Prescribing Pattern Analysis in Ureteric Calculus at a Tertiary Care Hospital, Erode, Tamil Nadu


Department of Pharmacy Practice, SSM College of Pharmacy, Jambai, Erode , Tamil Nadu, 638312, 7010129252, India

Abstract

Urolithiasis is one of the most common medical condition of genito-urinary tract which affecting almost 5-15% of the world population and nearly 12 % in India. Nearly 50% of affected patients will have recurrence within 5 years, making it a lifetime disease. Since it is a recurrent condition, the treatment options are not satisfactory for the cure or prevention of ureteric calculus. The present study is mainly evaluating the prescribing pattern of ureteric calculus in a tertiary care center. A retrospective observational study was conducted with 105 prescriptions in the in-patient department of urology in a tertiary care center. The data collected were analyzed by MS Excel sheet & descriptive analysis. It was found that, 72.38% of patients were undergone surgery whereas 21.61% were treated with only drugs. Febuxostat and Hydrochlorothiazide were found to be the mainstay treatment options for the non-surgery patients. Acetaminophen + Diclofenac (375mg) was the most commonly used analgesic (65.71%) in all types of patients. Inj.Amikacin (1g) was the highly prescribed (24.04%) antibiotic during hospitalization and it switched over to T.Trimethoprim+ Sulfamethoxazole (960mg) (26.33%) during discharge. Out of 28 prescribed medicines, 17 were prescribed as per NLEM 2021. The study concluded that, the patients were treated rationally, but there should be a proper intervention on the drugs which are not in the list of NLEM for their use. The use of parentral antibiotics was high, so knowledge among the physicians should be improved by following the updated guidelines and continuous education on urology cases.

Keywords

Urolithiasis, Ureteric calculus, Parentral antibiotics

Introduction

Kidney stones are mineral buildups that can be free-floating or affixed to the renal papillae in the renal calyces and pelvis 1. Other names for kidney stones are nephrolithiasis and urolithiasis 2. Urgent patient presentations for medical or surgical evaluation are frequently caused by nephrolithiasis 3. The presence of stone crystals in the urine bladder is known as urolithiasis 4. Urolithiasis has been more common around the globe in recent years 5. Kidney stone aetiology is multifactorial 6. A significant number of people throughout the world suffer with urolithiasis, which is a prevalent illness. According to the survey, ureteric calculus affects 12% of the population of India 7. Since past centuries, dating back to 4000 BC, humans have been impacted by urinary stones 8. Ureteric calculi are among the most frequent cases seen in the urology department 9. Recent studies have found that ureteric stones are often microscopic 10 and that, depending on where they are located, their size, and their laterality 11, 70–90% of ureteric stones pass entirely by themselves 9. It is a condition with a 50% chance of recurrence12. According to reports, ureteric stones most frequently lodge in the smallest anatomical locations, such as the PUJ, VUJ, and the region where the external iliac arteries cross.

According to recent research, a nanobacterial illness like Helicobacter pylori infection and peptic ulcer disease is the cause of kidney stone formation13. The majority of kidney stones (97%) have nanobacteria in the central nidus, and mineral plaques (Randall's plaques) in the renal papilla also contain nanobacteria, which are microscopic intracellular bacteria that create a calcium phosphate shell (an apatite nucleus). Risk factors include dehydration, a high-fat diet, a lot of salt, animal protein, and obesity have an impact on the formation and further crystallization of stones.

The most significant variables that affect crystal formation are urine volume, solute concentration, and the ratio of stone inhibitors (citrate, pyrophosphate, and urinary glycoproteins) to promoters. When two ions are present in a solution at a concentration greater than their saturation point, crystallisation takes place. Urolithiasis is a potentially life-threatening condition that frequently causes severe abdomen, low back, flank, or groin pain 14, 15, 16. If stones occurs in the kidney, ureter, or urinary bladder, the symptoms will vary depending on where it is located. Even without any symptoms, kidney stones might still exist.

The patient may also have flank discomfort, nausea, scorching urination, blood in the urine, urgent urination, fever, and chills if the stone moves into the ureter. Ureteric colic is the medical name for this condition 17, 18. The blockage of the urinary system by calculi leads to ureteric colic 19. Males are more likely than females to develop renal calculus.

Types of Kidney Stones

Calcium oxalate

About 80% of all urinary calculi are calcium stones, the most common kind of kidney stone. Calcium stones are more likely to reoccur than other kidney stones. A nidus for the deposition of CaOx is a calcium phosphate concretion, also known as Randall's plaque and illustrated below by arrows.

