Macedonian pharmaceutical bulletin, 65 (2) 11 – 21 (2019)

ISSN:

UDC: 615.33.03(497.733)”2016/2018”

DOI: 10.33320/maced.pharm.bull.2019.65.02.002

Original scientific paper

Antibiotic consumption and management at

Kocani General Hospital – Annual report

Nada Ilieva, Milena Nikolova, Donka Pankov, Maja Simonoska Crcarevska,

Kristina Mladenovska, Dushko Shalabalija, Ljubica Mihailova, Olga Gigopulu,

Marija Glavas Dodov*

Faculty of pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, 1000 Skopje,

R. North Macedonia

Received: April 2019; Accepted: June 2019

Abstract

The aim of the study was to get detailed insight into the antibiotic consumption trends in the three year period (2016-2018) in

Kocani Hospital, to identify the most often prescribed antibiotics and to determine whether the treatment of given diagnosis was in

accordance with the official guidelines. The survey covered all pediatric and infant patients admitted to the pediatric ward. Patients’ data

included gender, age, diagnosis, antibiotic used and doses. The majority of admitted patients were in the age group of 0-1 (27.48%,

25.94% and 30.77% for 2016, 2017 and 2018, accordingly) followed by age group of 1-2 years (20.86%, 22,0% and 23.83% for 2016,

2017 and 2018, consequently) and 2-3 years (16.06%, 16.1% and 14.63% for 2016, 2017 and 2018, consequently) .The most frequent

diagnosis was acute tonsillitis which was determined in ~21% of patients, pneumonia without complications in ~18% and acute

bronchitis in ~16% of patients in the period 2016-2018. Results from conducted survey identified high prescription rate and use of

antibiotics predominantly ceftriaxone (82.58%, 81.05% and 50.85% in 2016, 2017 and 2018, respectively) contrary to official

recommendations and evidences based on clinical data for treatment of the diagnoses in question. So, it is foreseeable to conclude that

there is urgent need for restrictive and educational measures i.e. to strength the surveillance and monitoring of antibiotic prescription and

usage and hence to promote awareness for rational use of antibiotics on all health-care levels.

Keywords: antibiotic prescription, antibiotic consumption, pediatric wards, annual report

Introduction

Antibiotics also known as antimicrobial drugs are

commonly used for treatment of bacterial infections.

Antibiotics are one of the most powerful medicines that

have saved great number of people’s life, despite the fact

that in Greek, the translation of their name means anti

bios (anti life). They inhibit or prevent the growth of

bacteria, fungi and some parasites, but they cannot kill

viruses. People misused antibiotics during the 20 th

century

and this irrational consumption of antibiotics has resulted

with occurrence of so called “resistant bacteria”.

Antimicrobial resistance occurs when bacteria and other

microbes adapt and become less responsive to treatment.

The rapid rise and replication of antimicrobial resistant

organisms worldwide is a problem of huge dimensions.

The antimicrobial resistance causes about 700,000 deaths

annually around the world, and each country is potentially

affected. The figure can rise to 10 million till 2051. The

root causes of this problem are multifactorial. The

emergence of antibiotic resistance is highly related to

their inadequate use (Arnold et al., 2011; Laxminarayan

et al., 2013; Leuthaner et al., 2013). Studies showed that

__________________

* [email protected]

N. Ilieva, M. Nikolova, D. Pankov, M. Simonoska Crcarevska, K. Mladenovska, D. Shalabalija, Lj. Mihailova,

O. Gigopulu, M. Glavas Dodov 12

Maced. pharm. bull., 65 (2) 11 – 21 (2019)

30-60% of the prescribed antibiotics in the hospital sector

are unnecessary, inadequate, or suboptimal (Bergmans et

al., 1997; Kollef, 2001; Kollef and Fraser, 2001; Roberts

et al., 2011).

Prescribing antibiotics and antibiotics misuse,

undoubtedly contribute to the growth of antibiotic

resistant bacteria. Epidemiological studies demonstrate

direct dependence between antibiotics consumption and

the emergence and replication of the resistant hospital

bacteria. The optimal use of antibiotics is crucial in the

healthcare setting, especially in the era when antibiotic

resistance increases and there is a lack of new

antimicrobial development (Arnold et al., 2011;

Laxminarayan et al., 2013; Leuthaner et al., 2013).

