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OJHAS Vol. 8, Issue 4: (2009
Oct-Dec) |
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| Pattern
of antimicrobial agents use in hospital deliveries: A
prospective comparative study |
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Sachidananda Adiga MN,
Associate
Professor, Dept of Pharmacology, Kasturba Medical College, Manipal, India,
Alwar MC,
Additional Professor, Dept of Pharmacology, Kasturba Medical College, Mangalore, India,
Mirabel Pai RSM,
Professor & Head, Dept of Pharmacology, Kasturba Medical College, Mangalore, India,
Usha S Adiga,
Assistant
Professor, Dept of Biochemistry, Kasturba Medical College, Manipal, India |
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Address For Correspondence |
Department of Biochemistry,
Kasturba Medical College,
Manipal - 576104, India.
E-mail:
ushachidu@yahoo.com |
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Adiga MNS, Alwar MC, Pai MRSM, Adiga US. Pattern
of antimicrobial agents use in hospital deliveries: A
prospective comparative study. Online J Health Allied Scs.
2009;8(4):10 |
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Submitted: Nov 12, 2009;
Suggested revision: Nov 19, 2009; Resubmitted: Nov 20, 2009;
Suggested revision: Apr 5, 2010; Resubmitted: Apr 6, 2010; Accepted:
Apr 15, 2010; Published: Apr 30, 2010 |
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| Abstract: |
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Objective:
Drug utilization pattern identifies the problems that arise from the
drug usage in health
care delivery system and highlights the current approaches to the
rational
use of drugs. The
present study evaluates the utilization pattern of antimicrobial agents
in hospital
deliveries
of different setups. Methodology:
Two hundred hospital deliveries from a government hospital GroupI (G-I)
and 100 cases each from two private hospitals Group II & Group III
(G II & G III) were studied. Groups, drugs, numbers of antimicrobials used,
duration with indication
for their use were the criteria taken into consideration for comparison.
Results: Beta-lactams, nitroimidazoles and fluoroquinolones
were commonly prescribed
groups of antimicrobials. The duration of prophylaxis was 6.73±1.79, 5.77±1.10
&5.14±1.53
days in three groups respectively which was significantly different (p<0.01).
Caesarian section, episiotomy were the commonest prophylactic
indications. Conclusion: The present study calls for an urgent review on rational use of antimicrobial
for prophylaxis.
Key Words:
Antimicrobial
agents, Infection, Prophylaxis, Hospital deliveries |
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Prescription order is an important transaction between
the clinician and patient.(1) It is an order for scientific medication for a person at a particular
time .Now a days the prescribing pattern is changing and it has become
just an indication
of medicine with some instruction of doses without consideration
of it’s rationality.(2) Antimicrobial agents (AMA) deserve their place as one
of the most powerful pillars of modern medical
care.(3) AMA along with vaccines and oral rehydration salts
represent potential agents in
preventing
mortality as well as morbidity.(4) The problem of overuse is
a global phenomenon.
In India, the prevalence of use of antimicrobials varies from 24-67%,
where as in the Duke University
Medical Centre England it accounts for 34%. Antimicrobials as a group
contribute significantly
to the cost of drugs and is claimed worldwide to account for
15-30%
of total health budget. In India, the cost of AMA is as high as 50% of the total
health budget.(5,6) In obstetrics practice, use of AMA either prophylactically or to treat
infection has reduced the
infectious morbidity following caesarian section and other infections associated
with deliveries. Depending upon the geographical location and
sensitivity pattern to
AMA, the choice of these differ from one clinical setup to another.
As per Kunin’s
criteria
it was observed that 64% of total antibiotics prescribed were either
not indicated or
were inappropriate in terms of drug and dosage.(7) The present study was
undertaken to evaluate the utilization pattern of AMA in hospital
deliveries. Serial studies
such as this help to evaluate the changing trend with respect to prescribing
patterns.
This prospective study, approved by institutional
ethical committee was undertaken in a government
teaching hospital and two private hospitals. Four hundred cases were selected
by stratified random sampling. Proportion wise samples were taken from strata
(hospital),
there by 200 cases from government hospital, group I (G- I), and 100 each from
two private hospitals, groups II and III (G- II & G- III). Cases were selected in such a way
that only those who were prescribed AMA were included in the study. The prescriptions
were analyzed with respect to group, number, and indication of AMA use and duration of use.