Struvite or Magnesium Ammonium Phosphate Stones

Infection stones and triple phosphate stones are other names for this type of stone, which occurs in 10-15% of cases. Proteus mirabilis is the most frequent cause, whereas Klebsiella pneumonia and Pseudomonas aeuroginosa are less frequent causes. Women are more vulnerable than males.

Uric acid stones or Urate

It is found in around 3-10% of all types of kidney stones. People who have gouty arthritis are more likely to develop it. It is more frequent in men than in women. Causes include hyperuricaemia, idiopathic hyperuricosuria, and hyperuricosuria.

Cystine stones

It accounts for fewer than 2% of all kinds of kidney stones. It is a hereditary condition that affects how an amino acid and cystine are transported. The Rbat gene on chromosome 2 is defective, which leads to poor disease absorption in the renal tubules. Cystine stones formed as a result. kidney tubular abnormality is one of the major causes.

Drug-induced stones

It accounts for around 1% of all kidney stones. Drugs that cause stones include guaifenesin, triamterene, atazanavir, and sulfa medications 20, 21.

Aim

The main aim of this study is to analyze the prescription pattern of ureteric calculus patients with or without co-morbidities.

Objectives

The main objectives of this study are:

  • To analyze the prescription pattern of ureteric calculus in tertiary care hospitals

  • To determine the % of patients affected by ureteric calculus based on the age, gender

  • To know the treatment methodology (Surgical/Non-surgical)

  • To classify the drug prescribed for patients during therapy

  • To classify the drug prescribed for patients during discharge

  • To determine the risk factors of this disease

  • To find out percentage of antibiotics prescribed in these prescription

Need of Study

Since ureteric calculus is a recurrent condition, the treatment pattern for the same should be analyzed to ensure the complete cure or prevention of the condition. So the present study is aiming on the evaluation of prescribing trends in patients with ureteric calculus.

Materials and Methods

Study design

A retrospective observational study was conducted on inpatients admitted with calculus complaints to the urology department of a tertiary care hospital in Erode.

Sample size

The sample size consists of 105 male and female patients who have been admitted to a tertiary care hospital with ureteric calculus.

Subject selection

The patients for this study have been selected depending on inclusion and exclusion criteria.

Inclusion criteria

1. Patients over the age of 18 who have ureteric calculi in both genders.

2. Patients who have co-morbid conditions or not.

3. Patients are only admitted to the urology department's inpatient ward.

Exclusion criteria

1. Patients under the 18 years of age are not enrolled.

2. Patients who have visited the outpatient department with ureteric calculi are not included.

3. In this study, women who are currently pregnant or breastfeeding are not included.

Study duration

The research took four months, from April 2022 to July 2022. Data collection and analysis were done.

Source of data

All data for the research was gathered from patient profiles and medication records using specially prepared forms, which included demographic information, past medical history, past medication history, family history, social background, diagnosis, laboratory tests, drug prescriptions on treatment, drug prescribed on discharge, and whether or not surgical intervention was performed. We got approval from ethical committee.

Study procedure

We routinely visited the research location and made patient selections based on inclusion and exclusion criteria. Data were then gathered using specially prepared forms for data collection.

RESULTS AND DISCUSSION

The information was gathered from 105 individuals admitted to a tertiary care hospital in order to evaluate the prescription pattern of patients with or without ureteric calcification.

Gender wise distribution

In the study, there were 105 patients, of which 72 (68.57%) were men and 33 (31.42%) were women. According to previous research, males are more impacted than females. Distribution of patients based on gender shown in Figure 1.

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Figure 1: Gender wise distribution

Age wise distribution

The majority of the 105 patients in the research population who are older than 18 years are between the ages of 30 to 44 (36.19%), followed by 45 to 60 (24.76%). Then, 25 patients (23.8%) are between the ages of 18 to 29. The least number of them in the over-60 age group consists of 16 patients (15.23%). In the following publications by Ansari M.S. et al., Khan G. et al., and Rajeev T.P et al., the majority of them had an average age of 30, 33, and 42.89. (2018). Distribution of patients based on age shown in Figure 2 .

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Figure 2: Age wise distribution

Based on stone size

There were 105 individuals in the study group, 76 (72.38%) affected by stone size larger than 6mm and 29 (27.61%) affected by stone size larger than 6mm. Distribution of patient based on stone size shown in Figure 3.