Providing reliable and comparable national data about the

consumption of antibiotics is a prerequisite for

understanding of the epidemiology of antibiotic resistance

in Europe since their inadequate use is one of the main

factors responsible for resistance to antibiotics (Arnold-

Lefevre et al., 2013; Goldman et al., 1996; Kollef and

Fraser, 2001; Landman et al., 2002; Lipsitch et al., 2000;

MacDougall and Polk, 2006; Malhota-Kumar et al., 2007;

McGowan, 1983; Paterson, 2006; Ricel, 2008; Shalaes et

al., 1997; Sieve et al., 2013; Thomas et al., 1998; Zillich et

al., 2006).

Having in mind previous, the aim of the study was to

analyze the antibiotic consumption trends in the three year

period (2016-2018) in Kocani Hospital, to identify the

most often prescribed antibiotics and to determine

whether the treatment of given diagnosis was in

accordance with the official guidelines.

Materials and methods

The retrospective survey for prescribing and

consuming antibiotics for the period 2016-2018 (January-

December) was conducted in May, 2019. The survey

covered all pediatric and infant patients admitted to the

pediatric ward. Patients’ data included gender, age,

diagnosis, antibiotic used and doses. The quantity of given

antibiotic as treatment and prophylaxis was coded as a

daily dose – DDD for 1 or more days of prophylactic

treatment. Data were collected from software program

“Moj termin” (My term) and official medical records from

the Kocani Hospital database. The data covered all

hospitalized pediatric patients in the above mentioned

period. However, it has to be emphasized that all data

were available as group data, and were not collected per

patient admitted in pediatric ward of Kocani Hospital.

Obtained data were tabulated in Microsoft Excel®

(Microsoft Corp. Redmond, WA, USA) and were

computed and consequently evaluated using statistical

software STATGRAPHICS Centurion XVI evaluation

(StatPoint technologies Inc., USA).

Table 1. Detailed data related to gender and age of patients admitted in Kocani Hospital pediatric ward for period 2016-

2018 year

2016 2017 2018

age male female male female male female

0-1 78 88 75 70 73 91

1-2 67 59 64 59 58 69

2-3 57 40 48 42 28 50

3-4 25 22 23 27 20 24

4-5 17 12 14 13 8 14

5-6 14 16 12 8 10 12

6-7 7 10 6 9 4 9

7-8 15 9 13 8 11 10

8-9 8 4 9 6 2 2

9-10 7 8 6 7 5 6

10-11 3 4 8 3 5 2

11-12 8 3 5 2 6 3

12-13 2 5 2 4 1 4

13-14 4 2 3 3 2 1

14-15 3 0 3 1 1 0

15-16 4 0 2 1 2 0

16-17 2 1 3 0 0 0

Subtotal 321 283 296 263 236 297

Total 604 559 533

Antibiotic consumption and management at Kocani General Hospital – Annual report 13

Макед. фарм. билт., 65 (2) 11 – 21 (2019)

Table 2. Number of patients by diagnosis admitted in pediatric ward in Kocani Hospital in the period 2016-2018 year

2016 2017 2018

ICD-10-CM code female male total female male total female male total

1 J 00 Acute nasopharyngitis [common cold] 9 8 17 7 4 11 3 10 13

2 J 02 Acute pharyngitis 31 17 48 21 24 45 9 30 39

3 J 03.9 Acute tonsillitis, unspecified 54 73 127 60 57 117 49 58 107

4 J 04.0 Acute laryngitis 7 6 13 5 1 6 1 4 5

5 J 18.0 Bronchopneumonia, unspecified organism 59 52 111 53 47 100 56 42 98

6 J 18.9 Pneumonia, unspecified organism 18 9 27 9 11 20 10 12 22

7 J 20.9 Acute bronchitis, unspecified 47 49 96 49 44 93 32 56 88

8 J 21.8 Acute bronchiolitis due to other specified organisms

4 4

1 1

1 1

9 J 21.9 Acute bronchiolitis, unspecified 28 25 53 28 16 44 19 28 47

10 J 40 Bronchitis, not specified as acute or chronic

(asthma)

