Drug Utilization Evaluation of Corticosteroids at Secondary Care Public Hospital in Tamil Nadu
Deepalakshmi M, Vignesh Kumar K, Nandini R, Norah HVL Hriatmawii, Arun K. P*
Department of Pharmacy Practice, JSS College of Pharmacy, Ooty - 643001, The Nilgiris Tamil Nadu
(A Constituent College of JSS Academy of Higher Education and Research), India.
*Corresponding Author E-mail: kparun@jssuni.edu.in
ABSTRACT:
This Study was carried out with the objectives of assessing the rationale of prescribing corticosteroids, the most common type of corticosteroids prescribed, and common adverse reactions of corticosteroids and to perform drug utilization evaluation for corticosteroids. Materials and Methods: This prospective observational study was carried out for a period of 6 months by including every case prescribed with corticosteroid in the general medicine wards. The data was captured in a structured form and analysed using SPSS. Result: Amongst the 269 patients included into the study, 51 % were male and 93 (35%) of them were in the age group of 41 to 60 years. Dexamethasone was prescribed more (86%) than other corticosteroids. Common adverse effects observed were abdominal pain and rash. Conclusion: Use of Corticosteroids was found to be appropriate as per standard treatment guidelines.
KEYWORDS: Corticosteroids, Drug Utilization, Dug-Drug Interactions, DUE, Steroids, DDD.
INTRODUCTION:
Drug Utilization Reviews (DUR), also referred to as Drug Utilization Evaluations (DUE) or Medication Utilization Evaluations (MUE), is defined as an authorized, structured, ongoing review of healthcare provider prescribing, pharmacist dispensing, and patient use of medication[11-16]. DUE involves a comprehensive review of patients' prescription and medication data before, during, and after dispensing to ensure appropriate medication decision making and positive patient outcomes[17-21].
The defined daily dose (DDD)is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is normally expressed as Drug usage = Items issued* Amount of the drug per item/DDD. The defined daily dose is a unit of measurement and does not necessarily agree with recommended or prescribed daily dose (PDD). Drug utilization figures should preferably be presented as numbers of DDDs/1000 inhabitants/day or, when in-hospital drug use is considered, as DDDs per 100 bed days[22--25].
This study broadly aimed to evaluate the patterns of corticosteroids utilization in a secondary care public hospital and with the specific objectives of assessing appropriateness of prescribing of corticosteroids, drug interaction with corticosteroids, the most common type of corticosteroids prescribed for the patients and to determine the disease conditions in which corticosteroids prescribed more for the patients.
MATERIAL AND METHODS:
This prospective observational study was conducted for 6 months with the purposive sampling in a secondary care public healthcare setup with420 beds. Patients of either sex prescribed with corticosteroids were included in to the study. The study was approved by the institutional review board and written informed consent was obtained from all the patients recruited into the study. The patient’s prescriptions containing steroids other than Glucocorticoids and Mineralocorticoids like androgens, oestrogens and progestin steroids were not included and patients who were terminally ill were also not included. The data were collected prospectively by direct observation in a defined preform at to capture the data such as demographic, diagnosis, subjective, objective assessments including laboratory parameters, prescribed drugs with their doses, adverse drug reactions if any. The following data about all the drugs in general and corticosteroids in particular were recorded: name, dose and dosage, duration of therapy and route of administration. The collected data were tabulated in the Microsoft Office Excel sheets and statistical analyses were done using SPSS v.21.
RESULTS:
269 patients’ prescriptions were included as per the inclusion and exclusion criteria from all the wards at the study site. The age distribution details are given in Table 1. The male to female distribution of the study participants was found almost equal with the percentage distribution of 51:49 (n = 136 and 133) respectively.
Table 1: Age distribution of corticosteroids to patients
|
Age (Years) |
n (%) |
|
0-20 21-40 41-60 61-80 |
21 (8) 66 (25) 93 (35) 89 (33) |
It was found that corticosteroids were prescribed for 27% of patients (n=73and 72) each at intensive care unit (ICU) and general medicine (male) ward, closely followed by 24% (n=64) of patients at general medicine (female). The remaining percentages were shared by the patients at obstetrics and gynaecology (17%; n=45) and paediatrics (6%; n=15).
