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intervention was done in Calcutta National Medical College and Hospital, Kolkata, west. Bengal, India for a period of two month under ICMR's (Indian Council of ...
   

Review of Global Medicine and Healthcare Research

Volume 2 Number 2 (2011) Publisher: DRUNPP Managed by: IOMC Group ISSN: 1986-5872

Website: www.iomcworld.com/rgmhr/    

REVIEW OF GLOBAL MEDICINE AND HEALTHCARE RESEARCH (RGMHR) ISSN: 1986-5872

Study of Drug Utilization Pattern and Cost of Therapy in Patients Undergoing Cholecystectomy in a Tertiary Care Hospital S.M. Naser, Arnab Naha * CNMC&H, India * Corresponding author; Email: [email protected]

ABSTRACT Introduction: In a resource poor country like India, choice of drugs like antibiotics, analgesics should be done properly to reduce the burden of cost among patient families. Cholecystectomy is one of the most common operation done in our setup, in both forms, i.e open and laparoscopic Cholecystectomy. There are no definite guidelines to follow regarding antibiotic and analgesic usage causing indiscriminate use of these drugs in a post operative Cholecystectomy case done with complete aseptic measures producing excess burden of cost on patients. The study was done based on this procedure to generate data regarding cost effectiveness of pharmacotherapy, specially antibiotics and analgesics in open and laparoscopic Cholecystectomy and to study the usage pattern of these drugs in the tertiary care hospital setup so that a guideline can be formulated for use in the future. Objectives: 1. To study the pattern of drug usage with special emphasis on antibiotics and analgesics in post operative Cholecystectomy patients. 2. To study the cost of pharmacotherapy of the patients based on duration of stay in the post operative period. Sample Size: The sample size of the study was 67 cases. This study was done for a time period of two months. We have included all the admitted cases for surgery of Cholecystectomy (both open and laparoscopic) in our study within the stipulated 2 months time period. Methodology: An observational, prospective analytical study by collection of data without intervention was done in Calcutta National Medical College and Hospital, Kolkata, west Bengal, India for a period of two month under ICMR’s (Indian Council of Medical Research) short term studentship programme with 67 cases of patients. Informed consent and Ethical committee’s approval was duly taken. Data were collected in the department of general surgery from the bed side tickets of the patients after taking a short history and informed consent from the patient. Patients were followed till discharge and the cost of the therapy was calculated from CIMS (Current Index of Medical Specialities) and CENTRAL MEDICAL STORES. Result: Open Cholecystectomy done in our setup is 58.20%, in which females are 97.43%. laparoscopic Cholecystectomy is done in 41.79% cases, in which again the majority are females with a percentage of 85.71%. Among antibiotics, Metronidazole (97.43% in open & 64.28% in laparoscopic cholecystectomy) and Cefoperazone-sulbactam (30.77% in open & 57.14% in laparoscopic cholecystectomy) are used most commonly. The other antibiotics used are amikacin (10.25% in open & 25% in laparoscopic Cholecystectomy), Ceftriaxone (12.82% in open and 14.28% in laparoscopic cholecystectomy), Cefotaxime (in open Cholecystectomy 12.82% and laparoscopic Cholecystectomy 3.57%), ciprofloxacin (in open Cholecystectomy, 8 % patient were given ciprofloxacin while in laparoscopic Vol. 2 No 2 (2011)

