Introduction
Urology is a surgical specialty that treats diseases of the male and female urinary tracts and male genitalia. Various urological diseases include urinary tract infections, prostatitis, kidney stones, BPH and LUTS/prostate enlargement, frequency/overactive bladder, prostate cancer, impotence/erectile dysfunction, bladder cancer, kidney cancer, testicular cancer, and urethral cancer. This can lead to drug interactions, adverse treatment outcomes, and increased medical costs, leading to patient mortality. Therefore, drug use studies are usually conducted in health care settings, analyzing trends in drug prescription and whether drugs are rational or irrational. Different brands of the same drug are available to the patient and provide the same therapeutic effect. An analysis of these costs can reveal "price differences between brands" that can cause significant financial burdens and moral and ethical problems for patients. Therefore, in this work, the use and cost analysis of medicines is necessary to improve the general state of health and health care.
The majority of infections tend to affect the lower urinary tract, which includes the bladder and the urethra. A urinary tract infection, on the other hand, has the potential to extend into the kidneys, resulting in significant health complications. Symptoms are not always presented by UTIs. Typically, when bacteria infiltrate the urinary tract via the urethra and begin to disseminate within the bladder, it induces pelvic discomfort in females, particularly concentrated in the middle of the pelvis and surrounding the region affected by UTIs. The purpose of the urinary system is to prevent the entry of bacteria. Prostatitis frequently leads to discomfort or hindrance during urination, accompanied by pain in the groin, pelvic region, or genitals. Chronic bacterial prostatitis is characterized by an ongoing or recurring bacterial infection that typically presents with milder symptoms. Chronic prostatitis, or chronic pelvic pain syndrome, refers to an enduring or recurrent discomfort in the pelvic region along with urinary tract symptoms, despite the absence of any infection. Kidney stones can potentially affect any part of your urinary tract, extending from the kidneys to the bladder. Prostate cancer is a disease that affects the small, walnut-shaped gland in males responsible for producing seminal fluid. Another type is adenocarcinoma, where the cancer originates in cells that produce mucus and other fluids.1, 2, 3, 4
The most commonly prescribed drug classes in urology are alpha-blockers: which relax the muscles in the bladder and neck to improve urine flow, and 5-alpha-inhibitors, which treat an enlarged prostate by preventing the production of male hormones associated with prostate enlargement. Alpha-blockers, also called alpha-adrenergic antagonists, are used to treat certain symptoms of benign prostatic hyperplasia (BPH). This is a non-cancerous enlargement of the prostate gland. Alpha-blockers currently approved to treat BPH symptoms are short-acting drugs that work quickly but only last a few hours. These medications are usually used in combination with alpha-blockers to improve urine flow and bladder emptying in men with genetic BPH. They are sometimes used with alpha-blockers or 5-alpha-reductase inhibitors for genetic men with BPH and OAB. Anticholinergic medications currently approved to treat overactive bladder include: anticholinergic medications can cause side effects such as confusion, dry mouth, constipation, blurred vision, and rapid heartbeat (tachycardia). These drugs can also slow the flow of urine in men with BPH.
Cost analysis is a type of partial pharmacoeconomic evaluation that compares the costs of two or more alternatives, regardless of outcomes. Different brands of the same drug are available to the patient and provide the same therapeutic effect. Analysis of these costs can reveal "price differences between brands" that can cause significant financial burdens and moral and ethical problems for patients.
Review of Literature
Rajiv Ahlawat et al.5, conducted a cross-sectional study on “Drug Utilization Pattern in Chronic Kidney Disease Patients at a Tertiary Care Public Teaching Hospital.” A total of 408 patients diagnosed with CKD were included in the study. The average age of the patients was 53.8 (6.4). Of all, 18% of the patients were on dialysis. It was found that 42% of the patients belonged to the end stage of renal disease. The mean (SD) of the drugs was found to be 6.57 (2.3). Only 19% of the drugs prescribed on the Indian National List of Essential Medicines (NLEM) No drug was found to be prescribed by generic name. Out of the total 2,681 drugs prescribed, the most were cardiovascular drugs (33.9%). Further, it was also found that 14.7% of the patients were prescribed antimicrobials. Among all, 22.3% of the patients were vaccinated with the hepatitis B vaccine. The five most prescribed drugs were calcium carbonate, vitamin D, iron, torsemide, and amlodipine (13.9%, 12.2%, 11.5%, 8.1%, and 6.1%, respectively). Ninety-five percent of the patients were prescribed phosphate binder (PB). Calcium carbonate was the most commonly prescribed PB for 91.1% of the patients. Sevelamer was prescribed to only 18 patients.