2 2

3 3

1 1

11 J 44.1 Chronic obstructive pulmonary disease with (acute) exacerbation

1 4 5

2 2

1 1

12 N 39.0 Acute cystitis 4 2 6 9 1 10 7 1 8

13 N 39.9 Disorder of urinary system, unspecified 2

2 2

2 1

1

14 A 08.0 Rotaviral enteritis 3 1 4 7 2 9 3 3 6

15 A 09 Infectious gastroenteritis and colitis, unspecified 4 2 6 2 3 5 4 3 7

16 D 69.0 Allergic purpura 1 1 2 1

1 1 1 2

17 B 34.9 Viral infection, unspecified

2 2

1 1

1 1

18 F 31.7 Bipolar disorder, currently in remission 1

1 2

2 1

1

19 G 40.90 Epilepsy, unspecified, not intractable 2 1 3 1

1 1

1

20 G 80.03 Athetoid cerebral paralysis 1

1

0 1

1

21 H 65.9 Unspecified nonsuppurative otitis media 1 1 2 2 3 5 1 2 3

22 I 47.9 Paroxysmal tachycardia, unspecified 2

2

0 1

1

23 K 12.1 Other forms of stomatitis

1 1

1 1

1 1

24 K 29.9 Gastroduodenitis, unspecified 1

1 2

2 1

1

25 K 52.9 No infective gastroenteritis and colitis,

unspecified 10 8 18 6 12 18 10 11 21

26 K 56.0 Paralytic ileus

1 1

1 1

1 1

27 L 04.0 Acute lymphadenitis of face, head and neck

3 3

1 1

2 2

28 L 20.9 Atopic dermatitis, unspecified

2 2 3

3

1 1

29 L 23.9 Allergic contact dermatitis, unspecified cause

3 3 3

3

4 4

30 L 27.9 Dermatitis due to unspecified substance taken

internally

1 1

2 2

1 1

N. Ilieva, M. Nikolova, D. Pankov, M. Simonoska Crcarevska, K. Mladenovska, D. Shalabalija, Lj. Mihailova,

O. Gigopulu, M. Glavas Dodov 14

Maced. pharm. bull., 65 (2) 11 – 21 (2019)

31 L 50.0 Allergic urticaria

2 2

1 1

1 1

32 L 50.9 Urticaria, unspecified 5

5 4 4 8

7 7

33 M 60.9 Myositis, unspecified

1 1

1 1

1 1

34 P 39 Other infections specific to the perinatal period 3

3

2 2 4

4

35 R 10.0 Acute abdomen 1

1

3 3

1 1

36 R 10.9 Unspecified abdominal pain 1

1

1 1

2 2

37 R 11 Nausea and vomiting 21 2 23 20 10 30 20 8 28

38 R 55 Syncope and collapse 1

1

2 2

1 1

39 R 56.9 Unspecified convulsions 2

2

1 1 1

1

40

T 39.9 Poisoning by, adverse effect of and under

dosing of unspecified no opioid analgesic, antipyretic and antirheumatic

1

1

1 1

1 1

Total 321 283 604 296 263 559 236 297 533

Results and discussion

The overall number of patients admitted at the

pediatric ward of Kocani Hospital in the study period

2016-2018 was 1696. Detailed data related to gender and

age are given in Table 1.

One-way ANOVA (p<0.05) indicated that there was

no statistical significant difference between total number

of patients, as well as male and female patients in each

year of studied period. However, it pointed that there is

statistical difference between age groups. From results

presented in Table 1, it can be clearly seen that the

majority of admitted patients were in the age group of 0-1

(27.48%, 25.94% and 30.77% for 2016, 2017 and 2018,

accordingly) followed by age group of 1-2 years (20.86%,

22.0% and 23.83% for 2016, 2017 and 2018,

consequently) and 2-3 years (16.06%, 16.1% and 14.63%

for 2016, 2017 and 2018, consequently). Overall results

indicated that the number of patients decreased with age.

From detailed results presented in Table 2, it can be

seen that the most frequent diagnosis was acute tonsillitis

(code J03.9 according to ICD-10-CM (International

Classification of Diseases, Tenth Revision, Clinical

Modification)) which was determined in 21.03%, 20.93%

and 20.08% of patients in 2016, 2017 and 2018,

accordingly, followed by pneumonia without

complications (ICD-10-CM code J18.0) in 18.38%,

17.89% and 18.39% and acute bronchitis (ICD-10-CM

code J20.9) in 15.89%, 16.64% and 16.51% of patients in

2016, 2017 and 2018, consequently.