The information was collected from the case sheets and for any additional information,
the doctor in charge or nursing staff were enquired. Each AMA was counted once
irrespective
of any change in dosage regimen. The percentage for each of the parameter was
calculated. Individual comparison was done (groupwise) by Guassian test (Z) and
significance
was found P< 0.05, analysis was done using S.P.S.S.( version 12).
Beta-lactams, nitroimidazoles, fluoroquinolones and aminoglycosides
were the common categories of AMA prescribed
in this study (Table1).
Table 1:
Categories
of AMA prescribed
|
AMA |
Group I (%) |
Group
II (%) |
Group III (%) |
| Beta –lactam
|
202 (53.16) |
62 (35.18) |
122 (92.42) |
| Nitroimidazoles
|
139 (36.58) |
35(19.70) |
01 (0.76) |
| Fluoroquinolones
|
06 (1.58) |
76 (43.50) |
05 (3.79) |
| Aminoglycosides
|
21 (5.53) |
01 (0.51) |
02 (1.52) |
| Others
|
12 (3.15) |
02 (1.11) |
02 (1.13) |
| Total(n) |
380 |
176 |
132 |
Single AMA was prescribed more
commonly in G- II (ciprofloxacin, cephazolin) and G- III (cephotaxim); two AMA
(ampicillin
and metronidazole) were prescribed more commonly in G-I (Table-2).
Table 2: Number
of AMA prescribed.
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No.
of AMA. |
I (%) |
II (%) |
III (%) |
Total (%) |
| 1 |
51 (25.5) |
60 (60) |
76 (76) |
187(46.75) |
| 2 |
123 (61.5) |
39 (39) |
20 (20) |
182(45.50) |
| 3 |
21 (10.5) |
1 (1) |
2 (2) |
24(6.00) |
| > 3 |
5 (2.5) |
- |
2 (2) |
7(1.75) |
| Total (n) |
200 |
100 |
100 |
400(100) |
Prophylactic use of AMA (64,
90 and 72%) exceeded the infectious indication for AMA (36, 10 and 28%) in all the
three groups; differences between the groups were significant (Table 3).
Table 3:
Rationale for prescription of AMA
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Rational |
Group I (%)
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Group II (%)
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Group III (%)
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Total (%) |
| Prophylactic
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128 (64)*
|
90 (90) **
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72 (72)*** |
290 (72.5%) |
| Infectious
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72 (36)
*
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10 (10)
**
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28 (28)
*** |
110 (27.5%) |
| Total (n) |
200 |
100 |
100 |
400 |
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*G-I
Vs G-II (prophylactic and infectious), P<0.001; **GII
Vs G-III (prophylactic and infectious), P<0.01;
***G- III Vs G-I , prophylaxis P<0.05 , infectious
P<0.001.
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The duration of prophylaxis
in G- I, II and III was 6.72±1.79, 5.77±1.10 and 5.14±1.53 days respectively which was
statistically significant (p<0.01). Duration of antimicrobial agents use in two categories,
infectious and prophylactic indications are given (Tables 4, 5 and 6).
Table 4:
Duration
of AMA use in prophylaxis and infections.
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Duration
of AMA use in days |
Group
I(cases) |
Group
II(cases) |
Group
III(cases) |
Total |
|
Prophylaxis |
Infections |
Prophylaxis |
Infections |
Prophylaxis |
Infections |
Prophylaxis |
Infections |
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1 |
02 |
- |
- |
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- |
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02 |
68 |
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2-4 |
03 |
- |
01 |
- |
08 |
- |
13 |
28 |
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5-7 |
74 |
38 |
86 |
10 |
58 |
20 |
218 |
14 |
|
8-10 |
49 |
25 |
03 |
- |
05 |
03 |
57 |
110 |
|
>
10 |
- |
09 |
- |
10 |
- |
05 |
- |
- |
|
Total(n) |
128 |
72 |
90 |
20 |
72 |
28 |
290 |
110 |
| Mean
±SD(days)
|
6.72+ 1.79* |
7.52±2.52 |
5.77+ 1.10** |
6.01±1.05 |
5.14+1.53*** |
7.5±3.22 |
5.53 + 1.24 |
6.94±1.35 |
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*G-I Vs G-II (prophylaxis)
P<0.001; **GII
Vs G-III (prophylaxis) P<0.01;
***G- III Vs G-I (prophylaxis) P<0.010 |
Table 5:
Showing infectious indications for antimicrobial use.