Ahmad Najma et al.5, from Bhopal, conducted a cross-sectional study on “A Cross-Sectional Study of Drug Utilization Pattern in Indoor Patients of Tertiary Care Teaching Hospitals in Central India.” A total of 77 patients were included, 62% male and 38% female. The maximum number of patients admitted for infectious diseases was 34%. Pantoprazole was the most prescribed drug, and ceftriaxone was the most prescribed antibiotic. The average number of drugs prescribed per encounter was 4.87. The oral route was the most preferred. The percentage of drugs prescribed by generic name was 42.44%. The percentage of drugs prescribed from the essential medical list was 49.33%. Multivitamins and non-steroidal anti-inflammatory drugs (NSAIDS) were the most prescribed fixed-dose combinations in our study.
F. Boronat, et al. 5, from Valencia, Spain, conducted a prospective study on “costs and hospital procedures in the urology department of a tertiary hospital." "Analysis of groups related by their diagnosis” A total of 32,510 outpatient consultations, 7527 techniques, 2860 interventions, and 4855 hospital stays were made during 2014. The total cost was 7,579,327 €; the cost for outpatient consultations was 1,748,145 €; 1,229,836 € for technical consultations; 2,621,036 € for surgery procedures; and 1,980,310 € for hospital admissions. Considered as income by the current rates applied in 2014 (a total of 15,035,843 euros), the difference between income and expenditure was 7,456,516.
H. V. Bimba et al.5 from Mangalore conducted prospective studies on “Drug utilization, rationality, and cost analysis of antimicrobial medicines in a tertiary care teaching hospital in Northern India: A prospective, observational study.” AMMs were prescribed to 37.9% of outpatients and 73% of admitted patients. Outpatient encounters with AMMs were 40.6% (medicine) and 25.6% (surgery). The total DDDs/100 patient days of AMMs in medicine and surgery were 3369 and 2247. Bacteriological evidence of infection and AMM sensitivity was present in only 8.5% of cases. Over 90% of AMMs were prescribed from the hospital's essential medicines list. Most of the AMMs were administered parenterally (64.9%). Multiple AMMs were prescribed more to inpatients (84.2% vs. 4.2% of outpatients). Overall, expenditure on AMM was 33% of the total cost of treatment for medicine. ABC analysis showed that 74% of the expenditure was due to newer, more expensive AMM, which constituted only 9% of the AMM used. The AMM therapy was found to be appropriate in 88% of cases, as per Kunin's criteria for rationality.
S. R. Gawde et al.5, from Mumbai, conducted an observational, prospective study on “Drug Utilization Pattern and Cost Analysis in Rheumatoid Arthritis Patients: A Cross-Sectional Study in Tertiary Care Hospital, Mumbai." The majority of patients (67%) in the study population were on a combination of two DMARDs. The most frequently prescribed combination of two DMARDs was methotrexate and hydroxychloroquine (64%). The average total cost per prescription was found to be 763.39 (US$ 14), while the average hospital and out-of-pocket expenses were 281.12 (US$ 5) and 482.88 (US$ 9), respectively.6, 7, 8, 9
Materials and Methods
Method of collecting data
A standard data collection form devised for the study, a drug list, and a facility care indicator form for the institution were used as study instruments, fulfilling the eligibility criteria, and included in the study. Demographic characteristics like age, gender, educational status, and occupation were recorded. Information regarding diagnosis (cause for admission), comorbidities, medical history, ongoing treatment, documented adverse drug reactions (ADRs), and investigations performed was collected from the patient records available in the wards.
