Study on Steroid Utilization Patterns in General Medicine Department

 

Vishwanath Gouda¹, C. S. Shastry^1*, Uday Venkat Mateti^{1, 2}, Chetan Subrahmanya³,

Sharad Chand¹

¹Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences,

Nitte (Deemed to be University), Deralakatte, Mangaluru- 575018, India

²Department of Pharmacy Practice, G. Pulla Reddy College of Pharmacy, Hyderabad- 500028, India

³Department of General Medicine, K.S. Hegde Medical Academy, Nitte (Deemed to be University)

Deralakatte, Mangaluru-575018, India

 

ABSTRACT:

Background: Corticosteroids are of great value in treating a wide spectrum of inflammatory conditions as they provide rapid symptomatic relief, especially in the short term. These highly efficacious drugs are mostly used for the treatment of various autoimmune, respiratory, and dermatological conditions. The frequent use of steroids for their palliative effects often leads to its misuse in medicine practice. Periodic monitoring of the drug utilization pattern is one of the methods to analyse the rationality of drug use and has been an effective tool to constitute guidelines for improving the utilization pattern. Aim and objectives: to study the prescribing patterns of steroids in general medicine department, to study the prescribing and administration related factors. Methodology: A prospective observational study was carried out in 324 In-patients from the general medicine department of the hospital during eight months period and subjected to statistical analysis. Results: Out of 324 patients, 207 (63.9%) were males, and 117 (36.1%) were females. More than half of the study population (53.1 %) belonged to the elderly age group of 51-70 years. Social habits of the patients revealed that 105 patients were smokers, 149 patients consumed alcohol. 154 (47.5%) of the patients were teetotallers and non-smokers. Almost 38.8% of reasons were related to respiratory tract infection for which steroid prescription was found to be common. Out of 324 cases common morbidities were COPD (34.9%), asthma(17.0%), broncho pneumonia (16.0%), other pulmonary diseases (8.6%). Other reasons included severe allergic reactions (7.7%), allergic conditions (7.4%), tuberculosis (4.9), dermatological Diseases (2.5%) and septic shock (0.9%), etc. budesonide was the most prescribed steroidal drug for 214 (66%) patients followed by hydrocortisone 56 (17.30%), prednisolone 29 (9%) and so on. Conclusion: It may be concluded that clinical pharmacist can play an important role in the prescription audit and safety assessment of steroid medications in hospital settings, including corticosteroids. The commonly used corticosteroids were budesonide and frequently used in respiratory diseases like COPD and Asthma.

 

 

INTRODUCTION:

The World Health Organization (WHO) in 1997 defined drug utilization as the marketing, distribution, prescription and use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences.

 

Drug utilization research is an essential part of pharmacoepidemiology and pharmacoeconomics as it describes the extent, nature, and determinants of drug exposure. Drug Utilization Evaluation (DUE) allows the pharmacist to document and substantiate the benefit of pharmacy intervention in improving therapeutic and economic outcomes¹. Corticosteroids are of great value in treating a wide spectrum of inflammatory conditions as they provide rapid symptomatic relief, especially in the short term. These highly efficacious drugs are mostly used for the treatment of various autoimmune, respiratory, and dermatological conditions². Steroids are commonly used as the main stream treatment for some inflammatory conditions like systemic vasculitis (inflammation of blood vessels) and myositis (inflammation of the muscle). As early as in the 1930s, the hormone cortisone was isolated from the adrenal glands, and its efficacy for treatment of rheumatoid arthritis was empirically demonstrated in patients suffering from this debilitating disease³. The frequent use of steroids for their palliative effects often leads to its misuse in medicine practice. Steroidal drugs are also having certain major and minor side effects, especially when used for a longer duration of time. The dose of corticosteroids that are prescribed, dispensed, and administered must be carefully considered as too little steroid can show a poor response, whereas excess application can increase the risk of adverse reaction⁴. For this, rational use is necessary to minimize both systemic and cutaneous side effects. In India, most of these medications, especially topical corticosteroids, are sold without any prescription. The patient can easily obtain these medications from local pharmacy⁵. As per the information available on the Central Drugs Standard Control Organization (CDSCO) website, the off label use of the steroidal drug is quit rampant.