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Cholecystectomy 3.57 % were given ciprofloxacin), ofloxacin (in open cholcystectomy, ofloxacin was not used but in laparoscopic Cholecystectomy, 17.85% of ofloxacin was used.) Among the analgesics, Diclofenac Sodium (48.71% in open and 57.14% in Laparoscopic cholecystectomy) and aceclofenac-paracetamol combination (46.15% and 42.85% in open and lap.Cholecystectomy respectively). The average duration of stay in post operative period in open Cholecystectomy was found to be 6-7 days and that in laparoscopic Cholecystectomy was found to be 3-4 days. Cefoperazone-sulbactam, amikacin, ceftriaxone, ciprofloxacin has the highest cost per day which are Rs. 334.36, Rs. 116.00, Rs. 159.50, Rs. 179.20 respectively. The average cost of pharmaco-therapy in case of open Cholecystectomy is Rs. 600-Rs.800 and in laparoscopic Cholecystectomy it comes out to be Rs. 400 – Rs.600. Conclusion: Cholecystectomy is performed in major operation theatres of Surgical department of Calcutta National Medical College under complete aseptic measures, still surgeons use antibiotics as prophylactic measures, also analgesics as and when required. The different group of antibiotics and other drugs are used as pick and choose method due to lack of standard treatment protocol. Judicious use of antibiotics and other drugs may reduce the economic burden on the patients. Open Cholecystectomy is still performed in higher percentage in this setup, thus increasing the duration of stay in the post operative period. This again increases the cost of the therapy associated with the procedure. Study Limitations: 1. The study should be conducted over a longer period of time. 2. The number of patient selected for the study should be large enough to generate data for designing a standard guideline for treatment. 3. The study was an observational study without any intervention. Intervention with drugs may have shown a better result regarding cost effectiveness data generation. Keywords: Cholecystectomy, laparoscopic cholecystectomy, drug utilisation in cholecystectomy, cost effectiveness in cholecystectomy, 3rd generation cephalosporins, metronidazole

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INTRODUCTION Cholecystectomy is the commonest surgical procedure done in our institute which may be either in the laparoscopic method or in the open method. Laparoscopic Cholecystectomy requires a short operating time and also a short post operative stay period in the hospital for the patient. A short post operative stay period definitely reduces the post operative treatment cost per patient as most of them are from middle to low socioeconomic conditions. Open Cholecystectomy is still performed in our institute in high percentage (nearly 58.2%). Open Cholecystectomy has a long operating time and a long post operative stay period for the patients too, thus increasing the cost of treatment per patient. Both laparoscopic and open Cholecystectomy operations are performed under strict aseptic conditions. To prevent any complication, intravenous antibiotics are preferred by most surgeons as prophylaxis. There is a general trend of using 3rd generation cephalosporin and metronidazole post operatively, thus increasing the burden of cost on the patients and patient families as most of these drugs are not supplied from the hospitals. In a resource poor country like India where majority of the population visiting the tertiary care hospital are from middle to low socioeconomic condition, proper choosing of drugs specially antibiotics and analgesics may reduce the burden of cost among the patient families. Proper usage of drugs and reduction in cost of treatment will increase the turnover and urge among the patients from middle to low socioeconomic conditions to accept the health care delivery system more frequently thus increasing the health standards of the community. It was an observational study conducted in the department of surgery within 2 months period including 67 cases who underwent either laparoscopic or open Cholecystectomy, their antibiotic, analgesic and other drug usage were recorded and the cost of the therapy were calculated along with the post operative hospital stay, which indicate the turnover rate of this operative procedure. Tertiary care hospital was chosen for the study as within a short time period of 2 months only a tertiary care hospital can provide a large number of cases with varying presentation from different strata of the society. Though this is conducted in a tertiary care hospital there is no definite guideline to follow regarding antibiotic and analgesic usage which may create situations where there is a chance of indiscriminate use of these drugs leading to extra burden to the patient and his/her families. I was seeking whether it is possible to frame any such guideline which will be cost effective for our setup.

REVIEW OF LITERATURE •

Halsall AK, Welsh CL, Craven JL, Hopton DS, Peel RN have studied in 116 patients in double blind control manner the use of metronidazole as prophylaxis in Cholecystectomy, where they could not detect any significant difference in the occurrence of infection in the treated and control groups. As metronidazole is used very commonly in our setup, it has a relationship with this work. [1]

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Gorecki P, Schein M, Rucinski JC, Wise L Have shown in their work that there is a chaos and confusion in choosing and appropriate dosage and duration of the antibiotics use in different surgical procedures. Among 211 patients, in 156 patients there was inappropriate administration of antibiotics causing extra burden of cost and complication like diarrhoea. They have made a comment that many surgeons were not familiar with appropriateness regarding selection and duration of therapy of antibiotics.[2] Illig KA, Schmidt E, Cavanaugh J, Krusch D, Sax HC have come to a conclusion after studying 250 patients, where 128 patients received antibiotics where as 122 patients didnot, after elective Cholecystectomy operation in low risk groups. They found that there was only one major complication among the patients who did not receive antibiotics. Thus they reported that prophylactic antibiotic is not necessary for elective laparoscopic Cholecystectomy. [3]