The drug utilization pattern among male and female patients was evaluated using the prescribing indicators recommended by the WHO: average number of drugs per prescription, percentage of prescriptions (encounters), injections prescribed, percentage of drugs prescribed by generic name, and essential drug list. Additionally, detailed information about the medications prescribed, demographic details, medication history, laboratory data, drug class, route of administration, dose, frequency, and duration of administration The data collected has been noted in a self-designed patient data collection form.10, 11, 12, 13, 14, 15
Statistical analysis
The data was collected and entered in Microsoft Excel software 2019 and interpreted by descriptive statistics that were presented to analyze and express the report as counts and percentages in the form of tables, charts, and graphs.
The statistical analysis of the collected data was performed using IBM SPSS version 26 statistical software.
A p-value of >0.05 was taken as significant.
Ethical Consideration
Results
Patient’s age wise categorisation
Out of 200 cases, the patients are divided into seven categories according to their age. Patients who are aged between 50 and 64 have a high probability of being admitted to the hospital with urological disorders. A total of 128 patients were above 50 years of age, while 72 were below 50 years of age.
Gender distribution
In the current study, the dominant gender was male (129) and the remainder was filled by the female gender (67).
Patient’s diagnosis
Out of 200 cases, the patients' diagnoses of various urological disorders are listed below in the Table 1 and depicted in the Figure 1.
Patient with comorbidities
The highest number of patients with more than two co-morbidity diseases is 45 (22.5%), and the patients with no co-morbidities are 118 (59%).
Table 1
Patient Distribution with Co-Morbidities
Total patients with Co-morbidities
Out of 200 cases, 82 patients were assessed with co-morbidities, while 118 patients were free of co-morbidities.
Class of drugs prescribed
For 200 patients diagnosed with urological disorders, the classes of drugs prescribed are listed in the table below. The major portion belongs to analgesics and antipyretics (274), followed by antibiotics (186). The least prescribed class of drug is loop diuretics (with only 56). The data is given in the table and chart below.
SPREad of srugs prescribed
In the 200 cases collected for the current study, the most prescribed drugs for the treatment of urological disorders were tabulated below. A total of 938 drugs were prescribed, out of which T. DOLO (paracetamol) is the most prescribed tablet and Inj. KEPHAZONE is the most prescribed intravenous drug. The following data is depicted in a table.
Table 2
Spread of drugs prescribed
Cost minimisation analysis
Out of 200 cases, the total medication cost for the treatment of urological disorders was calculated and listed below in the table. The cost of brand and generic drugs is taken into account to perform a cost minimization analysis. The generic drugs are endorsed with the same effectiveness as their respective brand-name counterparts. The total cost of medication for 200 patients while on brand and generic drugs is 250668.1 and 118921.531, respectively. The average cost for a patient if prescribed with brand drugs is estimated at around 1253 rupees, but it reduces to 594 rupees when on generic medication. 16, 17, 18, 19
Table 3
Cost minimization analysis
Drugs per encounter
In the 200 cases studied, the average number of drugs in a single prescription was found to be 6.94. The WHO indicated that the average number of drugs per single encounter falls to two per prescription.Figure 6
Number of prescription according to WHO prescribing indicator
The number of prescriptions the physicians prescribed according to the WHO indicators is only 34 out of 200, while the rest of the cases contain two or more drugs in a single encounter. The data is listed below and charted.
Drug count distribution
Among the 200 cases analyzed, the maximum number of drugs prescribed on a single prescription was 14 for one patient. Notably, prescriptions containing 7 or 8 drugs per encounter were the most common, occurring 43 times. This data highlights a concentration in prescription complexity, with a significant frequency of prescriptions involving 7 or 8 drugs per patient encounter.
Drugs prescribed by generic name total number of drugs prescribed
For 200 patients, 1769 drugs were prescribed for the treatment of urological disorders. For these drugs, 421 (23.79%) were given as generic drugs, while the remaining 1348 (76.20%) were prescribed by their brand name.
Number of generic drugs according to WHO indicator
The percent recommended by the WHO for prescribing generic drugs is 100. In the study with 200 cases, 23.79 percent were given generic drugs.
Encounters with antibiotics
For 96 patients out of 200, the physician has prescribed an anti-biotic medication along with other urological treatment drugs. The 104 patients who are not prescribed antibiotics have a preponderance over other patients.