 

Periodic monitoring of the drug utilization pattern is one of the methods to analyse the rationality of drug use and has been an effective tool to constitute guidelines for improving the utilization pattern. This will not only constitute a rational therapy but also lead to economic benefit and easy identification of the problem related to drug use like poly pharmacy, drug interactions, and adverse reactions. The prescription of steroids depends on factors such as the choice of the physician, socio economic condition of patients, comorbidities, drug interactions, patient’s idiosyncratic reactions^6,7,8. The data regarding drug usage patterns of steroids in general medicine department are particularly lacking. The present study is undertaken to study the prescribing patterns of steroids in General medicine department of a tertiary care hospital located in semi urban settings of Dakshina Kannada district, Karnataka. The outcome of the study gave us valuable data related to corticosteroids usage, prescription pattern, prescription errors, patient compliance, etc.

 

MATERIALS AND METHODS:

Ethical Consideration:

Ethical approval (Ref. No: NGSMIPS/IEC/18/2018-19) was obtained from the Institution Ethics Committee (IEC) for carrying out the study.

 

Study Design:

A prospective observational study.

 

Study Site:

Department of General Medicine, Justice K. S. Hegde Charitable Hospital, Deralakatte, Mangaluru.

Duration of Study:

Eight months (15th August 2018 – 15th April 2019)

 

Subjects:

Patients prescribed with any steroids

 

Sample Size:

The sample size was calculated by using below mentioned formula 

 

                                      z₁²-α/2.P.Q

n = –––––––––––––––

                                            d²

Where, z₁ = 1.96

P  = 0.30 (precision)

d  = 0.05 (prevalence)

α = level of significance

The minimum sample size for this study is 324.

 

Inclusion Criteria:

Inpatients above 18 years of age and either gender admitted in the general medicine department prescribed with any type of steroids.

 

Exclusion Criteria:

Pregnant and lactating women, psychiatric illness, critically ill patients, and the patient who were not willing to participate in the study.

 

Data Collection:

The patients who met the inclusion criteria were enrolled in the study after taking Informed Consent (IC) before commencing the study. The demographics information such as age, gender, comobidities, occupation, educational details, domiciliary status, and social habits were collected. Steroid therapy related information such as type of steroids used, potency, classification based on the duration of action, Systems associated with steroids use and status of steroid abuse data were collected and documented in the case record form. Medication history, using the generic name of the drug, dose, frequency of administration, direction for topical application & legibility of medication orders, were also recorded. All the inpatients were taken for follow up for assessing the safety of steroids.

 

Data Analysis:

Categorical variable was analyzed by using frequency and percentage. Confidence of intervals for the percentage of the users in different formulations, potency, duration, indications was calculated and presented in graphs and tables by using SPSS software (Version 20.0).

 

RESULTS:

Age-gender distribution:

Three hundred and twenty four inpatients confirming to the inclusion criteria were recruited for the study, 63.9% were males, and 36.1% were females. It was found that the age group wise distribution followed a normal line with 33% of the patients in the age group of 61-70. 74% of the study population was more than 50 years of age (Table 1). Statistical analysis was done for age-gender distribution using (ANOVA), and the results showed a significant difference in gender distribution among the different age groups with a p-value of 0.029.

 

Table 1: Gender and age group

Age-group	Gender		Total	Percent
	Male	Female
18 to 30	15	15	30	9.3 %
31 to 40	15	4	19	5.9 %
41 to 50	16	19	35	10.8 %
51 to 60	38	27	65	20.1 %
61 to 70	77	30	107	33.0 %
71 to 80	32	19	51	15.7 %
> 80	14	3	17	5.2 %
Total	207	117	324	100

 

 

Domiciliary status:

Out of 324 patients, 69.75% of patients from a rural area, and 30.24% of patients were from urban settings. This may be because the study centre is located in a rural area, and the urbanites have got excess to more hospitals (Table 2).

 

Social habits:

The analysis of the social habits of the recruited patients revealed that 105 patients were smokers, 149 patients consumed alcohol. 154 (47.5%) patients were teetotallers and non-smokers. We found seven patients were substance abusers (Table 3).