• Kochhar P, Suvarna V, Duttagupta S, Sarkar S have done a pharmacoeconomic study comparing the cost effectiveness between cefoperazone-sulbactam and amikacinmetronidazole-ceftazidime combination to come to a conclusion that use of cefoperazone- sulbactam is much more cost effective than the 3 drug combination[4] • Wilson YG, Rhodes M, Ahmed R, Daugherty M, Cawthorn SJ, Armstrong CP have come to a conclusion after studying 55 patients post operative of laparoscopic Cholecystectomy surgery who either received diclofenac sodium or placebo and assessing the pain score at 4, 24 and 48 hours interval that intramuscular diclofenac sodium significantly reduces the post operative pain after laparoscopic Cholecystectomy.[5] • B. Palmer, K. Mannur, W. Ross have done an observer blind trial over 509 patients to evaluate the efficiency of co-amoxiclav against cefuroxime-metronidazole combination. 230 patients were given co-amoxiclav and 225 patients were given the cefuroxime-metronidazole combination. They came to a conclusion that difference between wound infection rate was not significant whereas the cost of co-amoxiclav was half of that of the cefuroxime-metronidazole combination[6] • I. Gangan, S. Duca, Ovidiu Bala, Nadim AL Hajjar, A.R. Cota have evaluated from a clinical and economical view point that the duration of post operative drug therapy (both antibiotic and analgesic) reduces significantly. Out of 4270 patients 3756 patients were operated laparoscopically. The duration of analgesic was on an average 5-6 days in open Cholecystectomy and 2-3 days in laparoscopic Cholecystectomy and the duration of antibiotic theray post operatively was 6-7 days in open and 3-4 days in Laparoscopic Cholecystectomy.[7]

AIMS & OBJECTIVE 1. To study the drugs with special emphasis on antibiotics, analgesics and other drugs used in post operative patients of Cholecystectomy. Vol. 2 No 2 (2011)

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2. To study the cost of therapy of these patients.

MATERIALS & METHOD Study Design: Observational study by collection of data without intervention. Type of Study: Prospective analytical study. Study Site: Calcutta National Medical College & Hospital (CNMCH), Department of General Surgery & Pharmacology, CNMCH, Kolkata, west Bengal. Duration of Study: From 1st May 2010 to 30th June 2010 (2 months) Number of Subjects: 67 cases Informed Consent Procedures: Each patient was explained about the study and the data collected only when they gave their consent on a pre designed consent form. Ethical committee Approval: The ethical committee approval was taken from the EthicalCum-Screening-Sub Committee, CNMCH, Kolkata, West Bengal. Inclusion Criteria: • Patients undergoing planned Cholecystectomy operation (open or laparoscopic method) in the department of general surgery. • Both male and female patients in the age group of 20 – 60 years are included in the study. Exclusion Criteria: • Patients having severe systemic diseases like uncontrolled diabetes mellitus, renal failure, chronic liver disease, immune compromised patients etc are excluded. • Patients having acute cholecystitis or any acute surgical condition are excluded. The Data Collection method: 1. Patient admitted in the department of general surgery for Cholecystectomy (Both open and Laparoscopic) were included in the study based on the inclusion/exclusion criteria. 2. Basic demographic data along with a short history was taken from the patient about the progress of the disease, the symptoms and any associated disease after taking necessary consent. 3. Informed Consent was taken on first contact with the patient after explaining the procedure to the patient.

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4. On post operative period, the patients bed side tickets were used to collect the data regarding antibiotics, analgesics and other drugs prescribed with their dosage and route of administration. 5. The patient was followed till discharge for any addition of drugs and on discharge the discharge date was noted which signified the length of drug used during the post operative period. 6. The cost of the therapy was calculated for the antibiotics, analgesics and other drugs prescribed using the “CIMS-Current Index of Medical Specialities” and also by visiting and enquiring the “CENTRAL MEDICAL STORES” 7. The follow up of the patients for any complication was not possible in this set up.

RESULT & OBSERVATION: A total of 67 Cases of Cholecystectomy (Both open and Laparoscopic) were recorded as per the inclusion and the exclusion criteria stated.