Encounters with injections
Out of 200 cases, 96 (48%) patients had not been administered injections. The number of patients who were given at least one injection fell to 104 (52%). The data is given below in the table.
Drugs prescribed from national drug formulary
1769 drugs are prescribed for 200 patients. All the drugs that are prescribed for the treatment of urological disorders are listed on the National Drug Formulary, which ensures their efficacy and safety.
Polypharmacy in treatment of urological disorders
Out of 200 patients, 128 were over the age of 50 years. In these 128 patients, 116 were prescribed five or more drugs, which eventually resulted in polypharmacy. The percent of patients having more than five drugs is 58%, which is quite high. The collected data is shown below.
Drug interactions
Out of 200 cases, a total of 50 cases had drug interactions. In which 100 drug interactions were found, 32 of them were major drug interactions and 68 were moderate drug interactions.
Discussion
Among the 200 cases collected for our study, we found that the majority of patients aged between 50 and 64 (37.50%) had a higher percentage of being admitted to the hospital. A total of 128 were above 50 years of age, and 72 were below 50 years of age. The study was found to be consistent with the study conducted by Rajiv Ahlawat et al., which indicated that male patients are more prevalent when compared to female patients. (Figure 1)
Out of 200 cases, the majority were males (129, 66%) and females (67, 34%). (Figure 2)
Out of 200, 26% were diagnosed with benign prostatic hyperplasia (BPH), followed by 21% with urinary tract infection (UTI), 20% with left renal calculus, 19% with CKD, 14% with left VUJ calculus and acute gastroenteritis, 12% with right VUJ calculus, and 9% with CA bladder. The common diagnosis was found to be BPH and UTI. (Figure 3)
In our study, patients with co-morbidities were found to be 82 (41%), and patients without co-morbidities were 118 (59%). (Figure 4)
Patients with more than two comorbidities of hypertension and diabetes mellitus and others were 45 (22.5%), which indicates that hypertension followed diabetes mellitus and hyper and hypothyroidism were the most common comorbidities associated with various urological disorders. The morbidity and mortality rate can be reduced by controlling risk factors like hypertension, diabetes mellitus, and others. (Table 1)
200 prescriptions from patients suffering from urological disorders were collected. 274 prescriptions of analgesics and antipyretics followed 186 antibiotics, and the least prescribed drug was only loop diuretics (56) constituting 26.7%, 18.1%, and 5.5%. (Figure 5)
In 200 cases, a total of 938 drugs were prescribed. The most prescribed drugs for the treatment of urological disorders were T. DOLO (paracetamol)-166 (17.69%), which is the most prescribed tablet, and INJ. KEPHAZONE-96 (10.23%), which is the most prescribed intravenous drug. (Table 2 )
The average standard mean of brand cost was 1253.3405 and generic cost was 594.607655. The total cost of medication on brand and generic drugs is 250668.1 and 118921.531. The average cost of brand drugs prescribed is 1253 rupees and 594 rupees for generic drugs, implying that the average cost of generic medication is less expensive than the cost of brand drugs. Less economic burden will be placed on the patients if drugs are prescribed under generic names, assuming they have the same efficacy as the branded drugs. (Table 3)
The average drug per single prescription was 6.94, and the WHO indicated that the average drug per single encounter falls at 2 per prescription. (Figure 6)
The drugs prescribed according to the WHO indicator are only 34 cases out of 200, while the rest of the cases contain two or more drugs in a single encounter. According to the WHO, 17%, and not according to the WHO, 83%. (Figure 7)
Among the 200 cases analyzed, the maximum number of drugs prescribed on a single prescription was 14 for one patient. Notably, prescriptions containing 7 or 8 drugs per encounter were the most common, occurring 43 times. This data highlights a concentration in prescription complexity, with a significant frequency of prescriptions involving 7 or 8 drugs per patient encounter. (Table 4)
For 200 patients, 1769 generic drugs were prescribed for the treatment of urological disorders. Of these 421 drugs (23.79%) given as generic drugs, the remaining 1348 (76.20%) were prescribed by their brand name. (Figure 8)
WHO prescribing indicators with generic drugs are 100%, and out of 200 cases, 23.79% were given with generic drugs. (Figure 9)