Total quantity of antibiotics ordered from hospital

pharmacy and used (2016-2018) in pediatric ward of

Kocani Hospital is given in Table 3. Results pointed that

97% of ordered antibiotics were used. The most common

used antibiotic was ceftriaxone with a share of 82.58%,

81.05% and 50.85% in 2016, 2017 and 2018 year,

accordingly. The lower share of ceftriaxone in 2018 is

related to the significant increase of ampicillin usage

compared to previous years (32.58% in 2018 vs 1.04% in

2017 and 0% in 2016 year). In accordance were the

findings of Quaak et al. (2018) for the antibiotic use in

secondary care urban teaching hospital in Rotterdam, the

Netherlands. Namely, in the surveyed period 2010-2015

most commonly used antibiotics were cefotaxime and

ceftriaxone, and hence their use showed a significant

decrease during years due to the increase of amoxicillin

and amoxicillin/clavulanic acid usage. The situation was

similar in pediatric wards in hospitals in Latvia where a

one-day cross-sectional point prevalence survey

conducted in November, 2012 indicated that the third-

generation cephalosporins were among the mostly used

antibiotic groups for pediatric patients with share of

cefazolin and ceftriaxone of 24.2% and 21%, respectively

(Sviestina and Mozgis, 2014). In the study of Porta et al.

(2012), conducted in 2009 in UK, Italy and Greece, 37%

of all antibiotics were penicillin b-lactam antibacterials

with type of b-lactam varied between hospitals. In UK

hospitals use of co-amoxiclav prevailed, while in Italy and

Greece hospitals ceftriaxone/cefotaxime and

cefuroxime/ceftriaxone, respectively were dominantly

used. Such high share of ceftriaxone use might be

explained with social acceptance of the common believe

that intravenous antibiotics are “stronger” than oral ones

(Sviestina and Mozgis, 2014).

Usage of antibiotics per given diagnosis is presented

in Tables 4, 5 and 6 for 2016, 2017 and 2018, accordingly.

Antibiotic consumption and management at Kocani General Hospital – Annual report 15

Макед. фарм. билт., 65 (2) 11 – 21 (2019)

Table 3. Quantity of ordered and used antibiotics in pediatric ward of Kocani Hospital 2016-2018 year

2016 2017 2018

ordered used ordered used ordered used

Amp. Ampicillin á 1.0 g 0 0 60 27 1650 1644

Amp. Ceftriaxone á 1.0 g 2080 2029 2129 2113 2640 2566

Sir. Cephalexin á 250 mg/5 ml 6 5 1 1 2 0

Caps. Cephalexin á 500 mg 48 48 70 60 192 192

Sir. Amoxicillin + clavulanic acid á

4oo mg/ 57 mg/5 ml 37 35 65 59 55 53

Sir. Cefaclor á 25o mg/5 ml 19 15 30 30 27 25

Amp. Cefotaxime á 5oo mg 270 270 220 210 325 306

Amp. Amikacin á 5oo mg 30 30 73 64 130 130

Amp. Gentamicin á 40 mg/2 ml 10 0 50 43 80 80

Amp. Gentamicin á 20 mg/2 ml 30 25 5 0 50 50

Having in mind that most commonly in the period

2016-2018 patients admitted in pediatric ward of Kocani

Hospital were diagnosed with acute tonsillitis, pneumonia

without a complications and acute bronchitis it is

normally to expect that most of the prescribed DDD of

antibiotics were related to these conditions. 36.55%,

39.56% and 23.6% of all DDD of prescribed antibiotics in

2016, 2017 and 2018 were related to pneumonia without

complications and in case of acute tonsillitis 18.19%,

19.33% and 23.58% and acute bronchitis 15.06%, 11.2%

and 14.36% of all DDD of antibiotics were prescribed in

2016, 2017 and 2018, accordingly. Respiratory infections

were also most common diagnosis in pediatric wards in

hospitals in Latvia, where 34.7% and 13.9% of pediatric

patients were diagnosed with lower and upper respiratory

tract infections (Sviestina and Mozgis, 2014). However,

in the study of Patel et al. (2012) in UK, Italy and Greece

hospitals, antibiotics were most commonly used for

surgical prophylaxis (21%) with differences between

surveyed hospitals (2% and 31% in two UK hospitals

(Center 1 and 2), and 18% in Italy and 31% in Greece

surveyed hospital. In UK Center 1 and Italy hospital the

main indication for antibiotic treatment was lower

respiratory tract infection in 17% and 37% of children,

respectively.