Table I: AGE AND SEX WISE DISTRIBUTION OF TOTAL OPEN CHOLECYSTECTOMY PATIENTS (N=39) AGE GROUPS

NO. OF OPEN CHOLECYSTECTOMY PATIENTS MALE

FEMALE

1. 20 years – 30 years

0

1

2. 31 years -40 years

0

6

3. 41 years – 50 years

1

20

4. 51 years – 60 years

0

11

1

38

TOTAL

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20 20 15 11 6

10

Males 1

5 0

Females 0

0

1

Females 0

20 yrs ‐ 30 yrs

31 yrs ‐ 40 yrs

Males 41 yrs ‐ 50 yrs

51 yrs ‐ 60 yrs

Comment: Total Open Cholecystectomy Patients are 39 (58.20%). Out of these 39 patients, 38 are females (97.43%) and only 1 male (2.56%). From the data obtained it can be seen that majority of the open Cholecystectomy patients are female within the age group of 41 – 50 years.

TABLE II: AGE & SEX WISE DISTRIBUTION OF TOTAL LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS (N= 28) AGE GROUP

NO. OF PATIENTS MALES

FEMALES

0

3

2. 31 years – 40 years

0

4

3. 41 years – 50 years

1

8

4. 51 years – 60 years

3

9

TOTAL

4

24

1. 20 years – 30 years

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Comment: Total number of Laparoscopic patients obtained = 28 (41.79%). Out of these 28 patients, 24 are females (85.71%) and 4 are males (14.28%). Most of the Laparoscopic Surgery is performed in females in the age group of 51 – 60 years (37.5%)

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TABLE III: PATTERN OF ANTIBIOTIC USE IN OPEN CHOLECYSTECTOMY PATIENTS (Multiple response table) ANTIBIOTICS

NO.OF PATIENTS

PERCENTAGE

12

30.77

2. Metronidazole

38

97.43

3. Amikacin

4

10.25

4. Ceftriaxone

5

12.82

5. Cefotaxime

5

12.82

6. Ciprofloxacin & Tinidazole

2

5.12

7. Amoxicilin & Clavulinic Acid

2

5.12

8. Cefpodoxime

8

20.51

9. Ciprofloxacin

1

2.56

10. Cefixime

1

2.56

1. CefoperazoneSulbactam

Comment: The Antibiotic usage in open Cholecystectomy shows that mostly metronidazole (97.43%) and Cefoperazone – Sulbactam (30.77%) are used post operatively.

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TABLE IV: PATTERN OF ANTIBIOTIC USAGE IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS (Multiple Response Table) ANTIBIOTICS

NO. OF PATIENTS

PERCENTAGE

1. Cefoperazone-Sulbactam

16

57.14

2. Metronidazole

18

64.28

3. Amikacin

7

25

4. Ceftriaxone

4

14.28

5. Cefotaxime

1

3.57

6. Amoxicillin & Clavulinic Acid

3

10.71

7. Ofloxacin-Ornidazole

5

17.85

8. Ceftriaxone-Sulbactam

2

7.14

9. Cefadroxil

1

3.57

10. Cefoperazone

1

3.57

11. Ciprofloxacin

1

3.57

12. Cefixime & Cloaxacillin

1

3.57

No. Of Patients 2

1 1

1

Cefoperazone‐Sulbactam 1

5

16

Amikacin

3

1

Metronidazole

Ceftriaxone 4

Cefotaxime 7

Amoxicillin‐Clavulinic Acid 18

Ofloxacin‐Ornidazole Ceftriaxone‐Sulbactam Cefadroxil Cefoperazone

Comment: Antibiotic usage in Laparoscopic Cholecystectomy shows that Metronidazole (64.28%) and Cefoperazone – Sulbactam (57.14%) are used post operatively. Vol. 2 No 2 (2011)

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TABLE V: PATTERN OF ANALGESIC DRUG USAGE IN OPEN CHOLECYSTECTOMY PATIENTS (Multiple Response Table) ANALGESICS

NO. OF PATIENTS

PERCENTAGE

1. Diclofenac

19

48.71

2. AceclofenacParacetamol

18

46.15

48.71 60 40 20 0

19

46.15 18

Percentage No. Of Patient

No. Of Patient

Percentage

Comment: The analgesics usage in Open Cholecystectomy patients were mainly by diclofenac (48.71%) TABLE VI: PATTERN OF ANALGESIC USAGE IN LAPAROSCOPIC CHOLECYSTECTOMY (N=28) ANALGESICS

NO.OF PATIENT

PERCENTAGE

1. Diclofenac

16

57.14

2. AceclofenacParacetamol

12

42.85

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TABLE VII: Post Operative duration of antibiotics in open Cholecystectomy patients (Multiple Response Table) Name of Antibiotic