Out of 200 cases, 96 patients were prescribed an antibiotic drug along with other drugs, and 104 patients were not prescribed an antibiotic. (Figure 10)
Out of 200 cases, 96 (48%) patients were not administered injections. The number of patients given at least one injection was 104 (52%). (Figure 11)
The percentage of drugs prescribed in the national drug formulary was 100. (Figure 12)
Polypharmacy was also observed in our study. Out of 200 patients, 128 (64%) were over the age of 50. In these 116 patients prescribed 5 or more drugs, the percentage of patients having more than 5 drugs is 58%, which is quite high. 12 patients were prescribed less than 5 drugs, and the percentage of patients having less than 5 drugs is 6%. (Figure 13)
In a total of 200 cases, 50 had drug interactions. In which 100 drug interactions were found, 32 were major drug interactions, and 68 were moderate drug interactions. (Figure 14)
Out of 200 cases, a total of 29 cases had adverse drug reactions (ADR). major reactions with ceftriaxone 9 (31.03%) and least with tramadol 7 (24.14%), aspirin 5 (17.24%), furosemide 2 (6.90%), glimepiride 2 (6.90%), pantoprazole 2 (6.90%), atorvastatin 1 (3.45%), and metformin HCL 1 (3.45%). (Figure 15)
Out of 200 cases, based on age, polypharmacy, and concurrently interacting drugs with the occurrence of ADR, there were 44 (100%) cases, respectively. Based on age, the number of occurrences is 15 (34.09%), the polypharmacy number of occurrences is 11 (25%), the concurrent interacting drug number of occurrences is 18 (40.09%), and the total number of occurrences is 44 (50%). (Figure 16)
In 200 cases of ADR management, 63% of drugs were withdrawn, 25% of doses were altered, and in 12% of patients, doses were altered and drugs were withdrawn. (Figure 17)
Conclusion
This study offers health care information and drug utilization trends for professionals who manage associated co-morbidities in hospitalized cases of urological disorders.
In our study, patients with co-morbidities were found to be 82 (41%), and patients without co-morbidities were 118 (59%). Patients with more than two comorbidities of HTN and DM and others were 45 (22.5%), which indicates that hypertension followed diabetes mellitus and hyper and hypothyroidism were the most common comorbidities associated with various urological disorders. The morbidity and mortality rate can be reduced by controlling risk factors like HTN, DM, and others.
In our study, the overall prescription pattern of drugs is satisfactory in the urology department and provides valuable insight.
Our study shows that most of the drugs are not prescribed by brand name, which results in high treatment costs.
The physicians should be encouraged to prescribe the drugs with a generic name to the maximum that could reduce the cost burden on the patients, receive rational treatment for the disease, and avoid polypharmacy or other medical-related problems.
The result of our study was to help physicians or prescribers enhance patient management by bringing rationality to prescription.
Polypharmacy, overuse of analgesics and antipyretics, and proton pump inhibitors were areas of concern.
Prolonged and irrational use of antibiotics for treatment was noted in patients in the urology department.
Out of 200 cases, 96 patients were prescribed an antibiotic along with other drugs, and 104 patients were not prescribed an antibiotic.
Acknowledgement
As he is the first and the last, we thankfully bow with reverence before the almighty, who is the source of all wisdom and knowledge, the creator, who, by his wishes and blessings, made us attain the successful completion of this dissertation. We express our deepest sense of gratitude to our Honorable Secretary, Sri H. R. Kiran, for providing the facilities and extending his support. We express our deepest sense of gratitude to Dr. Narayana Swamy, V.B., Principal of RRCP, for his sincere gratitude and support. We express our sincere gratitude to Dr. E. Satheesh Kumar, Professor and HOD, for his constant guidance and support. Our sincere gratitude to all the teachers for providing their support to accomplish this wonderful work. Our sincere thanks to all the doctors and hospital staff for providing their continuous support throughout the work. Finally, our deepest gratitude goes to our beloved parents, Narasimha Rao J, Krishna Veni J, Sheeja Subair, Subair, M. Sunil KUMAR, and SINDHU M, for their unflagging love and unconditional support throughout our lives and studies. You gave us all the resources and your hard work to get a better education. We express our sincere gratitude to all those who have directly or indirectly supported us in making this work a success.