The drugs concomitantly prescribed with any one of the corticosteroids are presented in Table 2. Antihistamines, bronchodilators and antibiotics were found to be the top 3 drug classes prescribed along with corticosteroids.
Table 2: Drugs concomitantly prescribed with corticosteroids
|
Classification |
Number of Drugs Used along with corticosteroids |
Percentage of drugs used along with corticosteroids % |
|
Antihistamines |
294 |
20.6 |
|
Bronchodilators |
283 |
19.8 |
|
Antibiotics |
202 |
14.1 |
|
Nutritional Supplements |
151 |
10.6 |
|
Diuretics |
66 |
4.6 |
|
Analgesics |
65 |
4.6 |
|
Calcium Channel Blockers |
58 |
4.1 |
|
Anticoagulants |
52 |
3.6 |
|
Vitamins |
42 |
2.9 |
|
Anticonvulsants |
40 |
2.8 |
|
Proton Pump Inhibitors |
27 |
1.9 |
|
Non Steroidal Anti Inflammatory Drugs |
27 |
1.9 |
|
Statins |
24 |
1.7 |
|
Biguanides |
16 |
1.1 |
|
Antianxiety agents |
13 |
0.9 |
|
Anticholinergics |
12 |
0.8 |
|
Prokinetics |
10 |
0.7 |
|
Beta Blockers |
10 |
0.7 |
|
Antacids |
9 |
0.6 |
|
ACE Inhibitors |
7 |
0.5 |
|
OTC |
6 |
0.4 |
|
Insulin |
3 |
0.2 |
|
Sulfonylurea |
3 |
0.2 |
|
Antiemetic |
3 |
0.2 |
|
Xanthine |
2 |
0.1 |
|
Immunosuppressant |
2 |
0.1 |
|
Antidotes |
1 |
0.1 |
Table 3: Defined Daily Dose (DDD)
|
Drug |
Dose |
Route |
Net quantity (gm) |
WHO DDD (gm) |
DDD |
DDD /100 bed days |
|
Dexamethasone Dexamethasone Dexamethasone Dexamethasone Hydrocortisone Prednisolone Prednisolone Methylprednisolone |
4 mg/ml 8 mg 0.5 mg 6 mg 100 mg 10 mg 5 mg 250 mg |
IV ORAL ORAL IM IV ORAL ORAL IV |
7.344 0.66 0.009 0.192 13.9 0.79 0.69 2.5 |
0.0015 0.0015 0.0015 0.0015 0.03 0.01 0.01 0.02 |
4896 440 6 463 79 79 69 125 |
446.3 40.1 0.5 42.2 7.2 7.2 6.3 11.4 |
From the data presented in Table 3, shows that Defined Daily Dose (DDD) of corticosteroids were identified as per ATC/DDD methodology from WHO collaborating centre for drug statistics methodology, among the listed corticosteroids we categorized as per drug, dose and route of administration. Among them446.3 grams of dexamethasone 4mg/ml through oral, followed by 42.2grams of dexamethasone 6mg through oral and followed by 40.1 grams of dexamethasone 8mg through intramuscular for 100 bed days.
Fig.1: Most Common Corticosteroids Prescribed (%)
Dexamethasone was the most commonly prescribed corticosteroid in the study site and the percentages of other corticosteroids prescribed are shown in Figure 1. The possible interactions of corticosteroids with the co- prescribed drugs were assessed using the standard resources and the data are presented in Figure 2.
Figure 2: Types of interactions with corticosteroids
There were about 402 interventions done in during this study, among which 62 (15%) were no interactions, 206 (51%) were minor interactions, 57 (14%) were moderate interactions and 77 (19%) were major interactions. It was found that major interaction was with Ciprofloxacin. Minor interactions were with Ondansetron, Metronidazole, Salbutamol, Deriphylline and Omeprazole and moderate interactions were with Amlodipine, Atorvastatin, Clopidogrel, Diclofenac, Heparin, Furosemide, Metformin, Nifedipine, Ibuprofen and Phenytoin.