Duration (with number of patients) 5 Days 6 Days 7 Days 8 Days

1. Cefoperazone – Sulbactam

3

6

2

1

2. Metronidazole

7

24

5

2

3. Amikacin

0

3

1

0

4. Cefpodoxime

2

6

0

0

5. Ceftriaxone

1

2

2

0

6. Ciprofloxacin – Tinidazole

1

1

0

0

7. Cefotaxime

0

5

0

0

8. Ciprofloxacin

0

1

0

0

9. Cefixime

0

1

0

0

10. Amoxicilin – clavulanic Acid

1

1

0

0

57.14 42.85 60 40 20 0

16

12

Percentage No. Of Patient

No. Of Patient Percentage

Comment: In Laparoscopic Cholecystectomy, the analgesic mainly used is Diclofenac (57.14%)

Comment: In open Cholecystectomy, the average duration of stay is 6 -7 days. Maximum number of patients with 6 days duration received metronidazole.

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Table:VIII: Post operative antibiotic duration in laparascopic cholecystectomy (Multiple Response Table) 3 Days

4Days

5 Days

6 Days

1

9

4

2

1

0

2

1

0

0

1

9

5

2

1

4.Amikacin

1

4

2

0

0

5.Cefadroxil

0

1

0

0

0

6.Ceftriaxone

0

1

2

1

0

7.Ofloxacin-ornidazole

0

1

0

0

0

8.Cefoperazone

0

1

0

0

0

9.cefotaxime 10.Ceftriaxonesulbactam 11.Ciprofloxacin

0 0

1 2

0 0

0 0

0 0

0

0

1

0

0

12.Cefixime-cloxacilin

0

1

0

0

0

Antibiotic 1.Cefoperazonesulbactam 2.Amoxicilin clavulinic Acid 3.Metronidazole



7 Days

Comment: In Laparoscopic Cholecystectomy, the average post operative stay period is around 3-4 days. Cefoperazone sulbactam and Metronidazole combination has been given in these cases mainly.

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Table IX: Cost of Antibiotics in open Cholecystectomy ANTIBIOTICS

UNIT PRICE (Rs.)

COST/DAY(Rs.)

1. Cefoperazone-Sulbactam

167.13

334.36

2. Metronidazole

16.07

48.20

3. Amikacin

58.00

116.00

4. Ceftriaxone

79.75

159.50

5. Cefotaxime

34.52

69.04

6. Ciprofloxacin & Tinidazole 7. Amoxicilin-calvulanic Acid (oral) 8. Cefpodoxime (oral)

55.00

110.00

19.95

39.90

14.00

28.00

9. Ciprofloxacin 10. Cefixime (oral)

89.60 16.00

179.20 32.00

Comment: Cefoperazone sulbactam, amikacin, ceftriaxone, ciprofloxacin have the highest cost among prescribed medications.

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Table X: Cost of Antibiotics in Laparoscopic Cholecystectomy

Antibiotics 1. Cefoperazone –Sulbactam 2. Amoxicillin –Clavulanic Acid (oral) 3. Metronidazole

Unit Price (Rs) 167.13 19.95

Cost/Day (RS) 334.36 39.90

16.07

48.20

4. Amikacin

58.00

116.00

5. Cefadroxil (Oral)

16.56

33.12

6. Ceftriaxone

79.75

159.50

7. Ofloxacin-ornidazole

6.00

12.00

8. Cefotaxime

34.52

69.04

9. Cefoperazone 10. Ceftriaxone-Sulbactam

361.51 100.70

723.02 201.40

11. Ciprofloxacin

89.60

179.20

12. Cefixime-cloaxacillin (Oral)

16.00

32.00

Comment: Cefoperazone-sulbactam, Amikacin, Ceftriaxone, Cefoperazone, ceftriaxone – sulbactam are among the costliest medications prescribed in post operative period of laparoscopic Cholecystectomy.

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Table XI: Cost of Analgesics in Open and Laparoscopic Cholecystectomy Analgesics 1. Diclofenac Sodium 2. Aceclofenac – Paracetamol (Oral)

Unit Price (Rs) 103.44

Cost/Day (Rs) 103.44

40.50

81.00

Comment: The analgesics used in our setup are similar for open and laparoscopic Cholecystectomy. Diclofenac is costly but is used more due to its efficiency.

