sulfonamides and nalidin acid (100%), and rezistance
against amoksiklav. Serratia odorifera is sensible against pancef, amikacin, negram and glaufos (100%), and resistent
against cefaclor and cefalexin. Staphylococcus epidermidis is sensitive against amoksiklav, klindamicin and ery-
thromicin (100%), and resistent against penicilin and ampicilin. Pseudomonas aeruginosa shows high sensibility
against inipenem, norfloksacin and orfloxacin (100%), while the resistance is the most high against cefotaxin, cef-
tazidem, amoksiklav and amikacin.
Conclusion: The sorts of Staphylococcus koagulasa negative and Staphylococcus aureus were the most high
sensitive against cefahlor, klindamicin and sulfonamides. The sorts of Staphylococcus epidermidis were the most
high sensitive against eritromicin, amoksiklav and klindamicin. The sorts of Pseudomonas aeruginosa were with
high sensibility against inipenem, norfloksacin and orfloxacin. The sorts of Staphylococcus koagulasa negative,
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus faecalis are the most high resistent against peni-
cilin and ampicilin, while Pseudomonas aeruginosa is the most resistent against amikacin, cefotaksin, ceftazidem
and amoksiklav.
Macedonian pharmaceutical bulletin 53 (1,2) 109-110 (2007)
PP - 4
109
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Osetlivost i rezistencija na izolati od hemokultura na sepsa kaj
novoroden~iwa vo Bitola za period od 1999 do 2002 godina
Bla`evska I.
1
, Adamovska E.
2
, Xarlieva M.
3
, Trombeva D.
4
1
Sklad za sanitetski materijal, ARM-Skopje  
2
Zavod za zdravstvena za{tita-Bitola
3
Oddel za neonatologija, Klini~ka bolnica-Bitola 
4
Oddel za kontrola na lekovi, Klini~ka bolnica Bitola
Cel na trudot e da se prika`e osetlivosta i rezistencijata na izolatite od hemokultura na sepsa
vo neonatolo{koto oddelenie pri Klini~ka bolnica-Bitola.
Materijal i metodi: napravena e analiza na pozitivnite naodi od hemokultura na sepsa na novoro-
den~iwa za period od ~etiri godini (1999/2002 godina). Upotrebena e disk difuziona tehnika. Podatocite
se obraboteni so standardni statisti~ki metodi.
Rezultati: Od vkupno 282 hemokulturi na sepsa, 104 ili 36,9% bea pozitivni. Naj~esto izolirana
e Staphylococcus koagulaza negativen (68%). Koagulaza negativniot stafilokok poka`uva najgolema senz-
itivnost sprema cefaclor (87,3%) a najmala sprema macropen (4,2%) dodeka rezistentnosta e najgolema spre-
ma penicilinot (71,8%) i ampicilinot (49,3%). Staphylococcus aureus poka`uva najgolema senzitivnost
sprema klindamicin (87,5%) i najgolema rezistennost sprema penicilinot (79,2%) i ampicilinot (54,2%).
Streptococcus faecalis poka`uva senzitivnost sprema eritromicinot i sulfonamidite (100%), a rezistenci-
ja sprema penicilinot, ampicilinot, klindamicinot i cefalosporinite. Klebsiella species e senzitivna
sprema cefaclor, azitromicin, amikacin, sulfonamidi i nalidinska kiselina (100%), a e rezistentna na amoksiklav.
Serratia odorifera e senzitivna na pancef, amikacin, negram i glaufos (100%), a e rezistentna na cefaclor i cefalex-
in. Staphylococcus epidermidis e senzitiven sprema amoksiklav, klindamicin i erythromicin (100%), a e rezisten-
ten sprema penicilin i ampicilin. Pseudomonas aeruginosa e najpove}e senzitivna na inipenem, norfloksacin i orfloxacin
(100%), dodeka poka`uva pogolema rezistencija sprema cefotaxin, ceftazidem, amoksiklav i amikacin.
Zaklu~ok: Soevite na Staphylococcus koagulaza negativen i na Staphylococcus aureus bea najmnogu
osetlivi na cefahlor, klindamicin i Sulfonamidi. Soevite na Staphylococcus epidermidis bea najpove}e
osetlivi na eritromicin, amoksiklav i klindamicin. Soevite na Pseudomonas aeruginosa bea osetlivi na
inipenem, norfloksacin i orfloxacin. Soevite na Staphylococcus koagulaza negativen, Staphylococcus aureus, Staphy-
lococcus epidermidis, Streptococcus faecalis se najpove}e rezistentni na penicilin i ampicilin, dodeka Pseudo-
monas aeruginosa e najpove}e rezistentna na amikacin, cefotaksin, ceftazidem i amoksiklav.