|
Indication
|
Group I (%) |
GroupII
(%) |
Group
III (%) |
Total (%) |
| U.T.I &
associated condition |
35 (48.60) |
4 (40) |
13 (46.42) |
52 (47.23) |
| Wound
Infection
|
25 (34.71) |
2 (20) |
8 (28.57) |
35 (31.82) |
| Puerperal
Sepsis |
08 (11.11) |
2 (20) |
5 (17.85) |
15 (13.63) |
| Worm
infestation |
2 (2.77) |
- |
- |
2 (1.8) |
| U.R.T.I. |
2 (2.77) |
2 (20) |
2 (7.14) |
6 (5.45) |
|
(n) |
72 |
10 |
28 |
110 |
Table
6: Depicting the various indications for antimicrobial prophylaxis.
|
Indication |
Group I |
Group II |
Group III |
Total |
| R.M.L.E. |
27 (21.09) |
42 (46.67) |
35 (48.61) |
104 (35.86) |
| Surgery
(LSCS+
PPS) |
71 (55.46) |
35 (38.89) |
22(30.56) |
128 (44.22) |
| Meconium
stained liquor |
13 (10.15) |
8 (8.89) |
8 (11.11) |
29 (10) |
| Perineal
tear |
8 (6.25) |
5 (5.55) |
5 (6.94) |
18 (6.20) |
| P.R.O.M. |
9 (7.05) |
- |
2 (2.78) |
11 (3.72) |
| (n) |
128 |
90 |
72 |
290 |
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RMLE - Right medio lateral episiotomy, LSCS
- Lower segment caesarian section; PROM -
Pre mature rupture of membrane.
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In this study,
inclusive of all three groups there was a total of 14 cases where AMA administration in prophylaxis
was a failure; G- I 9/128 (6.7%) and G- III 5/72 (7%).Prescription
by a clinician may be taken as a reflection of his attitude to the
disease
and role of the drug in its treatment.(8) It brings into focus the
diagnostic acumen and therapeutic proficiency of the clinician with
instruction for palliation or restoration of patient’s health.(3) AMA use varies from geographic area and with the health care
system.
The data obtained from this study is unique, as the pattern of AMA
utilization
was assessed in hospital deliveries which has not been studied in India
in the recent past. The findings in this study may explain that despite
the promiscuous availability of AMA and their use in hospital deliveries, the incidence of puerperial sepsis has not declined;12.6% in
1993,16.1%
in 2003.This has partly attributed to the rise in maternal mortality
rate in India. The microbial flora of female genitourinary tract
consists
of a wide variety of organisms demanding the use of either a single
AMA that covers the entire spectrum or combination of two or more AMA
for prophylaxis or treatment of infection.(9) Preference is to
prescribe
a single AMA with wide spectrum of activity and not a combination of
drugs so as to avoid possible adverse reactions, suprainfections and
decreased patient compliance. In this study one AMA was used in 46.75%
(187/400) cases. This was significantly higher than a similar study where
single AMA use was 17.77%.(10) The increasing trend towards the use
of one AMA is an indication of improved prescribing skills on the part
of the clinicians and the availability of effective AMA with wide
spectrum
of activity. The higher percentage of single AMA used in Gs II
60% of cases (ciprofloxacin, cephazolin) and III 76% of cases
(cefotaxim)
is related to the affordability by patients in private hospitals. In
contrast, two AMA (ampicillin and metronidazole) was prescribed
maximally
in 61.5 % of cases of G-I in a government teaching hospital.
The choice
of AMA depends upon the type of infection, its severity
and availability of AMA, efficacy, safety profile and cost.(11) The use of beta-lactam in this study (56%) was higher when
compared
two studies 39.61% and 40.4% respectively.(9,12) Among
the beta-lactams used, the penicillin group
(aminopenicillins-ampicillin;
penicillinase resistant Penicillins - Cloxacillin) and cephalosporins
(cefazolin and cefotaxim) constituted 57.73% and 42.27% respectively.
In G-I ampicillin constituted 100% of beta-lactam antibiotic used, in
G-II cefazolin was the commonest prescribed beta-lactam antibiotic
(98.38%), in
G- III ampicillin with cloxacillin and cefotaxim were prescribed almost
equally.