Table XII: Cost of other drugs used in open and laparoscopic Cholecystectomy

Other Drugs 1. Ranitidine

Unit Price (Rs) 4.62

Cost/Day (Rs) 13.86

2. Calmpose

21.67

21.67

3. Ondansetron

41.34

82.68

Comment: Ranitidine is used in each and every patient, the rest of the drugs are used only when needed or symptomatically.

DISCUSSION The sample size of the study was 67 cases. We aimed at studying the pattern of antibiotic and analgesic use during open and laparoscopic Cholecystectomy operation and the cost of therapy in a tertiary care hospital setup i.e at Calcutta National Medical College Hospital, Kolkata, West Bengal. Among the 67 cases, 39 cases were of open Cholecystectomy (58.2%) and the rest 28 cases were of Laparoscopic Cholecystectomy (41.79%). Females showed a higher percentage of undergoing open (97.43%) and laparoscopic (85.71%) Cholecystectomy especially in the age group of 41 -50 years and 51-60 years respectively. The post operative antibiotic therapy was mainly given prophylactically to cover up for the gram positive and gram negative organisms in the hospital setup, in spite of proper aseptic measures during the operation. In open Cholecystectomy combination of drugs were given with Cefoperazone-Sulbactam, Metronidazole and amikacin. It was seen from the result obtained in our study that metronidazole was used in almost every case in a very significant percentage of 97.43%. Cefoperazone – sulbactam was also used alone and in combination Vol. 2 No 2 (2011)

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with metronidazole. The usage percentage of cefoperazone –sulbactam was 30.77%. In laparoscopic Cholecystectomy, the post operative use of antibiotic prophylactically as assessed from our study showed that metronidazole in combination with cefoperazonesulbactam was used significantly with percentage of 64.28%. cefoperazone – sulbactam was also used alone with a percentage of 57.14% in laparoscopic setting. The use of metronidazole in high percentage was mainly based on the surgeons choice. In open Cholecystectomy, Cefoperazone sulbactam was given to 12 patients along with the combination of metronidazole or used singly post operatively. This was used in IV form (Intravenous) followed by oral formulation. Metronidazole, which was the most frequent drug (given in 38 patients) used in combination, had been given singly in 2 patients. Oral formulations which substituted the IV drugs in follow up were mainly amoxicillin- clavulinic acid, cefpodoxime and cefixime given to 2, 8 and 5 patients respectively. The duration of hospital stay in open Cholecystectomy even after using cefoperazonesulbactam, metronidazole and amikacin combination was around 6 days rather than using cefoperazone-sulbactam alone which was comparable with the study done by Kochhar P, Suvarna V, Duttagupta S, Sarkar S who have stated that cefoperazone sulbactam use alone can reduce the hospital stay rather than the 3 drug combination.[4] In laparoscopic Cholecystectomy, Cefoperazone sulbactam had been given to 16 patients used singly in IV doses. Metronidazole was used in 18 patients. Oral formulation of Amoxicillin – clavulanic acid, cefadroxil and cefixime had been used as follow up in 3, 1, 1 patients respectively. The duration of stay in open Cholecystectomy was 6-7 days whereas the duration of stay in laparoscopic Cholecystectomy was reduced to 3-4 days. This observation was in favour of the study done by I. Gangan, S. Duca, Ovidiu Bala, Nadim AL Hajjar, A.R. Cota who found out that hospital stay was reduced to 2-3 days in laparoscopic surgery. Proper prophylactic antibiotic therapy was given in both the cases.Though in our setting, we have found that open Cholecystectomy (58.2%) was performed in more occasions than laparascopic Cholecystectomy (41.79%).[7] Cefoperazone – sulbactam usage costs around Rs. 334.36 ($7.39) per day (unit price: Rs.167.13), metronidazole usage costs Rs 48.02 ($1.06) per day and amikacin Rs. 116.00 ($ 2.56) per day. The post operative stay period in open Cholecystectomy varied from 5 days to 8 days. So the cost of treatment increases with the use of antibiotic combinations and greater number of antibiotics were used in spite of proper aseptic measures per-operatively. In Laparoscopic Cholecystectomy, the duration of stay was 3-4 days on an average, so the total cost is reduced as the antibiotics and other drugs were used for shorter duration in Laparoscopic Cholecystectomy. Amoxicilin-clavulanic acid was used in few patients in the present study. Majority of the prophylactic antibiotics used was cefoperazone sulbactam and metronidazole. In a study done by B. Palmer, K. Mannur, W. Ross, they have concluded that co-amoxiclav is much more cost effective than metronidazole combinations.6 According to the study done by Halsall AK, Welsh CL, Craven JL, Hopton DS, Peel RN, there was no significance of using metronidazole as it could not control the infection in post operative patients well. In our setup and from our study, we observe that metronidazole was