Macedonian pharmaceutical bulletin 53 (1,2) 109-110 (2007)
PP - 42
110
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Pharmacokinetic parameters of lidocaine in patients 
with hepatic cirrhosis
Marija Petronijevic
1
, Branislava Miljkovic
1
, Katarina Vucicevic
1
, Milena Pokrajac
1
, 
Jasna Bjelanovic
2
, Ivan Palibrk
3
1
Department of Pharmacokinetics, Faculty of Pharmacy, University of Belgrade, Serbia
2
Institute of Clinical Chemistry, Clinical Centre of Serbia, Belgrade, Serbia
3
Institute of Anesthesiology and Reanimation, Clinical Centre of Serbia, Belgrade, Serbia
Objective: 
Lidocaine is a local anesthetic agent with antiarrhythmic properties. It has a narrow therapeutic index and
toxic effects are generally dose or concentration related. As it undergoes almost exclusively hepatic metabolism,
liver dysfunction may significantly alter the pharmacokinetics of lidocaine. The aim of this study was to estimate
the pharmacokinetic parameters of lidocaine in patients with hepatic cirrhosis.
Methods: 
Eight patients with hepatic cirrhosis were included in the study. This group consisted of 5 males and 3 females,
at age from 19 to 73, and with body weight in range from 65 to 93kg. Two of them were receiving therapy due to
cardiovascular comorbidity, and detailed inspection of applied therapeutic agents ensured absence of pharmacoki-
netic interactions. The patients were given bolus intravenous injection of lidocaine (1mg/kg) in order to make eval-
uation of their liver function. For pharmacokinetic calculations three concentrations were obtained per patient. Plasma
samples were collected 15, 30, and 90 minutes after administration of lidocaine’s injection. Measurement of con-
centrations was conducted by Fluorescence Polarization Immunoassay, Abbott Diagnostics. Pharmacokinetic analy-
sis was performed by noncompartment approach using WinNonLin 4.1. Software, Pharsight Corporation, which cal-
culated the following pharmacokinetic parameters: constant of elimination rate (
λz), half-time of elimination (t
1/2
),
clearance (Cl), volume of distribution (Vd), dose normalized partial area under the curve (AUC
90min
/D), dose nor-
malized infinitive area under the curve (AUC~/D), mean residence time (MRT). 
Results:
Estimated average values of pharmacokinetic parameters in the examined group of patients with hepatic cir-
rhosis were: 
λz=0.5902±0.2207h-
1
; t
1/2
=1.3840±0.7037h; Cl=0.5309±0.203L/h/kg; Vd= 1.0531±0.6293L/kg;
AUC
90min
/ D=0.0162±0.0070mg*h/L/mg; AUC
∝/D=0.0279±0.0089mg*h/L/mg; MRT=1.9529±1.0293h. Significant
variability in parameters' values was found within the group examined. The estimated values of coefficient of vari-
ation (CV) were: CV
AUC~/D
=31.9%, CV
λz
=37.39%, CV
Cl
=38.25%, CV
AUC90min
/D=43.47%, CVt
1/2
=51.3%,
CV
MRT
=52.69%, CV
Vd
=59.77%.
Conclusion:
Comparing obtained results with literature values of lidocaine's pharmacokinetic parameters in healthy sub-
jects, indicates decrease of lidocaine's Cl. This was expected, since diminishing effect of hepatic cirrhosis on lido-
caine's Cl had been reported in literature. Large variability in parameters' values is likely to be result of differences
in patients' age and cardiovascular function.
Macedonian pharmaceutical bulletin 53 (1,2) 111 (2007)
PP - 43
111
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FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION

Determination of haptoglobin at Wagner classification of diabetic’s
ulcerations on the foot (DUF)
Efremova S., Kostov I., Kostova N., Efremova D.
Special City Surgery Clinic “St. Naum Ohridski” – Skopje, Macedonia
Goal: To estimate the effect when we use the Wagner classification (W-C) in the treatment of diabetic’s ulcer-
ations in the foot, with following the haptoglobin values. Haptoglobin is a serum protein that functions as an antiox-
idant by virtue of its ability to bind to hemoglobin and thereby to prevent the oxidative tissue damage that may be
mediated by free hemoglobin. It has been recently found that haptoglobin phenotype is a predictor of the risk of
micro vascular and macro vascular complications in diabetes.
62 patients (58±3.1), 30 male and 32 female with diabetes mellitus (NIDDM treated with insulin) and dia-
betic foot disease were classified under the 5-stage of Wagner classification, which is based on lesions deepness,
gradient of infection and gangrene extension. 0-stage: Without open lesion-10 patients (18.5 %); 1-stage: Superficial
ulcers-18 patients (33.3 %); 2- stage: Deep ulcerations-12 patients (22.2 %); 3-stage: Deep ulceration with abscess
and osteomyelitis-10 patients (18.5 %); 4-stage: Limited gangrene-9 patients (16.6 %); 5-stage: Expanded gangrene-
3 patients (5.5 %). All of them were examined with routine laboratory analyses, Doppler sonografy, and Colour
duplex scanning and haptoglobin values measured by Automatic analyser Mira-Cobas ROCHE diagnostic. We found
that the level of haptoglobin is elevated in all cases, significantly associated with progression of diabetic foot dis-
ease. The obtained haptoglobulin values suggest that an increased oxidative stress in diabetic patients with macto
vascular complications exists and helps in determination of the treatment protocol. 
Macedonian pharmaceutical bulletin 53 (1,2) 112 (2007)
PP - 44
112
^ETVRTI KONGRES NA FARMACIJATA NA MAKEDONIJA SO ME\UNARODNO U^ESTVO
FOURTH CONGRESS OF PHARMACY OF MACEDONIA WITH INTERNATIONAL PARTICIPATION