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Figure 3:
Table 1: Drugs on Treatment

SI.NO

Drugs Prescribed

Category

Number of patients

Percentage

1

Ondansetron

Antiemetics drugs

94

17.7

2

Acetaminophen + Diclofenac

NSAIDs

69

12.99

3

Ranitidine

Gastric acid secretion inhibitors

69

12.99

4

Amikacin

Antibiotics

63

11.86

5

Ceftriaxone

Antibiotics

51

9.6

6

Cefoperazone + Sulbactam

Antibiotics

37

6.96

7

Tramadol

NSAIDs

32

6.59

8

Hydrochlorothiazide

Antihypertensive drugs – Thiazide diuretics

22

4.14

9

Pantoprazole

Gastric acid secretion inhibitors

19

3.42

10

Esomeprazole

Gastric acid secretion inhibitors

17

3.2

11

Lignocaine

Local anaesthetics

12

2.25

12

Tetanus toxoid

Vaccines

11

2.07

13

Febuxostat

Antihyperuricaemic drugs

11

2.07

14

Acetaminophen

Analgesics

7

1.31

15

Levofloxacin

Antibiotics

5

0.94

16

Metformin

Antidiabetic drugs

5

0.94

17

Furosemide

Antihypertensive drugs – Potassium sparing diuretics

2

0.37

18

Meropenem

Antibiotics

2

0.37

19

Sodium bicarbonate

Urinary alkalinizer

1

0.18

20

Tramadol + Acetaminophen

NSAIDs

1

0.18

21

Cefixime

Antibiotics

1

0.18

Total

531

100

Table 2: Drugs during discharge

SI.NO

Drugs Prescribed

Category

Number of patients

Percentage (%) used

1

Acetaminophen

Analgesics

74

20.67

2

Trimethoprim + Sulphamethoxazole

Antibiotics

69

19.27

3

Ranitidine

Gastric acid secretion inhibitors

52

14.52

4

Pantoprazole

Gastric acid secretion inhibitors

41

11.45

5

Levofloxacin

Antibiotics

33

9.21

6

Hydrochlorothiazide

Antihypertensive drugs – Thiazide diuretics

19

5.3

7

Syp.Potassium citrate + Magnesium citrate + Vitamin B6

Urinary alkalinizers

11

3.07

8

Aceclofenac + Acetaminophen

NSAIDs

11

3.07

9

Diclofenac

NSAIDs

11

3.07

10

Esomeprazole

Gastric acid secretion inhibitors

8

2.23

11

Febuxostat

Antihyperuricaemic drugs

7

1.95

12

Ondansetron

Antiemetic drugs

7

1.95

13

Metformin

Antidiabetic drugs

4

1.11

14

Silodosin

Alpha adrenergic blockers

4

1.11

15

Tramadol + Acetaminophen

NSAIDs

2

0.55

16

Cefixime

Antibiotics

1

0.27

17

Sodium bicarbonate

Urinary alkalinizers

1

0.27

18

Furosemide

Antihypertensive drugs – Potassium sparing diuretics

1

0.27

19

Rabeprazole

Gastric acid secretion inhibitors

1

0.27

20

Hyoscine butylbromide

Anticholinergic drugs

1

0.27

Total

358

100

Table 3: Antibiotics prescribing pattern

S.No

Antibiotic prescribed

Antibiotics Category

Numbers of times given

Percentage

1

Trimethoprim + Sulphamethoxazole

Cotrimaxozole

69

26.33

2

Amikacin

Aminoglycosides

63

24.04

3

Ceftriaxone

Cephalosporin

51

19.46

4

Levofloxacin

Fluoroquinolones

38

14.5

5

Cefoperazone + Sulbactam

Cephalosporin + Pencillin

37

14.12

6

Cefixime

Cephalosporin

2

0.76

7

Meropenem

Carbapenems

2

0.76

Total

262

100

Based on procedure done

There were 105 individuals in the study group, 76 (72.38%) of whom underwent surgery, and 29 (27.61%) of whom received non-surgical care. More than 26% of patients who underwent surgical procedure treatment for ureteral stones between 6 and 10 mm had to have surgery 22.

Risk factors

In both surgical and nonsurgical ureteric calculus patients, risk variables such as smoking and alcoholism were investigated. According to alcohol usage in 76 surgery patients, 49 (64.47%) were non-alcoholic and 27 (35.52%) were alcoholic.