The
nitroimidazoles
which are effective against B.fragilis present in the normal female
genital tract was the second commonest group of AMA prescribed in this
study, 25.43 %(table 1), which was higher compared to the two
independent
studies 11.35% and 15.36%.(10,13) Fluoroquinolones was the third
commonest group of AMA used in this study (12.66%)(Table1) which was
higher compared to the above mentioned studies 9.66% and 8.96%.(10,13) This
is despite that fluoroquinolones are secreted
in human milk and are contraindicated in pregnancy as well as in
childhood. Aminoglycosides
prescribed in this
study was much lower (3.5%) compared to Rehan’s (14.15%) and Srishyla’s
study (21.49%) (Table 1).The higher use of aminoglycosides
in G-1 is an indication of availability in government hospital.The
negligible
use of aminoglycosides in G- II and G- III is related to the
availability
of beta-lactams, nitroimidazoles and fluoroquinolones which have a
better
efficacy and safety.
The
prophylactic
use of AMA in this study exceeded infectious indication (72.5% Vs 27.5%)
and also exceeded the prophylactic use in previous studies (32% and
54.4%).(10,13) Studies have indicated that prophylaxis is justified
in the dirty contaminated surgical procedures where the incidence of
wound infection is high as in resection of colon, which constitutes
less than 10% of the surgeries.(14) Most (75%) of total surgeries are clean
surgical procedures and include the surgical interventions mentioned
in this study (Table 6).The expected infection here is less than 5% and
may not justify the uniformly higher use of AMA in all three groups
of this study (64,90 and 72%), inspite of specific clinical indications
and physician’s personal benefits. The second irrationality analyzed
in the prescribing pattern of this study, the importance of which
outweighs the first, is the extended duration in days for which
prophylaxis
was given. The average duration of AMA for prophylaxis was 5.52±1.24
days in this study, which though is shorter when compared to another
study(8.08 ± 0.83 days)(Table4) (10), is much longer than the common
recommendation of one-three doses of AMA for prophylaxis. Prolonging the
duration of AMA does not provide for an additional therapeutic benefit while the
cost and the adverse effects simultaneously escalat.(9) The significantly longer duration of prophylaxis in G-1 (6.72
±1.79 days) is an indicator of delayed admissions of patients in transit
to tertiary care referral hospital with failure or complication in the
previous hospital, combined with the lower nutritional status and poor
hygienic condition of patients in G-1 admitted to government hospital. The
average duration of antimicrobial therapy was 6.95±1.25 days without
significant differences between the groups.
AMA for
Treatment of Infections(Table 6): UTI was the commonest indication, followed
by wound infection, puerperal sepsis and URTI in all the three groups.
The higher incidence of infection in groups 1 (6.7%) and III (7%)
following
caesarian section may be related to inadequate aseptic precautions and
delay in initiation of AMA prophylaxis (beta-lactam). In group II the
incidence of infection following caesarian section and prophylaxis
failure
were less. This may reflect the proper timing of AMA administration,
better aseptic precautions, use of effective AMA (cephalosporin,
ciprofloxacin
and tinidazole combination) and better adherence to treatment protocols.
Timing of AMA: In this study AMA were used in the post operative period in groups
1 and III and immediately after clamping the cord in group II. In case
of artificial rupture of membrane, episiotomy and postpartal
sterilization
it was administered 30 minutes before in group II and after the
procedure
(once the patient is shifted to ward) in groups 1 and III.
We conclude
from our study that,
- Duration of AMA
prophylaxis should be reduced to 24 –36 hrs as against the findings
in this study which was 5.58 days in all three groups. Only in
presence
of gross contamination, should prophylaxis be continued. Duration of
prophylaxis is reducing, though still very far from the required of
1-3 days.
- There is an increasing
trend to prescribe single AMA and decrease in the trend to prescribe
aminoglycosides.
- The time of administration
of AMA should be modified in GI and GIII. AMA should
be administered after clamping the cord in caesarean section and not
preoperatively or post operatively. In artificial rupture of
membranes,
episiotomy, perineal tear, post partal sterilization it should
be administered 30 min before the procedure as against the finding in
the study where AMA were administered after the procedures.
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Number of
antimicrobials used and class of antimicrobial used are interdependent.
As for as possible use of ONE or TWO of wider spectrum were recommended. Since
the antimicrobials with wider spectrum (cephalosporins) were not
available
in G-I. (Government hospital), we should convince the authority for
the supply of same which will be beneficial to the patients in terms
of cost & convenience of administration and also
discourage the use of fluoroquinolones during hospital deliveries.
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