 

Table 2: Domiciliary status and gender

Gender	Domiciliary status		Total
	Rural	Urban
Male	149	58	207
Female	77	40	117
Total	226	98	324

 

Table 3: Social habit and diagnosis

Social habit	Diagnosis
	COPD	Asthma	TB	BP	OPD	SAR	AC	DD	SC	Total
None	46	33	4	25	18	8	12	7	1	154
Smoker	4	6	1	2	3	1	2	1	1	21
Alcoholic	33	8	6	11	2	3	2	0	0	65
Smoking and Alcohol	28	8	5	14	3	11	7	0	1	77
Smoking, Alcohol and Substance	2	0	0	0	2	2	1	0	0	7
Total	113	55	16	52	28	25	24	8	3	324

COPD – Chronic obstructive pulmonary disorder, TB – Tuberculosis, BP - Broncho pneumonia, OPD - Other pulmonary diseases, SAR - Severe Allergic Reaction, AC – Allergic Conditions, DC - Dermatological Diseases, SC - Septic Shock.

 

Table 4: Age group and diagnosis

COPD – Chronic obstructive pulmonary disorder, TB – Tuberculosis, BP - Broncho pneumonia, OPD - Other pulmonary diseases, SAR - Severe Allergic Reaction, AC – Allergic Conditions, DC - Dermatological Diseases, SC - Septic Shock.

 

Reason for admission:

The reason for admission was mentioned as generalized weakness due to the complaints of cough and expectoration, fever, breathlessness, cold, pain, and vomiting possibly due to respiratory tracts infections. In some other cases, the admission was made for neurological, dermatological, and haematological reasons.

 

Disease-age correlation:

We also analysed the disease pattern among the patients of the different age groups. One hundred seven patients of each age group of 61-70 constituted the largest group receiving the steroids followed by 65 patients of the age group 51-60. Interestingly age wise distribution of several people receiving steroids also showed a decent normal distribution curve. 34.9% of patients with COPD received corticosteroids, which found the largest group in our study. This was followed by asthma (17%), bronch-pneumonia (16%), and another disease (32.1%) (Table 3.4).

 

Steroidal prescription:

Three hundred and fifty nine prescriptions containing steroids were made. Several steroidal prescriptions varied from 1 to 3, with an average of 1.1.  A total of 10.18 % of study participants received multiple drug therapy compared to 89.81 % of participants who received a single drug. We came across two prescriptions with three steroidal drugs.

Table 5: Number of steroids and diagnosis

 

Of the two patients who received two corticosteroids, one was admitted with broncho-pneumonia. To manage the acute case, the doctors suggested budesonide and hydrocortisone for quick recovery. The second case was of COPD and allergic condition. This patient was also prescribed with three corticosteroids budesonide, hydrocortisone, and prednisolone. The decision was taken to quickly manage inflammation and acute broncho congestion. Otherwise, as stated above most of the conditions are managed with one steroid (Table 5.)

 

Steroid combination therapy:

The most widely used combination was Budesonide + Hydrocortisone (6.68 %) and Budesonide + Prednisolone (1.39%) (Table 6). Most of the patients were prescribed corticosteroids for not more than 1-2 weeks.

 

Table 6: Steroid combination therapy

Combination	No. of patients prescribed
Budesonide and Hydrocortisone	24
Budesonide and Prednisolone	5

 

Table 7: Pattern of corticosteroid prescription

Steroidal Drug	Percentage (%)
Budesonide	66.00
Hydrocortisone	17.30
Prednisolone	9.00
Beclomethasone	7.10
Dexamethasone	4.30
Deflazacort	4.30
Betamethasone	1.50
Methylprednisolone	0.60
Fluticasone	0.30

 

Prescription pattern of corticosteroids:

The analysis of results on the steroids prescribed revealed that only nine steroids were used in the study population. The pattern of drug prescription for treating various disorders with steroids showed that budesonide was the most prescribed steroidal drug for 214 (66%) patients followed by hydrocortisone 56 (17.30%), prednisolone 29 (9%), beclomethasone 23 (7.10%), dexamethasone 14 (4.30%), deflazacort 14 (4.30%), betamethasone 5 (1.50%), methylprednisolone 2 (0.60%) and fluticasone 1 (0.30%). (Table 7, Fig 1)

 

Past medication history of steroid use:

53.7 % of the study population had received the corticosteroid treatment earlier (Table 8).