According to smoking in surgery patients, there were 76 patients, of which 48 (63.15%) were nonsmokers and 28 (36.84%) were smokers. According to alcohol use among non-surgery patients, there were 23 (79.31%) non-alcoholic patients and 6 (20.68%) alcoholic patients. According to smoking in nonsurgical patients, out of 76 patients, 19 (65.51%) were non-smokers and 10 (34.48%) were smokers. According to this study, non-alcoholic and non-smokers had a lower risk of spontaneous passage (non-surgery) in patients with stones larger than 4 mm 23. Risk factors for Non-Surgery patients and Surgeried patients in Figure 4, Figure 5.

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Figure 4: Risk factors for Non-Surgery patients
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Figure 5: Risk factors for Surgery patients

Prescribing pattern for drug used during therapy

The total number of medications utilized in 105 prescriptions was 531. The majority of patients (29.94%) received an antibiotic prescription. Antibiotics are used to treat and prevent bacterial illnesses. Antibiotics were the most commonly recommended medication, followed by antiemetic (17.7%). Antiemetic drugs were administered to treat nausea and vomiting. In 70 (13.18%) of the patients, NSAIDs were used to treat pain and fever. Gastric acid secretion inhibitors like Ranitidine are administered to 69 (12.99%) of patients. Gastric acid secretion inhibitors like Pantoprazole, Esomeprazole were administered to 6.77% of patients in order to control acid production in the stomach. The quantity of acid secreted by the stomach was decreased when using an H2 receptor antagonist. NSAIDs are administered to patients in 6.02% of cases. NSAIDs were used to alleviate pain. NSAIDs are used to relieve the pain of renal colic 24. Oral diclofenac have been shown to be effective at reducing the number of new colic episodes. This have been shown to significantly reduce further admission to hospital by 28-57% 25. Antihypertensive drugs like Hydrochlorothiazide were prescribed to 4.14% of patients. Therapies that increase renal fluid output such as diuretics might theoretically facilitate stone passage and elimination because of the associated increased hydrostatic pressure within the ureter. The most effective and best tested diuretics agents are thiazide diuretics like Hydrochlorothiazide which are efficiently used for calcium stones 26. Local anesthetics were prescribed to 12 (2.25%) of the patients. Vaccines and anti hyperuricemic drugs were administered to 2.07% of patients. Anti hyperuricemic medicines are xanthine oxidase inhibitors that are used to lower uric acid levels in the body. Analgesics was administered to 1.3% of patients. Antidiabetic medicines were administered to 0.9% of patients because they had a history of diabetic mellitus. Antihypertensive drugs like Potassium sparing diuretics were administered to 0.3% of patients. Potassium-sparing diuretics are used to treat hypertension. Urinary alkalinisers were prescribed to a relatively small (0.18%) percentage of patients. Urinary alkalinisers administered to neutralize excess stomach acid. Drug prescribed during discharge are given below Table 1. Prescribing pattern of drugs on treatment shown in Figure 6.

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Figure 6: Prescribing pattern of drugs on treatment

Prescribing pattern for drug used during discharge

The total number of medications utilized in the 105 prescriptions was 357. Antibiotics were used to treat the majority of the patients (28.77%). Analgesics were combined in 20.67% of patients. One study demonstrated that addition of calcium channel blocking agent, a steroid, acetaminophen, prophylactic antibiotic to routine therapy increases the stone passage rate and decrease surgical intervention in patients with symptomatic ureteric calculus 27. Gastric acid secretion inhibitors like Ranitidine were administered to 14.52% of patients. In 13.96% of patients, Gastric acid secretion inhibitors like Pantoprazole, Esomeprazole were administered. Alpha adrenergic blockers were administered by 1.11% of patients. Anti-emetics were taken by 1.95% of patients. NSAIDs were administered in 3.63% of cases. Thiazide diuretics were prescribed to 5.30% of patients. 1.95% of patients took anti-hyperuricemic medications. NSAIDs and urinary alkalinizers were used by 3.07% of patients. Anti-diabetic medications and alpha adrenergic blockers were administered to 1.11% of patients. Type-2 diabetes mellitus is treated with anti-diabetic medications. Because some people have a history of Type 2 diabetes mellitus. In the smallest percentage (0.27%) of patients, Antihypertensive drugs like furosemide, anticholinergic medications, and Urinary alkalinizers were administered. Anticholinergic medications prevent cholinergic transmission in the stomach and pelvic parasympathetic ganglia, which results in a spasmolytic action on the smooth muscles of the gastrointestinal, biliary, urine, and female genital tract 28. Alpha adrenergic blockers are used to promote stone ejection in urine 29. Drug prescribed during discharge are given below Table 2. Prescribing pattern of drugs during discharge shown in Figure 7.