Fig. 3: Common adverse drug reaction with corticosteroids
Among the ADRs of corticosteroids reported from 7 (3%) patients, 6 patients (2%) were identified with abdominal pain and 1 with rash (Figure 3).
Table 4: Types of interventions and their outcomes measures
|
Parameters |
Types |
No of Interventions |
|
Types of interventions |
Pharmacokinetic Pharmacotherapeutics Drug information Others Major |
153 175 2 6 11 |
|
Level of significance |
Moderate Minor |
187 138 |
|
Outcome measures |
Potential ADR/toxicity prevented Enhanced therapeutic effects |
88 248 |
Interventions done by the pharmacists during the study period were classified and presented in Table 4. Level of significance and outcome measures were also analysed and reported.
DISCUSSION:
Corticosteroids being widely used powerful anti-inflammatory and immunosuppressive agents and have become one of the most prescribed drugs in acute and chronic inflammatory diseases[1]. Corticosteroids though are lifesaving drugs; it produces adverse reactions which may be mild or life threatening[2].
In this study, we found that corticosteroids were prescribed more for respiratory tract infections. But, a study done by Merin Susan Abraham et.al found that corticosteroids were given as topical (creams, ointments) for eczema and psoriasis among 282 collected prescriptions containing corticosteroids[3].
Among 269 patients, male were slightly more compared to women. This was contradictory to the results reported in the literature by Dr. Aruna Bhushan et.al, in which out of 760 patients’ (inpatient and outpatient) prescriptions, 498 were female and 262 were male[4]. But another study by Pradeep Kumar Thakur et al showed that, out of 109 outpatients from various departments of the hospital, they found that more corticosteroids were prescribed to male patients[5].
This study found that, patients aged between 41-60 years (35%) were most widely administered with corticosteroids followed by aged between 61 – 80 (33%). Merin Susan Abraham et.al found 18-40 years patients are in taking of corticosteroids was more[3].
Concomitant drugs prescribed along with corticosteroids are Antihistamines (20.6%), Bronchodilators (19.8%) and Antibiotics (14.1%). Concomitant use of antihistamine will block both the neutral and vascular H1 receptors and have a clinical effect on symptoms such as nasal itching, sneezing, and rhinorrhea. H1- antihistamines are absorbed rapidly and begin to reduce the symptoms within one hour.
Defined Daily Dose (DDD) of Corticosteroids were identified as per ATC/DDD methodology from WHO collaborating Center for drug statistics methodology, among them we categorized them by drugs along with their dose and we found their average drug used in percentage. Among them dexamethasone 4mg/ml Intravenous (IV) shown (78%) highest average followed by Hydrocortisone Per Oral (PO) (9%), Dexamethasone 6mg Per Oral (PO) (5%), Prednisolone 5mg Per Oral (PO) (3%), Dexamethasone 8mg Per Oral (PO) (2%) and Dexamethasone 0.5mg Per Oral (PO), Prednisolone 10mg Per Oral (PO), Methyl prednisone 250mg Intramuscular (IM) had shown 1%..
Since, this drug is more prone to adverse drug reactions and drug- drug interactions. Drugs interactions with corticosteroids was categorized based on the three criteria’s as Minor, Moderate and Major Interactions, during the focused study, we identified 402 interventions, in that 62 (15%) were no interactions, 206 (51%) were minor interactions, 57 (14%) were moderate interactions and 77 (19%) were major interactions. Study done by Thomas Zacharia et.al assessed with 10.9% of major interaction, 36.36% of moderate interaction and 52.73% did not show any interaction with steroidal drugs. In contrast with the above study, minor interactions were more i.e 51% and moderate interactions 52.73% were found in their study. The variations may be due to the population among the studies, drugs prescribed or mainly due to irrational usage or over usage of the drug[6].