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used in high percentage as prophylactic antibiotic. This result was not in favour of the study already done. [1] The Analgesics used in open and laparoscopic Cholecystectomy were similar in our setup. Diclofenac sodium and aceclofenac – paracetamol were used in our setup. Diclofenac was more commonly used (48.71% in open Cholecystectomy and 57.14% in laparoscopic cholecystectomy). The use of diclofenac in high percentages definitely showed its effectiveness in the present study and also its effectiveness was assessed by Wilson YG, Rhodes M, Ahmed R, Daugherty M, Cawthorn SJ, Armstrong CP who came to the conclusion after assessing the pain score that diclofenac was most effective. This is in coherence with our study [5]. The cost of Diclofenac per day (in parenteral route) in a TID dose was Rs. 103.40 ($2.28) whereas the cost of Aceclofenac –Paracetamol combination in BID dose is Rs. 5.40 ($0.119) per day. There is a huge difference in cost but still diclofenac was preferred due to its effectiveness in reducing the pain post operatively. Few other drugs like Ranitidine, Diazepam were used symptomatically, which have been kept out of the study for simplicity in calculation. It has been rightly pointed out by Gorecki P, Schein M, Rucinski JC, Wise L that there is a chaos in choosing the right antibiotics prophylactically by the surgeons to reduce the post operative complications. In the present study, the same condition was seen with the large number of antibiotics usage without any protocol in both open and Laparoscopic Cholecystectomy. [2]

CONCLUSION Cholecystectomy is an operation done in perfect aseptic condition in major operation theatres in the department of surgery of Calcutta National Medical college & Hospital, still the surgeons use antibiotics as prophylactic measures, also analgesics as and when required. The different groups of antibiotics and other drugs are used as pick and choose method as we donot have standard treatment protocol regarding these cases. Cost of therapy like wise varies in different groups of patients which at times may be incompatible with the economic condition of the patient concerned. Average cost of therapy in case of open Cholecystectomy is Rs. 600-Rs 800[$13.2699 -$17.6932] (only cost of therapy) and in laparoscopic Cholecystectomy is Rs. 400 –Rs 600 [$8.8466-$13.2699]. If possible the study may be performed on a wider scale so that standard treatment protocol for the Cholecystectomy patients can be worked out in future and thereby we can reach to a rational therapy which is cost effective.

SUMMARY This study had been done in the department of general surgery along with the pharmacology department of Calcutta national medical college, Kolkata for a period of 2 months from 1st may to 30th june 2010, with the objective of finding out the drug utilization pattern and cost of therapy of use of antibiotic and analgesic in open and laparoscopic Cholecystectomy. Vol. 2 No 2 (2011)

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All consecutive patients in the department of general surgery who were admitted for Cholecystectomy and being operated between the age group of 20-60 years were included in the study as per the inclusion and exclusion criteria. The data was collected from the bed side tickets, ward record book and the cost of medication obtained from CIMS (current index of medical specialities) and Central Medical store of this hospital. There were 67 cases (Male = 5, Female = 62), 39 cases were operated by open method and 28 cases were operated by Laparoscopic Method, with average hospital stay of 6-7 days and 3-4 days respectively. Both groups got prophylactic antibiotic therapy mainly in combinations of cefoperazone-sulbactam and metronidazole. Other options were, Amikacin, Ceftriaxone, Cefotaxime, Ciprofloxacin, cefadroxil, amoxicillin – clavulanic acid, etc. IV antibiotics were followed by oral antibiotics specially in open Cholecystectomy course with Amoxicilin-clavulanic acid, cefpodoxime and cefixime. On analysis of the cost, the cost of antibiotic therapy varies from Rs 600 –Rs 800 [$13.2699 $17.6932] in Open Cholecystectomy for per patient per day and Rs 400 –RS 600 [$8.8466$13.2699] in Laparoscopic Cholecystectomy, per patient per day, but there was no definite protocol to follow. We can conclude that, standard guideline may be framed which will help reduce the cost of pharmacotherapy of this procedure.