 

 

Fig 1: Pattern of corticosteroid prescription

 

Table 8: Past medication history of the steroid

Medication History of Steroids	Diagnosis
	COPD	Asthma	TB	BP	OPD	SAR	AC	DD	SC	Total
Not having	44	35	8	19	14	10	13	7	0	150
Having	69	20	8	33	14	15	11	1	3	174
Total	113	55	16	52	28	25	24	8	3	324

 

Table 9: Steroidal drug and diagnosis

Medication History of Steroids	Diagnosis
	COPD	Asthma	TB	BP	OPD	SAR	AC	DD	SC	Total
Budesonide	99	26	13	38	20	10	8	0	0	214
Hydrocortisone	12	9	4	13	6	4	4	1	3	56
Prednisolone	3	0	0	4	6	11	4	1	0	29
Dexamethasone	0	2	0	1	3	1	5	2	0	14
Betamethasone	0	0	0	1	0	0	0	4	0	5
Methylprednisolone	0	0	0	0	0	0	2	0	0	2
Fluticasone	0	0	0	0	0	1	0	0	0	1
Deflazacort	2	12	0	0	0	0	0	0	0	14
Beclomethasone	6	14	0	1	0	0	2	0	0	23

COPD – Chronic obstructive pulmonary disorder, TB – Tuberculosis, BP - Broncho pneumonia, OPD - Other pulmonary diseases, SAR - Severe Allergic Reaction, AC – Allergic Conditions, DC - Dermatological Diseases, SC - Septic Shock

Drug-disease analysis:

The drug-disease analysis revealed that five corticosteroids were prescribed for COPD in 122 prescriptions. Budesonide was the drug which was prescribed in the majority of prescriptions (99).  Budesonide was also the main drug prescribed for the management of asthma (26 prescriptions).

 

However, four other steroidal drugs, namely hydrocortisone, dexamethasone, deflazacort, and beclomethasone, were also prescribed for asthma (Table 9). Bronco pneumonia and allergic conditions were treated with six different steroids by different practitioners. Overall budesonide has emerged as the preferred steroid for the treatment of most of the ailments except dermatological diseases and septic shock.

 

Prescriber related factors:

The rationality of steroids is measured based on prescriber related factors. Out of 324 prescriptions, very few drugs were prescribed in a generic name. Frequency and dose were mentioned for most of the drugs.

 

Table 10: Prescriber related factors

Prescription Factor	Frequency	Percentage
Correctly mentioned Dose	276	85.2
Correctly mentioned dosage Frequency	312	96.3
Prescription by Generic Name	14	4.3

 

DISCUSSION:

Prescription writing is a science and an art. Prescriptions should be legible, precise, and accurate. It has to convey the course regimen to the other healthcare professionals such as the nurses who are involved in the administration of the drug, pharmacists who dispense the drugs and the patients who are the inducers. Although steroids are considered as life-saving, careful monitoring of the prescription is necessary to minimize the numerous side effects associated with them and too avoid drug-drug interactions that lead to increased patients morbidity and mortality. Rational prescriptions and timely review enhance the therapeutic efficacy and reduce the adverse reaction of drugs, but without systemic monitoring of the steroid, prescriptions may associate with numerous side effects and drug-drug interactions that lead to increased patient’s morbidity and mortality ^9,10.

 

Three hundred twenty four patients were enrolled in the study from the department of general medicines. Male patients were 63.9 %, and 36.1 % were females. The higher number of the male patient visit hospital that may explain the higher number of male patients in this study. However, Jacob et al. reported the almost equal distribution of male and female patients in their study on drug utilization evaluation of corticosteroids. More than half of the population were in the age group of the 51-60 years. Majority of this, elderly patients had COPD, asthma, and other pulmonary ailments similar observation was made by Aryal et al.^11,12.

 

Our study revealed that 46% of the patients consumed alcohol, and 32% were smokers. These are the contributory risk factors, especially in patients having respiratory ailments, which contribute to the increased use of steroidal drugs. Targeted drug delivery system such as nebulizers and inhalers, which deliver the drug to the lungs are commonly used for the treatment of respiratory disease. Interestingly 113 persons (34.8%) were admitted to hospital for COPD which are similar findings like in LiuV et al. and Zacharia et al. Of these 113 patients 32% were smokers, and 55.75% of patients were consumed alcohol these risk factors would contribute exacerbation of COPD and associated increase in the corticosteroid usage^7,8. More than three drugs were prescribed to the COPD patients, 81% of COPD patients the thereby increasing the chances of adverse reaction and economic burden. These drug included steroids, antibiotics, expectorants, etc. to manage exacerbated COPD. Like Mohamoodan et al. he also found that budesonide was most commonly prescribed drug¹³.