In 269 patients, 7 (3%) patients were found to have adverse drug effects such as abdominal pain and Rash. Among 7 patients, 6 patients (2%) were found with abdominal pain and 1(0%) were found with rash. Dr. Aruna Bhushan et.al observed common adverse effects with skin atrophy, purpura, striae and weight and betamethasone was the most common causative drug[5]. C. Dhandapani et.al assessed reactions in 75 patients and was monitored, 39% were found with adverse effects and 61% were free from adverse effects. In that 39% they were found to be with single adverse effects (72.4%) was hyperglycaemia nearly 62% and multiple adverse effects (27.5%) was hyperglycaemia with hypokalaemia nearly 6.8%. They found that dexamethasone had shown very less adverse effects when compared to methylprednisolone and other steroids. They also found that the route of administration had an influence in the development of adverse effects[7].
Many pharmacist interventions were made during the study periods and reported and these interventions are classified into Pharmacokinetics interventions 153, Pharmacotherapeutics interventions 175, Drug information 2 and others 5. Level of significance and outcome measures were analysed and reported for the interventions found during the study, among them 11 interventions showed major significance, 187 showed moderate and 138 were minor significance. And 88 potential ADR or toxicity prevented and 248 enhanced therapeutic effect outcome measures were found. This intervention was done by using interventions form which will be a benefit for clinical practices to identify or classify any information regarding to the treatment. In this study 336 drug interaction with corticosteroids and 7 adverse drug effects were found.
The prescribing of corticosteroid was appropriate. Repeated monitoring of drug usage is essential. This study may explain relatively less adverse drug reactions[8]. However, the amount of drug to be used by the patient should be clearly mentioned in the prescriptions in clear terms. The pharmacist intervention outcome measurements represent the scope of improving the efficacy of corticosteroids by minimizing Pharmacotherapeutics and Pharmacokinetic interventions[9]. Hence, pharmacists play a critical role in counselling and ensuring more drug utilization studies to compare the rational use of corticosteroids and also to emphasize that all the prescribers adhere to the prescriptions of corticosteroids[10]. Every case treated with corticosteroids should be considered with regard to relative risk and benefits[11]. Therefore, it should be used rationally and judiciously to minimize the side effects and distresses of the patients.
REFERENCES:
1. Parthasarathi G, Hansen KN, Nahata MC. Drug Utilization evaluation. in, Textbook of Clinical Pharmacy Practice. 2nd ed., Orient Blackswan Private Limited 2012; 44-465.
2. Bhuvana Kolar Bylappa et.al Drug prescribing pattern of topical corticosteroids in dermatology unit of a tertiary-care hospital. International Journal of Medical Science and Public Health. 2015; 4: 1702-1717.
3. Merin Susan Abraham et.al ‘Drug Utilization Evaluation of Corticosteroids in Dermatology Department of a Tertiary Care Teaching Hospital at Palakkad, Kerala. International Journal of Health Sciences and Research. 2016; 6: 130-136.
4. Bhushan et al. Evaluation of adverse effects and utilization of glucocorticoids in a tertiary care hospital; World Journal of Pharmaceutical Research. 2017; 6(1): 724-733.
5. Pradeep Kumar Thakur et al. A Prospective Study on Drug Utilization Evaluation of Corticosteroids among Out -Patients of Teaching Hospital. International Journal of Pharmacy Teaching and Practices. 2015; 6(4): 2630-2634.
6. Thomas Zacharia et.al Prescribing pattern and use of steroids in asthma patient International Research Journal of Pharmacy.2016; 38-41.
7. C. Dhandapani et al. Drug Utilization Evaluation of Corticosteroids Based on Safety: A Prospective Observational Study. International Journal of Pharmacy Teaching and Practices. 2015; 6(1): 1591-1597.
8. Mirshad PV et.al. Prescription audit of corticosteroid usage in the department of dermatology at a tertiary care teaching hospital International Journal of Basic and Clinical Pharmacology. 2013; 2: 411-413.
9. Wahane Pravin Kumar A, Jagtap Rohini P, Ghongane Balasaheb. Evaluation of corticosteroid use pattern in steroid responsive dermatological conditions.