It can be seen that patients diagnosed with Acute

tonsillitis (ICD-10-CM code J03.9) in 2016 and 2017

were most frequently treated with Amp. Ceftriaxone á 1.0

g (93.06% in 2016 and 90.87% in 2017 of DDD of

prescribed antibiotics for the J03.9). However, in 2018

only 37.14% of patients were treated with this antibiotic

vs 58.54% which were treated with Amp. Ampicillin á 1.0

g. The treatment was prescribed empirically in all cases

(no microbiology analysis were required and conducted).

According to guidelines for medical care of tonsillitis and

pharyngitis in pediatric population issued by Ministry of

healthcare of Republic of North Macedonia

(http://zdravstvo.gov.mk/wp-content/uploads/2015/08/

Tonzilitis-i-faringitis-kaj-deca1.pdf) if infection is caused

by group A streptococci it should be treated with

penicillin 70 mg/kg daily (100,000 d/kg/24h), or in

patients allergic to penicillin with cephalexin 50

mg/kg/24h, in two doses for 10 days. Short-term

cephalosporin therapy (2 to 6 days) may be effective but

is associated with more side effects. Shorter therapy may

be used if there is difficulty in prolonging a child's

antibiotic treatment. Macrolides are used to treat

tonsillitis only in patients with penicillin or cephalosporin

allergy.

Patients diagnosed with pneumonia without

complications (ICD-10-CM code J18.0) were treated with

Amp. Ceftriaxone á 1.0 g in 79.37%, 81.88% and

74.76% of DDD of prescribed antibiotics in 2016, 2017

and 2018 year, accordingly. Similar was the situation for

treatment of bronchopneumonia in Pediatric Clinic in

Sarajevo where first (cefazolin in 40.4% of patients) and

third generation of cephalosporins (31.7% of patients with

most often used ceftazidime followed by ceftriaxone and

cefixime) and penicillin antibiotics (25% of patients)

were commonly used (Zec et al., 2016). According to the

guidelines for medical care of pneumonia in childhood

issued by the Ministry of healthcare of Republic of North

Macedonia (http://zdravstvo.gov.mk/wp-content/uploads/

2015/08/Pnevmonii-vo-detstvoto.pdf) medicine of choice

in preschool children as first-line therapy is amoxicillin

40-50mg/kg/day in 3 doses for 7 days. The same

recommendations are for treatment of pneumonia in

school children, but having in mind that Mycoplasma and

Chlamydia infections are very often in this group it might

be considered that the treatment may be based on

1 6

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Table 4. Usage of antibiotic per given diagnosis in pediatric ward of Kocani Hospital in 2016 year

ICD-10-CM code

Amp.

Ampicillin á 1.0 g

Amp.

Ceftriaxone á 1.0 g

Sir.

Cefalexine á 250 mg/5 ml

Caps.

Cefalexine á 500 mg

Sir.

Amoksicilline

+ clavulonic acid á

400 mg / 57 mg/5 ml

Sir.

Cefaclor á 250 mg/5 ml

Amp.

Cefotaxim á 500 mg

Amp.

Amikacin á 500 mg

Amp. Gentamicin

á

20 mg/2 ml

Amp. Gentamicin

á

40 mg/2 ml

1 J 00 Acute nasopharyngitis [common cold]

37

2 J 02 Acute pharyngitis

223 5 16

3 J 03.9 Acute tonsillitis, unspecified

416

16 7 8

4 J 04.0 Acute laryngitis

40

3

5 J 18.0 Bronchopneumonia,

unspecified organism 746

16

136

6 J 18.9 Pneumonia, unspecified organism

227

1 28 30

7 J 20.9 Acute bronchitis, unspecified

214

25

106

25

8 J 21.8 Acute bronchiolitis due to

other specified organisms 8

2

9 J 21.9 Acute bronchiolitis,

unspecified 74

10 J 40 Bronchitis, not specified as acute or chronic (asthma)

4

11 N 39.0 Acute cystitis

16

12 N 39.9 Disorder of urinary system,

unspecified 4

13 H 65.9 Unspecified

nonsuppurative otitis media 20

1 3

Total 0 2029 5 48 35 15 270 30 25 0

1 7

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Table 5. Usage of antibiotic per given diagnosis in pediatric ward of Kocani Hospital in 2017 year

ICD-10-CM code

Amp.