LIMITATIONS: The present study is not free from limitations. A few suggestions have been given which will help us conduct more such studies: 1. The time period of study was short, just two months. It should be longer. 2. The number of patient selected for the study i.e study sample size was small and not appropriate to define a standard guideline for the treatment protocol. 3. The study was an observational study without any intervention. Intervention with drugs may have shown a better result regarding cost effectiveness data generation.

REFERENCES [1] Halsall AK, Welsh CL, Craven JL, Hopton DS, Peel RN (1980): Prophylactic use of Metronidazole in preventing wound sepsis after elective Cholecystectomy; British Journal of Surgery; Volume-67(8); Pages 551-552 [2] Gorecki P, Schein M, Rucinski JC, Wise L.( May 1999) ; Antibiotic administration in patients undergoing common surgical procedures in a community teaching hospital: the chaos continues; World J Surg; Volume 23 (5); Pages 429-432; Discussion 433 [3] Illig KA, Schmidt E, Cavanaugh J, Krusch D, Sax HC (April 1997); Are prophylactic antibiotics required for elective laparoscopic Cholecystectomy?; Journal of American College of Surg; Volume 184 (4); Pages 353-356

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[4] Kochhar P, Suvarna V, Duttagupta S, Sarkar S (March 2008); Cost effectiveness study comaparing cefoperazone-sulbactam to a three drug combinationfor treating intra-abdominal infection in an Indian Health care setting; Volume 11; Supplement 1; Pages S-33-S-38 [5] Wilson YG, Rhodes M, Ahmed R, Daugherty M, Cawthorn SJ, Armstrong CP (October 1994); Intramuscular diclofenac sodium for post operative analgesia after laparoscopic Cholecystectomy: a randomised controlled trial; Journal of Surgical laparoscopic Endoscopy; Volume 4(5); Pages 340-344 [6] B. Palmer, K. Mannur, W. Ross ; An observer blind trial of co-amoxiclav versus cefuroxime plus metronidazole in the prevention of postoperative wound infection after general surgery; Journal of Hospital Infection, Volume 26, Issue 4, Pages 287-292 [7] I. Gangan, S. Duca, Ovidiu Bala, Nadim AL Hajjar, A.R. Cota; 2004; Acute CholecystitisLaparoscopicCholecystectomy versus open cholecyatectomy; Volume 1 8. Current Index of Medical specialities (CIMS); April to July 2010 (update 2) 9. K.D. Tripathy; Essentials of medical pharmacology; 6th edition (2008); Pages 703-709.

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APPENDICES

CASE STUDY FORM FOR STS 2010 STUDY OF DRUG UTILIZATION PATTERN AND COST OF THERAPY IN PATIENTS UNDERGOING CHOLECYSTECTOMY IN A TERTIARY CARE HOSPITAL

Name of Patient: Address:

Age:

Sex:

History of Present Illness:

History of Past Illness:

Associated Illness:

Addiction History:

Drug History:

Socioeconomic History:

PerCapita Income:

When Diagnosed:

Modality Of Diagnosis: OPERATIVE HISTORY

Mode Of Operation: used:

Anaesthetic Agents

Post operative Analgesics:

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POST OPERATIVE PHASE Drugs: ANTIBIOTICS: NAME

DOSAGE

ROUTE

Purchased/Supplied

COST

ANALGESIC AND OTHER DRUGS: NAME DOSAGE ROUTE

Purchased/Supplied

COST

Date of Discharge: stay:

Duration Of

Total Cost of Therapy:

Drugs on Discharge: FOLLOW UP AFTER 2 WEEKS

Any Complications:

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Medication:

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INFORMED CONSENT FORM

STUDY OF DRUG UTILIZATION PATTERN AND COST OF THERAPY IN PATIENTS UNDERGOING CHOLECYSTECTOMY IN A TERTIARY CARE HOSPITAL

Study Case No. Hospital Registration No.

Date:

I, , aged years, S/O Do hereby give my consent to participate in the said study after being well informed about the study and knowing the effects and side effects which the study drugs may cause. Name of the patient: Address of the patient:

Signature of the patient & date:

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