10. D C Weir, R I Gove, A S Robertson, P Sherwood Burge Corticosteroid trials in non-asthmatic chronic airflow obstruction: a comparison of oral prednisolone and inhaled beclomethasone dipropionate. 2017; 6(1): 112-117.
11. Raj Kumar R, Praveen D, Palani Shanmugasundaram A Prospective Study on Drug Utilization Evaluation of Antibiotics for Surgical Prophylaxis. Research Jounal of Pharmacy. and Technology. 2016;9(7): 867-869.
12. Yogesh Joshi, Punam Gurung, Siddhi Jain. Evaluation and Assessment of Drug Utilization in Patients of Urinary Tract Infections. Asian Journal of Pharmaceutical Research.2018; 8(3):167-169.
13. S Palanisamy, A Sumathy, C Sundaramoorthi and KSG Arul Kumaran. Drug Use Evaluation of Anti-Hypertensives at a Teaching Hospital in South India. Research Jounal of Pharmacy. and Technology. 2009; (3): 477-481.
14. Bhamare A.B., Bhamankar K.H. and Khairnar A.S .Drug Utilization 90% of Urinary Tract Infections Drugs – A Simple Method for Assessing the Quality of Drug Prescribing. Research Jounal of Pharmacy. and Technology. 2011; 4(8): 1328-1330.
15. Avinash S. Khairnar, Mangesh S. Bhalerao and Pravin M. Bolshete. Drug Utilization (DU) 90% Study in Burn Population. Research Jounal of Pharmacy. and Technology.2011; 4(8): 1246-1249.
16. Pradip A wale, Devendra Sonawane, Sangle Dhananjay et al. Study of Drug Utilization 90% in Health Centre. Research Jounal of Pharmacy. and Technology .2013; 6(8): 899-901.
17. Avinash Khairnar, Supriya Jamdade. Prospective Cross-Sectional Observational Study on Evaluation of Drug Utilization 90% Study in Cardiovascular Diseases. Research Jounal of Pharmacy. and Technology. 2014; 7(9): 981-986.
18. M. Sumithra, Avantika, Prabhabanik. A Prospective Study of Drug Utilizationand Evaluation of Gastro Intestinal Agents. Research Jounal of Pharmacy. and Technology. 2017; 10(1): 166-170.
19. Anis Fathima.A.G1, Dr. Vara Prasanna Rao2, Dr. P. Shanmugasundaram A Prospective Observational Studyon Drug Utilization Evaluation of Atorvastatinin Tertiary Care Hospital. Research Jounal of Pharmacy. and Technology. 2017; 10(7):2183-2188
20. Ms. Merry Raphael, Dr. Vijayanarayana K, Dr. Girish Thunga et al. Utilization Pattern of Anti-Diabetic Drugs in Type 2 Diabetes Mellitus in Tertiary Care Hospital. Research Jounal of Pharmacy. and Technology .2017; 10(7):2063-2068
21. Maheshwari. P, Manimekalai. P, Anuja. P, Abuk Biar. Antibiotic Drug Utilization and Evaluation in Pediatric Patients. Research Jounal of Pharmacy. and Technology .2017; 10(8): 2704-2706
22. Sweileh WM. Audit of prescribing practices of topical corticosteroids in outpatient dermatology clinics in north Palestine. Eastern Meditern Health Journal. 2006; 12(1): 161-169.
23. Defined Daily Dose (DDD) [Internet]. World Health Organization. 2019 [cited 25 September 2018]. Available from: https://www.who.int/medicines/regulation/medicines-safety/toolkit_ddd/en/
24. WHOCC - Definition and general considerations [Internet]. Whocc.no. 2019 [cited 25 September 2018]. Available from: https://www.whocc.no/ddd/definition_and_general_considera/
25. Salas M. Drug Utilization Studies [Internet]. Pharmacoepi.org. 2012 [cited 25 September 2018]. Available from: https://www.pharmacoepi.org/pub/?id=1c22e0d8-2354-d714-51fe-68590802a0ae
Received on 19.04.2019 Modified on 16.05.2019
Accepted on 20.06.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2019; 12(11):5456-5460.
DOI: 10.5958/0974-360X.2019.00946.6