Ampicillin á 1.0 g

Amp.

Ceftriaxone á 1.0 g

Sir.

Cefalexine á 250 mg/5 ml

Caps.

Cefalexine á 500 mg

Sir.

Amoksicilline

+

clavulonic acid á

400 mg / 57 mg/5 ml

Sir.

Cefaclor á 250 mg/5 ml

Amp.

Cefotaxim á 500 mg

Amp.

Amikacin á 500 mg

Amp.

Gentamicin

á 20 mg/2 ml

Amp.

Gentamicin

á 40 mg/2 ml

1 J 00 Acute nasopharyngitis [common cold]

40

16

2 J 02 Acute pharyngitis 10 236

16

3 J 03.9 Acute tonsillitis, unspecified

17 45

10 10 9

4 J 04.0 Acute laryngitis

40

1

5 J 18.0 Bronchopneumonia,

unspecified organism 845

18

119 50

6 J 18.9 Pneumonia, unspecified

organism 148

9 36 14

7 J 20.9 Acute bronchitis,

unspecified 196

41

55

8 J 21.8 Acute bronchiolitis due to other specified organisms

5

4

9 J 21.9 Acute bronchiolitis,

unspecified 65

43

10 J 40 Bronchitis, not specified as

acute or chronic (asthma) 12 1

11 N 39.0 Acute cystitis

38

12

N 39.9 Disorder of urinary

system, unspecified 6

13 H 65.9 Unspecified nonsuppurative otitis media

24

4 11

Total 27 2113 1 60 59 30 210 64 0 43

1 8

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Table 6. Usage of antibiotic per given diagnosis in pediatric ward of Kocani Hospital in 2018 year

ICD-10-CM code

Amp.

Ampicillin

á 1.0 g

Amp.

Ceftriaxone

á 1.0 g

Sir.

Cefalexine

á 250 mg/5

ml

Caps.

Cefalexine

á 500 mg

Sir.

Amoksicilline

+

clavulonic acid á

400 mg / 57 mg/5 ml

Sir.

Cefaclor

á 250 mg/5 ml

Amp.

Cefotaxim

á 500 mg

Amp.

Amikacin

á 500 mg

Amp.

Gentamicin

á 20 mg/2 ml

Amp.

Gentamicin

á 40 mg/2 ml

1 J 00 Acute nasopharyngitis [common cold]

304 50 32

50

2 J 02 Acute pharyngitis 428 260 32

260

3 J 03.9 Acute tonsillitis, unspecified 692 439 32 10 9

439

4 J 04.0 Acute laryngitis 220 40

2

40

5 J 18.0 Bronchopneumonia,

unspecified organism 883 96

124 80

883

6 J 18.9 Pneumonia, unspecified

organism 220

10 64 50

220

7 J 20.9 Acute bronchitis, unspecified

368

40

118

50

368

8 J 21.8 Acute bronchiolitis due to

other specified organisms 10

2

10

9 J 21.9 Acute bronchiolitis,

unspecified 178

80 178

10 J 40 Bronchitis, not specified as acute or chronic (asthma)

10

10

11 N 39.0 Acute cystitis

68

68

12 N 39.9 Disorder of urinary system, unspecified

12

12

13 H 65.9 Unspecified

nonsuppurative otitis media 28

1 4

28

Total 1644 2566 192 53 25 306 130 50 80 2566

Antibiotic consumption and management at Kocani General Hospital – Annual report

19

Макед. фарм. билт., 65 (2) 11 – 21 (2019)

doxycycline (children older than 8 years, 200 mg as single

dose in the first day, followed by 100 mg once a day

during the next days). These guidelines are in accordance

with recommendations published in Cochrane Database

Systematic Reviews by Lodha et al. (2013) where

amoxicillin as first-line therapy should be used, but with

additional possibility to use cefpodoximе and cefuroxime