 

Corticosteroids played a significant role in the management of asthma. Of the 324 patients who were recruited in the study, 55 patients were asthmatics, and prescribed corticosteroids for the management of these 55 patients, 62% were females, and 38% were males. The most commonly used steroid was budesonide 26, followed by beclomethasone 14, deflazacort 12, hydrocortisone 9, and dexamethasone 2. Preferred rout of administration was inhalation⁸. In asthmatic attacks, the steroidal drugs were prescribed from parental routes. During counselling of the patients, we found that the use of inhaled steroids has increased quality of life, decreased the asthmatic episodes. We did not come across any major adverse reactions.

 

Corticosteroids are today among the most commonly prescribed medications in dermatology clinics due to its wide indications and high potency. The clinical effects are mediated by their anti-inflammatory, vasoconstrictive, anti-proliferative, and immunosuppressive properties. Out of 8 prescriptions from the dermatology department, all prescriptions contained single steroidal drug for topical application⁹.

 

We also came across budesonide inhaler and nebulisers being prescribed for lower respiratory tract infection, fever, pneumonitis, and bronchitis. Which is not recommend a line of treatment (inappropriate prescription) similarly inappropriate prescription of deflazacort for obstructive lung disease, dexamethasone for Rheumatoid arthritis were also noticed. The improper mentioning of the dose and the frequency inadequate dose tapering also contributed to the in appropriate prescription. However, most of the drugs were correct and by GOLD therapeutic guidelines and WHO therapeutic guidelines. This study reveals that the advances in drug therapy where steroidal drugs are involved have greatly enhanced the quality of life, especially in elderly patients. The study also revealed that the drugs are prescribed in brand names rather than generic. Using generic names minimises prescription and dispensing errors.

 

CONCLUSION:

From the current study, it may be concluded that steroid prescription amongst patients was under the standard prescribing guidelines. However, dosing regimen for inhalation, topical, and parenteral is remained uncertain and was found to have a different pattern of usage of corticosteroids between patients. It was identified that budesonide was the most commonly prescribed medication. This is because COPD was the most common diagnosis amongst the study population. This study also shows that despite advice to stop smoking, a large proportion of patients were still smoking. So a separate smoking cessation counselling programme may helpful to overcome these problems which are not conducted in the present study. Educational interventions among physician, patients as well as students, should be carried out to promote rational drug use. Establishment of standardized approaches for steroid usage for various indications is highly essential for the Indian set up. It may be concluded that clinical pharmacist can play an important role in the prescription audit and safety assessment of steroid medications in hospital settings.

 

REFERENCE:

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3.      Karankumar VB, Amit P. Corticosteroids and way of inflammation. Research Journal of Pharmacology and Pharmacodynamics. 2012; 4(1):45-54.

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7.      Liu V, Winthrop K, Lu Y, et al. Association between inhaled corticosteroid use and pulmonary nontuberculous mycobacterial infection. Annals of the American Thoracic Society. 2018; 15(10):1169-1176.

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9.      Gupta R, Malhotra P. Prescribing pattern of corticosteroids among the dermatology inpatients in a tertiary care teaching hospital of north India - A retrospective, observational study. National Journal of Physiology, Pharmacy and Pharmacology. 2018; 8(2)1:158-162.

10.   Wahane P, Jagtap R, Ghongane B. Evaluation of corticosteroid use pattern in steroid responsive dermatological conditions. International Journal of Medical Research & Health Sciences. 2016; 5(1):82.

11.   Jacob L, Siddiq A, Mariya A et al. Assessment of Prescription Pattern and Monitoring Adverse Drug Reactions of Corticosteroid Usage in a Teaching Hospital. International Journal of Pharma Research and Health Sciences. 2016; 4(2):1067-1071.

12.   Aryal A, Kunwar K, Shadvar S, et al. Study on steroid utilization pattern in a tertiary care teaching hospital. Indian Journal of Pharmacy Practice. 2017; 10(2):96-103.

13.   Mahmoodan M, Mahesh M, Ramdurga B. Drug utilization evaluation in chronic obstructive pulmonary disease patients. Der PharmaciaLettre.2017; 9 (6):142-151.

 

 

 

 

 

 

Received on 24.05.2019           Modified on 14.06.2019

Accepted on 02.07.2019         © RJPT All right reserved