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Figure 7: Prescribing pattern of drugs on discharge

Antibiotics Prescription patterns among Ureteric calculus patients

Antibiotics were prescribed to nearly all patients. The majority of the antibiotics were administered as prophylactic medicine. Antibiotics are given before several surgical operations to avoid surgical site infections. Trimethoprim + Sulphamethoxazole (26.33%) was the antibiotic that was prescribed the most frequently out of all the others. Cotrimoxazole is the name given to the drug combination of trimethoprim and sulphamethoxazole. It is effective against S. typhi, Serratia, Klebsiella, Enterobacter, Yersinia enterocolitica, Pneumocystis jiroveci, S. aureus, Strep. Pyrogens, Shigella, Enteropathogenic E. coli, H. influenzae, Gonococci, and Meningococci. A number of urinary, digestive, and respiratory tract infections have been successfully treated with the antimicrobial drug combination trimethoprim-sulfamethoxazole 30. Amikacin was recommended to patients in 24.04% of patients. Aminoglycosides include Amikacin, which prevents the synthesis of bacterial proteins by forming a strong, reversible bond with the 16S ribosomal RNA of 30S ribosomes 31. Aminoglycosides are particularly effective against members of the Enterobacteriaceae family, including Escherichia coli, Klebsiella pneumonia and K. oxytoca, Enterobacter cloacae and E. aerogenes, Providencia species, Proteus species, Morganella species, and Serratia species 32. Ceftriaxone was prescribed to 19.46% of patients. Ceftriaxone, a broad-spectrum beta-lactam antibiotic, has been demonstrated to be effective in vitro against both Gram-positive and Gram-negative aerobic and anaerobic bacteria. Ceftriaxone inhibits the synthesis of cell walls, which results in a bactericidal action that is mediated by its binding to penicillin-binding proteins. In 14.12% of patients, a combination of cefoperazone and sulbactam was administered. Cefoperazone-sulbactam is made up of a third-generation cephalosporin and a beta-lactamase inhibitor, and it has potent in vitro action against a variety of anaerobes as well as gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus and Streptococcus species 33. 14.5% of patients received a prescription for levofloxacin. Levofloxacin is a commonly used FQ for the treatment of complicated UTIs and is effective against a variety of Gram-positive, Gram-negative, and atypical bacteria. Cefixime and Meropenem were given to 0.76% of patients. Meropenem is a carbapenem antibiotic with antibacterial action against gram-negative, gram-positive, and anaerobic bacteria. Meropenem is used to treat a number of bacterial illnesses, including urinary tract infections, meningitis, intra-abdominal infections, pneumonia, sepsis, and anthrax. In order to avoid infection, it is administered before surgery. By impeding their capacity to form a cell wall, it often causes bacterial death. Most typical adverse effects include diarrhoea, rash, nausea/vomiting, and injection-site discomfort 34.

The uropathogens were still susceptible to the cefixime antibiotic, which was still safe and effective. Cefixime is a third-generation oral cephalosporin with a broad spectrum of action that operates by inhibiting bacteria from forming a cell wall. Percentage of antibiotics prescribed shown in Figure 8, Figure 9. Antibiotic prescribing pattern shown in Table 3.

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Figure 8: Percentage of antibiotic prescribed
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Figure 9: Percentage of NLEM listed drugs and Non-NLEM listed drugs

CONCLUSION

When we compared the results of our study to the National List of Essential Drugs (NLEM) 2021, 17 out of the 28 medicines (71.79%) were included. Percentage of NLEM listed drugs and Non-NLEM listed drugs. Drugs outside of NLEM should be appropriately assessed for their usage in certain circumstances. Antibiotic parenteral use was also very prevalent. Antibiotic surgical prophylaxis should also adhere to conventional protocols. Physician knowledge should be strengthened by following updated recommendations and continuing education on urological situations.

ACKNOWLEDGEMENT

Nothing to disclose

Funding Support

Nil.

Conflict of Interest

The author declared that no conflict of interest.

Ethical Approval

The study was approved by the institutional ethics committee.